SELECT RESEARCH PAPERS ON EVIDENCE BASED DRUGS IN AYURVEDA J

DEPARTMENT OF INDIAN SYSTEMS OF MEDICINE AND HOMOEOPATHY MINISTRY OF HEALTH AND FAMILY WELFARE GOVERNMENT OF INDIA

FOREWORD
Ayurveda is one the ancient systems of medicine, originated in lndia thousands of years back and having successfully practiced over many centuries. The unique feature of Ayurvada is it's emphasis on promotion of positive health and prevention of possible diseases apart from the curative aspects. This system has been founded and evolved on solid fundamental principles based on hypothetical approach. Many Saints and Rishis, by their extra perception and super natural power, have contributed for Ayurveda. They have documented their findings through constant expetimentations by trial and was practiced as such over centuries and error methods. Hence A y u ~ e d a stood the test of time. Since Ayurveda is becoming very popular in many foreign countries, it has become the need of hour to prove A y u ~ e d a treatment as safe and effective confirmed by scientific trials, clinical and experimental. In India, such trials are being conducted in many Govt. Institutions like Central Council for Research in Ayuweda and Siddha, Banaras Hindu University, Oujarat A y u ~ e d a University, National Institute of Ayu~eda,Indian Council of Medical Research, 1\11 lndia lnstitute of llledical Sciences, Defence lnstitute of Physiology and Allied apart from many private Sciences and Post Graduate Colleges of A y u ~ e d a organizations and drug industries. I am very glad to place this compendium of 29 such research studies conducted on five areas i.e. neuroactive drugs, immunomodulators and adaptogens, antiarthritic drugs, hypolipidimic agents, Kshar S u t r a a specialized Ayurvedic surgical procedure for the management of piles and fistulain-ano and finally some general research articles. These research papers quickly and randomly collected by the Department of ISM 8 H , represents a sample of voluminous research work carried out in lndia with international parameters as per the W O guidelines. H I hope this compendium will be of much use for the reference to the scientists, scholars and researchers as well.

Date :0152001 Place: New Delhi

(Dr. G. Veluchamy) Director, Central Council for Research in A y u ~ e d a and Siddha

INDEX

SL.NO.

TITLE OF THE STUDY

PAGE NOS.

I
1.

NEUROACTIVE DRUGS

I
I

A Double Blind Clinical Trial to Objectively Evaluate the Efficacy of a Herbal Preparation on Memory

2.
3.
4.
5.

I
Neuropsychopharmacological Effects of the Ayurvedic Nootropic Bacupa monniera L ~ M . (Brahmi)

12 19
I

I
I

. I

Role of an Ayuwedic Drug Brahmi (Bacopa rnonnieri ) in the Management of Senile Dementia Role of an Ayuwedic Drug Brahmi (Bacopa rnonnieri) in the Management of Senile Dementia The Effect of Mandookparni (Centella asiacita) on the General Mental Ability of Mentally Retarded Children

25

31

I
6.

I
Short Communication - Antistressor Effect of Wiihania somnfera A Double Blind Study of the Effect of Mandookapami on the General Mental Ability of Normal Children
45

I
7.

I
48

IMMUNOMODULATORS AND ADAPTOGENS
8.
I

Adaptogens in High Mountains
I

54

9.

Membrane Integrity Changes at High Terrestrial Altitudes (with Geriforle - Himalaya)

61
I

1

I

10.

1I Endurance Enhancement in Adverse Environment
A Clinical Study on the Role of Amalaki Rasayan in the Management of Subadusti with special reference to Asthenozoospermia Effect. of a Composite Indian Herbal Preparation on on&! Effectiveness in Low-intensity-conflict Operations Enhanced Thennogenesis in Rats by a Composite Indian Herbal Preparation -I and its Mechanism of Action

67
7b

11.

I

1
-

1

12. 14.

78

92

ANTI-ARTHRITIC DRUGS

15.
I

A Pvliminary Controlled Clinical Trial of Indigenous Conipound Drugs in Cases of Rheumatoid arthritis
I

99
108
I

16.
I

Eff~cacy of Rhumayog and Rhumayog with Gold in Rheumatoid arthritis - A Double Blind Study Study of Ayurvedic Drugs in Rheumatoid arthritis Compared to Auranofin Open Study to Evaluate the Efficacy of Sallaki as an Addon Therapj along with NSAID in the Management of Patients with Osteoarthritis Double Blind Randomized Controlled Trial of Sallaki (600 mg) vs. Diclofenac (50 mg) in the Treatment of Rheumatoid arthritis

17. 18.

120 135

19.

160

HYPOLlPlDAEMlC AGENTS

20.

Guggulipid : a Promising Hypolipiadaemic Agent from Gum Guggul (Commiphora wighlii)

189

I
!I.

Commiphora wightii Engl. (Gum Guggul)

KSHARASUTRA
22.

Multi-centric Randomized Controlled Clinical Trial of Kshaarsootra (Ayurvedic Medicated Thread) . in the Manigement of Fistula-in-Ano

229

I
2%

Treatment of Fistula-in-Ano by a Medicated ThreadKshara Sutra Treatment, Review and Follow-up of 182

I

238

GENERAL
24.

Pharmacology of Medicinal Plants and Natural Products Pharmacology of Medicinal Plants and other Natural Products Pharmacology of Medicinal Plants

25 1 289
31 7

25.
26.

27.
28.
I

Vijaysar, Pterocarpus marsupium in the Treatment of Madhumeha (Diabetes mellitus I - A Clinical Trial Flexible .Dose Open Trial of Vijayasar in cases of newlydiagnosed Non-Insulin-Dependent Diabetes mellitus
I

356

363

29.

Managing Morphine-Induced Constipation : A Controlled Comparison of an Ayun'edic Formulation and Senna

369

~UROACTIVE: DRUGS

AIM : The aim of the study was to evaluate the efficacy of a polyherbal formulation on the essential components of memory METHODS : A double blind, randomized, placebo controlled parallel group study was undertaken in normal human volunteers to evaluate the efficacy of this formulation. The individual ingredients of each are known for their effects of cognition. The treatment was administered for a period of 35 days. Various parameters which were used to evaluate memory were Sensory Perception (SP), Centrd Integration (CI) and Sensorimotor Co-ordination (SC). Tests used for SP were D2 cancellation test for SC were Choice Reaction Test (CRT) and V i s b l Reaction Test (VRT) and for CI were Immediate and Delayed Verbal Recall (IVR & DVR), Figure Recognition (FR), Digit Span (DS) and Critical Flicker Fusion Frequency (CFFF). The computerized tests were developed in the ~ e ~ a r t r n e n t Pharmacology. Grant of every Medical College, Sir J. J. Hospital, Mumbai. Volunteers first under'went tra~nfng two or three days to get acclimatized to the above test battery. The tra~ningwas provided in the period of two weeks prior to study. They were evaluated on a weekly interval till the end of 5 weeks. This study showed interesting results in terms of objective evaluation and cognit~on

RESULTS : Detailed results will be discussed CONCLUSION : The preparation had a stimulant effect on detection percepbon and recognition of stimuli which made the volunteers more alert and Improved thelr concentration. It had beneficial effects on many essential aspects of memory

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS

and 7 60 %for Figure Recognition. Day 7. 70% for Immediate Verbal .e. Day 21.o To evaluate the efficacy of the preparation containing five herbal ingredients in improving ones memory To study the effect of the combined formulation in a setting where its effect on the essential components of memory as mentioned below were studied. The training was continued tlll the Individual scores for each test reached a plateau and showed no further increase. placebo controlled parallel group study TRIAL SUBJECTS: Medical students' 18-22 years of age NUMBER OF SUBJECTS: 10 in each group INCLUSION CRITERIA Medical students of age 18 years and above of either sex EXCLUSION CRITERIA Subjects who are smokers alcohol~cs are on any other drugs or Subjects wlth end stage renal d~sease hepat~c or disease Sublects with underlying d~sorders l~kely affect the lnterpretatlon of the trial results to lmmunocompromlsed or pat~ents wlth dlabetes meliltus METHODOLOGY Subjects recruited in the trial underwent trainlng 2 weeks prlor to the study day. The volunteers underwent the same tests every week i. Day 0. Day 14. > 60 %for Delayed Verbal Recognit~on Volunteers having a score less than the above values in any singie test were not included in the study. Day 28 and Day 35 respectively. for every 2-3 days for acclimatizing to the test-battery. Recognition. The cr~teria which were used before randomizing the volunteers to receive either of the two treatments were that their individual Score should be. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 4 . + + + Sensory perception Central integration and processing Overall sensorimotor coordination TRIAL DESIGN: Double bllnd. random~zed.

MEMORY The followng tests were employed to evaluate memory IMMEDIATE VERBAL RECOGNITION (IVR): The volunteers were subjected to a series of meaningful words on the computer screen at a speed of one word every three seconds. Five such series were given totally with 50 total digits. The volunteer was then asked to press YESlNO key to indicate whether the word was shown before or not and the score was given. immediately after which 24 similar looking or sounding words were displayed which included 12 previously shown words. based on the number of correct answers with a maximum score of 24. FIGURE RECOGNITION (FR): The volunteers were shown 12 geornetr~calf~gureson after the computer screen at a speed of one figure every three seconds lmmed~ately whlch 24 figures were d~splayedwhich Included 12 previously shown flgures The volunteer was then asked to press YESlNO key to indrcate whether the f~gurewas shown before or not and the score was given based on the number of correct responses w ~ t h maxlmum score of 24 a DIGIT SPAN (DS): The volunteer was asked to listen to a series of 10 digits played on an audiocassette recorder and immediately recall the digits in the same sequence. The number of correct digits wa$ considered to be the total score. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 5 . DELAYED VERBAL RECOGNITION (DVR): The volunteers were subjected to a serles of meaningful words on the computer screen at a speed of one word every three seconds. 20 minutes after which 24 similar looking or sounding words were d~splayed which included 12 previously shown words. The volunteer was then asked to press YES/NO key to indicate whether the word was shown before or not and the score was given based on the number of correct answers with a maximum score of 24.

Visual reaction test is carried out taking into consideration the number of correct entries and the time taken in seconds to complete the correct entries. reduced starting at a higher value till the light source appeared to be fl~cker~ng This was taken as the decreasing readings. following which a serles of digits were displayed rapidly and the volunteer was asked to press YES every time the displayed digit appeared on the screen. The volunteers were asked to press the respective numbered key for the respective circlelcolour. After 10 seconds helshe were asked to cancel the ds in the next line. This was noted as increasing reading.2. Numbers 1. Similarly the frequency was slowly again. 14 such lines were completed and the number of d" and d. CHOICE REACTION TEST (CRT): Red. Helshe was asked to cancel the number of d2s in a specific l~ne 10 seconds. cancelled would determine the total score of that volunteer. Mean of the reaction time was displayed on the computer screen as CRT.ATTENTION TASKS VISUAL REACTION TEST (VRT): A digit was displayed .in seconds to complete the correct entries. CRITICAL FLICKER FUSION (CFF): The volunteers were subjected to a particular light source of fixed luminosity flickering at a spec~ficfrequency. The test was carried out till the marked digit appeared 10 times on the screen. D2 CANCELLATION: The volunteers were given a chartlsheet containing ds and ps with one or two commas or apostrophes attached to the particular alphabet in a random in order. yellow and green coloured circles were displayed on the computer screen. The mean time taken was displayed on the computer screen and considered as visual reaction time. the three coloured circles will be displayed in a randomized fashion. Totally 25 such circles were displayed. SELECT RESEARCH PAPEHS ON EVIDENCE BASED AYURVEDIC DRUGS 6 . Choice reaction test is carried out taking into consideration the number of correct entries and the time taken. The frequency of the flickering was increased and the investigator was asked to note the frequency at which the volunteer could no longer perceive the flickering and found the source of light to be stationary. Thereafter.3 were displayed below the circle respectively.on the computer screen.

To get the volunteer accustomed to the various test batteries involved 2. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .EFFECT OF LEARNING ON THE TEST BATTERIES 45 U Y) 25 z 10 0 Sessmn 1 Session Sesvon Servon Session 1 2 3 t1VR-m-DVR+FR+DS 4 1 Sessmn Sesslon 3 2 Sesslon 4 t V R T CE +D2 -+CFF 1 ~ 2 ~ )Z E P z / E L R l 1 The preliminary experiments were performed with 2 objectives: 1. To get the maximal reading as the plateau reading following which the volunteer cannot improve further SENSORY PERCEPTION D2 CANCELLATION TEST GRP ~ ~ PLACEBO GRP ~- ~ ~~ ~- p~~ ~ PLACEBO GRP UTEST GRP fls: NONSIGNIFICANT DIFFERENCE FROM PLACEBO * : SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0.001.

IMMEDIATE VERBAL RECOGNITION (IVR) DELAYED VERBAL RECOGNITION (DVR) FIGURE RECOGNITION (FR) PLACEBO GRP SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 8 .CENTRAL INTEGRATION CRITICAL FLICKER FUSION The test results did not show any statistically significant ~mprovement CFF at the end in of the study in both placebo and the treatment group.

: SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0. : SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0.n Tuc n r V n ** *** SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 9 .004. referred to as Visual Reaction Ratio was calculated to determine the exact time required by the volunteer to complete the maximum number of correct entries.SIGNIFICANT DlFFERFNCF cD".005.DIGIT SPAN (DS) TEST GRP PLACEBO GRP ns : NON-SlGNlFlCANT DIFFERENCE FROM PLACEBO * ** *** a : SIGNIFICANT DIFFERENCE FROM THE DAY o SCORE AT PC 0.01. A T Dc n n17 . : SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0. VISUAL REACTION RATIO ' w w 150 0 100 z 50 0 TEST GRP PLACEBO GRP 2 I IlS : NONSIGNIFICANT DIFFERENCE FROM PLACEBO : SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0.03 SENSORIMOTOR CO-ORDINATION VISUAL REACTION TEST The ratio of v~sual reaction correct entries 1 time.001.

CHOICE REACTION RATIO ns : NONSIGNIFICANT DIFFERENCE FROM PLACEBO : SIGNIFICANT DIFFERENCE FROM THE DAY 0 SCORE AT PC 0. DAY 21 AND DAY 28. referred to as Choice Reaction Ratio was calculated to determine the exact time required by the volunteer to complete the maximum number of correct entries.037 * ANALYSIS OF DATA All the above results have been analyzed by using the following statistical tests: 1. DAY 14. Within treatment group paired T Test 2. Between treatmenl group: T test Results displayed are only of DAY 0 and DAY 35 although the test were carried out in the interim perlod I e DAY 7. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 10 .CHOICE REACTION TEST The ratio of choice reaction correct entries I Choice reaction time. The tests were repeated in the interim period to ensure that the volunteers would not forget the tests once acclini=tized to it.

concentrationand reaction.It was found that this comb~ned preparation has some interesting findings: The preparation has a stimulant effect on detection. DVR. which is the basis of most skilled behavior especially. This made the volunteers more alert and their concentration improved. attention. perception and recognition of a stimulus. It was found that when a ratio of correct entries to time was calculated the ratio was found to be statistically high thereby indicating its effect on memory. For the sensorimotor coordination. However as of now we claim that the effects seen from the combined preparation are helpful in acquisition and retention of memory and affect all the aspects of memory.e CFF showed no effect. - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . we have used CRT and VRT. FR) the better used parameters of this test for effect on central integration i. From the above discussion we can claim that the combined preparation has a stimulant profile and a beneficial effect on all aspects of memory. Although the preparation showed improvement in short term memory and learning (IVR. We studied not only the reaction time but also the number of correct entries as we felt both the components were essential for indicating memory. attention and reaction. not only for a short span but also enabled them to maintain their concentration for a longer period of time as shown by the D2 cancellation test. A lot of work yet remains to be done to elucidate the mechanism of action of the preparation and further studies are yet warranted to further our results. The tests used for detecting the effect of the preparation onthe central integration and processing aspect showed some conflicting results. recalled information.

India.D. The hypolipidemic agent is being marketed. An infusion of the plant has also been used in Indian folklore as a nerve tonic3.N.). have found that !he alcoholic extract of the plant and chlorprornazlne improved the performance of rats in motor learning. which has been in use since times immemorial as nerve tonic for improvement of memory. acldvc cond~t~oncd between an averslve (LICI) and oalalable ftu~d fsucrosc) In the condilioncd taste aversion ICTAI resomse. hepatoprotective. The authentication of the traditional claims ol brahmi was initiated by investigating the effect of an alcoholic extract of this plant on acquisition.dcpendenl lacrlilationof discretion response. The etiology of the mental disorder according to Carak is a combination of anxiety. Jal Neem) (Family : Scrophulariaceae).. SINGH.of the whole plant exhibited tranquilising effects on albino rats and dogs. Based on the medicinal properties of selected plants as described in the Ayurvedic texts. our Institute has in recent yeats developed several drugs for refractory diseases lor which' no effective remedy is available in the modern system of medicine.lndian Journal of Pharmacology 1997. Correspondcncc: B. Bacosides also altenualed the' retrograde amnesia produced by immobilisation induc'ed sires. the first clear reference to its CNS effect is to be round in Carak Samhifa written in the tst century A... Susrutu Samhita describes brahmi as efficacious in loss of intellect and memory.Ved (C 800 B. it has been frequently mentioned in the religious. Another promising lead thus obtained is the confirmation of the traditional claim of Bacopa monniera (Linn.N.0.e. Bacopa monmNeraLinn.C. weak intellect and lack of concentration. macrofilaricidal agents etc. Another authentic Ayurvedic treatise. social and medical treatises of lndia since the time of Alhar . x 3d) was manifest in all. The facililatory effect of Ihe brahrni extract (40 mghg. Bacopa monniera is a perennialcreeping plant found throughout lndia in wet.K. where Brahmi is prescribed as a cure for menlal disorder (retardation) leading to insanity (10:62). These include hypolipidaemic. consolidation and retenlion in the shock~molivated brightness discrimination avoidance responseand produced a dose. Dhaw SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 12 . Aithal and Sirsis found that the alcoholic extract. active conditioned avoidance response and Sidman conlinvous avoidance response. conroliation and relentinn of Wee newly acquired behaviourd responses in albino rats. viz. and to a lesser extent the aqueous eXtraCt. They also enhanced protcin kinase octivily and produced an increase in protcin in hippocampus. Malhotra and Das reporled a sedative effect of glycosides named by them as hersaponins. The bacosides significantly improved the acquisition. (BRAHMI) H. a foot-shock motivated brightness discrimination response. Bacosides \. 29: S359-5365 NEUROPSYCHOPHARMACOLOGICAL EFFECTS OF THE AYURVEDIC NOOTROPIC BACOPA MONNIERA LINN. the science of life..) HBLK) (Hindi: Brahmi. B. p. has provided a rationale basis for treatment of various ailments. Although. ECS and scopdamine. ~rakash and Sirsi6./Th8 plant has been investigated in several Indianlaboratories forits n e u y pharmaacological effects. DHAWAN Central Drug Research Institute.) Pennel (Syn: Herpestis monniera (Linn.!h8 three learning responses as it augmented both the cognitive function and mental retention capacity. SUMMARY Lucknow . The chemical constituent responsible for the tacilitatory eflect of b r a w l on learning schedules was identified as a rnixture of hvo saponins designated as bacosides A and B. Ayurveda. (Brahmi) has been used since times immemorial as nerve tonic fW improvement of memory. damp and marshy areas.rere also lound to be sale in requlalory pharmacolo~ical and toxicological studies and wcce well tolerated by normal healthy male human votunleers in single dose (20-300-mg) and multiple doscs f1OO and 200 ma\ administcred lor 4 ceceks in double blind olacebo controlled an3 non-crossover KEY WORDS Nsolropic Oacopa monniera bacos~des Brahrni Biological evaluation of plants based on their use in the trad~tional systems of medicine is a sound and cost effective strategy to develop new drugs from Since time immemorial. i. on the other hand.226 00(.

have used GRT and VRT We studled not only the we react~on t~me but also the number of correct entr~esas we felt both the components were essential for ~nd~catlng memory. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 11 . However as of now we claim that the effects seen from the combined preparation are helpful in acquisition and retention of memory and affect all the aspects of memory. recalled lnformat~on. This made the volunteers more alert and their concentration improved. A lot of work yet remains to be done to elucidate the mechanism of action of the preparation and further studies are yet warranted to further our results. concentration and react~on It was found that when a ratlo of correct entrles to tlme was calculated the ratlo was found to be statlstlcally h ~ g h thereby lnd~catlng~ t s effect on memory.It was found that this combined preparation has some interesting findings: The preparation has a stimulant effect on detection. attentlon and reactlon From the above discussion we can claim that the comblned preparation has a stimulant profile and a beneficial effect on all aspects of memory. Although the preparation showed improvement in short term memory and learning (IVR. attentlon. CFF showed no effect. perception and recognition of a stimulus. For the sensorimotor coordination. not only for a short span but also enabled them to maintain their concentration for a longer period of time as shown by the D2 cancellation test. The tests used for detecting the effect of the preparation on'the central integration and processing aspect showed some conflicting results.e. whlch the bass of most skilled behav~or IS espec~ally. FR) the better used parameters of this test for effect on central integration i. DVR.

The M n g consisted of 40 trials. whichever even1 occurred first. h direction of alley illumination was changed after n Wery 3 triak to avoid position discrimination. the change in the direction of alley illumination. Barnrides pre~reament m )leads toan improved rclentipn as compared to !he canlrols (Dl. x 36) on immob~!~ml~on . i.' 0 . were used lo.. and the first run alter.O.e the dillerence between RR (positive responses during relearning) and TR (posilive responses during training).however.10 run into the illuminated alley 01 the chamber to avoid an loot-shock (I mA) given in the dark alley.n alolno rah lraining (Ts) and relearning (Rs). Number of negative WS.NEURWSYCilOPHARMACOLOGY O F BACOPA MONNERA 5360 fisure I Eneclol Dacorider (20 mg*g. the rat ran immediately into the lighled alley in the last run prior to.i.O.01 ( a s compared 10 31 Sinha7 has repofled that a single dose 01 the glyaside hersaponin is bePer than pentobarbitone in facilitating acquisition and retention of brightness discrimination reaction: It is d~llicult. -. . f a ) . induced amnEria. The results obtained from the relearning lest were also analysed on the basis ol increase in posit~ve responses during relearning (&R). Retention was tested 24 h aner training using a relearning procedure similar to the training procedure. expressed as per cent of the former: Percent Savings = Ts-Rs x IOOTTs. Rals were trained.eat.) which was also given in com5 bination wilh the unconditioned stimulus (loot shock 01 I mA) for lurlher 1 s. 0 1 compared to 1) . . p. In the active conditioned avoidance response. which was the second learning schedule. po. consol~dal!on and relenlnon ol href newly acqulred behavioral responses . A response was considered to be positive wher.calculate percent saving which was the dillcrence bctween the two. The lirst learning schedule was a l w t shock mobaled brightness discriminafion reaction in a semit i c Y-maze. A tone 01 50 Hz was used as a conditioned stimulus (presented for 1 sec.d by invest!galng its ellect M the acqu sltlon. Ihe number 01 shocks received during SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 13 . the rats had to jump on a wooden pole l o avoid a loot-shock. l o Merprel these results fn the context of the available known traditional claims. Therelore the evaluation of the traditional claims ol brahm was in. ( Anmeria induced by immabilirason (m)is anenualedby bacoride.O.e.01 far compued lo ~ far 3 ~ I p.01 la$ compared lo 3) 4) 00 p. The trial ended either aller 5 the animal responded by jumping on the pole or afier 30 sec.

0. The ?nsemble. when no avoidance behaviour occurred. a . OHAWAN Figure 2.e: in.hock i. A support dose of 40 mgkg p. In the conditioned avoidance response. p. vas assured between avoidance behavior and shock and another interval of 1 see.S3G1 H.K. 3 days prior to commencement of experiments. Thus a minimum intewal of 25 sec. (as (as (as (as compared compared compared compared to to to to 3) r 70 SAVINGS 1) 4) 3) ihe third learning schedule was the continuous -ivoidance response as evolved by Sidmang. once daily for SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 14 . and well trained ani:nals respond repeatedly by lever pressing at a starate to avoid shocks. The brahrnitreated animals also showed signilicanlly improved retention as evp dented in the delayed extinction. the retention parame1ers. . - The effect of the extract on the acquisition. time per response. Similarly in the re-learning test. Ellecl ol bacos~der (20 rngkg. number of positive trials and number of positive responses as compared to control.e.he procedure extracted 2. The alcohol was evaporated under reduced pressure and the 2xtract was suspended in water using 10% gum :cacla.e. crease in posilive responses and percent savings .:oved O( ) retenlion as cnmpared lo the controls ( 0) The ECS induced amnesia ( is anenua:cd b bacosides ( y B). Brahmi sip nificanlly facilitated all the temporo-spatial panmeters of the acquisition. of the brahrni treated animals were significantly higher than the controls. earnsides preVeamenl( H )ieids to an im. 1heexperimental group also learned \he avoidance reacton -he air dried Plant material was powdered and a :Ot alcoholic extract (90% ethanol) ws prepared.6% material on fresh ?\ant basis (20% on dry plant basis). The training comprised daily session of I h (Monday Friday).for the present investigations. between shock5 . i. SINGH /\NO B. JO other contingencies between avoidance behav3ur and extetoceptive stimulation were involved. consolidation and retentionolthe newly acquired ness behaviour was judged by changes in re-learning and The facilitalo~effecl the brahmiextract was man(ol lest in the training (acquisition) itself. with lever ?ressingselected as the avoidance response. The experimental groups received the exmet in a dose of 40 mgkg orally. x 36) on ECS induced amnesia. It is 1 relatively easy task for rats. was proirammed so that each leverpress delayed theshock 3r 25 sec. every allernate day was given in all experimentsexceptin the brightness discrimination reaction.N.i.0.

effect of brahmi extract is manifest both in facilitating the cognitive function and augmenting the mental retention capacity. z a. Ellecl of bacorides (20 mgkg.01 (as compared to 4) 0 v v p. n m)leads to an improved retention as cumparod to the controls ( T e chdinolylic scopolamine caused amnesia ( 5 ). The experimental animals evidenced conditioned response after 6 days.Ol (as compared to 1) . we have investiaated the mnemonic effect of the mixture of these two-saponins.increase was accompanied by a progressive decrease in the number of shocks received. This facilitatory effect was manifest also in the significant increase in number of positive trials both during training and relearning.01 ( a s compared to 3) more quickly than the controls. a tified compounds included two saponins designated as bacosides A and 0. 1~. the next logical step was to identify the chemical constituents tor this activity. and bacosides abolished il (m). Similarly. p*O.lACOLOGY OF BACOPA MONNIERA 5362 figure 3.o. The . in the Sidman's avoidance response.0. pa. rats required significantly less The bacosides time to perform the trial both during training and relearning. given for three days produced fa0 on the training pedormance in the cilitatory Shock motivated brightness discrimination reaction.01 - l a s compared to 3) 00 o. whersas the control animals took more than 1 davs. in the a+ve con- The results of the investigation using these three learning schedules clearly indicate that the . the brahmi treated rats showed a successive increase in the number of lever-pressing responses which was statistica!ly significant from the controls. SAVlNGS = 80r . used as aqueous suspension in several learning schedules13 The learning schedules used were shock motivaled brightness discrimination reaction and active conditioned avoidance response.NEUROPSYCHOPHARI. 0 Likewise.0.. x 36) o scopolamine induced amnesia. Having conlirmed the traditional'claim. which W s agaln significantly lower than the controls. The mixture of these two saponins in a dose of only 1 mgkg p.31 pc0. h Eacoridcs prolreaimenl ( ) a/. Since these saponins were the major chemical components ol the plant. as described above and conditioned taste aversion (CTA) response.' ~the idenand -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 15 . The percent savings was also significantly higher for the bacosides treated group. Several chemical comPWnds had already been i ~ o l a t e d ' ~ .

15 LiCI (1 m11100g body days) and in between these exists an intermediate weight). The bacosides are thus markedly effectivein increasing the probabilities in a variety of responses.K. In the CTA response. SINGH AND B. . all rats started drinking immedialely afler presenlalion. i. of 20. Congruent lines of evidence have pointed instead to an intricate. viz. An important prerequisite of stationary retrieval condition is that prolonged testing dces n3t cause CTA extinction. cosides A and B are the actual constituents which have lacilitatory effects on bothmemory and learning in a wide variety. The amount of each 24 h relearning test also produced a significant em hancement in the relearning index's. them simullaneoulsy to two drink spouts. male rats were kept in individual cages containing openings for two 30 ml Richter tubes with 0.^ motivation of the animals to avoid the aversive concenlratlons eilc~ting moderate gastrointestinal dlsorder after the ingestion of a few ml of isotonic solution of LiCl (0. apparently due to their abili!y to consolidate the The bacosides produced a dose-dependent efretention at the earliest form. The group V was deficits apparently occur at points where the lablie exposed only to the experimental environment and phase of one memory overlaps with labile phase not totheaversive fluid withanobject of investigating of the other memory The bacosides i n a dose. Each was allowed to drink tap water for I h only every morning..5 mg!kg) ol bacosides and at least. tistically significant increased intake of sucrose sG lution. But memory formation is not a direct flow of neuronal activity from short lerm to long term storage.0 h training at .0. required significantly less time l o jump on the wooden pole as compared to controls after 7 days.ld long-term (few hours to I-IV were intubaled with 0.5 m g k g doses resuliing in a sla. multiphasic palhway of consolidation. at 1. A single exposure to LiCl was sufficient form of memory (few minutes to hours). This is significant as lhe bacosides facilitated the responses which are susceptible to the effects punishment as well as reward. the mgestion of vrhich leads to undesirable side effects (moderate gastrointestinal disorder). i. viz.e. The effect ol ba.5 ml gradations. each subgroup (excepl the control) in a shock motivated brightness descrimination rea received oral administration of bacosides in doses action abolished these deficits when relearning W s similar tothose prior to LiCl exposure. in this experimental model.e. Thirty minutes done at various time intewals after training.15 M) can servo as a combined CS (sal:y taste) and US (symptom of poisoning). it was presumed that I-V) of 9 rats each. Two days later.ning inlerval..e. short-term and long-term. -relea. there are pep were immedialely presenied wilh a novel 10% su. These results solution consumed by ihe individual rats during the suggest that the lacilitatory effect of bacosides are following 30 min was recorded. given every alternate days. short-term (few crose solution for 2. Essentially memory exisls in two forms. cosides is manifest both in negative reinforcement (shock -motivated brightness discrimination reaction and conditioned avoidance responses) as well as positive reinforcement (condilioned lasfe aversion). The hvo to elicit the aversive response. A trained rat rapidly finds the sucrose containing spout and starts drinking therefrom. The hypothesis was tested in the foot shock motivated brightness descrimination reaction in the Y-maze and it ivas found that the retention curve instead of being Vshaped was W-shaped.N. Both these forms starl simullaneousl)~ and a deficit in retention curve is obtained at a poinl where these hvolorms overlap. the other containing an aversive lluid Lithium Chloride (LiCI). i.The facililatory effect of bacosides persists eve" SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . HI.5 . After the stabilisaiion of licking.7.5 h and 4. Therefore. A feature ol memory formation across the animal kingdom is its progression from short-lived labile form lo a long lasling slabte form. sucrose is suddenly replaced by the aversive LiCl fluid by exchangicg the position of the spouts. of responses. The results of these investigations confirm that ba. OHAWAN dttioned response.. Ninty minutes later group secondsto minutes)". subjects were presented with dose of 1 mg!kg p.0.. These rats were lesled in exposing the gustatory discrimination a p p a r a l ~ s ' ~ . short-term memow fect wilh 5 and 7.haps three forms of memory. A SUP* 0 after administration.S363 H. there were deficits ocThe rats were randomized into 5 qroups ( G r o u ~ c u r r i n ~ two points.5 min. Each group was treated with graded doses (2. mglkg p. bacosisdes treated animals in 0 a dose of 1 mg/kg po. on the capability of rats to avoid a novel lood or liquid. The rals had adlibitum access to food pellets. when given 30 min prior lo trainlng the elfectof bacosides on non LiClexposed animals. given 30 min prior to the sucrose and LiCl solutions. The CTA test 1 based s . After a few exposures. one delivering sucrose.

. REFERENCES I. After obtaining the approval of the Drug Controller (India). :. While most of the arnnestic agents used induce retrograde amnesia. Par: 111 . 5 . ad? a! tllc 6:mn tnd.~l induced by scopolamine is not total... Ohaaan BN. a Cholinergic receptor blocker.2:1.NEUROPSYCHOPHARl. Some empirical behavioral data indicalive 01 concomitant bio-chemical reactions.flc tilD National lr:l. For instance. Rocki. 7. Electroconvulsive shock (ECS)..oia.. This treatment caused 3 significant impairment of the retention in rats and the attenuating effect of bacosides is manifest when the experimental group is prelreated with a dose 0 20 rnglkg p o . serotonin. ~ ~ - ti. Avoidance condilioning wilth b r ~ eshock arld l no exteroceptive warning signat. In order to have comparable ii1formation.lli HcaIl>.... IAilalI~otla Das PK. 0. 1. and toxicdogical studies. r... -?.' c > . a k. Similar 8. and rctrograde amnesia was produced in rats by 2n im. The bacosides pretreatmen: signilicantfy attenuated !he amnestic elfects of these treatments as shown in Figures 1 snd 2. 3.. i t was found that scopolamjne (0.l'lj6.) Both Ihe treatrncnts viere admirlistered immfdiatsly after ihe completion c l tlainir. Prmeedings of the 58th fndian Science Congress.iu:e of h!s-. acetylcholine or NMDA receptors.n I-! .202. The trial was double blino placebo controlled and noncrossover.118:157-8.9.rilr In. 3:--.. ".mobilisation stress administered for 1 h. 1993'197.i~-l. 2 p>.7.. (arahmi]. 1971. for three consecutive days (Figure 1 31 chanois were also observed in h ~ ~ O t h a l a m u s anti cereb. and Nou. Nalion~llr5i.stering ECS (0.l. : . there are others which cause temporary amnesia. . Furlher biochemical sludies have indicated lack of effect ol bacosides on catecholamine. COCIIIO. Indian J Cherrl 1~67:s a4-6.oii tier.ii~ R. the imPairme. . Dhai ML. Sidman M... J Sci lndusf Res 19G2:21:93-6. hypoxia disrupts intermediate memory specifically when administered immediately after trainingI6.n:#fic In. 8. tt. 3 L . .. Bas" N.e experimental protocols were kept uniform. slvdiesaf Herpeslis nilnniera Linn. . SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .. Cno. . Che:ii~catexaminallon a: Sacopa molritera Wcllsl.. Glcssa. . as measured by % savicgs in the relearning test performed 24 h after tne cornpl-lion of training.ia IC. <j.32. Y\o51m.sciencer.42rii:inaI PIan:r Nsw Sc!I>i Councl! ot Sci~.. 4 .macotogicirl mv6st~gat. The training scii~. 1395105. it appears that memory consolidation involves both serial and paratlet processing of information. The bacosides in single dose (20-300 mg) and multiple doses (100 and 200 mg) administered for 4 weeks were well tolerated and were devoid of any untoward rcaction or side effects.p.: . . J ~ f h . 5OHz. or by 8 aamin. disrupted through administration of a wide variety ofamnestic agents.. ..5:?05-14.!~\COLOGY OF BACOPA MONNICRA 5364 hen the other two forms.5':" . .* -~ Re$i:i. . hypothermia and hypoxia are some of the non in"asive procedures which induce retrograde amnesia. Sirsi M. Therefore. Comparallve s1ud. Sinha MM.5.:: . Raslogl R?. .. and du'rtnai R~scaic5. . Under our experimental conditions..tule Menof IJI He3::h. Singh HK. 5)1 S.. intermed~ateand long term memories occur. rnemory can be.5 mA.: -..f ol [he eltecls 0 : Brahmi (Bacopamonniera) and chlorpromazineon rnolot learning in rats. Plia. Scicnce 1953.t " .?lly ncrin3 agents from Indian p. A1th21 HN. i d .63 mg!kg i.) al tnd:an r..al corlex.: . :. Prakash JC.. Pmnesia was also proddced with scopclamine.t *-.htl~lily V.s . .. r .-. During the penod of consolidztion. x 3 d.illc ti:@.) when administered I before relearning produces amnesia and the retention is disrupted. 10.. no~harmacal 1982. disrupts intermediate rnemory when applied before trainingI6. ?harmacolog. Sirs.. The amnestlc treatments ied to a significant disrup!ion of consot~s'ationin control groups.?':". EHect ol Bacopa monnicra Linn. Indian J Msd Res 1459:47:234305.. diethyldithiocarbamate.. an inhibitor of synlhesis ol noradrenaline.<.h in h:Cn131 H i a l ! ~ ? d IJcilrost rnces.. 6. Dhawan EN. The bacosides enhanced the pro:?in kinase activity !"ippocampus. (26%) OCCl.5 sec.3cosides were used in a dose of 20 rngikg p o .. N3y2i SL.-. . ' 3.a~USARcscn:ci~ tn Mcnlal HcaII!... (Brahmi) exlract in avoidance responses in rats. Phase I clinical trial in single and multiple doses were conducted in male human volunteers. Chowa RN. They a'so jnduced an increase '0~:lIein and serotonin and lowered the no'epinephrine level in the sams region.B2coside 5. 4.duIc used v!as a b:ightfiess disci:mlna!ior~ reaction. Rocki. :>.20. Unl~kethe amnesia caused by other pha:macological agents. icd J D1~arm~:y 1961:23:2.. Similarly.. 1.~cat CL. The bacosides were also found to be safe in regulatory pharmacological. Ceo:r. an pc5:is rnlnn. .

Chemical Cxaminalion 01 &.82. cha~erjen Raslogi RP. Pan-l lsdalion ol Chemical ~onsliluenls. Indian J Chem 1965. s hemsbviJ 1979:28:537-45. Rarlogi RP.ohawanBN. OHAWAN 11.7. Singh HK. SlNGH AND B.2093-2096) has shown that caloric restriction slows the age-related decrease in amounts 01 a naturally occurring steroid hormone. Phyiolherapy Res 1988:2:70-75. Orozck G. October. Dhawan BN. No. Buressova 0. Vol. 1992:189. ieds). . Tully T Disseclh memory lormatian: from behavioral pharmacology lo lecular genelics. Chaltorice N. 14.cop monniera Wcltrt. Srimal RC.202. A second study (J Clin Endocrin Metab.5. Roy Verdew at the Arizona Center on Aging shows that a 30 percent reduction in calories in a monkey's diet leads to elevation in good cholesterol (HDL2B) levels with a subsequent reduction in risk for cardiovascular disease. 16. Dhar ML. 36.N. It is demonstrated for the first time that caloric restriction c a n lead to changes HDLs and other lipid profiles that may be associated with health benefits. in - --- -- . One new study ( A m J Physiol. 1997.Buros 1. Trends in Neurosciences-1995. Dwgs anecting learning ory In: Tandon PN. 12. DHEA. Dhar ML.Chemical examination N. 4) from the National lnslitute on Aging (NIA) and Dr. PhysiologiCa .K. Enecl 01 bacosides A and B on avoidance responses in rals. Using natural DHEA levels a s a biomarker of aging may assist scientists in their search for a w a y to slow down the aging process. Qwled b y OeZazzo J. Wadhwa S. 15. Rasl~gi RP.- - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .18!212. CALORIC RESTRICTION MAY EXTEND THE LIFE AND HEALTH Two recent animal studies offer a possible explanation for how caloric restriction might possibly enhance h u m a n health and help extend lite as well. filani V.Indoan J Chem 1963:1:212. 13. EleClrophysioiopiWI analysis or relrieval ol conditioned lasle aversion: phyuolopical lechniqver and data processing. Allwcis C. singh"~.5365 H. New Deihi. 1997. Wiley Easlern.3:24-9. L m r e S in Neurobidogy. . 01 &copa monniera Wensl: Parl I! The conslifulion of Bacoride A.

ve impairment in cognitive functions. in a five your follow-up.kI. of cerebral aging under control or to mitigate its. Shankhapu~hpi. Hrahm~ (Hawpa rnonnlcn). Alzheimer's.i ty$ 1s Ascussed Key llbrdr Acetylcholmne. neurochemistry of the brain. but mod of these f i s study is part of a larger p r o g r m e devoted to scientific and clinical investigations of indigenous drugs like Jatamanasi.commencement of the study.N. B.in patients with cerebral infirction and with neuronal atrophies in h ? e dementia.". 1976. 3. Bil'ren and Schaie (1977) and Eisdorfer and Friedel (1977) also state that cognitive and emotional alterations (deficits) constitute an inevitable manifestation of normal aging. Lipton. piracetam. neurochemistry and neuropharmacopsychology during the last more than three decades have led to the discovery of established deficits in electrocortical activity. commonly know as Smnri Ra. Attempts have beeh made to bring this phenomenon. G.wry fact that the population of persons o w r 65 years of age is the most rapidly . Varanasi Ahstmo. P. Banaras Hindu Ilpivmity. bath within the 64-79 yrs age-range at tk. vincamine. inregardto biogenic aniinn. 1976)...47-52 Role of an Ayuwedic drug Brahmi (Bacopa monnieri) in the management of senile dementia Aruna ~grawal'. Rrahmi (Racopa'rnonnieri). the most dramatic alterations in memory and neurotransmiYers hpve been found . I r p mull The advances in neurobiology. K. Eleilheriou & Elias. The ellicacy of an Ayurvedic drug. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDlC DRUGS 19 . Varanasi 'Department of Psychology. non-verbal and perceptual learning and memory. 1978.worst effects by neuro-interventions using mainly the nootropic drugs such as hydergine. The enormity of the ptoblem may be judged from. Eisdorfer & Friedel. Corkin et al . centrophenoxine. However. Corkin & Growdon. 1982. An important problem which has baffled the scientists all over the world is the. lnstitut'e of Medical Sciences. nafiidrofuryl (see for review: Gershon & Raskin. The fuulbdlty of drug's use In dcmen(la qf N7helrna. Senlle dementla.Phamawpsychoecologia (1990). DiMascio & Killam. 1977. the.~a. and verhal. in the management ol xnilc dementia was examined The drug was adminisled to diagnosed cascs of W e dementia and normal controls.w~as. Memop. age. especially learning and memory. The results reveal: (I) Brahmi arrests rnembiy loss in normal as wl as el dementia cases: (2) Brahmi also leads to slowine 6f acewlcholine loss in dementia cases. B. Elias. Wurtman.U. &.S. 1975. Varanssi %ofessor Emeritus Institute of Medical Sciences. neurophysiology. Ilrahmi. 1983. and cognitive hnctioning (capabilities associated particularly with learning and memory) as a consequence of aging. Faculty of Ayurveda. ~ldtrpd 'DepaNoent of Hasic l'rinciples. Huntington's and Parkinson's disease (Meyer et al. Reisburg. 1984). Banmas Hindu U~versily.gowing segment' and about 10-15 per cent of this populati6n are the likely victims of m e or the other form of dementia. Guptd. cerebral circulation and metabolism. prohlem of senile and other forms of demmtia exhibiting symptoms of progrm.

done on albino rats.' (1 975). lust below the last line. The preliminary results of a study. In Ayurvedic system of medicine many herbal preparations have been advocated for slowing down the aging process and thus prevent memory loss and dementia. subject was given the list conlaining 34 words printed in the upper patl of a shed in six horizontal lines. 1967) is commonly used by the practitioners of Ayurvedic system of medicine for the improvement of memory. flowem. M o n o 7 measurement. and the remaining 8 dementia cases and 10 normal conhols were kept on placebo. AU the cases were thoroughly mo~tored for their general health as well as behavioral changes throughout. Rastogi & Dhar. have indicated that Brahmi not only facilitates discrimination learning but also mitigates stress induced by sleep deprivation. in a powdered form concealcd in a capsule. served as subjects. The subjects could. Acetylcholine was measured by the method developed by McIntosh and Pmy (1950) and mdfied by Pandey.interventions are far from satisfactory because they suffer from serious side-effects. l h e number of categories for awuslic categorization was also six All 34 words were pnnted in six h h n t a l lines on the upper part of the sorting page in such a way that Ule word5 to be categorized in a category were not closeted togetha. For the acquisition task. animals. Aceqlcholine m e n m m e n t . 1965. Brahmi (Bacopa monnieriChatterji. In a series of other experiments Brahmi has also provided encouraging results in the prevention of epileptic seizures. Materials 1 . The dose of the Rrahmi exhact was one gram Both Hrahmi and placebo were administered. 2. 6. classify the words either in terms of conceptual or acoustic relationships. 6. An incidental learning paradigm was used for the measurement of memory. Materials and Methods Quite a few cases died during the five year tenure of this long$udinal study. twice a day. In still another invdgatmn (unpublished) Brahmi has provided promising results in the management of mild and moderate mental deficiency. category (conceptual or acoustic) names were printed in six columns (one in each wlumn). for live years. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . For the . frruts. in identical capsules using a double-hlind procedure continuously for live years Only thosc p m n s who gave a nfiten consent were allowed to m c i p s t e in the study. Procedure Twelve cases of senile dementia and 12 normal controls were given the organic exlract of Brahrm. Rastogi & Dhar. and immediate and delayed free recall of the diagnosed senile dementia cases and the normal controls in a five year follow-up. wupations or professions. 6. both in the 64-79 yn age-range at U commencement of the study. The purpose of the present investigation was to study the effects of the organic extract of Brahmi on the acetylcholine levels. relatives. this drug has led to an increase in the memory span of school going children. In all six measurements were taken for each subject: one basal and others a h every one year. Singh and Udupa (1975). 5. therefore. 6. 5). In another study (unpublished) also. Complete information wuld be obtained only for 20 dementia cases and 22 normal wnlrols.Subjecls Twentv diagnosed w of senile dementia and 22 normal wnhols. ' h e list used for the measurement of memory contained 34 words from Hindi language in six categories selected from the BaUig and Montapue (1969) norms (cities. C I I'ersons abusing one or the other kind of psychotropic drug (incluhg alcohol) or surering from depression or other psisten1 endocrine disorder were excluded. The details of the method are given in Pandey el 81. The I e were selected in such a h manna that they could be equally potent as alternative sorts into conceptual or rhyming categories. The acetylcholine activity was expressedin terms of mglml RBC.

63 15.56 13.56 10.10 0.19 2.31 0.24 0.62 14.27 10.14 0.13 0.14 0.34 2.34 2.31 2.31 0.77 9.65 3. Acetylcholine level (mghnlRBC)in n mcoutal ultcporv names.32 0.25 2.14 10. k s"bject was told to sort wads accading to their acoustic relationships and mite them &UP Normal Tetet ramn Placcbo (N=lO) Mean SD Mean SD Mew SD Mew SD Initial 0.85 3.31 0.15 Bratuni (N=IZ) Inmediate Delayed p>O.64 1.82 14.34 2.61 0.001 p>0.79 A m 2 yrs 14.01 8.65 3.64 Comparison Initial vs Afler 5 VTS p<0.15 2.91 10.98 7.68 0.22 0.13 0.54 3.60 0.50 2.85 1.12 d and demmtia cases following Brahmi treatment Acetvlcholine level A h After After After After Iw 2 ITS 3m 4m 5 ITS 0.96 12.13 0.98 2.05 p c0.27 2.69 2.09 Comparison Initial vs ARn 5 y s p > 0.13 0.19 0.17 0.66 0.78 9.69 11.62 8.05 Brahmi (N=12) Dementia Placebo (N=8) Brahmi (N=12) Table 2.78 1.67 0.13 0.05 0.OOI p>0.04 1.41 9.89 2.97 2.21 15.30 2.82 13.68 2.31 0.34 10.49 3.29 11.63 10.05 p>0. Free recall scures of normals unda various conditions Task Treahnent Testing condition Immediate Delayed Mean SD Mean SD Mean SD Mean SD Mean SD Mew SD Mean SD Mean SD Initial After l yr 14.38 1.31 0.79 14.11 0. For acoustic categkzation.Brahmi and ~ a n mof t senile dementia aoncevtual catemktion l & subikt WBP told to .57 8.97 1.12 0.04 3.63 2.98 10.31 13. sort &r& wx&q lo their'coxepk relatiamhip and mite them on the sotling ghed llOder appmpriate Table 1.95 2.67 1.38 7.01 13.59 2.07 1.84 3.41 11.68 3.78 10.OS p > 0. the .67 0 20 0.18 10.66 018 0.34 12.43 1.05 p>0.14 0.02 2.08 3.64 0.52 11.56 2.64 2.05 Brat (N=12) Immediate Delayed SELECT RESEARCH PAPERS O N EVIDENCE BASED AYIJRVEDIC DRUGS .13 10.18 0.60 0.67 019 0.01 15.05 p<O.92 2.61 012 0.90 14.97 3.45 11.67 14.22 0.32 0.91 1.76 14.75 2.11 9.11 0.62 0.95 2.70 2.01 9.35 Free recall Afler After After 3 yrs 4 ~ T S 5 yrs 13.32 0.76 2.04 12.05 Acoustic Placebo @=lo) Immediate Delayed p<0.05 Conceptual Placebo (N=10) 15.09 0.12 0.04 8.01 p<0.79 14.34 3.30 0.89 2.01 11.

Studies are underway in 22 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Following tbe sorting task. subjects under the immediate free recall condition were asked to recall words b r n the scrted List and write tbon in three mindes on a sheet of paper provided for this plrpose. The t-test was applied to test the significance of differences between the initial (before treatment) and final (five years after the commencement of treatment) mean values of the respective groups. the obtained significance levels are reported in the last column of the corresponding tables. This sequence was changed b m year to year. The results of the study show quite unambiguously that Brahmi.. Half tbe number of subjects in each of the Brahmi and placebo groups (for both dementia @ normal wntrol d a cases) w e e first tested on the conceptual task and one week lata on the acoustic task: the order was reversed for the remaining 50 per cent subjects in the two groups. as many as tbey could remember and in any orda that occurred to l h m . The subjects mx told to came for the w n d session ihe nnd day at ihe same hour hut no information was given to them as to what t b q would be required to do in tbe s m d session. an indigenous drug. not only arrests further memory loss but also slows the process of subsequent acetylcholine reduction in persons suffering from senile dementia. The measure of memory was the numba of words recalled Results and Discussion Means and standard deviations for the criterion scores. i. On their arrival a similar type of free recall test was gival. the level of acetylcholine and free recall scores for the conceptual and acoustic tasks of the two groups are given in Tables 1-3. The study also shows that memory loss due to normal aging is arrested by the drug. Free recall scores oidrmentia cases under various conditions Task Treatment Testing Initial After ARer After After After Comparison Conceptual Placebo (N=10) Immediate lklayed Mean SD Mean SD Mew SD Mean SD Mean SD Mean SD Mean SD Mean SD Brahmi (N=I2) Immediate Delayed Acoustic Placebo (N=8) Inundate Delayed Brahmi (N=I2) Immediate Delayed on the sorting page unda a p p n a t e acoustic category names. The ttest was also applied for other mean comparisons.e.Table 3.

Maine: FAR (iershon S.~tp.:.smrrh m ' Thempie. Memory has been suggested to be intict particularly dependent upon cholinergic (Smith & Swash. P r z FI. 13. Achar VS. 2: (iore. Dhar ML (1965) Chemical J examination of Bacopa monniaa wenst.Cambridge: Center u for Brain Sciences and M t b l s eaoim Charitable Tnrst Zometzer SF (1978) Neurotransmilter. 3: Neurdiologv ofAging. Methods in A4edical Research. In Honineister F. Chicago: Year Hook Medical Publishers Elias MF.(19%) U Neurotransmtlter failure in cerebral mfmtion and dementia. Muller C (Eds) Bmin Function in Old Age. Killam KF (Eds) (1978) Pq~chophormacolagv: A tienemhot1 o f Pmgress. The main focus of these studies is on attentional capacity and processing speed.7he constitution of Bacopa A. Davis KI. Swash M (1978) Possihlr h~cchemical hasis of memory disorder in Alzheimer's disease. Raskin A (Eds) (1975) Aging. In I.3. In Tary RI). Indian Journal o Chemislty. Vol. 394407 Lipton MA. New York: Van Nosmnd Chalteqi N.$in B i d o l y Bar Harbor.471 -473 f Wurtman W . Welch KMA. Montague WE (1969) Category nanns for verbal items in 56 categories: A replication and extension of the C o ~ e c t i c u tcategory norms.'Mathew NT.$. Singh RH. 84-XO 5. Friedel KO (Eds) (1977) (hgnihve and Emotional Disturbance in rhe Elder@. M ~ RP.Dhar MI. Raven Ress Eidorfer C. pp. BerlinMeideltergMew York: SpringerVerlag. ibl. 2. f 80 (3. 1978) function. 3.78-81 Meyer JS. Cnowdon M (I*) (1984) C Alzheimerf iJzsease: Advances in Basic Re.l'arl Ill. Udupa KN (1 975) An improved melhod for biological assay 01. @2). Reisburg U Ed) (1983) Ablteimrr:~ II8seare. Gershon S (Eds)Aging.. DiMascio A. Peny WLH (1950) Bioaswy of acetylcholine. The present study showing arrest of further acetylcholine loss in persons suffering from dementia by Brahmi leads us to speculate that some components of this drug perhaps cross the blood-braiir barrier and regulate the cholinergic system by acting on some specific receptors in the brain.ipton MA. 1978) or noradrenergic (Zometzer. ee Miyakawa Y. ~ h o l o p r c Disorders in the i<lder!v.. DiMascio A.~i. Val. New York: Raven Press References Batlig WF.mndnlation and memory: A new neuropharmacological phrenology. A m a h o hieUr010gv. 1 4 5 Birren JE. C d y e Jl.n)lhrccytes acetylcholine. New York: which the effects of Brahmi are being examined on the recall and recognition measures of the aged persons after varying the level of complexity. Eleftheriou BE. Hrstnik 1'. Kim HS. 'Titus JI. It is quite established that these are the functions which get greatly disrupted in dementia. transmission mechanisms seem to decline in activity andlor efficiency with age.. 24-29 f Corkin S. . Indian Jovmol o f Exp'mencal Biology. r n h Sli. Ellas PK (Eds) (1976) Expenmono1 Aging Reseomh: Pragrees. Killam KF (Eds) Ps)vhophamu~cdogv: A SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 23 . Suzukt M. As memory impairment is the prominent feature of the Alzheimer's disease.: Part II. might also be successfully used in the management of dementia of Alzheimer's type. 327-33 1 Rastogi RP. New York: Raven Press Pandey HP. 3.r und Trpommrt 4 P . New York: Kavcn Press Koclln W (1979) Ncunnphysiology of aged nln~tnals 13iophysical and hi~~hemlcal nervous system aspects of aging. Indian Jmmal o/('hemi. (1967) Chemical examination of Hacopa monniera wettd. Koella (1979) also states that both dopaminergic and adrenergic. Brahmi. NewYork : E Press m Smith CM. Journal o Eqerinental Psychdogv. Cmwdon JIi U d i n E.I3acoside I%. it is speculated that the drug. Wlutman RJ (Eds) (1982) Alzheimeri Iliseare: A Mclntosh FC. I M w n I .B h and management of senile dementia Repofl o j P m p r in Research. Schaic KW (Eds) (1977) Handbook $the PsychologvofAging.

Generation o Progresc New York: Raven f Ress. Dutey Psychosomatic and Biofeedback LaWory DmuUnent of Basic Pnncioles Banaras Hindu University Vnranasi 221 INS. 637449 G.P. pp. India SELECT =SEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 24 .

W u r t ~ n a ~ ~ . Faculty of Ayuned& Institulo of Mcdical Scicnccs.its cflccu n c u r c l ~ i n ~ r v c n ~using nlninly by ons culalion and mclabofi?m. AbstrncLnlc efficacy yf e. in a fivc ycar follow-up.Thcrcsulu rovcal: (I) Braluni nncsls mcmury loss in normal as well 4. Br8hmi (Brcupr monniui). Uirrcn and Schaic (1977) and solislaclory bccausc tltcy sullcr lrom scrious sidc-clEisdorlcr and Fricdcl(!977) also s m c U t a ~ c o g ~ ~ i ~ i v c 1ccu. 1978. Iqrlilutc of M d i c d Scicnccs.llcnoxil~c. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 25 . and fognilivc runcliorling tilc noouopic drugs sucll as ~lydcrgillc. Yunnnsi . piracclallt. bul ntosl of lllcsc inlcrvc~~lio~ts far lrolll nrc and memory. ccrebnl inlvclion and with n z u r p ~ ~ auol~llicsin d c ~ t s r ~ t i a .Alzlj~imcr's.gc activity. KN. and crnolional al~cratiohs (dcliciis) consliluu: M ineviwb~emani~cs~~on~jnona4~aging.~c . lnrgur progranutle Jcrutd lo seicnlilic and clinical invcsti~n~iustr in~Jifc81ot1s of Jnlns likc Jaunanui.i Ayurvcdic drug. with ngc. n t c enor.corn~nonlyuscd by Ur prnclilioncrs 01 Ayurvcdic lu::l~citt~provc~~~c~ttol~~~c~nury.H.ccll~rol.iLlercd lo dingnosd wsu sf nil^ Jcrnenlin and norrnnl conlmis. An inl~or.alld YC~OJI.view: Gcrsllon & Raskin.pacunenlofll~c study. pairmcnl in cognihvc Frictions. n l o drug w q adn.U Varnnvi 2~cputment Prychqlpgy.Ilcisburg. Scnile dententic..~owcvcr. l3. Uic world is Urn problc(~~ofsenilc ocher lormg 01 DiM3Kio & Killaln. 1965. Dmrru Hindu Univcrsily. SIIJRWIP~UIII~I~. mily of UIC pmblcm-qi~ybc jl~dgcdlmln UIC vcry $yslcot o f ~ ~ ~ c d i c i n c fact Ulat t l ~ c populatioq of pcrsrt~~s 65 ywrs of Thc prclilninary rcsults 01 n sltidy. n:ll~idroluryl(see [or and memory) as a consequcnu: of agillg.~ u b e y ' . ~ d u ~ a ' '. 1975: E I ~ ~ wnlproblcn~ l ~ i clrai bdfled chc scicnlisu all ovcr w l~ Elias. Vuanasi of '~~plcssor Eqcri~w. ~ I U E ~ U biog~llic I I I L I W . Liplon.. i ~ I O ~ non-vcrbd nnl paccped levninp awl memory. ~ u ~ > r d . Thc loss fcnsibiiity of drug's us? in dcrncntia of AW~cimer'slypc is discussed. donc on albino ovcr no1 ogc is thc'most rapidly growing scglncnl w ~ d aboul rau. In AyLrvcdic syslclll 01~llcdicillc tllilll)~l l c l h l llavc h n b d v o c a t c d lor S l 0 ~ i l l g down lnosr d r a m a t i c altccalions in nlclnory a n d prcpw~ticns lllc aging proccss and Ulus prcvcltl ~ncniory loss and ncuromsmilcrs llavc been round in p a l i c l l ~ Uraltlni (Bacopa ~nonrticri Cltollcrji. (ca~abililicsassociald particularly wit11 lwmillg villcolllillc. ltavc indiwtcd ilraL Brfill~ni ollly lilciliUt~3 f Tltir study is pul of. Eisdorlcr & Fricdcl. al senile dc~ncnlia. cspccially l w n ~ i r ~ g 1984). 1967) is l Parkinson's d i s u s c (Mcycr ci:~I. . 1977. Bmnrrr Hindu Univcrsiv. 1983. huntinglon's and Rastogi & Dllar. c~nm~only UrJmai. Corkin ct and lYXZ: dcmcntia cxhihiiing w ~ p l o m ~progrcssivc im. known ~ S m r i lRPIO~O-. boor wiIlliIl h c 64-79 of yrs agc-range u Lhc corq. in h c rnmagmcnt of senile dcmcntia wn.DS. Kcy Words Acctylchqllnc.f senile deiilciltia Aruna ~ ~ r a w a lUP. ncuropltysiology. 01 Corkill Sr Cirowtlo~~. Freo rccnil. dcmenlia cascs: (2) Brahmi also leads to slowing oface~yls!~oliic in dcmcnrin cnscs. ncurochcrni~yyof UIC brain.ncurochcmisvy qrld ncurophar~nacopsychology victitns of onc or d ~ odlcr Corm 01dcntcntin. 10-15 per ccnt 01 Ulis pol~ulalion arc Iltc likcly The advanccs ill ncurobiology. Raslogi & Dllu. '~cpurmmtofl3asic Pfinciplcs. Memory. cerebral cir. Bralmi (Uacopa monnicri). 1976). 1976. c during Ulc l a 1 mon: 1Ilan Uucc dcwdcs havc lcd lo Allctnpu havc bccn lnndc lo bring Ulis phclloOlcdiscovcryofcswb!isllcd dcEciu in cl~=uocortiwl lncnon orccrcbral under conlrol or lo 1nitig. exunincd.Role of an Ayurvedic drug Uraliini (Uacol~a ii~onnicri) n tllc i lnanagelnent y.

60 0. A n I I Lllc words 10 bc calc~orizcdn n C ~ I C C O ~ Ywcro I W ~ IP I i " closc~ed logclllcr.05 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 26 . twicc n day. I ~ A 34 CrccrecalloCtl~cdingnoscdscnilcdcnicnliacascsand lines on UIC ul. ox C il.In a scri.61 0. . dorc 01 utc iirdtfit~i s u " ~ ~u ono gmstt. 1\11 dcmcnlin C~LTCSitnd 22 llornlal COIIIIUIS.pcr yrl01tltc rar~ing pngc in sucll n way lllc normal ConUulS in a five v u r rollow-un..osll J !..uline I c v c l Olldnll KIlC) in r w r r l l ~and d~nlcnlia l CIISCI Treu(- Man SU Croup nneut Allcr 1 yr 0. Sitigli and Uduw (1975). ollicr expcri~ncnlgB r e l ~ ~ IUS n i also provided Cllrlowcrs. o blcln.. S).12 Norrnol I'lacclxl (N=ID) i' 5 yrs p > U. incidental l e a m i n i paradigm was used Tor ilic lncaurcrncnt o l r n c m q y .udcy cl nl. Proccd~trc M a l c r i a l s ittttl M c l l l u d s 'l'\vclvc cues 01 seltilu dcmcnlio nnd I 2 t ~ u r ~ a a l canuolr wcrc givcn ll... i n lllc 11rd1vagc111cr11r o c"lcbarier sclcsled m. .60 0. rruils.rubjccl w a ~ i v c n lisl Illc conkmu~g wordf ~ r i s l c d lhc upper 34 i n 10Ii0wiu~~ Ilr:8ls1nkilr~itl!~!ct)L or a r l ~ c ci ln 1.. ~ l c-cs wcrc ll~oraughlyn~unilorcdlur lllcir gcncml ~ c Ileallll as wcll ar brhnviaral cliulgcs ihruug~:oul blarcrirrls - . Acelyl~l. ~ (1950) and n~c. 111still l 2....~rs ngc-rv. Illc lncrnory spa11o r s c l ~ wgoing cllildrcn.rtertr. Y.blind procdurc con.difidby I'nndcy.. during IIIC livc ycirr ~cnurcor t i i s longitudinal sludy.-. L*ldl in dac 64-'l'J.5.~cc~ylcl~oli~~cnc~ivity worcrlrrcsscd i n l c r n ~ s o l ~ ~ ~ d n ~ l publisllcd) also.. Acclylcboline hfcuurcne~u. discriminadon Icaining but a<<? i l l i l g i ~ ~ c s strcss in1'11~d~lails l l ~ c or IIIC~IO~ arc given i n 1'. .l'ltc l i s l uscd lor lllolacnranOlllCr iltvcs1ig. i n a Subj. and ilnlncdialc and d e l a y 4 wcrc irnc . In dl sir rncnrurcmcnu wcrc lakcn lor cncl~ subjccl: Complclc inlonnslion could bc oblaiscd only lor 20 ond basal and atl~crs aller cvcry onc ycar lnr five )cars. l ~ s s i l y ~ u c lllc The puvose of dlc prescnl invesligalioll was words c i d l u in ICor conltptunl kir%courdc relalionsLudy lhC yr *Ic c en'rac' ucBrallrni c[fecLS Organi rl~ips. ~~ ~ . 6. (1975).~.. ing calcgoricr. ins dcoliol)orsu[lu!ing lrolndc~r-ionorolllerpusistcnt I ~ ~ U O W for five ycms. 3 For h e acquisition la5 .privalioll. -- nlc 1.14 Allcr 3 yrr 0.64 0...13 Alter 2y s 0.sewed as subjccu. abuiing olleor Ole ygrcr k i ~ ~ i o f p s y c I ~ o U o y i c(includdr~g in idcnlical winga doublc. occupnlionr orprolcssions.llioli (unpublisllcd) Uri1111ni laas urentcnt 01 nlsvnoty contdncd 34 words l r u n ~ lliidi Improvided l~rolt~isi~&! rcsulc.clry.61 0. r 6: 6: ". d u c d by dl.. illailodIcr l'l~e. hlmaory hfcasue. rela1ivcr.0 dlc ~IXC)~.P.13 ariron initi. I'crsoW of Uollt Umluni a.i l d in ~ sh ~ also .ix.d ploccbo were ndn~i~tirlerd.62 0.-.l md 6uag in m i l d and modcralu nlcnwi dcficicllc~.is *rug lo all in KIIC. tl~crclorc. nlwsurd e m c ~ o d d c v c ~by y c ~ by ~ .cctylcl~olu~c was.12 Allcr 4 yrs 0.nI vs Arlcr . 0.Tl~cnurnbcro1 catcgoricr lor ocousliccnlcgorizalion [lie acetylcholine lpvcls. T l ~ c u b j m could. c wl conuncncc~Cnl ihc slu*~.jecl$ powderd form concedd in a cnpsuls m d l l ~ rcrnnining e Twcn~y dingl~oscd cases 01 scniic demenlia and 22 8 dcrncn~ia corer arid 10 norn~nl co~xuolrwerc kcyl on n o m d cunuol*.Tllc couraging r c s u l h in dlc p r C v ~ l l t i 0 no f cpik. . ~ .of M~~~~~~~ (1969) norms (cilicr.12 "Icr 5 yrs 0. Quilc a lcw c a w d i d wriucn consent were o l l o w d lo participate i n Ihc nudy. m.plic words wcrc rclcclcd in such a manncr l1. 6.1 llley could bc equally w l c l l l ns nllcrnalive sorliinlo conccplu~d rllynlor SC~LUCS: . only dl sc persons who gave I~ o cndocrinc disardciwcrc cacludd..c orgnnic crlmcu o f Urnluni.

L! 6 2 LL ri " $ " 5 .s.silc dernenlia a U p i v 0 q 0 0 4 v 4 A 4 n 4 v 4 v 4 h 4 h 4 O N on a- l E l s 20 + d 55 : 5 - 52 gq 2 $5 : =. b 45 f - . ?: s = d . zz . E E 2s .. 2 -: 2: ..- wt " .iu>~i - nnd msllrgenncnl of rc.z : * O m 23 2 2 N ) U o m q-! 2" \DO. NN 0..N 3.-a -3 ! ! ! ! I & 24 cr- zd 9Ezz 6 O. I? z U .2 5 2 E $ : 27 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .9 OP sr'. ..s P-N 9" WVI bvl . J hW Y-: vs U)- rr: -00 e.- .q 4" -a 3 .2 252 " Z 553 I I5 V I 5g I 5g 0 Z 52 " 4: .< G z.- ON zc..i. 5 z . -a i 3* % < -f- 2 : .1 - 23 -q Z 90 6.g b > 0 2 .

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 28 .

Cldcago: Y C J ~ in other mcan comparisons. -. Following llm sorting tr(~k.. U~IIIII~.nral Psycltology. Kas~ogiKP. pcrsons sullcring from scniidrlc~~~cnlia. Half lllc number of bubicru in w c l ~ lltc of II drug.lcr'r Dircnrc: A Rcporl of nificancc lcvcls arc r c p n c d i n tllc lastcolu~nn I I 01 I C Progrcsr b t Rerenrch.p. New Yurk: Ilnven I'resr arrcslcd by ihc drug. an indigenous d p g . n l c t-kst cxxnin~lion llocopn ntonrlicrr welsl. Ilur m c s l s lurlhcr mcmory loss b u l also slows lllc 1Ixlar. Davis K L Growdon 1 1 Urdh E.Dd llic rarling pagc undcr npproprmm ocnwlic calcgo~y prcally J i s r u ~ ~ l ci d dc111cntia. (10 (3. ncxlday 1 lllcsamcl~our 1 bulno i!llorn~aLion givfn lo was 'lllun as lo w l ~ o ~ l l would bc rul!dird 10 do i n ihcscmnd ~cy is As tnclnory inlpair~l~cnt [he pmlnincnt fcascssion. Wmk Mcdical Publirl~crr Thc rcsulls of lhc study sllow quilc unalnEli. tit (ccncopludor ocounic)nmu wc(8:prinlcd insix colutanns :aria i n each culunm). Thc I k. .= ~UIL IEILC~ 011 LUI EO~ICE~IU~I W IU~ and onc WECL Ialcr on (I acousdc msb. u extcilsian01 ~ l t Conncclisu~ c c~~tcgorj. On lllcir arrival. inunuliclo Iroo rccall sondilion wncr ask. hloslzgt~cW E (1969) Calcgory n o ~ ~ s s fur .norimntnl liner. a similtt lypo of lrcc rccnll lerl lurc o l lllc Alzllci~ncr's tliswsc. m i g l ~Also bc succ&slully uscd i n IC l Uralm~i l~laccln md groups (for Lw~h domcaia and itor~nal I l ~ ic ~ a n ~ g c ~ ~l dcn~cnlia l Alzl~cilacr'sljqrc. 2 Ccncrir . hlullcr C (Cclr) nroi. Lipun hlA. Ittdia!~Jourt~ulO/ 01 bclwcin rho initial (bcforc uyficnt) nnd final (live Clmnisrry. 1.r in Old Agc. Vol. Ul~:u hlL (1965) C l ~ c ~ n i u ~ l tllc two groups arc givcn in 'lablcs 1-3.407 1.uncrio. study Tlbc o ~ t d 'liroltnoa o P. Uihlascio A. ~ d EmriortdDisr~ubonc~rl8e Elderly. Vol.cycliologic Dirordcrs i n rlae / also shows lhal mclnory loss duc lo llonnai aging is Eldcrly. Raskin A (Ws) (1975) Agir. Ncw Yurk: Van scorcs. nor~ns.lgittg.45 Rcsulls 2 n d D~SCUSS~UII B Mcans apd swndard dcvidons lor lllccrilcriol~ Uincn J Sclmic K\V (&Is) (1977) llmslbmk o/ lhc Prychology o/ .of w"i.!.hlF.t aller varying ihc lcvcl olcornplcxily. Fricdcl KO (E&) (1977) Cng.mgcdfron~ ypruv~ycu. 11at12).xu in lltc two groly~s.. 1 1 394. crgic syslctn by acting 011 solnc slxcilic rcccplors i~! Tl~c subjccu werc lold lo come 1 1 e rccand rcssian lltc 0h lllc brain. luk.cd u rocall words . Elel~l~eriou Elinr I'K (Edr) (1976) f_rIIE. Jurlofb renil$:dcwrntia cnlegoty sir cl6~'ur last tits. t o ~cnl o conuol CJJEI) E. 2. l l w order w u ~ C Y C ~ I C ~ IE Hclcre~~ccs lor llic rcdnaining 50 per ccnl sul. I t is ~ l u i l c scousiccalcgoriuliun. UIC lcvcl of acc!y!cl~olinc alld Ulc frcc Nosumd r c w l l scorcs lor tllc conccplujj and acoustic u k s of CI~allcrjiN. Eidurfcr C. Studies q c undcrwny i n wllicll Kocll~ \VP (1979) Ncur~~pl~yrialogy ngcd ~ n i ~ ~ ~ a l s : 01 dlc clfccu 01Brallmi arc k i n g cxail~incd UIC on Ilioldtyrical nrnl biucltemicnlncrvrn~r ryrlrlu inrlrclr r c w l l and rccogl~ilion rncasurcd 01Ulc agcd persons of ?zing. l l ~ c obwincd sig(Eds) (1982) . hlaine: EAK process of subscqucnt acclyl$holinc reduction i n Curlson S.z as n l a ~ ~ ylltcy u uors i!~irblood-bnin banicr and rcguloa lllc cl~olincould rcmcmba ~d in m y ordyy lllal occuncd la tllcm. I l e r l i n / l l e i d e i l r ~ ~ Yurk: Slxingcr-Vevlng.. . Uallig \\'F.1~ rfcnllcd. Ncw York: Kmen I'rcrr corrcspnding wblcs. was also applicd for . Killant KI: (Cds) (1978) .Ilrheir. values o f lhc rcspccdve groqlls.n:cmeasurc verbal ilsn~si n 56 cnlcgorier: A rcl. ' 01 lllcsc sludics i s OII auclllional capacily and proccssingspccd. I 24-29 ycars d l c r thc commcnccmcllt of ucauncnt) m a n Corkin S. not only perirncm'ol Agltag Rcrcwcb:Pro~rcrri t 8 Oiology. Far lllc cu~nccl~aol caegociwlion ..~i nwnogcntenl nnd . ili s spcculalcd tllqt w u givcn. Jootrt~al o/rxpcrbu.liclnion nnd olnlcmory w LCnumb.. Tllc Ilrcscut sldy n nnmes..Tlhis sequcncc w= cl. sons s u l l u i i ~ lrr o r l ~ JCIIICIII~by U r n l l ~ llcuds us l o ~l lrom lllc sorlfd lilm d wrile ~~IFIII in llum I LUC on n ~I I S s@cculalc I I t p solnc coa~ppncnu f l l ~ i clrugpcrll:lps o s sheer of papa providcd lor IIw p1drpl. llw subject w u lold lo sorl i ~ r dnaardin&p hcif l K X I (1979) also SWLCS I I ~ L ~OIII d ~ ~ ~ a l l l and ~ r g i ~ ~ ~ i ~ w n q l u a l rclalionrlip m d w! rc cl~cmon lltc rorling ndrcncrgic um~s~nission ~ c c l ~ a nsccm l o l l c c k ~ c ~~ isms rllccl undcr aouomiaw cnnccn~ud cawrow n w . biguously that Bnhmi. I n Ilallnteir~crF. ~ u b j c s uundu llno illowing ur&t o l lurtllcr ncclylcl~olinc loss ill ixr-. - -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 29 . . LC.: I ' n r l I 01 I was applied to &st thc s i g n i l i w ~ ~ c c dillcrcnccs of n l c cons~i~u~ionllac01>a A. lluo rubjout v o s gold lo to81 wouJs cswblisl~ul Ulat tllcsc arc I I l u ~ ~ c l i o wllicll gc! IC ~ls according lo lltfir OSOYIL~C rcI~L/ol~dllpt wtilo lltcnt on . Wurunan KJ 1. For i n nclivily nn~llorclficicncy wit11 ngc.Tl~cmain locus I.~irivc o .

" ~ c h a r VS. D h u ML (1967) Chcmicd cxvninvion o l G. : Pandcy HP. Psycholomatic d Uiolcedback Laborator). DiMvcio A. ~ . Gcrshon S (Eds)A h * . Mag~cw NT. O r o w d o ~JII (Eds) (1984) ~ Ncw'York Hayn Prus Alrhcimcr'r Discarc: Advor~ccsin Dnsic Rrscanh andllcrapies. Csntbridp: Ccntw lor Urain Scicnm Mclnmsh FC. Welclt KMA. New York: Hav-m-~ru. Killam KF (W) Ncumuansmi~~u failure in cezcbral infuslion uJ ~ s ~ c b ~ ~ h m a c A lGemtoion of Progrus. v Miyakawn Y .78-81 modulalion ~d Mcycr IS.ric Principles Reisburg B (Ed)(1983)AlzhrLnu's Disease. 3 Ncwobidogy if gin^. Mdhc+ in M e d u d Research 3. Zurncrrcr SF (1978) Ncumtrans~~tillcr i m mcmory: A ncw neuro~ll~~naacolugicd pluct~olu~y. Wurlman RJ.~~rnwnl/D~~hcylOupldUdupa Psychopl~rmacology: A Gcrwafion of Progrus. V d . 3. P u c z FI.6 3 7 a 9 dementia. G d y a J L Hrrtnik F . 471473 India SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 30 . K HS. I'cny WLH (1950) Uiousay of acctyland M c ~ b o l i r n ~ CI~arihbb TIMI cholii. JnTcuy RD. o o~~: NcGYork Rovcn P r c s s . S i g h RU. ~ 327-331 Rulogi RP. Udupa KN (1975) An improved 8a1ylmethod for biolvgiul assay of ay~luocy~ea cholinc.' Dodson RP (1976) in Lipton MA. Dcpamncnt ofB.cosi& D In. Tilw J L Svrvki M. Dubey Buopa nmnnieq w c l b ~ :P u t 111-B. l n d i Jflwna! of&xpcrimuUdDidogy. d i m JOWMIof ~ h u n k y5: 8 4 4 6 . 13. Corkin S l l . New York ~ a i u l l y Ayurvcda of Frcc P r u s lnstitulc 01 Mcdicd Scicnccr Smih CM: S w u h M (1978) Possible biochuniul b u i s llnnuns Hiidu Univcrsily of memoly disorder in Akhcimu's discA & VWMYI 221 005 of NcwoIogy.P.

A. Appo h a .05) after six months. thi Voluritary Health Services. L a k s h ~ n i ~ x ~Unit for Itesenrch in Intlinn iledicine.'0 ) The results of a double blind trlnl of A1nndooliapr. This ~ I r u gllas been llie~~tioned for its Rasayana Property and inec-lhya effect in Ayurvedic c1assics. - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 31 .~rch Assistant ( I'sycliology ) "'Research Assistxi~t( Statistics ). * (Dr. In the hclinvioural area. T. u ~ d atte:~:ion & cunce~~trztlon (P.l -2--___ project Olficcr . R.0000. M a n d ~ o k a ~ a r(~Centelln nsiatica) is an hyiiri-cdic herb used extenli sively as Rasayana drug. I<anchana Sr~nivasan** and hlr. . I{oteswara Raodh+ ( Late Dr. D l ) oi tirug ndrn~iiislrntion.NDCUKAPARI~I (CENTELLA RSIACISA ON TKE CEflERA! FflE!iTAL AGHITY OF BJEIGTALLY RETARrfED GII19RSM Airs. 001) and after 6 inonths (.- THE EFFECT OF F~~.**I?ese.mprovement was found in tlie overall general a~ljustrnent(1' . bI:~clras. V. Adyar.-111: Sanskrit ( Ccntella nsintica ) intlicatcd that there was significant increase ill a the general mental ability of nientally retarded children after 3 rnontlis (difference from the controls P. 11.05) . significant i.ililference from the controls P .

g Ua~nettand Latnpert. flitha1 & Sirsi. records of .. vitamins (e. 1960) tmt~qnillizers(e.. Ijlue et al. were selected for this t . thern~wrreg1ut:lnlic acid (e. 1961) indicate th the alcoholic extract is non-toxic even in fairly high doses. institution and also froin parents residing locally. Various dru have been tried with meutal'retardates to irnprove their intelligence. g. 'A protocol tor recor case histories was prepared and filled up before drugs administratioil..1) etc. Zimrnennan et al. 1949. g. Indian variety. (e. 3 inontlls and mostly of the socio-economic statits and free of epilepsy anrl other ~leurolgical deic frorn a local home for the mintally retarded. 1900) sti~nulantsand cnergisers like deanols metrazonal. g. 1957. 1 glridice.AYC April. g. 1957) Indian lierbs ( e . mines etc. Tarjan et al. 1 1 I i 1 10 Morris et al. li The chemistry and pharmacology pf the Centella glycosides of : Centella asiatica. 1969) and its effect on growth. Toxicity studies ( hfululterji. SELECT RESEARCH PAPERS ON EVlDENCE BASED AYURVEDIC DRUGS 32 . The present stiicly deals with the effect of Ccntella asiatica on general mental ablllty of thirty menially retarded children.. 195. Amo. have been studied by Bhattacharya (19: Basu and Rastogi (1967) and Ramaswamy et a t (1970). 1953. . Subjects : Tllirty chiltlren ( 7 girls and 25 boys ) in the age range of 7 to years \rill] a11 average agc of 13 years. arnpil. T h e effect Centella asiatica on the blood constituet~tsof normal healthy adults in age group of 45 to 50 years over a peroiod of 42 months has been repori by Appa liao et al (1967. The case histories of the children were obtained from t h e .. tissue biochemistry on albino rats has been reported by Rajagopalan et (1970). longevity 2.

and other inborn errors uf tnetal~oliat~i.1976 AYU T h e Binet ltatnat test (1964 revision) was selected for intelligence since the test has mainly 3 advantages over its counterparts namely: test is s t a n d ~ r d i s e dto It~clian population. The detailed tlescriptibn of the iest is givcu in Kamat's book.children were given the BinetKamat test and their Intelligetice Quotients were recorded. A thorough clinical esaniin:ltion id all t l ~ ethirty cliiidrct~ was also done. basis of 10 itetirs natnely. speech (coherence) and overall general adjusttnent with 3 rating (poor. A separate protocol for evaluating beliavioural ndjustmetit of the children was also prepared :inti filled u p during the actuol intelligetlce testing of the children. Apart form tninor notritiotlal deficiences. tablets. Procedure T h e whole plants of cent ell:^ asiatica were tlrie.iT. (Kamat. 5 At the time of selection of sullahlc cl~ildrcn. good. 1967).he. (0. Thc teclinique.~ p r i l . :he' verbal items of the test were tliougut to be not too complicated for the sample in this study. very good) f o r each item. Silly giggling and grimacing 33 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . puwderetl ant1 made into 0.) a dny for six mot~tlis. 1. The protocol comprised co-operation. Bcfore administration. lopled led for the :ssue of drug was basetl on a coniplctcly ranilotniscd double blind method. I<atnat himself has used t!ie est with mentally retardecl children and found it satisfactory (I<amat.children were given I tablet. e. 5 gm. all the. 1\To detectable inborn errors of inctabolisn~ were tlctcctctl atnotl:: the seleclctl :roup. attention and concentration. The last item i. Placebo tablets were tnadc of starch ntid \vcre suitably coloured to rnalcli tile drug t. the uriiie uf the children vas screetied for atiiii~oaciiluria. no triajor illnesses were found. gtn. 1967). overall general adjustment was rated on the.lblets. . tnemory.

int.l\J-ie 1V a). and the resulting improved understanding and that by the Drug group thk repetition of the trst plus tlie effect of the drug.l that of the Placebo group was statistically significant a t P. and P. it can be inferred t l s ~ t SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 34 . she. Q. Postural movements incoherent responses 9.good. respectively. 1' 2. ( T a b l e : T h e tlnta with regards to the bellavioural items of the Drug group a t I initkrl examination were compared with t l ~ a tof the l'lacebo group and fou t o Sc not statistically signliic. Apathy and indifference t o the test lO. 9. there weie no significant differences in the improvem in I. 9. - repeated after 3 months and 6 months of drug administration' along wi the protocol for behavioural adjustment. Irrelevant : . the increase in I . G montl~swhen compared c.. S c a n t a n d ttivial conversation 3. T h e Binet-Kamat test 11. However. vT. coultl be attributed t o thc repetition of test itc. between 3 months and 6 months indicating that the drug I in the intellectual level of the mental retardates q produced a n increase 3 months after which it had maintainetl the same 'improveme~i~. was found that the increase sho~vnin I. Stra?. 5.001. All the other conditions being the sanle. Ilcnce we could coi~c!. 0 1 statistical 1 annly (Table I1 b) using L't'' test. Overt tension or " Nerves on edge" 6 Repetit movements and bizarre mannerisms 7. From Figures of coefficient of variation . by the Placebo group. that both the samples were [row the same populntion. by the drug group a t the end of 3 months and. Results T h e observed difference in I. it. Self muttering 8. Fixecl face? ancl blank stare 4.~Restlsessi-.: . a t the initial examination betwc the Placebo ant1 Drug group was not statistically significant.AYU April. and fidgetiveness. between 3 & 6 I More 'than six less than sysmptoms indicated poor adjustme very good.(Table 11 b).

From a psychiatrist's point of view. as Blacliman ( 1957 ) pointed aut "any drug which malies a 'just notieable dii'lerence' in a positive direction should be considered to be effective" since total cure is ruled out. The beneficial effects of Centela asiatica seen in the study would therefore :o a long way and should have very significant implications in the care and inanagcment of mentz. relating to the behavioural b.April. 9. 1976 AYU improvement shown by the drug group a t the end of 3 months and 6 months was more consistant when compared with that of Placebo.05 for both). ratings is given in Table IV The results of tlrc present study clearly de~nonstrzte the elfect of Centella asiatka in i n ~ r o ithe intelligence and gcnernl ntlaptive i~ehaviourof the mentally retarded children. ( Trethowon.rtlnent of mental retardation relieves symptoms and reduces morbidity and allows the individual sufferer to operats the best way he can within the limits of his permanent disability. The drug had thus improved the powers of concentration & attention and also the overall adjustment of the mental retardatates. The statistical analysis of the data. i<specially in the field of mental retardation. As can be seen. the chi-squares for attehtion & concentration and overall general adjustment between the initial and 6 months alone were statistically significant ( P 0. The absence of significant increase in I.1 retardates. This finding was further supported by the evidence given by the Matron of the Institution from which the children were drawn. in the continuance of the drug indicates that peak action of the SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 35 . during the 3-6 months period. 1963) proper trc.

to treat secoi. attention etc.AY U - April.. I< S.iiary co. W e are tnankful to the Director. Tliiril model cot~ccriisrile use of drugs like vitainiris and glutaniir acid.Second model uses drugs lilie stin. i was proposed to repeat the inteiligence test and the behavioural protocol a t tlle end of one ycar to confinn whether the drug retains its effects eve.hich iniproce bclinvio~rrnlprocesses lilie arousal.unti cr!eigiscrs which ii~asirniseti:? subjscts utility of his currently exist it^^ resources. Sc 36 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . tin' i ~ n i l ~ r i l~ l u b a lintcili~ciicc. Acknowledgement : \17e are extremely grateful to our Project Officer. Centella asiatica. 127 intellectual area was attained at about 3 months and that it had maintainer a t the en:l of 6 months \vh:iteve: effects it had brought forth. First mciel concerns the use of drugs like tran- cluillizers.uiaiAL . Central Couucil for Research in lndiafi M e d i c i ~ ~ e Homoeopathy for pem~ittingus to publish this paper. Tlic tlr~i. Maclras hIedical College for his valuable cornrnents and suggestions. .. \:.l adjustment coulci be taken as a furtliei sul>stnriti:~tionof this.. 1966 ). W e acknowledge the co-operation and assistance given by the authorities and staff of " B ~ l aI'L'lar " home for-the mentally retarded. would fail c iiitu tliis invdcl 2nd t l ~ efiiiclii~~ it had substantially imjirored attcntio!.The ~:rcseiit drug. However.:!at S: cviiccntmtion and overall gcnc:. ihus l~ro~nises bc dcfiiiitely an advlu~ce to in the tl~erapyof ~ncntalretardation.:iitions like anxiety wliich interfere with tla furtller devclopmci~tof ~iitelligen:~. 3 models of drug action can be discenled ( Wolicnsbcrger. Emeritus Professor. Sanjivi. after it is vrithdrawn. Dr.. In the beliaviouml 'area.

Rajagopalan S. (111) Examination of the Indian variety.. M. Saponins and Sapogenins. 322-25. & Rastogi. C. P. Constitution of Centella asiatica L. Usha. & sarangan R. 2. 33-41. Linn. Journal of the Indian Chemical Society 1956. Preliminary phartnecological studies on Centella Asitatica. N. M. 3. P. CE Sarangan Study ot blnt~c\ookaparniand Punarnava for their' liasayana effect on normal healthy adults. S. (N. Nagarjun.. V. & Sirsi. Bhattacharya. Psycllological Izeports.. R. Antiseptic.1st noticeable difference" in 1. Rajagopalan S. 1957.. 1967.. S. remediation. Earnett. 6. H. Journal of Research in India Medicine.. 1969. 1249. Q. Appa I<ao &I. R. 1967. Basu. R.. 12.. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 37 . Appa Rao. Effects of metrazol on intellectual funcb tioning in duiectives. Toward the concept of a "j8. six ponths results of a double blind trial to study the effect of Mandookaparni and Punarnava on normal adults. 1961.I>. 551-54. c Lnmpcrt. 62. 1957. 33. Friterpenoid Phyto~hemistr~. S.C.. American Journal of Mental deficiency. 79-85. S. 405 09.ril. S. L. V.. 893: Blackman. 0 Umbelliferae). R. I. Srinivasam V. N. 1976 AYW REFERENCES Aithal. 58.

& Mathieson. V. 1 3 Mukerji U. Large doses of vitamin E as a factor iq the me]. 9 Del Guidice. Measuring Intelligence of Indian children. 1960. S. R. A . 15. The summary. experimental administration of Celastrus paiculata in mental dcficie practice. SELECT RESEARCH PAPERS ON EVWENCE BASED AYURVEDIC DRUGS 3I .. V. 1954. 852. J. 393. The effeet of methylnidate (Ritalin) on intellectually handicapped children. G. 1954. V. 1953. V. Nagarjun. 11 Kamat. 1967 12 Morris. letter to the e d t British Medical Journal. A. bloc Gillivary Ji. American chologist. 0. Constance.. S. & Sitaraman. W. Popular Book Del Bombay. 15 Rajagopalan. C. 14 Nadkarni. A. 8 Blue. Appa Rao M.) Oxford University Press. 59.W. & Miller. New Delhi. 21. 29-35. 235-44. Vol.. (4th ed. Amercian Journal of hlental Deficiency.S . (Abstract).J. Lytton. R. improvement of subnormal children. . I Council of Scicnt and Industrial Research.. 10 Hakin. Effect of M: ookaparni on growth and tissue composition of albino rats fed o low protein diet. 1951. 12. I. Indian remedies for poor memory. Indian pharmaceutical codex. Indian Materia Medica. 1960. I<. 1970. Vol. 2. 13. M. A.AYU April. E.

hhlenolascino. Bi~r_. !8 Trethowan. 0 Zirnmerman. T h e Journal of Mental Snbriormalily. Easic considcrrrt-ions in C% evaluating ability of dru:. '5 Putnn~n. S. 4. 0. American Jonrl?nl of hIe11ta1 Dcfccie:icy.s t o stiinulnte cogiiitive dcvclopnieiit in rctardates. J. Journal of Diseased child. \Vright S. A psychiatrist looks a t mental sub-norm2li:y. 105. 17. 11. of glutarnic acid upon the mcntal and physical growth of monyols... 9 Welfensberger.. Lowery V.. Tarjan. Periyasamy S. Use of chlorpromazine in P ic two hundred seventy eight mentally deficient patients. CV. E. 1970. B . Piiamaco1ogic. 1968. The effec!.. American Jourlial of Psychiatry. W. 160-75. II. 1976 AE'U d 16 Rarnaswamy. \Voll.~I studies on Centella asiatica Linn ( Brahma Rlanduki ) ( N.-G. 661-68 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 39 .crneistcr. T. Basu N.. Umf>elliferae ). 290-300. Fr:lnk. 1949. A. &I. T . 1905. 94. & Mrs. 18-24. 73. 414 - ?3.idian 1LIdicine.April. F. 1957. Journal of Research in !.

a t tho Initial Fxamination Group Sample size Mean levels of Standard deviation 11. i -I Statistical analysis of I.415 * t One child expired and two chidren went home. Mean Lcvcls o f I. montl- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 40 . Q. The obs5rved difference in tlie Mean levels of I.042t P L" 37. Q - Mean levels of I.AYU TABLE April.580 t Levei o significa~ Intelligence Quotient Experimental Control 15 12* 32. Q was not statistically signiiicant a t 10% level. Q.716 15. Group Experimental Control Sample size Initial 3 montlis 6.306 1.

0. showing mean difference and i t s standard Error.tatistical analysis of I.April. Group Inivital vs 3 months 3 months vs 6 months 0. shown by the experimental group when compared with that of the control group was statistically significant at The increase in I. P 0. 9. 1976 AYU TABLE II B - .923 ( 47.shown 9.303 + 0.001" P The ir~creasein 1.Olt Experimental 7.8 ) Initial VS 6 months 7 381 + 0.57 ) 0. Q. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 41 .576 + 0.05 ) P 0.353 ( 448.001.947 ( 48.01. by the experimental group when comparkd with that of the control group was statistically significant at P Figures in the parentheses represent coefficient of variation.

Raw Data with Regard t o Behavioural Ratings Experimental Gr Initial 3 months 6 month. - Poor good very Poor good very Poor good good good fi Co-operation Attention & Concentration Memory Speech (Coherence) Overall general adjustment 7 1 7 1 1 5 4 1 6 9 2 3 3 6 3 4 8 5 6 6 9 5 4 9 6 7 6 2 2 7 3 2 2 5 10 7 9 7 7 1 - Control Group Initial 3 months 6 rnontlls Poor good very Poor good very Poor good \ good good g Co-operation Attention & Concentration Memory Speech (Coherence) Overall general adjustment 5 7 1 8 1 6 3 5 10 1 0 10 6 5 11 0 0 10 2 10 2 1 3 2 6 7 0 1 2 4 0 2 5 1 6 6 4 1 42 8 2 SELECT RESEARCH PAPERS ON EVWENCE BASED AYURVEDIC DRUGS .AY U TABLE Ill April.

- TABLE I V A AYU Statistical analysis of behavioural data a t the intial examination between the experimental and control groups. N S. 2 Attention and Concentr. S.699 N. 4 S p e e c l ~(Coherence) x2 = 4. S.85 N. S.416 N. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 43 .072 N. -. 3 Menlory xZ = 2. S.t' a 1011 x2 = 2.073 N. 5 Overall general adjustment xZ = 1.. 1976 .--.------ April. 1 Co-operation x2 = 0. S. - Not statistically significant.-.

S. N.363. N S . sZ = 2.44. x2 = 0. N. N. N. S. -S. S. N.36. x Z = 1. N. x2 r2 =6'510.S. N. x2 = 0. 1976 TABLE IV B Statistical analysis of d a t a pertainings to behavioural rating. N.156. Coi~trol x L 0 00. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 44 .O!. 6 months xZ = 3. N. x2 = 0. S.045 N.00.345.88. iiIeo>ory Exj~eriine~rtal Control s2 = 0.28. Control = 3.AYI: April. x2 = N. N.33. S.P<O. N. S. xZ = S.28.840.58. i. Sjxccl~ (Colicrcncc) Experiinc~ital Control Overall General adjustment x2 = 0.00.S. -- Parameter Group - Comparison Initial vs Initial vs 3 months Co-opcmtion Attention & T < s ~ c r i ~ n e ~ ~ t a l s2 = 0. x2 = S. N. - Not statistically significant. 1. S. 2. S. N. S.S. Experimental x2 = 3.

accepted 1 June 1998 Abstract U'ithaniu sonlnijera is an Indian medicinal plant used widely in the treatment of many clinical conditions in India. Institute of &sic Medical Sciences. dyspepsia and rheumatism. Glycowithanolides withafurin-A and sitoindosides VII-X isolated from the roots of W. The root is regarded as a tonic. (Sanskrit) is an Ayurvedic medicinal plant which has been widely used as a home remedy for several ailments. The aerial parts 0378-8741/99/$ . It is used for all age groups. Its antistressor properties have been investigated in this study using adult Wistar strain albino rats and cold water' swimming stress test. A decoction of the root is used for colds and Corresponding author.Journal of Ethnopharmacology 64 (1999) 91-93 Short communication Antistressor effect of Withania sornnifera R. debility. University of Madras. Wirhania somnifera Dunal (Solanaceae). Various withanolides have been isolated from W. 1995). 1987). The plant is used in treating syphilis and a decoction of the root bark is administered in asthma (Nadkarni. commonly called Ashwagandha. Withaferin A and 3-P-hydroxy-2. PI1 S0378-8741(98)00107-X SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 45 . Antistressor: Cold swimming stress I.see front matter O 1999 Elsevier Science Ireland Ltd. All rights reserved. Introduction Ayurveda. Madras 600 1 13. Taramani. immunomodulating and anti-inflammatory properties (Budhiraja and Sudhir. Archana. somnifera. A. India Received 29 December 1997. All rights reserved. chills. aphrodisiac and is used in consumption.words: Uithania s o m n f e r a . emaciation. A'ej. the traditional system of medicine practiced in India can be traced back to 6000 BC (Charak Samhita. antiturnour. somnifera significantly reversed ibotenic acid induced cognitive defecits in Alzheimer's disease model (Bhattacharya et al.. Dr ALM PC. The results indicart: that the drug treated animals show better stress tolerance.3dihydrowithanolide F show promising antibacterial. O 1999 Elsevier S:ience Ireland Ltd. 1949). in both sexes and even during pregnancy without any side effects. received in r~visedform 18 May 1998. 1954). Namasivayam * Department of Physiology.

11 am) was kept 3. 1994). The present study was undertaken to evaluate the antistress activity of W. Group 2 (n = 10) rats were given the drug orally by intragastric intubation for. The commercialiy available powdered root of W. The pharmacological action of the different extracts from various parts of the plant have been studied extensively. In addition these ' . these parameters wcre near control values and an increase in the ~ o t a lswimming time was observed (Table 1 ). somnlferu treated rats. 1989). somnifera was manifested by the inhibition of stress induced increase in dopaminegic receptor population in corpus striatum (Sakena et al. 1992). India and its aqueous suspension was used at 100 mg/kg dosage. Adyar. 1987). soinnifera on cold swimming stress. Namasivayam /Journal of Ethnopharmatology 64 (1999) 91 -93 ..7 days and sacrificed on the 8th day.The data obtained from the total swimming time was analyzed using Student's t test. Result The results indicate a sisnificant increase in the plasma corticosterone level. All the data were statistically analyzed using One way ANOVA followed by Tukey's Multiple comparison test keeping the level of significance at P < 0. Similar increase in total swimming time in mice subjected to swimming stress has been reported by Grandhi et al.. In the rats pretreated with the drug. of W. somnifera yielded 5-dehydroxywithanolideR and withasomniferin-A (Atta-ur-Rahman et al. 1986).. In addition. Cold swimming stress has also been shown to increase the phagocytic index and avidity index (Sheela Devi and Namasivayam. immunomodulatory activity (Ziauddin et al. 1977) using heat killed Candida albicans and the phagocytic index and avidity index were calculated. The sacrificial time (9. Studies on its antistress activity have shown that in mice... Materials and methods Adult Wistar strain albino rats of either sex (weighing 150-180 g) were used for the study. 1989). On the 8th day. Ether was used to anesthetize the animals to collect blood samples using the technique of Feldman and Conforti (1980). The experimental animals were divided into four groups.. 1988). Group 3 (n = 6) animals were subjected to cold water swimming stress ( 10°C) till exhaustion and were sacrificed immediately. 2. which are subjected to swimming stress. (1993) in U sonlrlifern treated animals. these animals were subjected to cold water swimming stress till exhaustion and sacrificed immediately. 1995) and analgesic activity (Twaij et at. sonlnifeiu was obtained from Indian Medical Practitioners Cooperative Society. All the animals were maintained under standard laboratory conditions and fed with rat feed pellets and water ad libitum.. Group 1 (n = 10) were control rats.R ArchanaCA. (derived from recommended human dosage on body weight basis) in this study. 1962).OS. The total' swimming time for the rats subjected to cold swimming stress was also noted. better stress tolerance in these rats. phagocytic index and avidity index in rats subjected to cold swimming stress. The antistress effect of W. sornrtifera has shown antitumor activity (Devi et al. Madras. the increase in the total swimming time indicates. constant to avoid changes due to circadian rhythm. Group 4 (n = 6) animals were pretreated daily with the drug orally for 7 days. an increase in the swimming time and reduction in gastric ulcers was noted (Grandhi et al. Discussion and conclusion It is known that cold swimming stress increases plasma corticosterone level (Paris et al. W. 4. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS ' 46 . The phagocytic activity of polymorphonuclear leucocytes was estimated (Wilkinson. 1991).. anti-inflammatory activity (Al Hindawi et al. to avoid further stress and the blood samples were collected from the jugular vein in heparinised syringes for the estimation of plasma corticosterone (Mattingly. The present study indicates that the above stress indices have been brought back to normal in I+'.

M.D.S.~ Devi. R. E. Van de Kar. M. 1.M *Significantly different at PcO. Dur-c-Shahwar. R A .09 8. L. M. 7 2. A r c h . 1994.A. SF. M.. Patwardhan. Journal of Scientific and Industrial . S. Grandhi.38. A. Urban. (1991) New withanol i d s from Withania rpp. Furthermore it may be pertinent to point out that though many withanolides have been isolated from W. Participation of d o ~ l hippocampus in the glucocorticoid feedback effect o n . 131-135. Jamal. romnfem on n transplantable m o u e tumor. S.583.. Blackwcll Publicationr. 1995. Physiology and BEhaviour 39. Samina-Abbar.. Ziauddin. Sakena. 163-168. Diwanay.08 Group 3 Stm 107. Sheela Devi. A..30 0.395 i 0. P. Singh.24 Group 4 S I M and drug 99. Journal of Ethnophamacology M.U. K. p. A simple Ruorimctric method for the study of free Il-hydrory conicooteroids in human plasma.212. 1 -W . and Abbar. Elirha.. mI 6 Bhattacharya.. The above results indicate that W. Neuroendocrinology M. 1987. S.E.. (1988). Bethea. A. A companson of acute strerr paradigms: hormonal rerponwr and hypothalamic wrolonin. Review of biological activiV of withmolida.9 i 0.. 1986. A1 Deen.wy~t/Journal o E!hnophnr~colo~y (1999) 91-93 f 64 Table I stress Indices before and afvr W somnfira Parrmeterp Group l Control Plasma Corticorterone @#dl) P h a g q i c index Avidity index Total swimming time (min) p~~ ~ Group 2 Drug alone 98. Charak Samhita (1949) Translator: Shree Gulabkunverba Ayurvcdic Society. S. N.P...E.05. Analgcrlc rludicn on same Iraqi medicinal plants. Eflectr of @Ycomthanolids fmm Wirhoni. 3rd Ed. 1992. G. P.. Journal of Ethnophamacology 26. 271 2 7 7 . Mattingly. MS. somnifera treated mice indicating their antistressor activity. Popular Book Depot. Anti inflammatory activity of some lraqi Plants using intact rats. A comparative pharmacological investigation of Ashwagandha and Ginreng.. Journal of Clinical Pathology 15. Nomar.K.51 68. K. p. Singh. lnlernational Journal of Crude Research 27. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 47 .2 2.5' 98. Pan4 J. Sham. Richardson Morton. Nadkarni..and.261 i 60.20 i 0.. Twaij. Nabi. radian Journal of Medical Microbiology 4.. Phyiothmapy Revarch 9. H. romnifrro and Panax ginwng on dopamincrgic r a r p t o n in rat brain dunng strcrr. Khalid. Mujurndar. 1989. Stuttgart... Dixit. authors have also shown decreased numbers of gastric ulcers in W.13' 5. Frciburg. J... 33-43. S.M. Proceedings of the 36th Annual Congrnr on Medicinal Plant Rcwarch. Candida phagocytosir in acute stress. adrenocortical activity. Ismail. 1980.. C. 28. A . Bhurhan.L.. R..R. Choudhary.. A. 1989.H. Kamath. Atta-ur-Rahmm. Sarcoma 180. Indian Journal of Experimental Biology M. &dhirph R.5 i 0. Kumar. N. 1962.D. MA. 374-379.. Journal of Ethnophamacology 50. Wilkinron.M. 69-76. (ed. 109-1 12. ~. Gholal.. Studia on the Immunomodulatory cffmr of Ashwagandha. p. S. 2 7 69 6 i 0 . A. Bombay..95 i 0 . New York.. Jamnagar.I.. Lorens.519i0.56 2. D. (1977) P h a g q o s i s of killed Candida albicans In: Thompson. Thicmc. References Al Htndawi. Neeta. 169-172. somnifera is a potent antistressor agent in the crude form used in this study and further in-depth studies are required to elucidate its mechanism of action. India.K.. Seth. Oxford. Hence funher work with the isolated withanolides are essential to clinch the active component in this plant.77i0. 1995. P. H. However their results are not directly comparable with the results obtained in this study as neither the animals nor the type of stress used in both these studies are identical.C. 1987. 78 i 0. A.S. Joumal of Natural Products 56.. Eflect of Wirhoni.A.. Guota.14 68. Solomon. Patki.D. Namarivayam. Vol.1 + value are exp& as mean i SE. Sharada..A. 52-55. Ralhsd. M. somnifera it is not known which one of them has the antistressor activity. 46.. R a u ~ h 488-491. E. 110-113. 1292-1294.) Tshniquer in Clinical Immunology. (1954) Indian Materia Medica. Phansalkar. Sudhir.H.65 i 0. A.K. S.C. romn$c~a an animal model af Alzheimer's d i m and perturbed central cholinm a r k m of cognition in rats. Feldman.83 i 1.A. Conforti.840 i 0. F.A. In-vivo growth inhibitory effect of Withmi. Patwardhan.

he menta!ly (Thurstone & Ackerson.d bcbaviour of retarded children. those cascs who ~ ~~ ~ ~i ~ ~ l ~ ~ ~ ~ i points Or above 110 were rejected since they . before SELECTION OF CHILDREIS which the children should have been assessed TO ensure homogenity of population.ia. Strictly cases belonging to "average" category only. A DOUBLE BLIND STUDY OF THE EFFECT OF MANDOOI<APARXI ON THE GENERAL MENTAL ABILITY OF NORMAL CHILDREN K. 19jj) retarded and the results :ndjcated a positive have established the fact that a E. were taken for the as a hdigenoua systems of for variousskin diseases. 13 c . Of the 65 cases rejected.ica) is a slender trailing and rooting herb commonlygrowing in marshy placer all over come under . (xadkami. Q.more rapid during 'the develop mentally normal children. n stimulant of memory and intellige. However.keaearch Officer '2cXcaiarch Assistant (Prycholagy) "REc6~l.*backward" and *'above average" . (cia and for the remaining 11 cases the time lapse between the assessment and administration of raka Samhita).Q. should have =Carby Destitutes3 Home was selected for this been started on the drug. a for intelligence and if found fit. .) - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 48 .KUPPURAJAN1. -rhe intellectual and social maturity over short . 10 children were included with - ~ .acir. who were initially rejected for ths above . rmal child mmiftsts an apparently consistant increase in effect on the intel]jgencr al. Hence a period of 1 month was Metllods andMaterials tentatively fixed as the criterion period. go 1.intelligence quotients of whom only 57 said reason were again tested after a lapse of 'h:bjldren were found Et with their intelligence time of whom. 5 cases were above 110. B?yelej. Points. 3 cases were very non-c~o~erati\~e.lour. A . Many studies children of a local home for . ~ ~ ~ ( ~ d ~ t name-~entel[a k i. promoting'property in the ancient texts. Yoga & Howoeo.. KANCHANA SRINIVASAN' ANIj K. one rice etc. 49 were below diuretic. Voluntary Health Services bledicai Centre. Lalishmipalhi Unit for Research in Indian Medicine. 1977 ] quotient scores ranging between 90 and 110 Introduction were either below 90 1. tonic.The drug finds a variety of uses in the categories respectively. 1954). an alterative.r~h Assistant [stat. a study was conducted by Rao et a1 (1973) on the mentally retarded the drug exceeded one month. Adyar. JANAKIC' (Dr.India. / 1 9 7 8 Res. . 1929. since the drug has child was not conversant with either Enzlish bcec specially nlentioned for its intelligence 0' Tamil. Ind. e. these 11 Totally' 126 children were screened for cases.itudy Was undertaken to see whether thir drug intervals of time and the rate of progress is considerably. mental years. Med.!. tdd. Madras-20) [ Received for Publication on April 26.

b. The primary objective of a stud! designed t o assess a drug's ability to accelarat' development should bc to explore whether tb 49 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . and defects like stammering. Q. The detailed description of the test is given in Kamat's book (Kamat. rved difference between the mean levels o f the two groups a t the initial examination was found to be statistically not significant. Glutamic acid. scores. scores between experimental and control groups at 6 months and 12 month were tested by means of *'t" test and the observed differences between the mean values were found to be statistically not significant (t = 2. (Table 2 a. ~ s t i l and Ross. it is standardised to an Indian population. The children were given one tablet (0. was selected for intelligence tcsting.021 P > 0. it has both verbal and non-verbal items a n d the verbal items of the test were thought to be not too complicated for the sample in this study. 1967). Placebo tablets (0.021 P>O 5) (Table I). BI) (Harrell 1946) a n d Amphetamines \Loutiit. tablets. 1973) while this study had shown nb effect in normals.1 yrs. The whole plant of Mandookaparni (Samoolam) was shade dried. PROCEDURE A thorough clinical examination of the 57 children was done and apart from nutritiona! deficiences. V. The age range of the children selen cted was between 6 t o 12 y .05. weight and I. The plausible reason ~ b ! certain drugs act in mental retzrdates 3flE not in normals is outlined in ~olfensbergefl article (1968). The test has 3 advantages over its covnter-part?. of the 2 groups was tested with the help of s't" test and the obse. Kamat.5 gm. c).) were'made of starch and suitably coloured to match the drug tablets.Effect o Mandookaparni on the General mental ability f fresh I. Thiamine (vit. namely.5 gm. with a n average age of 9.653 have not been conclusively proved to bc effective in normals but generally accepted tc be effective in improving the intelligence of mental retardates. Before proceeding to find the efficacy01 the drug. The technique adopted for the issue of the drug was based on a completely randomised double blind method. no major illnesses were found. monoplegia etc. 19601. powdered and tabletted into 0. even for the initial screening. Mandookaparni had a19 shown a beneficial effect in retardates (App3 R a o et al. TEST USED The Binet-Kamat test (1964 revision) which is an adaptation of Stanford Binet test by V.5 gm. the homogenit). and weight in kgs.) a day for 1 ygar. 1947. The mean differences in the height. 1964. Before drug administration. Discussion A great deal of effort has been expended in search of pharmacological agents that will improve the intelligence and cognitive fun* tioning of normals and mental retardates. Care was taken to eliminate epilepsy and other neurological defects like hemiplegia. Results Of the 57 children. The remaining one child was found to be "above average" on 2nd examination and hence could not be included in the trial. (Zimmerman et a/. The Binet-Kamat Test was repeated after 6 months and 1 year of drug administration along with recordings of height and weight. Q.. all the children vere given the Binet Karnat Test and their intelligence quotients were recorded along with height in cms. ( t = 2. 14 dropped out of the trial due to various reasons like transfer to another orphanage and irregular intake of medicines so that only 43 (26 boys & 17 girls) children came up for the final analysis.

TABLE I Sample Mean - Group size I.96 3.56 *Values are corrected to two decimal points.45 2. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 50 .1 1 Standard error 5.82 6.00* 96.S.47 1.05 *N. Mean I I Mean Variance t P --4 *N. Q.87 0.71 10. 0.72 Variance 25. TABLE 2 C 6 Months 1 2 Months Variance t Group Sample No.22 *N. O 21 19 12 Months Variance t Mean Mean Variance t P bpcrimental Control 3.48 50.S. .70 11.05 ~ ~ ~ e r i r n e n t a l2+ Control 19 0. 24 19 Mean Variance t Mean Variance t >0. TABLE 2 B 6 Months Group Sample N. *N.68 32.41 1.89 1. 100.37 4.S.68 12.Not significant.hs Sample 1 2 Months No.S.9 t P >0.38 33.54 2.26 *N.40 0.5 P 1.S. Croup Experimental Control TABLE 2 A 6 ~on.89 >0. .56 20.50 2.

3. Journal of Research 10 Indian Medicine. (197 3) T h e effect of MandooLapami ( ~ ~ . these defects are not presect. lity (hledhya) of mentally retarded children.31 Mental response to addcd thiamin'l Journal ?02-4$. ( 1 9 4 6 ) : SELECT RESEARCE PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 51 . KO. Vol. a n d R o a . Appa Rao. W.Eflect a/ Mandookoparni on . p . Harrell. repetition of observed error.. 1n. and ~ e ~ u Project t y Officer. F. 4. 30. enhancing drug is likely to work gradu. In otherwords.. pp. inability to plan and lack of prevision. suqrnary The double blind stGdY of Mandookaparni on the height. weight and intelligence of men. R. V..itsastanam. perseveration in speech and action etc. M V. ~ ~ l I o asinticn) on the general mental abi.. 57.. We owe a debt of gratitude to the staff of this Unit for the help rendered by them. Astin. S I 1. Central Council for Research in Indian hledicine & Hoinoeopathy for financing and permitting us to publish this paper. ally. Charakasamhita 5 . thereby bringing about an increase in the intellectual status. 429-34. S. S. failure to compreheild the simplest. If the underlying processes do not show any change. S. tally normal children showed no effect. Chapter Rasayana. For example.MENT We are extremely grateful to our Project Officer. are not present in normal children and hence the drug which had improved the behavioural processes. M. America0 Psycholcgist. : 2. 8.he General nt~nral ability drug has got any developmental effect. Vol. Mr. Baylcy. Chil. (1 955) : : O n the growth of intelligence. U'P acknowledge the co-operation and assistance given by the authorities and staff of "Seva Samajam* Pallipattu. then no change is likely to be there on the global level. of Nutrition. in a 7 year old severely retarded boy. REFERENCES 1. (1960) Glutamic acid and human intelli~cncc Psychological Bulletin. The probable reason for not finding an merit is outlined. We are thankful to the Director. a developthe area men. Vol. additively directionally and selectively. failure to manipulate items of knowledge previously acqui~ed. R. N. A. Dr. Chari. Vol. ACKNOWLEDG. the observed signs of subnormal mental functioning like defective concentration. language etc. in mental retardates could not beneficially act in normal children in whom. exhibiting behavioural defects in speech. . Kancliana Srinivasan a n d Koteswara Rao. 9-16. Rajagopalan for their valuable comments and suggestions. 3l' 4.

qsmq (Double blind study) % ~ fi ma www mi pn $T I a8 T Y 5'iB k @ sha 8 I SIWW T@ ha* ihr r n ~ P P G ?Ten*$. Louttit. F. V. 569-83. and Putnam. and Menolascino. Indian Materia Medica.'il?liwi ahm n X ii T* SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 52 . J. A. T. American Journal of Mental Dificiency. Vol. L. (1965) : : Measuring intelligence of Indian children. A group study of the effect of glutam c acid upon mental functioning in children and adclesccnts.rf~ aih 8 ww TT .6 . 9.q?wii m a r . Vol. and Ackerson. Popular Book 'Depot. Burgemeister. I. Thurstone. B. Bombay. (1929) 10. Oxford University Press. 20. Chemical facilitation of intelligence among the mentally retarded. (1967) 7 . Journal of educational Prychologl. 8. K. V. Zimmerman. B. L. Nadkarni. 69.(1968) : 11. R. W. Psychosomatic medicine. The mental growth curve for the Binet tests. F. (1954) : : g. 73. 175-83. American Journal of Mental Deficiency.. T. Basic considerations in evaluating ability of drugs to stimulate cognitive dcvelopment in retardates. Wolfensberger. Vol. T . 414-23. L. Kamat. (1917) : sl. 495-50 1.

IMMUNOMODULATORS AND ADAPTOGENS .

UNDUAh! JOURNAL OF N U n L PRODUCTS A RM Special Number .

sports training.. The management of unusual psycho-physiological stress. viz. is that of using food supplements. Such a manageme~t does not endeavour to eliminate strsss but raise the threshold beyond which stress would start injuring and disturbing the life and living processes. dietaryelements. The techniques include increasing load of stress such as exercise. Delhi . This is essential. However. though it is an integral part of life. herbs and minerals for increasing physical endurance and mental per- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . The technology n f such management essentially includes.too muchstresswould lead to exhaustion.internalorexternal.inan organismandindividualhasacquired a dirty name. a larger degree of heat iolerance is observed among marathon runners and cold exposure may lead to betterhypoxictolerance.K. A certain amount of general resistance develops as a result of cross adaptation.Emotional and mental stress is the essence of competitive life. etc. K. psycho-physiological training and conditioning of the mind and body. Stress. I 0 054. therefore. A goldmine of information exist on such methodologies in ancient and medieval oriental medical systems. Another area of interest in several oriental medical systems including Ayurveda. stress hasbeen responsible for achieving the impossible and performancebeyond the 'capability' of man and extending its horizon step by step with time. has acquired enormous significance in day to day life. Mantras and Tantras.thepsycho-physiological response to a change in the environment. The processes which keep harmony and homeostasis maintained inspite of the hammering are theones which constitute development and adaptation in the living being.endurance running and mountaineering. stresses continuously hammer at the harmony and homeostasis of life. manifesting itself in the form of stress induced diseases and maladjustments. Thus. Lucknow Road. Its management is possible through powerful meditation and concentrationpractices such as those followed in different forms of Yoga. otherwise manwill be without challenges and would lead a lifewithout adaptation and therefore wither away without achiev~ng something which was hitherto beyond the capacity and 'capability' of man.ADAPTOGENS IN HIGH MOUNTAINS DR. Timarpur. Srivastava Defence Institute of Physiology &Allied Sciences. From the birth of an infant to the end of life.

formance. one needed an ex.ture to 37O C was determined. Using this model. functioning of central nervous sysThey increase tolerance to change in tem.perature of 23% was determined. scribed as 'Adaptogens' (Rasayana The physiological vital function moniand Vajikaran of Ayurveda).cold-hypoxia chamber and was alperimental evidence ofthe efficacyof lowed to recover at 32O i lo the C in such biologically active substances restrained state. which are and at least one physiological.chamber and cooled to Sic (cold). pain and infec. cardiovascular efficiency and environmental conditions and resis. The rectal temperature posure to cold.etalkuicles.an adaptogen.integrity of metabolic system of skeltance to noxious stimuli such as ex. Some spheric pressure in a decompression of them posses poweful adaptogenic SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 55 . The supplements have been claimed to rate and time to attain a rectal temarrest ageing processes and age in. vital related to endurance running. Again the rate and as vitalizers and rejuvenators was time to recover the rectal temperalacking. The perimental model which could repre. Adaptogens are biologically This vital function represented the active substances which improve thermogenic efficiency and capacity physical endurance for doing work in cold. we have Stress consisted of restraining it in evaluatedseveralherbalpreparations overnight fasting state in a restrainer and some composite herbal prepara(creating emotional anxiety stress) tions which contain minerals and vitaand exposing it to 428 mm Hg atmo.nature and shape of the curve during sent generalstresssituation. hypoxic and restraint(C-H-R) even in adverse circumstances and environmentand indicatedthe proper in difficult environmental conditions. heat. For this. However. tal model for general stress. This experimental model is with adaptogens.mins and single plant extracts. The experimental animal was white rat. tored tomeasure endurance was. the maintenance of body temperature. swimfunction which could deteriorate non ming time in cold water (23%) and specifically under stress and could be the nature of the themagenic promaintained as a result of treatment cesses. duced deterioration in physical and The rat at this stage was taken out of mental performance. were important indices. ex. Such health food state un'der cold and hypoxia.as stress fall of rectal temperature to 23O C and has many facets some common and recovery to 37O C along with the time other specific to one type of stress. capable of evaluating quantitatively the endurance promoting property of We developed an experimen. These have been de.oftheratstartsfalling in the restrained tious organisms.

diers. The stage now The environment of high ter. ctency and capability of man. d o not increase adaptogenic action on repeated intake.altitude (4800-6000 m) for 3 months. fashion during their stay in extreme The possibiliity of improving the per. adversely affected in rats exposed to similar altitude but without CIHP administration. The stay ana workin high moun. In some cases delay in fall of rectal temperature increased but recovery time remained unaffected. The subjects were divided in two accompanied with the deterioration groups. who had spent one year at tions. Some of this data is presented in Tables 1-3.4500 tains beyond 5000 m is invariably m).was two. in some the time to cool down to 23O C was unaffected but the recovery time to 37O C was shortened suggesting that the thermogenesis in cold-hypoxia was through different processlprocesses as compared with that occurring at 3Z3C in a restrained rat. with restrained-cold-hypoxia model The efficacy of the Panax ginseng suggested that adaptogens might be and CHIP. tablets twice a day (CHIP SELECT ESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 56 . one group stayed at extreme in physical and mental working effi. given to men during their of help in combating and arresting the induction and stay at extreme high high altitude induced deterioration in altitude was evaluated in double blind mental and physical performance. Whereas. restrial altitudes pose hypoxia.was set to carry out human trials.000 ft.high altitude and after their arrival in formance of man at high altitude by plains (230 m. Studies while the other stayed for 6 months. cold and isolation (anxiety) problems in A comprehensive humanstudy combination with some others like was undertaken on two hundred solincreased solar and cosmic radia. though acclaimed. for six hours a day1 six days a week.) The 'build up' dose means such as health food supple. As a result of these investigations. It was shown that a Composite Indian Herbal Preparation (CIHP) administrationstimulated oxygen delivery system to the tissues which in turn possibly maintained the muscular permeability integrity. the experimental model is now recognized t s a standard model for evaluation of adaptogens.property which keeps on increasing on repeated intake over several days and weeks(cumulative action).moderate high altitude (3000 . The experiments were started with rats exposed to a simulated altitude of 25. ments (adaptogens) has never been attempted This generated interest in exploring the possibility whether the adaptogens could be of any use in ameliorating the problems at high altitudes. whereas others. The acclimatization to hypoxia of extreme altitudewasfacilitated by the administration of CHIP during the exposure.

M.5 129.7 102 1.6 k6.5 i 3.5 * 5.0 8.7 i 5.2 * .3' i 5. Time in minutes Drug dose (mean S.Table 1 Effect of Single dose of various adptogenic substances on the fall of rectal temperature (T.9 k 3.5 * 141.9 7.' i 9.) (mode of administration To attain T. 124.1' .6 5.) to 23OC and recovery to 37% of rats in cold-hypoxia-restraint (C-H-R) model.E.7 * 3. 37OC per oral) Control Exptl Control Exptl * Panax ginseng Root extract (12) 50 mg/Kg * 67.2 74.1 124.6 .3 167.5 i2.7 3.5 105.I00 mg/Kg 83.3 76.' 33 k2. 23OC To attain T.5 k7.8 The number in parenthesis ihdicates size of treatment group Significantly different from controls at Pe0.2 5.05 .5 91.9 164.2 Ginkgo biloba 50 mgIKg Leaves extract (14) Whania sornnifera Root extract (15) 75. Composite Indian 15 mglKg Herbal Preparation I (CIHP 1 (6) ) aqueous extract I * 171.5' k 14.

4 122.4 101.2 12.1 .6 164." * 101. 4 9 f 2.7 7 1. k 9.2 5.5 141.8 118.05 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 58 .6 124. Drug dose (mode of administration TOattain T.5 f 4.23OC per oral) Control Exptl Time in minutes (mean S.5 k 5.E.4 k3.Table 2 Effect of five doses of various adptogenic substances on the fall of rectal temperature (T.) * To attain T.2 The number in parenthesis indicates size of treatment group Significantly different from controls at Pc0.0 116.9 k7.5 k 14.rn 100 rnglKg 83.7 50 mg/Kg * 75.9' f 9.1 k5.2 98.6 8. 37OC Control Exptl - Panax ginseng Root extract (6) Ginkgo biloba Leaves extract (7) Wifhania somnifera Root extract (15) 50 rng/Kg 67. . .w mr k 3.1' i5.) to 23OC and recovery to 37OC of rats in cold-hypoxia-restraint (C-H-R)model.2 193. - Corn~osite Indian 15 mnfKg Herbal Preparation I (CIHP 1 (6) ) aqueous extract t-vw.8' .8 k27.M.9 i3.2' k 5.3 7E 7 .

5 10.5 124.6 i 14. 37OC .E.8 40 mg1Kg 6 weeks 40 mglKg 12 weeks 107. 2 O 3 C To attain T.4 The number in parenthesis indicates size of treatment group Significantly different from controls at Pe0.0 99.9 107.6 k14.0 159.5mg/Kg ClHP I aqueous extract (12) 12 weeks 1 mg/Kg ClHP II aqueous extract (6) .4 1 0 0 4.3 * 165.1 i31.0 1 5 0 3.2 k15.' k4.8' 6.1 i 10.05 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 59 .2 * * * * 87.8 i 22.' k2.8 i 3.0 8.0 i 5. on the fall of to rectal temperature (5) 23OC and recovery to 37OC of rats in cold-hypoxia -testraint (C-H-R) model.Table 3 Effect of long term intake of various adptogenic substances.0 k32. Tme in minutes Drug dose (mean S.8 8. 6 weeks Rasa s~ndur ~n2% gelatin (6) Rasa s~ndur In 2% gelatln (6) 70.7' 7.M.0 87.7 154.' 4.2 116.0 5.3 149.0 165. per oral) Control Exptl Control Exptl * Composite Indian Herbal Preparation (CIHP 1 (12) ) aqueous extract 50 mglKg 6 weeks * 65.' 65 i6.5 i11 2 124.6 141.0 32.) (mode of adrn~nlstrationTo attain T.0 1 7 9 0.3 * 7.

thedeteioration in psycho-physiologicalperformance performance. R.K. Fakir Chand.M. Panex ginseng 250 mgl tab) for one week followed with a maintenance dose of one tablet twice a day for the entire period of stay in extreme altitude. They are Vimla Asnani. Radhey Shyam. S. Pahwa.R.As the proved in men given adaptogens dur. The above studies on comstored to normal level even by the administration of adaptogens. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . S. Omveer Singh and T. The recovery in physi.Upadhyay. A.adaptogens intake provided protecing three months of prolonged stay in tion from high altotude stress therethe high mountains. M.K.550 mgltab. The psycho-physiological 6000 m) environment. 1.Gautam.Divekar. aboutthefollowingvaluablecontr~butions. Developmentof a standard model for the evaluation of comprehensive antistress and endurance promotingproperties of an adaptogen accepted by the pharmaceutical industry.K. Ratan Kumar. posite herbal preparations of Indian the studies on the management of origin. Thus. ACKNOWLEDGEMENT The valuable contribution of a group of scientists who worked in the projects on adaptogens is greatfully acknowledged. However.K.and sensitive indices of oxygen availcal performance on return to plains ability to the tissues were improved improved and the sensitive indices of by the intake of adaptogens upto a oxygen availability to the tissues in. H. Grover. they should be given as health six months of stay.Gupta.period of three months stay in high cluding heart was shown to be im. Rasayana and Vajikaran extreme high altitude stress by the of Ayurveda established them as administrationof adaptogens brought preparations of real value.mountains (4800-6000 m). Bhardwaj. mental preformance could not be re3.L. the physical and food supplements. physical performance was arrested. viz. In the extreme altitude (48002.N. Panwar. M. during fore.

~rmembnne integrity and pcxmeability. Maintenance of cell membrane SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 61 . Lucknow. Exposure to high terrestrial altitude in man (4.000 m) and simulated altitude (6000 m) in white rats resulted in several fold increase in serum CPK activity. With 'acclimatization. K. Introduction High terrestrial altitudes pose a scrious multiple envimnrnental strcss situation.(R@t 6pm PRUtlb Val. Dcfcnce Institute of Physiology and Allied Sciences. Abstract Creatine : ATP Phosphotransferase (CPK) remains generally tightly bound within the cellular membranes in the neuroskeletal system. ~RIVASTAVA. This indicates aliention in cellul. India. it leaks out irito the circulation and its activity increases in the blood in neuroskeletal disorders as well as under such stress conditions which result in tissue hypoxia.Guibone (Himalaya) is continued without taking proper care of the individuals. specially in unacclimatized condition during the initial phase of high altitude exposure. This could be linked to the improvement in the oxygen delivery system of CHPadministered rats. New Dclhi 110010. Low partial prcssurc of available oxygen consequent to low barometric prcssurcs and cold constitute major'strcss producing elements. Administration of a composite herbal preparatio~i(CHP)* * was observed to decrease the hypoxia-induced increase in SCPK activity. *Prcscnted at Intcmational Confercncc on Biomcmbranu in H d t h add Disease.112-117) T MEMBRANE INTEGRITY CHANGES AT HIGH TERRESTRIAL ALTITUDES* K. the SCPK activity decreased to almost normal level. 1988. November 1 . Z Jm-Mm.4. Industrial Toxicology Research Ccnm. However. 1 m . K. Changes in cellular membrane integrity and pexmeabili~y have been implicated specially in lung alveoli. (Council of Scientific and Industrial Rcscarch). Hypoxia is a rnapr rcstraining element on physical activity. GROVER and UMA RAMACHANDRAN. XXLI NO. If the latter *. in high altitude pulmonary oedema. S. I . disastrous consequcnces in the form of High Altitude Pulmonary Ocdema rnay follow.

Taking SCPK activity as an indicator of the neummuscular membrane intcgrity. likely to be affected under conditions of low oxygen availability. who had never been exposed to high altitude anas WCFC sclecled for exposum lo high terrestrial altitudes of 4. exposure. its leakage in circulation was measured in rats exposcd to a simulated altitude of 6.90. The SCPK'activity was determined in the scrum by the colorimetric method of Hughes2. A ~ p h r t ~ tand Alaninc Amie notransfemsc activities and thcn trans- - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . For simulated altitude experiments. ported to a high altitude arca and rc-examined at intervals of 2. CHP was administered orally at a dosage of 150 mg1100g body wt once daily 30 min prior to exposure. Results The SCPK activity in man at sea 1 level (Dclhi). However-.000 metres with and without feeding a Composite Indian Herbal Preparation (CHP). which otheqvh a n generally contained within tight cellular permeability bamers.3f0. Aspartate and Alanine Aminotransferascs werc measured in man at sea level and during stay of two years at an altitude of 4.1 kg rcspcctively. 8. are likely to indicate the changcs in membrane permeability of the tissues in the abscncc of pathophysiological disordeis.permeability and its structural integrity is an energy requiring process' and. Wistar rats of 150-200 g body wt were exposed 6 hr daily for seven days to an altitude of 6. Thcir diet was composed of 4830 caljday. 62. pressure) in a decompression chamber. healthy men. In the beginning all subjects had SCPK activity upto 40 m IU with a mean value of 15. This pmpa&n was earlier found to enhance thennoregulatory endurance in rats under multiple stress of tcstraint.000 mctrcs in the Ladakh %@on. 3 diphosphoglycerate (2. residents of plains of coastal south India.3 DPG) was estimated in whole blood by the enzymatic method utilising Sigma kits. They were first examined at the base lab (Delhi 200 m) for SCPK. 2. variation in blood enzyme levels. they were bmught back to Delhi and reexamined during the first and fourth weeks of their arrival.000 metres.000 metres (32OC. Keeping this in view. After the last examination at high altitude. thcrcfom. 345 mm am.2 . Within 8 weeks of their arrival at high altitude the activity increased to a mean value of 62 - Materials and Method A group of 12 normal. Aminotransferases were estimated by the method of Reitman and Frankel3 at 31°C and subsequently convened to international units. high altitude and on return from altitude has been presented in Table 1 as the percentage frequency distribution and the mean levels of activities with standard enor of the mean. cold and hypoxia. 40. Their agcs and body weights varied bctwccn 18-30 ycars and 47. 60 and 96 weekstof stay at Mgh altitudes. Such changes are difficult to measun in man. the blood levels of Creatine : ATP Phosphotransfcrase (SCPK). the rats were sacrificed by decapitation and their blood collected for SCPK and diphosphoglycerate estimation. On the 7th day aRer 6 hr of.

0 30.0 30.6 0 0 0 0 + Statistically significant as compared wid1 sca lcvcl (inidal) values (P<O.TARLE 1 APT :Creatine phosphotransferarc mivity of serrun in men d w h g 96 wee& qfstay a an t aIIifudeof 4000 metres and at sea h i (200 metres) - Range of activity Pcrccnt distribution Sea m IU .4 - I21 160 161 .5 0 0 altitude (weeks) Ser level mum 1 ( 80 0 70.1 0' 0 0 0 0 0 0 20.4 12.O5) - Serum aspartate a d alanine arninotranrferases in man during prolonged stay a high altifurl t and at sea level (values expressed in I are Mean S&) U - + Sea .9 9.0 0 0 0 0 4 87.0 20.6 33.0 60 0 66.0 0 0 % - Initial 1-40 41 80 81 120 40 0 0 10.0 40.200 201 .5 28. 0 5 rm - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 63 .0 0 1 80.levcl 100 0 0 0 0 0 8 0 71.level (Initial) Su level renun (weeks) - 'Significantly different f o initial sea level values at P ~ 0 .217 - 0 90.

052 .001 - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 64 . 4 24 f 00 .65 6.001 0 Significantly different from altitude exposed at P< 0 0 1 .0 Significantly different from CHP .7 .9 84 4.O5 Significantly different from Contml + CHP .05 - TARLE 4 Changes in oxygen .supplemented at P<0.001 Significantly different from altitude exposed at P<0. 17 f 0 0 .delivery .1 42 Significantly different From Control at P~0.cyslcm of while rats exposed ro a simula~edahilude of 6000 m (345 mm 11s) and given CIIP Conbol CH P Altitude Altitude + CHP * 2 3 DPG .3 . 3 + 0 Significantly diffcrcnt from Contml at P<O. 28 f 0 0 .2 . supplemented at P<0.6 43 33. umlml 19 f 0.TARLE 3 Serum CPK levels in whire rats exposed to a simulared alrirudr o dOOO m and given CUP f Control CHP Altitude Altitude + CHP m 1Uldl : mean f SE + +0 a Saum CPK 3.5 +.

As a corollary t such observao eu tions the increase in s r m CPK under conditions such as environmental stress. on thc othcr hand. 90% of the values shifted towards higher levels with a mean value more than eleven fold higher as compared with the initial sca . At thc cnd of 2 wccks' stay at an altitudc of 4. thc SCPK dccreased funhcr. Alaninc aminotnnsfcnsc. During . 3 DPG in whole blood (Table 4) indicated a significantly large increase in CHP-administered and altitudeexposed rats as compared with altitude separately.70f0.the 60th week the mean SCPK values decreased to a levcl quivalcnt to that obscrvcd during the 8th wcck. transport and delivery systems.3k6. Discussion The increase in blood CPK activity buring physical exercise4' aid cold exposud has been ascribed to relative tissue hypaxia as a result of increasep oxygen demand.lcvcl. suggest that undcr conditions of high terrestrial altitude hypoxia. the membrane permeability of the skeletal and neural systems undergoes al- Thc V ~ ~ U Cof Serum aminotransfcrasc's S arc prcscnted in Table 2.21. most of the valucs bcing in the range of 41 to 80 m IU. In muscular and ncural disorders serum CPK levels increase as a result of damage to the cellular membrancsI0. During the 40th week. its activity was almost 2 fold higher on cxposure to simulated nltitudc.94 and 5. at tissue and cellular levelsI1. However. On exposure to simulatcd altitudc CHP-administercd rats did nt.84f0. thc mean activity of this cnzymc dccrcascd to thc initial sca levcl value and remained morc or less unaffcctcd at altitudc and on rctum to the plains.000 mctrcs thc activity of aspanatc aminotri~nsfcrasc was incmascd to a valuc of 18. O r observations on increase in blood u CPK levels and more or less maintained levcls of aminotransferases. rcspcctivcly.i show such a large increase in SCPK activity. Under high altitude hypoxia. On return to sea . During suhscquent obscrvalions. Howcvcr. neous estimation of 2.Icvel valucs.53 IU. The major acclimatizational change in relation to high terrestrial altitude relates to oxygen capture. In rats the administration of CHP did not affect thc SCPK levcls (Tnblc -3).71.67. although the administration of the drug alone for seven days resulted in slightly decreased values for haemoglobin and PVC. the encrgy-requiring processes are known to bc deranged and improve with acclimatization. Hcncc in exercise-adapted individuals7 and in marathon ~nners'the increase in Mood CPK was not observed to that extent as was seen among sedentary men. Thc lowlandcrs had aspartatc and alanine aminotransfcrasc activities of 8. the serum CPK levels did not rise in acclimatized mountaineers9. Simulta- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 65 . has been ascribed to alteration in cellular permeability which is an energy-requiring pmCcss. as cxpcctcd.23f1. thcsc wcrc still significantly highcr as compared to thc initial valucs. Thc activity of this cnzymc dccrcxcd during thc 40th wcck and incrcascd during thc 96th wcck significantly. Subscqucntly thc valucs of SCPK morc or Icss rcmaincd at this Icvci. did not show any consistent pattcm of changc at altitudc. Similariy.

. and Cooper. S. Parhol. 1118. R. Clin.. I. Chem. serum crcatinc kinrsc nnd nldolrsc activity in norma1 and patholngicnl sera. Appl. I I . J. 'The CHP administration was earlier round to increase the therrnoregulatory cndurancc of rats in a cold hypoxic cnvironmnt. Albrccht.. Physiol.. ad M m y . S. and Om Rdcash. 1. F. 100. Thesc rcsults suggest that CHP might bc uscrul in acclimatization to high altitude hypxia. SELECT RESEARCH PAPERS ON EWDENCE BASED AYURVEDIC DRUGS 66 . E.R. and Albrecht H... Metabolism and hnematology at high altitude an& the effect of drugs on acclimatiznion. Petajan 3. 355. D. N u t d . The expcrimcnts on exposure of rats to simulated altitude confirm this. S c ~ m enzymes after n~arathonm i n g * 3.B. and Jones. (1970) : 29. 0. In: Biochemistry of Diseases (1957) :The MacMillrn CO.3 DPG levels of red blood cclls.. A mctlitd lor the cstinitttion of .e. Tissue and serum acatine vtivity in hypohFoid . REFERENCES' 1.. 10. Proc. Nuurl. ant1 Frnnkel. Physiol. enzyme levels in dogs. 597. 528. 3. Am. 125. and Critz J. K. 532. (1969) : 27. (1971) : 220. (1968) : 71. Def Science 1. Plasma neatine phosphokinase c h r n g u induced by frcezing injury and adaptation lo cold J. H. F. Am. p 693. 6..terations in comparison with the hepatic and renal systems. (1969) : 28.. Clin. 5. Creatine kinme and glutamic oxdoacetic tramaminam . ~ d s c L. ~ t k h c s B. With improvement in tissue oxygenation accompanicd with ac~limatization~~.Effect of high altitude. Q.. T. Q. Physiol. M.. Pardce. kinetics of change with exmire and effect of physical conditioning. Animal metabolism and nutritional rquirements under physiological stress . 7. Vogwill.iml . H. tissue membrane pcrthe meability also gets rcstomd but it takes nearly 10-12 months of stay at high temstrial altitude. 1. K.. It has been found lo partially prcvcnt CPK leakage into circulation with improvement in oxygen delivery system. E. Rodansky. APP~. Bousser. . 8. New York. M.au. A. Endoc. Laeg:erin8. 56. I. C h Med. 847. (1966) : 16. Membrane transport proteins. (1957) : 28. Lob. Effect of hyp x i a and muscular activity on plum. and Bodansky.. I>. Reitmm. B. Science (1968) : 162. . Fed. M.. 4. oxyhacmoglobin dissociation with incrcasc in 2. K. 4g5. I . (1962) : 7. 2. 9.ctiviry in rmun. J. Srivastava. ( l w 8 ) : 42.

Delhi. Another Composite Indian Herbal Prcpararion-II (CIHP-11)a&o tested and found to possess anti-stress and endurance promoting activiry. herbs and minerals (Rasuyanas and Vojikaran)for increasing phvsical endurance and mental pelformance. Ratan Kumar and SK Grover Abstract Success in battlefield depends on superior tactics. The Indian traditional medicines. the methodr and sechnology for increasing humnn endurance assumes great significance both in active a d passive combat situations.'A Composite Indian Herbal Pnparation-I (CIHP-I)was tested for its adaptogenic activity using a passive Cold-Hypoxia-Restraint(C-H-R)animal model and found to have a strong curnularive endurance promoting activity. optimaIly h e thc equipmenr to achieve the objectives set for them. potentiated oxygen delivery system and impnrved cell membrane permeability. 1999 ENDURANCE ENHANCEMENT I ADVERSE N ENVIRONMENT KK Srivastava. CIHP-I intake also alleviated the combat stress induced deteriorations in physical and mental performance of Bonier Security Fotre personnel engaged in anti-insurgency opemtiom. It incrtased glucose turnover and adipose fat mobilisation and its myocardid oxhkion. at 4800-6000 m helped in accelerating the acclimatization process and ~csroring n o d jirnctions in the high altitudes. all stressors elicit certain reactions in the living system which are non-specific and l e d to the development or loss of general resistance. has been using food suppfements. The most widely utilised method of increasing physical endurance effort. Ayurveda. CIHP-II intake for 3 months in anny personnel. -- I Defence Institute of Physioiogy and Allied Sciences. Ostober 13-15. In -a double blind placebo controlled trial. camitbe ad anti-oxidants have also been tested as potential mental Md physical performance enhancers. &pendent upon whether the living system is adapting or failing to adapt. mlerance and nsistance to a wide variety of stressors is exposure to gradually hcreding Ioad of such a stressor: However. This lerrdr io develov'ment of Cross adaptation. India SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 67 . The drug intake consewid glucose utilisarion.choline. nese subsmces have been described in modem medicine as Adaptogens. We may see in the near ficture the emergence of food supplements whkh endow man enonnous physical strength and mental balancefor rational decision-making M C oing and adverse Br conditions. high-tech odvMced equipments and high performing troops who can under any condition. Thus. India.Fmt International Seminar on Force Multipiicr Technologies for Naval and Land Warfare Vigyan Bhavm. New D&i. specially. Several dietaryfactors like amino &id. dietary elements.

(4) sustainment and ( 5 ) command and control. The mobility would mean soldiers capacity to move at a faster pace aided by mechanical transport system. acquires a better capacity to overcome the insults and develops tolerance or resistance to face an increasing load of strenuous work. the methods and technology for increasing human endurance assumes great significance both in active and passive combat situations. optimally use the equipment 10 achieve the objectives set for them. Then are rive distinct areas in which soldier's performance is to be evaluated and enhanced to the optimum limits under all conditions. (2) lethality. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 68 . his body flexibility to change his posture and his mental llexibility to adapt to changing situations including the psycho-social mileau. conflicting and difficult circumstances with insufficient or without information. Success in battlefield depends on superior tactics. the target could be enemy or a signal.The optimum performance of a task in any work setting requires the confluence of physical and mental processes. The experimental studies have been focused on measurement of physical performance at level ranging from the isolated muscle cell to the whole organism.a simple one such as low environmental temperature or a complex one such as in Combat and Psycho-Social stress. a large number of factors defining conditions of environment such as heat. The performance of a person. We are still unable to measure fatigue which has both cognitive and physio-biochemical dimensions. The lethality would mean using soldier's arms and ammunitions to pick out his targets out of background 'noise* with accuracy and'cettainty. Stress could be . The survivability is related to endurance of the vital life processess in extreme climatic and trying circumstances and sustainment generally means continuation of a repeatitive. is to be evaluated in both stressed as well as non-stressed conditions. though the techniques for accurate quantitative measurements of physical and mental "performance" are still not available. cold. Thus. high-tech advanced equipments and high performing troops who can under any condition. operational and otherwise. The command and control attributes are related to leadership and decision making in adverse. The available techniques [ I ] for increasing endurance performance are: PHYSlCAL TRAINING FOR ENDURANCE WORK rhe most widely utilised method of increasing physical endurance effort. (3) survivability. tolerance and resistance to a wide variety of stressors is exposure to gradually increasing load of such a stressor. The reduced endurance of man both physical and mental during a long and strenuous task results primarily due to decreased availability of energy to the system. The physical and cognitive performance measurements need to be well integrated. monotonous work for longer periods without deterioration in totai output. The organism over a prolonged period varying from few hours to several months depending upon the nature of stressors. However. These five capabilities are: (1) mobility. altitude and combat also result in d t c d performance as they incmse the demand on M y resources including energy. Such processes and interacting factors ate potential targets for performance enhancement.

YOGIC AND MEDITATION PRACTICES Yoga comprises a rich treasure of physical and mentai techniques which can be effectively used to creitte physicai and mental well being. such as heat production during cold and increased heat dissipation through sweating in man during heat exposure. Eleu~herococcvs re$i&ss etc. Yogic practices are claimed to increase the pulmonary vital capacity.7] and increased hand grip strength [8]. Genenlly.CROSS AIIAPTATION The elements which produce disturbance in the internal or external environment of a living system produce two kinds of reactions because of their alien nature. anaerobic threshold was found to be shifted towards higher side (75% V02 rnax as compared with 47. In another study. The endurance f ~ running and doing hard work and working in adverse environmental conditions appear r to be significantly increased in experimental animals and men taking Panux ginseng (Pg). all stressors dicit certain reactions in the living system which are non-specific and lead to development or loss of general resistance. It is an ancient Indian science and way of life. There are several substances known to have 'adaptogenic' properties. The first reaction is a specific response to combat the effect of that stressor. most of the times such remarkable achievements have been demonstrated by a [ew individuals who have attained a particular status in the art of yogic development. Panax ginseng. It has been reported to be used for increasing physical work eficiency and capacity of mountaineers. [l I]. Such substances have wide range of therapeutic activity having minimal alterations of body functions. Three months yogic training resulted in decreased lipid profile. It has been claimed that yogic practices can lead to remarkable resistance and tolerance to cold and hypoxic conditions 12-41. CHEMICAL INTERVENTION BY ADAPTOGENS chemical interventions for increasing endurance performance are largely concerned with increasing energy supply and influencing biosynthesis of proteins and nucleic acids. natural products of herbal nature called 'Adaptogens' have been found to possess such activity without leading to addiction. used in countries other than India vir. However. submariners. However. strengthen the heart muscle and improve mental tranquillity. This leads to development of cross adaptation.5% in SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 69 . manifest activity only under conditions of challenge to the system and their actions are non-specific. In a study conducted on Indian sportsmen taking a mixture of Pg with vitamins and minerals. miners. Pranayamas have been shown to modify oxygen Gnsumption and heart rate [6. Yoga training also improved visual perception in human subjects as observed by ability to detect intermittent light of fixed luminance at varying frequencies [lo]. dependant upon whether the living system is adapting or failing to adapt. soldiers and factory workers [12]. yogic pnctices in decreasing the exercise induced increased in heart rate and pulmonary ventilation was found to be associated with better maintained blood glucose level (91. cardiovascular risk factor and blood pressure in human subjects especially in those with elevated leveis of these panmeters [ 5 ] .

High terrestrial altitudes pose a serious multiple environmental situation which challenges army personnel's adaptability and capacity to endure physically as well as mentally. senricosus improved the mental and physical power of Soviet athletes. potentiated oxygen delivery system and improved cell membrane permeability [27]. an indirect evidence for increased oxidation of non-esterified fatty acids. herbs and minerals for increasing physical endurance and mental performance. dietary elements. In a double blind placebo controlled trial. Ayurveda has been using food supplements. In a single blind cross over study [17]. Using the same preparation. It also helped the subjects in their faster recovery and better physical performance on de-induction to plains from high altitudes [15].controls) [13]. Rasayanas and Vajikaran have been described to possess properties of Adaptogens [19]. The lndian traditional medicines. al. It is recommended to be taken in competitive sports for a minimum of ten days and maximum of one month before the event. better maintained cell membrane permeability and increased oxygen delivery to tissues by enhancing 2'3-Diphosphoglyceric acid levels. Kevital (Trade-name). cosmonauts and workers [I 81. Extract of E. it was again confirmed in animals that a dose of 11mg/kg body weight helped in increasing resistance to Cold (5°C)-Hypoxia(428 mmHg) and Restraint (C-H-R) induced hypothermia (Trec 23°C) and faster recovery (Trec 37'C) from hypothennia 1141. approximately by 23% and it was attributed to the increased maximum oxygen uptake. thus sparing carbohydrate reserves. The mechanism of endurance promoting effect of ginseng was partly explained by the investigation of Avakian et. Further.subjects. It had a carbohydrate sparing effect during stressful situations[28]. Panax ginseng was found to restrict high altitude induced deteriorations in the. ~ h mechanism of action of d CIHP-I1 was also investigated and found that drug intake conserved glucose utilisation. These substances. who stayed and worked at 4800-6000 m SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 70 . CIHP-11 intake for 3 months in army personnel.been reported to possess anti-stress and endurance promoting activity [20-221. specially. CIHP-I intake also alleviated the combat stress induced deterioration's in physical and mental performance of Border Security Force personnel engaged in anti-insurgency operations 1241. Asparagus racemosus and Ocimum sanctum have . methanolic extract of E. number of Indian herbs such as Withanin somrtifero. The efficacy of Pg intake at a dose of 500mglday for 3 and 6 months was tested on army personnel who stayed and worked at 4800-6000m. senticosus was found to increase work capacity of human subjects. In their study methanolic extract of Pg at a dose of 2 mgllOO g body weight prevented exercise induced lactate accumulation in the blood of rats. 11 6). Another Composite lndian Herbal Preparation-11 (CIHP-11) was also tested and found to possess anti-stress and endurance promoting activity [25-261. A Composite Indian Herbal Preparation-I (CIHP-I) was tested for its adaptogenic activity using a passive Cold-Hypoxia-Restraint (C-H-R) animal model [23] and found to have a strong cumulative endurance promoting activity. it was observed that CIHP-I1 intake helped in generating energy by increased glucose turnover and increased adipose fat mobilisation and its myocardial oxidation. Adaptogenic effect of Eleurherococcus senricosus in increasing endurance has also been studied extensively.

Caffeine is safe at levels required to achieve the desired effects and its effects are reversible overtime. Caffeine can be an ideal stimulant for use during military operations when performance declines secondary to sleep deprivation and sleep fragmentation. Stress elevates the brain level of tryptophan. Under stressful conditions concentration of tyrosine SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 71 . Neural monoamines (Tyrosine): When an organism is exposed to smnuons conditions.and micro-nutrients are required to cater for the caloric needs of working man in alien hostile environments 130) and maintain his endurance capability. mood and alertness and how these may be enhanced in combination with other dietary measures is warranted. was found to increase conditioned avoidance learning of rats viz. SUPPLEMENTATION OF FOOD COMPONENTS OR 'NEUTRACEUTICALS' Additional quantities of macro. In other words the physical performance of man in strenuous condi!ions is dependent on the availability of appropriate balanced diets pl-321. an effect that has not been observed for tyrosine [41]. However. In view of the above findings the intake of CEP-II as a nutritional supplement was recommended to be introduced for army personnel serving at extreme altitude [26].helped in acceIerating the accIimatisation process and restoring the normal functions in high altitudes. Another Composite Indian Herbal Preparation III (CIHP--EII)intake. The precursor for serotonin is tryptophan while for dopamine and norepinephrine is tyrosine. It functions as a weak stimulant that. The nutrition and performance research has been focused on following general areas: Dietary macronutrients: Fat and carbohydrates-are important oxidative fuels to meet the energy requirements of man during Situations of increased energy demands. When subjects were de-inducted to plains. Caffeine: Caffeine has been shown to be effective at maintaining alertness and to function as a potent reinforcer [35]. Therefore. 341 produce neuro-humorai changes which result into increased adipose tissue lipolysis to provide more circulatory free fatty acids as energy fuel at the time of energy deficit. Caffeine dose of 100 mg postpones the onset of sleep [37] and a dose of 300 mg significantly improves daytime alertness [38]. hypoxia and cold (33. At higher dose it reverses the sleep deprivati~ninduced deterioration in cogditive performance. Continued research on the mechanism for the evident effects of caffeine on cognitive performance. avoidance of electrical shock [29]. carbohydrate reserves are small and fat reserves relatively abundant. in iow doses tends to delay sleep and reduce the deterioration's in performance. the drug helped in their faster recovery and increased physical performance. the neuronal firing rate increases and synthesis of dopamine and norepineykiine also increases [39]. Caffeine at a dose of 20-250 mg has been shown to elevate mood and these effects can last upto 3 hours [36]. fat plays an important role of energy production in stressful situations lasting for long durations. mood and alertness. Acute stress (immobilisation)increased both rate of synthesis and turnover of serotonin (S-HT) in brain [40]. containing herbs reputed to possess beneficial effect on mental perfonnance. Stressors viz.

performing maximal exercise tests on bicycle ergometer. Free radicals induced damage i n muscular structures resulted i n muscle fatigue with lowered performance o f an individual [51j. Carriitine supplementation prior to exercise increased work output it1 some. risks and benefits of acute versus chronic administration and safety o f such large doses o f tyrosine. Vitamin C suppl'ementation was found to exert protective effect against eccentric exercise induced muscle damage [55]. Free radicals Stimulate rate of autocatalytic lipid peroxidation including damage in the muscular stmcture [48]. C(~rttiritre: The effect of carnitine (2. At~ri-oxidnrtts: There is evidence to suggest that the increase in energy metabo\ism b y aerobic. Substantial evidence indicates that intakes greater than the recommended dietdry allowances (RDA) o f certain vitamins and minerals reduce the risk of certain diseases but. The usual intake o f free choline or choline containing esters through diet in humans is 700-1000 mglday. 471. Maximal exercise induced increases i n plasma lactate and pyruvate levels were lower after carniline odminislri~tio~i 1451. C and selenium are important antioxidants. Supplementation o f dietary cholilie (2. 44). dose dependent functions for its beneficial effects. A choline intake o f 500 mglday resulted i n choline deficiency and reduced muscle performance. Cltoline: Choline deficiency i n diet decreases the conduction and velocity o f nerve transmission and produced fatigue. serving at extreme high altitudes.0 g) supplementation has been studied ill human subjects. but 1101 i n all studies [46. the margin of safety between the usual dietary intakes and the intake that would produce adverse effects varies greatly among the different nutrients [57] which should be worked out. intermittent exposure to hypoxia [49]. Choline si~pplementation was also found to enhance memory and reaction time in animills and enhanced memory lime ill humans [43.8 g) during a 20 mile (32 km) run was found to prevent the drop i n plasma choli~ie concentration usually seen and improved run time [42]. Vitamins A. longterm studies are needed t o confirm these findings. t o ameliorate deteriorations caused b y strenuous conditions and t o enhance performance. cold (501 and immobilisation (511. In an another study on humans [56] six weeks intake o f vitamin mixture (592 m g alpha-tocopherol: 1000 m g ascorbic acid and 30 m g o f (-carotene) with daily 30 min. In addition an appropr'w form for providing tyrosine supplementation is to be looked into. During the strenuous task. served to lower markers of lipid peroxidation but did not prevent exercise induced increase i n oxidative stress. E. Various anti-oxidant vitamins and minerals which ure dietary components viz. However.is limited by its supply which can be enhanced by a large dietary supplement to improve the performance. Tyrosine m a y have wide application as a performance enhancing f w d supplement for military personnel. ' SELECT KESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 72 . performance enhances intracellular concentration o f oxygen free radicals. Generation o f free radicals occur i n various stressful conditions viz. requirements o f antioxidant vitamins increased [53-54). exercise at 60% VO? max.

Acta. 1997. "lrnprovemcnt in visual perception following yoga train~ng" Ind. Adhikari A and Ghosh AK. 1961. Int. 1969. "Oxygen consumption during prmayamic type of very slow nre brcarhing" Ind. Ray US. Srlvamurrhy W. 129-133. Van zur .amunhy W. 357-363. Res.Prohc 10x7. Ltd. 30-31. Indian and Chinese. The effective technique of gradual increase in exposure to stresscr and keeping mental alertness for a rational decision making by yoga and meditation have been used since the dawn of civilisation to enhance endunnce. Pharmacol. Hrgde KS and Shanna RP. Tcllcs S and Desiraju T. Muscle power. "Physiological responses to cold ( IO°C1 in rncn at'tcr SIX months practtce of yoga exerctse". "lnvestigat~onson yogis claiming to stop their hcak hats". 36. 161 (Suppl. have been experimentally proven to be endurance enhancers in hostile and adverse climates. Mcd. 41. 1961. 9. Several dierary factors like amino acids. behaviour and attitudes of man. Whga A. Fulder S. . Scand. "S~udies rcmavc human physical working wpac~ty". 1988. camitine and antioxidants have also been tested as potential mental and physical performance enhancers. "Studies on Sri Ram Chandra Yogi during his stay in air t~ght box". Chtnna GS and Singh. the natural products including various food components. 45. Rcs. We may see in the near future the emergence of food supplements which endow man enormous physical strength and mental balance for rational decision-making under trying and adverse conditions. J. named now neutnceuticals. 1. 90-94. Sch~nidrI. 'The root of bang" Pub. Nimhans Journal 1983. J . Nagendra HR and Telles S. Phyriol. Several of such preparations derived from traditional systems of medicine. Rcs. mental alertness and neuromuscular coordination with capacity to think in a ntional manner under all conditions are of major consequence in a combat situation. 82-89. have also been known to influence mental and physical performance. "Evaluation of effects of Revitbl on physical performance in sponsman" Ind. Nagararhana R. Brekhman I1 and Dardymov IV. 419-330. choline. Nalr HS. 13. Sel\. However. 287-288. J. Pharmacol. Rev. 1991. 685-688. 71-74.Vuhlen A. 1992. 1992. Biomctcorol. JY. "Physiological effects of yogic practice". Mcd. ' - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 73 . 158-162. p. "New substmces of plant origin which increase non-specific resistance'% Ann."Changes in cardiovascular risk factors and hormones dunng a comprehensive residential three months kriya yoga training and vegetarian nutrition". 49. B. "Pranayamas increases grip strength with lateralised effects" Ind. Ahuja A. London. J. Telles S. 241. to 26. Physiol. Goswami A. Ind. Pharmacol. J. Anand BK and Chinna GS. Physiol. J. Telles S and Desiraju T "Hean rate alterations in different type of pranayamas" Ind. REFERENCES Sr~vasravaK K and Scn Gupra. Hutchinson and Co. 1980. Anand BK. 94. Psychol. Brabant G and Wagner TOF. Raghuraj P. 32. J. Ind. Joseph NT and Joseph S. Nagarathna R and Nagendra HR.CONCLUSION Enhancing mental and physical performance under various environments is of vital importance for the development of human civilisation. Practioner.640). I. Med. 1995. 188-193. 107-111. 1997.

Sci. Exp. Defence Institute of Physiology and Allied Sciences. Pahwa ML. Fulder S. 24. 1995.Kohli RP md Bhargava KP. Drug. 1996. "Stay in high Mountains . Kyeo H and lmai J. "The effects of caffeine and aspirin on mood pcrfonnaoce" 1.T a p c h l S and Horvath SM. 35. multiviLpminr and m i n t d ~ 'la. SELECT RE3EARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 74 . 23.Roehrs T. and Co-workers. "Perspective on the inter-relations between nutrition and the environment" Am. 73. Medica 1986. Divekar I i M . Kumar R. Sugimoto RE. 14/96. Phatmac~l. 6i(Suppl. A rejuvenating herbal drug which enhances survival during stress (an d a p t o g ~ n ) ~ J. Biol. Res. Sci. 175-177.Quart. f Avakian EV. Gupta AK and Srivastasa KK. o Physio\ogy and A \ k d Sciences. "Reinforcing effects of calfeine in humans" 1. IW6. Muramatsu S. Griffiths RR and Woodson PP. 11/96. MsuuZPJUA. Wurtlnan RJ. Singh N. "Anti Stress activity o f Ocimum sanctum linn". 151-154.ad P ~ M X sinscnp" Pub. "Effect of long term administration of the roots ol' Ashwagandha (Wi1hmtk. 0(3). a d Kohli RP. Drug. Grover SK and Srivastava KK "New experimental model for the evaluation of adaplogenic produc~s"J. 1991. 22. "Convenience foods : Nutritional requirements and environmental stress" Probe. 17. 1990.14. 2. 10."Effect o Panax ginseng extract on e w f metabolism during exercise in rats" Ronta. 29-98. 31. 33. "lndian Materid Medica" 3rd edition. f996. Clin. I. 1954. Clin. DIPAS. tManagement of environmental stress with Composite lndian Herbal Preparationi 1995. 32. 19. 'The drug that builds Russians" New Scientist. 24.39. Media. 576-579. 1985. Pharmacol. J B i o ~ c o L ' . DIPAS. 433-451. Pharmacology.3. Bhardwaj SK and Srivastava KK. 31. J. 1. . Askew EW. Raran Kumar.). "Effect o f Ha ureaticosus extrau on human physial -king capacity" Plurla. 18. Ind. Popular Book Depot. 1988. Srivastava KK and Co-workers. 1982. 1978. 27. Delhi. Res. Lumley M. 3L5-320. Bombay. Herbal Preparation (ClHP) administration" Report no. Biochemical and psychological correlates" Report No. Srivastava KK. 9 0 . Kumar R. 34. "Whmia santnifem thhwopondha).1980. Bhargava KP and Singh N.5 R 4 . "Experimental evaluation of a Composite lndian Herbal Preparation II (CIHP-Ill as an adaptopen and its mechanism of aclion" In!. Delhi. "Mechanism of increased toferance to stress after Composite Indian . 88. Grover SK. Wes. 246. 1982. 16. Zorick F and Roth T. 25. Miller SA. Gupta AK. 306-3 12. 198 1. Grova SK. tlmc sleepiness/alenness" Sleep 1987. 1995. Radhey Shyam and Srivasrava KK ''Enhanced thcrmogencsis in rats by Panaz gioscnp. Nsth R. SO. Liberman HR. Crude Inl. Emde GG and Coviella ILG. "Calleinc" Ann. Clin. 26. Bhardwaj SK. Nutr. 18. 1974. Srivastava KK and Co-worken. 29. 1984. 187-191. Sharma S Dehanukar S and Karandikar SM. 1987. Nadkami AK. 30. J. 21. 29-35. Lata A. I 33. 20. 141-150. "Biophysical and physiological basis of human cold acclimarization" Dcf. KubDyama M. Kaaumi A. Ther. Nalh R. Singh SP. Divekar fiM. 36.. Med. Srivastava KK and Co-workers.z Somnifrrrr) and Shatavari Msporogur mccinuus) in rats" Ind. Blilkrishna and Bhatia B. Expt. 148-k54. Dew PB. Asker D. 23. "Ethanol and caffeine effects on da!. "Studies oii combat stress: Physidogical. 631s-6375. "An erpairnenral cvaluatian of anti-stress effect of Gcrilortc (An Ayurvedic dmg)". 1994. Chattopadhyay DP. 678s-68 IS. 133-139. Sinph N. 20. TPkahashiz T Miyashita M. U. Dtugs. Ramachandran U. 37. Ethnopharmacol. 155-162. 23. hlisra N. . Rev. 28. 1995. 323-341. I. "Adipose tissue metabolism during hypobaria" Del. 7. 33. CrCdc. 61tSupptl. 21-29. 1. J. 1968. Divekw HM. N F 1995. 275-281. . Delhi. "Effect of Composke lndian llerbal Preparation ClHP I\\ on avoidance learning during endurance performance of rats" Ind. "Environmenfal and physical slress and nutrient requirement" Am. 125-136. Deftme h lW si 15 16. 38. Nurr.

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Stanford C. Fillnez 34,and Ryan E. 'The effect of repeated mild s m s on cerebro-conical adrenoreceptors and nor-adrenaline synthesis in the rat" Neurosci. Lett. 1984. 45. 163-167. Bliss EL. Xilion J and Zwan Ziger 1. "Metabolism of norepinephrine. serotonin and dopamine in rat brain with stress". J. Pharmacol. Exp. Ther. 1968; 1634. 122-134. Cunon G. Joseph MH and Knott PI. "Effect of immobilisation and food deprivation on rat brain tryptophan metabolism". J. Neurochem. 1972. 19. 1967-1974. Sandage BW. Sabounjian RN. White R and Wunman RI "Choljnc cirratc may enhance atheletic performance" Physiologist. 1992. 35. 236a. Bmus RT. Dean RL. Goas JA and Lippa AS. "Age related changes in passive avoidance retention: modulat~onwith dietary choline" Science. 1980, 209. 301-303. Meck WH. Smrth RA and Williams CL. "Organisational changes in choiinergic activity and enhanced visuospatial memory as a funct~on choline 3dministered prenatally or postnatally or both" Behav. of Neurosc~.1989. 103, 1234-1241. Silprandi N. Dilisha F, Pieralisi G. Ripari P, Maccari F. Menabo R. Giam Bendino MA and Vecchiet L. "Metabolic changes induced by maximal exercise in human subjects following L-Carnitrne adrn~n~str~tron" Biochem. Biophys, Acta. 1990, 1034. 17-20. Oyono ES. Freund H. 01tC. Ganner M. Heitz A. Marbach J. Maccari F. Frey A. Bigot H. and Bach AC. "Prolonged submax~malexercise and L-Carnitine in humans". Eur. J. Appl. Physiol. 1988. 58. 53-61. Vccch~ctL. Dilisha F, Pieralisi G. Ripari P. Menabo R. Giamberardino MA and Silprandi N. "Influence of L - C ~ r n ~ u ~dm~nlstration maximal physical exercise". Eur. J. Appl. Physiol. 1990:62, 486ne on
490.

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Bcnz~G. "Aerob~cperfc . lncc and oxygen free radicals". I. Spons. Med. Physical Fitness. 1993. 33. 205-222. R a d d Z. Lee K. Chai W. Sunoo S. Kizaki T. Ohishi S. Suzuki K. Tanaguchi N. Ohno H and Asano K. "Oxtdstlve strcss induced by intcrrnrttcnt exposurc at a simulated altitude of 4000 m decrc:: cs m~~ochondnal superoxide disrnutase content of soleus muscles of tats". Eur. J. Appl. Physiol. 1994. 69. 392-395. Bhaum~c Srivastava K K and Sclvarnurthy W. 'Tnc role of free radicals in cold injuries" Int. J. G. Biomcteorol. 1995, 38. 171- 175. Hisao K. Ikuko N, Sadao S. Seiki H and Yoshihori I. "Mechanism of oxidative strcss in skclctzl muscle atrophied by imrnobilisation". Am. J. Physiol. 1993. 165. E 839-E 844. Barclay JK and Hansel M. "Free radicals may contribute to oxidative skeletal muscle fatigue". Can. J. Phys~ol. Pharmacol. 1991, 69. 279-284. Brandt RB. Doyle BA, Chan W, Poland JL and Seibel HR. 'The effect of running stress on plasma vltamln A lcvels In the rat". Food and Chemical Technology. 1997. 35, 459-463. (Quoted in Nutr. Abstr. and Rev. Series G 1997. 67. 7594) Z Tverdokhlib VP, Shmakova EN, Blazheevich NV, Meerson F and Spirichev BP. "Influence of emot~onalpain stress on content of vitamrns-antioxidant in the blood. serum of rats". Vopr. Pitan. 1987. O(6). 52-54. (~uotedin Biolog~calAbstr. 1988. 86 (3). 31924. Jakeman P and Maxwell S. "Effect of antioxidant vitamin supplementation on muscle function after eccentnc exercrses", Eur. J. Physiol. 1993, 67. 426-430. Mitchell M K. Lori AN and John OH, "Effect of anti-oxidant vitamin mixture on lipid peroxidation at rest and post exercises", I. Appl. Phys~ol.1993. 74. 965-969. John NH. "Vitamins and minerals: Efficacy and safey", Am. J. Clin. Nutr. 1997. 66. 427-130.

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A Clinical study on the role of Arnaiaki Rasayana in the
management of Sukradus'ii with special reference to Astfienozoospermia
* Soni Haresh N.

** Prof. Gurdip Singh
asthenozoospermia. Keeping this in view Amalaki was selected in the form of Amalaki Rasayana. Because Amalaki is tridosaghna, Rasayana, Vrsya, Raktapittahara and Yonidosahara. Drugs which are Raktapittaghna and Yonidosahara are also benefical in Sukradusti (Ca.Ci. 301 147). Along with this Amalaki Rasayana is advised in treatment of Kaphaja Sukradusti (Ca.Ci. 301150).Amalaki Rasayana was prepared in University phan-nacy by triturating Amalaki Curna seven times with Amalaki decocticjn. Because this process provides potent vrsya effect to Arnalaki Rasayana (SU. Ci. 26/24).

Infertility is the clinical condition which obstructs t h l progeney, It is observed in past 50'-years that sperm quality is getting of poor vatu and sperm density is also declining (osser, 89). Poor semer, quality specially low sperm rnotility is also getting higher condition. Therefore, asthenozoospermia was selected as a problem for the present study. In this condition sperm motility is below of its normal value i. e. <50°/0. Therefore, the conceptual part of this study deals with the concept of Sulira, Sirkradusti, asthenozoospermia and critical eveluation of asthenozoospermia. During critical evaluation it was decided that according to Ayurveda asthenozoospermia is of tvcles :

In the present study 14 patients were registered for clinical evaluation, ( i ) asthenozoospermia related to From them one patient left out the Vatakaphaja Sukradusti. treatment, Selected patients were (ii) asthenozoospermia related to administered 3 gm. Amalaki Rasayan Upasarga. 3 times a day with Madhu, Ghrta and Treatment of the disease should I<sira for 30 days. Patients were be in accordance to involvement of followed up for further 15 days with Dosas. In asthenozoospermia all the suitable placebo. Results obtained on three Dosas are having their own role. the basis of observation of 14 patients Therefore, the drug which is and effect of therapy on 13 patients Tridosaghna, Rasayana and Vrsya gave the conclusion as presented should be employed in treatment of below :

-

* M. D. (Ayu.) Scholar. ** Dean & Head, Deptt. of Kayachikitsa, I F G. T. & R. A., Guj.Ayu. Uni. Jamnagar

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76

[ AYU 1 Total 14 patients were studied in this thesis, out of which 35.71 % were from age group of 21-25 years, 92.86% were Hindus, 57.14% were educated upto the level of secondary education, 35.71% were labourers, 71.43% were from lower middle class, 85.71 % were from urban area. 2 14.29% had mumps and 7.14% had testicular swelling during their childhood, 7.14% patients gave the family history of diabetes mellitus. 3 Maximum patients (64.29%) had Mandagni, Madhyama Kostha (57.14%),Vatakaphaja Prakrti (57.14), Rajasika Prakrti (42.85%), Madhyam Satrnya (42.85%), Tvaka and Mamsa Sara (28.57%), Madhyama Sattva (50%), Avara Samhanana (42.86%) and Avara Dehabala (42.88%). 4 Evaluation'of Nidanas showed the presence of Viruddhasana (50%), Tobacco addiction (50%), alcohol addiction (42.85%), hot water bathing (71.43%), prolonged use of tight .undergarment (64.28%), disturbed sleep (50%), exposure to antibiotics (42.86%) and analgesics .(35.71%) Akalayonigamana (50%), Rajasvalagamana (14.29%), Maithune Nigraha (14.29%), Atimaithuna (7.14%), Sastravibhrama (7.14%), Ativyayama (21.43%), Vyadhikarsana (21.43%), Narinamarasajnta (14.29%), Agantu Hetus (14.29%), Ativyavaya (7.14%), Cinta (7.14%), and Bhaya (7.14%) in 14 patients of asthenozoospermia.

5 Some of the clinical findings were tender epididymis (2'1.43%), enlarged prostate (14.29%). 6 N o incidence o f Varicocele, agglutination and Headless sperm was found. 7 Laksanas elicited were Vandhyatva (78.57%) Daurb 7lya (28.57%), Garbhapata (28.57%), Kindu after Maithuna (28.57%), Premature ejaculation (50%), loss of penile rigidity (35.71%), Lack of erection (21.43%) and lack of sextual enjoyment (21.43%). 8 Effect of Amalaki Rasayana : 13 patients of as~knozoospermia were treated by Arnalaki Rasayana for 30 days in the dose of 3 gms. 3 times per a day with Ghrta, Madhu and Milk, Amalaki Rasayana provided significant effect on RLP motility and in decreasing immotility. Other semen parameters were got improved except head abnormality but these effects on semen parameters were statistically insignificant. Sexual health parameters wer6 also increased and improved, amogst them pe,nis rigidity, ejaculation and orgasm were statistically significantly improved. Total effect of therapy on asthenozoospermia showed that 38.4 0% patients of asthenozoospermia got improved. 30.77% were markedly improved and 30.77% patients remained unchanged.

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Mil Mrd 1999 Nov:l64(11):814-9

Effects of a composite Indian llerbal preparation or1 combat efl eetiveness in low-intensityconflict operations.
Gupinnthan Phl. Grover

SK. Guptr AK,

E.rivrstrur KK

Defense l~utitrne Physiology and Allied S~:iences,Timarpur. Dclhi. India of [~cdliae record in process) The cl(ic;l~y of a compostte I d i n n herbal prcprration (CIHP) in sustaining tile mental perform:~nce ofsoldiets engaged in prolonged low-inten~ilyconflict operations has been evsluoted. For this purpose. a colionbf 56 soldiers acted as volunt:cn in combat situations. Aner recording their initial responses 10 psychologicnl tests such as Lhe d l tes~. rrsil-makingtest. the,serial addition tes~. short-term memory test. and the Institute for the the Personalityand Ability Testing Anxiety ScrL:. they were nndonily given either CIHP or placeto illa double-blind fashion for 8 days while they performed their urud combnr dulics. Tile l i m I 3 days of nssignmcnts included physically exhawtirq mnd life-threateningevents. On day 8. they were witltdrawn from combat duties and the yaycIt~)logicnl tests were readnvinis:cred immediately. Afier 7 .lays of mt. the tests werc repeated once again. Tl ~ results indicnte comparatively bctte:-perf ~rmonce c immedintely after the missic,n by the CltIP gloup. CIHP was effective at s'usraining \he menot abilities of soldiers in a low-in~onsity-cor~Rict ntviroclcncnt, PMID: 10578595. Ul: 30045557

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78

Effects of a Composite Indian Herbal Preparation on Combat Effectiveness in Low-Intensity-ConflictOperations
Guarantor: Kaushal I(. Srivastnva. I'hl) Contributors: P.M. Gopinalhan. MA: Strrjntler K. Grover. I'hD: Ajay K. Glrpta. B 5 : Katlshal K. Srivastava. I'hD The efflcacy of a composite Indian herbal preparation [CIHP)in sustaining the mental performance of soldiets engaged in prolonged low-lntenslty-confllct operations has been evaluated. For this purpose, a cohort of 56 soldiers acted a s volunteers in combat situations. After recording their initial responses to psychological tests such a s the d2 test. the trail-maklng test. the serial addition test. the short-term memory test, and the IPAJAxiety Scale, they were randomly given either CMP or placebo in a double-blind fashion for 8 days while they performed their usual combat duties. The final 3 days of assignments included physically exhaustlng and life-threatening duties and events. On day 8, they were withdrawn from con~bat .the psychological tests were readministered immediately. Altrr 7 days of rest. the tests wrrc rcpralcd onrr again Thr results indicate cornparatively k t t e r pcrfurt~~ar~cc immediately after the mission by the ClHP group. ClHP was effective at sustaining the mental abilities of soldiers in a low-intensityconflict environment sure ol ron~hat~Nertivencssshould lwus both objrctive and su~)cctivc lncasurcs and must include intuitive assessment of the unit colnmanders at the highest level possible. Several lormulaLions of natural products derived from plants arc reported to ltave antl-stress and physical- and mental-endurancc-promotlrtg properties.!' Various composite Indian herbal prrparations have been reported to have such properties. Recently. Grover et al.I2 reported that a composite Indian herbal prcparatlon (CIIII'] had adaptwnir cllerts on exposurc to extrcn~c high aliitudc. nulTcring the stressor e k t olcombal. sperifirally tllc fn~strc~tit~g, prolot~gcd;~nti-t~~iIit;it~cy operation. by c ~ ~ l ~ a n c i t ~ g illc iccline ol physical wcll-bcing is thc stratrgy attctr~pted hcrc IIV i ~ d ~ ~ ~ i ~ ~ i s t v t ' i n g ('liil',

-

Materials and Methods
171c study was canied out on 56 hcalthv male volunteers draltcd lrorn the paramilitary force engaged In combat assign ments altej obtatning their Informed consent. I h e combat duties of these soldiers include ambushing the bulwark of the militants located In deep jungles and capturing the militants. Illis task is very dangerous and anxiety provoking. It involves stren~rous trckking through unlaniliar jungles Illled Wth rnllitants with thelr deadly rontrapUons of explosives laid on appro;~cllpaths and snipers in the soaring trees surrounding their hiding places. I'eriodically, heavily populated buildings are to be checkcd for ihc militantsoccupying them, and this exercise gocs on lor rnanv hours and oltcn results in heavy msunllirs. Thcsr arc rrr~ly icw ol thc rouline tasks of thc partirlpati~iy! u soldiers. who were continuously engaged in these mission actlvlties for at le'ast 10 months without any rest or respite tmmedlately preccding the study. They were free from any clinical disorders and were not on any medications. The age, weight, and height of these subjects ranged fro11123 to 40 years. 5 1 to 69 kg. and 154 to 174 rm. rcspecttvely. Before the initial observations, the subjects were wiltldrawn from their active combat duties and rested for 7 days. During this period, they were glven detailed accounts ol the various te$s and the exact procedures to be followed during the psvchologlral testing. After the initial ohsetvation of physical vartables. the subjects were randomly divtdcd into two age-matched groups of 28. One group was given CltlP and the other group was given placebo in a double-blind fashion. The composition of CiHP is given in Table I. The plant extracts used in ClllP have been widely used in AytIweda. the Indlatl traditional system ol medicine. Wihania sornniJem extract has been shown to possess anti-anxiety and anu-stress elTects and is highly regarded a s an adaptogen. Asprmgus racernosus is a strong adaptogen that is known to Increase physical endurance. Mucuna pnvienus seed contains L-dopa and tryptamine and acts as a relaxant and a neuronic tonic. Aqyreia speciosa is known to improve general debility and digestion. firererib 11tMllilav Medicine. Vol. 164. November 1999

Introduction
he stress experienced by combatant arises from two diexternal. rauscd by verse milieu: Tvibration: and first. the thc ainternal, rauscdnoise. heat. cold. second. by pllvsiologlral or latigue. lack of sleep. food. ap8 drink. a d psycl~ologlcalfear. anxiety. and apprehension of the consrqucrlcrs ol the enrountcr. I.c.. k i n g killcd, maimed, or rapt~lrcd. inability to ovcrAn come elfectively or cope with ernotionc~lstress ~villrcsult in disnrglni7.rd ;md irrational Ixliavior that will r c d ~ ~ the rlTecrc tivrncss nl the it~dlvidual rombatant. Tlic problctn ol maintainlng ~nissionprrhnllat~ccundcr slrrss Ilas hcen ctrnsistcntly idcntilicd a s a priority area for military studies.' Tlie topic of battlefield stress was the focus ol militruy research as early as 1917.2 The prohlem ol combat stress-induced degradation of rombat emciency is doruntented luridly in the desrription of the Normandy can~paign during World War I1 by Sicgal et al." They reported that 'the soldlcr was slow witted: slow to romprchcnd ordrrs. dircrtbris and tccl~niqucs.Memory dclccts beeanlc so cxtrcnlc that he could rtot be taurlted upon to relay a verbal order." Ille concern with countering strcss derrements In milllury performanre is shared by many rountrics. as it~dlcatcdby studies cnrricd out by A~tlcrican.'" IJritish.'Isracli." and Soviet" researchers. In summarizing this thrcat. a repon from U.S. Army School ol Advanred Military Studies concluded. 'Combat stress will be one of the most significant causes of loss of man-

.

power.-"'
In a conflict. the only sure measure of combat eKectivcncss is the performance of the unit in actual combat. A realistic mea-~ -

1998.Ihc m i d nlanuscrlpt was nccrplrd lor publlm!io~~ Marc111999. 111 llrpnlll A ('olwrl~l!l :< bv i\ssorl;lllollor Mllllilw Surfimllsnr 1's.. I?KM.

k l h l 1 I 054. Indla. 0

D~lcllsr lnslllutr of Physlolopy and Allled Srlenrrs. Lucknow Road. Tinlarpur.

Tills elanuscrlp(was r~rlvcd rwiw In Mav lor

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS

79

Composfte Indian Herbal Reparation and Combat ElTecUveness
TA~UI

courwrnon OF couposnt INDIAN HERBALmuwARAnoN

1

I'orl ol

mmposlllon.

1

the pndl from the paper. Thls Is a Umed test of 60 seconds. Only comet connectforts made are taken note of, and the mean number o l uurect sequences fined per second C taken as \he sC0m.I' Arllltmrllr ICJWny&rial ArlrlMlnn TrsO Thls test determines the emclency of mental addltlon of randonlly calledout stngledlgit numbers. Slxty randomsingle-digit numbers are grouped Into 10 sets of six numbers each, and these numbers from each set arc read to the sublect at a llxed m t e d rate of one number every second. The subject is instructed to add the six consecuUw numbers read out and wtte down the sum agahst the numbers serlally on the sheets marked 'I to 10.'The pemntage o f m t answers Is reported as Ule arlthmeUc emclency score." Shai-Tenn M e m o n ~ Test Thls test Involves a 15-wordlist that is read to the subjects at a n l e of one word every 2 seronds from a 60-wordIlsl. Thls Ilst Is also kept upside down i n front of the silbjerts. and Immediately alter hearing all oflhe 15 stlrnuti words. the s~~bjertsitre asked to turn the list over and start marking as many of the called-out words as they can recall. The percenlage of c m c t recognltlons is the score.'5 Mop-PlottingTest n Thls Is a military task and has importance i a mllltary operational context. The tesl conslsts of a blank grid of 200 I-cm squares with hvo digits east and north. The task glven Is to mark the sector correspondingto a six-figure grM reference and label Ule sector with tile letters called out al the end ofgtid reference. A typical instruclion would be '46 37 81 PM.' Duringthe tesl. 10 surh grid references are called out at 10-semd Intervals,thus allocvlng the subjects 10 scronds to plol the referenceand lab1 I t wttll the lxilr of Icttcrs glvctr at the end of lhc six dlgils. The ]PAT Anxiety Scale is prlmarlly deslgned to measure freefloallng manifest anxlety level. whether I1 Is sltuaUonally determined or relati\*elyindependent of the immediate slt~ation.'~ Anxlety as measured by the ]PAT W e t y Scale Is hlghly and consistenlly associated with all forms of dlsoiier (neuroses. psychoses, character disorders. and physleal dlsablliUesI. I t is what comes clwe to belng the common element In all [oms of disorder. and lack of anxiety as reflected by a low score on the scale is reflective of sound mental health status. StaUsUcal Analysis Data arc presented as the nlean and SD. .Analyses ol the significance between dillerent groups arc based on two-way analysts of variance and Student's 1 tesl. p values 5 0.05 are consldercd slgnillcant.

D l m m r m ~ U M
An3mspfflmn.-

Rhlmmcs

Asphall exlrael

m m u M

-m

aAqueo~rs c t d all tngrrdlmts In the given pmpa~on dtkd b a urp vacuo and mlxcd.

berosa Is knownto Improve female reproductive functions and is an adaptogen. Dioscwea buIbrJemis known to Improve HbMo. volce. and conrplexlon In both males and females. Asphalt 1 a s conlplex mlxtrlre of mlnenls and organic che~nlwls and Is a well-knownAyl~rvedic multifunctional adaptogenmlxture. Piper lorqltm has bcen shown lo eohancc thc blologlcal emcacy of drugs In general and Is an adjuvant for many Ayurvedlc preparations. The placebo capsules contained lactose only. The ClHP and placebo capsules were Identical in appearance. and the dosage was one capsule twlce a day. After 7 days of rest In the laboratory premises, the Inlual readingswere taken. Thls lnltial phase Is phase 1of the study. lmmedhtely after completing the lnltlal readings, the subjects wcre sent back to their unit for operational assignments in groupsol I 0 each Iw8days.. U r last 3daysoltheir task Includeda very high degree of physlcal endurance and hlgh levels of mxlcty-pmoklngasslgnmelils (mlsslonl. On the morntng of the 9th day. the subjecls wcre wiUldrawn Iflots the mlsslon and hro~lght hark lo Ihc ncld 1;thoralory. All 1~01s rcpe;~tcd. wen. 'llits is lcnl~cvl pll;lw I toCtlic sttlcty. A lllirtl 1 ob&~ationwas made agatn alter 7 days or resl and rerupcraUon. which IS phase Illof the study.

PsychologicalTesta ConcenlmlbnAssessmen1 fd2 TesO Ihe test Is Intended to measureconcentratlon and conslsts or 15 Ilnes. each wlth 51 6s that have the lorn: d. .d. d. d'. 6. d. 6, or .&. The task glven to the subject Is to cross out the d's d', that have the form d'. d., and .' The Ume llmlt to complete the d. test Is 300 seconds. The d2 test conslsts of three subscales: speed. accuracy. and lack of concentratlon. Speed is measured by thc number of slgns sranned prr xcond, ocrrrrary Is measured hy t l x rluntber old's crossed mrrectly. and lack or conrentrallnn Is measured by mistakes, both omlsslons and commissions.

Speed and Allention ma-Making TesO This test involves two functions: motor speed and attention. The test sheet contans 52 scattered symbols, of whlch half are consecutive numbers and half are consecutive letters ol the d2 Test 'llie scan sped, whlch Is the number or characters scanncd e English alphabet. The subJst Is requiredlo t ~ s a trall Ihrnugh Ih~w synihols In r o m l scqucntli~l order but i~llcrnatlng hc- per sccond. for lhc plncrhogroup In phase Iwas 1.404, and alier tweert number and letter as fast as Ile or she can without lil'ttng the mission It was 2.292. Illis Increase was found lo be slatis-

MIUtafy Mcdleiru, Vd. 164, Novernlxr I!i!A

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS

Composllb lndlan Herbal Fl'cparaUon and Combat EIkcUMnesr
TABLE II
EFFECT OF COMI'OSrreINDIAN HERWL IW'ARATION ON CONCWRUnON ASSESSMEW ($27 M

CBP
ValM

0.552 10.zsn
mean (n = 251 ullh S in parrnlhm. D

0.4s

10.1361

0 . ~ 2 '(0.2484

Glgnllleantiy dlRercnl lmm phase I value % g N b n U y dllkrcnt Imm phase I1 value.
TABU

A N A L ~ I S VARIANCE FO'ORHZr (SCAN SIQEED) OF m ICORRECT X A N I

J.

m

AND^

TEST

% m dva-mll a
d2 lea Iscan sped

4
5

sum or Sqllarcs 49 177
36 452 62472

Ms

F

FTables W and M. 7hc w m m d m belmnDhase I and ~ h a s Ill c lhshman~ crlgnlGtfha~.=~L-nt'mtedat lhe md of phase 1 wwnot s~stalned. nt thc end of phase Ill 1 and them was a slgnllkmt Ip < 0.02) dekrkwaUon compared wlth the phase I p c n h m e . In the drug group. the lmprowment In 1 prlwmance notcd at the end of phase II was highly s l g n l h t

(p<O0001).andthercLapseshoMlattheendofphapeIIIwas
24

shofi.~llx compiulaon bchvccn phase I and phase II did not show any statiatkally a&nUkant change ~ndther the dnrg gmup or the placebo group fRiblc8 Rr and V). H m , at the end d lcharacterlxcondll & t m n cdtlmn mcans 5 0 523 0 105 1341 phase Ill there was a hlghly signllicant deterloration In the wween mw IIWN 24 2 723 0 1 14 2 538 placebo group Ip < 0.0(n) as well as In the drug group Ip < Restdual 120 5363 0447 0 001) compared wlth thelr phase I mponse. Thls signillcant ~ o l a ~ 149 8610 detedoraUon was obscmd only at the end of phase Ill. and thc phase I' and phase 'I1 'Iso showed a 'lgtlnlly highly slplllcant (p < 0 0 0 1 ) rraMcs II and Ill) The 'Omparlson ame also obsewed in drug p u p . the a"Incant d d m t h In both IPOUPS at the end 11 1 spondlng readlngs bdng 1 708 and 2 536, thls change was also YP~Plo* statistically hlghly slgnlkant (p < 0 0001) At the end of phase Both the placebo gmup (p < 0.02) and the drug group (p < Ill. the placebo group (2 7041 as well as dmg group f3 072) Improvement In the mapplotting shaved a further lncmse In scan speed, whlch was hlghly 0 003) showed a ~lgnllkant signilkant (p < 0 00 1 for the placebo group and slgnlllcant Ip < tesl at the end of phase Ill compared wlth the phase I response 1 I 0 01) for the drug group Behveen-group cornpatsans dld not WaMes V and Vln. 7%lhen was no slgnillcant change at the end of phase II In dther the placebo group or the drug group The yield any significant change 1 The correct wan per second did not show any slgnlllcant Improvement shown at the end 01 phase I 1 was very hlghly 1 changc between phase I and phase II for either the placebo signillcant (p < 0.0001) r o m p a d wlth the phase I values group or the drug group However, the comparison between phase 11 and phase Ill for the placebo gmup shaved a highly IPAT,4~uidySulc slgnlllcant (p < 0 001) Increase In c o m t aean, from 0.54 to was lnol s thl p( change the of dey In 0 652. The drug gmup showed only a significant b < 0.01) &herthe dmggmupor the placcbogmup a Ill Increase. from 0 456 to 0 592 l r a k VI and VII) TRU-Wlng T a t In the placcbo group, there was no slgnlllcant dlffbeDiacwsion hnen the MI-making test score In ph& I and phase 1: how1 The present study assaua, menW performance during hvo ever. at the end d phase Ill thls group showal a hlghly slgnlllcant improvement (p < 0.0011 Vables W and Vl. The drug gmup important faeets of combat stress. Flrst. it measures the status e a showed hlghly slgndcant improvement (p< 0.0051 at the end of ofm@Uve ~unctlonal f f ~ e s durlng and Immedlatdy afphase 11. Thls lmprovnnent was sustained through phase Ill at t e r a h l g h - r l s k ~ ~ I n a p low-lntensltym n -tbn. nw Mit mP m , eW ota cmnplte a hlgher kvel ofslgnlllcann @ < 0.00021. lndlan hwbal pqarathm. Sedd MdltlonTest The d2 testis a test d focused attenion. wlth sped, a m The placebo gmup showed statlstlcally slgnlllcant @ < 0 . W ) rev,and lack dattmtlan as Its components. 'lhe hlghly slgnlflmpmvement only at the end ofphase.11compared with phase I lcant Inmeas2 1 scan spml in both gmups denotes the the
Wual

letam~erl~ll 1*tumnmlumn means Delwccli rmv nttanr

120

9835 1 512 0521

la921 2 916

not statatlstidly s Um @k t

compared with phase 1 1

~ o l a ~ dz 11 ~comcc scan

149

-

,,,

t E

M W M ~ d bVd. 164. Novanhr 1999 U l .

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS

lulll~y!c % l FHt n l m e l l I I'Ladw UIIII' II'AT Alukly Scale lraw smrel I'laccbo Ctlll' 4 8 57 I28 767l 1 I'llasr Ill A ($5101a" 125.M36 F 6. S E W AODmON TEST.363 (0.225) 85.451 110 5571 Phase Il l O.. 17 Reslcl~lat 135 Tolal 187 Scrlal .532 10.These two h ~ n c t b n s a r e rclevanl i n a mmbat envlrnnmenl.&121 Phasr l l 0.%l 82.llvc~neliu lc EFFECT OF COMI'OSITE INDIAN HERBAL I'REI'ARATION ON TRAIL-MAKINGTEST.21.8391 66. 1 1.II~II.UlTIN(i 'TEST AN0 II'AT ANXIETY SCAlE.858'" 113.p . W (0. 1 2 1c 1 1 27 135 I<ralrl88al 167 Tolitl sn 2.%)7l 35.IVW)I rowS K II I.42 133.857 121. showing that the specd-acrurary tradmlT prlnclple Is operative to some exlent wlthoul any delrlmcntal cllecl o n overall emciency. The suslalned Increase shown at the end of phase Illin I h c CIHP gmup as well as (he placebo grnup Indicates that the stresslul mivvlon events In mmbat stress orlents the mgnltlve systml loward emrlent vlgllance.Iw~r~~-rou.714a(11. W K1.60 7554 70 I'llML4 Ill 2lAWlI X I 876 5 270 8 104.1 4 130 2 W4 8.309 112. AND SIIOlV..W K)l1.--.50 I%8441 46. I S2.c d l l nlral\s ~n~~ 5 UI. Vd.6041 78.. Nnvc.--. The corrwt scan dld not reglsler a rorrespondi~lg slgt~lflranlInrrcase. It.9291 Tlall-msklq1-1 lcomcl seq~meclvcrmdl Placebo ClHP S e w addlUcn teslI9b m m c l l Placebo ClHP mIII eO r-IS t I'Iarrho CIHI' menay I n 1 I%!m m c l molpllllonl Vttlt~rs III~~II281 wlllb Sl) 11) ~ x ~ r t ~ t 1 l l 8 a ~ .MX) I.239 8..MAKING TEV.~sslgnmenl.4847 50 4382.11 (102821 l'l.1:3 1.C o n ~ l ~ m iInctlun Il e l l w l I'relhm-allnn anct Conltwl &Ilec.1211 72.119. The beneficial eliects oCClHP in combat Mtltla~y Mcdkinr. I l ~ e cnn~pirralkelybetter values shown by the drug group may I : n attribulable to the known speclnc performance relurblshmenl actton o l C l l l P i n stressh~l ~ n d i t l o n s ..1201 0.Wd10.mbcr I!JY!I SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 82 . . ' ~ S I ~ t ~ l l l r nl~&~ rl tl~ l In.TERM MEMORY TEST Sot~rrc olVarlallon 41 Stlnll dSql~ams I &IS 02617 0 0R:l8 0. c l r y 1 TABLE V ANALYSIS OF VARIANCE FORTRAIL.MUl rhange brnught abnul by the exceptlonal demand placed o n l the rogntttve resnurces by the r o m l ~ amisslon . I'REI'ARKI'ION ON MAI' I'I.~ 11 Milp-(.2001 0 .s~lly ~llllrrco~l PII.'JP Tralt-nlaklllg lrsl lrolrecl ~ t ~ r n r e / x c o ~ ~ d t t k ~ w u n . AND StIORT.W 221250 :17040.3941 81.380d'tIO 6891 72.5741 73. ~ ' c The trail-making test involves two lunctbns: motor speed and nllenlbn.2221 O .81 1) 83.-I 5 890 W7Y.4 1 2.~C IICB~~I I\.--.2491 78. and any decrement In lhex Iimcttons will be dewmenla1 l o combat pedormance.~.038" 118. Tlal l'll.lERM MEMORYW Test Phase l 0.8431 36. "SI*lIllr.68 TABLE YI EFFECT OF COMlVSrrE INI>IANIIEHHAI.-p--p----. 164.442 10.3111 85.788 195.714 lZ0. The stgnlllrunt Increase i n the correct scan may be a n addillonal a m m i i l l o n o l lhls h r t ..lni (lltaw 1 value.uldltioa lest l'k correct1 Belwcen M~IIIIII o~entw 5 k l w r n ~ r~~ri~ns mw 27 1: I S Rcshlual 167 Tolal Shun-term nKlllOry lest (lit rorrcrl rcmgnnLMIl Htlmcn-col~~nlrl means 5 lJ~.26 17.036.033l 72. SERIAL ADDWON TEST. ~ ----------p.

anlnud U: I ' ~ . fiwdn w.nd U merh. have fully met the requirements for prwenuve measures against psychdogical stress and thus were able to maintain the anxlety level wlthln normal llmlts.Tmlo.wm .s-.a r k t w w l ~ ~ ~ . cogniUve p e d o m n e may depend on I I. llrw FW. test Ml: M HN8n. I ~JI~hwnsO ~ I PI I IS+% XI: 14s-sr.~I .~. so.~ w ~ ~ have spedllc &r on mgnlthn functlona. and thereby enhancing their combat elTectiwness. as nlkcted by thelr responses to the IPATANdely Scale. immediately anei the compleUon of a dangerous mission aslgnment. attenUon and vlsuomotortracking. mndWons. Thls task places 1 demands on the wwklng memory and mental models. 6 . According to Abraham.r a & n . . slgnlfying that mmbat stress per se did not alter the visuomotor tracking emclency. and b p l n Lab. I*!. dIhc---llon. and dmg groups. dmWmnrvr -tar vndcr ~ htunr our m k b n assigninenla for the prcccdlng 8 to 10 months. The placebo group did not show any statlsUcally slgnllkant change at the end of phase 11. in 10 war. &KS.comavnd.oratories lor e u o d v l m ~ l ~ ~ ' a n d b o M mr Uw spcUlratlons elven. Inlmduud dvlnp lmlnlq lar d pl(orawrr m svMlul J llum In a hlghly m a i n g combat W m n m e n t Nth frequent danger71-8. U S ~ Y MD. M. ~mB C ~ ~ I ( C ~ rh CA. w ~~: * r r l o p n r n ~ d ~ ~ ~ U M s(J~~~~~ IW rrslnrn~ n c ~ r rrprt ISZ. Vd. I=.e. t h e significant Improvement shown at the end of phase Ill Indicates the llmlts imposed by the combat envimnalent nkntlng and thereby (adlltathg better p e r f o n n w . 'Sast~ys @a&fully &d 1 cant deteioratton. did not reglster any slgnlncant change m either group. S*wJa w m m l d slm In Anny O p c m l h .lttem ofsho. and thelr reticular 6' ~ ~ ~ ~ ~ ~ n R W m " . ~syrhd e v 18: 8% 11s.&ycn ~ e~i y e h m ~ ~ l d ~ U S U ~ U Fpn . The comparaUvely better performanceIn the d2 test and the trail-maklng test by the CIHP group I a clear indlcatlon olthe emcacy ofClHP In s strengthening the crltlwl task elements of combat. This again confirms that Ill I I. Rrwnlednl~uulnualmecUq at the end of phase Ill both groups showed a highly slgnlncant 5.. thae suqjecls had been 8. activating systems andlor thelr general state of arousal mlght 7 ih s 10 IU~ i i nrparrd I ~ h r W ~cduuc-d Km IT r u W w*. After the mlsslon assignment.19. 'lhe ImpllcPtlonr of UU8 llndlng arc that CIHP may lo' ~ & ~ ~ & ~ b .m m t .. 1. the p l m b o gmup also showed a sfgnilkint Improvement only at the end of phase II compand wlth their ~ u d y~u t e s~ u m lor ~ r i u n r u n u q .ndbaenl swrcdkp. US h y . mulawn 11. . In such Inm4. In fhls test. and thelr limlted availability may allst performance advascly. D W c l J E : T ~ l a r I h c M t l e . November 1999 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . ~ ~ c eognlthn m u m s may be adversely aaected. challenge mlght have e a u d edb dctcrloratkm In thdr lmrnedlate r e d . Ill oha Stauatkal tml.IE.. .. h Ikyrkd IW.Composlle lndlan Herbal Rcparatlon and Combat Ellecllveness end of phase 11compared with phase Ii values.hda. N: NCW sutomrm d p b t unl d h ~ncrrvx mnstress-fm environment. Iw. Pd-n W. and the better performance of the d ~ group g 1s tndicatlve of the emracy of CIHP in impmvlng combat ellecUveness. ~ IY 25: performance In adverse environments.N. CIHP helps to cope wlth combat stress and sustain mental 1 vn*o WI: ~'q~huluyy r r b ~ l m ~ h c . and 9. f m W r m m e n t olT&q no It nandlmum w. Thls Improvement wlthout corresponding improvemenl In the placebo group points to the e k t of CIHP on cognitive performance amelloration during Ih-threatenfng mission episodes of combat stress.~ ~ .~. which mlght have nt enhanced thelr confidence of s u d u l l y aecompllshlng the m l m n tasks.e. and tasks that place heavy demand on the 12. the impmvement el thr end of In References phase I1 was Illghly slgnlncant (p 0.A. loss. arduous lralnlng. WW" C:" I a"d I& ha~d ssllulmm'lM m hr nvponsec:alegov. the ohmved changes mlght fall under the normal M WlW" h1k! X l lmporcantly. Wese subjects were conthuously In the mmbat environment wUh f r q ~ ~ ehigh-rlsk mlsslon assignments.h pmdwl81. compllshments. and d l s U c combat tralnlng. and at the end of ~ h a s c there was a sII!IIIII. bank fPtlgoemupled N t h the safe. Frhdbd N. lnltlal m w n s e . the drug group and the group. the dmg group. Thls nndlng sh& that the mlsslon &lgnment places a hcavy demand on attentional resources for ac. there was no staUsUcally slgnlncant change In the level of anxlely of these subjects during the study. and the pllasell response 4. w Mllitary Medldne. these subjects were resthg and recuperathg. ~ rite T m h d a ~ Cmpmtlan Itngram have been at a low ebb because there was no demand. the task demand. Attenlional focus and motor speed are t o critical cognitlve aspccts of comw bat perlormanre.'" mmi ellective preventhre measures against psychological stress are group coheslon. In the combat environment there are many tasks competing for the allocation of these mgnlthn resouras. Sllhv WE.lerm was ldentlcd In :I. " T r s l ~ ~ * U ~ ~ ~ 7 T e c h n I . showing a slgnlficant Improvement only at the c n ' - - m ~ ~ $ . 'lhese subjects. 164.44: 4 ~ 5 1 . . However. by vlrtue of their 8 to 10 months of continuous exposure to combat. Map Ilocllng r!!h m t l B e l m n mlurrtn 5 27 117196 454493 88497 0 23439 357 16833 2 56 655 5 meam Mmn m m m Residual Total 135 135 s t r s s conditions are seen through the results ol this test.00011 and the relapse at the end o l ~ h a s e iuas not slgniflcant.pgn . 1. V W ~ applUilttons and W trmds. and any fallure to fulnll the demand may result In ineplit~~de. adovan Ma* me p.. ~ U I W ud thr rmu~ury. and In a relaxed. ~ S I C ~ D h a Y ~ ~ K R r r U W ~ R m n ~ ~ ST(Mv Y M.I. IUC ~qmmnul * u ~ md n cmmwllc lndm w prrparallon 11 m ?he map-plotung 1 s t response was ldentlcal in boUl placebo sd.. The serial addlllon test response also showed the e k t of Acknowledgment ClllP in reinforcing the cognitive component of combat pedornwncc.&t i f data by ~:~lshnanl V. ts. n)e drug group reglstcred a hlghly signUlcant Improvement In tlie trall-maklng test at the end of phase II. deterloratlon in immediate recall.

c~rIx!r I!ll!l Vd. Indlr.dy#caoclam O a h l p n u r r l r r l ~ m k h hnponynnvl hnllh and B*+nj. Nn IlvIN. 164. ~V. IS.1-4 r l IhSmnnd Inlmwlkml Mllilsly Mcdlcl~~e. ~~lhn1Y.Go&nwthmPI(:Mar. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 84 . Nu\.~MlcnIlubh 1511: 8: 167.IWwPShmrrW:Rdrd~UmhhcYlrUeu ~ndu.~d~~~hmaUlpabrmrrr.Cornposile Indian Herbal Reparallon and Combs1EllaUvmesr 1WB.

M.. Bic~lo~ical stress. 'urn- (Kothari er al. A Composite Indian Herbal Preparation 11 rrssrte tt~crc~bolire ~ ~ c c r r r r a ~tvercs nor alrered during c~ ion (CIHP 11) contains these and other herbs. has been found safe and nontoxic on prolonged me iological functions of the organism. a11Ayiir~fedic conrbirrariotr of severalplanr Crgre. Singh et al. cc. chemical.~paragus racenloslls \\:ild. rlre release of crearas 198 1: Chatterjee er 01.1969). It is possible to support the body's in liquid form or as tablets made from powder mix ati. 1982. Asparagus adsce.~rmaco~nosy i.se~.. tolerance to anosra and decreased the gastric ulceration in rats induced Cc:. The approximate LDSOof the drug in albino mice was between 5-6 glkg hod! ISTRODUCTION weight when given p. of cold and immobilization (Singh er al. multiple stress. H. 33.A. in response to physical.~i:c~lrsrr~ c swirnrrrrtrg exercises tvirlr lirrle difference in blood (Lilliaceae). hypoxin. resrraint-cold- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 85 . T / I I ~ u ~ g e s r e o n s h .vpo.fect during swimming (Singh er al. Delhi 110054.tposr1r.200 rnglkg body weight (Singh er al.l i .. So. 11 had a curnrilarive A number of Indian herbs such as Wirlrat~iasotlro~icproqerrlc properr!.ll o i I'l~. CIHP I1 rtlrake resttlred in a11 irn~ r r r ~ trrcrit~rerrnr~cc blood Q ~ ~ I C O S lC ~ ~ eor rhe e~td ~rd of e ls of nif.and coated with lactose (The Himalaya Drug Co. 1 9 8 ) . for humans the recommended dose for the i-~~!ogical emotional change. t c r : S ' I S tcsrr~icrcdor1 CIHP 11 Ormkc.K. 1985.~l I?''>.ld he addressed. consists of a pat.rma et al. 1984). India ABSTRACT CIHP 11. Sen el al. 1592.lptxion by using chemical intenrention. A. have been reported to possess antr-stress and rc.ra D ~(Solanacene). restraint. Divekar. Srivastava* Defence Institute of Physiology and Allied Sciences. Several products and preparations derived from animal and ~ .lr:pulatron.Ac&eno \\. 1978 ).first 7 days is 30 mglkglday followed with a mainteand tern drenctions that help to strengthen the organism nance dose of 15 mglkglday.. M.o.16 15/9513302-0I -1SC6. Pahwa.pp. Ratan Kumar.ie.... ~ / t o k i ~ rr n s e r r circirlariort durirlg hvpobaric 11..ilrrlor rt~etrrbrorre perr~rectbrlirv. was CIHP I1 liod a srrorrg udaprogerric acrion in single.L. and under multiple stress.bclliferae) and Ph~(lanrhlls emblica L.horn J I I correspondence sho.154 0925. 1991: Shar1 1 1 ~ . Bhardwaj. pb. T11cCIHP I1 oppenred ro irtdrtcc a srare r~it..K. therby cold and restraint.3 Diphosplrogl~cerrc acrd (2.ALUATION COMPOSITE OF A INDIAN HERBAL I1 (CIHP 11) AS AN ADAPTOGEN PREPARATION AND ITS MECHANISMACTION OF S. '1938). 1. The present study evaluated rn. I JY. 1978) under ancitic reslstnllce. and act only under conditions of challenge to the systcm.AJaptogen. Euphorbi3ceae. rrritlriplant 'Iairn possess such properties (Brekhman and D a r d ~ m o v . 1986). Such preparations increase non-spe. exercise.ldens R ~ (Lillia~ lorrrc nerd ns corrrptired tvrrh conrrol rats wirhour CIHP /I tnr. Grover.K.P ro hypobnric h ~ p o r i a11U~rproved endurance promoting properties (Bhargava and Singh. Vol.er. c. ls . ~ . s ~ . However. orld prolorrged dose sclleditles.ernl 1991).c~n-rl~rcrfic rrrcrcased resisrar~ce (SNIR) drtrtrrg stress..00 Q Suets Sc Zei~linger EXPERIMENTAL EV.3DPGr l e ~ ~ con r. .K. ceae)' Ocimum cd of Cenrella Urban CIHP // I ! rrs foltr~dro porenriare rlrc o r x c n deliver?.. CIHP 11 rltt rt3srittgsmre. r ~ : n a t t o ~Jourrl. cause minimal disorder in the phys. Hou. and sub. The drug increased swimming time.oxia (Tomar er al. as well as a passive. 197s). The drug is used either rSsJ!e.. s t m e s ha\ ing such 3 property are called "adapto_~ens" India). Gupta and K.::ords: .rvr ! rt~crrrisrrrg I \ tcd cell 2.a r i o t ~ glrrcose rr~rlisarion.~ / r o .. the adaptosenic effect of CIHP I1 using stvimminp . and Roy er a / . CIHP I1 has been tested for its antistress ei1L2:arev. S. resred for irs adaprogenic acrion.e~. and its effective dose was 100. clicnrs artd rr~it~erals..

) Husk. was concentrated in vacuo in a flash evaporator.7 .S6 157 . (Celastraceae) 1. The rats y e r c kept in S a room [hat W ~ maintained at 25 2 "C with sulficicnr ni~tuml light. (Myristisaccac) Piper longum L. Caprain o l the Himalaya Drug Co. (Zingiberaceae) 1.73 2. (Legurninosac) Mjristica fragrans Houtt. (Xlal\ aceact gum Etttbelia rrbcs Burm:f.16 2.73 0. (Solanace3e) Abhrak bhasma Rasa sindur (Hg. (Compositae) Adharoda vasica Nees (Acanthaceae) Argyreia spcciosa Boj. The rats were made to swim until their rectal temperature (T. 4. CIHP 11 powder was extracted with 75% ethanol In Soxhlet apparatus for 6 hr.) Maton (Ziigiberaceae) I.S.73 0. (Liiiaceae) Cenrella asiarica Urban (Umbelliier3e) G1ycprrlli:a glabra L.\TERIXLS AND METHODS El?-riments icere carried out on randomly bred.14 1. R. (Solanaceae) Terminalia arjuna Wight & Am.14 C~ircirma longa L.p..14 0. Calcutta). (Leguminosre) Eclipta alba (L. The oral drug dose was water extract equivalent to I rnglg body weight of CIHP powdcr.lceae) Berberis arisrara DC. the rars \\..xtract was equivalent to 240 rng of CIHP powder. (Leguminosac) Terrr~rrrnlia belerica Roxb. ex C.11 Elerraria cardamomum (L. (Legum1nos3e) Tertninalia chebula Rctz.57 7 : -. The intraperitoneal (ip) dose of the alcohol extract was equivalent to 48 mg1100 g body weight of CIHP Powder. (Cornpositae) Cassia occidentalis L. Composition o i CIHP I1 Powder (Concentmri@n in w/w%). + CIHP 11 P r e p a r a t i o n CIHP 11 in powder form (Geriforte) was supplied by Dr.3 2.3 2. the alcohol extract o f CIHP I1 was given to rats at a dose of 48 mgi100 g body weight either once or once a day for five consecutive d q s by intraperitoneal administration. The composition is given in Table 1.) Merr..CIHP I1 EVALUATION h!poxia IR-C-H) animal model (Ramachandran et (11.B. after hitrariun. & Hook. CIHP I1 in powdcr form tvas ~ o a k c d water overnight. SI.). The suspension was in tiltcrcd rhrouzh rnuslin cloth and aclear brown colored aqu:ous-suspension was obtai. wiped dry and allowed to recov- Shilajeet (purified) Abhrak bhasma Jasad bhnsrna Saffron Loh bhasrna Mandur bhasma Extracts Wirhania sornnifera Dun.3 2.14 6. (Combretaceae) Capparis spinosa L.) DC.3 2.J.46 1.14 Clarke (Umbelliferae) Celasrrus panicularlcs Wild. 2. (Liliacc~e) Bombax tnalabaricutn DC.) Sweet (Xlaivaceaei Asparagus adscendens Roxb. 1.3 2. (Convolvul.ned.46 1.Anders. CIHP I1 was administered to overnight fasted rats 30 min prior to forced swimming in cold water (23'C). (Lcguminosae) Tamari. One ml of diluted e. The dricd resinous substance was diluted with \vatcr to the required concentration. and the mechanism of action. (Solanaceae) Asparagus racernosus Wild. (Zygophyllncew) 1Virltania so~~tni/cra Dun. (.16 3. extract.)DC. 1990). I4 Syiygiurn aromaticum (L. (Berberid~ccae) Cacsalpinia digyna Rottl.hl. (&lyrsinacex) Hygrophilia spir~osa T. (Cornbretaceae) Cantm copticrtm (L. hc-!thy.57 4. i. India. (Guttiierae) Nutmeg Sandal Wood Tenninalia chebula Retz. It contained many plant extracts and mincrals prepared 'in 3 rcproducibie manner. 3. (Combreraceae) Tribiclirs rerresrris L. 4. All experiments were done on o\s:nlght fasted mts.~ gallica L. Control rats \\ere given an equivalent volume of normal saline. I .67 1.le) rUrtclina prlrriens (L.-\cmthacc. Chayavanprash Concentrate t Euphorbiaceae) Black pepper Cardarnon Cinnamon tamala Clove Ginger Long pepper Mesiiaferrea L. One ml of aqueous q t r a c t was equivalent to 200 mg crude powder of' CIHP 11. The.3 23 .ere taken out. (Capparidaceae) Cichorium intybus L.Benth.3 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 86 .57 3.)reached 23OC. Adaptogenic activity using cold water swimming and restraint-cold-hypoxia models In experiment one. (Tamaricaceae) Mace 1. Table I. At that point. Bomba!.) Pltyllant/tris emblica L. (Piperaceae) Solanum nigrttm L. (Compositae) Mrrcrma p r u r i c a (L. L. (Combretace3e) Abltrilon indicrrtn (L. adult male albino rats of the Sprague DawIc! s:rain \veighin_r 1 7 0 2 30 g. & Perry (h4 y rtaceae) Acllillea ttlille-. The room remained dark from day 191>0hrs until morning The animals had free access to dr~nkingwater and food in pellet forrn (Lipton India Ltd.

1957). and adrenal gland weights were also determined.and processed for further analysis. and cholesrerol (Zlatkis et al. Blood it.3-DPG ~Sclson. the rat csntinued to be in the restrained state.Chem. i t was taken our of the chamber and 3llowed to recover to normal colonic temperature of 5i'C at atmospheric pressure and at 32 -+ 1OC. i. tvarhed in cold normal saline.p. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . New Delhi) and muscle (Smolelis and H3rtsell.were analysed statistically using the Student's r test. 1959). Rats were forced to s\\*im in cold water (23 OC) for 25 min and taken out. The other control group was not exposcd to gr\en an aqueous extract of CIHP I1 intragastrically hypoxia.1944). 1919).1957) was estimated in gastroc. The control group was given normal saline and further subdivided into two groups. In whole blood. C S. The wind flow in tcrdecompression chamber way 2 literslmin.m past the rcclum. . In experiment t\vo. fa11 to 13'C and its recovery to 37'C \\ere used as a mcasurc of endurance in advzrsc environmental condrtions.35 collected from the jugular vein. Liver '11. after 25 min of swimming 'and after 80 min of recovery. After six weeks. Glursmate-pyruvateaminotransferase (Sigma Diagnostic Kit. the rats wcre removed. 1944) and lactic acid (Barker and Summerson.4L Estimation of some tissue metabolites and enzymes in rats exposed to hypoxia Rau were divided into two groups.K GROVER ET. Gers:~iinc.\once a minute. once a day for 7 days 30 min prior to hypoxic exposure. Co. 6 hr daily for 7 R.was collected from the jugular vein. 6 hr daily for 7 days. 195 1 ). he~ n a i y s ~Blood ~ l u c o s e s. IYbj). the aqueous extract of CIHP Il at d o s e of 1 mg/g body weight was given ro rats orally once aday through gastric canula for six weeks. After the hypoxic exposure on the seventh at a dosc of 1 mglg hody weight for six wecks. creatine phosphokinase Gr~. W. In this model. One group was days. wiped dry and allowed to recover at 32 rt: 1 "C for 80 min. Sigma (GPTI (Re~tman and Frankel.e. In the day. The fall in the rectal lemperaturc to 23' C and its recovery to 37 O C at room temperature (32 ? 1 OC) was continually recorded with a YSI telethermometer initially every minute and later ar 5 min intervals. lysozyme from Ranbaxy Diagnostics. fasted overnight and sacrificed by decapitation.olia..(SCPK) [Hughes... After six Lveeks the rats were fasted overnight and subjected to the multiple stress of R-C-H. blotted. St. + nemius muscle and weight of adrenal glands \\. an equivalent volume of normal sa. However. free fatt!. glutamate-oxaloacetate-aminotrans. Blood control group. carbamoyl-or. 1911) levels were estimated colorimetrically. Louis) were estimated. acids (Anstall and Trujillow. Blood upeighed. The hypobaric hypoxia was at a simulated altitude of 6096 m at 32°C in a decompression chamber. Tissues were hematocri~value was determined using a microhcremoved. protein (Lowry et glycogen (hlontgomery. xveighed and processed for furthe? many). tri_c!ycerides (kit obtained te:ase (GOT) (Reitman and Frankel. Blood glucose a n d lactic aciil'levels after cold n-ater swimming a n d recovery frqm cold Rats were divided into two groups. Control rats were given normal saline. Tissues were line \vas given orally. 1951). The control group was given normal saline i.. Blood was collected from the tail vein three times.X. Blood glucosc (Nelson. 1957).p. 1957) were determined.irs uere divided into two groups. in a volume equivalent to drug. One group was gisen an alcohol extract of CIHP 11. 1962). 1944). glucose (Nelson. of The trr~le T. wasestimated in whole blood moglobin (Dacie and Lewis. Procedure NO 665. The rats ~ ' c r e k c p t a restrainer and its colonic temperature in (TI\ \ u s mon~torcdcontinuously with a Isothermex Trmpzrature Recorder (Columbus Instruments. One group was given an aqueous extract of CIHP I1 orally through gastric canula at a dose of 1 mglg body weight. When the rat attained a colonic temperature of 23'C. the rats were sacrificed by decapitation. blotted. er in a room maintained at 32 "C. at a dose of 48 mgl100 g body weight 30 min prior to swimming. 1963) and 2. Serum proni~hine aminotransicrase (COT) (Brown and tein (Lotvry er a[.S.compared with saline treated c o n m l animals and data gcn (hlontgotner~. rats were exposed in 3 decompression chamber maintained at 5'C and lo\\*atmospheric pressure of 428 mm Hg pressure equivalent to an altitude of 4572 m. 1953) were The results of CIHP I1 administered animals \\ere measured colorimetrically in serum. i.. immersed in cold physiological norms1 matocrlt centrifuge (Carl Zeiss Instruments. hluscle glyco. Estimation of some tissue metabolites and enzymes ' one group was exposed to hypoxia 3 0 min after adduring the resting state ministration of normal saline orally.as recorded. before swjmming.. The rectal probe was inserted 2 ~.

ct o i C I H P I1 admtnistrcltion after single and t i \ ? JOSSS [he fa11 and recovery of rectal temperen Jturc (T.11rect~l rsmpsrature ( m ~ n ) i. ~ b w e v e r recovery time from .o there was no change in weight of adrenal glands.2 50.1 7. and COT) and lysozyme were comparable in'CIHP I1 administered rats with control rats (Table 4). Effect of six weeks of CIHP I1 (aqueous extract) at modcl. .3 Serum free fatty acids ( W I L ) 937. enzlmes and adrenal weight in rats.Serum cholesterol (mg%) perature (32 I°C).CIHP I I EVXLCXTlOi': T ~ h l c .1lue5are me2n 106 4 f 5.3 149. .Seruin protein (g%) f 1. the time For attainins Tr 13°C was increased intake on some tissue metabolites.7 200. Serum GOT (pnollmin/l) at 37°C Control CIHP Serum GPT (pnollminll) (n=6) (n=6) at 37°C Time raken to attain 23 "C 87. GPT.001) (Table but Control ClHP I I did not cause any significant change in the ~ u n c e n (n= I I) -~--Tn=i) 1 [ration of blood $ucose. Eliect of six weeks of orai administrationof CIHP 7. When the adaptogenic activity of CIHP I1 was tcstcd in rais after six weeks of CIHP I1 ~ntakc a dose o f I mglg body weight in the R-C-H Table 4.i.\l.1 f 6. In control rats..0 ~oxic stress (4572 m) and recoverv at room tem. si~ntficcln~l) < 0. Control (n= 10) .5 * Adrenal weight (mg) normal rectal temperature (min) f 12.9 I. free fatty acids andrhserved c:lrhohydrates in the form of muscle glycogen in restBlood glucose (mg%) 103.4 107.1 819.4 0.I Trot' 23°C increased significantly after single and I I V C dobes o i C I W 11.E Values are mean f S. I 0.7 enzyme activities of aminotr~nsferascs(GOT.001 tl! trom r S.u) rectal temperature (min) f 6.4 perature under acute cold (5qC).9 Muscle glycogen (mglg tissue) f 0.E. T.3 'Table 3. El'l'cct or 1.9 69.0 tng rats (Table 4).4 f 10.8 * Serum COT (m. 'idm~nratrationof CIHP I 1 (ethanol extract) on maintenance of rectal temperature while suimmlng 2 ln C P I ~\ \ x e r t 25'C) 2nd reco\.5 f 10.1 112.restraint and hy205. cholesterbl and 1.E.5 S i ~ n ~ r i c ~ nd~ffsrer~t controls: P<0.3 Serum lysozyme (pglml) Time taken to recover 160. Serum protein.p. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 88 .) of rats while swimming in cold water 1°C) IS shonn ~ n .5 92.001) and recovery to 37 "C was IP 3150 significantly reduced ( P < 0.001 Values are mean f S. 23?C to 37'C was not affected by single o r five iloscs ol' CIHP 11.8 f 13.0 I1 (aqueous extract) on maintenance of rectal tem.0 f 55. Single dose (n=9) Five dose In=S) Tl~nc raken to reco\er ilur1n. RESULTS Thc ctI. Blood glucose and lactic acid concentra~ionof rats swimming for 25 min at 2C and after recovery 3 ' of SO min at 32'C are givcn in Table 5.2 f 5.5 86. blood glucose decreascd after swimming ( 6 0 4 ) and recovered more than 50C.ery 3t room temperature 32 i 1°C. T a b l e Swtmnilng time to reach 2. of the loss after SO + + + - Sien~ficantlvdifferent from controls: P < 0.

Afrer S mln O of reco\.9. Control (n=12) Pactcu :ell volu~ne Hypoxia (n=i I) Hypox~a CIHP I1 + (n=6) (t) H~cmoclobln 8C'i) R'ed cell 2. Blood glucose (mgQ) Control CIHP I1 ClHP I1 Single Five dose dose (n=6) (n=6) (n=6) Blood lactic ac~d (mgQ) Control CIHP I1 CIHP I I Single Five dose dose (n=6) (n=6) (n=6) After 25 min of c\vlmmlng . Hypobaric hypoxiacaused significant increase in SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .1.9 f 7.5 f 1.05 Values arc mean f S.rle 6.z lrc.9 f 0. GROVER ETAL Table 5. T.K.2 ' ? 6.Adrcnals weight Imp) + Signiiiiantly differenr from controls at P c 0. rng protein) L ~ \ e uetrht r . Lactic acid levels increased hy about 80% after swimming exercise'but after recovery period the values were comparable \\ ith initial values.E. after 25 mln of s\\.c.p. Lactic acid increased after swimming and was comparable with controls at the end of recovery in CIHP LI-treated rats (Table 5)..+luscle glyco$en tmgfg ctssue) Serum lr~glycer~des 11ng5) Serum CPK cm.7 f 0.7 19. The blood glucose recovered 314th of initial loss after the recovery period.4 21. 89. enzymes and in organ wci~hts rats exposed to hypobaric hypoxia equivalent to 6096 m.E.9 21.. mean k S.05. Effect of CIHP I1 (aqueous exlract)'inrake on some hematological parameters.3 t 0.ery period. P < 0.S.05 Valu.cry 53.3-DPG ~umol:ml) %)ood glucose 0 5) : . Effect of ClHP I1 (ethanol extract) i.7 Stgn~licantlydifferent from control.imming. mln ot' the reco\. the decrease in blood glucose level5 \ v n j df the magnitude observed in the control group.2 * 72. tissue metabolites. In CIHP 11-treated rats.c : . Slynliic3ntly different from hypoxia group at P < 0. administration on blood glucose and lactic acid in rats swimmine ior 25 min at 23 'C and after 80 min of recovery at 32 f 1°C.

The intake of CIHP 11. This proved to be a prs:lse 2nd specific indicator of the physical and nicn~:~I psrt'ormance capacity of the organism (Bergh.ClHP I1 E\'ALUATION p-:L. both in single and five consecutt\c doses. 1969). Thus.-. In mts treated wirh CIHP 11. cornprable to that seen in control rats. Swimming in cold water required heavy'expenjiture of energy for escrcise and maintenance of bod?tempenrure.eight) prior I(> !I posic exposure further increased blood 2. and lysozyme levels were maintained.3-DPG impro\ed (he delivery of oxygen to the tissues (Claude er ul. 1968).wirnrnins tn cold or warm warer until exh. The mechanism by which the CIHP I1 promoted the thermogenic process during acute cold stress and during recovery from hypothemia required investigation. Circulating proteln.. 23'C was 72% and recovery was enhanced by 4670.3 DPG.. Polycythemia enhanced the oxygen carrying capacity.3-DPG. h>poxia-induced increase in PCV and deL .) while swimming in cold water I ~ Z ' C ) facing acute multiple strcss of restraintor cold-hypoxia (R-C-H) as an indicator of the resistJniz In LIII adverse environment. 1950 ~ n Colquhoun. It appears that ClHP I1 intake stimulated fat utilisation for energy purposes and spared glucose utiiisation. cholesterol. of rxs reached 23'C. The increase in circulating CPK is a sensitive indicator of structural integrity of the neural. cardiac and skeletal systems. a decrease in blood glucose level and an increase in lactic acid occuncd at the end of 1 5 min of swimming in cold \r.ed that CIHP 11 intake did not result in any metabclicalteration in the bodydurin_e the resting stare. The lactic acid increase..'while 1. The preparation did not affect the body weight gain of the animals in comparison to controls during 6 weeks of administration. 1980) or ~o:<sd. by about 5 0 8 . The ylucosr. or muscle glycogen concentration. h! CIHP I1 inrakc prior to hypoxic exposure.. Ht. 37'C. the blood glucose level was better maind tained ~ n recovered more rapidly than the conlrol rats. 1981 and Martin.. The CIHP I1 intake prior to hypoxic exposure potentiated the increase in hypoxia induced red cell 2. \\r: i h \ c uscd the capacity of the rat to maintain its i<>rr: rctnpcrature (T. This suggts. Polycythemia. CIHP I1 intake also arrested the hepatic and adrenal gland hypertrophy induced by hypoxic stress. In subsequent experiments we have used water extract of ClHP 11. ho\vever. blood 2. an increase in RBC U D P C kt els and a decrease in carbohydrate res6rucull. the blocJ glucose level partially recovered. 3-DPG in rats.d cell ~ o l u m e (PCV). Hw\ever.ar-r (23°C).ed swinimtn: time in cold water until the T. prior to hypoxic exposure restricted the release of CPK to only 1 3 0 8 .~ir:\.\lrJct cqutvalenl to 48 mg1100 g body weight) incrca. aminotransferases (GOT. CIHP I1 was found to be 3 strong adaptogen with a cumulative action. without affecting recovcr! ttme ro T.ery at 31'C. Long term administration of s ClHP 11 ( ~ q u e o u extract equivalent to 100 mgllOO g body weight for six weeks) resulted in strong resistance to cold stress and also decreased recovery time oi rats in the R-C-H model.uit~on t ) ~ . 1986). 32'C). 198J) and Elr~rtherococctrs senricostrs (Katsum~ el al. D!jCCSSION E\~luatlon i the endurance-promoting actibity of o ~ d ~ p r o < r :1ssgenerally done by either t'orcing a rat n or niousr: to clirnb i n endless rope (Fulder.iitseng (Avakian u a/. . Jsath (Brekhman and Dard)nlov. The circulation of this enzyme was increased (about 200%) in rats exposed to hypoxia in comparison to unexposed rats. serum CFK a11d I ~ \ eand adrenal uetghts in rats (Table 6).un. Th~s suggested that water extract of CIHP I1 had a curnularive action and favorably affected endurance lo cold and recovery. Some tissue metabolites and enzyme levels ucre determined in rats treated with CIHP I1 for 6 nceks. After 80 min of reco\. was. In our experiments. Similar changes were observed by us in rats exposed to hypoxia (6096 m. this did not explain the mech'anism of increased thermal resistance. The 6 week intake of CIHP I1 (100 m_e/100g body wetght) did not affect the circulating components such as blood _ulucose and free fatty actds. Ir\-el SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .cr. 1970). 1975) are well-know respomcs to hypobaric hypoxia. GPTand COT. J:.r:~sed SCPK levels and prevented the increase In '!\cr and adrenal weights observed in controls not g!::n CIHP I1 and exposed to hypoxia (Table 6). It appears that CIHP I1 \\-as able to restore energy processes required for the maintenance of the cellular membrane pcrmsability. CIHP 11 intake (alcohol d e. Similar glucose sparing effects have been observed in the case of other adaptogens such as Parras:. This would improve the availability of oxygen to tissues. r ClHP I1 adtninistration (1 mg/g body \\.>cJ Acletal muscle glycogen was not modified r. The delay in attaining T.

K.V. J & A Churchill Ltd. and Frankel.6 3 . lnd.. Comp. 11: 741-747. A. (1959). Smoletis. (1986). Parhol.1. M...G. Clements... I. (1986). N. S. Kugo. R. Hutchinson.Quored from Brekhman..H. (198 1 ).P. Scand. Physiol. Lub.. Katsumt. Clitz... Tala McGraw Hill Publishing Co. Bucr. and Dardymov. A.. Lazarev. (19531... C13udc.S. and Boyle. (1938).11. (1934).K. R... Am.v . R. 2 : 56-63 .M. I. Probe 24: 25-27.V. N. (1944). 122-125. CIHP I1 administration did not result in any metabolic alteration if taken long term in the resting state.. John. Mrd. 5th 731-736.. Takahashi.~ method "Determination of lactic actd" (1941) as descnbed in Hawk's Phy~iologtcal Chemistry S I V ed. S. Chakraborry. and 54: h i 7 . and Imai. and Kohli.M. A. G.N. Barter and Sumrnerson. Eugcnta. L. R..Y. D~cic.F.V.. Shanna.L. Am. Tazuchi.S. Probe 25: 316-322. T.. pp.P.. Biol. Clrern. Appl.J.4. A.. S... R.M. Sen. L. A. F. pp.K. 29: 1 17. BioL Chem 193: 265-275. 1. C. T. ZlatLis.. H. l Bti~rg3\. S. N.. E. Tomar. lnd. lava. J. F. I. E.. H. Plrysiol. Singh. Plror1. Farr. (199 1). I d . 1. Kliboyama. Shanna. S. (1968). M. and Horvath. 1103-1105. D. Clin. A. Bc:yh. Anstall. Montgomery... A. 3: 175-177.. Dehanukar. (1984). (eds. Further. Rev.. Puri. and Valdman. N. I. Bioche~n. Inr. R.A. A. (1957). and Sri\as. Erp. L.. 3(k 29-31. Haimanti. (1981). Matsuzaka.3rd ed. (1957). SO: 151-1 54. (1958).. R. Int. Drug. (1992).C.M. and Talukdar. and Hansell. Manin. S. (1960). M.. Supirnoto. S.. (1949). 16(3): 125-136. Kothan. and Karandikar. Jose. Clin. Clin. 1. Ramachandran. Biol. P. Prncrrcal Hen:nrolog~. London.. Res. Miyashita.. Colquhnun. Brelh~ian. Hu_ehes.Atm. Cltrm.B. Nath. 8 Roy.. S.S .rp.\. Kohli. bird. .) (1963).. Singh. H. (1975). Wr. V. A.. Ray. and Jose.P.a. Ethanophar1nacol29: 275-281. Plnnra Med.Grover.. A\ d i m ... mnr<. Clin... 2652-2656. (1969). (1985). R. S. ~ o \ (1965). S. Divekar. Singh.J. S. S. Acccp~ed: October 7. GROVER ET. 14-33. London. (1950). Pkanta Mrd..K. Fuid-r. Rosebrough.-IL. Audulov.. 1 Biol. .B. Ergonomics 13: 558-560.B. and Patni.K. Crude. N. K . T. 70: 427-434. REFERENCES Allin. and P~thak. 109: 1-39. Quarterly J.. bled. N. I. A.V.IM. and T ~ u J ~ ~ D. and Bhargava.P. during and after exhaustive swimming exercise was hettcr maintained in rats fed CIHP 11.. A. . Lata. U . Crude Drvg Res. H. 1993 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 91 . lrwcsr. S. N. more work is required to explain its mechanismof action.E. 50: SS9-89 I . L.P. lrrd I. K. Muramatsu. P. Singh. Singh. (1982). (1992).1 and Dardymov. N.. In: Tlrc Roo1 of Being. J. Phannacog. 1. (1970). J..K.9: 419-430. Chem 153: 375-380. A. Drugs 23: 133-1?9.J. 123: 758-765. 41: 486-492. Arch Biochem Biophs. 1976. J. (1962). Irl.1. 39: 258-261. Sclye. and Lewis. 47: . J. Nelson. R. Lowry. E.V. Dass. Narh. R. J. Clin.. 73: 443-45 I .P. it strengthened the oxygen delivery system and maintained ceilular membrane permeability during hypo\ic exposure. S. Rcs. . Mi=.. and Randall.!. 30: 592-596. However. (1990). Grisolia. O. Ch3lterjee. W....P. 67: 378-386. Reitman. Physiol. Ltd. N. I. pp. Lub. and Singh N. S.W. A\ta.. Acfu 7: 597-600.126.P.S. Cesar. Brwn.K. Malti.(1969). 1. and Kohli. F a m c o l Toxic01 21: 81-86.P. (1951). (1978). Plrysiol.. K.

INTRODUCTION erbal formulations have been in use for many years not only in Asian countries but globally for well being of human beings (Brekhman. M. Some Indian herbs such as Withania somnifea. Fulder.D. CIHPI treatment restricted the release of creatine phosphokinase (CPK) into the circulation during C-H-R exposure. 245-251 M~N Ann Uebert. 1994). It improved cold resistance during C-H-R exposure and enhanced recovery from hypothermia. B.. Number 3. A.S..Sc. ABSTRACT Objective: A composite Indian herbal preparation-I (CIHFI) containing ingredients derived from 7 different plants and asphalt was tested for its adaptogenic activity and its mechdnism of action was investigated. Asprngtcs rccemosus. Rectal temperature (T. Design: CIHP-I was tested using the cold-hypoxia-restraint (C-H-R) animal model in which the restrained rats were exposed to 5°C at 428 mm Hg atmospheric pressure.K.I. H which claim to enhance physical endurance.5 mglkg-'lday-'. The energy-dependent cell membrane permeability was maintained.K. Resdts: After 12 weeks of administration of an oral dose of 7. Ph. 19%. and Pueraria tuberosn have been shown to enhance resistance to stress and phys- Department of Biochemistry. Defence Institute of Physiology and Allied Sciences. GUMA. The Indian system of medicine. India. and nonspecific resistance of the body have been termed adaptogens (Brekhman. mental functions. Ayurveda. . CIHP-I helped impmve resistance to C-HR induced hypothermia (. New Delhi. DIVEKAR.THE JOURNAL OF ALTERNATlVE AND COMPLEMENTARY MZDlClNE Volume 5. B.K. Srivastava. M S . A.D. and K. These herbal formulations. (FFA) from adipose tissue. H.. Asparagus adscendens.. B.D. 1954. Ph.P.. has particularly used a number of herbal formulations for this purpose (Nadkarni. Conclusions: The results suggested that CIHP-I is a s m n g adaptogen.. CIHP-I was found to possess significant adaptogenic activity. GROVER. 1980. M. 1980). 1980.. riods.. The time for fall of T to 23°C and its recovery to 37OC were used as indices of endurance and the adaptogenic activity. 1994). Ph. M.Sc. Nadkami. RADHEY SHYAM. Enhanced Thermogenesis in Rats by a Composite Indian Herbal Preparation-I and its Mechanism of Action RATAN KUMAR. Inc. Stored lipids were mobilised and possibly used for thennogenesis in preference to carbohydrates. pp.. S. 23°C) in animals by increased mobilization of free fatty acids T .M. Ocimtrm sanctum. SRIVASTAVA. An ancient Chinese herb Panax ginseng has been described as an adaptogen (Kumar et al.D.A. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 92 . 1954).Sc. Srivastava. 1999.) of the rats was continuously monitored during the exposure and the recovery pe. Blood glucose and dluscle glycogen levels were maintained.C.S. Carbohydrate and lipid parameters were investigated to find out the nature of fuel being used during thermogenesis. T i u r .

1981.DC M~rc~r~rn ~~rtrriots. Grover et al. 1981. Wild Wil11n111n sortrrr~firrr. The mechanism of action of this CIHP-I1 in ihcreasing tolerance to stress was also evaluated and shown to be due to its action in increasing glucose turnover rate and preferential utilization of fat (Kumar et al. The rats were maintained at 25'C 2 2°C with natural light during the day and no light after 1900 hours until morning. the desired dose of CIHP-I was administered to rats orally in 0.aluated for its antistress and adaptogenic activity and its effect on fat mt~bilizationfrom adFpose tissue in rats. The shelf life of the preparation was 1 year. Asphalt (Shilajeet) which is a palo brown to blackish brown resinous product of fresh and modifiod remnants of humus. p i s rnwiirosrs. occurs worldrvidc in steep rocks (at altitudes ranging from 1200-5000 m). fed nd libihtrir.46 8.. Sohrab. Another composite Indian herbal preparation (CIHP-I) that contained only 7 hrrbal components LVitlmr~in soirrirjfirn. CIHP was ekluated for its adaptogenic activity after a single Jose administration (starting from 0 to 150 mg/kg-I body weight) using cold-hy- Aspnrnnprts n~ci~rrrii.23 'Aqucous extract of all the ingredients in the given proportion was vacuum dried and mixed... India. of CIHP-I for rats was more than 10 g/kg-' body weight in a 14-day observation trial after administering it in a single dose per day. and asphalt has been e\. 1978.33 16. and had free access to water at all time. 1951). 1985. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 93 . In the experiment one. Several composite Indian herbal preparations (CIHP) are being developed and have been evaluated for their antistress and endurance-promoting properties (Kandeparker and Kulkarni. 1992. It is used in Indian medicine to stimulate pnvsical and mental performance (Nadkarni. 1995).5-mL volume with the help of a gastric cannula.5 mL water. Shanna et al. A CIHP I1 containing 39 plants and 6 minerals has been observed to have antistress properties (Singh et al. healthy. Median lethal dose (LDH))amount of substance to kill one-half of the population of test animals. The animals were reared on a laboratory chow (Gold Mohur rat diet from Lipton India I-td. 1995).Dunal Pclcrnrtn r~thrrosn.KUMAR ET A L ical and mental performance (Bhargava and Singh. (India) as One-Be.). .. CIHP-I powder was dis~ o l \ ~ e d water in concentration of 40 mg/mL in and suhscqut~ntlvaftcr dilution. in press).46 4.92 Roots Tubers hds Rhizomes Whole plant Fruit 8. The composition of the CIHP-I is given in Table 1. admixed with plant and microbial mctabolitcs. Several batches of the drug were produced by a reproducible process..n brtlb!firn..its. Control rats were administered orally 0. P~rrrnricihrbcrosn. Experiments were carried out on randomly bred.46 8.32 Asphalt extract 7. q l r i n sprciosii. adult rnalc albino rats of the Wistar strain weighing 100-150 g. Diossort. Jani et al. Aslinrn-. 1954). Kulkarni and Verma.Sweet Pipcr I U ~ I $ I I ~ I I . Linn Rcmts 29. 1982). To evaluate the adaptogenic activity. Singh et al..The chemistry of asphalt has been worked out (Ghosal et al.92 16. 1981. A l . DC Diosmrc-ri Il~rlh~firn.. MATERIALS AND METHODS The CIHP-I in water soluble sterile powder form was provided by Lupin Labs Ltd. The CIHP-I is being commercially produced by Lupin Labs Ltd.i~rr. Pipcr lorrgtirir. Linn A r f v r ~ nb}?rciosn. Mttstrtrn pr~tri(.

kidney. constant room temperature was maintained because the recovery time to T 37'C of rats de. Cat. One milliliter aliquot of incubation medium was taken out at 1 hour of incubation and FFA were d c termined in the aliquot by the method of Falholt et a1. 7C Stntistical ailnlysis The results from CIHP-I administered anitissue liyol!/sis nild mals were compared with water-heated control animals in all the experiments and the data Rats were given CIHP-I for 12 weeks (7. adipose tissue was removed. When the T reached 23"C. during the recovery period. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .:Gastrocnemius skelebl muscle tissue was digested in 30% (w/v) KOH and 0. and glycogen was isolated by the method of Good et al. When the rat attained a rectal temperature of 23°C it was taken out of the chamber and allowed to recover to normal rectal temperature (T.. as any furthcr fa11 in rectal temperature was found to result in high mortality. The time and pattern of thc . blotted free of kg-' day for up to 3 weeks kesulted in low . The rat was kept in a restrainer and its rectal temperature was monitored by a 16 Channel Isothermex Temperature Recorder (Columbus Instruments. The cooling of thc rats to 23OC was taken as the termination point ot the cold-hypoxic exposure. pends on the room temperature. thp rat continued to be in the restrained state. epididymal fat pads of an average weight of 250 mg were incubated in 5 mL Krebs Ringer bicarbonate buffer. To determine the adipose tissue lipolysis.However. uiz. The last dose was administered 30 minutes before exposure.. In another experiment another set of rats was given CIHP-Imlly at a dose of 7. and exposed to the multiple Results were considered significant at the p < stress of cold hypoxia-restraint (S°C. blood.. (1973). The rectal probe was inserted 2 cm past the rectum. 428 mm 0. 75. and 150. heart.5 was analysed statisticallyusing Student's t test. an. OH) once a minute. testes. After establishing optimum dose. lung. mg/kg-l day). Other organs. fall to 23OC and its recovery to 37°C T were used as a measure of endurance (Ramachandran et al. (1933) and dissolved in 5N HzSO4. at B dose of 15 mgl Epididymal adipose tissue and-gastrocnemius skeletal muscle were removed.) of 37°C at normal atmospheric pressure in a room maintained at 32'C z lCC.5.The CIHP-I wasgiven at a dose of 7. NO. pH 7.. 1972). After neutralization suitable aliquots of this solution were taken for estimation of free glucose equivalents of glycogen by the kits obtained from J. adrenals. Blood glucose in hepahizedblood was estimated using kits obtained f o J. 1951) and free fatty acids (FFA)were estimated by the method of Falholt et al.(1973). rm India (Glucose oxidase/peroxidase.. Hg pressure).4 (Umbreit. The results are expressid as microequivalent FFA released per milligram protein per hour at 3 ° .5 mg/kg-' body weighf for 6 and 12 weeks. 196. and spleen were removed and their weights were recorded. 1990). washed with normal saline and after delipidization.0. Mitra k Sons.0 mg/kg body weight orally as described earlier to overnight fasted rats 30 minutes prior to exposure in an animal decompression chamber maintained at 5 C and low atmospheric presO sure of 428 mm Hg equivalent to an altitude of 4572 m. Mitra & So*. once each Jay prior to the C-H-R exposure.THERMOGENESIS BY CIHP-I AND ITS MECHANISM poxia-resttaint (C-H-R) animals model (Ramachandran et a]. CIHP-I administration.5% (w/v) NazSO. l set of rats was given CIHP-l orally at a dose of 15 mg/kg-I body weight. 15.05 level.Serum protein (Lowryet a]. At the end of incubation. The serum creatine phosphokinase (SCPK) activity was_assayed by the method of Hughes (1%2). Blood samples were also collected for serum separation. and processed for further analysis. 1990).1) containing So/" fat free albumin in an atmosphere of 95% O2 and 5% COz at 37'C in a Dubnoff metabolic shaker (Exton et al. 1951).0. imals were killed by decapitation and blood RESULTS was collected in heparinized hrbes. liver. Columbus. once a day for 5 days. ME0 12000). weighed.DeM. A. protein content was determined (Lowry et al.

The duration of cooling time to 23°C increased by 30% at a dose of 7 5 mg. 3' 7C SEMJ - Vehicle (controls) 75 .60 2. TABLE EFFECT SINGLE OF CIHP-I 1 RATS ox MAIWEXA~CE 3. OF ~XBE s OF RECTAL TEMPERATURE OX EXPOSURI: (.) to S0C. CIHP-I treatment also restricted the release of CPK in circulation by 48?" (Table 6) during acute hypothemia (T.0 mg/ kg body weight. m r (15MG/KG/DAY) THREE W R WEEKS AND THREE WEEKS THE BODY OF. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 95 . to 3TC from 2 ° was ie f T 3C also observed to be decreased (approximately 40%) at a dose of 75. When the CIHP-I dose was reduced to 7. in the C-H-R given in Table 3.. 23"C).75 lf0. 157. The low gain in body we~ghtwas observed in control rats given CIHFI (Table 2). WEIGHT GAIN RATS OF M y wight (g) mcun 2 SEM %/BSEQUE~TLY R C ~ E D C OVER FOR Weeks Initial First week Second week Third week C~OSJOV~~ Fwrth week Fifth week Sixth week -- After third week. prior to C-H-R ( T .72 103.00 t 5. is shown in Table 5. T. respectively. 3T"C decreased by 18%.47 163. After 6 weeks the duration of the cooling time was increased by 11550 (from 65 minute to 110 minute) as compared with control rats.0 65.0 150.5"h and 26. and 150.5 mg/ kg-'/day) for 12 weeks were also not different when compared with control rats (data not given).0 mg/kg.02' 04. TABLE E c O F CIHP-I ADMINlSTlUllON 2.0 5 5 5 5 5 75.5 ing/kg-'/day) for 12 weeks in rats. Significantly different as compared with vehicle led control rats.5 mg/kg per day and given for 12 weeks. At a dose of 150.7%after 6 and 12 weeks. 45 f Recovery t m o . CIHPI administration (7.5 mg/kg. to fall to T 23°C was increased by 9% after administration of single dose of CIHFI. (Mcnn - To nttaB~T.3 = T~gnificantly different as compared with veh$k fed control rats.00 = 6.I .RE RESTRAIPCD IS STATE fTintc i ~ tniirtl Dose tngAcg- ' To attain n T W°C .80 t 2. Composite Indian herbal preparation-! (CJHP-I) was given to controls and its intake in experimental animals was *ope. after oral administration of CIHP-I for 6 and 12 weeks at a single dose of 7.5 mg to 75. maintenance 01T during exposure.0 mg/kg the cooling time was observed to be further increased ( ! % o control values). C W . adipose tissue lipol$is. The effect of single dose of CIHP-I at different dosage.5. are given in Table 4. rliz.0. 15 mg/kg-'/day. muscle glycogen..40 2 2.20 t 3. body weight gain as compared with the control rats.42' 85. c o m p i t e Indian herbal preparation-. 0 r 42' 34 .KUMAR ET AL.80 2.80 2 3 6 ' . and serum FFA levels in comparison to control rats (Table 6). The time required for . 75.9 95. The effect of a single dose of CIHP-1 administration. The thermoregulatory capacity of the rats during exposure. It was not increased further with increasing dcsage kom 7. 7. The weight of different organs of rats administered CIHP-I (7.62.23 83. 15. animals were crossed over.. 2') 3C. The administration of CIHP-I was crossed over in the following 3 weeks. in relation to maintenance T model are and recovery of . there was no significant change in the body weight gain as compared with the control rats. 428 hlhr HC ATMOSPHERIC PRESSL. resulted in a significant increase in blood glucose. When the rats had been given five dose of CIHFI 1 dose per day.0 mg/kg and above. the time for . 15.86* 9 . to fall 23°C was significantly T increased by 29% and recovery time of'T. for 5 days on the .00 2 6. The intake of CIHP-I decreased recovery time by 34.0.

57 7. \ ~ \ I ~ ~ I . (control) Single 6 86.00 = 107.\rcccr ) 0 E\I*~-L re> 5'C... T.rhal prepamtion-I..il1 = n..70 =5. '\C .II\ I I tT.) Adipow tlssue lipolysis (meq FFA released/mg proteinihr at 37C) Serum CPK (mlU) 5 5 3 .60'177.\\~ I c (11. .15 ~0.tori.00'=10. \'~-l~~zlc.5> \ I ~ I I \IG/K(. XPK.E os GI.THERMOGESESIS BY CIHP-1 AISD ITS MECHANISIM DISCUSSION CIHP-I administration at a dose of 7.N 0.T ..cL.\SIS ASD SCPK A c r ~ v ~ n R ~ r s (IF Eurhl v ro Ct11v . 42n \I\( He. (.) c>s E X ~ L R TO 5'C.30 =1. EII:I:C.rjwrbr~c~~rtnl 105. I 545. The prepara. but was unable to increase rats. \ (7. I ~ H IPHESSLIII RISTI<. Au11. free fatty acids.5 mg/kg.10 B I I M J gluccw Img "it) hluxle glycogen mg/g tissue Serum FFA (mq/L) Serum protein (go:.iN) = 5.38 2565.l\.\III h.20 = 55' .I . lnd~an hcrbal prcparattc~n-I.19 7.80 '%<~i~l~t.(X) I 3.2l)* 2. 428 11s1HG E AT>~OSPHERIC PRESSURE RESTRAISED IS STATE T !I{I I q. fTi1il)te1 I I I ~ I I ~ 11 (T.18.15 0.00' Ih5.5 mg/kg.T CIHP-I :IU\II\ISTII.tr.i TISSLE LIPOI. Dowrs~ 1 1 ( M L ~ = ISE. SI~ L \ IPlrirrl.~K.00 7.IX) 14o. rectal temperahare.69 =O.. CIHP-I.OII SEIM) = n svl.07 E. serum creatine phosphokim...rp$rrrc~ obtnr11111~q 23'C) T..81 ~0.\XU H ~ I T ) \ ( i. 37'C control animals up to 12 weeks.56 52.:i-C o II I (MI. Co#ltn~l 65.MLWI. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 96 . C-If-R 1-.00 32.10 87.89 ~0.21 10.00 r 5 .00' 153.32 18.W z 4. \ wc \ Sr ( TIIIIC1 111111I 1 1 )I T ettitr~~ 23°C o T.l) ~ I tion had no gross effect on the weight of the internal organs even after prolonged intake for Vehicle 6 76. the recovery from C-H-Rstress at a CIHP-I CIHP-I. -Sisnificantly different in comparison to vehicle ied and cold-hvpoxia-mtrain (C-H-R)exposed control rab..tN) r 4.00 = -1.U E .20 r 1Ih. SI:RL\I FFA.its CII 11'-I. 428 \ I \ I He.)\ R..rjmsrrriP II (011 A k r C-H-R ~.51 171.208showed that the preparation was effective in increasing the resistance to cold-hypoxia at a 'Signlticantly different irom vehicle ied control rats.70 3. composite Indian h. iompiisltc.30~ 7.06 = 3.. / ~ .M 135.91W.60 ~53.60 20.65 12 weeks at a dose of 7. ~ p e n ~ ~ ~ n ~ t n l Co11tr01 68. FFA. 7O.KI )C.50 = 2. 0 . Bt.30 = 5.20 +3.89'20..5 \ I C .45 =U.. T ~ I ~ ~ ~T.80' ~3..30 = 2 5 ' .31 0.~ntly dllh~rent from vrhlclc t c d iontrcll r. composite Indian herbal preparation-I.84 The-single daily dose response of CIHP-I Five 6 98.70 = 3. and body weight was comparable with To attiti11 T 2jCC To attaal T.6)I0.9 167.58 10. -5gnificimtly different irom single dow administered dose of 7.. .LCOST. ~zimtroll CIH1'-I Trc~trd Vchlclc icontrol) Cllir-l Treat4 n 12 h 12 h5.5 mg/kg body weight was found suitable for prolonged intake.?\vt~cL~.48 23.\rs c)\ MAI~TI:X.\III~\ K IOI<) T ~ I I WEEKS BICWO I ill: (7.36 51 1.~0 159.62' ~0.69 3 =0.80 +2.07 12 7.Z - - 169. EI ITLT or SI\ \XI> TWI ir LVI I h\ 01CIHP-I A I ~ I I \ I S T R . I. RI i r \ I Ti-\l~-ra.03 ~0.\IXI\(.\.00 'Significantly different in comparison to unexposed rats of the respective group. Ar\loLj1~111:~1(~ I PHFSSURE)ATT. \..28 0.\I\I. 23°C 0% Tub.I:\.

India for providing the CIHP-I and sponsoring this work. ACKNOWLEDGMENT The authors thank Lupin Laboratories Ltd. Clin Chim Acta IYi3. Gupta AK.trr~tt I. 1YA).ii~ti. 37'C. Chattoyadh\ay Dl'.7597-600 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Urrkhman 11. The results also suggcsted that CIHP-I acted in s p r i n g carbohydrate reserves as evidenced from better maintained blmd glucose and muscle glycogen Ic\.~491. administration of ~ ~ ~ (7. Intrractic~n of glucocorticoids with glucagon and epinephrine in the ccmtrol of gluconrogenesis and glycogenolysisin the liver and oi lip~lysis in adipose tissue. 23OC) of animals by more mobilisation of FFA from adipose tissue and better maintained carbohydrate reserves. Five herbal components i n d asphalt presbnt in CIHP-I were common to ClHP 11. Activr Suhstancrs. Stress-induced neurohumoral changes play an important role in increasing adipose tissue lipol!. Fricdmonn X.. An easy colorimetric mi. l'ahwa ML. Kramer H.A.5). J Biol Chem 197?. S . In normal and pathological serum.Divelwr Hhl.5 nig!kg) for 12 weeks and exposed to C-H-R (Table 6). Lund B Falholt M . Ccmd CA.24:155-161. and &jolaw jctivit. Adipow tissuc mrtabolism during li\pobaria. IYH1.sis and providing more FFA (Chattopadhyay. Ghcwal S. I'ark CR. ~ d a ~ t o ~ e n been shown to restrict the release of CPK in circulation by aiding the oxygen delivery system (Srivastava.33:1*13.5 mg/kg per. it was able to increase the recovery time as well. \Ian aiid Bic~logic. The thermoregulation capacity of the rats under extreme conditions increased significantly after 6 and 12 weeks of CIHP-I (7.5 mg/kg) for 12 ~vccks and cxyosccl to C11-li (T. 1991). We lia\. REFERENCES Uliarg. Carbin JD. The increase in SCPK activity is a sensitive indicator of energy-dependent cellular permeability and injury to muscular. Int J Pharn macW"Y1995. The determination of glycc~en. Dcf Sci J 19. Srivastava KK. Hakim SAE.4. :\iitistrrss ~ctivit!. lndian remedies for p r memory Br Med J 1951. The chemistry of shilaiit (dour.117:3519-3588. Exton JH.1 weight) for l2 weeks was observed '0 restrict the release of CPK into the ~ i r ~ u l a t iof l l ~ C-Hexposed rats. New Scientist lY(W.5 mg/kg) intake in terms of delayed . 109. BicJ Chem 1933:11K).. The adaptogens offer an interesting alternative to managing cold and hypoxic stress of extreme terrestrial altitudes.. Bhardtvaj SK. ' cromethod ior routine determination oi free iatty acids in plasma.. body p . T fall of T to 23°C and faster recovery to . \Vong .. Oxiord: I'crgamt~nPr~?is.. Ind J Chem 1993. Kumar R.. Clin Chim Acta 1%2.5 mg/kg-'/day and it helped with better resistance to the C-H-R-induced hypothermia (T.. comparison to control rats. Fulder S.ill!. Saiki K. an earlier investigated preparation which contained 39 plant components and 6 minerals (Grover et al. A method for the estimation of serum creaHughtine kina.SLB:4o-U. Singh.73:443451. The results of the present study show that CIHP-I had strong adaptogenic activity as tested by C-H-R animal model.b:37&3i9.. in This suggested that some part of FFA mobil i ~ c dfrom adipose tissue is being utilized for cvtra energy generation under the influence of CIHP-I intakc that might be responsible for increased cold tolerance (T.Kawanishi K. and administration has neural cells. This suggested that CIHP-I had a cumulati\re action. Ellcii H. Park JB. J Grover SK.2:851-853.c observed that in rats administcreci C1HI'I (7.0 mg/kg. Falholt K. wherr they undergo intramitochondrial oxidation to generate energy. Ind I %1'~1 Rc?.5':ab wliile thc rise in serum FFA was only 3H. The CIHP-I evaluated in the present study contained 7 herbal components and asphalt. dose less than 75.23°C) in the animals. However..els in rats treated with this preparation (7.16:IOF111. 01 ~~irttttott u?rrt.KUMAR ET AL. when CIHP-I at a dose of 15.Wq9.iva KI'.0 mg/kg was given for 5 days.U. 1974) through the circulation to energy Jc~ticicnttissues. In the present studv. cardiac. observed earlier. The preparation had a strong cumulative effect during long-term administration even at a low dose of 7. The drug that builds Russians.Experimental evaluation 1 of a Commite Indian Herbal Pre~oration1 (CIHl' 11) as an a d a ~ t q e and its mechanism of action. adipose tissuc lipolysis increased bv 43. 23"C). Somcxyi hl. This suggested that CIHFl was acting at a cellular level in maintaining the energy dependent process of membrane permeability.

herbal psychotropic preparation in A .lt~c.fi~.inti IA~p. Singh SP. Drug Res 1978. 246-549.3-:3Y.r~t~stt~. nlques: Minneapolis. c I Eth.l XIc~li~3.AL. mlnlhtratlon. Lrnbreit WW.\K. Protein XI.lgcnt.~~ii~h.Z. Int J Crude Res 198220:29-35.I~III.ldPrinters & Publishers.. b \ I'ii~m.stol Phdrrn~col1991.~.THERLMOGENESISBY CIHP-1 AND ITS IMECHANISIM Jan1 YK.19:93-95.D. Kohli RP.r ~ J I Kurn.r\ O H . edition.itih.P. Gro\. Ray. ell.astava KK. Antltatig~le etiec!s ot inherbal drug which enhances survival during stress (an di~enous r u ~ d 'Centorte' in rats. ~ ~ l . trt D~7111i1 10 054 (Irrrlin) I\. -. Manometric TechI. Gupta AK. M. Ro~ctrrcxtxh Fxr . Bt>oL K.er SK. Divekar HM. I Y q I . Grover SK.\ 1tli.l~tmln~slr.astava Kidwa~ AM..tn\.~v.4 (&lentat\.. Indl. Kohli RP. a rejuvenating Kandcprkar CK. Address reprint requests to: \.l\. Ramachandran U..indr. Srirnstflzn M.cnrs~s rats in iolop and Allied Sciences. Nath R. Stauffer IF.~~nililtc.y.11 H. K.ct> long tit ttSrm . Ind Drugs 1981.v:..Nath R.-iYl. Delhi.1 . 11iti1.7-2s I Llrckt~oi~ o d . I<.n 'the . 19M:132. brane integrity changes at high terrestrial altitudes. ~ p t i ~proctuits. Ind D r y s 1981.Srivastava KK. The memmctcc)rol IWh:. Bhargava overview.~icutlcalBiol (in prms). Tiiimrprr R <I\.il nu)Jel tor thc c\valu.I Ileh. L:.lni.~ch. Pawl RB.2Y: ~t~tl~ airti A l l i ~ ~Sri~vrccs ii -. Evidence for nootropic eifect of evaluation of anti-stress effects of Geiiforte. India: Today & Tomorrow iornposltc Intitan herbal preparation I1 (CIHPll) .ir 5M. Srivastava KK.~t. Stay in High .lrm. In: Kumar R.A. Director (Projects) Kh.ititiih.16. Yishra N. Q J Crude BR. 1994. Sri\.lragusracct i i o ~ t 111~119 l~ittIlru+ IYSi. rnult~vttarnina and minerals.1: P~~pi11. New cxycr~m~~it. Lata A.lrn~ . h.~r 5.1n1.3629-34. Witlm~rm sotitrr!~trn(Ashwagandha). lc13 2(>.Sc.501-505. D. Enhanced thermol.itrrt.~ctil IY40. Shyam R. WN: Burgess Publishing Cornrncasurcmcntz wth Foiln-phenol rc. Plr.in \l. KP. An experimental Kulkarni SK.Mountains and Pa)tfl. Kulkam~ RD.rr. Sri\. J Biol Chem pan!.lr R.ir Dcpot. 3rd 130nib.lr~ .iY:IS. Rand.cr SK. Int I Bio. ~ r.A.7.i . New Delhi.\ Cro\.~t tih. Patel \lR.3-25. 1954. Pharm.ista\. Singh N. ro~thot :\hh!vd~dndh.r.?:i. 1991. Verma .i of 3-- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 98 .ill RJ. Ptrt*riirm ttrll~*rowl: An Singh .Sri\.lt~ontit Difcrice lr~stitlltc Plty~lsiolugy .~ A I. V I c. Ind I Ph!. Pahwa ML. Slechan~srnot ~ n c r e a ~ d tolerance to stress . Radhey w11. Divt*harHSI. Biomembranes in Health KK.\I. India: Publication Detence Institute of PhysSh\am.18: adaptogen).liter and Disease. rnlzc.16:15136.~noph.ln C. Upreti RK. Burris RH.

ANTI-ARTHRITIC DRUGS .

K. H Singh . R e p r W from : Rheumatism Vol. 19 No. S S ~ishra .A PRELIMINARY CONTROLLED CLINICAL TRIAL OF INDIGENOUS COMPOUND DRUGS IN CASES OF RHEUMATOID ARTHRITIS* By : R. S Bhat . M. 2 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 99 . . Tripathi & N.

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 101 . in cases which could be followed up for a period of three months a r e summarised in tables 2-6. The grades of these manifestations showed a minor reduction in 11 patients treated in group A. (Table-5).R. (b) Grip power in both hands and (c) The pressing power measured with the help of a sphygmomanometer. In psychological assessment only 10 cases (4 in group A. swelling. (2) The rate of shift of the grade of severity of major signs and symptoms of the disease rated with the help of a symptom rating scale (Table-I).) RESULTS AND DISCUSSIONS The results. The clinical manifestations like fatigue. here is evidence of reduction in state and free floating anxiety after treatment. The 'e $ cases receiving trial treagment in group B showed notably better result-s I compared to other group (Table . (5) Psychological assessment in terms of changes in tbe level of anxiety measured k i t h the help of Swamoolyankan prashnawali (anxiety scale. (I) Qmptomatic relief and changes in feeling of well/ill being. The patients were followed up every fortnight and the results were recorded on the following parameters. canstipation. The haematological studies revealed significant reduction In E. U. joint pain. constructed by Dr. (4) Laboratory investigations in terms of changes in haemogram and E. loss of appetite. R. H. soft tissue changes and deformities if any were found influenced by the treatment. stiffness. R. Thus if can be conclued that the drug Rh-1B (Rhumayoga)may have a moderate degree of anti-arthritic effect insubacute cases of Rheumatoid arthritis. (3) Rate of functional recovery in terms of changes in the following indices : (4 Walking time.S. The patients treated under this trial showed a moderate degree of improve&ent both at the level of symptoms and joint functions. tenderness. Tripathi of the Department of Psychology of 'B. while the haemoglobin percentage and other aspects of haemogram did not show any change.(Table-4).R.2). fever. Similarly the assessment of the functional status showed only a slight functional improvement in case of group A while the functional recovery was found more in case of group B (Table-3). malaise.tablet8 three times a day. 5 in group B) could be followed up for a conclusive duration of time.S.

which did not show very good response in acute cases. 2 2 3. Rh.Rh. 1A (AU)was tried in the dose of two tablets three times in a day in three patients of Rheumatoid arthritis with acute presentation for one montheach. However. Stiffness 0 1 2 3 0 1 2 3 0. Deformity SELECT RESEARCH PAYkHS ON EVIDENCE BASED AYURVEDIC DRUGS 102 . 1A (AU) also. Swelling 4. Further extended trials are suggested. it appears useful and is worth trial in acute Rheumatism.took a minimum of one weak to show respoose in acute cases. Joint pain Absent Minor Moderate Severe Absent Minor Moderate Disabling Absent Minor Moderate Severe Absent 0 1 2 3 - - - - 2. 3 0 1 2 3 0 1 2 3 Functional Disability Absent Minor Moderate Crippling Absent Minor & Localized Moderate Severe and Multiple 6.6) and tbe drug appears to be superior than the two other coded trial drugs. Sbowing Rating Scale for Symptoms of Rbeumtfslll 1. Tenderness . Minor Moderate Marked 5. These patients showed significant improvement (Table.

5 0.29 21 . 10 .77 Muscular wasting 0.0 11 .2 1 6 12 .0 1.60 1.50 .36 2. 0.0 1.0 1 6 1.90 1 9 1.1 2.45 2 1 .00 1.0 0.6 12 .0 2. 10 .6 17 .5 2.6 1.72 13 .8 18 .1 1.3 . 14 .55 1.0 19 . 12 . - 1.W 16 .40 .18 21 . 04 . 14 .3 1 7 1.00 1 0 .0 1 6 1.0 0.20 10 . 16 .75 10 .0 16 .3 1.6 20 . 0.00 0. 15 . 10 .80 . 06 .33 13 . SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 103 .10 1. 04 .52 22 .00 . 16 .3 1.90 1.27 2.40 .0 1. 10 .63 0.6 2.3 .66 1.40 Soit tissue Loss of function Deformities 11 1 . 15 .75 0.47 2. 06 . 3 .11 Local temperature 1.20 16 14 .5 07 .75 1.10 1 7 .2.7 11 .8 2. 10 .50 17 .1 .64 16 .00 05 .1 0. 10 .77 2.82 2.3 09 .83 19 .0 2 3 2.0 16 14 .00 10 .60 1. 12 . 10 .75 0.1 16 . 12 .Sbowing the rate of symptomrtic recovery in terms of grades of some systemic and local manifestation in the twe comparative groups Group Rh IA Observations Initial Group Rh IB Initial 15 days I 2 month monfhs 15 days I 2 month nronths Fatigue Malaise Fever Loss of appetite Constipation Joint pain Stiffness Tenderness Swelling 1.44 16 .58 2.70 Values are mean grade Scores.3 1. 08 .25 1. 12 .17 1. 10 .

5 25. 4 1.23 21. hand Pressing ponrerin m a Hg.6 Showing the haematological changes following treatment in two groups - Investigations Group Rh I A Initial Follow up Group Rh 1B Initial Follow up 35.OO 32.5 49.00 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 104 . S.19 72. R.50 Walking time in second Grip power in mm Hg. hand Et. in am.Showing the pattern of functional recovery in the two compuati~e pomp& -- Functional tests Group Rh I A Initial Follow up 28. hand - 66. Rt.0 Group Rh 1B Initial Follow up 45.1 63.14 Et.42 31. Rt.14 51. hand 58.19 62.50 E.0 55.

2 +++ +++ + 54 84 53 49 ++ +++ + 82 45 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 105 . Abrar Ahmtd Ram k h a w Average +++ 4++ 70 56 +++ ++ 35 60 + +f 42 63 + +++ 51.5 ++ ++ Group Rh 2B Anxiety Initial Trait Free Slate floating 49 40 42 S . Awadhesb Yadav Banarasi Pd. Anxiety Initial Trait Free State flooring 73 64 66 a+++ S. No. 4 . 4. 2.25 63 +++ -t++ 58 +++ 42 -t+ - ++ ++ 58 59 .. Patient# State Follow up Trait Free floating 1. 61 39 + 49 + ++ 54.5 31 - ++ + 34 47.6 74 62 54. Asha Rani Dasa Raj Nath 2. 3. No. Showipg the pattern of ebisgee is anxiety level io selected cases in the two group Group Rh IA.6 70.3 + 58. Patients State Follow up Trait Free floating 67 46 1.5 + 36.8 54. Singh Subhash Chandra 46 3. +++ +++ + +C+ +++ + 103 80 76 91 64 80 +++ +++ +++ +++ +++ +++ Sahodara Singh 76 63 80 74 67 82 +++ +++ +++ +++ +++ +++ 44 32 47 Amar Deo Cbaubey 37 51 57 + + ++ + + Average 58. 5.

g SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 106 . Pressing Power R L H. 45 m m H . 40 mm H .Showing the pattern of shift of grades of symptom towards the betterment in some systemic. 75 m m Hg. g 30 m m Hg. 30 sec. and locrl manifestations. 35 mm Hg. and some fanction81 changes -by the Rh 1A (AU)h Acute Rheumatoid Arthritis cases. g 70 m m 65 mm Hg. R 5 60 mm Hg. Observations Initial Follow up Systemic Features Fatigue Malaise Fever Appetite Constipation Others Local Manifestations Joint p a i ~ Stiffness Tenderness Swelling Local temperature Soft tissue Loss of functions Deformities Musclar wasting Functional Tests Walking time Grip power 40 sec.

SUMMARY The modern treatment of Rhotubatoid Arthritb is lpostly pplliative. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 107 . Rh-IB and Rh-1 (Au) . In tlks controlled clinical trial Rh-1B is found to have moderate degree of anti-arthritic effect in subacute cases of Rheumatoid Arthritis. Rh-1 A. Furqer extended trials are suggested. Rh-l' (Au) is found to be d i in Acmte Rheumatism.were tried clinically. Indigenous compound drugs. Certain indigenous drugs are suggested to W useful.

.R.. Congress of Rheumatology held at Barcelona.Hyderabad Paper presented at "XVlllth (ILAR) International League Against Rheumat~sm. Span.R Naidu Additional Professor T. of Medicine.4.Ref.1. Santa Cruz (E).R. NIMS. Bombay-400 098 (a 61 1 6170 or 613 0329 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 108 ...... Hyderabad K Venubabu Resident. Lawrence Apartments 11.C! .. Dept.S.K.. Reprint fim : The Indian Practitioner Vol. GY. XLVl No. NIMS.U. Rao Addttional Professor. Bhatt Medical Director (Ayu).PPc2. 101.. NlMS. General Medicine. Hyderabad N.Shobha Senior Resident CPMR.. . Bombay M. Vidyanagan Marg. Zandu PharmaceuticalWorks Ltd. 12 Cllnlcal Trlal DECEMBER 1993 Pages:931-941 Efficacy of Rhumayog and Rhumayog with Gold in Rheumatoid Arthritis A Double..Blind Study - U. Kal~na. July 1993.... Kumar Assstant Professor U.

05). Rheumatoid Factor (p=0.001). Seropositive-21) with active rheumatoid arthritis were studied to evaluate the efficacy of Ayurvedic products Rhumayog (Rh)) (n=:5) and Rhumayog with Gold (Rh Au) (n= 15) for a period of 6 months. lgA (p=0. E S R (p=0. Both drugs showed antiinflammatory and disease modifying activity. The currently used drugs in relieving the symptoms are not free from untoward side effects. *Additimal Professor.U. pain index (PI) (p=0.01). of Medicine.05) and IgM (p=0. *Assistant Profesx)r. Hyderabad.001). 12 Efficacy of Rhumayog and Rhumayog with Gold in Rheumatoid Arthritis A Double Blind Study - U. Gold salts which belong to the group of DMARDs are not without side effects but are used in therapy of established disease2.'Senior Resident. Hyderabad.Zandu Phamaceutical l Works LM.R. Ayurvedic preparations Rhumayog and Rhumayog with Gold have positive role in the management pf Rheumatoid Arthritis due to their antiinflammatory and disease modfiing acivities. Naidu*. NIMS.01) and in lmrnunoglobulins (IG) (p=0. WT (p=0. Ayurvedic Drugs.period. CRP (p=0.Congress of Rheumatology held at Barcelona. Drug therapy forms the mainstay of the treatment which has two fundamental objectives: 1. Paperpresentedat '.. Venubabu" SUMMARY Thirty patients (women-22. Spain.05).001).R. T. General Medicine.01).K. Short term suppression of inflamma- achieved by nonsteroidal antiinflammatory drugs (NSAIDs) and 2.S. However. July 1903". CPMR. generally Additional Professor. N.Shobha+.IgG (p=0. Long term suppression of inflammation which may lead to presewation of joint structure and function to lessen the likelihood of deformities which is achieved by disease modifying anti rheumatoid drugs (DMARDS)'.001). ESR (p=0. Rh Au was better in improving the grip strength (p=0. NIMS. the major being gastrointestinal. -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . U.01).me Indian Practitioner Clinical Trial December 1993 Vol. I3hattQ.01). Rao*. M. @ ~ e d i c aDirector (Ayec). tion in joints which lead to lesser pain and greater mobility. Dept. Bombay. XLVl No.05) and morning stiffness (P=0. walking time (WT) (p-0.001) and lg levels .K. DMARDS. INTRODUCTION RheumatoidArthritis (RA) is a chronic disease with uncertain aetiology affecting about 1 per cent of the population. Patients on Rh showed improvement in articular index (A/) (p=0. KEY WORDS Rheumatoid Arthritis.YVlllth (ILAR) International League Against Rheumatism. Kumarw*. Untreated deformities and/or ankylosis of joints will ensue with marked suffering. Rhumayog. *+Resident. NIMS. No side effects were encountered with the drugs during the study . Hyderabad.R.

Inclusion and Exclusion Criteria Male or female cases with R A seropositive or seronegative . Two Ayurvedic pharmaceutical preparations Rhumayog (Rh) and Rhumayog with Gold (Rh Au) in two earlier preliminary studies were found to exhibit a moderate degree of antiarthriiic In an experimental study Rhumayog also was observed to potentiate the antiinflammatory activity of other NSAlDs when used concomitantly9. Walking Time (WT) 15 mt in seconds and Morning Stiffness (MS) in minutes. serological.Haemoglobin (Hb).with morning stiffness of more than 30 minutes and E S R levels more than or equal to 30 mmllst hr. haematological. - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 110 . Loop Size (LSI) left. Loop Size (LSr) right. Routine parameters including liver and renal function tests were also done at regular interyals so as to notice any untoward effects. 12 The lndlan Prectltloner Ayurvedic medicine widely practised in India has description of disease similar to RA and is claimed to offer treatment of the same through drug and non drug therapies31415 Gold preparation in a different form as Gold Bhasma a colloidal form of metalic gold. immunologjcal and biochemical. EvaluatlonCriteria The parameters for evaluation were as follows Clinical. IgA. the haematological biochemical and urinalysis every two months whereas the immunological and radiological studies were done at the end of 6 month therapy. Patients having active peptic ulcer disease or major systemic illness with renal or hepatic impairment and female patients planning for progeny or lactating mothers were excluded. radiological evaluation. After basal evaluation the clinical evaluation was done every month. Rheumatoid Factor (RF) . sulfasalazine and methotrexatewere also excluded.. Pain lndex (PI). The diagnosis of R A was based on the American Rheumatology Association (ARA) criteria1'. MATERIAL AND METHODS Thirty three consecutive cases with R A attending rheumatology services of Nizam's lnstiitutp of Medical Sciences were enrolled into the study. auranofin.is used in Ayurvedic treatment for variety of disease including R A ~ . Patients using steroids or disease modifying drugs such as chloroquine. belong to the age group from 18-60 years were included for the study. Erythrocyte Sedimentation Rate (ESR). A case recordform specially designed for the study was followed.Articular lndex (Al). The disease was graded according to the Steinbrocker's classification1'. A double blind study involving Rhumayog (Rh) and Rhumayog with Gold (Rh Au) was undertaken to evaluate 'the antiinflammatory and the disease modifying effect in patients with active RA. injectable gold. Grip Strength (GS) mm Hg. bM).December 1993 Vol. Laboratory. C-Reactive Protein (CRP) and Immunoglobulins (IgG. Each patient had thorough clinical. XLVl No.

XLVl No. (Table24 In the Rh-2 group statistically significant improvement was observed in Al (P<0.01). totally 33 cases were enrolled of which 3 were dropped. However.001) and RF (P<0. There was significant fall in ESR (P<0.73 t 26. diclofenac or ibuprofen were allowed.001). Figs 7 and 8 provide the same in ESR and immunological parameters respectively.4 (range 22-52) (Rh-2) Rhumayog with Gold 15 10: 5 38.001).01).The Indian Practitioner December 1993 Vol.05) and MS (P<0. In the Rh-1 group statistically significant improvement was observed in Al (P<0. IgA (P<0.40 12 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .01) 1. A provision for record of any other illness during the period study and that Of any effect were in the case record form. 2 due to non compliance (non reporting) and 1 due to occurrence of pregnancy. There was significant change in immunoglobulin levels (P<0.01) WT (P<0.005). There was significant fall of acute phase reactants namely ESR (P<0.001).05). WT (P<0.01) and CRP (P<0. RESULTS The study was designed so as to get 15 cases in each of the two groups which either will complete the study or provide specific information for the drop out.60 + 33. GS (P<0.01).05') with the treatment. in group Rh-2 belonged to functional class II or Ill and anatomical stage II or Ill. PI (P<0. (Table.13 + 09.2 + 10.34 (range 22-50) 25.13 9 Female : Male Age (years) (Mean + SD) Duration of Disease (Months-Mean+ SD) Seropositivity 36. At the end of the six month trial it was known after decoding that there were 15 patients' in each group of Rh-1 (Rhumayog) and Rh-2 (Rhumayog with Gold). IgM (P<0. Figures 1 to 6 indicate the Comparative Percentage Variation in clinical parameter with both the drugs.3).001). naproxen. The change in immunoglobulin levels though variable was also significant [ IgG (P<0. The demographic data of the patients is given in Table-1 The analysis of results showed improvement and interestingly comparable results. All the patients except one case The analysis of variance though did not show any statistically significant difference between the drugs. Table 1 Demographic Data Parameter No. No concomitant therapy such as aspirin. PI (P<0.001). 12 The medicines coded as Rh-1 and Rh-2 were supplied in the identical capsules to the randomised patients in a daily dose of 4 capsules (500 mg each) three times a day in a weekly packing which was specially prepared for the study. of Patients (Rh-1) Rhumayog 15 12: 3 38.

The quath possess a mild antiinflammatory activity (Sharangdhar Samhita Part 2. steroidal fractions of Guggulu show a marked inhibition of platelet aggregation by ADP. Adrenalin and Serotonin. Guggulu is always prescribed together with Maharasnadi quath in the Ayurvedic practice. Many of these drugs have Guggulu. the effect being comparable to that of clofibrate14. The steroidal component of fraction A of the petroleum ether extract has marked antiarthritic effect. 12 The Indian Practitioner DISCUSSION Ayurvedic durgs are claimed to have beneficial effects in the treatment of Rheumatic disorders. " A steroidal moiety isolated from guggulu the main component of Rhumayog was found to be more potent than hydrocortisone in inhibiting the severity of the secondary lesions in the animal model of adjuvant atthritis12*". Purified.gum exudate of a plant Commiphora Mukul. XLVl No. Chapter 2). another component of Rhurnayog.December 1993 Vol. comparable to that of hydrocortisone. The antiinflammatory potential of some SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . is the main irtgredient. The exact mechanism of their beneficial action is not yet fully known in terms of b i h e m i wl prameters16 Rasnadi Quath. has Rasna (Pluchea lanceolate) as main ingredient. anq more potent than ~henylbutazone'~.

complement systems. Progressively decreasing acute phase reactants with improvement in clinical parameters denote regression of rheumatoid disease activlty.The Indian RaotWoner December 1993Vd. Antiinflammatory activity is measured by the reduction of pain and swelling of joints.05 0.46 + 58. modifying property. of inflammatory activity. IgA (mg/l) IgM (mg/l) 1 582. This was 0bse~Bd both groups in SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 113 . They include ESR and CRP".47 484. The disease modifying property is guazed by reduction of acute phase reactants as well. Rhumayog is considered to be analgesic and antiinflammatory where as Rhumayog with gold has both antiinflammatory activity and disease.18 2. it is unclear whether this reflects direct ahion of gold on the disease itself or epiphenomena.86 + 292. reduction of severity and duration of morning stiiness and improvement in grip strength and walking time.64 185.01 Ayu~edic formulations containing b j the Pluchea lanceolate extract was tested on experimental Arthritis and granuloma pouch. monocyte and neutrophil activitiesf8. Although remission induced by gold therapy may be associated with better immuno regulation and suppression.2 + 84.26 + 291.9 0. lymphocyte. Gold has been shown to alter the humoral immunity. 14. This showed marked antiinflammatory activii in both rn~dels'~. XLVl No.46 5. 12 13.46 267.

- 1 2 5 6 MONTHS AFTER TREATMENT Fig.. 6 0 . -... -% .-3 4 -. 1 -a-RHUMAYOG-NOGOLD _ .. -70 I I 1 0 1.--.--- - -0- -.. --------I . . - 4 0 ----.-.. .-. . - ---._ - -----50 -80 0 -- - .--.. - -30 .. .- --A- 2- ..-I ..I --. 12 The lndlan Practitioner i RHUMAYOG I N RHEUMAT010 ARTHRITIS CLINICAL :ARTlCULAd INDEX o \ -10 X CHANCE .- ..-. -P.\< -- -- I _ _ I - --- -- __-_ - .-..RHUMAYW&O GOLD +RHUMAYOG -WITH GOU) - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 114 .. 3 4 ' - 5 ~ .. ..-.December 1993 VQI. XLVl No.-----.2 .I I --. 6 MONTHS. AFTER TREATMENT ~ i g2 . -. +RHUMAYOG -WITH GOLD i 'RHUMAYOG IN RHEUMATOID ARTHRITIS CLINICAL :PAIN INDEX .-.-... -..--..

. -.Q- . . ' $ '--*-.-...- . - .-... .. . . -____. . 3 -0-RHUMAYOG-NO GOLD +RHUMAYOG -WITH GOLD RHUMAYOG IN RHEUMATOIDARTHRITIS CUHICAL :WALKING TIME (SEC) 0 ....3. -.- - ---. .RHUWYOGNO GOLD +RHUMAYOG -WITH GOLD SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 115 .-. . .-- -- . -... I -80 1 I ' .- --a . - . --..-. 2 I 2 3 I 5 6 MONTHS AFTER TREATMENT Fig.--.-...=- -33 -40 -50 - - .. ... 3. .- -..-.. - -- .... -60 ---.:.. 4 -a-.--- .-..-\.---i3.. .The Indian Practitioner December 1993 Vol. a*-. ....-I I -.-.... .. -- -80 * I 1 \ I I 1 2 3 -1 5 6 MONTHS AFTER TREATMENT Fig.0 " -..1 .. 5 CHANCE -0 -- '\ - - .> -10 . .. 7 . +: -20 v... XLVl No. --. 12 RHUMAYOG IN RHEUMATOIDARTHRITIS CUNICAL :MORNINQ STIFFNESS (MIN) --_..

.-. 5 8 -a---RHUMAYOG-NO GOLD - ARHUMAYOG -WITH GOLD SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 116 . OHANCE 150- . 100 - ..-- . . . . 5A -+RHUMAYOG-NO GOLD +RHUMAYOG -WITH GOLD RHUMAYOG IN RHEUMATOID CLINICAL : GRIP STRENGTH (RIGHT) ARTHRITIS zoo 5 -.I 60 40 - .---- I I 0 1 2 3 4 5 (3 MONTHS -AFTER TREATMENT Fig.--20 0 I I -- I : I 2 3 1 5' 6 MONTHS AFTER TREATMENT Fig. 12 The Indian Practitioner RHUMAYOG IN RHEUMATOID ARTHRlnS CLINICAL : GRIP STRENGTH (LEFT) X CHANGE 120 100 80 ..-. & : L /-a' _- - .December 1993 VOI.--. XLVl NO.

-. 6A -fl-RHUMAYOG-NOGOLD A R H U M A Y O G -WITH GOLD RHUMAYOG IN RHEUMATOID ARTHRIIS CLINICAL :JOINT CIRCUMFERENCE (RIGHT) X CHANCE I U .-2 - -.The Indian Practitioner December 1993 Vol._. ......-r3 -. _ - --- - ----..- -3 I -----..- .- --.. 12 RHUMAYOG IN RHEUMATOID ARTHRITIS CLINICAL :JOINT CIRCUMFERENCE (LEFT) 1 . . .a..--. I -4 - -I -- -5 0 1 2 3 4 5 6 MONTHS AFTER TREATMENT Flg. XLVl No. : CHANCE -3 -4 0 ' I I 1 2 3 4 5 6 MONTHS AFTER TREATMENT Fig.... -----. 6 8 -0- RHUMAYOENOGOLD +RHUMAYOG -WITH GOLD SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 117 .------I -----..

7 -a-RHUMAYOG-NOGOLD- +RHUMAYOG -WITH GOLD J RHUMAYOG IN RHEUMATOID ARTHRITIS IMMUNOLOGICAL PARAMETERS % CHANGE AT THE END OF TREATMENT X CHANGE 0 -1 0 -2 0 -3 0 4 0 -50 ROSE W U R TEST IgG (mg/L) (nW/L) IN (mi3 L) MONTHS AFTER TREATMENT Fig.. - - . 12 The Indian Practitioner RHUMAYOG IN RHEUMATOID ARTHRITIS CLINICAL :ESR (mm.lhour) z CHANGE -20 - -30 -40 0 -- - - . XLVl No. 8 -0--RHUMAYOG-NO GOLD -CRHUMAYOG -WITH GOLD SELECT RESEARCH PAPERE '2N EVIDENCE BASED AYURVEDIC DRUGS 118 .-.December 1993 Vol. -- --- -50J 2 I 6 MONTHS AFTER TREATMENT Fig." ..

Arora RB et al.Philadelphia1989: 982-92.C. Harris ED. J Am Med Ass* 1949. Management of Rheumatoid Arthritis. Plbli. Gordon DA. Meyer PJ. Rasa Tarangini. Bull BS. Rheumatism. Harris ED. 770-71. The American Rheumatism Association 1987 revis. Master. 7. X Annual Conference of Andhra Pradesh Chapter of Association of surgeons of India Kakinada 1985. L. J. Ruddy S. J. Chowkhamba Sanskrit Series Office. Pharmacol 1960 : 4: 267. Steinbrocker. 1979 : 37: 367. D-pt ~icillamine and levamisole. 7:825. 4. and J. XLVl No.Bix 8. Ind J Exp. Paudus HE. In Kelly WN Harris ED. Runge LA. 315-24. Drugs 1984: 27:373-377. RH. P. Bhatt-NS. W B Saunders Co. 15 V. 5. Trager CH. O'Duffy JD. Harris ED. Sharma J. Though the latter was better in irnproving morning stiffness and grip strength and reducing RF titres there was no statistically significant difference in both groups. Bombay 1985. Gold Compounds.2 PP 1-8. In the Text book of Rheumatology. 19. Arthritis Rheum 1988 : 31 .O. Bhatt NS.ed ctiteria for the classifmtion of rheumatoid arthritis. Isolation of crystalline steroidal compound from Commiphora mukul and its antiinflammatory activity.Philadelphia 1989. CONCLUSION Both ayurvedic preparations Rhumayog and Rhurnayog with gold were found to be efficacious and safe in the management of RA. Sledge CB (Ed) Text book of Rheumatology WB Saunders Co. Ruddy S. P. MotilalBanarasidas. 486-92.60: 920. Antiinflammatory studies on a crystalline steroid isolated from Commiphora mukul. Batterman RC. East West Conference on Rheumatology Madras 1988. Upadhyay VP.9: 403. A preliminary controlled d i n i d trial of Indigenow Compound Drug in cases of Rheumatoid Arthritis. In the present study both the drugs did not elicit any side effects. Arora RB et al.Bid 1979. Sledge CB (Ed) W B Saunders Co.N. Med. NO. Bacon PA. It requires further studies involving larger group for longer periods. 140: 659. Husain Z. Lancet 1989. Role of Ayurvedic Treatment in rheumatic disorders (Ab). Westengard JC. N Dhure Sons Pvt.K. Therapeutic Criteria in rheumatoid arthritis. Mahajani SS and Parikh KM. Varanasi. Ind J Med Res 1972. REFERENCES 1.. Agarwal RK. Treatment complications of rheumatoid arthritis with gold. ibuprofen and indomethacin2'. steroidal antiinflammatory drugs. hydroxychloroquine. 2: 965-67. Current status of disie s a e modifying drugs in progressive rheumatoidarthritis.are well known with established DMARDs such as gold salts2' and NSAlDs such as aspirin. Ruddys. Chap. Yoga Ratnakar. Varanasi 1955. Some experimental observations on the antiinflammatory activity of Rhumayog An Ayurvedic herbomineral formulation (Abstract) workshop on selected medicinal plants used in traditional system of mediane. Amavata Chikitsa Publi. et al: Planta Med. Luhra HS. Karandikar G. In Text book of Rheumatology Kelley WN.1 Kelly WN. - Arnett F C et at. 1984 : Vd. Chopra RN Indigenous dru$s of India. 75. Pullarao G: Rhumaycg with gold the drug of choice in the treatment of Osteoarthritis. Calcutta 1958:444. Tripathi KM . Sledge CB (Ed). Farr M. et al: Ind. Treatment complication . Ltd. Nepali Khapada.) . 6. Box. 3. on SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 119 . Chaudhary VP. 2. 79. Staurd J. (PP. J.The Indian Practitioner December 1993 Vol. A dinical trial of Ajmcdadi Churna and Yograj guggulu in Amavata (Rheumatoid Arthropathies): Nagarjun 1980 : 23 (6). Efficacy of tests used to monitor rheumatoid arthritis. k i n AK. ~ i n g h Mishra SS. Jain: Ind. (1960) 48: 482.804-23. Res. 12 taking Rhumayog or Rhumayog with gold. Rbeum 1090. Philadelphia 1989.

N. Professor Radhamadhavan Addnl. The Indian Practitioner Vol. Medical Director (Ayu). Department of Rheumatology. 6 Drug Action JUNE 1994 Pages: 489-502 Study of Ayurvedic Drugs in Rheumatoid Arthritis Compared to Auranofin ChandrasekaranA. Biochemist. Madras-600 003 (India) Bhatt N.. Zandu Pharmaceutical Works Ltd. Santa Cruz (E).V~dyanagan Marg. Professor Parthiban M. Research Division.Reprint f i o m -.S. 0 61 1 6170 or 613 0329 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 120 . Lawrence Apartments-ll. Madras Medical College and Gevernment General Hospital. Kalna. Bombay400 025 (India) 101. XLVll No. Bombay-400 098. Asst. Professor and Head Porkodi R.

6 The Indian Practitioner 489 Drug Action Study of Ayurvedic Drugs in Rheumatoid Arthritis Compared to Auranofin Chandrasekaran A. INTRODUCTION Rheumatoid arthritis is a chronic inflammatory disorder due to inflammatory mediators generated by immunocompetent cells during the process of elimination of the hypothetical antigen from the system. a disease which is described as ~mavaata*. Professor -Addnl.000) duration of morning stiffness (0.001) and plstelet aggregation (0. It is concluded that there is a disease modifying effect in group A (Ayurvedic Drug) as in Auranofin. Ayurvedic Drugs. the ancient system of medicine. Group C drug showed statistically significant improvement in Ritchie lndex (0. Zandu Pharmaceutical Works Ltd.75 and 34.0 13). whereas DMARDS have marrow.N. Most of the NSAIDS have gastrointestinal side effects ' *Professor and Head.008) platelet aggregation (0. have been widely used3. and Group C (Auranofin) and studied for a period of 6 months. Clinical and laboratory parameters including Serum Gold levels were assessed periodically and analysed statistically by Wilcoxon's signed Rank Test and Friedman's Test for Trend. Rhumayog. 60 patients with definite RA were randomly allocated into Group A (Ayurvedic Drug).*. Research Division. renal KEY WORDS Rheumatoid Arthritis.020) and platelet aggregation (0. Depattment of Rheumatology. . Bombay 400 025 (India) SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 121 .000).000). ~ u r a n o i n . Group A drug showed a statistically significant improvement in Ritchie lndex (0.*. XLVll No. 17:3 and 18:2 and the average age in years were 39.. Bhatt N. DMARDS.June 1994 Vol.15. Indian subcontinent for' many centuries and several drugs are used for the treatment of rheumatoid arthritis.s. -Biochemist.006) duration of morning stiffness (0.90 in respective groups. the long term suppression is achieved by the DMARDS' . of joints involved (0.@ SUMMARY In a randomised double blind clinical study two Ayurvedic drugs were compared for their DMARD potential with Auranofin in Rheumatoid Arthritis. The goid used in Ayurvedic system is in a colloidal form.000). Group I3 drug showed statistically significant improvement in Ritchie lndex (0.19) sero conversion (0. Professor. Female to male ratio was 18:2. no.012). walking time (0. Radhamadhavanm Parthiban M * . -Asst. ~ and hepatic Ayurved. In the modein system of medicine gold is used in the form of gold salts. is practised in.38. Group B (Rhumayog with Gold). Madras 600 003 (India) @~edical Director (Ayu). Not only anti inflammatory drugs are used but also gold preparations in the form of Gold Bhasma. While drugs are available to ameliorate the symptoms due to inflammation in the form of NSAIDS. Madras Medical College and Government General Hospital. Porkodi R.

plain Rhumayog. 8 patients dropped out and remaining 60 formed the comparative groups. C3 and C4. creatinine clearance.2 caps of Auranofin (3 mg each) and 2 caps of placcL. Circumference of the proximal interphalangeal joints 4. immunological Parameters: RA factor both by Rose Waaler and RF Latex Agglutination methods as well as important markers CRP. The drugs were administered in the form of capsules of 500 mg each in the dose of 4 capsules three times a day. Biochemical Parameters: Hepatic and renal toxicity. Serum Gold levels were specifically studied. Evaluation Criteria The following criteria were followed: Clinical: 1. Patients with other connective tissue disease and with clinically manifest abnormal test function of heart. Urine analysis. Cholesterol and Serum cortisol levels were studied. P. The period of study was from December '89 to June '92. 50 feet walking time 7. Functional class by Steinbrocker's classification Laboratory parameters Haematqlogical: Complete Haemogram.a. lungs. Noon and evening doseplacebo. and C. protein excretion fbr 24 hours. XLVll No. were studied. of Rhumayog with gdd corresponding to 1 mg of Gdd in each and 1 cap of plain Rhumayog.B. GroupC: Morning dose . Noon and evening doses . Blood sugar. It was decided to have minimum 20 completed cases in each group for better comparison.comply with the therapeutic schedule were included in the study.Complete urine analysis. kidney or those with endocrinological or neurological distrurbances or those having haematological or psychiatric disorders were excluded from this study. liver. of the above extract. and C. ANA IgA.The Indian Practitioner June 1994 Vd. Duration of morning stiffness 5. IgM. Group 6: Morning dose .3 caps. Patients having malignant tumours were also exluded. IgG. Platelet aggregation.T.T. The patients were randomly allocated into groups A. one corisisting of Guggulu extracted in Triphala water and the other Rhumayog with Gold with Auranofin an existing DMARD in a randomised double blind study.T. SELECT RESEARCH PAYERS ON EVIDENCE BASED AYURVEDIC DRUGS 122 . Inclusion and Exclusion Criteria Patients above the age of 18 years suffering from active rheumatoid arthritis 2. The dose of comparable drugs being quite different administration required special packing as follows: Group A: Ayurvedic Drug (Guggulu extracted in Triphala water) Each Capsule contains 500 mg. 6 and who consented to ... B. Ritchie Index The two Ayurvedic drugs were found to be effective in preliminary clinical studies4". It was therefore decided to compare the efficacy of these two Ayurvedic drugs. MATERIAL AND METHODS 68 patients fulfilling the ARA criteria for the diagnosis of RA were included in the study. Number of Joints involved 3. Grip strength 6.

Basal and every fortnight Haernatological and biochemical Patlent Consent Informed consent of the patient was obtained in writing before administering the trial drug. Time schemes for evaluation was as follows: U@e Analysis.rays of the involved joints were'taken. Mean Age b. XLVll No. 39. General followup and drug supply .June 1994 Vol. RESULTS CLINICAL TRIAL ON R~UMAYOG I N RHEUMATOIDARTHRITIS Table 1 Parameter: a.Basal and at the end of the study. lmmunological Radiological .75 yrs. 38.60 yrs. 18-57 yrs. Age Group A Group B Group C 20-52 YW. Sex Female Male 18 2 17 18 2 3 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 123 .Every week .Basal and every two months .Basal and every month Clinicel assessment . 6 The Indian Practitioner 491 Radiological Changes: X .90 yrs.15 yrs. 34. Age Range 27.

XLVll No. 6 Parameter: Total no of Joints SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 124 .The Indian Practitioner June 1994 Vol.

June 1994 Vol. 6 The Indian Practltloner 493 Friedman's test for trend 0.'(P=O.046* I Total 15 S 20 15 5 20 4 19 1 20 Improved Deterlorated P. XLVll No.OS) SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Value 2 2 NS 7 3 NS 0 Signj.

The Indian Practitioner June 1994 Vol. 6 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . XLVil No.

June 1994 Vol XLVll No.225 ns Group C Mean 59..308ns .50 57.485 ns SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 127 . .00 Wilcoxon'ssigned rank test Friedman's test for trend - .30 66.678ns :63 ns I 62.50 . 6 The lndlan Practitioner 41 & Friedman'stest for trend .

The Indian RactRloner June 1994 Val. 6 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 128 . XLVll No.

75 .00 295.794 ns 298.90 .60 0.85 0. XLVll No. Group B ~ean Wtlcoxon's slgned rank test Fr~edrnan's for trend test Group C 284.760 ns .571 ns 273.815 ns 248.433 ns . Fr~edrnan's test for frend Wilcoxon's signed rank test Fr~edrnan's for trend test Group C Mean W~lcoxon's s~gned rank test Fr~edrnan's for trend test ' I - .420ns 2813 5 .60 .463 ns 255. 6 The Indiah Practitioner Table 15.277 40 259.June 1994 Vol.570 ns 0. Mean Wilcoxon's slgned rank test ' .95 283.829 ns SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .478 ns 275.337 ns 281.45 .695 ns .5?6 ns 2d.090 ns 257.091 ns .205 ns - - .75 .968ns .673 ns 306.50 0.25 . Parameter: lgGU IU/ML Drug Group 0 Months after treatment 1 2 I 4 1 6 Group A Mean Wllcoxon's s~gned rank test Frledrnan's test for trend .519 ns .167 ns .95 .60 .00 289.

00 . XLVll No.30 .50 .844ns .The Indian Practitioner June 1994 Vol.721ns I Group C I Mean [ - 1314. 6 Table35 Parameter: C 3 Mglml.40 .2% ns SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 130 .064* 392.248ns 1 1068.067 ns 1 Wiicoxon's signed rank Jest Friedman's test for trend .40 1131.407 ns 1023.00 .00 .705 ns ' - I Friedman's test for trend I I Group B Mean Wilwxon's signed rank test Friedman's test for trend 1 1 58.687 ns .602 ns Qroup C Mean Wilwxon's signed rank test Friedman's test for trend 431.259 ns 443.00 .50 .693ns .75 I - .825ns I 1200.480 ns 1116.749ns Wilcoxon's signed rank test Friedman's test for trend - .00 .409ns .747ns I I 11 76. Drug Group 0 Months after treatment 2 4 6 Group A Mean Wilcoxon's sianed rank test 10086.50 .605ns I 1171.40 .981ns .50 1 1113.05 .I70ns '1 1148.55 392.

The steroidal constituents of guggulu may be responsible for the antiinflammatory action.fit W ~ 'Mf6@1 '$Sif. n h f t&@q!& ~st%ta~dn%dP &its m q w g ~i!$iW%gk$&!Q o " b k c 9 h j ri. C .- Rheumatoid arthritis is -an inflam- I sqt-l& bpu#shef+found to have antiinflammatory effects". ey ac y In I I lng p a e e aggregatni bCt 9CM3R29t 6 xarrdi k~rrsiarcsludprzGra4wd b @ was ~ ~ r n b ~ t l B ~ d d . bMml.l:ss~tlne~z ' ~y significant irRij?6HW~F R 9fid "%hu#P~%)agiSlad~9flbwflIa IltYME81a i W Writ xebd~pr~wftmmt intnsnt$%~ nt p q p W s r e J J~ b n # W ~ o ~ a f L s t ~ b a ~ @ ~ -mg@tb Wl~mplpvaC). & ~ E B l ~ ~ ~ .~ r n s t i llr I s W i W Mprmmllbttf).n&~~~Fti6~Su~ &w fertWi&W%R @fWri#B@ifiQQ%~i! bsrl -mt nwode bsrl zjnsl:sq 3 .m s l r w l u v r .

of joints Mvolved. duration of morning s t i i e s s and walking' time. Similarly the fa! in the Rheumatoid Factor titres was also not significant though 5 patients had become sero negative by Rose Waabr t?t. AUP*WOm Latex aggutination test.and two patients had became seroi . Similarly IgM levels had shown a fall though not statistic811y significant.*= . 2 patients had shown irnprovement in their functional class while 2 had deteriorated. .' 1 I 0 1 2 3 4 S 6 MONTHS AFTER TREATMENT AWRVEDIC DRUG -! BBWYOO-rn [ ) WU '*. a8 shoyn by the Friedmq'a test for trend: Platelet' . No.I 1 &. The Friedman's test for twnd was also siggnificant faf all these parameters. I@ paraineteq . Thefe was a remarkable improvement in the functional 7 patients had improvedwhile non had deteriorated.negative by latex agd glutination t ~ t the end of ihe trial.& * ..aggcegruti& had SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 132 .L --. The fall in the CRP levels also showed EL statisticdlly significant trend by Friedman's test. The ESR had also shown a fall at the end of the trial though not statistically significant. elks. several clinical . .The Indian Practitioner June 1994Vol. 6 AYURVEDIC DRUG / AURANOFIN I N RHEUMATOID ARTHRITIS ESR (mm/hr) 10 x CVCE -30 -40 I . In We paramatp. -. 4 patients hed shown improvement in'their functional class white 3 had deteriorated. XLVll No.ESR had f how Lb a'fall.. platelet aggregation8howqta signiflm irriprovement by Friedman's test: The fdl in ESR was not statistical@slgnifkant.. parameters like Ritchie Indw. In the ..". Group 6 drug (Rhumayog with Gold) showed a statistically significant improvement in Ritchie Index and Friedman's test for trend wes also significant. .. Group -'C drbg (Auranofin) in the present also'showed a significant impmvment in .

REFERENCES 1. AYURVEDIC DRUG / AURANOFIN IN RHBUMATOID ARTHRITIS ! ROSE WAALER TEST I -60 i' 0 I I 1 I 1 2 3 4 5 6 MONTHS AFTER TREATMENT i - AWRVEDIC DRUG RBUYAYOG-WITE GOLD -". Current Status of disease moditying drugs in progressive Rheumatoid arthritis.63 to 2077. Serum IgM levels and sero conversion by Rose Waaler test. The 8 dropouts were due to non compliance of the patients and not due to side effects of the drugs. Ayurvedic drug shown negligible amount of Gold in few cases.27: 373-77. Among the two Ayurvedic Drugs Group A drugs has a definite disease modifying tendency as evidenced by a fall in the levels of ESR. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 133 . Luhra HS. Patients who were on Group C drug namely Auranofin showed a significant level ranging from 10. Drugs 1984. while patients on Group B drug namely Rhumayog with Gold had lower levels ranging from 1. Duffy JD. This study confirmed our previous study that Auranofin has disease modifying efficacy.50 nonograms.. AURANOPIN shown a significant fall Sero conversion by Latex aggultination while 4 had become negative by Rose Waaler test. 6 The Indian Practitioner . A unique feature in this study was the estimation of Serum gold levels. Patients on group A. The side effects with all the three drugs were mild and did not necessitate withdrawal.50 to 457. Probably the amount of Ayurvedic Gold (3 mg) in Group B drug was not sufficient to have any disease modifying effect.5 nonograms. CRP. Thus this study shows that Ayurvedic drug is comparable to Auranofin in its disease modifying property in rheumatoidarthritis.June 1994 Vd. 0. XLVll No.

Ramakrishnan S. S lvest J.4ibom szss . rikob@wC#ale Arthritis.lnetnsj pni.The Indian Practitioner :2-. Rad- r~QtracAmgmkeSabrtn-&rtBs orf~b&Mar&i&i nbanedhnmro~C8antR6~aia~~~dz E. June 1994 Vol. Bhatt N S.-. l.~ ?'%%hid 011 19@&@&6bdOkm~9dl 11. ~ . sod Vinterharg H.WfiWer!) n.~ g q ma192 nFdP?H$%iYRldt.OH !IVJX.eitiidfis biotsrnusdR ~ f l 00WiuJla?Bi&QMT3116Wri#w .WisplMdslaplnb aibsv 6.-- -- 8.&Bet a~uiCJ .r I ja~~~~dkre 2.IOV pee t snuL A AWRWDIC DRUG 4 - REUU~OG-~ITH COW .. XLVll No..J si ces Academy 1989. Rheu at~sm. b~51f?!?f%3 as y. Auranofin Vs & w d ~ ' b % .n:$il!)zr. o & q . & s. Aamavata chikista. r:&?rd stfl 8 . : ~ j & ~ r y j m w t r ib ~ ~j '1 ~ ~ digenous compound yd Rheumatoid arthrlt~s.- moa HTW-~OYAW'JHH - c l * AURANOFIN wao s l a s a w ~ - 1% 2 # Yog Ratnakar.-".----- . Review of ~ y i r v e % c~#tnlcal Re- zs 63 gt ni bioa 7.No. Chandrasekaran AN.". -. Publ. l @V &% c ~ u i b ~niytiborn szse IT-CTE :TS . Pharma.eeuib srlt to ej39tf9 sbie ot sub . Vol.tonsruA f rf vbutz es.21-25. da~1)8qtaWo1 j w 3 d non .SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 134 rE h 2 3 U R U 31a3VRU'llA a 3 Z A 8 33MRUIV3 MO 21I34AP H 3 R A 3 2 3 R T 3 3 J 3 2 -. I &q&@~.. 6 a . Manthrope R. Horbov S. 2.

E.OPEN STUDY TO EVALUATE THE EFFICACY OF SALLAKI A S AN ADD-ON NSAM).rMFNT.TSF1.CN . in Medicine K. Rajadhyaksha M. Prof.OF! PATIRN. LTH * Author for correspondence Dr. A. Mumbai . Parel.400 0 12 -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVED~C-DRUGS f33 . hospital.M. Assoc.D.THF M4W4CirF.

Paracetamol tablets were used as rescue analgesics during the washout as well as the trial period. A statistically significant improvement in VAS score. paracetamol consumption. time to walk 50 feet. tenderness and swelling of the affected joints and a decrease in the number of swollen joints was observed.d). The duration of the treatment period was four weeks. grip strength.ABSTRACT In a double blind. ESR and overall efficacy by the physician. digital joint circumference.i. Rheumatoid arthritis SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVRDIC DRUGS 136 . ~ o t h drugs were well tolerated but a trend towards the fewer adverse reactions of SallakiQ was found. The following variables were tested: Duration of morning stiffness. No statistically significant differences were found between SallakiB and Diclofenac sodium.i. Key words: Diclofenac sodium. An interval of five days was established as a washout period.d) or Diclofenac sodium (50-mg t. randomized parallel grobp study. number of swollen and tender joints. forty-seven patients with classic or definite rheumatoid arthritis were treated with SallakiO (600-mg t. Sallaki @. degree of swelling and tenderness in the affected joints. duration of morning stiffness. pain severity using VAS score.

This could be due to the inhibition by NSAlDs of only one of the mediator of inflammatio. They also stimulate pronounced_plasffia exudation in vivo . optimizing fbnction and reducing disab~lity Amongst drugs. Elderly patients are particularly prone to develop serious NSAlD related gastrointestinal complications like Perforation. as the disease progresses. Leukotrienes. i.a period of inactivity may be prominent but usually lasts less than 20 minutes Functional impairment in OA however is highly variable and depends on associated muscle wasting and weakness and correlates with the radiological severity of the disease.78% . stiffness and disability in the involved joints. Bleeding (PUB) and death Some NSAIDs particularly aspirin and indomethacin have been implicated in cartilage degeneration'and their . From t b e f i y ~Tleukotrienes type mediators. superoxide production.and release of hydrolytic enzymes.arx a h .i d v d in the initiation and the maintenance of inflammation. However their use is limited b i gastric and renal toxicity.e. use is best avoided in osteoarthritis The preferential cyclooxygenase 2 (COX-2) inhibitors like meloxicam that are chondroneutral. it may become persistent. It is a leading cause of chronic disability in the elderly population rendering them unable to perform their daily routine activities independently. The progress of the disease is variable and in some patients relentless. calciu~rlnslocation.. leukotriene Bq is a potent stimulator a£-leukocyte responses like chemotaxis. 'The most common presentation of osteoarthritis is insidious onset of pain. leading to end stage joint disease necessitating joint replacement. and changes in the synovial membrane.INTRODUCTION Osteoarthritis is one of the most common rheumatological conditions to affect humans.on an average there is 30% improvement in pain and 15% improvement in knction 5 . f& which the 5-lipooxygenase (5-Lox) is the key enzyme. but. cell adhesion. synovial lined) joint and is characterized by degeneration of articular cartilage. thc prevalence of osteoarthritis in adult rural population was found to be 5. cyclooxygenase. In India. Ulceration. non-steroidal anti-inflammatory drugs (NSAIDs) are most often prescribed for relief of pain and control of inflammation. Pain in and around the involved 'joints is a cardinal symptom in OA that typically is aggravated by joint use and relieved by rest. ' The disease represents failure of a diarthrodial (movable. Treatment of OA is aimed at nlinimizing pain..9 Thus cgaedmitant administration of lipooxygenase inhibitors and cyclooxygenase inhibitors wmkflead to a better control of inflammatory conditions SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 137 . equally effective and with fewer side effects are thus widely employed in the management of osteoarthritis "4 However the magnitude of improvement with NSAlDs is generally modest . hypertrophy of bone at the margins. Stiffness of the involved joint on arising in the morning or after .

tk'd(aJa%kfI treatment of inflammatory diseases is a potent inhibitor of 5-lipooxygenase but does not impair t h d .m) ltihc11lf71.r~3rllf'i 23filrl18n U 111.I.3d iI j $ 1 tY~.rt 3r 1 IJ 3.The gum resin exudate of Bo.&%a~htitwJ ~ 4oQ e $ l9?WW!#&&84b@~~fi!hc~~' .f .wi&i t i 2 ~ 1 i r 1 1 l! r. j *{~ h.t ~ W.?F.:31 . hemorrt$gt$bkp@i& &ilmaNdio? 1 1 electrolyte retention ' .il:irl l~. 'jrj ~ I I J ~ I I ~ ~~ 1 3 d * 3 i ( j 3 1~ Z I .\rl~ Ir11oi h311(1..&bWalC6~~~rc'~dLLce&cp!%t~~silifd~ltheldaottesttnoplp&e&~aI ~iW&&%cier~hd84%~&~@&& &fe'fl8h618&&f@&t?r.3ldr. I 1f.i.!*f/' ~ I J : ~ r4r.irc r ~ o . IRI Wsfh#tId G@' r A tffi%%kfiM tI re&@ao.I 2 A marked analgesic effect has also been reported for the drug I .~.k$heJ*y~&~isll~fq~l:mP ~ m d n w h i R h m t n e 1 6 & ~ w8efC4h w@~#B B ~ H ~ A tnodifyingpot..&of etaddlt10n2~syT!omatic re e o deRts wti.!312h f > f J C I O I<17t.!rl r r ~ f i f : : ~ I J ~ ~ O ~t{>iJtmll~bltn~ r I ? 'fr' 1:)111102 bfttr r t [ t .$.rlr1/2. "'t'i ' -3i * .f!l early cases having mild pain with no radiological standing disease w ~ t h moderate to severe radiological changes it showed a fair to poor response 19 )I sa\\&i ~ 2 Q R w H ~IWft)vjr.~ ot#o~i~~t ~ && h e r~ ~ $ ~ b& .&~irh g ~kw. ' ) I ~ ~ > L rflf.dl'$ IF dd 1 % ]I! i./r113df ?a P L L ~ I ~ ! I ! ~(:~!%IL-IL~c~ ~ 3rr10.3!. dtllcular ln-h& ~ W P Ifi~8 ~Qr96t 8?_1elr$umfjtremIg$ats@b~&h.& f l ~ l ~ & i ~ ~ sr~o i n3 ~ o $1A %V .l1~>1nk./n 13qIJZ ~ &o t .7d riotlid1rln1 'h : h uikd a b' f. ~ t s i m ovrv nr 11orj6bu-/.i!17 tj. ~ C ~ I $ ~ I ~ J I t a- . Y Z I ~sri'i ..s xrnzslq bs3nuonorq sjs. v o f j l a r ~ a t m ~ ~ t b ~ & I M d f i i i n s d~ ~ s t ~ M i~ i t g sb.p ~a & { ~ # ~ ~ ~ ~ ~ f h ~ g g g sl' i & : ~ e f @Hbrrt~fich? ~2 & &f#tg~ jzor11 -XI r t o grir.! 1 .f E%petiwnfal $ t b d i e s f m d d n h h llpmbd.lurntJz Acute inflammatory flares and low-grade persistent inflammation has been shown to be present z i n M M f t a & i t i 8 ) ~ ~ 9 ~ibds~-b!&Md %dbg$~&@fn~o~da%tl~BPrind~ijltt~&ihd8)me2t~i~ ir articular cartilage and worsening of the 63 0 ~ofsrtrmsIfni lo. tti. 2 2 l~.* .ti6 ~~lthilsrrt i f l t s .weIlru serrutu used In traditional Ayurvedic ~!.. 1 r i j .i0 t.H!H~P~kh~rcsitR1%t&aWfik~PAC1f~JI~rll g ~ ~ ~ n ? ?(I @ ~ & ~~~ " ~ h e l & s d L ~ r ~ & ~ ~ ~ a @ r kn m ~ & & t~~% ~ d p&W%iA. i i 30 'i31l3i t i r -. ~ a j j s d of bsvl blr~ow 70 s .$ i .3it'fjb?tri 2All J .arhi4n&W&toyt) J agent devoid of side effects like gastro-intestinal irritation. number of joints. $1 nior:ea 21 d l l X C f ::iiJ f 3 r n ~ vIi rrlr to t) <)fi.rlw. % h a t o l d arthntls ~ b u s ~ i k ~c a i ~ tf kr.y ~ I w ~ ~ r dka I a e y r )rl rniltrmethacin and ibuprofen f o ~.rj ( I I ~ ~ ~ 51s?irt31lt$7 ~ l i ~ i r l ~ t2 i d i ~ o t ~ c 1 I 1%1.:ttol (bun11 !h1.!nllr. ~~ akhifl~ ~ w y t r b i ~ a k s y E ~ l rebM ai1mats t~bke3ld9treox&&di~ajMtIb1 ~ i & t ' E W ~ ~ i t & ~ 16mf&b&dis3@113 spondylitis without a n ~ : ~ 8 a ~ t l A ~-" th" ~fi ' L 3 3 3 1 1 szsserb tnrol ~gfildilns oJ gnrbrcrl . ? ~ & l ~ b c l ~ e h ~ t& 444FIr~&~l&idatttl~&t~ 6&4@4U€&$ W W & % ~ M ' ~ Y1 W I ~ ~ 'ndtno W tb6c~ifcrlwt~tra$PBd~~k6jl~~~rkd!~&Sih b p G ~ f k O ' d ( # t~ i ad 11I dhdt~%~@ @~b d d :&-I l!ahk+t~j @ t ~ l d ~ t b d e t1i~~ r ~ d B s d r ~ ~ ~ f i t h t : 3 m d l ~ ~ o ~ d ~ f d ~ z u ~ f i s t : A b !m$xitanneaAbelt$w~~~ :Jr~r:r-rom rrr y!lr.~ i 1 ! 1 1 j j a t>jt>~'3fbJ ~ I ~ I I .j!>j: H I .I r: ~ j ~ ~ .r!~.?&&tFe3 &Wi. ' ! ~ I ~ [?ti' : ~ * > P h a f ~ l u g i c ~ j ~ p o t s t i $ ~ t@I. n/h p~ m .111 2 ~ 4 1 t % 8~1I ~ G U Z U flld !i19:11111<* ~ i (bril { t i Jlf'>bril :! ~ ij j 6al l&L+I (40Q m g t i d ) twkn ~>trdrarmab & & a n g ~i~ i ~ n ~ t i n 8 a m m drugs.rjno:. 11 rill rrIfr~ostA.ey4ediithfe &&I i i gI ~ rr tpda&&. h e u n .~~atcbi&~~l~~ produced a statistically s~gnificantImprovement with respect to pain score.r period Q&&'AI&IQI$~ ipl&*pith ..

& ~ fi e .&*fl.It was conceived that if a lipooxygenase inhibitor i.e. probably be.disease wovld. SaIlaki and KZ~C16bti)ige"nae Zh'itjitbi i. p ~ofi4Fidp.achieved.a@ symptqvs' of the . (-$~$~$NGI ~ j F ~ * h ~ ~ ~s~wlt$ "a~ a @t~at 1s 9 ~ dutej . G+3Niiiif1 P a m of the . $ i { a so f y free I side ~ ect3 would help in contaj&g.6: NSAIDs were used simultaneously in the treatment of osteoarthritis a considerable jmnrouernenk in the pigns .

The physical function questionnaire was admin~steredonly at the end of the fourth and sixth week. or had active peptic ulceration or prior gastrointestinal bleeding. a complete medical history was taken and a general examination performed. along with their routinely prescribed NSAID. In addition all patients included in the study had: 1 history of taking any one NSAlD in adequate doses for at least past one month without satisfactory relief ii pain and/or stiffness in the knee and/or hip joints and/ or difficulty in walking and/or climbing The patients were excluded if they had undergone prior replacement surgery or were incapacitated or bedrhden.e. A scoring pattern different from the one used for arriving at the KGMC Index was adoptid owing to the failure in obtaining the original scoring pattea. right hip and leR hip o n a five point scale. The patients ihen underwent a global assessment ooMioting of an administered questionnaire. significant disease of any other major organ system. concurrent ayurvedic drug therapy. At the end of the study both the investigator and the patient assessed the overall efficacy and tolerability to the tre-ent. All the patients gave written informed consent before enrollment into the trial. concurrent anticoagulant therapy. Other exclusion criteria included cardiorespiratory insufficiency. swelling. or eligible for surgical intervention. allergy to aspirin or other NSAID.D. Hospital were enrolled into the study. morning stiffness and hnctional impairment for the right knee. tenderness. lee knee.P.MATERIAL AND METHODS Patients selecti Consecutive pat1 nts with primary osteoarthritis of the knee and/or hip (clinico-radiological 3! ARA criteria) attending the rheurnatology O.M.E. fourth and the sixth week i. at the end of the second week.d. After the patient satisfied the entry requirements. or recent systemic or intraarticular corticosteroid therapy. the final assessment. - / SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . The patients were in the age group of 18-70 years. The questionnaire included all the thirteen physic4 function criteria of the KGMC Index.E. Hospital. T y 'were asked not to change their therapy or consume any other analgesic "8. at K. 'Ilkus the KOMC Index w s renamed as Modified KGMC Index EorPhysical Function Criteria a The disease activity measurements were conducted during the screening visit. Study deslgn The study was conducted as an open trial.i. The patients were k d to consume Sallaki (400 mg) 1 t. which is a validakd-nmdified WOMAC Index to evaluate response in Indian Patients with osteo&tic bee. The protocol had been reviewed and ratified by the ethics committee at K. The disease activity was measured by' grading the pain.M.

1 = Mild. left knee. right hip. Averaging the Morning Stiffness score of the affected joints arrived at the Morning Stiffness score. 1 = Mild. Averaging the swelling score of the affected joints amved at the joint swelling score. and left hip was graded separately by the investigator as 0 = Absent. left knee. Morning StiBess: Morning Stiffness in the right knee. ii. right hip. Functional Impairment: Functional Impairment in the affected joints was graded separately by the patient as 0 = Absent. 1.e. and left hip was graded separately by the investigator as 0 = Absent. Week 4 and Week 6. 3 = Severe. The maximum attainable score is 3 while the minimum attainable score is 0 3. left knee. Averaging the Functional Impairment score of the afiected joints amved at the Functional Impairment score. The patients were instructed to contact the investigator at any time if they developed an exacerbation of any of the symptoms.i d. at Week 2. iv. Joint Pain: Pain in the right knee. 1 = Mild. 1 = Mild. 2 = Moderate. and left hip was graded separately by the patient as 0 = Absent. The maximum attainable score is 3 while the minimum attainable score is 0 4. right hip. 3 = Severe and 4 = Prohibitive. Evaluation procedures Efficucy parameters The disease activity was assessed at the screening visit. 3 = Severe Averaging the pain score of the affected joints arrived at the joint pain score. Joint Tenderness: Tenderness in the right knee. and left hip was graded separately by the patient as 0 = Absent. 3 = Severe. The maximum attainable score is 3 while the minimum attainable score is 0 5 . 2 = Moderate. left knee. Modified KGMC lndex for Physical Fun~tion Criteria: The patients were asked to describe the difficulty in performing the below mentioned functions as 0 = Absent. The maximum attainable score is 3 while the minimum attainable score is 0 2. 1 = Mild. Ascending stairs Descending stairs Rising from sitting Standing Walking on floor Going shopping Rising from bed v. i. 1 = Mild. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 141 . iii. Averaging the tenderness score of the affected joints arrived at the joint tenderness score. Week 2. 3 = Severe. Joint Swelling: Swelling in the right knee. 2 = Moderate. The maximum attainable score is 3 while the minimum attainable score is 0 6. 2 = Moderate. Week 4 and Week 6 the patients were asked to participate in a questionnaire for adverse events. 2 = Moderate. right hip. for a period of additional two weeks At every visit the return tablet count was made to ascertain the compliance to the medication. 3 = Severe. vii. 2 = Moderate.during the study period At the 'end of the fourth week the patients were asked to discontinue their NSAID medication and consume only Sallaki (400 mg) 1 t. vi. The following symptoms were assessed. Additionally at every follow-up visit i.

.1 d8e% = = K f P S ~ ~ $ J $~ 9 94%olyf?jtl&M~WYthet@rn@%:.~W\~~RQR&@MW#W~~ S f t parameters aey TheL*dq&sesemti&to thes-&io~ ift!im$ w ~ s ~ ~ m d c k k ~ ~ W k@&atH'JCheck %pd%y' z h ~ ~ list #.abh . $did@ 5 = $.?~-c3?ar 5 !YM ~rctaa~4wormiagrbPsymptmg.&epsog* patient as: 1 = Good . S E L ~ RESEARCH P # ~ ~ ~ ) E B C B X S E T J ' ~ Y ~ # ~ D I ~ ~ C . diil fl-khv-y ddm9t4c diititis' 'Bqh~W&'fdrdoiM Getting inlout from cycle/autorickshaw -+hCTh&l~ b ~ ~ ~ & ~ i b h ~ Daily prayers raki#'a.vliit &![I x. 1 = MiId.$he. . 1-42 T I : the . irg'~iktdg vii IJ ~ ~ s f i 'iSd$€o?t ~ f n ~ viiP E iil h 9 n) i? a ix E igastric burnihg x ~&S*W&G The adverse reactions were graded as 0 = None.when'there is minimal relief of symptoms = x ~ e ~ I ~ m ~ ' s q 0SYSBIPtOls.dbtf? ' The ~ o d i f i e d ' ' k & h tihd& kdr~h'ysica~ Fdnction Ctiteria 'comprised the sum of the score for all the thirteen physical function criteria The maximum attainable Modified KGMC Index for Physical Function Criteria is 52 while the minimum attainable index is 0 lnve&gators hsessment of Overall Efficacy: The 49veSt%?t9.2 = Moderate and 3 = Severe Investigatomassessment ~f overall tolerability The investigator graded the overall tolerability to the inve~tigati*~&.Pmsx8 O % 9f! t @ s f tit w I ~ A ~ $ ~ d ~ ~ W l k @I rebeftclf3~rnPtQlW 3 = Far .severe side effects requiring withdrawal from therapy.~q.no side effects 2 = Fair . Pnd ~ f l h e s e c a d ~ M h ! a r rs&lrdesk W1Q ~ ~ w B ~ P & ~ T o w #&@8fi~''' ri I~ I Heavy headlheadache ii :f&l&r&ctlrsisi~cmi iii Qiddihesst iv I @ mtruth @ v wd.us& vi. &WP ~7 &%J~PR~.mild to moderate side effects 3 = Poor . xi?. xii.

1. 8 btrealm~~t. N S f l ~ . ~ ~ x A&~if&&&i$i&@&&1 ~ ~ j ~ ~ ~ ~ ~JL4 . t#~~kidk&ir.. 0 ) t i n fiifXQ~Qbt8mtstbhiCiq-6ved p i & q n M i h d l b i ~ b f l b ~ 0 ~ gN3(m~ tha jflaT@b ww W$@of M s m .39 that was significantly(fe%w ??a9 0.:\ M.3.ri%f 4y w t h gfiiia yisg dk * %4djtvvT ' *o P?d JW 89.e<. alil~~i~7~o~2~~ ." 4%6?qrcz&!4 ?& &9ftttrff4&% ~@#%@~ot%%kf?fi~teds~&i&*Is9' ..Q2a24. .tbw 2 6 5 0.~5 f mpg~iitllrwrt r Cqmpurl~onof pre (NSAlDs supp~~pfin?.cx~py~d 1 Demographics and patient k f i ~ d ~ FiRy patients were enrolled in the study amongst which forty-six patients c o m @ k % d W lKb#l fiW s g a + s f f a h q ~ o d Y ~ ~ ~ ~ ' i e ~ s t & ~ t b i n p ~ 6 e d ~ t h s l ~* \~ ~~ b T I i b W i & g h #%t?. d t ( cdhg~rPliti&ws +~_cl$e e Se% iL..~ ~dlt~%uft~Ck&aSc809e~aB '%W' e % cbf M at the end of the sixth week was 0. iSaUakiI$Bed w w e f i ' ~ m~l&J11. manths Clinical efficacy Results 'The cllnlcal responses of the patients were determined and the r e s ~ ~ & ~ ( ~ \ s W & i n \ T W \ \ w Joinf paln g$~fy.th.th.Yll ~ 1 l \ \ ~ duration of the disease was 3 1 46 * 39 59 months The nature of the complaint of the ehP&!XI ~2%t~uf5sf4n@~~$s1~a%.p :@n.iGndmm. f s ~ t . R.a ) ?! @ h ~ a i 1 & .y!.&~~fi'fi{f 2 'hb$lhne@lrg l h i ekiiiiiib pain of the affected joints at the ??-wee an 4 week e mean score for joint pain at the end of the second and fourth week were 0 96 i 0 4 and 0 66 & 0 28 resggs%&\.Ws'Wi& t k ~ at'g~sigmcatdt! levdl W ~ ' O W t $y th.42.< 0 05).$i.42. d m h ~ ~ ~ h i ~ b t m & ~ m e r . the mean baseline score for joint pain (Figure 1) *w*cnu~n~e2p~ &M#.lfi:antly less (p.bqeline si~orgf~r.k8-&fim.bres ~!@oi&i'% & w & ~ ~ ~ @ s ? r ?nbll h h o hells t ste he significant difference within the group for change from fourth and sixth week.73 0. r.'&W#WBf3"aMXctifify' 3S~ssment'vy.ltiz3i~d~i&1rd ~ ~ ~ 1 6 ! @ @ j $ & & t @ h i ~ $ b ~ & ~ ~ ~ ~ ~ ~ 0 g ? .e me@. .

27. no significant diffwence in the morning stiffness score at the sixth as compared to the fourth week was observed.54 0.69 0. no significant difference in the joint tenderness score at the sixth as compared to the fourth week was observed.tenderness at the end of the second and fourth week were 0.3 respectively that were significantly less @ < 0.05) than 1.05 0.35 that was significantly less (p < 0.46 h 0.33 0. the mean baseline score for morning stiffness pigure 4).05) than 1. However the mean ocore.46.82 0.82 0.33.34 and 0.05 0. * * Comparison of pre (NSAIDs supplemented with M & and post treatment (Sallaki after I) withdrawal of NSAIDs) values When therapy with NSAlD was withdrawn and only Sallaki administered for a period of two weeks from the fourth week of study period.05) than 0.34 0.%llakr} s values Supplementing the existing NSAID therapy with Sallaki resulted in a significant reduction in the swelling of the affected joints at the 2-w&k and 4-week endpoint.47 0. the mean baseline score for joint pain (Figure 2).33. the mean baseline score for joint swelling (Figure 3).09 0.37 that was significantly less @ < 0.3 and 0.29 respectively that were significantly less (p < 0.09 0. the mean baseline score for jbint swelling (Figure 3) * * * Comparison of pre (IvSAIDs supplemented with S a l U ) and post treatment (Sallaki sfter withdrawal of NWDs) values When therapy with NSAID was withdrawn and only Sallaki administered for a period of two weeks fiom the fourth week of study period.27. The mean score for morning stiffness at the end of the second and fourth week were 0. However the mean score for joint tenderness at the end of the sixth week was 0. * * - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 144 .for morning stiffness at the end of the sixth week wab 0.05) than 1.31 respectively that were significantly less @ < 0.two a weeks &om the fourth week of study period.28 and 0. The mean score for joint swelling at the end of the second and fourth week were 0.7 0.46. However the mean score for joint swelling at the end of the sixth week was 0. the mean baseline score for joint tenderness (Figure 2).46 0. no significant difference in the joint swelling score at the sixth as compared to the fourth week was observed.05) than 0.45 0. * Comparison o pre (NSAIDssupplemented with Sallaki) and post treatment (Salk& after f withdrawal of NWDs) values When therapy with NSAlD w s withdrawn and only Sallaki administered for a period of . * Joint swelling Comparison of pre flSAIDs therapy) and p i treatment (NSAIDs supplemented with .05) than 1. * * Morning s t i f f n ~ s Comparison of pre (1VUIDs therapyl and post treatment (NLUIDssupplemented with SallakI) values Supplementing the existing NSAID therapy with Sallaki resulted in a yignificant reduction in mcrning' stiffness of the affected joints at the 2-week and 4-week endpoint. the mean baseline score for morning stiffness (Figure 4).33 that was significantly less @ < 0.

the mean baseline score for functional impairment (Figure 5).c.SAIDs supplemented with Sallaki) and post treatment (. Modified KGMC Index for Physical Functjon Criteria omp par is on of pre (N.!!llub) values Supplementing the existing NSAlD therapy with Sallaki resulted in a significant reduction in the KGMC lndex for Physical Function Criteria at the 2-week and 4-week endpoint. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 145 . (Table 4) Overall tolerability All the forty-six patients who completed the trial reported a very good tolerability to the treatment.05) than 22.%llaRi) and post treatment fsbllak~ afier withdrawul of NLWIDs)values When therapy with NSAlD was withdrawn and only Sallaki administered for a period of two weeks from the fourth week. One patient reported of vomiting and epigastric burning of mild severity on the fourth week of study period but it discontinued gnrdually until the sixth week without necessitating any change in the medication.86. The mean index at the end of the fourth week was 14.4. However the mean index at the end of the sixth week was 16 7.39 that was significantly less (p < 0.64 h 0.3 k 5. no significant difference in the functional impairment score at the sixth as compared to the fourth week was observed. An excellent response to the treatment in four patients. The mean score for functional impairment at the end of the second and fourth week were 0.29 respectively that were significantly less (p < 0.4 and 0.86.62 6.14 0.%llaki after withdrawal of NS4IUs) values When therapy with NSAlD was withdrawn and only Sallaki administered for a period of two weeks from the fourth week of study period.Functional Impairment Comparison of pre (IvSAIDs therapy) and post treatment (NSAIDS supplemented with Sallaki) values Supplementing the existing NSAID therapy with Sallaki resulted in a significant reduction in hnctional impairment of the affected joints at the 2-week and 4-week endpoint.05) than 1. * Comparison of pre (N.05) than 22. a good response in twenty-one patients. a poor response in four patients while a very poor response in just one patient.53 that was significantly less (p < 0.88 0.3 5. However the mean score for hnctional impairment at the end of the sixth week was 0.58 0. a fair response in sixteen patients.AILlstherapy) and post treatment (NUIDS supplemented wzth .43 that was significantly less (p 0. the mean baseline score for fiinctional impairment (Figure 5). the mean baseline index (Figure 6). * * Overall efficacy The investigator reported the following responses as the overall efficacy of the treatment.05) than 1. * * * Comparison of pre (hrWfLls supplemented with . the mean baseline index (Figure 6). of study period.4. no significant difference in the KGMC lndex for Physical Function Criteria at the sixth as compared to the fourth week was observed.14 0.

~ f i .{fl. Analgesics such as paracetamol and at times even a combination of paracetamol and codeine arf+&&gg~a ~ &g. y ptM& c tien" d xi n3m m P b n o l f 3 q lobs 6A0!#i bJii+d.!to72J0JRt~ 9 ~ f !?R&P%c!~.Y(~I\~@BR b c\~RI~% ~ ~ e pW f I m q m ~ ~ .F~~&f3 reassuran e.433+r-C 9ijJ t6 fi11911:1'30 1 3 3 i t ~ qI ~ ? i ~ ? ( 6 1~3bfrI fajo tncreasing obility ~ $ 1~ 9roving9We fpatient'se q u & l i (mta~ad~tfh i ~QbePi .~?fiL~~~$~nQ~~~~&i?Ck\cjAv.$%~~e~Q.+br16 ..~ ~ ~ ~s~ n $ f t ~ f ? f i ~ k a ~ ~ t t~ ! 81 5 # ~~ ~J~~@ T ~ f P f ~ ~i ~ ~ i U &I ':a~y'8\bbhs'? divided into non-drug therapy and pharmacological options The vigor of the therapeut~c terv i~ dic(gg~~~..-. -.&@e SI IOBJ~~V 7 .1)frrsrnlrsqrnr Isnoifantjt 161 As the articular cartilage is aneural.M$1 ub e $f f'l y 1 cfisea~e 3 or ations w ~ I ~ ~ ~ ~ 3 1 ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ h . &htainIng $R:~B~?!~FP~~S+ \xJ. no p b~ t ~ ~~~~9~~~ ~ grg.k3w ~ J X I Z d t ' i ~ ' Y h 2 r i p ~ ) & 9 ~howev& is $liatrve.~iiirr< 16 db ~ R C [ Q F T + d I Z6W .9&m?i#hfi T ( Z siug1.H?$sPT~~!R f Pain-=.%%t~ w~PMIR B$$@ (k dh@cl yP ~ w ? & evlden'Ee o synovia in ammation may e as marked as that in the synovium of a p+twJ&h rheumatoid arthritis Synovitis in OA may be due to phagocytosis of shards of cartilaie and%one from the abraded joint surface t "04 9 % ':mmuni compjexes.fegs. ?f&$$b$# ! ~8 adf an i Jnernslqq 11% i xs bsyFtjs~ ~ f % ~S&~WHF i & n 11 d 3Mi)A ns c \ ~ .. instruction in joint p~otection.'.?&Q \1)%-4 anse%om microfractures m s u h p 4 mY ~ ~ ~ .. m ~ ~ y the progression of.&!%fitah.-. d%n sd~%~3?&~fuX~~f$~B BRF~ J~&RRI%B~ ~klp$rp*itLt &m~wd~s4fan~nf&$9f@t B i. ~ q < ~ l \ ~ y ~ y ~ J s bn3 ad1 ti3 xabni nssm b rl. -."ih .a * ..@e ..~~~~q~.. Y may ~~ % G h e nsion ca v&?. or reverse the pathologic c anges of OA in humans.\":. the joint pain in OA must anse from other structures In t' n it ma b d o eop e. in otters it \?% %J &\~A@R&W~C.~M~. .Uiiitl"s"ii'c"duiB 'ih"'mosf'p&~le and is probably the most common joint dlsordefi. ~ re ~ 3 f ~ ? w ere a a swt 3 % ~ S ~ ? $f B49 e~intRfi&~fi~i~~9i~fide7t a esic sr f 4 1 M ~~z trot nt 9znocJh 1%f&$W (1PbdP B % ~ @ ' B ~ ~ E o N ~ @ M sni~3znoqr. especially those related to the gastrointestinal tract is growing yfTbmmk.DISCUSSION fnstfr'liaqml Isnoifx~ar? ~BP&a.n (P sldsT) fnsi3~ sno Concern with respect to the appropriateness of NSAID administration in OA because o their side effects.

quantitative tool to assess symptomatic benefits in Indian patients with OA knee Thus it cab be said that s~multaneous administration of Sallaki results in significant reduct~onIn pain and disability while improving the mobility tFt. the second major mediator of inflammation by the concomitant use of lipboxygenase inhibitors would probably result in a better control of inflammation. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . significant number of patients previous1 controlled on NSAIDs were x2-23 able to continue on paracetamol alone for the duration of the study Given that the symptomatic relief afforded by NSAIDs is no greater than that achieved by simple analgesics while the frequency and severitv of adverse effects are more with the former. tenderness. multidimenaonal. should be employed for short periods of tlme ( L 1 to 2 months) and attempts continually made to withdraw treatment and reintroduce or mcrease the dosage of analgesic drugs Thus it may be concluded despite their being an inflammatory component in the pathogenesis of the disease. no significant differences were found 20 between the treatments in terms of disability or pain on walking . The present study was conducted with an attempt to prove the assumption Patients w ~ t h osteoarthritis were prescribed Sallaki (400 mg) t i d for a period of four weeks in addition to their routinely prescribed NSAID After a period of four weeks their therapy with NSAlD was withdrawn and only Sallaki administered for an additional two weeks perlod A significant improvement in all the variables assessed was observed at both the Zweek and 4 week end points The improvement in the signs and symptoms was sustained until the sixth week i e even aRer discontinuation of the NSAID therapy Supplementation of the existing NSAID therapy with Sallak~ resulted in a significant reduct~on in pain. swelling. NSAIDs are used only when analgesics and other hleasures have failed However NSAlDs when used.In a short-term study comparing an anti-inflammatory dose of ibuprofen (2. morning stiffness and fbnctional impairment of the affected joints the effect was observed both at the end of the second week and fourth week The modified KGMC index for physical function criteria also decreased at the end of the fourth week The KGMC index for physical function criteria is a powe&l instrument to study the health status of OA patients belonging to the Indian population It is a reliable and valid. Also in two recent 2-years comparative studies o f NSAIDs (naproxen and sustained release diclofenac) in the treatment of osteoarthritis of the knee. In a study in which patients were repeatedly randomized to receive paracetamol or diclofenac.4 dday).2 glday) and paracetamol (4 glday). about 305'0 reduction in pain and 15 % improvement in €unction However the inflammation needs to be controlled as persistent inflammation ftllther results in cartilage degeneration and worsen~ng the disease of It may be suggested that the poor control of Inflammation is due to the inhibition of just one of the mediators of inflammation i e cyclooxygenase Simultaneous inhibition of lipooxygenase. the magnitude of improvement afforded by NSAIDs is generally modest-as reported on an average. an analgesic dose of ibuprofen (1. symptoms were adequately controlled by paracetamol alone in approximately 30 % of patients 21.

Furthermore. the improvement in the clinical signs and symptoms were maintained even after withdrawal of the NSAID therapy thereby suggesting Sallaki to be effective even when used as a sole therapy One may conclude from the present study that in OA patients once treatment with NSAID and Sallahi is initiated the need to continue with the NSAID is obviated It is preferable to continue w~thSallaki on a long-term basis and gradually reduce the dose of NSAID or use it only intermittently i e during exacerbation of joint paln SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 148 .A synergistic effect of lipooxygenase inhibitors and cyclooxygenase inhibitors thus exists in controlling the inflammatory component of osteoarthritis.

'omparison of an anti-zn$ummatoory &. 20. Rheumatology 1993. A. 1935-41. 110.~dprc?fen. 5. Internal medicine 1 4 ed. Kahan. 3 .. N-of-] trials comparing u non-steroidal antilinflummutory drug andpacetamol on osteoarthritis. et al.. Pharmacology. 407-4 12.. 12. Chopra. Hawkey. et al. 4 - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 149 . et a1 (Eds): Harrison's Principles of ~ Edition 1998: Vol.. an analgesic dose of ibuprofen and acetaminophen in the treatment patienls with osteo&rthritzsof the knee. 37: 946-5 1 4. 107-1 10. H. Spinger-Verlog.N.R.. 74. (1995) JIRA. K. J. et al. A.. Braunwld E.A. Eflect of . J. Pharm.V.. Hawkey. J. 18.116. Cushnagan. K. (1 9sb) Agents and Actions. Malmsten.. et al. 13. S. 18. (1981) Br. Patil.:omparison of naproxen mui acetaminophen in cr two-year study of treatment of osteoarthritis of the knee.. Ramakrishnan.. Praxis (1972) 4& Ed. M. 2: pp.264. L. Vol. Arthritis and rheumatism 1993. Assessment of the therupeutic ~fll?ct Sallczki (Boswelliu qf serrata) in the treatment of juvenile rheumatoid arthritis. K. compared with piroxicam: Resutts of the safety nd eficacy large scale evaluution of COX-inhibiting therapies (SELECT) trial in osteourthritis.. Dieppe. 10.. Scand. C. The International MELISSA Study Group. 57. March. 3 .P. Br. . C. In~rnational 6.341..449. T.K. C.M.M.. 22. A two-yeur placebo controlled trial of non-steroihl untiin$ammatory therapy in osteoarthritis of the knee joint. Br. Ammon.. A.. 3. Atal. 7(4). et al. et al. J. K. The BHIGWAN (India) COPCORD : Meth@ology a d j r s t infomation report. 16.D. L.... 11. Atal. K. Chandigarh.REFERENCES 1.'linical Trzal of Ro~wellia Serrata &ScdZuki)in the trecztment of Osteoarthritis. Osteoarthritis:Diagnosis and management.Sirllaki in the treatmen1 c?f Kheumcrtoid arthritis. J.. 9. J. et . H. (1980) Acta Physiol. G.et al.No. Heidelberg New York. Irwig. 3 -No. Brandt.. 32-595. Rheumatol 1998. (. Das. Kar.D. et al. et al.M. Ward. Br. Dequeker. et al. Lohokare.D.. 19. 7... et al. J . 113.59. 19. C. J. 2.646. Brandt. 286. J... (1995) JIM. 15. M..JIM. l(1): 145-54. 3. 14. 139-145. 37: 937-45. Atal. Chandrashekaran A. 333 . J. et al. 325-87 21.E. (1982) XV IPS (Abstract). 17. Bray. 3. (. 36: 1196 23.72. W. 483.. N. (1995) . S. S. 491. meloxicm. et al (1980) Nature. 8. Ford-Hutchinson. et al. B.No.et al. Singh.309: 1041.203 . Vol. Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor. (1971) Planta Medica. K. Bradley.. (1980) Ind. APLAR Journal of Rheumatology 1997. Rajagopal. (1991) Planta Medica. et al. Mc Graw-Hill. A. Williams.J. Gas@ointestinaltolerability of meloxicam compared to dzcofenac zn osteoarthritispatients.12.. 289.al. Menon. Wedmore.M. (1981) Nature. (1981) Br. Rheumatol 1998. 1991. Berlin. B. Vol. C. P. C. 101-106.J. L. 1994.. Kahan.ye of ib. A (.. K. J. Hagers Handbuch der pharmazeut.. et al. 3 / 4. 3.207. 203.. Osteoarthritis: In Fauci AS. Vol. J. JIRA 1999. S. C. A. 111 pp. Parn1.

..Table I.-.....-. - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 150 ...... II 42 14 19 ..-..-- . ..--p--.-... .. Nature of cornpla~nt Complaint ... Pain in knee joints Pain in hip joints Stiffness in knee joints Stiffness in hip joints ~ i i ' f i c u l in walking and/ or climbing t~ - ..

i.meloxicam T.d 400 mg t.d 25 mg t. nimesulide T. ibuprofen T.i.d 100mgod No of patients on the medication 18 19 2 1 3 1 I The medication described is the one on which the patients had been stabilized for the past onemonth.d 15mgb.i. dicloram Dose lOOmg b. - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 151 . Details of the medication Medication T.i.dolonex C.Table 2.d 20mgo.d 75 mg o. indocid T.indomethacin C .

d.66 0.26+ 0. in osteoarthritis -.73 0.05) SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 152 .96 0.i. deviation of 46 observations ( 0.Table 3.28 * Week 6 .39 * * * * 069h033 * 046*031 * 046*035 * 054i028* 07h034* 088%04* 033*029* 047&03* 058*029* 146*653* 034+033* '045*037* 064*043* 16+739* -- * : significantly different from baseline values atxp Values are expressed as the mean * std.42 109+033 082*027 105*046 114+04 22 3 + 5 86 Mean Score on Week 2 Week 4 0. Efficacy results with Sallaki (400 mg) t.- Clinical Parameters Joint pain Joint tenderness Joint swelling Morning stif'fness Functional impairment Modified KGMC lndex for Physical function criteria Baseline 1.4 * 0. 0.

Table 4. Overall efficacy of the treatment Response Excellent Good Fair Poor Very poor No. reported by Investigator 4 21 16 4 1 Values given are the number of responses reported by the investigator for the 46 enrolled subjects. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 1 53 .

.i.Figure 1: Ef'fect of treatment with Sallaki (400 mg) t.0 05) "significantly different from Basel~ne L'ali~esare expressed as the Mean + Std Deviation of 46 observations SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 154 .d. on the Joint Pain Score of patients with Osteoarthritis score at (11 .

.. ~ -~ ~.-. on the..---~ T'" significantly different from Baseline score at (p .-.~ ~ .. . ... . --.Figure 2: Effect oftreatment with Sallaki (400 mg) t.05) 0 : Values are expressed as the Mean + Std Deviation of 46 observations * SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 155 . Joint Tenderness Score of patients with Osteoarthritis -- - . ..d.i...

Deviation of 46 observations SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 156 .d. on the Joint Swelling Score of patients with Osteoarthritis * : significantly-different from Baseline score at (p < 0.05) Values are expressed as the Mean It Std.Figure 3: Effect of treatment with Sallaki (400 mg) t:i.

significantly different from Baseline score at (p < 0.05) Values are expressed as the Mean + Std.Figure 4: Effect of treatment with Sallaki (400 mg) t. Deviation of 46 observations SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 157 .d. on the Morning Stiffness Score of patients with Osteoarthritis * .i.

on the Functional Impairment Score of patients with Osteoarthritis * . significantly different from Baseline score at (p 0 05) Values are expressed as the Mean + Std Deviation of 46 observations SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 158 .d.Figure 5: Effect of treatment with Sallaki (400 mg) t.i.

Deviation of 46 observations * SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 159 .d.Figure 6: Effect of treatment with Sallaki (400 mg) t.i. on the Modified KGMC Index for PhysicalFunction Criteria of patients with Osteoarthritis * : significantly different from Baseline score at (p < 0.05) Values are expressed as the Mean Std.

D Lecturer in Medicine K. M u m b a ~ 400 0 12 Dr A Rajadhyaksha M D Assoc Prof 111 Medlcine K E M hospital. Kini M. S.400 0 12 Dr. Parel.E. L S .E M.M. Rajadhyaksha.DOUBLEBLIND RANDOMIZED CONTROLLED TRIAL OF SALLAKI (600 MG) VS DICLOFENAC (50 MG) IN THE TREATMENT OF RHEUMATOID ARTHRITIS * Bichile. hospital. Kini. Mulnbai - 400 0 12 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 160 .Bichile M. Mumbai . Parel.D. Professor & Head Department of Medicine It Chief Rheumatolgy K. Parel.L. S ' * Author for correspondence Dr. A . hospital.S.

d) along with the NSAID. Morning Stiffness and Functional Impairment for the hip and knee joints. The following variables were tested: Joint pain.d) administered for an additional two week period. which they had been routinely consuming for their disease The duration of the treatment period was four weeks. Sallaki 8. A statistically significant improvement in all 'the variables were observed at the Week 2. Osteoarthritis SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 161 . The improvement was thus sustained even after withdrawal of the NSAID therapy. Joint swelling.i. Week 4 and Week 6 end points. fifty patients with primary osteoarthritis of the knee andlor hip were treated with Sallaki8 (400-mg t.ABSTRACT In an open study. Joint tenderness. At the end of the forth week treatment with NSAID was withdrawn and only Sallaki8 (400-mg t.NSAID.i. The drug was also well tolerated with no reported incidence of adverse drug reaction Key words:. The patients also participated in a questionnaire that included all the thirteen physical hnction criteria of the KGMC Index.

INTRODUCTION Recognition of rheumatoid arthritis as a "medical emergency" led to a change in the therapeutic strategy fiom " go-slow-and-go-low" to "aggressive early treatment" aimed both at symptomatic relief (controlling synovial inflammation) prevention of joint destruction and loss of fknction (modification of the progressive course of the disease). work disability.e 30 minutes which lasts for about 2 hours has been 7 obsewed with the non-phenolic extract of Boswell~a serrata These findings suggests that the gum resin exudate of Boswellia 'serrata can play a role in controlling the signs and symptoms of RA by virtue of its anti-inflammatory and analgesic effect and can also prevent the progression of the disease by inhibiting the cell mediated and humoral responses SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 162 . However the use of DCARTsIDMARDS as well as of NSAIDS are associated with a wide spectrum of side effects ' A recent study on the pattern of adverse drug reaction with NSAIDS. and mortality rates observed in the patients Long term treatment with DC-ARTs/DMARDS is therefore instituted early in the course of the disease before the occurrence of irreversible joint damage. The gum resin exudate of Boswellia serrata that has been advocated in the treatment of 'rheumatism in Sushrutha Samhita and Charak Samhita is known to possess remarkable anti3 inflammatory and anti-arthritic effect and to be devoid Of toxicity on prolonged use . DC-ARTs/DMARDS and steroids on Indian population revealed that gastrointestinal disturbances is the most frequent adverse event and observed in 54 1% of patients Cardiovascular 1 respiratory system abnormalities were observed in about 3 1 88 % of the patients. cutaneous reactions in 2 20 8% and nervous system related symptoms in I 1% of the patients 2 Thus the search for agents with anti-inflammatory and disease modifying potential whose long-term use would not be associated with side effects still continues. Pharmacological studies conducted on the extract of Boswellia serrata to delineate its mode of action revealed the extract to be acting by a mechanism similar to non-steroidal group of antikthritic drugs with the added advantage of it being free fiom side effects and gastric 4 irritation and ulcerogenic activity The extract can inhibit the prodbction of leukothene-type mediators of inflammation at low concentrations and prostaglandin-type mediators of inflammation (the PGF series) at higher 5 concentrations without impairing the PLAz action The extract can also inhibit the expression of 24 hour delayed type hypersensitivity reaction (cell mefliated immunity) and primary humoral response to SRBC in mice (humoral 6 immunity) Marked analgesic effects of rapid onset i. Reasons for the increasing popularity of the aggressive approach were the uncommon natural remissions and the substantial morbidity.

If the extract is able to control the persistent tissue inflammation (i e persistent T cell activity) that is reminiscent of delayed type hypersensitivity reaction occurring in response to soluble antigens or microorganisms. ESK and CKP.Recent evidence suggests propagation of RA to be an immunologically mediated event with the inflammatory process in the tissue driven by the CD4+ T cells infiltrating the synoviunl. grip strength. swelling score.d) with Diclofenac sodium (50 mg t i.i.vwellru serrutcr resin is available 111 the Intf~anmarket under the trade name "Sallaki" from Gufic Health Care Ltd Well-controlled clinical trials \ ~ t Sallaki ha\ e h been conducted in the past on patients with rheumatoid arthritis and osteoarthrltis Sallaki (400 mg t. PIP circumference. indomethacin and ibuprofen for a period of six months in patients with rheumatoid arthritis.serrutu over conventional drugs on account of the absolute freedom from side effects it is imperative to evaluate ~ t s antiinflammatory and disease modifying potentials in RA patients The crude extract of Ho. A significant reduction in the rheumatoid factor was observed wh~chseemed to suggest ~ t s probable disease modifying potential ' When Sallah~(400-mg t I d) was assessed for ~ t s therapeut~ceffect in j u ~ e n ~ l~heumdto~d e arthr~tls it demonstrated a potentla1 In produc~tig a remlsslon In the clln~ciil s ~ g n $ 'ind symptoms Besides histologically ~tshoned to produce healing In the svnm [urn bv Inciedsi~le 9 fibrosis aFter sixth month of therapy Sallaki (200-mg t i d) when used in the treatment of osteoarthritls showed encouraging results in early cases having mild pain with no radiological changes In the jcrlnts In the patlents ~clth long-standing disease with moderate to severe radiological changes ~t shomed a fair to pool 10 response Results of the three clinical trials with Sallaki seemed to suggest its efXcacy In relleving the signs and symptoms of rheumatoid arthritis and osteoarthi-itis w~thoutproducrng any side eff'ect eken on long-term use The results of the previous trials encouraged us to conduct a study where~nthe eflficac? of Sallahl would be compared with the routinely prescribed anti-inf1amnl:ttor-y agents in reliev~ng signs and symptoms of rheumatoid arthritis the Thus the objective of the present study was to compare the ef'ficacy and tolerance of Sallahr (600 mg t. produced a statistically significant improvement with respect to pain score. number of joints.swell~u .i.d) in providing symptomatic rel~efto patients with rheumatoid arthritis The trial was conducted as a double bllnd randomized parallel group study SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 163 . articular index. it may help in preventing the progression ofthe disease However before one can claim the superiority of Bo.d) when administered along with anti-inflammatory drugs like aspirin.

M. All the patients gave written informed consent before enrollment into the trial. attendin8 the Rheurnatology O. grip strength. hypnotic.D. at The patients were includcdif they had K E M Hospital were enrolled into the study atleast four of the seven diagnostic criteria established by the A. duration of morning stiffness. andlor anti-inflammatory drugs were prohibited during the trial to avoid any interference in evaluating the investigational drug treatment The protocol had been reviewed and ratified by the Ethics committee at K.MATERIAL AND IMETHODS Patients selection Consecutive patients with active classical or definite rheumatoid arthiitis. time required to walk 50 feet and VAS score The painhl and SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 164 . tranquilizers.P. or thdse with severe disabling arthritis rendering them eligible for surgical intervention or those incapacitated or bedridden were not included in the trial. determining the digital joint circumference.A.. methotrexate. Hospital. Patients with severe renal.E. penicillamine or lithium or having undergone a thaapy with the same in the previous three months were also not included in the trial Pregnant.R. Study Design The study was conducted as a double blind. After the patient satisfied the entry requirements. or those exhibiting hypersensitivity and / or intolerance to NSAID's including a history of aspirin induced bronchospasm were excluded from the trial. hepatic.A. hemopoetic disease or severe cardiac insufficiency as revealed by laboratory investigations or other tests were also excluded from the trial Previous anti-inflammatory treatment were discontinued for atieast five days prior to initiating the therapy with the investigational drugs and only analgesic therapy with paracetamol was allowed to control symptoms of pain during the wash out period Consumption of other analgesics except paracetamol.R. Patients having received any investigational drug in the preceding one-month _or having donated blood in the past three months were also excluded from the trial. lactating women or women at a risk of becoming pregnant were not included. dorticosteroids. hydantoin. and if their disease state was characterized by the presence of atleast two of the following: 1 duration of morning stiffness of at least 3 hour or more 4 2 atleast six painful or tender joints on motion 3 three inflamed joints 4 erythrocyte sedimentation rate greater that 30 mrnhr as determined by the Westergreen method Patients having developed rheumatoid arthritis before 16 years of age. according to the American Rheumatism Association (A. a complete medical history was taken and a general examination performed The disease activity was measured by counting the number of tender and swollen joints. Patients with a history of active peptic ulcer in the preceding six months or bleeding ulcers at any time in the past. randomized. paraliel group comparative trial. gold. antipyretics.) criteria. Patients with ongoing therapy with anticoagulant.

s The disease activity was assessed at the screening visit.using the VAS score. 6 . 2 or 3 to evaluate the severity of the inflammatory condition of each joint.swollen joints were scored using a scale of 0. CRP. Proximal. The following symptoms were assessed: 1. hematological and urine routine were performed at baseline and then repeated at the end of the study i e Week 4 At the end of the study the investigator assessed the overall efficacy and tolerability to the treatment. Grip strength in mm Hg: The cuff of a mercury sphygmomanometer was inflated to 20 mm Hg after which the patient was asked to squeeze the cuff to the best of hislher ability and the rise in the level of the mercury was recorded.e. Number of swollen joints: The presence or absence of swelling in the following joints were determined. Metatarsocuneiform (MTC). SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 165 . Week 2 and Week 4. Interphalangeal (IP).interphalangeal(PIP) (2-5). hip. Duration of morning stiffness recorded in minutes 3 . The dose of Sallaki was (600 mg. ankle tarsus. elbow. Rheumatoid factor. Proximal interphalangeal PIP (2-5) and Metatrsophalangeal P (MTP) (1 -5). VAS score: Patients assessment of pain severity during . Digital interphalangeal (DIP) (2-S). 4. Interphalangeal L (feet). Swelling score: Swelling in the affected joints was graded as 0 = Absent. 1. 1 = Mild. The patients were instructed to contact the investigator at any time if they developed an exacerbation of any of the symptoms Evaluation Procedures liflicczcy /xzrrzmeter. Time to walk 50 feet recordid in minutes. at the end of the first week. Acromioclavicular (ACL). Week 0. ankle mortis. wrist. at baseline i e prior to initiating the investigational drug therapy (Week 0). Sacroiliac (SI) .up visit At every visit the return tablet count was made to ascertain the compliance to the medication and the paracetamol consumption. 3 = Severe and a composite swelling score was arrived at by averaging the swelling score of the affected joints. t i d) and of Diclofenac sodium (50 mg t I d) divlded morning. The patient was asked to place a mark on a 10-cm long standarti scale assuming that 0-cm indicated no pain and 10-cm indicated maximum pain.day and night was evaluated . 2. at baseline i. knee. second week and thereafter at the fourth week i e the end of the study. afternoon and night The rescue medication paracetamol and the invest~gatlonal drug were provided to the patients at every follaw . 2 = Moderate. at Week I . Temporomandibular ( TM ) Sternoclavicular (SCL). blood chemistry. shoulder. The distance of the point marked from O cm was calculated and recorded in Iiiln. Metacarpophalangeal (MCP) (1-S). Laboratory investigation like ESR. The disease activity measurements were conducted during the screening visit. The mean rise in mm Hg calculated for three tries by each hand was taken as the grip strength) 5.

r rlit ~ncestig~tto~ ~ ~ lt11t (l . effect\ i r. 4 7 Wlleui~l~~to~d at baselme and Week 4 fact01 -I (' Keact~ce pruteln at basel~ne Week 4 and s oplnlon on efficacy at the coniplet~on the tr~al of graded as f i d l o ~ Ciooti s 10 Pn~est~gittor s~ginticant ~mprc)\ernent. . wincing and withdrawal.qriliIII: \h. i asseb>rnclliS.i~r. ~ ~ ~ v. . specially des~gned 7.!st I I L C .ibleshhpther measured or calculated were subjected to 'I ~ . I= Paln.~niie~i \$[be~oiiip. IJoor = seLcrc \1(1c . 4= Patient d ~ d not allow palpitation and the composite tenderness score was arrived at by averaging the tenderness score o f t h e affected joints. \ < ~ r toler:ti>~l~ty the ~ n c e s t ~ g a t ~ odrugl on lnterrogiitlng the ~i ec ~ll to r~a ld patient as t luod 1 1 0 S I ~ Cefle~ts.m bi~\elineassessment calues at the fourth week ~)l.i:~- Ill ii~~t. 'She fiillaw~ng porctmeters were also evaluated to determine the efticacy ii'aracetamcil ccmsurnptlon throughout the trial per~od e f o u ~ueeks I I 2 Er~throcytesed~mentat~on (Westergreen method stated In ninilhr) at basel~neand rate Weel-. ~I L . The swelling in the digital joints was evaluated using jeweler's rings (diameter ranging from 10-33 mm).tnge frc.b n ~ r ~ n ~ to {nodel-ate slde ctrects. ~ .Number of tender joints : The presence or absence of tenderness in the above mentioned jo~ntswere determined 8.Complete and d~fferent~al :inalks~s Blood sugal (fkst~ng) Blocrd L I I ~ C I nltrtrper~ Serum creat~nrne 5erurii b~llrub~n. N I ~ Y .no stat~stic~ill\ s r z n ~ f i ~ ~ i~l~l'fcrcncc I I I I ~ .ill 15on and c'tel~ lICcjt.lobulin Ln~est~patc~i\ ~ \ \ i ~ ~ c ofl lo\tl.tLgi 5U/< ' Ilc i i h ( . : 9 hc n~rll hypothes~s tested h a s that there was . Zs( ' I E . 9 Digital joint circumference.IL . I ~ G iil C t~lt'ttment groups and wlth~ntreatment groups for basel~ne ch.~crr 11.il p1citrllis Album~na n d c. 11 cc>nlpar1sonswere tested at a s~gn~ficance A level of p .il! tr>le~~rl)~llt\ .Fair = moderate ~niprovemciitand Poor = no Irnpln~ement 1. tor treatment effects to e ~ a l u a t e safety uslng palred t test \!ere cons~deredsrpn~fic. ~tlid~d\c~tl thernln ti0111 I ' . . ~ I I QI .+~ \%a\ inidde for B)lclofenac sudiuni velsus Sallak~ also ~ ~ t h ~ n (..!I . r t o i ~ were anal\:ed tesls Ill t.0 05 In tr~ticr t:i suinmar~ze -I beech tredtnient results. 3= Pain. I ~ I I [ > . I c~t.tllr-. only the mean assessment ti>r bascline thc ' ~ n dthe nie'ln assessment at the end cif the treatment perrod (4 weeks) are presented as Weel (1 !#-ti. 2.4 iespecti\el\.end .inf (p 0 05) at SELECT RESEARCH PAPEha ON EVIDENCE BASED AYURVEDIC DRUGS 166 .abolator~ ~ncest~gatlons 'B'lie following lnvestlgat~onswere conducted at bascl~nc and ~ e p m t c d the tcrm~nat~onf t h e tr~al e Week 4 at o I cvh~teblood cell count t '~lilt Wed blood cell count Hernoplob~n.Pam and wincing.l~cnt groups . Tenderness score Tenderness of the affected joint on palpitation was graded as O= No pain.

sigtiiticantly less ( p . 0.9 years and were not significantly difrerent from each other * * Clinical Efficacy Results The clinical responses of the patients were determined and the results are as shown In 1 able 1.28~3 VAS score ('otiip~zri.e ~ t w Sclllczki and I ) I c I O ~ ~ ~ ~ L I C h~ ~~cn . Bes~desthe mean absolute difference between the pre-treatment and Week 4 grip strength score for the Sallaki and D ~ c l o t n a c SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 167 .03.42 22.15 that is not significantly higher than the rnenn baseline grip strength of 75. * G r i p strength ('otn/~cwi. . The mean duration of the disease in the Sallaki group was 3.sodirrrn There was no significant difference between Sallaki and Diclofenac sodium i n increasing thc grip strength at Week 4.09 i.~.77 years while that I ~ the I diclofenac sodium group was 2 3.c~ti~.49 that is significantly less (p .9 and 21.57 27. Similarly the mean grip strength for the D~clotenac sodium group at Week 4 is 90.7.2.:ore of 57 71 23. The mean baseline grip strength score for Sallaki and L)rcloltnac were not significantly different from each other.~~t~ and post /rt?utrnen/vcr1iic.58 44.06 + 25 which is also . Similarly the mean VAS score for the Diclofenac sod~urn group at Week 4 is 44.9 which is not significantly higher than the rneiiil baseline grip strength of 82.sodil~tn There was no significant difference between Sallaki and Diclofenac sodium in reduc~ngthc patient's perception of pain.58. 0 0 5 ) tllan the mean b~seline VAS s.07 i.son ofpre czrzdfio.27.v Both Sallaki and Diclofenac sodium produced non-significant improvement in the grip strength at the 4-week endpoint when compared to baseline The mean grlp strength in the Sallaki group at Week 4 is 82.05) than the : mean VAS score at baseline of 64 14 + 28.OBSERVATIONS Demographics and Patient characteristics Forty-seven patients were enrolled in the study amongst which thirty-thl-ee patients completed the trial (18 on the diclofenac sodium group and 15 on the Sallaki group) The mean age of the patients in the diclofenac sodium group is 37.7 * * l )i/Ii.47 i 13.st lrelzfrnentvu1ue.5 whi!e the mean age of the patients in the Sallaki group is 43.14 37.4.s ofpre Both Sallaki and Diclofenac sodium produced very significant improvement in the pat~enl's perception of pain at the 4-week endpoint when compared to baseline.67 13. The mean baseline VAS scores for Sallaki and ~iclofenac \\el-e not significantly different from each other Besides the mean absolute difference between tllc pre-treatment and Week 4 VAS score for the Sallaki and Diclofenac sodium group that were 24 63 k 22.74 i 42. * * ll~fferenct! hetweet?Scrllc~ki utzd I)ick!fencrc . Twenty-six amongst the thil-ty-ttlree patients who completed the trial were females while the remaining six patients were males.06 respectively were also not significantly different from each other. The mean V.4S score for the Sallaki group at Week 4 is 48.

There was no s~gniticant d~fference betwcen Sallakl and Dlclofenac sodlum In decreasing the time requ~redto walk 50 feet at Week 4 The mean baseline value for the time required to walk 50 feet for Sallak~and D~clofenacwere not s~gnlficantlyd~fferentfrom each other Besides the mean absolute difference between the pre-treatment and Week 4 value for the tlme requ~redto walh 50 feet for the Sallak~and Dlclofenac sodium group were 11 98 + 12 3 and 12 47 11 05 respectively and were not s~gnificantly d~fferent from each other * Digital joint circumference ('om/~urzson q'pre undpost treuttnent vu/ues Both Sallaki and Diclofenac sodium produced non-significant decrease in the digital joint circumference at the 4-week endpoint when compared to baseline The mean digital joint circumference for the Sallaki group at Week 4 is 22 8 + 6 4 which is not significantly less (p < 0 05) than the mean digital joint circumference at baseline of 23 2 + 2 86 Similarly the mean digital joint circumference for the Diclofenac sodium group at Week 4 is 23 1 1 h 2. 2 6 i 188 1 )l fferencc~ helween Sullukl rznd Dlclofinac sodium .73 + 37 9 and 23.4 + 19.88 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .37 + 14.5 wh~chI S not significantly less than the mean time required to walk 50 feet at baseline of 4 3 .2.24 + 18 3 respectively were also not significantly different from each other Duration of morning stiffness ('ompczrzscm ofpre undpost trecztment values Both Sallaki and Diclofenac sodium produced non-significant decrease in the duration of morning stiffness at the 4-week endpoint when compared to baseline The mean duration of morning stiffness for the Sallaki group at Week 4 is 61 93 + 76 46 which is not significantly less than the mean duration of morning stiffness at baseline of 68 36 + 63 2 Similarly the mean duration of morning stiffness for the Dlclofenac sodium group at Week 4 is 51 33 + 59 2 which is not significantly less (p 0 05) than the mean duration of morning stlffness at baseline of 80 88 + 5 l 8 Ihference between Strlluk~ I)rciqfenuc sodzutn und There was no significant dlt'ference between Sallaki and Diclofenac sod~um decreasing the In duration of morning stiffness at Week 4 The mean baseline readings for duration of morning stiffness for Sallaki and Diclofenac were not significantly different from each other Besides the mean absolute difference between the pre-treatment and Week 4 readlnps for duration of morning stlffness for the Sallaki and Dlclofenac sodium group that were 38 53 + 40 29 and 44 84 + 42 7 respectively were also not significantly different from each other Time to walk 50 feet ('ompczrison of pre tndpost treuttnent values Both Sallaki and Diclofenac sodium produced non-significant decrease in the time required to walk 50 feet at the 4-week endpoint when compared to baseline. The mean time required to walk 50 feet for the Sallaki group at Week 4 is 33. Similarly the mean time required to walk 50 feet for the Diclofenac sodium group at Week 4 is 36.sodium group that were 39.80 5 16.4 which is not significantly less than the mean time required to walk 50 feet at baseline of 35.

43.5.5.2.44 + 5.05) than the mean baseline value for number of tender joints of 13.79 + 12.05) than the mean score for number of swollen joints at baseline ot' 8.5* 12. Similarly the mean value for number of tender joints for the Diclofenac sodium group at Week 4 is 13. II~fference between S U / / U czndUzclofen~rc ~Z sodzzltn There was no significant difference between Sallaki and Diclofenac sodium in decreasing the number of tender joints at Week 4 The mean baseline value for the number of tender joints for Sallaki and diclofenac were not significantly different from each other Besides the mean absolute difference between the pre-treatment and Week 4 value for the number of tender joints for the Sallaki and Diclofenac sodium group were 7 56 6 71 and 7 92 8 28 respectively and were not significantly dif'ferent from each other * SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 169 .9 which is not significantly less (p < 0.88 + 9.16 + 2.05) than the. lhfference between Salluk~and Dzclofenac sodzum There was no significant difference between Sallaki and Diclofenac sodium in decreasing the digital joint circumference at Week 4 The mean baseline value for digital jo~utc~rcutiiference for Sallaki and Diclofenac were not significantly different from each other Besides the mean absolute difference between the pre-treatment and Week 4 value for dlg~ial joint circumference for the Sallaki and Diclofenac sodium group were 2 41 + 5 58 and 0 83 i O 87 r~spectively were not significantly different from each other and Number of swollen joints ('ompcrrison of pre ~zndpost treatment i~alues Diclofenac sodium but not Sallaki produced a significant-decrease in the number of swollen joints at the 4-week endpoint when compared fo baseline.1 which is not significantly less (p < 0.mean baseline value for the number of tender joints of 19.5 + 10.1 which is not significantly less than the mean score for number of swollen joints at baseline of 11.88 which is significantly less (p < 0. The mean score for number of swollen joints for the Sallaki group at Week 4 is 9. 'T'he mean'score for number of swollen joints for the Diclofenac sodium group at Week 4 is 4:63 + 3. tlic hnseltne value for the number of swollen joints for the D~clofenac group However the mean absolute difference between the pre-treatment and Week 4 value for the number of swollen joints f o ~ the Sallaki and Diclofenac sodium group were 7 59 + 6 I0 and 4 71 5 4 36 respect~\elvand were not significantly different from each other Number of tender joints <:ompcrrisonqf pre and post treatment vali~es Both Sallaki and Diclofenac sodium produced a non-significant decrease in the number of tender joints at the 4-Week endpoint when compared to baseline The mean value for the number of tender joints for the Sallaki group at Week 4 is 14.which is not significantly different (p < 0 05) from the mean digital joint circumference at baseline of 23.9.88 + 17.42 7. 1)~firence between SaZlakr and D ~ c !ferric sodium b There was no significant difference between Sallakr and Diclofenac sodium In decreasing the number of swollen joints at Week 4 The mean baseline value for the number of s\\ollen jo~ntsfor Sallaki was 15 21 which is significantly higher than (p 0 05) 7 58.

9.05) than the mean baseline composite tenderness score of 30.13 which is not significantly less than the mean ESR at baseline of 45.Composite swelling score ('c)m/)~:rlsor~ and post treatment va1zre. The mean ESR for the Sallaki group at Week 4 is 39. ( 'omp~~rison/)re of * I)rfirrnce betweet1 Strllukz and J)lclJfenuc sdzum There was no significant difference between Sallaki and Diclofenac sodium in decreasing the composite tenderness score at Week 4 The mean baselme composite tenderness score for Sallahl and Dlclofenac sodium were not significantly different from each other Besides the mean absolute difference between the pre-treatment and Week 4 composite tenderness score for the Sallak~ Diclofenac sodium group were 12 59 i 12 5 and i 1 9 2 d 9 85 respectively and and were not significantly different from each other Erythrocyte sedimentation rate urdpost treatment values Both Sallaki and Diclofenac sodium produced a non-significant decrease in the ESR at the 4week endpoint when compared to baseline.6 that is significantly less (p < 0.00 + 20.55. Rheumatoid factor and C. ( i)tnp~rri.71 5 16.sor~ cfpre SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . The mean Week 4 composite tenderness score for the Sallaki group is 17.5 which is not significantly less (p <: 0. Hbwever the mean composite tenderness score for the Diclofenac sodium group at Week 4 is 15.05) than the mean composite tenderness score at baseline of 17.ac sodium group at Week 4 is 42.36 that is not significantly different than the mean ESR at baseline of 38..s c?fpre Diclofenac sodium but not Sallaki produced a significant decrease in the composite swelling score at the 4-week endpoint when compared to baseline The mean composite swelling score for the Sallaki group at Week 4 is 11 33 k 11 25 which is not significantly less thhn the mean composite swelling score at baseline of 15 33 1 1 The mean composite swelling score for the Diclofenac sodium group at Week 4 is 5 56 4 28 which is significantly less (p 4 0 05) than the mean composite swelling score at baseline of 9 00 + 5 8 * /)/fferetlce between A % z / /arzd 1)rclofenuc sodlum ~ There was no significant difference between Sallaki and Diclofenac sodium in decreasing the composite swelling score at Week 4 The mean baseline composite swelling score for Sallaki and Diclofenac sod~um were not significantly different from each other Besides the mean absolute difference between the pre-treatment and Week 4 composite swelling score for the Sallaki and Diclofenac sodium group were 9. Similarly the mean ESR for the Dic:!.25 + 8 9 and 4 71 3 92 respectively and were not significantly different from each other * Composite tenderness score atzdpos[ treatment vultres Sallaki but not Diclofenac sodium produced a significant decrease in the composite tenderness score at the 4-week endpoint when compared to baseline.::.05i 14. they were not subjected to statistical analysis.3..16 14.4. reactive protein As the data of very few patients for the above two parameters were available.

Two patients 'complained of GI side effects amongst which one suffereft from dyspepsia for 7 days. Safety Comparison of pre and post treatment laboratory values No abnormalities in the laboratory tests were observed for both the treatment groups (Table 4.28 18. 5). fasting blood sugar. * * Overall efficacy The overall efficacy of the treatment amongst the 15 patient who completed the trial with Sallaki and 18 patient who completed the trial with Diclofenac sodium is as shown in Table 6. Patients complaint One patient in the diclofenac sodium group complained of abdominal discomfort for 15 days that was of moderate severity requiring discontinuation of the therapy. serum creatinine.9. - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 171 .7 which is not significantly different from the mean paracetamol consumption in the Sallaki group of 53. One of the patients on therapy with diclofenac sodium complained of piles without bleeding during the last 10 days of treatment. white blood cell count. No statistically significant change in the pre and post values for hemoglobin.-blood urea nitrogen. serum bilirubin.Paracetamol consumption The mean paracetamol consumption throughout the study period (4 weeks) in the Diclofenac sodium group is 49:52 25. SGPT. A very good compIiance to the medication was observed for both the groups. Comparison of the overall tolerability The overall tolerability to the treatment amongst the 15 patient who completed the trial with Sallaki and amongst the 18 patient who completed the trial with Diclofenac sodium is as shown in Table 6. One patient in the Sallaki group complained of dyspepsia of mild severity. serum proteins albumin and globulin was observed for both the groups.

pain severity. But the baseline swelling score in the Sallaki group was significantly higher than the diclofenac group It was therefore decided to compare the decrease in the swelling score at the end of the study period for the two groups. four patients after one week and two patients after two weeks of therapy. The present study indicates that the eflicacy of Sallaki (600 mg t. In the present study we observed a statistically significant decrease in the articular index (tenderness score) at the end of the study period i e four weeks in the Sallaki group The decrease in the articular index at the end of the study period in the diclofenac sodium group was however not statistically significant But comparison of the decrease in the tenderness score observed for both the groups revealed them not to be significantly d i f f e ~ n from each t other The results of the composite swelling score seem to indicate diclofenac sodium to be more efficacious than Sallaki in reducing swelling in the joints. increased volume and pain may influence grip strength and bone deformity.and one patient was dropped after inclusion owing to the detection of-interstitial nephritis.DISCUSSION A total of forty seven patients who Mfilled the diagnostic criteria of classical or definite rheumatoid arthritis were enrolled in the double blind. randomized study to compare the efficacy and tolerability of Sallaki (600 mg) with the routinely prescribed Diclofenac sodium (50 mg) in relieving symptoms of rheumatoid arthritis Eighteen patients completed the trial on Diclofenac sodium and fifteen patients completed the trial on Sallaki. Six patients had lost to follow-up after baseline assessments. Two of the patients had to be dropped from the study owing to develepment of adverse drug reaction.i d) is comparable to that of diclofenae sodium (50 mg t i. The two groups were found to be comparable with each other in decreasing the swelling score Thus it may be said that a comparable positive result was obtained with both the treatments SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . The objective value of both these parameters is subject to V'lfiscussion since they have no direct relationship with the inflammatory state of the joint. Assessment of the articular index and the functional index are sensitive parameters in evaluating changes induced by treatment. Factors such as limited mobility.. while exostosis and chronic swelling of the paraarticular structures may also affect the circumference of the digital joints A realistic approach to estimate the minor or major changes induced by a pharmacological therapy is the patient's hnctional disability.d) in relieving the symptoms of rheumatoid arthritis This can be concluded from the non-significant difference between Sallaki and jliclofenac sodium in decreasing the duration of morning stiffness. There is a clear and well-documented evidence of efficacy of diclofenac sodium in the treatment of rheumatoid arthritis. number of swollen joints and the scores for swelling and tenderness in the joints. These objective measurements of efficacy were supported by the investigators subjective global evaliration of the patient's response to both the therapies The other two measurements of grip strength and digital joint circumference failed to show any evidence of efficacy.

and perhaps specific. It is illso k n o w ~ ifi. tcndcrness and liniitation o f motion.. WI~II C(~I~SCIIII~II~ ~onlplcnient activation and ~ ~ . may he t l ~ toe inliib~tion ~ tlic o1'5-li~~oo~~\~gcnitse .~scol' Ii\. additional autoantigens are revealed and the nature o f the T cell response broadens ils additional clones ofC1)3-1-T cells are recruited into the inflammatory site.~tio~i~ ~ i t ~ l ) o d y .I potent inhihi. i ~ i t ~ i i iil \. it stimulates ~"nnouncedpl.potent s t ~ ~ i i ~ r l .~r.ocess in the sy.~io\ ial tissuc and acute inflatnmatory process i n the s\.~rictyof'cli. supcroside production. ~ and tlic~.l i ~ i ~ l ill c l i ~ niani1'Cst.persc~cs~t11y react iori i\ I(ccent lindings Iinve suggcstctl tIi.i\ 'l'lie tfec~. ccll cnlc~uni translocation i111d ~. The presence o f activated T cells can induce polyclonal B cell s t i m i ~ l a t ~ o n the local production of rheumatoid factor. As and tissue damage occurs.otlu~tion oftlic J>I. ~ c e ~ i tlic ('L)4+T cells by ~ ~ i l i l t ~ . The pathology o f rheumatoid arthritis evolves over the dul-ation o f tlie disease.' CI~I~IC~III. lipoo. dckclop.I iuid TNI.~tactlc fi1ct01 ('5iiI2 'l'he tissue i~illaniniationIS I-eni~n~sccnt ol'tlclayctl type hypersensitivity reaction occurring i n rcspu~isc ssolublc antigens or ~iiicroorgicnis~iis to illso tllc cylokiries rclcascd by the 'r cells.csultof pel-sistent e\posiIre to tlie inflammatory milieu.11 the pr.ii t l u ~ d I ~ i l i i O ~ tof5-I1~~oosygcnasc ~o~i acfivity prc\.~l Iluid c. the function o f s\novial fibroblasts is altered i ~ n dtlley niay acquire destructive potential that no longer requi~.ml?to~iis preventing progressive damage t o articular structures and 'l'lie constituent o f Sallaki.isticdcfi)~.l>i~tio~l i n f l a n i ~ ~ i i ~ t o ~ .~sni. alpha play an important role by stiniulating the cells ol' the pannus to )~.criirilatio~i in rlic s!.. ~iiac~.!.clironic infl.~nin~atory i ~ ~ i ~ ~ ~ i ~ i~xoccss iinc tlie hope o f ameliorating or~olog s\.OCCSS of'a~iapliylatoxins. ~t~o~i c.oducc colla~enaseand other neutral proteases.cnts the synthesis of' Icucot~..om cspcrinicntal studies Iliat I ~ o s w c l l i :serrat.cs stimulntion fi.ienc typf: ~i~:li~ntors of ~ntla~n~nntion I..\i~cc~.luses s\\clling..' . response o f CD4+T cell is induced that amplifies and perpetuates tlie intlaniniation.~sc lcndcrncss ill10 S\CCIIIII~. Subsequently.c~iti.c cs~rd. IS a .l i )cells ~ i ~ ~ i g r. \:or manageinent o f such pi~tients the various tlierapies cnlployed are directed at nonspecific suppression of' the inll.rom tlic family o f Icucotricne-tvpc inediators lcuhotriene B. 'I'hus Sallaki may possess disease-modifying potential by preventing tlie progression o f the disease. an initial.efi)~. 11.ol)ilgi~tion I< is nn i r l i ~ ~ i ~ ~ ~ i o l o g mediated ol' A ically cicnt..oni 1 cells (.ccter.Thus it inay be conctuded ti-om the study that Sallaki does have a role t o play in the pathology o f rheuniatoid arthritis.opliagcs ' I. Finall\ as n ~. The earliest eve18 is a nonspecific inflammatory response initiated b y an i~nlinown stiniulus.ol't o ~ .~ ~o~l into i ~ . i. a tllcnsynoviurii 'l'lie 'I'cells p~.no\i. C3a and C5a. gum resin c\udiite oi' Boswcllin scrratn is .spenase a c t i ~ i t y and can inhibit tlir acutc inllamniatory pl.tl~. resulting in bone and cartilage destruction I2 As the extract of U o s \ ~ e \ l i a serrata srin inhibit the delaycd type hypersensitivity reactian i t tnay be proposed that it could play a rote i n preventing the persistent T cell activity and the subsequent cartilage and bone damage. adhcsiori.:.niitics ~~ioti.~t~ori o 111 \.lit. ~ Oy !lie l)~.\..~cicli i ~ i l i ~ bthe delayed ~ it In. w ~ t l itlic inllaniniatory proccss 111 ~ l i ct~ssuc k i n g c l ~ ..ilions o f acute inflammation.. ~ Icucoc\~tcresponses like cll~~ll~)t.clc. I that ~ ~ ~ o l ~ f ' c illid td~fl'C~.is. illl(ltllc! cllc111.~~ ~ i i .e may promote also If~ c i 1) lccll st in111 ion 'l'lie rcsu Itant ~)~rjcluct 01' i~iiriirrnoglohrrli~~ rheumatoid factor ~ la1 icm and call Icild to 1111111111ico ~ i i ~ >l Ii c .otl\~cc variety ol' c y t o L i ~ ~ c s promote B cell r~ g .olytic cnzymcs Additionally. With persistent i ~ ~ t l .II.~.lctivity.c. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .

i. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 1 74 . encourage hrther investigations on the therapeutic potential of the drug in modifying the disease process.d) in RA.D. The result of the present study of Sallaki (600-mg t. However Sallaki is better tolerated than diclofenac sodium by the patients.e demonstrable predisposition for gastric intolerance with antiinflammatory medication. Considering the fact that rheumatoid arthritic patients hav. We are also grateful to Dr Harshad P.B. ACKNOWLEDGEMENT The authors wish to thank Ciufic Healthcare LM1. Thakur M.In the present study Sallaki was better tolerated than diclofenac sodium as except for on case of mild dyspepsia no other incidence of GI disturbances was -observed. CONCLUSION The result of the study indicates Sallaki and diclofenac sodium to be having comparable efficacy in the treatment of symptoms of rheumatoid arthritis. we believe that Sallaki will benefit these arthritic patients who can not otherwise tolerate these anti-inflammatory medications. for carrying out the statistical analysis of the data. never showed any pathological modification in both the groups. for providing the drug samples (Sallaki (600 mg) and Diclofenac sodium (50 mg)) for conducting the trial. D. Clinical laboratory studies. performed before and after the study.M..

06 i 25 p < 0.i. Efficacy resul'ts with Diclofenac sodium (SO mg t. deviation Number of observations = 18 * SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 175 .7 Week 4 44.Table 1.d) in rheumatoid arthritis patients Parameter Vas Score Duration of Morning Stiffness Grip Strength Time to walk 50 ft Digital Joint Circumference Total Swelling Score No.71 k 23. of Swollen Joints Total Tenderness score No.05 S Values are expressed as the mean score std. of Tender Joints Week 0 57.

14*28. of Tender Joints Values are expressed as mean score + std deviation Number of observations = 15 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .Table 2.49 p< 0.05 S Durati6n of Morning Stiffness Grip Strength Time to walk 50 ft Digital Joint Circumference Total Swelling Score No. Efficacy results with Sallaki (600 mg ti. of Swdlen Joints Total Tenderness score No.57*27.d) in rheumatoid arthritis patients Parameter Vas Score Week 0 66.03 Week 4 48.

92 4.98 f 12.24 .3 12.71 NS NS NS No.83 0.47k 11.9 7.28 P NS NS NS NS Vas Score Duration of Morning Stiffness Grip Strength Time to walk 50 ft Digital Joint Circumference Total Swelling Score No.Table 3 Comparison of Diclofenac sodium (50 mg t.59 f 12.85 7.82 * * * NS NS 4.73 f 37.84 k 42.41 =t 5.7 23.63k22. of Swollen Joi-nts Total Tenderness score * * 18.56 k 8.5 7.10 12.d) with Sallaki (600 mg t.3 2. of Tender Joints Valyes expressed are the mean absolute difference between the Week 0 score and Week 4 score for each parameter Values are expressed as mean std.29 39.06 44.i. Sallaki 24. deviation * SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 177 .05 0.59 =t 6.71f 3.53 40.d) therapy in rheumatoid arthritis patients Parameter Diclofenac sodium 21.92f 9.25 % 8.42A22.9 38.58 9.92 6.9 11.36 11.71 4.i.

Mean of laboratory tests in 15 patients sumring from RA.i. given Sallaki (600 m t.Table 4.05 NS Albumin Globulin Values are expressed as mean Number of observations = 15 std. deviation SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 178 .5 * 1.83 * 2.13 Week 4 10.34 p< 0.d) for four weeks Parameter Hemoglobin WBC Fasting Blood Sugar Blood Urea Nitrogen Serum Creatinine Serum Bilirubin SGPT Serum Total Protein Week 0 11.

deviation Number of observations = 18 -- - -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 179 .08 3 .31 NS Values are expressed as mean .6*2071 89.27 * 39.2 5 1.09 k 13.27i13.00 h 1.69 k 29.04k149 p< 0. 0 k 1.81* 1.A.92 11.64 2 . Mean of laboratory tests in 18 patients suffering from R.93 * 3.06 Week 4 12. given Diclofenac sodium (50 mg t.7 * 0.82 7.i.3*2364 87.59 8193.Table 5.87 15. 6 * 1.64 7486.t std.1 13.52 2.4 0.05 NS NS NS NS NS NS NS * SGPT Serum Total Protein Albumin Globulin *3 7 42.16 29.d) for four weeks Parameter Hemoglobin WBC Fasting Blood Sugar Blood Urea Nitrogen Week 0 11.5 9.

d) Treatment Sallaki Diclofenac Responses to Overall Efficacy Fair Poor Good 1 7 7 12 Responses to Overall Tolerability Good Fair Poor 2 12 4 Values expressed are the number of patients reporting the responses SELECT RESEARCH PAPEKS ON EVIDENCE BASED AYURVEDIC DRUGS 180 . Overall efficacy and overall tolerability to treatment for four weeks with Sallaki (600 mg t.i.i.Table 6.d) and Diclofenac sodium (50 mg t.

et al 'lmmunomodulutory activzty of Bo~we[/zcUCZ& (penta~yclic triterpene acids) jkom Boswellia serratu ".REFERENCES I. Phytotherapy Research.No 3. et al. 57.sz$cution qf rheumatold urthntls" Arthritis Rheum 1988 3 1. pp101-106..allakz(Boswellru serrataj zn the treutment ofjuvenile rheumatold urthritrs " JIRA. 113-116 11. "The American Rheumatism Associatran 1987 revised criterza for the cls. Vol. "Pharmacology of an extract of salul guggal ex-Boswella serruta.NO. 6 No 1 . et al. Atal. K "A C/inzcal Trzul of Boswellzu Serruta (Sallukl) In the treatment of Osteoarthrztzs. pp3 15-324 12." JIRA. C. 3. Vol. M. T. pp 333-34 1 uf 8 Chandrashekaran A N. pp 107-110 I0 Lohokare. 1995. pp. Vol 12. et al. Mack. 6 Sharma. Kar. V01. 1998. A. 3. Vol 3 .. Jhaj. "Adverse drug reactions with anti-rheumatic h g s in a Rheumafology clinic" Journal of Indian Rheumatism Association 1998..B..L.E. et al.K. 9 Rajagopal. R. M K. A. 18. Singh.No 3..T... 19. A "Analgesic and psychophurmacologzcul effects of the gum resrn e m ~ h t e -Boswellza serruta " Planta Medica 1971. 1996. 5. Arnmon. Inc. pp 3-6.Indian Journal of Pharmacology 1980.. 47. pp 912-91 7 2. "Assessment of the therapeutic effect of ". Atal. P. Mac Graw Hill Companies. R.. Vol. 3 . pp407411. "Inhibition of leukotriene b4 formation m rat pertioneul neutrophils by ethanolrc extract of the gum resin exuhte of -Boswellru serruta" Planta Medica 1991. Arnett. 1880-1888 - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 181 . Kaushik. F C... ''Recent udvances in drug therapy for rheumatoid arthrltis" Journal of Association of Physicians of India September 1999. et d. Kaul. "Rheumatoid Arthritis" in Harrison's Principles of Internal medicine. H.. 1995. a new non-steroiclal anti-inflammatory agent" Agents and actions 1986. pp 203-207. S. V O ~ O(2)' p 107-112. G. et al. 4. 1995. Uppal. C.Lipsky1 P. VOI 3 . Malaviya.P. 1 7 Menon. S. No 10 pp 59. "Efect of S'allakz m the treatment of Hheumatozd arthrltis " JIM.K. 1 4 ' ~ ~dition.N.

Parikh M. Professor and Head Department of Medicine & Chief Rheumatology.22.23 One case report form has stated the patient's discontinuation from the study Patient No. Mumbai. 1999 for subsequent. Dr.S.D. 12-15. Thanking you once again for your kind cooperation Yours truly. Sub: Receipt of the completed case report forms and the drug supply returned by the patients Dear Dr. 20.17. For SPC Interface Dr. 12. 4 . 17) was collected ~ back from the site on 3 0 June.August. We gratefully acknowledge the receipt of twenty-two completed case report forms of the patients enrolled in the trial namely "Clinical trial to evaluate the eficacy of Sallaki 600 mg with rheumatoid arthritis" and bearing the patient number (1-10. M. 21. in pat~ents Amongst these. 2 . 13 case report forms of the patients bearing the patient number as mentioned below are complete for all the follow up visits i e 4 weeks PatientNo 1 . 1 7 . The drugs returned by the patients bearing the patient number (21-26) will be collected back from the site for subsequent disposition today. 13. 14.D.1999 To. 15. 3 . H. (Mrs) L. Bichile.S.21-26). 9.12-15. 5 . The drugs returned by the patients bearing the patient number (1-10.400 012. K E M Hospital. Patient No. Parel. 2 4 8 ~ 2 6 Six of the case report forms of the patients bearing the patient number as mentioned below are not complete for all the follow-ups as the patient's lost to follow-up.disposition. 10.25 Two case report forms as mentioned below have been filled for adverse drug reactions Patient No 7. 6 . 8 . Bichile. SELECT RESEARCH PAPERS ON kvIDENCE BASED AYURVEDIC DRUGS 182 .

H. 18-20. Dr.D. The drugs returned by the patients bearing the patient number (1 1.To. K. 3 1.S. 27-34). 16.400 012. Sub: Receipt of the completed case report forms and the drug supply returned by the patients Dear Dr. 18. Bichile. Hospital. 12 case report forms ot'the patients bearing the patient number as mentioned below are complete for all the follow up visits i. Amongst these. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 183 . 34. 33 One of the case report form of the patients bearing the patient number as mentioned below I e not complete for all the follow-ups as the patient lost to follow-up.e. 20. 28. 29. 27. We gratehlly acknowledge the receipt of thirteen completed case report forms of the patients enrolled in the trial namely "Clinical trial to evaluate the eficacy of Sallaki 600 mg in patients with rheumatoid arthritis" and bearing the patient number (1 1.E. 27-34) will be collected back from the site for subsequent disposition today. Patient No. Parikh M. 4 weeks Patient No 1 1. 16.D. (Mrs) L. Mumbai.S. Parel. 18-20. M. 1 9.M. 30 Two case report forms as mentioned below have been filled for adverse drug reactions Patient No. 16. For SPC Interface Dr. Professor and Head Department of Medicine & Chief Rheumatology. Bichile. Thanking you once again for your kind cooperation Yours truly. 32.

Thanking you once again for your kind cooperation. 39.M Hospital.D. (Mrs) L. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 184 .400 0 12. Professor and Head Department of Medicine & Chief Rheumatology. Yours truly.e. 37.S. Patient No 3 5 . Amongst these. 41 & 42 Three of the case report forms of the patients-bearing the patient number as mentioned below are not complete for all the follow-ups as the patient's lost to follow-up. We gratefully acknowledge the receipt of nine completed case report forms of the patients enrolled in the trial namely "Clinical trial to evaluate the efficacy of Sallaki 600 mg in patients with rheumatoid arthritis" aiid bearing the patient number (35-43). Mumbai. 38. 2000 To. H. Sub: Receipt of the completed case report forms and the drug supply returned by the patients Dear Dr. 36. Parikh M. Parel. Bichile. Dr. Bichile.S.E. 4 weeks Patient No. 6 case report forms of the patients bearing the patient number as mentioned below are complete for all the follow up visits i. M D .. 43 The drugs returned by the patients bearing the patient number (35-43) will be collected back from the site for subsequent disposition today. K. For SPC Interface Dr. 40.February 25.

M. K. Dr. Parel.45 & 46 Three of the case report forms of the patients bearing the patient number as mentioned below are not complete for all the follow-ups as the patient's lost to follow-up. Mumbai. Bichile.D. Bichile. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 185 .M.e. Amongst these.400 012 Sub: Receipt of the completed case report forms and the drug supply returned by the pa tients Dear Dr. Parikh M. Thanking you once again for your kind cooperation. Patient No.S. 3 case report forms of the patients bearing the patient number as mentioned below are complete for a 1 the follow up visits i. Hospital. (Mrs) L. For SPC Interface Dr.E. 2000 To. 44. Yours truly. We gratehlly acknowledge the receipt of four completed case report forms of the patients enrolled in the trial namely "Clinical trial to evaluate the efficacy of Sallaki 600 mg in patients with rheumatoid arthritis" and bearing the patient number (44-47). 4 weeks 1 Patient No.March 3 1. 47 The drugs returned by the patients bearing the patient number (44-47) will be collected back from the site for subsequent disposition today.D. Professor and Head Department of Medicine & Chief Rheumatology. H.S.

Professor and Head Department of Medicine & Chief Wheumatology. Parikh M. (Mrs) L. Bichile. 3 reported for adverse drug reaction and 1 1 lost to follow up.D.400 012. The balance payment for the remaining case report forms will be made at the earliest Thanking you once again for the well-conduction of the trial Yours truly. We also take this opportunity to once again express our gratitude at receiving 47 completed case report forms of the patient you had enrolled in the trial. M.June 28. We would like to reiterate for your perusal that amongst the 47 patients you had enrolled in the trial. 33 patients completed the four weeks of the trial. K E. We are extremely pleased to receive the report entitled "Double-blind randomized controlled trial of Sallaki (600 mg) vs Diclofenac (50 mg) in the treatment of rheumatoid arthritis" of the clinical trial conducted by your department.D. Dr. Murnbai. For SPC Interface Dr. Parel.S. Sub: Receipt of the report of the clinical trial Dear Dr. B. H.2000 To.ichile.M Hospital. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 186 .S.

Publirhcrs London San Die New York Boston Sydney okyo Toronto ?? - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 187 . WAGNER Institut fur P h a r m ~ u t i s c h e Biologic der Unkmsitiit Miimhn. il >st Cennary NORMAN R. FARNSWORTH Program for Cqllaborative Research in the Pharmaceutical . .4 ACADEMIC PRESS Harcouri B r m Jovanooitlr. University of Illinois at C k g o .ciencis: College oj Pharmacy.lfGn~hcrl. Chicagoy Illinoisy ~h.Economic and Medicinal Plant Research Volume 5 Edited by H.

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... Economic and Pharmacognostic Aspects dGuggul Gum ..................\lcdical Literatlrrc ..... Concluding Remarh ........ like Ayumeda....r~ f and Ethnornedicinc ... C..............................\ledical ILscarrC.............. Indian C Snu Drlhi-1100?9.................... History of Guggul in jncient Indian .................... Uses o G u g p l in Folk1o......ts ............ledge'and over two decades and offcrs i n ~ r e s t i n g wisdom of the ancient medical systems of India................ The evolution of C.................. l n d i ~ d cf .... EKmt of Guggul Gum on C+gulation Fytors and Body \\'eight ......... A.......... ..................................... PhaIIna~~lOgiCid Stud+ ofGuggu1 Gum ..................... Hypolipidaernic Acti\iv of Cuggul Gum .... Chemical Investigations oCGuggul Gum ........ B................................... A...................... CliScal Studies on Patients ha\ing Hcmiplegia ...... Clinical Studia on Guggul Gum ....................... ...................................... 1ntroduction ....................................................................................... in a tiny laborator\.................. B...................................................of the SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 189 ...... Appendix ................. Refennca ..................... Guggulipid................ Other Pharmacological ~ c & i t i r s C u d Gum ............................. B.................... Hypolipidacmic Activig ............................. Acknowledgemer.. A....................................................+van ........... of : I S .... :...............................Vale.........................?................ Erect on Body Weight .......................... Hypolipidaernic Agent ................................... S... A..... Toxicity and Side-EfFect$ of G u p l Gum ......................... Clinical Studies on Patients ha\isg lschacmic Heart ................. uligltlii gum resin as a hypolipidaemic drug spans insights into the rich kno\\.............. Studies on the hiechanisrn of k d o n of Guggul Gum as 3 ..................... The saga of guggul as a hypolipidaemic agent started in 1964.............................................. a 'mixture of lipid steroids isblated from the olcogurn resin of Commiphora uqightii (guggul gum) has been available cn the 1ndian market since 1988 as a potent hypolipidaemic agent.......... Ethnomcdical Information on Guggul Cum . VIII.............Guggulipid: a Promising Hypolipidaemic Agent from Gum G uggul (C o m m i ' o r a wightii) Sznibr Dcpup Director-Gqnd........

F G 1 Original Sanskrit verse from the Xyun. th~:reic.m . well known as an X~ur\. p ~ g u lwas:.mmfw f k h F m m 7-PT ~ \ n m.ii..c d h>-percholestzrolaemia.edic classic Sushru:.on the anti:r.bwdm3 i i i i ~ r n . druz and !\.ntratc. in the well known . & s x r n s r n *. Until then.tlan~mator?-lantiarthriticactivit!.c.C. (For 3 Ii~rra!mla6M1 of the z 3: '" vcrr+ see . 1) ~' was i~ Sanskrit.?hen College of Medical Sciences of the Banaras Hindu Ur.siri. i'aranasi i. atherosclerosis and obesit). Shim: 15.atr rhesi. (BHL7. The story.A!-unedic treatise Sisi.gul \$.hen Sat!-avati and d h m4 a r n a m ~ ~ ~ c t W e & G .asfirst rzportcd in a cioira)l. which inspired the \-cry first investigation on rhr \1?.n~lipi5cmic u i )o xvt. and irjociated lipid disorders and their complications. ) SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 190 .lndiai.c q + M l f a . e> J * y? w?T n -qlrqy54~a~<~q*m~~~~~qsz~& ha u .as \tide!! wed -in the rrrntment ofvarious types ofarthritis.of ar.cl nit\in!>. S F ~ I \ i ) Ct4 '-'1 1 - l & f = w a . cceurse.ril -ElTect. Prior to this work. l S .re. 600 B.Sam& Im#tra I.\-itti ??iiLl rzkrenre r . of . Inspirtd b. this shloka.--*.i-sit?.C.+. ! gug.) 6.m h . i r h rq-lqnw*< t. actually bagan \\.. r r c m - + f T 7ek m - f W m w c r + rn 9 .:) ir! the holy Indian city of k'aranasi. f g ~ guggvl at B a n a m Hindu University.as selected fcr screening for its possible h!.etlic.t 5Rqlqfl4llddwh'~dmit3. = M m T m . $q-1 mrmfl Ji9?.dies on guggul a-ere naturally conc:t. ~ W I I ~ + ~ : T&fkmmmb: cW&tf+ &dm. Tt~ch) jxiipidaemic action of the drug \+.4ppendix I .) This stanzaq deals in a n estraordinarily lucid and scientific r?anner 1%-ith the aetiolop. pattiogenesis and trearnient o i n k l r l .ojh (Fig. .o!a Sumhita -. of the gr1n1 rt.: ~r!ir. a rather ot)scurc stanza or i.MIB. indigenous drug on disorders of lipid nlc:t'it)oli~rn .(m~dorogn)'sut~rnitredro rhc Bsr-\rtrs Hindu ~ n i v e r s i 5%-hich inspired bj.pharm~cological i:l. in fact.polipidaemic activity in laboratory animals as \$-ell as in patients of ohesit?.

2 ) ha\.c been discussed in detail e l s e ~ . ' .?eri@wral' ' Hem~pleg~a lschaem~c Heart Disease Gangrene Many Complicat~onshcludlng W t a V~koras ( w g v a r a n a j ~ f )i Leodlng to Death FIG. 4 . T h e English translation of Sr~shruta'cnriEinal reft:rence is given in Appendis I. High i n Calories Total tats Scturated Fatty Acids 8 Cholesterol Sushrutg Dalhana ( Overeating Shleshmaldh6ra ( ~14isht6h6ra) + Lack of Exercise ) Sushruta Me:oholism: Hyperlipemia with Cholesterol Lipid4 ipoprotlen 'Amarasa Produced at t k level of - Metabolism I Llpld Deposds (11) Narrow~ng of Coatlng 8 Obstruct~on of Channels .9 ~ SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 191 .een the ancient concept of Sushrura (600 B.Coronary : . h a l o g ' d r a ~ n ber~seen andcnt concept of the pathqenais of . h e r ~ .omplications (Fig. 321.Llt&mgo and the the modem concept of the pathogenesis of athrrosclerosis (on the bsis of Daihana's commentary S w h Samhr:~:Smtra Sllwrut: 13. T h e implications of this a n s l o s ~ (Fig.gy txltw.Cerebral .~ rn~ioroga of Modern Ancient Unbclanced. 2).lRDAEMIC AGENT Du:trakanaril found n strong ana10.) the modern concept of the pathqencsis and of arhcrost1r1-osisand its fatal c.CLGGULIPIV: A PRO\1ISIYG HYPO!.C.

a v&'** (one of the four \veil-known Vtdm or holy s e p t u r e s of the Hindus).C.. significantly the serum cholesterol leveis in patients \\. based on Ayunledic literature. ETHNOMCDICAL INFORMATION ON GUCCUL CUM A. number of pharmacological and clinic. physical qualities. 0 Gdg~du! either bon..D.) in tbt &sic (or Samhifu) period and also in various Nicphontus (or hledical lexiams) which \\-ere w-ritten between the 12th i d 14th centuries X.)'*~and \'agbhata1= [Tth century =\.ere undertaken on gum suggu! ( C.D.A detail& history of guggul. 1966). 3).cts these aninlals aqninst cholesterol induced artht.crc samcc .our name d both q!pcs for the rerno\af o diseaxs.itirs.c.ed phytochernical and p h x r ~ c o g n o s t i c by studies.bile some of these studies were initiated under the Composite Drug Research Scheme (CDRS) of the Indian Council of hledici 'Research. 11.tiich i~vpcrliparmis1\-22 znduced by feedirig cholesterol (in hydrogenated vegetable oil). These were soon follo~.al srudies \\. at the 2 r t y streak siage.ere canied out independent1). on oral administration.'. urefully planned str~diest\.rosclerosis. \\.' . It was thus dmonstrated h r the vrr) first time that. f a- Detaged description of the varieties.by various scientists in dEerent parts of India. others \\. indications ofguggul are available in the rreatises o f ~ h a r a l i at' :+300 Siuhmfa (600 B.' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 192 .ic rabbits i)ur also p:.TG t s t this analogy.ct. ~ B.:ut {over a p e t i d of 2 yearsj on rabbits in x\. .irscs and deer. HISTORY OF GUCGUL IN ANCIENT INDIAN MEDICAL LITERATURE The earliest reference to the medicinal and rherapeutic properries of guggul is in -4thcln. a interest among other Indian scientists at BHU and eIse\\-he~. The TAX: resin also reduced the body weight of the animals. which devotes an entire stanza to the drug (Fs.irh obesin 2nd hyperm cholesterolaernia was obsemed in clinical studies with crude ~ c guggul' (Satyavati. uightii) with paniculzr referefie to its ti!-polipidaemjc a d related zcti\. crude g:m gug\gul (watrr estrsct) could not only lottrr sig~liticant!~ semnl cholesterol the (and pi:orpho!ipids) in h>-percho1esterolarr:-.). has been published.frorn S h & i or fromthc s a . The results of this pioneering work done at BHL7 provoked ccnsiderable Soon. a c t i o ~ uses and .i. (I) &ant ). The English translation of this verse is: G~sease (consumpuon) does ncu diet and thc cu-e n x c r ? f i ~ r sk h O ~ tht d~l~cious ~l odour o the beding Guggd pcnctratu (spre~blf The disehier also fe &ay in i dirccuans from him % h. The tissue lipids were aho lo\cercld'si~nifiwntly.-4 similar trend to reducc.

In other words. A large n u m b e ~ d such p r e p a t i o n s with guggul as the main ingredient afe n t t n t i d in the Ayurvedic Medical lexicons. U E OF GUGGUL IN FOLKLORE AND ETHNOMEDICINE SS Externally. however.erse. B. in this \. gum guggul has'no action on unbroken skin but on the abraded skin and mucous membranes. obesip.sources are a~ailable.1" Summaries of r\yun.12' . arthritis as well as cardiovascular conditions. a fresh sample of'the drug is claimed to have the opposite effect of increasing body \veight. 3 Earliest reference available on the medicinal value of guggulu in Athenmuch (Kanda: 19: Sno::~:38). during thc \.nferrcdupor1 plants (Ilkc g lggul) known to have healing p o x * ers.edit period. Another unique feature of guggul is that major Ayurvedic treatises very emphatically stress that most of the therapeutic properties relating to fat disorders aetributed to the drug relate to 'old' samples of guggul. actions and uses of gugqul from various literaq. particularly with respect to its effect on obesity and fat disorders.\ISINZ HVPOLlPlDAEhliC AGWT FIG. properties. Ayurvedic physicians have used guggul extensively for centuries in the treatment of arthritis and rclated conditions.and lipid disorders make it a unique drug in the Ayurvedic matnio medico. The fresh gum guggul is said to have the opposite effects.CUGCULIPID: A PROX. mainly in the form of compound preparations.'251'27NO such information is a\ailable regarding its action on arthritis and other conditions. Many of these preparations are awihble commercially in India and neighbouring counmes. In clinical practice. divinity is c~.6. it acts as an astringent and antiseptic. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 193 . while a n 'old' sample of guggul is described as highly effective in reducing body weight and lipids.\bu:The drug is rel'crred ro by the name 'gulgulu'.~-*>'*~ The \vide therapeutic range of guggul and its indications from healing of bone fracture to inflammation.edic degcription including synonyms. As was the practict.

salivation and heaviness of the s t o r ~ c h . The main Indian commercial centres of pqgul are the states of Rajasthan (mainly the western region) and Gujawr (Kutch are division) as shown on the map. neurological disorders. tracts of the states of Rajasthan.'~. cultivation.4 9 ct Tbe ant can be prop~gated vegetative means. diaphoretic. ' ~ I11 the lotion Form. n a d catarrh.extensively reviewed by . attempts are also being made to determine the optimaleethod of tapping to btrtain the maximum yield o the guggul resin. the gum resin s f C."*" A healthy mature m e yields 250-500 g dry resin of guggul in one collecting season. anaemia oedema. 4). ECONOMIC AND PHARMACOGNOSTIC A P C S O SET F GUGCUL GUM . ccbolic.'~ . marketing ij well as grading of guggul in India have been . Engl. zightii) mixed with other herbs is u'xd for skin diseases. tapping and collection."The gum resin is also ~ s e d the in : reamen t o rheumatism. et~. Similar efhrts arc being made by the Department oi Environment and Forests. sore throat and related anditions. ~ . ul trastructure of the gum resin ducts of C wightii have also been . wightii ' h .Administered intmallg. Pharmacopmtically. the Central Cocncil for Research in Ayun-eda ana Siddha (CCRAS) has undertaken cdtivation and propagation of the guggul gum plant. it acts as a carminative. marare stem The development. slphilis. is used as a . in spongy gilrns. guggul is used for ulcers. phthisis. without adversely affecting ttj: health f of the plant. in gargle form it b used for dental care." The microscopic features of the young stem. antispasmodic. found in the arid.* ' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 194 . (Fig. rnukul) Hooker Stedor.~udied. the macroscopic characteristics of all the parts of t11e plant h v e been studied. urightii (Indian Bdellium) is a much branched Spiny shrub cr a small tree 2-3m high (Fig. It is also used as a substitute for African Bdellium. Recently.nchius. Gujarat and Karnataka in India and in the states of Sind and Baluchistan in Pakistan.". On this farm. hrr.\part from its medicinal and therapeutic uses.'~ The distribution. scrofula. a lap-ngitis. tonsilitis. antisuppurative emmenagogue and I s Tibetan medicine. histochand and leaf have been des~ribed." Ill. obesiq and rttzted disr orders. and skin and urinary dis~rders. e t ~ .Bhand (syn. 5).'~. ~ 5 e r e a few minor guggul-producing arcas.). Fumes from burning g u ~ g u 'l re recommended for hay fmer. Burseraceae. the plant (C. the Council of Scientific and Industrial Rexarch. iL r farm ~f by neariy 140 acres in Mangliakas in Rajasthan. rocky. binding and disintegrating agent in tablets and also as a suspe~cingand emulsifl~ing agent.' C.I6 It is used widely as an incense and also as a kuative in perfumery. Apart from these regions. C.

) u i g u ) am. A PROMISIN<.GUCGULIPID. (courtesy ofCcnrral Drug b e a r c b InSLi~te. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 195 . I-IYPOLIPIDAEMICAGENT FIG. 4 Guggul gum (Co-@ra Lucknow.

'5 The main adulterants of gum guggul available on the Indian market are the gums of plants like Albiziu kbbeck. Acacia smrgal. For tapping.of@ The gdn is ready for co1lection 1-2 hrtks aftu. hloringa oki&ra. SATYAVATI . !Reproduced from A d d el. BosweIIia srnata. Acacia arabuc. Subsequent cdlection of the oleogurn resin k made at intervals of approximately 2 weeks during the tapping season. etcn SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 196 . A pale yellow aromatic fluid which oozes out through tbt cuts on ulr bark slowly hardem tci form the golden brown or reddish brown~1cogurn. rhe first incision. FIG 5 Xlap showing the lacAoo d guggul producing states in India.G V.rrsk. healthy plants which are over 5 years of age are selected and an incision is made on the bark.'=) Tapping of the tree is usually done in the months of So\-ember to January 2nd collection~continuesuntil May-June.

Luckno\%(India).. the routine n-pe incl~rding nature of sugars.29 \Vith the discover). as well as a waxy solid w-hich i s a mixturc of esters based on homologous long-chain tetrols (and faulic acid) with a unique structure reported for the first time in nature These lignans are structurally similar to phytosphingosines which are present in the cerebroside and ganglioside components of specialized biomembranes. CHEMICAL INVESTIGATIONS O GUGGUi GUM F Prior to 1972. wightii responsible for the hypocholesterolaemic/h~polipaemic activity of the gum resin. the chemical studies done on the gum of C wightii were of the . 6. it apparently eserts a synergistic action on the pharmacological activity of the ketone. The ethylacetate soluble portion of gum guggul was found to possess hyplipid?emic as well as anti-inflammatory activity. acid and neutral portions. of the hypolipidaemic activity of the gum systematic and carefully plannea'chemical investigations were initiated at the National Chemical Laboratory. This scheme on segregation of guggcll is shown in Fig.. while the acids show anti-inflammatory activity. As the eth>-lacetate insoluble portion representing the carbohydrate gum constituent reported . As the neutral firaction contains several ketones (\\-ith significant hypolipidaemic activity:.* found to be toxic. this fractirm was further segregated into ketonic and non-ketonic fractions with the aid of semicarbazine-on-silla gel.% These chemical investigations soon revealed that guggul resin i a s complex mixture of various classes of chemical compounds such as @xis and lipids. Vadodara (India. diterpenoids and The naturc: d. The neutral portion is responsible for the hypocholesterolaerraic activity. Sukh Dev and colleaguesa6 separated the ethylacetate soluble resin into basic. This fraction was therefore fur:her segregated and investigated chemicallj-. Pune. and later at the Malti-Chem'Research Centre. h a i o n . Although the non-ketonic poi-tion is devoid of any significant hypolipidaemic! activity. a viable separation scheme was evolved by the chemistry team headed by Dr Sukh Dev. In the next phase. first at the National Chemical Laboratorl. Pune. For this purpose.GUGGULIRD: A PROMISING HYPOLIPIDAEMK AGENT IV.these compounds is s B o m in Fig. The main aim of these chemical investigations was to isolate and chemicaIIy characterize compound(s) of the gum resin of C. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 197 . no further studies were earlier by Bose and ~ u p t a ? ~ was ~ undertaken'on this portion.23the structure of the degraded and methylation and peridate oxidation studies. in collaboration with the pharmacology team ofthe Central Drug Research Institute. 7 From the benzene phase (constituting 14% of the gum resin) four lignans have been isolated (of which two are new).?' seed oil'"" and flowers.25 Chemical studies undertaken on the other parts of the plant were related to the volatile oil."*16 leaves.

whereas d the others-are pregnanedeuvatives.I Benzene phase 750t0 @ MeOH aq. $1." SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 198 .~ The gum resin of C. wightii proved to be a rich source of steroid.Of the 10 steroids isolated and characterized from the reslli (Fig. ~ ~ The stereochemistry of guggul tetrols has also been reported. I1 and 111) are C27 steroids.zkul01. Among these. (Z)~gygge. four (viz.ulsbcroat (E)-guggulsterone (together constituting approximately 2% of the gum resin) have been fmnd to be responsible for the hypolipaemic activity. cholesterol and gugguktemids I. Guggulsterones may offer an economically viable alternative rnatrnal for the synthesis of cortiscosteroids like dexamethasone and b e t a m e r h ~ n e . ( R c p r m h d from Sukh Dev 36) The tiexane phase yielded two diterpenoids: cemberene A and rn. phase 25% Ant(-inf lammatory activity Hypocholesterolemic activity Toxic m A FIG 6 Sclleme to sllow the chemical segregation proass of guggul gum.

I GUGGULLIGNAN -11 HO n ol3. 7 The lignans.S) SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 199 . lipids and diterpenoids isolaicd hwn guggul gum.15 (minor : n =11.16.14.12. ( R e p r o d d from S u b Dc\.17) MUKULBL FIG.GUGCULIPID: A PROMlSlNG HYPOLlPlDAEMlC'AGENT "p%pQ ~ o M OMc OMe GUGGULLIGNAN .

revealed by the steroids of guggul in the unique ocaurence of cholesterol along with each of the key intermediates (with the additional oxygenation at C 16) of its catabolism. in the same plant tissue (Figs.2 % (based on Z . 9 and 10).G . 5 4 NAVATI HO Cholesterol & 8.km gcggcl gJm. in sequence.jfi has drawn attention to another interesting chemical phenomen~i. (Reproduced from Sukh Dn Sukh l3ev. The h>polipidaemic activity of ( Z ) .Guggulsterone 0 E-Guggulsterone HO do 0.4% h H.and (E)-guggulsterones has been found ro be quantitatively comparable to that of the total ethylacetate SELECT RESEARCH PAPERS ON EVTDENCE BASED AYURVEDIC DRUGS 200 .Guggulsterol 0 Z .e-QH GugguLsterol-I1 Guygulsterol-III ") FIG. 8 Sreroids d a t e d . V.

-GUGGULIPID: A PRaWlSING HYPOLlPlDAEMlC AGENT Cholesterol ow Guggulsterono ZFIG. detailed phannacologid.") extract of the gum resin. (Reproduced fro^ Sukh Dcv. combined efforts of the chemical team led bv Sukh Dev and the pharmacology team - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . as the other components of the ethylacetate extract appear to exert a significant synergistic effect with regard to the lipid-lowering activity. Furthermore. toxicalogical and clinical studies were undertaken by the CDRI.and (E)-guggulsterone per 1OOg (on the basis of an estimation by . This standard extract i the b s s of s ai the commercially available guggulipid (Guglip marketed by Cipla Ltd. c?neanethylacetate extract standardized to contain 40 g of ( Z ) . The credit for taking the drug to the point of technology transfer to the pharmaceutical industry for the promotion of its commercial viability as a hypolipidaemic agent should be given to the systematic. Lbckriow. Bombay). 9 Biogeneiis of guggul steroids. m a s of high performance liquid chroma\ography).

9%). PHARMACOLOGICAL STUDIES OF GUGGUL G U M A.%as Indian investigators in several species of animals."' and domesac pigs. as compared with the initial values. the atbcroaclerotic pn>ms in the aorta. trig&-ccrides. Thus.^' Fraction A and its steroidal fraetion protected r a against isoproterenol induced myocardial ~ infarction." who reported that this compound ! enhances iodine uptake b.6%) significantly. '. of the gum resin has k n shown by other Indian scientists. 'Thus. the steroid fractior.7% and 31. rendered blperlipidaemic by a high-fat diet. two new sterols from the chloroform estract of p q g u l guln (guggulsterol 11' and guggulsterol \I) were isolated and cha~cterizedon the basis of spectral evidence and chemical reaction^.G.31 The alcoholic estract and a pure steroid ofguggul lowered serum cholesterol in triton treated rats. trig&-ceridesand total lipids in hl-perlipidaemic chick^. the petrol-soluble fraction (A1 and the alcoholic extracts of the gum resiAi\\-err reported to lo\+-er the serum cholesterol in hypercholesterolaemic chi&.thyroid in rats. Thr various steps of this collaborative investigation ilavt: been elaborated in excellent reviews by Sukh Sporadic interest in the chemistr?.% In tritor. 51.* The alcoholic estract shows a similar effect in rabbits3'.690.i:. total lipids and phospholipids in wstrogen induced hyperlipidaernia in cf. lowered serum cholesterol f and triglycerides and also reversed. respectively. rrigil-cerides I3>'39. the gum resin (3p kg-') given for 1 month in the diet.'.lred to dofibrate which lowered the same parameters by 47.^ Z-Guegulsterone has also been isolated and characterized b! means of ~prcrroscopiciriethods by Tripathi tf al.i~ks. The steroid h u t i o n of guggul also lowered LDL cholesterol (f6.as co. 'J." Fraction A also reduced serum cholesterol.5%).0%. The ratio of HDL cholesterol to total cholesterol in tbc steroid treated monkeys was significantlv higher at all intervals. HYPOLI~IDAEM~C ACTIVITY OF GUGGUL GUM The hypollpidaemic activiy of the gum resin and its extracts first demonbeen confirmed by various strated by Satyavati and coworkers. to some extent.~* Fracaon A revealed significant hypolipidaemic effect in Mongolian gerbils. ofguggul I~wered total cholested (bs 60." SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 202 .53 In \\bite leghorn chicks.0%..SATYAVATI icd hv Nit. 41.. induced hyperlipidaqnia induced in presbytis monh-cys.'. nnand. acids a) (by -k2.4%-1-$fiospholipids and also xion-esterificd f n .ggul gum reduced serum cholesterol.jO The petroleum ether extract ( h a i o n A) and erhylacetatc estract (fraction B) of gu. in which hyperlipidaemia was induced by diet.1%) and VLDL c h o l e s t d (40.T1.

preliminary studies with \ ariolls fractions of guggul further phmacological investigations attht-eDRf.he ratio of HDL to LDL cholesterol. In hyperlipidaemic rabbits and rhesus ~tlonkcys. L p b w a concc-ted maiinly on guggulipid (a standardized 'ed-ylaoetate a m c c supplied by Sukh Dev). guggulipid led to significant changes in the lipoprotein profile by reducing the serum cholesterol and triglycerides and aliuing .^'-^' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Guggulipid also afforded partial protection against isoproterenol induced myocardial necrosis in rat^.CCIGGULIPID: A PRO~MISING HYPOLIPIDAEMK AGENT HO Pregnenolone Subsequent to . apart from regression of tthemmatous lesions.

did not l. . the alcobhc extract of guggul gum administered for 5 days showed only a mild h>pocholesterolaemic action in normal rabbits.\ also increase the late of removal of cimIcsterol. d petroI ether extvct.i activity in rats and chicks. the ethylacetate extract. Ascorbic acid. mukul gum tested in uitro for inhibition oi acetate [I-"'c] incorporation inti cholesterol. The mode of action suggested is rapid degradation of cboksterol by activation of the thyroid. Nityanand and ~ a ~ o o have' r e p r e d slight inhibition of cholesrerol biosynthesis in rats by the alcoholic esrsxt and a steroid isolated from this extract.' t ] cholesteiol) in \\'istar rats revealed a n enhanced rate ofacretion of cholesterol by fraction A of C. reveal any hyplipidaemic effect at a l To study the effect of thr dmqs on the phagocytic indes of the reticuloendothelial system. The effect of hction A was similar that of clofibrate in this The ketosteroicl of pl-ggul gum was tested for its effect on th?m . whereas Atromida showed a ciqificant lipid low-ering action in these animals.epithelia1 cr2s and the reduced j3'I uptake under the iduence ofneomercazole was 'cpned to be countered by guggul ketosteroid.' an anion cxchanqe property with bile acid sequestration leading to enhanced escrrcion of cholesterol as one of the possible mechanism of its hypolipidaenx action.* The ketosteroid (3mgkg-' given for 1 month loweled the serum cholesterol. the various fractions of C. radiometric clearance studies with '3'~-labelled human serum albumin were undertaker.*eiI as by clofibrate.b o n g . The thymid stimulating actkip of the drug was evident from the high 13'1uptake and active vacuolizadon of the colloidal substance. ~ Kinetic studies canied out on the rates of cholesterol turnm-tr (using ( 4 . STUDIES ON THE MECHANISM O ACTION O F F GUGGUL GUM AS A HYPOLIPIDAEMIC AGENT The first study done on gum guggul had suggestedi. The classical proliferah of thc.In another independent study carried out at CDRI.& SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 204 . Fraction . as compared tc Atrornidg -6chlorophenoxyisohutyrate) in liver slices. the steroid fraction revealing maximum i n h i b i t i ~ n . by acetatell-14c] incorporaric*~. possibly through the gut. phospholipids and higlycerides in male u-hireleghorn chicks. Limited efforts have subsequently been made by _a few groups c. The rat? of clearance of '371-labelled protein bound i~dine(PB'~'I) round to br increased in rabbits treated with atromid but not with eitk. petrol ether extract and the steroid showed inhibition. howevci. as -.rr quygul (alcoholic extract) or ascor\>ic 0.5 scientists gum to work out the mechanism of the hypolipidaernic action of the ~ : r ~ m l r~ and its various fractions.

. pggulipid (lOOmgkg-') causCd a significant increase in. the results arofirrncd &at alterations in biogenic amines and dopamine $-hydroxyl&c aczivlty may be one of the possible mechanisms of the antilipaemic effect of guggulster~ne. Furthermore. the media containing gum guggul extract showed a s i g d c a n t increase in the uptake of 13'1 as well as T3 (triiodothyronine) along with PBI and free thyroxine index..1%) in membrane lipids of gugsllsterone treated rats. In nonnal rabbits.and (E)-guggulster~ne isomers) the purified fraction of C.5%). The levels of norepinephrine and dopamine and activity of dopamine f3-hydrosylase (the norepinephrine biosynthesis enzyme) increased progressively with an increasing dose of guggulipid (60. was studied on biogenic monoamine levels and Copamine 0-hydfoxylasr activity of rat brain and heart.ane. On the basis of these results.~ In guggulsteronc treated rats (20mg kg-' for 6 days).GUCGULIPID: A PROMISING HYPOLlPlDAEMK AGENT \%%enthyroid explants of young mice (6. there was a significant decrease ir.7 weeks old) were cultivated in media containing melatonin and petroleum ether extract of guggul gum." The dfect of guggulipid on the levels of catecholamine and dopamine @-hydroxylaseactivity of normal and cholesterol fed rabbit tissues was studied. The results suggested that inacase in catecholaminebiosynthesis by guggulipid is one of the possible mechanisms of its hypolipidaemic activity. phospholipids (25. Guggulstuone administration to rats led to an inhibition of brain dopamine fl-hydroxylase activity with a marked stimulation of heart both in oitro and in uiw.7' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 205 .69 The effect of guggulsterone (mixture of (Z). whilst serotonin 2nd histamine con tents ~ e r e enhar. mukul resin. the levels of cholesterol (23. Catecholamine levels were also similarly inhibited by guggulste. respectively. Thus. the dopamine 6-hydroxylase activity and catecholarnine levels.cd in the brain but decreased in the heart. The catecholamine levels and enzyme act~vity were found to be decreased in cholesterol (500 mg kg-') fed rabbits. It also helped the hypcrcholesterolaemic rabbits to recover the decrease in catecholarnine biosynthesisb8 Studies were next carried out on the effect of guggulipid on the levels of catecholarnine and dopamine B-hydroxylase activity of the brain and heart tissues of rhesus monkeys. suggesting direct stimulation of thyroid gland by guggul extract.5%) and triglyceride (34. 120 and 240mgkg-I).it has even been suggested that gum guggul may be of use in the treatment of hypothyroidism and a\:xiat-d condition^.^' Adrninistra tion of (2)-guggulsterone ( l mg/ 100g) led to an increase in the iodine uptake by thyroid in rats and enhanced the activities of thyroid pcroxidase and protease as well as oxygen consumption by isolated slices of liver and biceps muscle. membrane urperiments showed an increase (90%) of high-aifinity binding.

aged 40-60 years) having coronary anuy disease (diagnosed on the basis of pmious history of myocardial infarction.74 In a double-blind cross-over study with placebo canied out at Pariala on 60 obese subjects. VI. cholesterol. confirming the hgocholesterolaemic activity of gum guggul andlor its fractions Thus." but a l m t similar in a subsequent report by the same pup. a double-blind clinical trial on three groups of 40 obese patients. phospholipids and total lipids in 20 patients having hrperlipoproteinaernii. one treated with crude guggul (2g three times daily). another with fraction A of petroleum ether extract (0. triglyceridcs. alterations in biogenic amines. fraction A of gum guggul (1. of India on the hypdipidaernic activity of gum guggul were reported in quick succession. Varanasi.'-49 Following these reports. Thus. while no changes were observed in these parameters with placcbo. serum cholesterol SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 206 .The foregoing studies indicate that guggd cxuts its hypolipidaernic action by inhbiting the biosynthesis ofcholestml as well as by promoting rapid degradation and exczetion of cholesterol. The h>-pocholesterolaemiceffxt of the crude drug was found to be higher than that of fraction A in o m study. The hypolipidaernic effect of fraction A was found to be better than that of clofibrate administered to 20 Other clinical studies from different part. showed that gum guggul administered in a dose of 2 g three times daily in patients with obesity andlor hyperlipidaemia not only reduced their serum chde~terol phospholipid and levels but also their body weight.1. at Madras.5g thm times dailv) and the third with plaubo. a number of clinical studies were undertaken by various scientists in difXercnt parts of India which confirmed the lipid lowering ac9vity of gum guggul and a few of its fractions. HYPOLlPlDAEMlC ACTIVITY Clinical studies carried out at BHU. ECG findings. CLINICAL STUDIES ON CUGCUL C U M A. crude guggul gum (4g in three divided doses administered d for 4 weeksj revealed a significant El in serum total lipids. and anion exchange have been suggested as the mechanisms of hypolipidaunic action of this complex drug. high-amnity binding. uiglycerides and f3-lipoproteins.ogday-') administered for 12 weeks was reported to lower suum cholesterol. for 21 days sho\ved significant lowering of serum chdaterol by crude guggul and fraction A from the tenth day onwards. Thyroid stimulation.75 In an open trial carried out on 25 patients (14 males and 1l kmales. which decreased further by day 2.

~ In a double-blind cross-over study of the effects of fraction A of guggul gum (0.. after 40 days in rats and 5 weeks in humans).m In a clinical study at Sewagram (Wardha). followed by the administration of 2g guggul gum three times daily for 3 months. 4 wek) on 38 hypercholesterolaemic subjects at Pondicherry. fraction A significantly reduced the serum cholesterol levels and n the cholesterol pool size through: (i) a significant increase in the rate of excretion of cholesterol from the body.weeks in 51 and 10 patients of hyperlipvproteinacmia (types 11. In three patients with xanthomatosis treated 59th fraction A. but complete. in only one of the three patients of santhomatosis was thm complete res~lution. Serum triglycerides showed reduction only after 2 months ofguggul administration and the reduction lvas maintained during 3 months follow-rtp. This study. fraction A led to highly significant reduction in serum ch$estcrol and a significant reduction i ~ i total lipids. triglycerides and non-esterified f ~ t t y acids.~" Faecal sterol studies in 12 patients of hypeilipoproteinaernia showed that fmction A as well as dofibrate enhanced the faecal excretion of s t e r o ~ s . as evidenced clinically by resolution of xanthomotosis.5g t h m times daily) and placebo (administered b r . did not reveal an.J I\').5 dayw') compared wit11 clofibrate (2 g day-') over a mew period of . The drug not only reduced the serum cholesterol and triglyceride levels but also reversed elecfrocardiDgram (ECG) abnormalities (e. In the first part of the study the effect of the drug was investigated without attaining isotope equilibrium.GUGGULIPID: A PROMISING HYPOLlPlDAEMlC ACFh'T and triglycerides).e. 47 patients were first given placebo for 1 month. 1Vith clofibdte? however. T-wave inversion and S-T segrnint depression) 'in 16 patients. as well as triglycerides. however. ! humans. 111 and .g. whereas the second part of the study was done after quilibrium had been attained (i. A significnt fa11 in serum chrilesterol was reported at monthly intervals until 3 months after cessation ~Cguggul gum administcation. there was gradual. Serum plipoproteins revealed significant reduction only after 3 molsths of therapy and during a follow-up of 3 months.e. 3t all periods of observation (i. purified gukggul gum was administered in the form of pills in a dose of 12-16gday-' in four divided dose. both drugs showed highly significant lipid-lowering e&ct on serum cholesterol. for 3 months. Tllerc \\.~~ Kinetic studies with 14-'"c] cholesterol were carried out to elucidate the effect of fraction A of guggul gum in rats and humans. respectively. resolution of the lesions in about 40 weeks. significant alteration in the serum phospholipid level.as also a ieduction in body weight at a rate of 1 kg month-' In a !ong-term clinical study at Sew Dclhi on fraction A of guggul gum ( I . and (ii) a mobilization of cholesterol from tissues. at an interval of 10 weeks) up to 75 weeks.n '" - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 207 .

iron. while 27 obese subjects (10 males and 1 7 females) received placebo for 4 weeks. a mixture of Tenninialia drtbuln.as significant reduction in serum cholesteroi and triglyceride le\-& in the group treated with guggul gum ftaction A.b/ eand Emblitz of/.g? A double-blind dinical trial was carried out with fraction A d guggul -gum (300 mg capsules three times @ly far 12 weeks) in 51 patients of obesity and compared to placebo (groundnutoil) administered to X patients of obesity with hyperlipidaemia. The fafl in serum cholesterol was 23%.n ~ h o l a ~ o ~Only. There \\. There was no reduction in lipids or fiee fatty acid levels. mica and copper). but also to the other drugs like P k u m which is a kno\r. marginal reduction m body . f 4 Another open trial compared the &ect o guggul gum ( 3 0 0 ~ of petroleum ether fraction A t\rice daily for 1 mouth) with gariic estact (one garlic pearl twice daily for 1 month) and dofibrate (500rng nrict daily for . ~ ' ~ o t w a n studied healthy. i~~ disease and reported that serum cholestepA and triglyceride la-& were reduced significantly by guggul gum only u r b the initial serum cholesterol levels were higher than 223 mg% in healthy subjects and coronary artery discase patients.10 in pch group. moderate (serum cholesterol 2j0-300rng9b) and severe (serum cholestq-01 >300mg%) hypercholesterolaemia.JDL cholesre. 23. followed by those receiving dofibrate and garlic pearls.ul levels was found in t h i group iicei\ing bggul gum. triglycuidcs.e. one part of which mixed with tw-o parts of Triphala (i. 2nd . Plumbago z&nica and Picrorhiza kurrcm Tt~ii trial was carried out on 101 in&\iduals (69 females and 32 males) with mild (serum cholesterol 200-23:lmg%). three pans of Shilajit (asphalt) and four parts each ofpure guggul gum. kspectivdy. The drug w a s administered in the form of tablets (six tablets in three divided doses.e. The reduction in body weight WQS marginal and not statistically significant.individuals as well as patients of coronnr). The hypocholesteroIaemic actioa of the compound preparation was attributed not only to guggu1 gum. No rosic effects or side-effects were ~ k t d . M~ximum regression_in serum-cholattrol.4%. h month) on 30 adults with IA\-perlipidaemia. 240g three times dairy). in the three groups.4% and 36.tudy.indis). ue ~ weight (which was not sta~isucally significant) was obsened in this . In a controlled (single-blind)clinical trial at Pondicherry on obese patients (10% overydeight for height. sulphur. 35 obese individuals (8 males and 27 females received 1. who were treated \\-ith (he drug Awavardhini for three months.An open vial was carried out on a haborninera1 preparation [drogva&i) with five bhasma or ash preparations (of mercury. The goup receiving guggul capsules showed significant reduction in serum cbdcsterol and serum tri@vcerides SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 208 . T.5g of fraction A of guggul gum in three divided doses. ape and sex. i. acwrding to the Index s-the Life Insurance of India).

5% for c!!olestd and 30. Phase I1 (efficacy) of the study on guggulipid (j00mg thrcc dmes daily for 12 weeks) was camed out on 19vpatients with primary hypaiipi4aemia (seven with a past history of myocardial infarction. however.as found to be completely safe and devoid of any effect on liver function.:tk with ischaemic heart disease. No signi6can~ side-elrects were obse~vedduring the trial. guggul gum (@ed according to the ayurvedic method) was administered (1 g three dmes daily) for 3 months. showing reduction afia 4 \veeks with elevation at 8 weeks and again a significant reduction after 12 weeks of drug treatment.showed significant rcdAction after 8 and 12 weeks in the group treated with guggul gum.artery disease). blood sugar.@ A for body weight. ho~\. Gugplipid \\. despite a consistent trend for decline in body weight. Guggulipid was effective as a hypolipidaemic agent in type I1 B and type'IV hyperlipidaemia and also in familial combined hypercholesterolaemia. pharmacological and clinical studies on various. The average lowering \\. serum total Lipids. The dect on. systematic.er. a significant reduction noted s after 4 weeks was not maintained after 8 atid 12 weeks in this doubI&blind trial.e\. Ho\v:ver. undertook. three -. the CDRI concentrated more on the standard ethylacetate extract fraction designated as guggulipid for pharmacological and clinical studies. two with diabetes." In a long-term (6 months) cross-over clinical trial. the reduction in serum triglycerides and free fatty acids mas not statistically significant. the drug dfd not significantly reduce body weighr even at the end of 3 months. in collaboration with the chemistry team. A significant fall in serum cholesterol and plipoproteins observed at the end of 1 month of guggul gum treatinent persisted 3 months after discontinuation of the drhg. was not consistent. and one of gout). Furthermore. Similarly.vith angina pectoris.CUCCULlP1D: A PROMKING HYPOLIPIDAEMIC AGENT after 4 weeks of treatment. there was no erect on serum phpholipids.as 17. blood urea. haernatological parameters or ECG findings In the efficacy study. The triceps skinfold thickness. three with diabetes and hyputension. tlte drug v-as not effective in familial hyper&ole~terolaemiaas &ng SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 209 . Lucknow. tltree with angina and hypertension.= As meptioned earlier. Phase 1 (safety) of the study on guggulipid (400 mg three times daily for 4 weeks) was camed out on 21 patients (nine with hypertension.chemical fractions. the CDRI. In this study. the effect being evident 4 weeks if<& drug administration. and three with ischaernic'heart disease and hypertension. folloning placebo administration for 1 month. and three with clinical suspicion of coronan. two with hypertension alone. After preliminary studies. in 31 male subjects with hypercholesterolaemia. which persisted up to 12 weeks.3% for triglycerides. serum cholesterol and/or trigly~en~ij&f.&e signihcantly lowered in 15 patients.

Bombay.2%) and free 5try acids (56. showed s significant decrease in serum total cholesterol. there was a significant decrease (38. some studies are still being undertaken on crude guggul gum. These trials showed that the hypolipidaemic activity of guggulipid was comparable to that of clofibratc the average reduction in serum cholesterol and triglycerides being 27% a x i 22% with the two drugs. although ir decreased platelet adhesiveness and increased fibrinolytic activity in patients of coronary artery diseasew \$= mg B. .2%) in the uric a levels at the end of 6 months ucatment with this compound drug. SATYAVATI Multicentric clinical trials (phase 111) were then organized by CDRI on guggulipid. significant rise in HDL iciralestero~. purified guggul gum and expressedjuice of Bacopa monjl-. In spite of the commercial availability of guggulipid. markcicd the drug o under the name 'Guglip' (on a non-exclusive basis). Cipla Ltd. \'LDL and LDL cholarml levels at theweeks 8 and 16.9%). with a sirnultan&us." Permission to marker guggulipid \\.G V. however. I n an open -triai on 50 patients of coronary heart disease. Bombay.en used mainly in combination with other herbal drugs and not sin&-.9%). it UZI: reported that the drug had no significant hypocholesterolaemic effm in healthy controls and patients of coronary artery disease.5g in two di\i& doses for 4 months) in comparison with placebo.' ( Brahmi) was administered in a dose of 6gday-1 (in the form of 500-mg pills) for a period of 6 months. guggul has L. triglycirides (41. total lipids (31.a In 1988. CLINICAL STUDIES ON PATIENTS HAVING ISCHAEMIC HEART GISEASE For clinical studies on ischaemic heart disease.Jaipur and Bangalore. a c-ompound preparation comprising q u a 1 quantities of I d a raccmosa (PukLmool) root powder. The lipid-:owering effect of guggulipid to age. Sew Delhi. as is the practice with Ayurveciic phgsidms. respectively.~~ i n an earlier study rrom the same department. in thk Fm of 500-mg tablets to be administered three times daily in mixed h y p e r l i m m i a (with serum cholesterol 220 dl-'. Apart from significz~t reduction in serum cholesterol (32.as obtained from the I . K G changes SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 210 .6%). sex or body 1%-eight. Kearly 80% of patients (of the 245%responded not related to guggulipid'action.. on 245 hyperlipidaemia patients at Lucknow. and serum triglycerides 170mS&-') hypercholesterdaemia (220 rns dl-') and hypemiglyceraernia (190 %dl)-'). w Controller (India) in June 19&6. in 40 patients with npc I1 hyperlipidaemia (the strum cholesterol levels being 275mgdl-' & above and serum and serum triglycerides above 145mgdl-I). One of the recm: studies on guggul gum (administered in a dose of 4.

Varying degrees of lmprovernent were observed in 40 patients.~ded these patients were declared cured (i. moderate rmprovement in 22 (55%) and no improvemrnt in 10 (25Y0) patients. plasma C-AMP levels were estimated by the radiometric method.6kg) was also noted after G monrllh of ~reatrnent. two of chose who came after 1 month of the attack. Five of dose of 6gdaY-'. it was reported that one patient with a recent attack. The improvement was evidenced by a trend towards normalization of ST segment depression and T-wave inversion. C-ABIP levels were reduced significantly at the end of treatment with Pushkara guSUgylu. the authors reported no change in six patients.as no changt. i e. adrenaline and noradrenaline as \cell as serotonin.5kg to 59. tt~ui~tcl and I . Plasma adrenaline levels showed no significant change. whereas in five there \\. whereas noradrenaline and. rortrnosa (in equal cluantities)'\~as administered to 30 patlenrf of ischdemic heart disease in a doses for . reliefofsymptoms in 10 and a high degree of relief (or cure) in :hree pa ti en^.e thry u ere totally devoid of anginal pain and showed regression of serum cholestcl-ol and reversion of ECG to normal pattern).~' A combination df the gum resin uf C. period o r 4 months. CLINICAL STUDIES ON PATIENTS HAVING HEMIMECIA In an open trial on 25 patients (aged 40-70 years) of hemiplegia (six with recent attacks. \Vith respect to ECG findings. in three di\. Plasma catecholamines. \\. of the 25 patients there was no improvement in 11 (44%). one with previous histoe of herniplegia and nine patients of paresis or partial herniplegia).A significant scd~rctiotlin body weight (from 63. Apart G-om recording clinical signs and symptoms. In the overall clinical assessment of treatment. Reduc:i~n in plasma C-AMP was also attributed ta reduced catecholamine and @-receptoractivity. . as well as ECC findings. There was also significant relief from precordial pain and dyspnoea. a con~poundpreparation Pushkara gugglu (comprising equal quantities of powered rcmt of lttula racnnosa and powered !gum resin of C mukul) in the form of capsules. nine who had the attack 1 month ago. and all niie patients of paresis recovered completely on being treated u-ith 'purified' guggul gum in a dose of SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 211 .CUGGULIPID: A PROMISING hYPOLIPIDAEhllC AGENT showed significant improvement in eight patients (20%).as in terms of normalization of ST segment depression and T-wave inversion. were estimated by the fluorometric method. Decrease in noradrenaline was attributed to reduction in sympat:~eticactivity due to a possible $-blocking pmperty of the drug. The improvement in ECG changes \\. of 6gday-' (in three dividel doses) for 3 months.as administered in a dose . In a clinical study on 25' patients of ischacmic heart disease (diagnosed on the basis of ECG findings).94 "'vq3 C. and a significant improvement in two (8%).. moderate improvement in 12 (48%).

The effect of crude guggulu as well as the two gumlstemncs ! E and 2 ) on platelet -aggregattion was studied using adenosine diphosphate (1 X 10-'m).sis persisted.. as compared with the initial levels and with rbt control group (which feceived placebo). The steroid mixture and purified (E)-guggulsteroneand (2)guggulsterone completely inhibited platelet aggregation induced bv ADP.4g capnrla twice a daily) for 30 days to 20 healthy individuals and patients of corartery disease each.effect of ia dofibrate at the same final w n c e n t r a ~ o n. which is independent of its action on b l d lipids. In another study q12tpatienb of ischaemic heart disease compared with 27 m m l s .* ~ f n l concentratian was reponed to be very similar to xhe inhibite. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 212 .g0Inddentallye this is the only clinical study which did not find a lowering d serum cholesterol b) guggul gum (fraction. guggul gum (1.2 g) increased the fibrinolytic activity in patients of ischaemic heart disease. triglycerides and free fatty acids were reduced highly significantly in all the 25 patients. no significant fallsin the serum cholesterol levels w a s observed in either group.12-16~day-I in four divided doses for 3 months.= Jain and w\vorker~*. EFFECT OF CUCCUL GUM ON COACULATICY FACTORS AND BODY WEIGHT A. without any significan: effect on platelet aggregationg7 A significantly prolong4 clotting time with no @cant changes in plasma fibrinogen levels in patients of ischaemic h e m disease was reported in another study.A).~~ found a significant fall in serum cbdeterol. Four patients showed only a slight improvement in their motor function.95 V11. whereas in one with a history of repeated attacks there'tvas no improvement. ~ When fraction A of guggul gum w s administered (6. EFFECT O N COAGULATION FACTORS ~ a s o y ~ " n 4Tripathi cf oLWfirst reported that crude guggul and its alcohol soluble fraction decreased serum turbidity and increased the mqulation time and prothrombin time in rabbits as well is in patients w r obesity ih and/or hyperlipidaemia. adrcoaline and serotonin. There was.2 significant inaease in serum fibrinolytic activity in both groups treated with fraction -1 along with a fall in the plztelet adhesive index The investigators d shis study therefore concluded that fraction A has a direct action on blood aagdatioil mechanism. In 10 patients there was improvement but residual paral!. The effect of the two gu&ulsterones ac 1 0 . howevr -. Serum cholestud: phosphoLipids.

free fatty acid levcls and @-lipoprotein levels on administration of crude guggul (2g three times daily) for 3 months in 47 hyperlipidaemic patients." All other clinical studies reported no significant effect of guggul gum on body weight. OTHER PHARMACOLOGICAL ACTIVITIES OF GUGGUL SUM Guggul gum is an important ingredient of most of the commercially available Xyurvedic drugs prescribed for arthritis and reldted conditions. therefore. !t is not surprising. ~ a significant reduction in body reported !\-eight by guggul gum in animals and in clinical studies. In the case of a l other studies. in the initial studies carried out at Banaras Hindu University. The CDRI study on guggulipid reported a total lack of effect on body weight in both animal models and in clinical studies.e an exactly opposite effect.78. conditions of storage and related aspects. thickness VI 11.\I1 the studies carried out at the Institute of Medical Sciences. Banaras Hindu University. Tho drug is used evtensively in India for the treatment of all types of arthritis by Ayurvedic physicians. that early pharmacological studies on this drug concentrated on its anti-inflammatory and antiarthritic activities in SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 213 .87 Such reports of an inconsistent effect of guggul gum on body weight requires special comment. no information is available as to t e source of l h the drug and its age.GULIPID: A PROMISING HYPOLlPlDAEMlC A E T GN triglycerides. but did not observe any effect of the drug on serum phospholipid levels or on bleeding and platelet count. EFFECT ON BODY WEIGHT .79 B. whereas a new sample of the gum resin is claimed to ha1.GUC. Only one other study reported a significant reduction in body weight and skinfold thickness in a cliniql situation.73.8'*&4. Varanasi. special efforts were made to procure (from Gujarat) guggul sahlples which were at least 5 years old. Kotiyal et aLe4 reported a significant after 8-12 weeks treatment with reduction in triceps skinfold guggul. In view of this.77.8j of the investigators Some did find a trend towards reduction in body weight but this treid was not statistically significant. ~ ~ . particularly in view of the emphatic statements and indications in all the avai!able Ayurvedic treatises that it is only the old sample of guggul that can decrease the body weight and havea beneficial efIect on fat disorders.74. ~ a r a n a s i ' . The inconsistency in the results obtained with regard to the effect of the drug on body weight could be due to the variation i i the samples of the gum resin (including its age in storage). However.

@us animal models. No analgesic effect or behavioural were obJen.'OG IX.'00 The oleoresin of guggul and its fractions were ncsl screened against Browniec's arthritis model and granuloma pouch and cotton pellet tests in normal and bilaterally adrenalectamized albino rats.anti antiarrhriric effect in all models at a dose of 12.j reparted against canaqenan induced rat paw edema. A dqressant action noted on isolated frog h h r t could be reversad by calcium-'" In clinical studies. I n t r a p e r i t o d doses of 400 and 600 mg kg-' of the essential oil did not lead to any effbx on *e central nervous system. The acid Craction of guggul gum showed thb effect even in the adrenalectomized rats. ' ~ Significant anti-inflammato~/antiarti1riticeffect of a steroid fraction of guggul gum against carragenan edema in rat paw and second* inflammation caused by Freund's adjuvant has been Three coqpound Ayrirvedic preparations (Mahayogaraja guggul.the \ w of the v r uterus. Purification (shodhanu) of a u d e guggul in T w l a decoction (as recommended by Ayuntedic texts) was found to diminate the Other side-effects reported incidence of side-eKects like skin ' SELECT RESEARCH PAPERS UN EVIDENCE BASED AYURVEDIC DRUGS 214 . Skin rashes were easily controlled on withdrawal of the drug aod also by reducing the dose. ovaries and cervix of rats with a concomitant ~dcrease tbe slycogen in a d sialic acid levels. (unpurified) crude guggul r e c d e d mild side-effects like skin rashes. which was not mediated thrpugh the pituitary-adrenal axis. The oleoresin showed significant antiMammator). as evidenced by reduction in. granuloma pouch as well as adjuvant ~ r t h r i t i s .'07 The LDdoof the essential oil of guggul gum in mice was reperz'd to be 705 mg kg-' intraperitoneally and 1669mg kg-' orally.ed and the oil had no action on frpg rcctus aldominis. bid pressure or respiration.''' Significant anti-inflammato~and antiarthritic effects of the oleogum resin \Vr. I t h ~ no action on f q heart or d on perfused frog blood vessels.lOOg body weight and above. All the three preparations (with guggul gl rn as one of the major iqrcdients) showed a significant anti-inflammatory effect. menorrhagia and irregular mensrmation. 'The action ofguggul against Bmwdte's formaldehyde induced arthritis in albino rats has been reported.~laharama and Samccrclpannagaras) were tested for anti-inflammatory acti\ity in rats using the formaline ifiduced arthritis and the granuloma pouch methods. diarrhoea. .5rng. TOXICITY AND SIDE-EFFECTS OF GUGCUL GUM An emulsion of-gum resin in 5% acacia gum had no significant action on dog heart. ''j A promising antifertility effect of the oleogum resin of guggulu and its acid fraction was reported.

Luckno\\. diarrhoea. it showed no advase effects in toxiaty studies over a period of 6 months and in teratogdc studies in rats. central nervous system. to blood sugar. It had no embryotosic. anorexia. three and one patient. rabbits and rhesus monkeys. Pespite the large numb& of theses submitted and paperslreports publishtd. restlessness and apprehension in one patient. as.u4 not report any side-effects on administration of did fraction A of guggul gum for varying periods (4. blood urea. Bombay) mentions that the drug is devoid of any a d v a x etfect on the central nervous system or cardiovascular system and has no diuretic effects and that safety evaluation has showed Guglip to be safe in rats.~~. T h e brochure also mentions that Guglip is to be used with caution in hepatic disease impairment and also in gastrointestinal disturbances (ex. blood urea and haematological parameters in phase I dinical studies.13 These .. dysentery). ' . cardiovaxular or diuretic effects.78181. " ~ Guggulipid administered in (a dose of 400 mg three times daily for 4 u. ~ ' .~ theses represent not only different types of research but also coverdifIknmt branches of modern science and two different systems of me-&cine: r4. abdominal pain.12 weeks). monkeys and ~ > e a ~ l e s . biochemistry. fetotoxic or teraeogenic effects. Guggulipid (the standardized ethylacetate estract) was subjected to fxtensive preclinical toxicity at the CDRI.'~ Diarrhoea. in a group of 33 obese individuals who were given crude guggul gum (4g twice daily) for 4 weeks.dataon the effcct of the drug in children is inadequate. and hiccough.86v!" Khe information brochure on Guglip tablets (manufactured and marketed by Cipla Ltd. etc." Iiotiyal ct a1.63 while mild gastrointestinal irritation \%-asnoted in some ~tudies. phytochemistq. polyurea and menorrhagia were observed in seven. tilziwria.eeks was r e ~ r t e d be devoid of any adverse effects on liver functiom. In rats. X. respectively. Other clinical studies aIso did not report any notable adverse reactions. CONCLUDING REMARKS The hypolipidaemic activity of guggul gum has been a popular topac of manv doctorate theses in different parts of ~ n d i a . or haematological prameters: I t was found to be devoid of any hormonal.werc diarrhoea in three patients. ' ~ 9891'3-116. Its use in children is not rcawamended. The drug did not reveal any adverse action on liver function. in a doubleblind cross-over srudy. which await solution SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 215 . -4yurveda ( K a p c/tikit~a)and allopathy or Western medicine (including clinical medicine and pharmacology). there are still a number of unanswered questions and 'grey areas' in tbe profile of guggul gum as a hypolipidaemic agent.

to the subsquent studies which suggcsrcrd that the drug not only inhibits cholesterol biosynthesis but also sirnuitaneously enhances cholesterol excretion thr. pharmacol~caland therapeutic profile of f this driig. while also revealing the complexity of m c h into natural products like guggul. R e v that the g u m resin lowers P-lipoprotein.G V. clinic~ans well as phytochemistr Carefully as planned. The studies camed out so far on guc@ gumihavenot addressed themselves to the imponant point referred to in .ns regarding the action of guggul gum on obesity and dated conditions. The saga dl'guggul gum. Furthermore. The story a SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 216 .piece together the results of research on the entire gamut so as to o h e biochemical... SATYAVATI Thus. Mere r e a d i n g of the body weight a t different points of time. What is required is IP-deoth metabolic studies under controlled conditions. without giving attentioa to other important factors cannot be expected to give an answer to tbt unsolved questio. despite its long and tortuous course serves a3 an example of the amazing insights of the ancient Indian medical anhorities like Sruhruta (600 a. The inconsistent effect of guggul gum on body weight reported by some authors seems to stem mainly from lack of serious efforts to concentrate on this aspect and also from thk scant attention p a d to the classic description of the action of guggul on body weight..aaion o this i~ckatile f drug. From an initial simplistic suggestion of an anion e x c h q e propertv. despite attempts by a few scientists to work out the mechanism of h of the drug.aetabolic and pharmacokinetic smdies in controlled coditions (in animals as well -as. Ven. metabolic. in fact.fat. inspire scientists to take up further advanced d.humans) ma? unravel exciting new frorcs of the .C. increases the HDL cholest&ol w h i k lowering LDL and VLDL choiesterol. \vh~ch throw light on its \side pharmacological and therapeutic can SPe-m.gut. mainly because o the lack of perseverance by any single group in carrying ow in-depth f studies. no evidence is zvailable of amsistent scientific research by an) qoup on these facets. Tbt emphnc claims in Aprvedic literature'*' on the diarnemcally opposite actions ofthe .old9and 'new' samples of guggul (Sushruta Samhita: chih'ts~~~thana) be investigated must seriously by pharmacologists. studies have investigated the effect on skinfold thickless and other paramccers of fat deposition in the body in humans or animal models. .\?un~edic literature on its m q u e dual dm on body weight. no clear-pt picture has emerged so far. with bile acid sequestration activity /akin to that ofcholestyramine'~ suggested as one of the possible meclianisms for the hypocholesterolaemic action of the gum resin of guggul.-.). it is essential to bear in mind the significance of the source and age of the guggul sample being tested. that it binds bile acids. which do not yidd a 'single' actiw principle responsible for their pharmacological and therapeutic profile.ngh :he . along nirh an antililipoiytic action should.

therapeutic synergism and action with refereme to pro-drugs and irnrnun~~tentiation. Ayurvcda also claims to offer a ne-. in close consultation with th? scholam and 3ystem. thus offers rich concepts basecl on ancient wisdom as illustrated in the case of guggul and its effect 6n lipid metabolism. antagonism.8~"8-'nHowever. ACKNOWLEDGEMENTS The author .ippendi:: I). by itsdf is a more significant discovev or 'milestone' than that of guggul gum. Such an approach must t&e into account \various imponderables such as the correct animal models. and other factors which can influence the outcome of m a r c h on natural products.I\)-urveda. 119 In contrast to 'ethnomedicine'. This. certain organized systems of medicine like .an isolated manner.GUGCULIPID: A PROMMffi HYPOLlflDAEMlC A G E M of cguggul gum is thus quite different from that of forskolin (from COLW forskoli).'23 The story of guggul gum should. . Special thanks are due to Dr C.is grateful to a l the scientists who provided lists of their l publications (along with reprints) on guggul gum. Atal and Dr Sukh Dev and to the editors and publishers of Economic Botanr. most research on natural products still continues to be done in. USA. but more became of the remarkable analogy found between Sushruta's ancient concept of &a and the modem scientific concept of artlierosclerosis.may pave the way for many more such physicians of the A j w ~ e d i c 'disco\. way of life throngb its holistic approach. therefore. the drug.I\yurveda offer much more than mere remedies or drugs for various diseases. which have been a in d this chapter.eries. which eventually can be applied for the benefit of mankind. 1 and .* The number of reviews and status reports published recently on current research into medicinal plants in India bear tedmony to the rekindled interest in research on natural produc~s.. but estensively investigated globally on account of its unique adenylatc q d a s e activation property.11' The need to'pursue research by means of a mcltidisciplinary approach in the casc of drugs like guggul is evident. another Indian herb not mentioned ir? the Ayurvedic texts. not so much because o the f 'discovery' of guggul gum as a hypolipidaemic q e n t . K. A systematic and opcn-minded study of selected chapters of the Ayun-edic Samhitas by modem scientists. be mnsidered as an important milestone in the history of biomedical research. other drugs have been listed by Sushruta for intervention in the pathogenesis of medoroga (Fig. and b r i n i t o light the 'hidden' kno\~-ledge and wisdom in these ancient systems of medicine. Apart from guggul. which literally means 'science of life'. and the W a n SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 217 .

pp.. Vol. Varanasi. 262 (1979). Research Professor of Pharrnacognosy. 1978. . 1%. ~ Dclhi. G. Calairta. Diwrwn and . and Shanna. formerly Dimaor. RS.C. Sharma and Shri S a ~ Praliash who assisted in the preparuioa of the a illustratior~deserve tl anks. & y V.V. and Kapur.kcpika (C'@I) 1.). India 1889. LSD. Cdi.4fciabalin in A p m d . Sn'. VoI. \'ol 11. 12. 69 (m). Nityanand. I. Effect of an indigenous drug on d i ~ r d e n lipid rmnbdisrn with of special dcrsnce to athcrosderwis and obesity (Medoroga)... Bombay. 102 (1960). for permitting reproduction of figures from their puhlicaripns. and Santra. 3.\fed. H*dtA o I d i o (Raw Afatniolg). 366. 6. 1958. J. S o o t i d 15: 32. Varanasi. Handa K. Satyamti. LucLnow. and Satyavati.. Lama. 343.. 191. thair (Doctor of Ayurvedic Medicine).N. Dr!Mrs) S. f Vd.V. India. h1. Reprinted by Cosma P bs l -.'. G. 1954.-S.N. Varanasi.':.S. Lucknow. Ind. Satyawti. Bull. 269-276. Ramani.V. Drazyaguna . 4th edn. 2. htyavati. University of Illinois. 313-314. m . C. Banaras Hindu University. 57.C. 1967. formerly Scientist.".muasi Das. 1950 (1969). Ltd. 285. Dwarakanath. 8. 4. New Delhi. T e able aszistance of Dr hladhu Sharma and Ms N w l j Tandon. C. f 11.. Calcutta. Sbat u-n of Government Printing.). U. G. Vaidya.PIorman Farnsworth. A Diciwna~of the Economiir ProducLc o I&. College of Pharmacy. C \ . 258-266. C. I . CDRI. !67-170.Vijmna. 1976. REFERENCES I. 2nd cdn. R@ar Book Dept. ' ~nrrwdah. CDRI. Miss Padma Vati and Mrs Harjeet Kaur is also ackno\\-ledged. and also for p i d i n g the photograph of the gum guggul plant. G. Indian Council of h l c d i d Rcscarch. 14. Chopra. New Delhi. 7. Indian Matnio hfcdiio. 54-58. Thanks are due to P~of. S. M &&%ido Mk. S. . Mathur.. h K . D w a r h a t h . Shuma.L..IndigDncCJ #-India. New Delhi. Pisllr f pp.V.N:Ind.M'an. and Tripathi.. 9. N. p. 6. . pp. Publications a d Idinmation Dimtorate !. in collecting reprints and checking the &ces and the patient secretarial assistance of 3lr T. The iiuthor is obliged to Dr Nityanand. and Dr B. Delhi. 13. P.. I. h ICMR. CDRI. Cbopra. Baidyanattr Ayurved Bhawan Ltd. for scheduling a NAPRALERT search on Comm@hra mukul. R. IN. Med Rrs. Hirr. 1972. including the CDRI ctossier oa gugulipid (submitted to'the Drugs Coritrclller of India). C b Sanskrit Sansthan. Sh. p. B G Nighanlu lad~rwL. 11. Lucknow. Cbowkhamba Vidya Bhrrr. Raina... Shri J.V. Xew Delhi. K. DwaraLulath. 1975. Chicago.C. 10.D. Kadkarni.. pp. 1968. M. Dhawan.K. fm permitting access to literature on guggul. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 218 . 60. 45. blotilal B. Dhur and Sons R-t. 193. . presently Director. \'ol. Calcutta. I . p. 5th edn.%dl& (6GO B.pp. 3rd edn. 5. pp.National Science Academy.

Aftd.C. J. Ind. J. HI. V. and Gupta.V. M. K. and Kapoor. 341 (1973) 39.B. T.10. PC. '. N. I d . Plrmlo A l d SO. Tefruhafnm 2949 (1982). C h . Malhotra.C. {d EElrlabbot. -411. Bajaj. 156 (1964). Audichya. K. I d . and Kalrah.K. joseph.BN. 8. J.hl. . SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 219 . 3 57 Ni~anand.. 54. H. 4 1-7 (1982). 494 359 (1983). Phamorol. 13. Phyml. 45. O. 11. 26. H. 17. 8i (1966).. Ahuja Pyf-MS. Pet J. 38. A 37. and Shah.. 354-375. 2341 (1972). dnn. A. I d . Cffi. B h i n . 28.. C. Arora. 900 (1969). 208 (19i5) :6. U.. A. d h. 1437 (1976). 4 (igfi). R... Agarwal. Nayak. 38 (1984). I d . Kumar.P.. Kapoor. Gupta. Bull. and Tripathi. and Sukh Dev.S. Atal. 1967. I . VS. and Sfislira. 9. V.G. Sukh Dcv. Yadava. J. 0 P. R. J.D. Patil. Sci. B. 53. 3 Nityanand. A. 1 & . 42. Xlchta. 'Phn~mpv l n d g m r r h g r . and Gupta. Tttr&dron 2 . Ind. 41. N.if&. I d . C. P a r t h ~ r a t h y . 417 (1981). j. J. E. K. 11.(fed. . Nayak. and Tandon. Agarwal. G:K and Dixit. 21 B113tt.D. 13 d (1981). TefmMm 34. V. Cinrral Council for Research in Ayuncda and Siddha. and Dha~an. Bull.L.S. Chnn.B. Chnn. Banaras Hindu University. U. J. Kakrani. K. Amdd. 22.CUC'CL:LIRD: A PROMlSlNG HYPOLlPlDAEMK AGENT 15. 1595 11973).L. Sukh Dev. . S. 2.S. C. 3. 166 (t973). Kakrani.L. S. 43..K. ] .\lrd.N.. V. Id.H. Sac. H.K. Sd Age 5 . Erp. E. and Sukh th. 41. 4. i .D. P P . Nayak. R. 221 (1981). M. fis. Biol.L.. Plcrnl M d P h ~ l o h . Kahrani.V.K. and Sukh Det. M. Pum-hothaman..V. Malhotra. I d J.51. Sukh Dcv.. and Pnsad.K. 27. uh 9 40. hblhotra. 13 (1987).. Bat. R. 23 Bms S.R.. Pmc.C. S.. i? ( 1980). 49. Taglc. S. Id. J. 44. Fitofcrapicr 54. Ind. Y. and Gupta.K. E. Dmgs 19. B. I d . Gupta. 143 (1977). Ranka.K.S.'Ind.S. N.A. Prasad. Bot 29.D. S. S.. 118 (1987). 356 (1971. 14 Setra.C. a d Sukh Dev. 24 h e . Sukh Dcv. 999 (1977). S. V. N.. S.C. C. f i s . Kapaor. Mehta.. Eiam.L and Pmad. S. J. 58.\'. Erp.K. S. V. I d . As=. and Cahn . Eng. d . 949 (1983). J. H. T. Clm.B.339 (1982).Vmc Lttt. and Hasan.18. Exp. 46. of Central Council For Research in A)UKC& & Siddha Sew Delhi. and Clardy. I . C h . h. Dm81 18. Ind.68 (1984). I d . 436 (1950).. and Mathur. S. 27.T e 43.G. \[. 52 Gupta. S. J. Patil. Sastry. . 1982. J.P. 5933 (1987).D.J.J. -Baldha. K. 23. EElluudof. U. Varanasi. Tcpathi.R. 14B. D.C and Sharma. C w .. and Ahq. V.R. I. R. O. B. G. B. on thrombotic phenomena associated ulth hyperlipaania (Snchabyapat). Asthana.. Rcr. . 36. 21 ( I S ) . 18 Raghunatharr. thais (Doctor dA>un-edic Xledicine). 55. 91 (1968). J. 5 (19i+). 29. 57 (1964)... J.P. K. Bajaj.P. Jlcd. R. 47. CCRiS . 394 32.P b % k u I 29.perirnental and di&cal studies on the dea d. Bhargab3. 38.802 (1970). 10 (1968).K. 52. Id. 31 Khanna. 58 (1981). 51. frpr Bid.L J.C. Rrr. Patil. K.Tripathi. Bid. 395 (1973). Y. and Satyatati. and Dhar. Tflrakdron 29..B. Rrs. 4623 2 (1981). 4..D. S K . e.K. Dennis. S. hlalhotra. 20 B1ll0. and S k Dm.1. Narl. Tt~rahdruuhtt.rc.X. S. and S u b Dm. dfzd. V. K. K and hlitra.9. 2 .. S.K. 12. Tttrakdron 28.Phamocd. 15. Bhari.. 30 Tnpathi. 9.C I d ..dcogum r c h d Cmmiphota d l Engl. .Nibanand. &fie.'. (1970).Gupta. 2.. Diy D. pp. hl. and A m . \bl.V. R.C. Shastri. and Kapoor.. Sci.

11 (cd. Keuti. Mrd.K. SS. S. Rishi. Pun. yol. N. Vijayal.N. Gupta.B.M.S. D. S. B.P.. 57th Anrrvol Meeting. hfot~ani. 61. S. Taori. Nityanand. S. 65.. Sci. J. Khan. 87. Bbl. 69. 335 (1980b. Lijr 4. Kuppurajan. PN. 23 (1982). 277 (I*). BJdwa. Etp. 22 (I-) 62. S. and Ahuja.15 (1975). Y t h c o p . SS. hf . I I (1975). J. J.. Ru.N. K. 123 (1971). and Nityanand. J. t&sis.K. Ranka. . and Wox.A. The effect ofguggul (ComnripAma mrPLul) on lipid profile a d -lation in ischemic hean disease. and Agarwid. N.I. 70. S. Seoul 1W. D. 66. S. thesis. A. S. Ph.). in ha mer. K.Stimulation of low density lipoprotein r e a p o r activin. Nityanand.P..N. and Rai. Washington. Upadhyaya.248 (1986)... I d . R. J. S. R. Nityanand. K. i3 85. J . P-P.K. and Kapoor. SA. and Lhvivedi.C. Asthana. 1131 (I*).r)O (1977). All India Institute of hfedical Sciences. Siha... Q6 (1986). a DC.. Rrs. I d . h1.. h-ivedi.K. h'cw Ddhi. P w . Singh. I d Mrd. 75. hI.P. J. Apr cu. Yalhotra. Haa. 1621 (1971)..K. h f a b k a . R and P&. Rj o& Mcd. O. G. J. Han.K. N. D. 1 1" Rmz&gs o II W l Om f a d ~CTC(YI CIildrol P h d n a d k p a h c s . J. Pachauri. Gupta. hI. f GK p. S. Slalhotra.C. Han. M. Apr Si&h 6.. AbsF j h rLrirm i? SJ. Rrr. Curi. 15 (1986). D. Rastogi). VS. Allvd Sci. 84. 10. 71. T.D.. P. S.Kuppurajan. S.P. 21. 1984. N. CSlR Centre for Biocbcmicah. Singtr. and Singh. B.. R. Rrr. Id. N. 67. 1974.58 Nityanmd. 1 76. J. 83 ( 1980). I d . Sn. Rajagopalan.N. In PIocudugs of&&& o b b g d ChrnpioLr f I d a .. J. 9-12 October I-. P.S. 64.S. D. 60. 53. 1 4 11 (1979). 1). Bfht. '~ri~athi. . M.S.. and Apmal. Shrma.S. S. 73. S. 34. I. Y. Sd 6. and Biiht.P. Harindth. 79. N.N.. p... Gupta.K. 80.K. S i h ..M. hI.R I d .rbrane ofguggul-sterone treated rats. A. 1 (Suppl. and Udupa.H. 84. B i d U. Nityanand. K.. Kotawan Rao. I d . M. 66.. 77. 1973. S. Prasad. Sracrl. and hlukherjee.b t a v a . I d M d hp H o m e . Astham O. In P m m d q s o FYI Asia and Ocrania Ca. OZ. C. Assoc. J. 81. S. 1. 63.. ICMR Bull. Sharma. K. Sonuni. Hasan. 86. AtpLicmr'Id 26. 10. D.P. A N .. 45.. Smdia on the rates of cholertad turnover in aperimentally induced hyperlipidaernia in rats. Kobiyal. Clinical studia w i t h guggdipid-a new hypolipidwrPic .nrss o f l h b i m l o g y . Rajagopalan. T w i N.C. 171 7hc Korean National Commission for UhFSCO and the Natural Product Ruearch Institute. p.hI.S. New Delhi. Kotiyal. PhI d 34.B. Saran. S. Mrd Ru. 367 (1978). Aguwal.N. S.S.K. V. Altd.. LD. A ~ S i a % a1. dluioll Sd. Das. Yoga Haorop.. i2.S.Kapoor. Ru.D. 1 (1973).N. Heart &s.R. bSi. T . 'Tripathi.P. Kotawara Rao... R. Malhotrr. M d 8.P. 83. A P . and Tripathi. and Sundanm. C. A. KatiyaI. 132 (1976). S. 664 August (1987). Jak. Jab. Asroc. J. 65.. KJL Clinicirm . Nityanand. f SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 220 . 59. J..P. Ph. S. Bddwa. Biol. bran. E. J.N. Sen.. Seoul National University. Chandigarh. and Ahuja. Gupta. 82. J.C.C. S. H. SR. Srivasta--a. Res. . j. Nagpur University. 78. Case history ofguggulipid-ahypdipidaanic agent. L. and Bisht. N.C. Res.. S. and Aganval. Gupta.D.P. and Sitaraman R J.1Corian a Mrdiriral Plunk a d Spiu. and Dwarakanath. M (I=).K. Cup.. W. and Jain.S. Ru. 504 Endocrine Society of India.C. 1981. 121 (1980). and Kapoor. Tripathi.P.. . Srivastava. B.P..the influence of hypolipkkmic agenu. and Sen. and Kapoor. Dhawan. Nagpur. I d M d la. 1 . i 3 (\%I).. J. Kana (ds. Gopal.S. J. and Kapoor. I d . 1 .S. Mrd hs. Xi. Ahuja. C B and Tpgi.S..S. Sinha. Pharmacological and clinical studia on the dfects of -a &l (guggulu) and dofibnte on certain aspccu of lipid metabolism.S.P.B.. S. Das. w 1 1 (1976). P.P. Singh. Ina! J.C. Singh. C. Res.

S. Shukla. I . Poona Uni\usity.bled. Gujral. and Sareen. Rhmaticn 4 141 (1969).N. P h o y l . Pun.4. and Nityanand S.. A. S and Tripathi.B. A and Chutturi.S. Satyanarayana D.K. expcimental animals. Phannarol.N. Tangri. 37. Sun. Sharmq R. Md. Lucknow .L. O.P. 249 (1984). 98. P.. Sharma. \ ' w a i . 245 (1985) 109. 0 1 1 1 Sinanand. e s et 4 89. M. Singh... R.. Sfisma. Lucknow Univenity.Rt-hrm 15. J. Ind. r mt nl u 1 u 13.hl. i 1 G u p t a 0 P. O.. K. R C . V. V 1983 114 Prasad.D.. S a w \ a t i . V.Upadhayay. K. G. M. P a d .N.N.. \e. Evaluatio~of C. Tripathi S . An assessment of the intermittent use of C o n n ~ . and Sharma. J. 19. 4. 157.N. and Chittom X1. J+id.C. R. Rcs.C. h f i .1982. and Gupta. 1980. 9. CDhY N w L f . s. 482 (1960). S. Kalyani. and hlanii.D. H. s I I CDRI Dossier on p g g P p i d .. B d a . Erp. 107.D. J Erp. 99 S~dhu. Iactnow. D N. K bC. R.K. K. Shanna.D. Ra. G. b . 16 (1976). 356 (1988). BanHindu University. 91. Upadhayay. Vama. Ph D.. 106 Amma M. Elfea o an indigenous m p d drug f PushLar guggulu on G A M P and biogmic arnina in ichaernic hearc d i s t s x in nne In R:ctrdings of thr I e a o a Snninur on Clinical P h a t w w ~ l 0 ~ .J ??rszoJ. 384 (1983). Med. A.K. 48. 90.D. and Dwiuedi.Vdt. Gupta. Bdd-a. I d ..D. Studies in terpena. p. B.N J. i 1 and Dhawan. S.. L. G V.K. O. M 84 * 1980). 93 T n p r h i . and Ratsor. hl. 32? (1988). Kakrani. R C .. h i s . Ranka.GUCGULIPID: A PROMlSlNC HYPOURDAEMK: AGENT 88. ~ a r a 6 nukul in the 221 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .. 87.. R u j a ~ h d J.S.. 96. Katl. S. S.D. n.N. Agarwal. S. Keerti. h1. B d . hl.an indigenous d r q i the f n & d e n of lipid metabolism (with special reference to atherosclerosis and abuisy). a new h>polipidaemic agent d eQ origin. Id. 5 (1980). Bid.K.D. Gujral. and Amma. 1021 (1978). R. q d J. B..B. 16. Tangri.. Clinical studies on guggulipid.D. I d J. T r i p t h i . 112 P&b. kl) 11..P.llhotra.D. 8.Drwloping Cmnfrits. hf.S. V. 115 Agarual. Sareen. thesis (Ayurvcda)..N. I (I 987). 992 (1979). Ph. Upadhyaya. M.. thesis (Biochemistry). K. 771 n. and Tripthi.. 6 (I%?).K. I d J .K. Rrr.. S. L. 103 Arom R. Sareen.l.D. &. Arya. 70. Asthana. nur&l (gum guggul) in o k i y .the stadrLI ' fracooa of Commifhra d u l . R. 9 ( 1984) 9. Santha Kumari.N.K. Ihandikar. Id.cd P J L and A c r ~ ~ b d i c London. J...V.L. A.Lftd. bl. Y. R t r I d h f d Y a p t .i986. thesis (hfedianc). 95.fd A~sor. 101. Arial Sn L/i. B. 108 Bagi.403 (1971).C.. and W A.. hi. BaHindu University. V. S. Rrr. Kapoor. Reddy... G..K. 60.. 1. Ph. Dani. R D . Gupta. Gupta. H. G. I d J. S. S. L u c t w ~ .P. S.L. 87. hi. Pune. Arnma.K.25.B.. F. M. 92. hlatcr. G u p a \ R and Tripathi. S. Taneja. and Sartxn. N.. McL. In h u d a g s of H'orld e r n r u e on C!m. r .. M d An 26. .... G u j d . Patiah..V. 1952.F w 56.. and Tripathi. S.. 1976. 367 (1979). Tnpachi. 104 Aror. In@.J.. IW..L. 105.f. Studies on the use o deoresin guggdu .A. K. Upadhyaya.N. S. . Id.S.. Dmi. 36 (1964) 102 Sana\ati.S. Planfa Mcd 37. Tokrance and hypolipidaemic acti\in d guggulipid . Raghunathan. Y B Studies on the &kt of Cannrijhom mtutul on thmoid function in mu a d . 267 (1960).I4 January 1986. and Cokhale.S. Is28 .S.mit). Y B J. S.P. 1973. P.P. Shtnna. tdKsi Fmjabi Uni\. G.K.929 119T2). 113 Tnpzthi.P 2nd Roy. J. hlater. Gulati. B. Sharma. S. Sd 1 . B.. and Prakash.K.N. S. S.K.

B . p. 1980.V. 5U. 119. in Sub Dev. 76 (Suppl. C h U m a h m m 5. e x d v e rlapiness. C . A. 129. thint. 1st FAR 1962. 1924. p.). of hypachdeatuolaemia and bypdipacmh - APPENDIX ENGLISH TRANSLATION OF THE SANSKRIT VERSE I FIG. v 128. Pharmacnlogy of medicid +nu md other natural p S & in C m l LMd in Prhnrrm~log~ I n h (1975-82) (cd. New Dw 1987. &MN. Mrd. and Tandon S.. cdn. Satyavati. 1986. Due to the sdtncs of the body-fat. 40-48. is determined by nw. The subject rffikrd by obesity exhibits a symptomatology which indudes brcathkssnus. F P ~ C1. hfotikl &narsi Das.).R. 3rd cdn. I'agbhata: Adangahridaya.. Viva Bandhu (Ed. the predominantly sweet-tzaing r which rcsanbia ae. Hoshiarpur. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 222 . Acad. New Delhi. Cowdl of hfedical Research. 1962. 16. as the case may be. G. p. India. Role ofguggulipid on hyperlipacmia:hlD (General hfedidne) M y Banrras H i u University. Gupta. Dk-xn). fetid body odour.C. 412.N. w circulata~throughoutt e.K. e 131.): C h i k i t u u t k a 26. 1980. Clta.V. Bhawpmkorh N i & n f ~ ~ . Dasgupta.C.V. A f b d a ( S d i . and Shah. fLs. N 1113 Obesity or wasting of the body. Ind. J . 131 (1986). Part IV. &d. Dhaum). The nourbbwnt r n . & s u hunger. 12 (1988). \-i Indian 11. Das and B. . G. 1919. Dhawan). London. G. V. mnjab. 125.V. Subbarayappa). hiotilal B a n d D s Varanasi. 1 16. 1% hfajumdar. A. P a d . p. New Dclhi. R. Indian x5md Science Aadcmy. ilfnikkol P W of la&. Das. ICAlK Bull. 121. C. Indian medicine in the h d i c period.t a s t i n g q p p is brmed-a&land rndsi which contribute to excessive corpulence (olirW/o). hFrom this s a t . (Ed. wheezing while a s l q &den catching of the breath. 40-45. Sm Delhi. Saxena.t q rf-S&uc in I& (ed. 45. Acdanic h Vol. 117. the dxse subject i rrndaaa -fit s h my kind of work . In C d Rruud on ~ e d t h d PI@& k I& (cd.~ I I ischaemic bevl dirca M D t h i s . VarariaG.M. Vihvahvaranand Ved~c Research Institute.hntra. 1975. Satyamti. z 1963. feeling of inertness of the limbs.C.N. heaviness of the t+ and idistinct speech. (Ayur~cda). Satyamti.K. p. 72. Clinical studies on medianal p u of India. In x p m o n of Shhhnsq u h bds a sdntary lire and is averse to physical cxmise. Charah Samahita (1000 B. t I . pp. 1st cdn. and hlishra.Banaras Hindu University. In C Rcsead on r\l~di~ilrol PI& in I d a (cd B .). NJ. Bose.icna Aadcmy. Sen and B.). Sri.K. 1%. 120.. Sadhu Ashram. 19i 1 127. P. D.N.. pp. Forskdin-an adenyhte cydue activating drug h m an e IPdirn herb. 1988. p. and Dhawan. S . 1984. IJ&D Xaoonal Sr.V.N. P. Aw..a&brd to dccphg in the daytime. 119 in Indian National Science Aradcmy. S P h a m a d o g a l studies on Indian m & i d plants. 11.. 1 (1982). boverindulges in foods that conduce to the production . A. 130. B. Ind. Nafl. Dwivcdi. I23 !haanti. V. 107. 216. SukY&saahi& (600 B. who overeats and is. G. D Swr. In EraMmu and dfrduiaal Bka. 156-159 (1941).R. h i d fSana-i 5th Dy Delhi. lpdhn National Science Academy. He suffers from diminished s a d r i v e . p. 1986. S. . In A Cadw H b .

obsenes Dalhana: 'the ploduction of amarasa does not arise . Cu. the predominantly sweet-tasting substances in circulation are con\erted to fat (medas). . however. and ch~nnels circulation by fat . etc. 1. thc suljecrs should br treated H II11 (Lrmulnt~ons u n ~ a i n i n ~ . In this sense. Dalhana in his commentary on the above. The formation of ama at the level of intestipal d~qestion. etc. ing Susruta's commentator. c among other drugs. is not the case in obese subjects. d ~ ~ a rot s n m o u s system (Vpfdhmu). Hncnnlnno.\ludga.in obese subjects whose agni is acute (dcepta). To say that obese uld sons \\.el) tvhich.. which alone accumulates in the body. The correct ~nterpretation (of Susruta's reference is this regardj is that it is dhatumgi I\ hlch is manda (dull) and. etc. is very low. Any diseace in them is apt to take a serious turn (ana cause mmplications) due to the ohstr*:.ama) and sllmnllng ur fat-rcn~o\ (Itthonn) therapies. Hence these subjects akvuld axold the aetidugical of Fncrors dcscribcd If the condition has already occurred. anal fistula ( / i h P J a d r a ) . .\ladhu. Elucidating the implications of the term 'sweet-tasting amarara'. C.. phenomena in this condition. The e the lifr-cxpcctancy.omutra. This results in the circulation of u metabolized substances (ama). which ma\ terminate in death. Tissues other than the adipose are. and they deteriorate. Jlonrcrka. therefore. it resembles the description of...a. Silajrtu. abscess ( l i d r d i ) . the digestion of food is as rapid and complete as tl~eirabsorption is quick. after formation and absorption. in consequence. L'ddaloka..hose digestion is 'acute' ptoduce ama ~ ~ ~ ointroduce an element of contradictior~as only an impairment of digestion can produce a m (at this le\.a). . . Tnphafu. In these cases.frven (jwara). SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .@. elimmates the possible 'gastrointestinal' contribution to obesity and focusses attention on the metabolic. does not occur in these cases.CUGGULIPiD: A PROMISING HYPOLIPIDAEMK AGENT and growth of tissrres other than the adipose tissue is i m p c d d due to the co\*cringl oxting of the cllannels of internal arculation by fat. the ~~r~rlnrrsa (chyle) not metabolized properly by dhatwagni.the covering/coating ( d ) of the pathways of circulation and metabolism (margalsrotac) by fat c medax).. lymph and nutrient pool. l . The A~urvedicdescription of the article4 of food that conduce to the production of shleshma suggests both proteins and Gts.su:r. In other words. as well as the resort to physical r x r r c i .lood plasma. not nourished and formed. h obese or cxcessivdy corpulant subject is susceptibk to such ~L-CS as diabetes mdlitur (pramha). and such food articles (pulz)a. thus c~dangeringthe b a k . a m is produced at the level of [Issue metabolism. Koruwb. ' l'. i h r a p .iun cJ the patb\. therefore. carbuncle (pidaLn). in these subjects.' 6 ' 1 he term 'rasa' has been defined as the fluid which is ever cir~uEtiiig-r&&&' the body like a rotating wheel transporting nutrients to and collecting waste products from the body tissues.

-SruhaYmeans oily /viscous substances. In the context of obuity. an index of uhic1. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 224 . The term 'aanrorcrro' refers to the chyle formed out of i m p i d digestion. both physical and mental. among other things. to factors concgrned with gastrointestinal digestion (jatharaagni). this. It comprises two aspects: ri. '.Tht tam a m refm. undigested or-partly digested.. h e ( V+ibalauiro&twam) and the inhibition of the olrrar of the disease ( V m p a &kaoib&tzuam). In the context of gastrointestinal digestion. Thc term 'crgnt' refers. is the capacity to do work. The tern 'bah' refers to: (a) body strength. immature. $ refers to factors concerned with the metabolism of nutrients. at the gastrointestihal level. and (b) rcsistana to disease li. antagonism to t virulence k bi t b c .khs' means fat/lipids. The term sweet-tasting amrara is reminiscent of the high sugar amtent of the blood as in hyperglycaemia. it refers to uneested or inoompietely digested food. both the aspms of bah are stated to be involved.&ancatw~'. to unripe.' and at the tissue k n l ( d k t uvogni). At the metabolic l e d .term refus to incompletely metabolized nutrients.

mainly on the entiinRam. pathogenesis and treatment of obesity and associated lipid disorders and their complications.plications.against matorylantlaru~ritic activity of the atherosclerosis at the fatty streak gumvasin. confirming these deals in an extraordinarily tucM and results.C. actually began when a strong analogy was discovered between the ancient concept of medomga of Sushruta (600B. Prior Carefully conducted studies in rabto this work. More recently.C. The Central Drug Research Guggulipid. in a tiny laboratory of the then cholegterolaemia (Sushruta SamCollepe of MedW Sciences of the htta. tbese pioneeri.0-15 GENE BANKS FOR MEDICINAL & AROMATIC PUNTS NEWS-ER Commiphora wightii Engl. 8anakq Hindu University (BHU) in the holy Indiancity of Vatanmi.). suBmitted to the BHU which number of experimental and clihical was inspired by a rather obscure studies were undertaken not only at stanza or ehbh ln Sanskrit In the BHU itself but also by different well knownAyurvedic treatise Sush.C. Followinng a doctorate thesis by Satyavati. (guggui gum) is available in the Indian market since 1988 as a potent hypolipidaemic agent.stage. - and utinz- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 225 . 718 chemicel and lowered the serum and tksue pharmacological studles w guggul cholesterolandplksphdiids levels were also thereforefoarssed. similar tion of the drug was first reporled in results were obtained. Among the therapeutic esting insights into the rich measures prescribed. The saga of guggul as a loboratory animals as well as in hypoliiidaemicagent was initiatedin patients of obesity and hyper1964. gum guggul howledge and wisdom of A y ~ ~ e d a vks selected for screening for its the ancient medical system of possible hypolipidaemic acthrity in India. Thls stmp hospitals in India. The hypolipidee* ac. gum guggul was Well bits by Satyavati (1966) demonsknown as an Ayuwedk drug of trated that on oral administfation.laboratories/medical colleges and Ntd WnMa(800 8. Inclinical studies also. The story. (Gum Guggul) scientific manner with the etiology.ng studies. till this but also protected the animals cholesterol-induced time. choice in the treatment of various gum guggul (water extract) not only types of aecltis. a large 1966.) and the modern concept of pathogenesis of The evolution of guggulgum resinas atherosclerosis and its fatal coma hypolipidagmk drug offers inter.). the drug has been intr6duced in Europe and a few other countries.amixtweof lipidsteroids isolated f m the oleogum w i n of Corn-m wghtli Engl. 600 B.

University. whereas collection continues untir'Wy-June.). Economic Aspects Guggul Gum of Apart from its medicinal and therapeutic uses. histochemistry and ultrastructure of the gum resin ducts of C. C. as an antidrug (Satyavati. the gum resin of C . A healthy mature tree (#w~ocourtesy :~ rJ. Tapping of the tree is ysually done from November to Januw. the. The main Indian commercial centres of guggul are the states of Rajasthan (mainly the The distribution. The gum is also used as a subqitvte for African Bdellium. rnukuf) HookerStedor.Numbers 3 & 4 6-15 GEBMAP Newsletter Instrade (CDRI). cultivation. wiQMii(indianBdellium) is a much branchedspiny shrub or a small tree 2-3m high. The gum is readyfor cd\ectbn 1-2 weeks ' a m the first incision. The microscopic features of the young stem. is used as a binding and disintegrating agent in tablets and also as a suspending and emulsifying agent. wightii have also been studied. 1975).R ahen) . Attempts are being made to determine the optimal method af tapping to obtain the maxlmum yield of the gugeul without adversely affecting the healthofthe plant by not onlv the CCRAS.S. m Tnmk lurced to MOW . Burseraceae. Commphon wightii piant /Photo Courtesv Dl Pharmacognosy of Guggul C. wightii(AKm. took up studies on gum guggul for drug development andfinally. rocky tracts of the states of Rajasthan. mature stem and leaf have been described. attempts are bBmQ made to produce guggul s t e m $ through In vitro approach at the M. h heterogenyty of gumveld in wd. healthyplantswhichare over 5 years of age are selected and an incision is made on the bark. gradrng of guggul in lndia have been extensively reviewed (Atal et al. Subsequent collection of the oleogum resin is ma* at inter- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 226 . Lucknow. but also the ~e~artment Environment and of ~ o k s t s d w ~ e \ h \ .Baroda. yields 250-5009 dry resin of guggu) in one collectina season. The plant can be propagated by vegetative means. ~ommi?ph~la. Bhand (syn. macroscopic characteristics of all the parts of the plant have been studied. view the . in 1988Jhe drug reachedthe market in the form of N i (mhltvre of two gugp gulsterones) hypolipkfemic 1991). Gujarat and Karnataka in lndia and in the states of Sind and Baluchistan in Pakistan. For tapping. Engl. A pale yellow aromati fluid that oozed out through the cuts on the bark slowly hardens to form the golden brown o reddish brown oteogum r resinof guggul. The Central Council f o ~ Research in Ayuweda and Siddha (CCRAS) has undertaken cultivation and propagation of the guggul gum plant n Rajasthan. grown plants. Pharmacognostically. The gum is also used widely as an incense and also as a fixative in perfumery. found in the arid. marketing as well as division). The development. tapping westem regibh) and Gujarat (Kutch and collection..

emmenagogue and aphrodisiac. Ethnomedical Uses of Guggul Externally. by Ayurvedic clinicians as a hypolipMemic/anti-atherosclerotic agent. Guggul resin is a complex mixture of various classes of chemical comditerpounds such as lignans. Another interesting fact is that major Ayurvedic treatises and lexiconsvery ernphatically stress that the therapeutic properties relating to fat disorders - 1 SELECT RESEARCH PAPERS ONI EVIDENCE BASED AYURVEDIC DRUGS 227 .guggulipid i lndia and a few other countries. physical qualities. and later at the Matti-ChemResearch Centre. written be. guggul is used for ulcers. systematic. No such inforMedical literature mation is available regarding its acThe Atharva Veda (one of the four tion on other conditions like arthritis.e. 1991). BheU) Or The wide therapeutic range of guggul and its indk+ions from healing of bone fracture to inflammation. Purie.wightir)mixed with other herbs is used-for skin diseases.. The gum resin is also used in the treatment of rheumatism. following the pioneering studies carried out at the BHU. detailed pharmacological. toxicological and clinical studies were undertaken by the CDR1. A large gul are available in the famous Ayur.The main aim of these chemical investigations was to isolate and chemically characterise compound(s) of the gum resin of C. arthritis as well as cardiovascular conditions. a viable separation scheme was evolved by the chemistry team headed by Dr. since the 1970's) that the drug is being used (Satyavati. conditions.tions are available commercially in tus (or Medical lexicons).) and Vagbhata (7th century lexicons and many of these preparaA. particularlywith been described. In Tibetan medicine. For this purpose. obesity and lipid disorders make it a unique drug in the Ayurvedic materia medica.number of such preparations with vedic Samhitas or treatises of guggul as the main ingredient are Charaka (1000 B. Pune in collaboration with the Pharmacology team of the Central Drug Research Institute(CDRI). and carefully planned chemical investigations were initiatedat the National Chemical Laboratory (NCL'). neurological disorders. In the lotion form.R. Ayurmedicinaland therapeutic properties vedic physicians have been using of guggul by devoting an entire stan. plant (C. a fresh sample of the drug is claimed Gum Guggul to have the opposite effect of inGuggul in Ancient Indian creasingbody weight. crude gum (photo c w r t e s ~ ~ J. Numbers 3 & 4 related disorders. however.0-15 GEBMAP Newsletter valsof approximately2 weeksduring. anaemia. obesity and Commiphonr wightii. penoids and steroids. tonsillitis. and skin and urinary disorders. holy scriptures of the Hindus) gives the earliest reference to the In clinical practice. mainly in the form of actions.C. laryngitis.D.gul.guggul extensively for centuries in za to the drug.lndia and neighbouring countries. As the other components of the ethylacetate extract appear to exert a significant synergistic effect with regard to the lipidlowering activity. gum guggulhasno action on unbqken skin but on the abraded skin an0 mucous membranes. 1975). It tweenthe 12and 14thcenturiesA. as a gargle it is used for dental care.D. Chemical Investigations of Guggul Gum With the discovery of the hypolipidaemic activity of the gum resin. on the contrary. Vadodara (India). lip~ds. The and hypolipidaemic activity of (Z)(E)-guggulsterones has been found to be quantitatively comparable to that of the total ethylacetate extract of the gum resin. Lucknow. oedema. ecbolic. on an ethyl-acetate extract standardized to pontain 40g of (Z). sore throat and related conditions. is said to have ping with ehtephon application has the opposite effects.compound preparations.guggulsterone per 1009 (on the basis of an estimation by means of high performance liquid chromatography). it acts as an astringent and antiseptic. uses and indicationsof gug. nasal catarrh. attributed to guggul pertain to 'old' samples of guggul. scrofula.) and also in thevarious Nighan. first at the NCL. etc. salivationand heavinessof the stomach. This standard extract Is the basis of the commercially available.C. (3-guggulsterone and (E)-guggulsterone (together constituting apgroximately 2% of the gum resin) hkve been found to be responsible for the hypolipaemic activity. Among these. phthisis. diaphoretic. Administered internally.respect to obesity and fat disorders. in spongy gums. is described as highly effective in Ethnomedical Aspects of reducing body weight and lipids. it acts as a carminative. antispasmodic. is only in recent years (i. Fresh gum gugthe tapping season (Atal et al. Lucknow. wightii responsible for the hypocholesterolaemiclhypolipaemic activity of the gum resin. This is said to im. An improved method of tap. Sushruta (600 mentioned in the Ayurvedic medical B. Detailed description the treatment of arthritis and related of the varieties. Sukh Dev. Fumes from burning guggul are recommended for hay fever. the . syphilis. antisuppuratie. bronchitis.). Thus. while an 'old' sampleof guggul prove yields by over 22 times.and (E).

H.V.)..In: Economic and Medkinal Plant Research. Studies of gum guggul fractions-on cholesterol biosynthes~s rats and kinetic studies with in 4-C'4 cholesterol in rats and human beings have attempted to work out the mecnanism of hvpolipidaemic action of gum guggul.V. ovaries and cervix of rats with a concomitant increase in the glycogen and sialic acid levels. F8m8WOrlh. A large number of compound preparations.) ' Maanam 15. Among its other pharmacologicalactivities potent antiinflammatory and antiarthritic effects of the oleogum resin has been reported against carragenaninduced rat paw oedema. p.60 Sukh Dev 1988. however. there are several important unresolved questions yet to be answered by modemscientists.dic Nighantus..V. Bot. DelM 1975.P. and Afw. C h a m Samhita (1000 B. A promising antifertility effect of the oleogum resin of guggul and its acid fraction is reported.158. It is hoped that application of appropriate biotechnological methods may come to the rescue of scientists to resolve this major bottleneck. Thesis (Doctw of AyurVarenasi.Ayuweoa and modem drug developmenl. Volume 5. 1991. The drug is used extensively in India for the treatment of all types of arthritis by Ayurvedic physicians. on the hypolipidaemic activity of gum guggul in animals as well as in human studies following the discovery of its hv~oli~idemictanti-atherisclerotic a&vi&.Numbers 3-& 4 . The other mechanisms suggested are thyroid stimulation. S. Ed : H. vadk Medicine). 1991). the dwindling supply of the gum resin from natural soums due to difficulty in cultivation and the need for a long waiting periodfor the collectionof the gum. In spite of nearly two decadesof researchon the drug.- . Guggul gum 1 an important ins gredient of most of the commercialy available Ayurvedic drugs prescribed for arthritis and related conditions. granuloma pouch as well as adjuvant arthritis. 29(3b. G. O. G. The saga of gum guggul as a hypolipidemic agent is unique in the history of research on herbal drugs as it is based on the remarkable insights of ancient A y u ~ e d i iexperts/scholars on the intricate metabolic aspects of a disease like atherosclerosis. Salyavati. he-most major setback to the success story of gum guggul is. Wyavati.-- G-15 GEBMAP Newsletter Pharmacological and Clinical Studies on Guggul Gum Several doctorate theses and nearly 100 researchpapers have been contributed so far. London. C. Clinical studies on gum guggul have also been carried out in patients of ischaemic heart disease and hemiplegia. Guggulipid:a promising hypolipidaemic agent hwn gum guggul (Cam rniphora wight@. Eco. SushNtasamhita (600 B.208. with guggul as the main inaredient are mentioned in medical leexicons or the ~9urve. i2. by research workers in different parts ot India. 0 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 228 . - -- -. as evidenced by reduction in the weight of the uterus. CMkHasmthana 28.40. but also by promoting rapid degradation and exertion of cholesterol. W a p r 6 N.R. includingits exact mechanismof action. 1963.G. Baneras Hlndu Unlvetany. Guptr.1075. Varanasi.1966. Plants and TRdC lied Medicine. Vaobhata : Astancrahridava 1st edn.K.1941.C. Proc InbanNatal Sa Acad 54a. An exhaustive review of these studies has been published recently (Satyavati. with resDect to hvpolipidemic/antiatheroscleroticactivity of gum guggul. M& Banarsi Das. ERect of an indlgem drug on disorders of lipid metabdhm wllh epecial reference to athetusdemk end obmW Wedofow). UItaitantra p. Ccnnnd@mm muW: Soum d guOOul h Indian system d medkine. It appears that guggul exerts its hypolipidemic action by not only inhibiting cholesterol biosynthesis. Satyavati Senior Deputy Director General Indian Council of M e d i i l Research New Delhi 110029 AM.C. Academic Press. 32 MotiU Banarsi Das.

.

Shukla (since Sept'86). It also constitutes a new drug delivery technique for conditions ltke anal fistula. New Delhi: G...M.N. ICMR Hqrs. Rajendra Singh.6 per cent of all surgical admissions. common condition prevalent all over the world. Radhakrishna..V. Shukla. It is conelodd8 that the long-term outcome with Kshaarasootra is better than with surgery. 3) Central Technical Co-ordinating Unit for ~ r a d i t i o n a l Medicine Research.R.S.I. ambulatory and safe alternative treatment for patients with fistula-in-ano. The median healing time was. (iv) Wardha: Department of Surgery. New Delhi Accepted February 2. All India lnstitute of Medical Sciences : M.K.A. Radhakrishna and D r G. Narang. D. based o n 150 patients in each series ' cent in the surgery series.. 1991 This paper reports the results of a multicentric.. J Mcd Res [B] 94.:.D. (I) Bombay : Department of Surgery. Nair. Mahatma Gandhi Institute of Medical Sciences: R. Rakesh Kurnar. Madras & Central Technical Co-ordinating Unit? ICMR.0. pp !77-185 Multicentric randomized controlled clinical trial of Kshaarasootra (Ayurvedic medicated thread) in the management of fistula-in-ano* I C M R Collaborating Centresf. Kshaarasootra thus offers an effective. Gupta. the healing time was least for subcutmeous fistula and highest in t h e case of high anal fistula. I) Collaborating Centres (According to alphabetical order of the city giving address of the Department. P. Nagral. its prevalence in a London hospital study1 was reported to be 10 per cent of all inpatients and 4 per cent of all new outpatients. however. Most of the *This . Dr R. Satyavati and A. Das. N. Sanjay Kapote. Complete healing was noted in all 265 patients in the Kshaarasootra series a n d all 237 patients in the surgery series. A retrospective study from India* reported anal fistula t o constitute 1. randomized controlled trial t o evaluate t h e emcacy of Kshaarasootra (Ayurvedic medicated thread) in the management of fistula-in-ano. Chandigarh. Medical Colle$e: R. R. - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 229 .V. Satyavati.03). although the initial healing tirne is longer. in comparison with conventional surgery. and the recurrence rates. A. Anand Kumari Sharma. fistula-inano leads to major physical. Tamby. significantly longer in the Kshaarasbotra series (8 wk) than in the surgery series (4 wk). Seth G. ~ o h i (till February 1990). Institute for Research in Medical Statistics. Mild anal incontinence was ohserved in 8 patients trestrd with Kshaarasootra and 13 patients treated with surgery. New Delhi a n d Wardha.I) Chandigarh: Department of Surgery.K. Dr S. N.I. Considered second to haemorrhoids in importance amongst all anorectal conditions.K. Ramesh Babu (since 1990) 2) Central Biostatislical Monitoring Unit. K. S. Bapat. Kapur (till Sept '86).K.i. Transient local hurnirig and increased discharge from the fistulo~rsopening were observed in rnost patients treated with Kshaararootrd. Post-graduate lnstitute of Medical Education & Research: Kuldip Singh (till March 1987). Ray. (. Girish i Pandey.T .K. S.layabal. a significant difference are 4 per cent in the Kshaarasootra series and 11 r (P.I) Delhi: Department of Surgery.~ -. R. In both t h e series. psychological arid social problems due t o the persistent discharge through the external opening'. Nair. Co-Investigator(s).. June 1991. Rajesh Nanda. This trial w u carried out a t Bombay. Though a benign condition. Madras: N.epon was prepared by a sub-comainittee comprising Dr N:K. Patients in both the series are being followed u p for onc year after the completion of treatment.V. Research staff o f the Collaborating Centres). (. Fistula-in-ano is an age old. Central Biostatistical Monitoring Unitz. Sh.G.Prakash. Ashok Hande. Principal Investigator. Katariya (since April 1987).G. Vinay Mishra. P. Narang. .G. G.

which is oflcn painful. Deshpande till 1987 and SELECT RESEARCH PAPERS C?.7 to 26. New Delhi. using specially devised uniform protocol and proformae. on (I) ihe healing of the fistulous trackand (ii) recurrence of fistula.experts and also the scientists of CBMU and CTCU. of a specially prcpared medicated thread coi~tedwith herbal drugs. Material & Methods The study was conducted as a prospective. and rendered alkaline. in comparison with .I MEI) KES [R]. designed with the assistance of a Task Force comprising experts in surgery/ proctology. non-operative Ayurvedic technique known as Kshaarasootra in the treatment of fistula-in-ano.. randomized multicentric clinical trial at 4 centres viz. The method described by the ancient Indian surgeon SushrutaR in his falnous treatise.): Chikitsasthanam: Chapter 17: Shlokas 29-33.' from the lpstitutc of Medical Sciences. Madras.the efficacy of Kshaarasootra (the Ayurvedic medicated thread). This y procedure requires hospi1alis:rtion and regular post-operative drcssinp. The d a t a were reviewed and discussed annually (or more frequently.r in the rnanagernellt of fistula-inano was identified as one of the thrust areas >elected. I Surgical treatment dcmands familiarity of the \urgeon with thc anatomy of the anoiectal region . Varanasi. pre-coded prol'ormae of each patient at monthly intervals t o the Central Biostatistical Monitoring Unit (CBMU) located at the Institute for Research in Medical Statistics. which verified.ion with the Central Technical Co-ordinating Unit (CTCU) for Traditional Medicine Research at the I C M R Headquarters. with it rlcw disease-oriented approach and the role of Kshaitci. the data were also reviewed by tile l C M R Scientific Advisory Group on Traditional Medicine Research. P. of Shalya & Shalakya. the Indian Council of Medical Research. Wardha and Bombay. I . All the participating centres were required to 'send regularly. New Delhi.the chances of recurrence (0. Banaras Hindu . Regular ~nonitoringwas done by the CBMU. through their pioneering work.soorr-.tkes from a few weeks to ~nonthh. into the fistulous track..shiracjsoo/r. J U N E 1991 fistulae de\relop after rupture inadcquate drainage of pyogenic anorectal abscesses which dcvelop secondary to infection of the cryptic gland' .C. through a special Manufacturing Unit set u p for this purpose (under the supervision'of Prof.Sushruta Samhrta (600B. surgery.' EVXDENCE BASED AYURVEDIC DRUGS 230 . Anually. computerized and al~alysed the data.5%) and incidence of anal incontincricc (5 to 40%)) being rather highs. biostatistics and also reputed Ayurvedic experts.1) involves insertion. Essentially. in collaborat.. when required) through meetings of Principal-Investigalors. Preparation and supply o f Kshaarasootra : The Kshaarasootr'a (medicated threads) were prepared according t o the method standardized a t the Dept. lnstitute of MediCal Sciences. t r ~ t l also with the pathogenesis ol' fislula-in-ano. introduced an alternative. New Delhi. Original Referencexon Kshaarasootra in. In 1984. after complete healing. !)eshpande and Sharman. revived its research on selectcd thrust areas of traditional medicine.J. I t was decided to evaluate the efficacy of K. clinical pharmacology. Task Force members/. Fig.Fig.University ( B H U ) .I \ l > l A S . through rnulticentric clinical trials. ('omplcte healing t. Chandigarh. the trial aimed to evaluate .illow healing O secotidary intention.C. I hc tl-c:~tmcnt usually comprises laying open or completely excising the fistulous track and then .r in comlxtrison with conventional surgical treatment. Val'anasi (India). Sushruta Sarnhira (600 B. the filled-ill.

Specially dehigned.isr)olr.tr~icipating ecntrc. after the coii~pletionof treatment. (it) repolt once a week for change of thread (Kshaarasoorra): and (iir) rcport once i n two moiithi lor one year for follow up. the patients found eligihlc l o r the ccmtrollcd study were randomly allocated. 20) with the fresh latex of $nuhi o r Euphorbia neriifolia (a cactus plant) a d a spekially prepared alkaline powder (known as kshaara) from the plant Achy-anthes aspera (Apaamyga) and turmeric powder from the dried rhizomes of Curcuma longs (turmeric. while the length was abopt 25 cm (Fig.!lion 01' Ksh. Whcrmcr thi\ was not possible.~. t r r ~ ~ ) l r i ~ (Ayur\. cclrdiova\cular disease. I h c p H ol the Kshaarasootra was ensured to he ahot~t c) 75.edicmedicated thread) ready for . 2 . before being sent to the CTCII. The thread is manually coated first with bhe latex ol' E. along w ~ t l ithose pai:ents (in each centre) who.tsc~otr. Chandigarh.:ct. K \ l ~ . i n sealed tubes. renal disease and cellulitis adlitcent to the dnorectal area were excluded from tlic randomrzed controlled study.~r:i\oorra (Data not included in this paper). and also the Departsic111 o l Pharmaceutical Scie~i~s:~.CLINICAL TR(ALS ON KASHAARASOOTHA IN ANAL FISTULA later with Prof. t Fig. d I he processing o f the thrhad is done inside a specially designed cabinet for drying the threads. and placed i n a polythene bag. Patients with diabetes. L e u Delhi. within each centre. followed by seven coatings of the latex and the ash (Kshaar?) of A. Fig. i . patienth attending the surgical proctolcrgical 0E'l)s were subjected to detailed clinicc~lexitmination and -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 231 . however. treated with Kshaarasootra and lollowed up under the 'non-randomized group'. Each batch of KshaBrasootra prepared ua\ subjected to qualify control. either the Pr~ncipal 'Investigator (PI) or the Research Officer appointed i n the project was trained in thc applicittion ol Kshaarasootra by @rnf. 2). Bcfoic the clinical trials started. an Ayurvedic expert well-versed In tho application of the k ~.~pplic. tensile strength and other physico-chcnircal paranieters dt the Central Drug Research Institute (CDRI). which is translcrred to a glass tube containing silica get a3 the dcss~citnt. Pathak as the officer-incharge). on refused surgery or ins~sted being treated with Ksh:r. i n tcrnis of pH. Lucknow.Panjab Udi\ crsit! . ~ r .~pplic:~tion. only the k l l o ~ i n g were considered eligible for inclusion in the randomized clinical trial: Patients with evidence of anal fistula and willing to ( I ) be hospitaltsed for 2 t o 6 wk to undergo surgery. the method o f preparing the Kshaarasootras is as follows:The Kshaarasootra was prepared by smearing a surgical linen thread (guage no. and dried.i. The CTCU supplied Ilic threads as Gel1 as the clinical trial proformac periodically to the Principal Investigators. After obtaining informed consent.. three coatiiigs o l thr latex and turmcric powder are given alrcriintivcl).I: the surgical OPI) o f tlic participating centre\). to Kshoiir~isootra or surgery groups by sealed Patients : At each p. Haridra).N. Briefly.aspera allernari\cl>. i t \ a co-invcstigatoi.3.tr. malleable probes for . S. Deshpande (cither at Varanasi itself or . The'se patients uric. -1 he thread thus prepared is sterilised hy cxposing'to ultra \iolci radiation for 15 tilin in the samc cahinei. before sealing the tube. I n thc final ' phase.nerii/oliir elevon limes.raar.l tcclin~quewa\ associated with the pru.

the complete fistulous track along with adjacent tissue was excised as a wedge and the raw area was packed. Mahatma Gandhi Institute of Medical Sciences. recurrence is deiined as leappearancc of the fistula at the same site or at different site. Using the probe as a guide. d l the patients were asked to report once in two months for a period of one year for physical examinatiqn for any complications (including recurrence). The time required for t k w o u n d to heal completely was recorded for each patient. Results Condition of patients on admission : In both the Kshaarasootra and surgery series. nearly 90 per cent were males and nearly 50 per cent aged under 30 yr while approximately 40 per cent were aged 3 0 4 yr. Wardha (77 patients). and the Seth G. A malleable probe was passed through the track till it came out at the internal opening. the patient was advised regular aseptic dressing with loose packingito allow the wound to heal from the apex. Post-operatively. For the nl*rpose of this study. viz. Probing of the f ~ ~ t u l o utrack preparatory to s application of Kshaarasootra. The pooled results from the 4 centres. within a period ~f 12 months.4(8). Bombay (73 patients). New Delhi (167 patients). based on 265 patients randomized to Ksharirasootra treatment and 237 to surgery arc presented here (Data of non-randomized series of patients treated with Kshaarasootra are not present4 in this communication). All India Institute of Medical Sciences.. JUNE 1991 in the subcutaneous and low anal types of fistulae and excision of the track below the anorectal ring along with curetting of the upper track. Postgraduate Institute of Medical Education and Research. Medical College and KEM Hospital. in case of high anal fistulae. Chandigarh (185 patients).INDIAN J MED RES [B]. (b) Change of Ksharrrasootra by the railroad technique. Patients from the New Dclhi Centre consti- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 232 . After' 'healing by either of the treatmew schedules.S. The randomized controlled trial comprised 502 patients of fitula-in-ano (between October 1984 and September 1990) drawn from four centres Fig.

and about a fourth of the patients in each series had previous anal surgery: The type of fistula was subcutaneous in 29 per cent of the K series and 26 per cent of the S series. The twp series were also similar with respect to . low anal in 56 and 61 per cent.C L I N I C A L T R I A L S O N KASHAARASOQTRA IN A N A L F I S T U L A tuted 38 per cent of the Kshayarootra (K) series and 28 per cent of the Surgery (S) series.0 61 2.0 1 ). are summarised in Table I. The characteristics of anal fistula.. the corresponding proportions being 36 and 38 per cent at Chandigarh. the proportions became fairly similar.0 77 5. 92 and 98 per cent respectively. By 40 wk.5 and 8 0 wk respectively.0 wk In subcutaneou. a\ compared ta 89 per cent in the S series (Table 11) -a significant difference (P<0.m a 1 ring. Subcutaneous Low anal High anal 29 56 I5 Depth of fistula (em) : Shape offutula : Radial Curved Straight Others* K S Dist8noc from a n d margin (cm) : <3 5 5 3-4 Location ofthe tiituloous opening : Towards rectum Towards anal canal Others** 63 29 8 70 26 4 75 17 Total number ofpatients 77 18 5 265 237 4. Surgery SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 233 . However. horse-shoe. in the Kshaarasootra series. 4.ow neous K S K anal H ~ g h anal S - Tmblc I.0 wk In low anal type and 15.0.0 80 ** Bilateral. In both the series. o n admission. 14 and 16 per cent at Wardha and 12 and 17 per cent at Bombay. in all respects. 8.01). Thus. Speed o f healing o f the fistulous track : Healing took place in all 265 patients subjected to Kshaarasootra and also in all 237 patients subjected to Surgery. Thus.1. Kshaarasootra: S. In short. K.e. the median heal~ngtime was 5.c type. and high anal in IS and I4 per cent. ~ o m b i ~ t i o f shapes eic.0 144 4..Characteristics of the anal fistula on admisslop Characteristic Percentage of patielits Kshaarasootra (n = 265) Duration ofdzscase(yr). the proportion with healing by 12 wk was 68 per cent in the K series.0 32' 8 Medlan healing time(wk) 8. the speed of heal~ngvaried appreciably with the type of anal fistula (P<0. i. 61 'r14 Type of fistula : . The median healing time was 8. respectively.other characteristics such as the depth ajld shape - of the fistula.5 39 15. viz. n Towards a n o .0 wk in Kshaarasootra series and 4.0 149 8. i k h i a l tuberosity etc.0 wk In hlgh anal type of fistula.01). 2. Suigery (n = 237) <I 1-2 23 49 33 17 56 21 23 26. The corresponding f~guresIn the Surgery series also showed a slrn~lartrend but were consrsrently lower. the healing was relatively slow in patients treated with Kshaarasootra. distance from the anal rnargin and the location of the fistulous opening. Nearly 50 per cent of patients in the K series and 44 per cent in S series had the disease for a t least one year. The difference in median heding t ~ m e between the Kshaarasootra series and the Table 11: Speed of healing or anal fistula in Kshaar:rsootra and Surgery series T~me Percentage of pallents w ~ t h heal~ng All Types K S Subcuta.0 wk in the Surgery series (P< 0. the Kshaarasootra patients and the Surgery patients were broadly similar on admission to the clinical trial.

83 are currently still under follow-up.cent. Increased discharge from the fistulous opening was observed in the first few days in most of the patients. anal incontinence. most of the patients were males the proportion ol male : female being 9:1.5 wk in low anal type and 7. tlict-c was an appreciable and significant diflkrcncc ( I ' = 0. mostly of mild type.t-cncc heing 6 and 3 per cent in those with. This lasted usually for a few minutes. the healing. as compared to l l pet. iespectively: ---- Table 111.0 wk in high anal type.torasootra o r surgery. ~ ~ .o~ anal . Thus the proportions with healing by 12 wk were 68 and 89 per cent. In other studies on surgical treatment of anal fistula. incidence of various types of fistulae also corresponded with those reported by o t h e r ~ " ~ ~ .tstrotr.0. 131 I1 14 11 208) ' 47 IOX 3 1 h 34 108 142 8 8 24 7 11 ? 4 IS5 f 16 i-~gure\ p ~ r e n ~ h c w v In dcnolc 111. Recu~rence rates of anal fisntla in Kshaarmootra and Surgery xrles f shaarasootra Surgery Pat~cntsPatients with Patients Patients with followed recurrence followed tccurrcncc No. rate was sloucr with Kshaarasootra. anal incontinence was observed in eight patients (5%) treated with Kshaarasootra and this was mostly of mild type (1.~blc I l l ) ..l ' .11 the than 20 patlents percentage is based on Ie5s Discussion Fistula-in-ano is known to be predominantly a disease of men and of middle agev. JUNE 1991 Surgery series. four of whom recovered sphincter control Recurrent perianal abscess and tncomplete rectal prolapse were observed in five and two patlents rcspecttvely Recurrence . During one year follow-up. incontinence to flatus or occasio.3 to 5. cent of 142 in the Surgery series(-l . In the present study also. but became 92 and 98 SELECT P3SEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . occurred in 13 patients (9%).INDIAN J MED RES [B]. With sutptcal treatment. of tracks : S~nglc Multiple Done Nor dolie l oral 139 Ih 4 (01 .ttistically significant (1'. Among these 297 pattents. A history of' previous anal surgei. On the other Iiatid. Among the 502 patients who completed treatment. Subcotaneous' 1.t series. as compared to 7: 1 and 12:l in other Indian s t u d i e ~ ~ . The age distribution of patients of fistula was also The similar to that reported by. the proportions wit17 t. the proportions bring 24 atid 7 pet. as compared to surgcry. With Side-effects and complications : Kshaarasootra treatment. per cent in 155 pattents treated with Kshaarasootra. Recurrent perianal abscesses were seen in ftve patlents and incomplete prolapse of rectum in two patlents. while the remaining 297 completed one yeat follow-up. Healing occurred in all the patients treated with either Ksh.t. almost all the patients complained of local burning sensation especially after the ftrst insertion. In the present study. single track being found in 9 0 per cent and low anal fistula in 59 per cent in the present series.0 wk in subcutaneous type.2). recurrence rate was 4. No $ Tvpe oflistuta . 3. requiring the use of a pad. 122 faded to attend regularly for follow-up. 0.~ally to liquid faeces) and six of them recovered sphincter control.6 per cent patlent\ failed to heal following \urgeryl' I' I h and most ol the patients who failed high anal fistula or associated to heal had e ~ t h e r anorectal discitself*. The recuricticc rate was not inl'lucnccd by the type of I'ihtula in either scrich (1-able I l l ) .02).tr-. and u'ithcut previous surgery ( P > 0. in the patients subjected to surgcr!.idl. and was rarely of a severe nature requiring medication. No. 'lhis difference of 7 per cent was st. the fistula in three ol 200 patients failed to heal. During the follow-up. % No.\lr.03). In the earlier study of Deshpande a?d Sharmae. other$". High anal 32 95 28 3 1 9 1 2 h 0 7 25 91 26 1 13 2 4 14 8 No. being 3.e.! did not seem to affect the recurrence rate in K. all the patients had post-opetattve pain lasting for a few days i n d requiring analgesics. varied with the type of fistula.

rrirsnotra treatment does not require I~Ospitalisation. and consequently. High risk of postoperative incontinence to be associated with high anal and complicated fistulae may be like surgical trauma to the attributed' to f a c t ~ r s anal sphincters.tsootr.onger. Mild anal incontinence was observed in patients treated with Kshaarasootra as also in those treated surgically. Deshpande and Sharma7 did not encounter anal incontinence in their series of 50 patients of high anal fistula.7 to 26.tr. which. during follow-up. A wide variation in healing time following \urgcry has been reported.INICA1. the recurrence rate of 4 per cent cited by them has an upper 95 per cent limit that is as high as 13 per cent. .5 wk for low anal and 8.0 wk for subcutaneous.k.t. Recent advances in surgical techniques and the advent of anal manometry have also led to a reduced rate of recurrence with surgeryI7. it is concluded that the long-term outcome (in terms of recurrence and anal incontinence) is better with Kshaarasootra than with surgery. their study did not have a surgery group as control. The median healing time was 8 wk for Kshaarasootra.tling rate of 74 per cent is reported" in uncomplicated fistula. even though the initial healing may take l. as compared 10 I I per cent in the surgery group and this rate was not affected by the type of fistula. Moreover.l0. TR'IALS ON KASHAARASOOTRA IN ANAL FISTULA per cent by 40 wk. 4. A lower incidence (3%) of anal incontinence has been reported with the recent use of mucosal advancement technique" following fistulectomy.l8.t. within 12 wk of surgery. as also observed in 9 of the 13 patients in our series.0 wk for high anal I'i\tula. through its herbal ~ngredient\. Ileshpande and Sharma" reported a recurrence rate of 2 per cent with Kshaarasootra. K~11. as was also tlemonstrated earlier hy I>cshpande and Sharrnah. the incontinence was transient and perhaps related to the stage of 'cutting through' the anal sphincters by the thread. Following surgical excision.Cl. (as compared to 8% in our series). O n the other hand. randomized clinical trial. 5 to 40 per cent incidence of anal incontinence has been reported.~and maximum for high anal f~stitla. and the presence of the thread did not bother them. Previous nnal burgery.Ilcshpande and Sharmah have reported that 92 pel. A 1ic. either concurrent or historic. but their series was small (56 patients). sensory nerve damage and. slow and gradual cutting with simultaneous healing and also complete destruction of the cryptic gland by the caustic action of the thread. the median healing time lollowing surgery. This could be due to a slow cauterisation .I4.5 per cent. however. High anal fistulae have been reporpd to be associated with higher Incidence of recurrence3.I<ccutrence rate over one year follow up was 4 pcr cent in the Kshaarasootra group. High recurrence after surgery i s mainly due to ~ncomplete laying openlexcision of track and laster union of skin e d p s .l2.subsequently led t o complete recovery.r.tt.The mcdiitn healing time was least for ~rhcut. though this was not observed in the present multicentric study. days'. In the Kshaarasootra series. Misra and Kapurlo recently reported favourable results with a technique involving the passing of a multistrand braided stainless steel wire through the fistulous track. the mean duration of absence Irom work in surgically treated patients has been I cported to be 49 days'. mostly of the mild type3. most of the recurrences (7742%) being reported within one year'. In the present study. In most cases. from 4 to 26 wk in low itnal l'ixtula ancl 8 to 52 wk in high anal fistulat.whereas the average hospital stay following surgery varies from 3 to 16. excessive loss of anal skin. Surgical treatment of anal fistula is known' to have a recurrence rate ranging from 0. adversely affected the recurrence rate in surgically treated patients but not in those treated with Kshaarasootra. On the basis of the results of this multicentric.pf the track by Ksh.5. Patients treated with Krhaarasootra could continue with their normal routine work. was 2. as compared to 4 wk with surgery. the damage is permanent. Similar results with respect to healing and recurrence were obtained with Kshaarasootra treatment in another series of 269 patients who were ineligible for the randomized control study (including those who refused SELECT RESEARCH PAPERS Oh' EVIDENCE BASED AYURVEDIC DRUGS 235 .~ncous fistul. ccnt of 200 patients healed within 12 \r. Low recurrence of listula treated with Kshilarasootra has been attributed by Deshpande and Sharma' to better drainage.

& Shalakya. This advantage of Kshaarasootra has also been emphasized by others6. Banaras H~ndu University. two others i. Institute of Medical Sciences. Subsequent t o his demise. Patients are ambulatory throughout the period of treatment and do not need regular dressings. Kshaarasootra can be more cost-effective than surgery and therefore. have not been given here. Pathak of the same Institute. Varanasi(India). neriifoIia is well known in Ayurveda2O for its wound vealing property (applicable in different types of sinuses and fistulae). Kshaarasootra technique offers an effective.J.19. who introduced Kshaarasootra to the scientific world and who was closely associated w~thtlic multicentric clinical trials reported here till his untimely. it appears that the combination of the three herbal ingredients. 1985). Deshpandepersopal communication. Among the three ingredients of the thread. The method is also more acceptable than surgery to most patients as it avoids any invasive (surgical) intervention.N. JUNE 1991 surgery).lNDlAN J MED RES [B]. The SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 236 . and ( 6 ) Standardization & Quality Control of Traditional Remedies/Natural Products at Panjab University. more suitable for developing countries with limited resources and facilities for inpatient services. Deshpande considered that the technique served to achieve what he termed as 'chemical' fistulectomy. No systemic side effects were encountered with Kshaarasootra. till 1987. The consolidated results of all patients treated with Kshaarasootra (randomized and non-randomized series) with follow-up data will be communicated separately. These local effects can be attributed to the caustic nature of the latex and the ash (Kshaara) used in the thread.. Curcuma longa or turmeric powder is used as the last coating on the thread to aid in (I) minimizing the severe local reaction due to the caustic action of the other twr herbal ingredients.d. whereas Achyranthes aspera Kshaara (ash) is considered necessary for ensuring the alkaline (Kshaara) medium. without which the thread is not at ail effective. Prof. 1985) Anti-inflammatory2'.J. Curcuma longa and its active constituent curcumin. ambulatory and safe.drath in August 1987. Despitdhese. anti-bacterial22 and anti-leprosy23 actions of Achyranthes aspera have beep reported and there are a number of reports or. to Deshpande. and also (il) for its known anti-inflammatory and anti-infective efficacy (P. Department of Shalya. to demonsirate anti-inflarnmaf~ry~'-~~ antiand bacteria128activities. The results of these studies will be reported separately. Another advantage of the technique is that poor risk patients for anaesthesia and surgery can also be subjected to Kshaarasootra treatment safely. the latex of E. in contrast to the 'physical' fistulectomy achieved by surgery (P. Studies are also under way to determine variation in clinical efficacy and physico-chemical charactetistics of different batches of thread manufactured under strict quality control. Recently. The mechanism of action of Kshaarasootra in healipg the fistulous track has not yet been clearly elucidated. although transient local effects like slight burning and discomfort were observed.J Deshpande . even at the Primary Health Centre level. Deshpande also prepared several batches of Kshaarasootra uscd in this clinical trial. As no hospitalisation is required. through the medium of the thread achieves the desired results. Research Assistant). The data of this series which invoked. Chandigarh. formerly Head. Kshaarasootra technique can be used in the outpatient department under local anaesthesia.personal communication. at Goa and Manipal. apart'from local burning sensation and increased discharge. took over the manufacturing of the Kshaarasootra (with the help of Sh. Useful slrggestions given throughout the period of the study by members of the Task Force on Anal Fistula 'and experts of the ICMR Scientific Advisory Group on Traditional Medicine Research are acknowledged. Acknowledgment This report is ded~cated the memory of the late Prof. In-depth chemical studies on the finished thread as well as the individual ingredients of Kshaarasootra (including quality control and standardization) are in progress jointly at the ICMR Advanced Centres on ( a ) Pharmacological Research on Selected Traditional Remedies at the CDRI. most appropriate for healing the fistulous track. In the case of Kshaarasootra. in addition to the 4 centres.P. Satya Ram.b. the resulk of preliminary chemical analysis of the thread used in Kshaarasootra have been reported29. alternative treatment for patients with anal fistula. Lucknow. Disadvantages of KshaarAsootra include the necessity for weekly l~ospital visits for changing the thread. The' technique 01 Kshaarasootra therefore constitutes not only a unique drug formulation but also a novel method of drug delivery. Dr S.

Br J Surg 75 (1988) 1093.. B. J.P. and Kapur. N. The assistance of Prof. Chandigarh 1 Sh. Medicinal plants ol' India. Dis Colon Rectlim 14 (1971) 134. 18. J Pharrn Pharmacol25 ( 1973) 447. Parks. 26. Results of treatment d fis!uta-inago.K. J Sci Res PI Mcd 4 (1983) 4. M. rectum and cokm. 24.V. 5. Successful nonopera- 21. Anal fistula in India. A new nonoperative approach to fistula-in-ano. 29. K. P. Sushruta samhita: Chikitsasthanam: Chapter 17: Shlokas 29-33. Acta Chir Scand 383 [Suppl] (1968) 1. C Lahiri.N. Sharma. 8. 5th ed. Hardy. and Srimal. IS. S .D.a study of 1000 patients. R. S. Raghavaiah. K. Br J Surg 63 ( 1976) I. A. Satyabati... A classification of fistula-in-ano. and Holmstrom. in standardization of threads used in the clinical trials.K. Am J Procrol(1976) 39.432. 17.G..(i. Reprint requests: Dr S. Surg (iynaecol Obstet IS3 (198 1) 73 1. Dhawan. 1). review and follow up of 200 cases. 5th ed. Hattori. Khare. 4th ed.N. B. Collste.Suppl( 1982) 27. Dis Colon Rectum 32 (1989) 588.. 27.K. Rastogi. 1. R. U.P.K. deserve special ntion. P.P.V. and i t \ constituent achyranthine. Raina and M. New Delhi) 1984 p 131. D i m t o r . New Delhi) 1976 p 13.B. M. Sainio. Vasilcvsky. Ewerth. and Stewart. IT. R. Fistula-in-ano a 6 year follow up study of 143 operated patients. Acta Chir Scand[Suppl] 482. R. Dravyaguna vignan.J. I. P.ucknow (India).S. Treatment of fistulain-ano by a new technique. G. Anal fistula .I Med Rrs 64 ( 1976) 854. Calcutta: 16. S. I. Pescatori.K.V. Sarin. I.C. In vitro anti-microbiol emciency of scrmc csscntiul oil%: Indian . Plasencia.. C. 22. Analysis of a thread used in the Kshaarasootra trcatmcnt in the Ayurvedic medicinal system.F. P. Lucknow: Prof. M.1col29 (1990) 199. Dis Colon Rectum 26 (1985) 496. Feror Hasan and Sharma. Sethi.V. W. 9.V:P. Pathak. Trop Doct 16 (1986) 44.s Colon R e a m 10 ( 1967) 42 1. Dhawan. Zutrhi. Hartman. J. Eds (Indian National Science Academy. P. Pharmacology of diferuloyl methane (Curcumin). P. C.M. Ahlberg.J. Radhakrishna. live treatment of high rectal fistula. 28. J.N. Wolffers. 12. and Namha. H.C.M. 7 . Anastasia. Xeogi. D. I. 6.. Institute lor Re\earch 1n Mcdic. Gordon. (Baillier indall. Anal manometry improves the outcome of surgery fur fistula-in-ano.G. and Ritchie. is acknowledged. Acta Chir Scand 151 (1985) 169. blanda. Madras 600031 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 237 . (Motilal Banarasi Das. Sharma.A.inn. vol. Pilapitiya. Maria.K. Lucknow. lnvestigltion of human fetal anal ducts and intermuscular glands and a clinical study of I50 patients.R. and Solanke. Goligher. and Sharma. N. G. Basu. N. London) 1984 p 181. J. G. In : C'urrent research in pharmacology in India (1975-82). Adams.C. K. 2. ChNput. in particular. and Husa. Khanduri. Hill.1 1978) 53.N. A. Ciewali. Fistula in ano -clinical features and long term results of surgery in 199 adults.. Dis Colon Rectum 2g (1985) 225. Joshi.R. G. Br JSurg 64 (1977) 84.S. 7. M. P. J Ethnopharrn. 13. Anal fistulas at St Marks hospital. Varanasi. Varawsi) I978 p .. 23.G. G. P. and Bokadia. Ani. and Dhawan:B. 14. (Chowkhambha Sanskrit Sansthan. Antiinflammatory drugs from the plantr. Lilius. T. and Sri~astava. 10.C.. CDRI. Spurtirnk Kwd. L>as and B. and Rinallo.K. S. Ma7ier. Chandigarh I Prof. Rtlerences Marks. and Dhawan. Mucoral advancement in the treatment of anal fistula. Fistula-in-ano. Hiological invertigation of Achyranrht'h aspera [. J . P. Aguilar.J. Pharmacology of medicinal plants and other natural p~oductr. B. 25. 19.R.C. and Hardcastle. Ikodhar. Srimal. G. Deshpanie. Int Surg 61 (1976) 243. R. W.a review of 82 cases.K.. Research on medicinal plants at the CDRI.C. I I.L.F. A m J Proctol24 (1973) 49. L. I'.S. T... 20. Fistulas and fistulous abscesses in the anorectal region: Personal experience in management.. M. A. and Kavalcik. Dis Colon Rectum 14 (1971) 51. and Sharma. J.R.CLINICAL TRIALS ON KASHAARASOOTRA IN ANAL FISTULA tinuing interest and advice of Prof. Preliminary study on the anti-rheumatic activity of curcumin (diferUloyl methane). A.D. M. Deshpande. a non-steroidal antiinflammatory agent. India) 1975 p 456. Satyavati.H.~lS t i ~ t i ~ t ~ c \ . S. J Pr13clnst Chenl29 (1957) 161.. M. Surgery o f t h e anus. The treatment and care of anal fistula . Vellore. Indian J Med Res 71 (1980) 632. vol. S. Eds (Indian Council of Medical Research. Indian J Med Res 76 .N. Ayurvedic treatment for fistula-in-ano. and Gordon. Misra.H.

(before Christ) described the use of seton to cure f i s h l a in ano. In spite of the best efforts cven today. Key words : Fistula ani.iute for ~ a k h . Takuji Fujikawal. Indian medicine. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 238 . the gatienls also have to suffer economic loss as they h z . Medicated threads. Masao Fujimakil Introduction I4ippocra'les 460 B. -- ': *: 3: 2nd of Department of Surgery. Various treatments have been tried to cure fistula in ano inclcding fistulectonly cvitii primary closure and s!tin graftingV4. The routine surgical treatment of fistula in ano srnployecl today i s f i s t u l e c t o ~ ~ i yfistulotoniy 2nd coring out method . in principle the surgiczl treatincnt of f i s h l a in ano has remained the same without much improvement. Some variations in classical operation of lay open have been added by Hanlcy? Parks6. the niain problems faced in the treatment of this disease. REVIEW AND FOLLOW UP OF 182 CASES t(enji Tazawal.~ a k u Toyama Medical & Pharmaceutical . University. C. 2530 Sugitani Toyama Shi. Shigeru Takemoril. fo llowing sphinct~?r-preservingfistulectomys. Toyama. Japan 930-01 Brindaranayake memorial Ayurvedic Research Institute Nawinna. Upali Pilapiriya3. Moreover. Thus.TREATMENT OF FISTULA IN A N 0 BY A MEDICATED THREAD-KSI-IARA SUTRA TREATMENT. and Goligher7. are : I ) extensive multilation of the ano-rectal and ischio-rectal area which i s a prerequisite for radical cure. Sri Lanka. The first surgical lay open of fistula in ano as practised today was performed in 1337'. Research Ir~sli. 2) prolonged hospitalization. Katuya Yamamotol. Ayurvedic medicine. and 3) high raie of recurrence.~ c be away fro111 their jobs and the society as a result of to 'prolonged hospitalizaiion and healing time. fdaszo Hatnri2. Tuneo Namba2. Maharagama.

Standard classification of fistula' in ano as desc~ibed in the modern medical text books was taken into account7. the patients were taken up for the treatment by "Ksharasutra". and more than ninety fistula patients weie successfully treated i n our university hospital * I 3 1 4 . Man studies have been. we describe a review of analysis of 182 patients treated by this method.published by Ayurvedic surgeohs recently with encouiadnl results for treatment of fistula in ano by use o f ~ s h a r a Sutralo-". This Ayurvedic treatment was recently introduced into Japan from Sri Lanka by U. Patients were advised some analgesics intrarectally on the first day of application. Unless the extent of the track was very extensive or associated with malignancy. the resulting open wound was then dressed with oirit~nent. A l l these :patients have been followed up for a minimum of one year. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 239 . on the first application or subsequent changing of the thread. This method i s non-operative and belongs t6 the parasurgical group. After the fistulous track is cut througli. In this paper.e patient was taken and careful systemic and local examination was done. These needed local or spinal anaesthesia. It invalves the application of a specially prepared medicated thread proce8sed with certain vegetable caustics. X detailed history of th. Rectal examination and probing was done in all cases t o assess the extent and the direction of the -fistula. the eminent lndian Surgeon9. and to wash thoroughly after each defaecation and take warm bath if practicable. Pilapitiya. active tuberculosis or severe anaemia. Materiala and Methods These patients either attended (lie outdoor: of the Toyama Medical and Pharmaceutical University or Fujikoshi Hospital with conlplaints of discharging sinus in .the anal region. The patients were advised to continue thei! normal work during the treatment.-- - The technique adopted i n the present work i s the revival of an age-oi procedure practised by " Sushruta ". The "Ksharasutra" ' was applied by the method described in earlier paper12.

local examination was conducted noting carefully the number.S. S. a surgical and medicated thread (Fig. tenderness. Second. is pierced through fistula several times and gradually this 'brings 3 JOU~ healing of the wound. distance.y the other hand.S. was moderately tightened and tied out side verge over the anoderm. i-he patient was put in a lithotomy position and the perineum was prepared 4th antiseptic lotions. l e probe was brought out of the anus leaving K. Selection of Cases : i n 182 cases of fistula in ano included in the present study. S. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 240 . till it touched the finger in the anal canal. The t-ash i s allowed to dissolve i n water and the filtrate is dried over the sun to afford an alkaline powder.I. 1 K. i s produced by cutting the whole into small pieces and burning tkam in a clay or iron pot i n the semiclosed air. induration and the position of internal and external opening.) : A l l patients were advised a rectal wash before the application of K. an' alkaline powder of the plant Achyranthes aspera L. Application of KshaTasutra (K. in the fistulous tract. il. 1) is prepared by U. l e K. A litable length of K. Rectal i n d proctoscopic examination was also done i n each case. discharge. The thread is then dried In the shade. S. by bending it. Preparation of Threads : In this medical procedure. site. Depending on the site of fistula.S. L: and in -alkaline ash of Achyranthes aspera alternately fop about seven times and finally coated with1yellow powder of Curcurna dornesteca L. II. the index finger of he ilght or the left hand was passed into the annal canal and a silver lalleable probe was passed into the fistuluos tract gradually and cautiously . The tip of the probe was brought out of anus. a cotton thread i s dipped in latex of Euphorbia antiquorum.. Pilapitya in following way : first.. was qut and threaded throvgh the eye of the probe.

-..3 29.-. 241 SELECT RESEARCH PAPERS ON EVIDENCE BASED AY URVEDIC DRUGS . S. - . 1 * I .4W 7. -^__ ^ -. 3.-----.8D (182) 1. C ..4 29.. gradually cut through fistulous tract.4T 6...in-nno ----- Healing T (weekj . as they had significant discharge of p: Kohata Sutra Technique in Fiuiula-. was replaced and tied on every 7th day i~ the cases by rail road technique till the last K.OD - I : Subniucous or subcutaneous fistula.0 12.5T 1. : Intersphincteric fistula.-A -.6W T Ype Ic ' 45 1I%* 114 I I I ~ ~ 23 mean h 1 --- Number (case) . ' removed at each change indiqated the _sliortening of the fistulous t r ~ lntrarectal analgesics were allo.-. (clay) Hos1. * " I I i : Transsphincteric or' high level fistula.7 -4- I : SuSmucous or subcutaneous fistula.- 8. leaving a smf'r healing ulcer at the anal verge.4 4.2 8.8 - Healing Time (week) operation kshalL _ r 3.. .1 D 19..---- 6 -------- ---- . S. *211 : Intersghincteric fiistula.2 7.wed in all cases and an3biotic was admi2 stered in all cases for 3 to 4 days.italization (day) --.. was measured and recorded. Shortening of the t h ~ ~ .1T 0.4 -- I*' I[%2 111~3 ---.40 29.*_ - Type Niirnvar (case) operation kshara 34 38 45 114 23 tfospitalizatior~ (day) operation kshara 26.2 13.7D --. * 2 1 1 . Only I c ('.7 8.AYU 1 IV --- ------- I A~igust Subsequent Changes A new piece of K.4w 4. S.OD 12.5D 8. Excl~ange Cutiing Time (thread) .1T 2.- - 0.ison of Operation 2nd Ksharz SuQra 1 _ ..7 W 4. taken on each occasion.red for these changes.- - -.1 D 9.I-. The length of K.1 53.-* --a ---- 13. *3111 : Transsphincteric or high level fistula.---. anesthesia was reqir. Compal.

of complication and dysfunction a) pus pocket formation : 7 3.7%) 4 I 3 - (2.were recorded.-. (0%) .-.(23) 5 (21.OZ) I SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 242 . This revival method of K.6% e) bleeding : 0 f ) stenosis : 0 g) incontinence : 0 ! No: of recurrence ------ 9 4..7.z b) mild deformity of anus : I 0.. : Subn~ucouaor subcutaneous fistula. (45) .------. S. 9 4..2%) .. . Anal defects and recurrences if an):.6%) 2 0 1 -1s pocket formation .3%) - 3 (3. ---- (182 cases) 1 No.. in Japan has been applied in.--- (2. . i1 : Intersphincteric fistula. : Transsphincteric or high level fistula..241 cases of fistula in arro at Jun 1991.-- (5.6% c) severe deformity of anus : 0 d) local inflammation : 1 0. _ __ _ _ __ __ .. I Follow up study 7 - in Mshara Sutra (1) _ I .August-19921 [ A Y ~ V Follow up A l l the cases were examined every month for the first 3 months aild f every 3rd month thereafter.Id deformity of anus 3 1 inflanlmation . Out of 241.9% Follow o p study in kcshara Sutra (2) (1 14) xse) 3mplication .9% . 182 cases fol!owed up over 1 year have been studied various angles in order to find out the optimum response of this treatment in a particular group of patients. 1 0 0 - 1 -- __ _ 0 -- -- :urrence 0 6 ----_..

S. (Table 2). in the fistulous tract. average durations of cutting time (in days).S. all the cases were anlbulatory after initial application and subsequent changes of K. was pain in a few cases.S. A few cases were confine3 to bed for a day or two because of pain. Table 1 gives the details regarding the number of fistulae. 9 days in cases of or intersphilicteric f~stulaand <9 days i n cases of transsphincteric or high level fistula.S. In this study. 12. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 243 . was easy in majority of the cases but some had difficulty in cases of high level fistula. 95.6% (114/182) intersphinteric. discharge and swelling in the perianal region.1% (1731182) of the cases had complete cu. A l l the cases Were traated on in patient basis. 24. 62.re while 4. but a few patients had to be non-hospitalized as they had come to work after this treatment.S.6% (23/1S2) transsphinteric or high level fistula (Table-I). average durations of hospitalizhtion (in days) and healing time (in weeks) in various types of fistulas encountered in the present series. Dfscusslon : The routine surgical treatment of fistula in ano is also by laying open the tract either by fistulectomy or fistulotoniy in Japan.S.7% (45/182) fistulae were subcutaneous and submucous.. The incontinence of faeces and flatus was not observed in any of the cases. The first application of K. The high recurrence of fistula in ano i s another common problem.. The average duration of cutting tinie in this study was six days in cases of subfi~ucous subcutaneous fistula. Subsequent application of K.AYU J Result 1 August-1992 Male patients were the usual sufferers (912 : 166/'182). But all cases had successful application of K. Distribution of cutting time in each type was shown in Figure 2.9% (91482) had recurrence after treatment with K. It was a common observation that incontinence of faeces or stricture of the anal canal are frequent in cases of high level fistula in ano. average changes of K. Majority of the cases complained of pain.

The treatment can 20 be employed to severlly ill patients of hypertension. antifungal.S. cuts slowly and gradually through the fjstulous tract from apex to the periphery. '. Deshpande et a l l 2 had advocated application of K. while in the present study it is lout 95%.S. The K.42) out of 3370.8:. antiinflammatory and antislough against (Table 3).urgical treatment of fistula in ano.The average duration of treatment when compared to conventional surgical treatment of fistula in ano was half week i n submucous. The rate of recurrence after conventional treatment of fistula as ported by E c n n ~ .S.ses out of 2CO) and 0.hesia. In the pre'sent series i t was only .87:) l~ out of 118 and by Sumikoshi16 was 418 patients (12.ows : The K.S. are antibacterial.e chances of recurrence are very much less in properly selected cases pyogenic fistulae in ano excluding horse shoe fistulae. The suggested mode of action of K. easy and safe. without anes. it SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 244 . (4 cases out of 498) respectively in a 2-9 years ilow up study. The treatment of fistula in ano by K. without local or spinal anesthesia.S.5% and 96%12 cure rate. and in addition. diabetesr~~ellitis. The results of treatment in the present study when compared to those $ Deshpande et all are almost similar in clinical course. is very simple. remains in direct contact of the tract and therefore. These authors ?d reported 96. Tlie causticsI4 l 8 applied on the medicated thread have properly of chemical irriiant and curetting for smooth cutting. Daslipande et a l l 2 and KothiaI7 reported recurrence rate of 3. art disease and Crohn's disease. subcutaieous and intersphincteric fistula.S. In cases of high level fistulae and transsphincteric fistula it was very much less than the hospitalizaiion in days by .5% (7 . But it was observed during the present study that i t was difficult to -pply K. t was 10 cases (8. is as foll. There is sn ideal simultaneous cutting and healing of the tract and no pocket of pus is allowed to stay back.

Hanley P. : Operation for anal fistulae. Soc. 1963.S..I Perrin W. Saronwale K. 1961.. 4 REFERENCES : . . 3) was towards the alkaline side13 'and thkrefore i t did not allow rectal pathogens to invade the cavity. : Primary skin grafting after fistulectomy in the treatment of fistula in ano. Colon. 8 Yoshikawa N. . Tindall and Cassell. The pH value of K. Hughes E. ~ r j k a w a J.: Primary skin grafting in proctological surgery. dose not allovr bacteria to . 1932. : Conservative surgical correction. slougl13 out the epitherial lining. 1972. C. 5 : 1291-1299. Arakawa a. London. Jc. 1 : 463-469. 25 : 338-346.R. H. Surg. due to its antibacterial property. Brit. 1953. ~astroenterologica~ Surgery. Proc. 1961.chemically curettes out the tract a n d . 6 : 436-440. 23 : 139-152. Sasai T. (Fig.. Dis. Bailliere. 5 6. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 245 . J. : The pathogenesis and treatment of fistula in and. Parks A.. Gupfa S. 19E2. : "Surgery of Anus. 8 : 364-368. Med.. Proctol. of horseshoe abscess and fistula. G.S.S. : Split thickness skin graft on granulating wounds follbwing extensive fistulectomy. P.. Rectum. Amer. : President's Address : Some landmarks in history of rectal surgery. thereby allowing the fistulous tract to cotlapse anu heal under the 'drug deliverly system. Rectum and Colon" 1st Edition.S. 2 3 4 ... 41 : 639-642. 7 Goligher J. Brit. Colon Rec. * 3 The K. 11 and 174-208.j965. Med. Roy. multiply i n the presence of Haridra. . pp. C. J. Dis. Khurana C.

Pilapitiya U. Hattori M. J. Bennet R. el al : Kshara sutra-its attempt and results.. 2 : 131-139. Tazawa K.. Yamashita I. N. .. 1988. Sharma K. Ethnopharniacol. Med. 10 11 12 13 14 15 - 16 Sumikoshi Y. N. 10 : 160-168.. Jpn. : Treatment of fistula-in-ano by Kshara Sutra.. Proc. Amer. J . It takes about 7 days to prepare the thread. 1986. .. Pilapitiya U.Paathak S. J. Okada M. J. Ind. J. Figure 1 Preparation of medicated threads : Surgical threads are impregnated 21 times with the sap of Euphorbia antiquorum.. Studies on Ayurveda in Japan. 27 : 39-47. 1976.. the alkaline powder of Achyranthes aspera . : Treatment of fistula-in-ano by a new techniq'uk-Review and follow-bp of 200 cases. 55. 1973. 16: 1693-1699.. Amer.9 Deshpande P. : A review of 40 cases of fistula-in-ano treated with Kshara-sutra.. : Successful non-operative treatment -of high rectal fistula. 17: 1790-1797.. Sharma B. Proctol. 1990. M. 1966. 17 Kotliia M. C. r o c t o l . 1987. 24 : 49-60.... Nagarjun. ~ e s h p a n d eP. 756-757.. Studies on Ayurveda i n Japan.33: 444-447. Deshpande P. J.: Analysis of a thread used in the Kshara Sutra treatment in the Ayurvedic medicinal system. Med... 1962. 1980.~ . Soc. Deshpande P. 18 J. 29: 199-206.. lwadare J. R. 'J. 18: i900-1904. Yamanloto K. Studies on kyurveda in Japan. Roy. 1968.. Soc. J.. Namba T. Yamamoto K.. Proctol. B. ~ o l o . B.: A review of the results of orthodox treatment for anal fistulae. Tazawa K. et at : Clinical study of anal fistula treated by Ksllara-sutra: its result and composition analysis. SELECT RESEARCH PAPEXS ON EVIDENCE BASED AYURVEDIC DRUGS 246 .. Sharrna K. Singh L. R. Res.fistula-in-ano.: Bhagandara-A study of Kshara-Sutra therapy. et al : Anatomy and physiology of the anus for the surgical operation of .(and the powder of Curcuma dornestica.. ~ e w a l iM.

Figure 1. of thread exchanges. C ~ Taare 2 Table 3 C l \ ~ . I t tl~~ prepare the thread. 1-0 Achyranthes Curcuma Eu~horbia Acpera Dol\\ostica A~\tir\uorum Powder Sap - 1 ) Impregnation 21 times in 7 days I '/ Thread medicatvt) with alkali - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . tcrnperat"re. Figure 3 Table 1 Mor~r~ values.. {'reparation of n~.recurrence ~ ~ t i types~ of~ fistulae in ~ ~ l i in various ~ follov~ up stud).trihution of duration of cut-through in days (cutting time) in various types. - [August 1992 _ _ I - . i~~l * : 111iiin conipouncls isolatecl and cliaractcrizecl for chemical cnut. Figure 2 DIt.1\cs. the alkaline powder of A c I \ y ~ r ~ n aspera~ and the powder of Curcunia doniestica. duration of cutting time ( ~ 1 1 1 fhiouyh).AY u1.and~. duration of hospitalization and duration of healing tinlo in various types of fistulae. k ~ - . Surgical thread No. of fistulae. ~ ~ . ~ .cauterizaiiorl ill niedicated thread of Kshara Sutra. .edicvltedthreads : Surgical tlireahs are impregnated 21 \Irncs with the sap of takes about 7 t l r ~ y y to Euphorbia antiquorum. Alktjlinity of Kshara Sutra i n water and normal saline solution at 5" C.

Distribution of duration of cut-through in days ( cutting time) in various iypes of fistulae. solution at 5'C temperature. Alkalinity of Kshara ~ u t r a in water and normal saline Figure 3.August 19921 [AY u Figuro 2. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 248 .

I ' glucos~des) lnokostcron I ccydys~cro.t 7 I *I I I. -. . 3.*turmerane I d i h y d ~ -turmerone a 1 zlneiberenc ptlcllandrcne I cincol I slorct~ pcnbossn I 110 laslum I oxalate I I I 1 I I I I * * KCL a c h y r a n t h l n .a-c -i ~ r-a n l-t l-l n.I j ! q l o ~ d c s._ .F 2 : R P SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 249 .' r Table Chemical c a u t e r i z a l i o n :in m.n a .edicaled l h r e a d knovn as Kshara sutra I Haridra ' I .. -1 I 7--- I 1 L ---.< t August-IS92 .AYU ] ' -.__ _ _ _ _ _ * CUPtl0l * * t r l~ r p c n e c cuphorbol I cycloarlenol~ anllquol A8q dllcrpcnc 1 7 I 1. -. ~~~~~~~~~~~01I I KCL I slro..--- : l 7 '* I + KzCOI - -) I 4 .. CAUSf l C S Y) .ds I (B-si t o s t e r o l ) r . .. .-.I KO11 a n t i f ungal antiinflammatory Jnl~oxidant anllcoagulatory an t l t ~ c p a l oo x l c t (:III!HIC'Al.

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 250 .D..B. ADITHAN.Status Report on Pharmacological Research in India.D. FIMSA. M. 1994-1998 Editor C . D. P~..Pondicherry.N. Department of Pharmacology JTPMER.. New Delhi-110 002. INDIAN NATIONAL SCIENCE ACADEMY Bahadur Shah Zafar Marg. FIPS..

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responsible for the facilitatory effect of Bawpa monniem on learning schedules. probably by stimulation of the hepatic microsomal enzyme system? Similar properties were exextract (PEE) of the roots sleepingtime. Fhe alcoholic extract of Bacopa monniera facilitated of the acquisition. th'e last 5 year period. In recent times. consolidation an-tention memory as seen by its effect on 3 newly acquired behavioural responses in albino rats. N. foot shock motivated brightness discrimination. time. the cognitive deficits and the reduction in cholinergic markers after 2 weeks of treatment. electroconvulsive shock and scopolamine and enhanced and increasedthe proteinconPhase Iclinical studies have confirmd the s a k of the bacosides in healthy male volunteers at both\shgle and multiple doses adminiqtered over a perioq of 4 weeka. 19941998.N. More than 13.' and. focus on plant research has increased all over the world and a large body of evidence has collected to show immense potential of medicinalplants used in various traditional~ystems.s has been publishedin peerreviewedjournals. R.The extract also potentiatedclonidine induced hypothermia and decreased lithium induced head twitches. The following paragraphs focus on the further work carried out durina the last 5 years. Be&rsal of perturbedcholinergic function Wp p f s to be the'possible mechanism'.000 plants have been studied during.used. the data based on the studies carried out with these i6rmulation. CNS Active Plants The scope of CNS active Indian Medicinal Plants in therapeutics has been illustrated in a review article by Vaidya2. active conditioned avoidance and Sidman continuous avoidance responses.S Medical College 8 KEM Hospital. cbacosides A & B.This indicates that it affects 5HT and noradrenaline mediated 251 - 2.Two of these sectiodeserve special mention one on nutracedtice. in which research on plants that form a park6f our normal diet has been compiled irrespedfie of activity and the second on phytochemWl studies which are associated with pharmqmfbgical activity. To facilitate the readers to look at their areas of inter: est more easily.A KULKARNI.thatit'on polyherbalformulations. the data in the present review have beenorganised in various sections according to pharmacotogical activities. thrnscription on individual plants is followed t?y. REGE Department of Pharmacology &Therapeutics. Parel. vk. The present review aims to compile data generated through the research activity using modern scientific approaches and innovative scientific tools in last 5 year period i. Further studies identified the chemical constituent. In the rest of the sections. a mixture of 2 saponins designated as. Muinbai-400 012 1 Introduction .The bacosides a l s ~ a f e the retrograde amnesia d produced by moblsatbn induced stress. i h e acetone solubld fractiorrof petroleum ether ex' tract of Lawsonia inerrnis (Mehendi) leaves showed significant nootropic effect on the elevated plus maze and passive shock avoidance paradigms. Seth G. Various extracts derived from the'seeds of Pongamia pinnata (Karanj) decreased pentobarbitone sleeping SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .PHARMACOLOGY OF MEDICINAL PLANTS AND NATURAL PRODUCTS S. Polyherbal forrpulations have been included as they are widely *. DAHANUKAR. It reversed both.A. probably PEE of the seed of tested for nootropic of Alzheimer's duced lesioningof nuclear basalis magnocellularis).e. as reflected in the study by Karandikar eta/.

These models were induced in rats by either injecting colchicine' (15 pglrat) intracerebroventricularly (i. it atlenuated the other effects of amphetamine. another herbal formulation. Pretreatmentwith Memorin (200 mgldaykg). increasing age and electroconvulsive shock (ECS) induced antero-grade and retro-grade a m n e ~ i a ~ Ramteke. Ethanol extract and cold aqueous infusion of Vitex leucoxyhn (Nirnochi in Tamil) leaf depressed spontaneous motor activity. Methanolic extract of rhizomes of Nelumbo nucifera (Kamal) was found to cause significant reduction in spontaneous activity. a PAF antagonist. On the other hand.~~. sodium nitrite hypoxia. All extracts [petroleum ether (PEE). EGb 761 and Ginkocer. improved learning (both speed and magnitude) on the Hebb Williams complex maze as compared to control. a polyherbalformulation. The results indicated that BR-16. choline acetyl transferase activity and muscarinic cholinergic receptor binding in frontal cortex and hippocampus of rat brain. Trasina improved both memory and levels of various cholinergic." demon. The results have been discussed on the basis of interaction of Panaxginseng with the functioning of various neurotransmitters. thus showing no effect on dopamine me. By contrast. on learning and memory. activity15. showed consistent and significant anxiolytic activity. Ginkgolic acid conjugates (GAC) (6-alkylsalicylates. was found to attenuate electroconvulsive shock induced retrograde amnesia in rats when tested for passive avoidance learning paradigms in a shuttle box1'. strated that administration of BR-16A to slow learning rats. acetone (AE) and ethanol (EE)] of the leaf of Abies pindrow Royle (Silver fir) showed potentiationof pentobarbitone sleeping time i.v. The PEE. n-heptadecyl-. It has been shown to augment acquisition and retention of learning in normal rats. viz. was found to exert significant nootropic effect following 21 days therapy in 2 experimental models of Alzheimer's disease. decrease in the exploratory behaviouralpattern by the head dip andY maze tests. suggesting that this fraction is devoid of anti-depressanteffect '*. as well as in states of cognitive deficits induced by variety of insults including pre-natal undernutrition. did not evoke significant activity. benzene(BE). BE. could facilitate learning and memory.and-n-heptadecenylsalicylates) isolated from the leaves of Indian Ginkgo bilobaUnn. Thus its nootropic effect may be attributed to correction of cholinergic dysfunctionls. did not show anxiolytic catalepsy. A lot of attention has been focused on the effect of BR-16A (Mentat). muscle relaxant activity and potentiation of pentobarbitone induced sleeping timeq7. significantly improved the avoidance learning during endurance performance in rats when tested on the Runimex. EGb 761 was found to increase rearing and decrease immobility time only in open field behavi0ur. behaviour.s effect may be due to weak antianxiety activity20. DAHANUKAR et aL.c. A. CNS depresbant effect.. Haloperido1catalepsy -potentiated while the behavioural responses of 5-hydroxytryptophanand \-dopawere both attenuated. antagonised d-amphetamine induced sterotypy and oxotremorine induced tremors and shortened the duration of immobility in the behavioural'despair' test in qicel6. Higher however. chloroform (CE). EE was found to potentiate immobility. Mitra. l8 have shown that the root powder of Panax ginseng did not affect pentobarbitone sleep time or spontaneous motor activity. It had no effect on haloperidol induced doses (10-200 mgkg).e. erably. a polyherbal formulation. The leaf extract of Azadirachta indica (Neem) exhibited anxiolytic effects comparable to diazepam at low SELECT RESEARCH PAPERS Ol\f EVIDENCE BASED AYURVEDIC DRUGS 252 . et a/. post-natal environmental impoverishment. a circular runaway. and could be categorized as a nootropic agent. n-pentadecyl-..reduced in the treated animals. 2 conjugates which are devoid of GAC. markers like acetylcholine concentration.) or lesioning of nucleus basalis magnocellularis by ibotenic acid (10 pglrat).S. stereotypy and lethality in aggressive mice.e. Although it potentiated amphetamine induced increase in motility. Bhardwaj and Srivastaval* have shown that Mentat (designated by them as CIHP Ill). Trasina. CE and AE (highest effiqcy) showed significant anti-depressantactivity. npentadecenyl. electrical shocks requiredto induce learning were consid-.et a/. . aluminium. It exhibited significant aggressioninhibiting effect in doses that had no effect on spontaneous movements. 22 Psychoactives .Thi. like piracetam. The number of stimuli i. namely n-tridecyl-. when tested in rats.doses (>400 mg~kg) diated behaviour7.

PCPA. Sedatives The non-polar fractions of the leaf of Vernonia species (~ahadevi) Vernonia lasiopusand Vernonia viz. a novel furopyridine alkaloid isolated from Pafiax ginseng was shown to have no anticonvulsant action. proate and carbamazepine against picrotoxinas well DSP-4. Reduction in swim stress induced immobility in Porsolt's behaviouraldespair test. Anticonvulsants Azadirachta indica showed analgesic properties in In a study carried out by Manocha. ment of tolerance and also the development of dependence to morphine in mice. SELECT RESEARCH PAPERS ON EVIDENCE BASM) AYURVEDIC DRUGS .ohol1c extract of Ochna obtusata(Kanakchampak)stem barka. has shown an analgesic effect (not involving the opioid pathway) against acetic acid induced writhing in miceu. demonstrating the role of GABA receptor in PTZ induced kindling and protection by BR-16A by its interaction with these receptorszs.e. potentiatedthe same.3. attenuated the analgesia whereas the seroas strychnine induced convulsions in mice. similar to morphine and involving multineurotransmitter systems. The PEE. Withania Suppression of acetic acid writhing was seen with both the ethanol extract and cold aqueous infusion somnifera showed no analgesic effectD.The PEE and direct EE of the seeds also showedssignificant analgesic activity at doses higher than 100 mgl kg. Pre-treatment with the opioid antagonist. Ceropegia juncea Roxb. Panax ginsengexhibitedanti-nociceptive activity and potentiated the anti-nociceptive activity of both pentazocine and aspirinia.6. bilobadecreasedthe protective effect of sodium valnaloxone and central noradrenaline depletor. indicating the involvement opioid i. Chronic administration of BR-16A was found to protect against pentylenetetrazole (PTZ) induced kindling in mice. Agents attenuating dependence assay). These results indicate the need for restriction of xanthinetcaffeine consumption in patients on carbamazepine therapp. reduction in escape failures concomitant with an increase in avoidance response in the learned helplessness test and attenuation of muricidal behaviour in rats demonstrated that it poss'esses antidepressant propertiesa. (Bhutumbi). 2.5.MEDICINAL PLANTS (NATURAL PRDUCTS) Administration of BR-16A for 7 days induced dose related anxiolytic effects as assessed by paradigms like the open field and elevated plus maze tests in mice and the social jnteraction andvogel's drink conflict tests in rats. Using the same model in rats. it is a potential candidate for clinical Chronic treatment with the root extract of Withania trials as an analgesic with the advantages of lack of somnifera (Ashwagandha) attenuated the develop. Further tonin synthesis inhibitor.4. of Vitex leucoxylonj6. Ginkgo mice.tolerance and dependence liability2'. a putative endocoid anxiety marker footshock induced aggressive behaviour in paired rats but failed to affect clonidine-induced automutilative behaviour. BE and EE of the roots of Pongamia pinnatashowed significant analgesic effect in the tail flick tesP. Analgesics - Gossypin . Thus. 2.life (2-fold) and reduce the bioavailability by 32% of carbamazepine in normal human volunteers. mainly the cholinergic and GABAergic neurotransmitter pathways. eta/". It attenuatedthe increase in rat brain tribulin levels. significant analgesic activity was detected in leaf and seed of Vernonia lasiopus and Vernonia galamensis and alc. Cerpegin. a bioflavonoid from the yellow petals of Hibiscus vitifolius (Bhasadwaji). nor did it potentiate the anticonvulsant effects of phenobarbitone and diazepam1'. No interaction was seen with sodium valproate. Caffeine intake has been shown to increase the plasma half. galamensishave been shown to have sedative properties in ratsn. picrotoxin) and modulation of action of the glycine neurotransmitter(for strychnine) by Ginkgo bilobaZ4. Gossypin pre-treatment significantly decreased the development of acute tolerance to morphine induced anti-nociception (acetic acid induced writhing 2. By itself. monoaminergic) may be involved in this of GABAergic system and chloride channels (for effectn. has been shown to have anti-nociceptiveactivity. studies showed that pre-treatmentwith Ginkgo biloba suggesting that both central and peripheral mechaextract potentiated the convulsions produced by nisms and complex neural pathways (opioidand non'picrotoxinand strychnine. 2.

All extracts of the root of Pongamiapinnata showed significant anti-inflammatory activity (compared to The methanolic extract of the aerial part of Sida phenylbutatone) in carrageenin and PGE. The ethanolic extradof the leaf of Vitex leucoxyIon showed significant inhibition of carrageenin paw oedema and granulation tissue formation in ratsqs. The triglyceride fraction of oil of Ocimum sanctum (Tulsi) offered higher protection against carrageenin induced paw oedema in rats and acetic acid induced writhing in mice. Alcotiolic extract of the roots of Clerodendron semtum (Bharanji) showed significant analgesic activity in micen.BE. lxora brachiata Roxb (Rasna) and Rhynchosia cana Willd were found to possess'significant anti-inflammatoryactivity against cotton pellet induced subacute inflammation in rats. Possible mechanism of action could be inhibition of prostaglandinsynthesis and decreasedcapillary permeability. Flavonoids and'terpenoids are polar substances effective in acute inflammationwhereas glycosides and steroids are non-polarsubstances effective inchronic inflammationm. pluronic F-127. oedema model in rats.AE and EE) showed significant analgesic effect in the hot wire inducedtail flic! response in rats. glutamate pyruAlcoholic extract of Ochna obtusatastembark dem. the cyclo-oxygenase and lipo-oxygenase pathways of arachidonic acid metabolism". Possible mechanism of action could be its inhibitory effect on PAF and prostaglandins as this plant contains phyto-constituentssuch as flavonoids and terpenoidstS. prepared using a commercially available. The aqueous suspensionof dried latex of Calotropis procera (Arka) showed anti-inflammatory property when tested in the carrageeninand formaiin induced rat paw oedema modelp. model of inflammation. properties are probably due to the presence of flavonoids in the flowers of these plantsq. The anti-inflammatory activity of linolenic acid present in the fixed oil of Ocimum sanctum was probably due to Mockade of both. The PEE and CE of the seeds of Pongamiapinnata showed potent acute anti-inflammatory effect whereas the aqueous suspension showed pro-inflammatory effects. The methanolic extracts of the flowers of Michelia champam Linn. PEE and AE inhibited histamine and 5. acid phosphatase.vate transaminase and glutamate oxaloacetate onstrated potent anti-inflammatory effects in the rat transaminase activities in the liver and serum. Fixed oil of 0cimum. Possible mechanism of action could pressant activity in the carrageenin induced paw be prostaglandininhibition. induced hombifolia(Atibala) showed significant oedema supoedema models. leukotriene and arachidonic acid induced paw oedema. 2. granuloma pouch and Freund's adjuvant arthritis. The anti-inflammatory property appears to reside mainly in the intermediatepolar constituents and not in lipophilic or extremely polar constituentsn. (Champaka).CE. However. These paw oedema and cotton pellet granuloma modelsn. reduced the intraocular pressure.sanctumand linolenic acid were found to possess significant anti-inflammatory activity against PGE. Probable mechanism of SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 254 . Further stvdies have shown that maximum anti-inflammatory effect was seen in the bradykiniri induced oedema model with the direct EEw. All extracts of Abies pindrow Royle leaf showed antiinflammatory effect in various animal models of inflammation such as carrageenin induced paw oedema. Chemical analysis indicated the presence of glycosides and steroids in the PEE and BE and terpenoids and flavonoids in the AE and EE.The results showed that the gel formulatian of Butea frondosa leaves.They also reduced the protein content. Anti-inflammatory agents The BE was effective in carrageeninbut not the PGE. the fractions were not effectiveagainst Freund's adjuvant arthritic model..7. as comparedto the fixed oilU. was comparable to flubiproten geP. The latter 2 drugs showed higher activity as compared to Michelia champaca.Different extracts of Abies pindrow Royle leaf (PEE.hydroxytryptamine induced inflammationprobably by their lipophilic constituents preventing the early stages of inflammation. The roots and leaves of Butea frondosa (Palash) were evaluated for ocular anti-inflammatoryactivity in rabbits. especiallyby EE and AE. decreased leucocytosis and miosis and.The latter finding indicates that the plant may not be effective in rheumatoidarthritis.

Gmelina asiatica(Gopabhadra) root powder was effective in reducing the oedema in the carrageenininduced rat paw oedema model of acute inflammation. the methanol extract of Nelumbo nucifera rhizome as well as the steroidal triterpenoid isolated f rom it (betulinic acid). possessed significant anti-inflammatory activity when evaluated in the carrageenin and B-hydroxytryptamine induced rat paw edema models. Alcoholic extract of the roots of Clerodendron serraturhshowed significant anti-inflammatoryactivity in the carrageenin induced paw oedema and cotton pellet granuloma models in ratss. It also normalisedserum albumin and serum acid and alkaline phosphatase levels. The water soluble part of the alcoholic extract of Azadirachta indicaexertedsig7ificant anti-inflammatory activity in the cotton pellet granuloma assay in rats.8. seen (as in the pith granuloma model) thus indicating that it did not interfere in the normal healing process. a polyherbal formulation. Studies have shown that. The aqueous extract of Gymnema sylvestre leaves showed significant anti-inflammatory activity in the carraseenin induced rat paw oedema and mouse peritineat ascitis models. lipid peroxide. In vitm too. mqantiWretic activity of TBR-002. a lation. was found to be almost equal to paracetamol in a rat model of pyrexia induced by su~cutaneous injection of yeast suspenoionu.. even at high doses. Treatment with Ease. thus indicating its possible use a$ an anti-arthriticm. When tested against the cotton pellet granuloma model of chronic inflammation. anti-oxidative and lysosomal membran'e stabilising effectsu. Possible mechanism of action could be by free radical scavenging activitp. Probablemechanism of its anti-inflammatoryeffect may be its anti-proliferative. Alcoholic extract of the roots of Clerodendron serratum showed significant antipyretic activity following typhoidTAB vaccination in rabbitsn. bradykinin etfl. As against these antipyretic plants. however. significantlyduced Freund's adjuvant-induced nonestablished and established arthritis in rats. it provided significant protection against protein denaturation and RBC membrane damage and exhibited significant proteinase inhibitory action. 5. the extract did not affect the integrity of the gastric mucosa. Methanolic extract of rporne of Nelumbo nucifera produced a significant dose dependent lowering of body temperature in normal rats and antipyretic effect in pyretic rats Rhynchosia cana showed significant antipyretic activity in ratsm. Antipyretics The ethanolic extracts of Ailanthus excelsa (Mahanimba). an Ayurvedic drug used in the treatment of rheumatoidarthritis showed significant anti-inflammatory activity when tested against carrageenin induced paw oedema and cotton pellet granuloma. 2. In addition. RNA. acid phosphatase and alkaline phosphatase suggesting the mechanism for the anti-inflammatory effect of Azadirachta indicau.~. agentsu. Jigrine. Toddalia asiatica (Kanchana) and Araucaria bidwilli (Monkey puzzle) showed moderate to significant degree of antipyretic activity in an experimental rat model of 20% yeast suspension inAndrographis elongata duced hyperthermia4@.MEDICINALPLANTS (NANRALPRDUCTS) action may be due to its inhibitory effects on release to be a less gastrotoxic anti-inflammatory agent as of mediators of inflammation such as histamine.The effects produced were comparableto that of phenylbutazone and dexamethasoneu. Effect on biochemical parameters suggested that the mechanism of its anti-inflammatory effect could be in its antioxidant and membrane stabilising effect".compared to other non-steroidal anti-inflammatory hydroxytryptamine. exhibited antiinflammatory activity against carrageenin induced acute inflammation but not against cotton pellet granuloma (subacute inflammation). showed more potent antipyretic activity when compared to Andrographis paniculata (Kalmegha)=. it not only reduced the weight of the granuloma but also the lipid peroxide content of granuloma exudate and h e r and gamma-glutamyltranspeptidase in the granuioma. DNA. thus appearing Sandhika. Levels of various biochemical parameters studied in cotton pellet exudate were also found to be decreased vk. Panax ginseng showed hyperthermic effect and attenuated the SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 255 . did not inhibit granuloma formation and related biochemical indicese such as bhO~proiine and cOmlagen. another poiyherbaiformulation.

.of GTE on neuromuscular junctions was found to be duced hyperthermia in animals1@. However..tionu. Studies on the effect of BR-16A on adrenergic and dopaminergic functioning in rats showed that it did not interferewith or. Co-administrationof gugulipid with propranololor diltiazem in normalvolunteers was found to decrease the bioavailability of both drugsu. Following are some of the attempts in this direction. 3 piants modulatlng autonomic and autacoid ac. In addition it antagonised the submaximal paralytic effect of d-tubocurarine and decamethonium. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 256 . However. frog rectus abdominis and heart and these effects were blocked by atropine. The petroleum ether and methanolic extracts of the leaf and oleoresin of Araucaria bidwilliishowedmarginal delaying effect on bleeding and clotting times at 1 hour interval in mbbits when tested usingWrightls and Dukes capillary tube methodn. its effects on mqbility in the open field test following challenge with clonidine or apomorphine showed that it enhanced dopamine post-synaptic receptor activity*. 4.Beta-adrenoreceptormediatedtracheal relaxationor form and Fusariumoryspo~m showed that Fusarium the decreased responsiveness of the tracheal smooth monilifofmhad irreversible and nonspecific MA0 in. Neurotransmitter modulation ent responsiblefor its effect on neuromuscular iunclnvestiaation of the neurochemical effects of differ. Dried flowers of Adenocalymma alliaceumwhen fed at 2% levelfor 6 weeks to hypercholeste[olaemic rats. probably by enhancing membrane permeability to calcium ionss. Hypolipidaemics The ethanol extract and coicfaqueous infusion of Vita leuco~lon lowered serum total cholesterol levleaf els in mice1'.9. it has been suggested that GTE might act on Ca2* channels at the skeletomotorjunction. GTE) had a facilitatory effedt at lower concentrations and a wralvtic effect at hiaher concentrations on skeleto~oto. lowered serum cholesterol levels significantly.the trend to evaluate agents modulating autonomic and autacoid activity is declining. importanceof using certain methodobgies like isolated tissue experiments to gather preliminary data regarding interactionof a plant product with host receptor systems remains unquestionable. terbutaline in guinea pigs was unaffected by Abana.This section describesvarious agents that have been evaluated for their effect on the cardiovascular system. pretreatment with Abana increased potassium chloride-inducedcontractionsand increasedthe sensitivity to the relaxant effects of isoprenaline. similar to that of GTE suggesting that the crude polyphenol content of GTE-W~S active constituthe 2. Anticoagulant . ipine reduced GTE-inducedfacilitation as well as inhibition of twitch responses. Gugulipid (an active principle of Commiphera mukul) is an agent that has been widely investigatedfor its hypolipidaemic activity.The effect of crude polyphenol Researchin cardiovascular~harmacolog~ Past in the few Years has been mainly focused on agents with h~~oli~idaemic Properties and plant drugs are no exCeption. Effect of the extract on isolated frog rectus abdominis muscle was blocked by pancuronium and potentiated by neostigmine". ent fu&rial toxins elaborated from Fusariummonili.hypothermic response of reserpine and BHTP in. . However.function but d i n o t have any effect on direct twitch responses or on acetylcholine and KC1induced contractures of denervated rat diaphragm. lowering the absorption of dietary cholesterol from the intestinesm.muscle induced by down-regulation of receptorswith hibitory activity comparable to nialamide*. Hot water extract of Camellia sinensis (Green tea leaf extract. terbutaline and aminophyllinefollowing such contractions. tivity a herbomineral formulation: This is probably due to lack of Abana's effects on B-receptorsof the airway.The effects of GTE were nullified in Since nifedthe presence of magn$sium~chloride. CVS active plants Over the years.2. -adrenergic and dopamine autoreceptor functioning. The effects of stem extract of Cuscuta reflexa (Amarvalli) resembled those of acetylcholine when tested on isolated rabbit ileum. 4. 4.

4 species were found to possess a bag0 zeylanica(Chitrak) root. ACE (angiotensin converting enzyme) inhibitors Seventy. pared to placebo in 12 patients with refractory CCF Treatment with Abana.Rutin. however. however. controversiesthat exist regarding ionotropic action9 drug for humansu. cholesterol. markedly reduced the infait size and premin E lowered HDL cholesterol levels as well. protected against lar stroke volume index and increase in left ventricuethinyl oestradiol induced hypertension and in. thus suggesting that it produces effects against ethinyl oestradiol induced hypertension by its syrnpatholyti~~property". It did some scientists have observed negative ionotropic not alter the force of contraction or heart rate at low and chronotroplc effects as well. DwivediNpointed out that the ethanolic ax. Hence. Data of placardiac arrest in diastolic at high dosesw. vented the loss of theiR'wave in anaesthetized rats he has advised caution about its use in patients and subjected to coronary artery lig8tion. malonyldialdehyde levels and prevented the loss of Administration of cell culture extract of Hemidesmus glutathioneperoxidaseactivity. Long term creased dopamine $ hydroxylass activity in these therapy (i. Hence. Similarly. enhancement of vaso-pressor re. cebo-controlled clinical studies carried out subseThe petroleum ether extract of Abies pindrow leaf quently with this plant is presented below. nut shell) extract also exhibited hypocholesterolemicaction and prevented cholesterol induced atherorna in hypercholesterolaemic rabbits3@. The results suggest that it Vaidya70in his editorial. It. alone and in combina.Though there are studHydroalcoholic leaf extract of Azadirachta indica ies proving positive icnotroplc effects of this plant. Preparationof the whole plant of Phyllanthusamarus (Bhuiamalaki) was administeredto 9 mild hyperten. Of these. had raised4he issue on the is a potential diuretic.MEDICINALPLANTS (NATURAL PRDUCTS) Semecarpus anacardium (Bhallatak. caused a dose-dependent hypotensive effect. It also reducedthe ligaiion-inducedincrease in serum size studies. There was also a significant decrease in liver and heart liiddl.6.4. a flavonoid. in MID.japonica. However. showed significant hypotensive effect in anaestheWhen the bark extract of Terminalia arjunawas comtized dogs1*. deon dopamine $ hydroxylase activity) and no effect crease in echo-left ventricular end-diastolic and endon the vaso-depressor responses of acetylcholine systolic volumes indbes. in in a phase II clinical trial. hypertensive animals. 4. LDL cholesterol and triglyceride levels in experimentally induced hyperlipidaemic rabbitsa. Terminalia belerica (Bibhitak) reduced the levels of lipids in experimentally induced hypercholesterolaemiain rabbits. significantlyreduced serum total nin content@'. Positive ionotropics sive subjects for 10 days. 24 months) too showed continued SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 257 . Rutin inhibited. it was observed that treatnormotensive rats produced significant lowering of ment with Terminalia arjuna was associated with an blood pressure. he had addoses in isolatedfrog heart. a polyherbal formulation. hypotensive and hypoglycemic. diet prevented hypercholesterolaemia~. sponses to low dose of noradrenaline (with no effect improvement in the NYHA class (from IV & Ill).4.five species of traditional medicinal plants belonging to 42 families have been investigated for their ability to inhibit the angiotensin converting enAdministration of ethanolic extract (50% vh) of Plum. had confirmation of these findings through larger sample no effect on heart rate and systolic blood pressure. thus indicating that its beneficial effect is probably due to its ability to impair the generation of reactive oxygen species". Sophora tract of Plumbagozeylanica root alone and with vita.zyme. obtained from the plant.improvementin symptoms and signs of heart failure.high ACE inhibiting ability and were low in their tantion with vitamin E. It. but caused a temporary vised more detailed experimental and clinical studies on the plant and its active principle.lar ejection fraction at the end of 2 weeks. of Terminalia arjuna(Arjuna). increase in the left ventricuand isoprenaline. indicus(Sariva) in rats also receiving an atherogenic luminol-induced chemiluminescence of rat PMN's.e.

from it (by TLC) demonstrated hypoglycemicpotency ondary to inhibition of arachidonic acid by the eth. Both exhibited significant human subjects. and pterostilbene) marsupin and pterostilbene significantly lowered the blood glucose levels and the 6. Plants acting on respiratory system 7. hot aqueous extract of the bark of ~ l b i u i a tricular ejection fraction and reducing left ventricular lebbeck(Shirish)was found to possess anti-allergic properties in experimentalmodel of passivecutanemass in coronary artery disease. CCF and left ventricular mass in els of passive cutaneous and mast cell 12 patients of myocardial infarctionwith angina and/ degranulation in rats. anolic extract.and Hirnachalol. but by trilobatum(Alarka).in ied their effects on mediator release and smooth Control of blood glucose (both fasting and post-pranlevels) was in 67 of 97 patients (69%) muscle contractions of sensitized and non-sensitized dial was 2 g guinea pig trachea using antigen and compound 481 Studied in l2 weeks and the Optimum Of the extract. derived erance and NYHA class among the . of the 3 imhave been shown (FVCl FEV** PEFR FEF25.Similarly. patients7'. cromoglycatewhen tested in the experiments\ modon angina pectoris. 5. HbA1c decreas$ signifi80 respectively. marsupium (Vijaysar)exerted a protective effect on Solanurn xanthocarpum (Kantakari) and Solanurn e~ythrocyte osmotic fmgility. Hypoglycemic plants Methanolic extracts of Drymaria cordata wilU and Leucas lavandulaefolia (Dronapushpi) were investi. improvement in the signs and symptoms. DAHANUKAR et el.(Pushkarmula)loweredblood glucose and enhanced tract of the seeds of NyctanthusaI. ous anaphylaxis and mast cell stabilization activit)rl.showed that epicatechin. there was no increase liver two diterpenes. A. similar to insulin. n anaphylaxis. a different parametersof In streptozotocin induced diabetic rats. However. effort tol. I anti-tussive activity. comparable to that of codeine n vitmstudies carried out by Rizvi haveshown phosphate and increasing concentrations . gree of degranulation of beta cells of pancreas. andrographolide and neoadro. glycogen in rats.The chloroform elutedfraction O the petroleumether f firmed in guinea pig ileal studies). isolated fromAndmgraphispaniculatam. ' Of tractions.The initial phase was primarily due to histamine release which was blocked by the extrad (con.pterosupin.in rats when compared to tolbutamideM. were found to possess signifiDwiiedi and JauhanR studied the effects of bark stem cant anti-allergic activity comparaMe to disodiurn powder of aquna.(Ponkoranti) and a fluorescent compound separated donic acid.cantly. the plants mentioned in Siddha. Apt[-allergic plants metformin''. a sesquiterpene alcohol..tients of non-insulin-dependentdiabetes rnellitusu. Their findings indicate the potentialof Terminalia arjuna improving left ven.in plasma insulin levels nor an increase in the degrapholide.A preparation of the whole plant of Phyllanthus effects in 9 gated for their effects on a cough model hduced by maruswas found to have hy~oglycemic sulfur dioxide gas in mice. 40180.bortri~tis(Parijat)~. Its SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 258 .The extract significantly innibitedboth n the initialand later sustained phases of trachea\con. 4 of whom were diabeticsu. The Ethanolic extract of Vitex negundo(Nirgundi)of was effects were compsirable Pferocar~us marsupium found to inhibit immunologicallyinduced degranulation of mast cells better than that wt compound has been further evaluated in a multicentric (4 ceni. from the hexane soluble extract of the wood of Cedrus deodan (deodar) #. No significant change was observed i the levelslipids.portant phenolic constituents of the heartwood of pulmonary 75%) in asthmatic subjects with mild-moderate pterocarpus (vir. marsupin asthmaT5.S. derived from the alcoholic ex. as to placebo. It also inhibited be oedema during active paw tres) flexible-doseopen trial in newly-diagnosedpaNair and saraf further stud.The latter phase extract of the root bark of Salacia oblonga Wall was due to release of lipid mediators from arachi. Inhibitionof the latter phase may be sec. an active constituent of Pte-rpus better inhibition of coughn7'. The alcoholic extract of lnula racemosa ' Arbortristoside A & C. or ischaemic cardiomyopathy.

. Leaf extract of Aegle marmelos(Bilva) was found to Chronic administration of Prunus amygdalus (AloV significantly reverse the raised K.suggested to contribute to the pathological state of diabetes.Dhawan eta/. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 259 . especially in chronic hypoglycemic effects of this plant drug thus appears cases as it helps in lowering the oxidative stress in t o be mediated through regeneration of damaged diabetes0'. indicative of an hypoglycemic and hypolipidemic effect of Ocimum anti-hyperglycemicpotential of the planta8.creased the fasting and post-prandialblood glucose fects in streptozotocin induced diabetic rats"." demonstrated that D-400.Jriglyceride and total lipids were significantly lowered tion in peripheral glucose utilization in diabetic rats in the liver. In another studyw. but n t . on the peripheral utilization of glucose (de. in diabetic fects pf mode of action of 3 structurally different rats.The protective effect of Capparis decidua(Karir) paylogical and ultrastructural) parameters in tissues af der on oxidative stress and diabetes in alloxan instreptozotocin induceddiabetic rats seen by light and duced diabetic rats has been evaluated. . marmelos significantly reversed the altered (histo. SW1 showed better blood glucose lowering effect cominsulin sensitiviv. a polyherbal Oral administration of the methanolic extract (but not formulation. Alteration in the quali.containing fraction (SW1) from the plant glycogen levels. single blind triaP. it blockedthe effects ide. Hot water extract of Camellia sinensis(Black tea leaf) significantly reduced the blood glucose level and was Ocimum album (Holy basil) leaves significantly defound to possess both preventive and curative ef. They indicate the and to some extent in normal rats.serum creatinine levels at the end of 36 weeks. Dubey eta/. placebo-controlled. leaf extract of Aegle in ratss. pared to tolbutamide. The data electron microscopy to near normal and improved indicatethat Capparis decidua may have a potential the functional state of pancreatic beta cells.the decreasedI4Cglucose uptake by liver slices in in tocin induced mild and severe diabetes in rats.hypoglycemic effect. However. Swertia chirata(Chirayata) in normal and streptozo. Inhibition age. Further studies by also contributee'." studied the effect of D-400. not only brought the raised blood glucose levhypoglycemic agents. Ex. AdminThe leaf extract of Azadirachta indica had no effect istration of Ocimum sanctum leaf powderto normal per se. blood urea and sethe water extract) of aerial parts of Artemisia pallens rum creatinine in alloxan-induceddiabetic rabbits.The active factor seems to be a tozotocin induced diabetic rats. values. phospholipidsand total lipids. total cholesterol. in strep. Total cholesterol. sanctum in diabetic rats".The rise in blood sugar too in the treated group of renal proximal tubular reabsorptionof glucose may was lower than the saline control. total amino acids. mond) seeds and its proportionatefractions viz. The leaf extract was also effective in re. tolbutamide.Significant hypoglycemic effect was observed with storing blood glucose and body weight to normal 1500 mgkg dose of juice of leaves of Lantana camara valuesw. uronic on hepatic glycogen in normal and streptozotocin acid. Saxena et a1 ga compared the ef. devalues of the enzyme malate dehydrogenase. D(Daman) led to significant blood glucose lowering in 400 significantly prevented the rise in blood urea and glucbse fed hyperglycemic and alloxan induced dia.vitro studies. The use as an anti-diabetic agent.non-oil fraction which is only partly soluble in ethyl tative and quantitative nature of the enzyme has been ethePs. triglycerinduced diabetic rats. of epinephrine on glucose metabolism and reduc. centpiperalonand els to within normal limits and raised the suppressed a swerchirin. an fatted seed and oil to rabbits demonstrated a definite important enzyme in glucose metabolism. but also brought towards normal. kidney and heart. on blood glucose.and diabetic rats for a period of one month resulted termined by intravenous glucose tolerance tests) and in a significant reduction in fasting blood sugar. levels in patients with NlDDM in a randomized. crossover. pancreas.MEDICINAL PLANTS (NATURAL PRDUCTS) action may be at the peripheral level by potentiating cept in rats with severe pancreatic damage. thus betic rats. Increased peripheral utilisation of glucose showing promise against alloxan induced renal damis probably the mechanism responsible.

The extracts of four plants i. tion in serum calcium kvels as compared to saline The second areawhich has been widely worked upon animals. to be normal with respect to foetal growth. propylene glycol and glycosidal extract) to HSD-hCG vaccine1@. anti-andro. Among the administered to adult and immature mice.Only the aqueous extract suspension in 5% propylceived the HSD-hCG vaccine. the process of healing was better prolonged estrous and metaestrous. This efby the increased uterine weight and early opening fect may be beneficial in their probable wound healand cornificationof vagina in immature rats and his.cream and gel) of the adults. in immature mice. The plants increased not only lysyl d SELYCT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 260 . The menstrual pattern and ovulatory status genesislw. when administered to onstrated that the alcoholic extract (oral and topical) male mice was found to stimulate sexual behaviour of Centenella asiatica improved the rate of wound as evidenced by an increase in number of mounts healing in rats. an Ayurvedic herbal formulation. the leaves of Aloe Vera. denced by the increase in collagen content and thickEthanolic extract of Trichopus zeylanicum ness of epith$iumtoB. litter size protein and collagen content of granulartion tissue and sex ratioto4. the atretic follicles and absence of corpora lutea indicated the antiovulatory effect of the extract. An increase in with the gel formulation. However. and in tensile strength. The leaves of Azadirachta chloroform. in the field of endocrinology is the reproductive sys-Intra-dermal administrationof the essential oils from tern. co-administration of ene glycol of Centenella asiaticaas compared to the Praneemvilci did not prevent the antibody response other extracts (viz. Anti. the extract showed oestrogenic activity as seen by the early opening of the vagina. the leaves of Eucalyptus hybrid and seeds of Seseli extract Of Bupleurum marginaturn was indicum increasedcutaneous capillary permeability found to have significantoestrogenic activity as seen when tested in blue treated rabbits. promotedcollagen synthesis at pups fathered by drug treated mice were also found the wound site as evidenced by the increase in DNA. root and root bark of Aegle marmelos and Moring oleifera and leaves of Trdaxprocumbeswere foun to promote wound healing in both normal an1 irnmunocompromised(steroidtreated) rats in a space wound model. Plants promoting skin and bone healing reduced streptozotocin induced hyperglycemia and also attenuated streptozotocin induced decrease in Methanolic extract of Cissus quadrangularis superoxide dismutase activity of pancreatic islet cells (Asthishunkala) promoted the healing process of experimentally fractured radius-ulna of dogs as eviin male Charles Foster idtstw.The cellular proliferation. significantly 9.e. toloaical features of the uteruslol.S. premature cornification of vaginal epithelium and increase in uterine weightto5. it resulted in an irregular estrous cycle with aqueous extract.strength. A DAHANUKAR at el. No untoward effects were ob.and pro-fertiliy plants nationsl".ltt showed that topiand mating performance. was found to be safe when administered ing of surgically produced cutaneous wounds in as a single intra-uterine instillation in 18 healthy guinea pigs as evidenced by an increase in tensile tubectomised women. DNA content. remained unaltered and the endometrial biopsy was normal. alcoholic. In the various formulations (ointment. a highly purified oil of Azadirachta EuphonSia neriifolia (Nivadung) facilitated the healindicaseed. The treated wound epithelialised faster and the rate of wound contracBenzene extract of Hibiscus rosea sinensis (Jaswand) flowers showed differing results when tion was higher as compared to control.al administrationin rats as evigenic'properties in male rats1". Topical application of aqueous extract of latex of Praneem vilci. In 10 of the above women who had also re. denced by radiologicaland histopathologicalexami8...promoted wound healing in experimentally induced open woundson topic.ing activitylq.The treated group also exhibited a reduc. epithelialisation and angioserved. petroleum ether. However. Trasina. indica were found to have a reversible. Suguna et dem(Arogyapacha in Tamil) leaf. Sunilkumar etal. Chronic administration of cal administration of the aqueous extract increased the drug was more effective than a single dose.

12. The stones formed were mainly of All four sitavirya plants viz. The SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .12. It altered the acid and induced by implantation of zinc discs in the urinary peptic activity of gastric secretionMn. oleoresin and petroleum ether extracts 'tent. 10. an Ayurvedic formulation was effective in the treatment of acne vulgaris as seen by the sig. a pyranocoumarin isolated from the seeds of Aegle rnarmelosCorrea. 500 mglky) were were found to Lupeol and a number of its derivatives derived from have ulcero-protective effects against 2 hr cold reCrateva nurvala (Varun) were found to possess sigstraint stress ulcers. 600 mgl also significantly reduced calcium and magnesium kg). Ulcero. reserpine.420 and 840 mglkg) in mice.Treatment with Ammannia baccifera (Glycerrhizaglabra: water decoction of root. cating its efficacy as an anti-diarrhoea1 agent116.and aspirin-inducedgastric ulcers in rats and cold restraintinduced gastric ulcers in rats and guinea pigs. 400 mglkg) and Aswattha (water decoctions of bark. histamine) and by cold restraint as dissolving pre-formed ones (curative) that were stress 5-HT and histamine. officinalis (Amalki) were evaluated for their effect on gastro-intestinal motility at different dose levels (210.1. Sa!avari (Asparagus magnesium ammonium phosphate with traces of racemosus:fresh root juice. It also showed significant reulcer model.The incinerated powder at lower doses. Gastro-intestinal pro. gave significant protection against pylorus ligation. pylorus ligation-induced gastric nificant an!i-hyperoxaluric and anti-hypercalciuric and cystearnine-induced duodenal ulcers in rdts. they were ineffective against acute aspiinduced hyperoxaluria and calci~rial"~. Sunder vati. rin-induced gastric ulcers'1g.Thus the plants not onlv hastened normal heal.Leaf and seed extracts of Vernonia lasiopusand Vernificant reduction in lesion count in patients with this nonia galamensis had antiulcerogenic effects when tested using either hydrochloric acid or ethanol as condition"'. 11. The EE but not PEE decreased acid duction of gastro-intestinal motility in rats. decoctions of bark. Kutaja (Holorrhena antidysentrica : wafer levels114. showed pro-kinetic effect. whereas at higher doses. the necrotising agent in rats2'. Cytoprotective plants tent in the granuloma tissue thus indicating that the plants probably exert their action at the cellular (nu. thus indipepsin secretion and increased mucus secretion.Yastimadhu calcium oxalate. Bergenin and norbergenin. gree of ulcero-protective activity in pylorus ligated rat model of gastric ulcerations8.The The methanolic extract of rhizomes of Nelumbo nucifera showed significant inhibitory activity against petroleum ether(PEE). Plants acting o n genito-urinary system The protective effect of hot water extract of black tea Ethanolic extract of Ammannia baccifera (Camellia sinensis) was demonstrate on ulcers in(Bhatjambol) was found to be effective in reducing duced in rats by various ulcerogens (NSAIDs.and anti-kinetic plants All exqracts of the seeds of Pongamiapinnatashowed significant anti-ulcerogenic effect in fasting mice3.1. ethathe formation of urinary stones (prophylactic) as well nol.protectives clear) level. but also reversed steroid depressed healing v2. 1250 mg/kg). induced cant anti-ulcerogenic effect in the pylorus ligated rat entero-pooling in rats. isolated from the leaves and roots of 'Flueggea microcarpa and luvangetin. benzene and ethanolic(EE) extracts of the root of the same plant showed significastor oil induced diarrhoea and PGE. The plants also increased the tensile 12.1. 5-HT. PEE showed significant CNS deoression as menThree different dosage formulations (aqueous extract. protein and nucleic acid con. activity when tested in rats against hydroxyprolii-le However. two isocoumarins. The dry powder and the aqueous extract showed pro-kinetic effect at all the 3 dose levels. bladders of rats. it decreased gastro-intestinal motility"'.The alcoholic. this probably relievjng stress induced dry powder and incinerated powder) of Emblica ulceration4.of leaf of Araucaria bidwillii showed moderate deing.MEDICINAL PLANTS (NATURAL PRDUCTS) oxidase activity but also. tioned earlier. Gastric and duodenal ulcers strength of the granuloma tissue probably as a result of the increase in the glycosaminoglycan con.

1. Ail extracts (petroleum ether. Flavonoids have also been shown to increase mucus secretion. Cauvery 100. the results being similar to sulfasalazine. When administered during the pre-operatwe period to patients with obstructive jaundice. work related to hepato-protective effects of various formulations available in the Indian market. Both the drugs increased the levels of DNA. Bhatt and Bhattln have not only compiled the informationavailable regarding the studies on various promising plant drugs from India but also have discussed !he problems and pitfalls pertaining to this research. picroside-1 and kutkoside obtained from Picorrhiza kurroa.the resultslm. Picroliv administration in rats followio~ exposure to Two reviews have been published which cover most alcohol resulted in lowering of various biochemical of the works carried out in this field.. RNA. induced by CCI. demonstrated significant anti-ulcerogenic activity in three experimental studies carried out separately by Mitra et a1 lZf.. another polyherbal formulation. Pretreatment wlth the aqueous extract of Emblica officinalisprotected against ethanol. as revealed from the stud\es in the rat model of cholestasis wherein Tinospora codifolia was found to decrease the mortality in cholestatic rats. increased pepsin activity and gastrin levels and increased the uptake of titnted thymidine into the~lcer area. . A. it was found to decrease the post-operative morbidity and mortality (due to sepsis and liver cell failure).2. better were .Though Tinospora cordifolia was found to significantly decrease the complications associated with pre-operative biliary decompression viz. benzene. Some of the agents worth mentioning are as follows: Tinospora cordifolia. The extracts contained terpenoids and flavonoids which were shown to have marked inhibitoryeffect on PAF. stages when evaluated on partially hepatectomised rats. Earlier the therapy following cholestasis. as compared to untreated animalsf2'. gastro-protectiveeffects of bergenin and norbergenin could be due to increased prostaglandin production as demonstrated using human colonic mucosal incubates. sepsis and immunosuppression. a plant which has been shown to decrease fibrosis in rats. a polyherbalformulation.This mechanismwas not responsible for the observed effects of luvangetinas it did not affect prostaglandin productioniz0. scan microscopical changes in rectal biopsies and blood parameters (haemoglobin. UL-409. Vaidya etal. The stool characteristics along with histopathological. It decreased the raised hexosamine and sialic acid levels in the ulcertowards normal. showed antiulcerogenic activity when tested against indomethacin induced ulcers in rats. by replacing the age-old procedure of biliary decompression by an immunomodulator129. basis for improved prognosis apThe pears to be the reduction in the incidence of endotoxaemia. prostaglandin synthesis and'blood flowye. 12.protected against ethanol It - - SELECT RESEARCH PAPERS u ~ l EVIDENCE BASED AYURVEDIC DRUGS 262 . Is parametersof liver and serum that were elevated with have reviewed the experimental and clinical research alcohol con~umption'~. phosphorus. a flavolignan component of Silyburn marianum seeds were shown to stimulate liver regenerationin the early . Vanisree et a1 lP and Kulkarni and Goel1%. Similarly.induced gastric damage in rats (evaluated by the Evan's blue method) 'I7. Both picroliv and silymarin. the prognosis was found to better when Tinospora cordifoliawas instituted alone in preoperative period. total leukocytes and eosinophils) improved following treatment with Boswellia serrata gum resin preparation. Picroliv is a standardised preparatio6 of irioid glycosides.S.proteins. chloroform. This raises the possibility that anti-fibrotic effect of Tinospora cordifolia is mediated through activation of kupffer cells'". was to significantly improved the' suppressed Kupffer cell function in another rat model of chronic liver damage induced by heterologous serum. protein and ch~lesterol'~'.restraint stress because of their anti-stress effects. serum iron.induced and cold restraint. DAHANUKAR at a/. This was associated with bolstering of phagocytic and intracellular killing capacities of polymorphonuclear tells. These findings focus on the need to alter the preoperative management protocol for obstructive jaundice. acetone and ethanolic) of Abies pindrowleaf showed ulcero-protective effect in a model of cold . calcium.Ulcerativecolitis Gupta et a1 lZs studied the protective effect of Boswellia serrata in patients suffering from (grade II and Ill) ulcerative colitis.

INH. alkaline phosphatase) and raised the root thickness and dosage forms (aqueous or powlowered protein concentration. SGOT. prothrombintime and liver lipid peroxide conand neoandrographolide. ATPase levels. (SGPT. Administration of the aqueous extract of Andrographis paniculatato mice The importance of morphological features and time suffering from liver damage induced by hexachloro. induced liver damage indicating that these drugs have a protective effect on hepatic enzyme activityq4' Liv. andrographiside lirubin. 100 is an improvisedherbal formulationof Liv52. an Unani cantly less in drug treated animals. liver GSH. Probable mecha. stimulated the binding of LDL with the liver receptors and enhanced the faecal excretidn of bile acids.drug has more hepato-protective activity than the age as seen by a significant decrease in malondial. lation Kumaryasava were found to stimulate de- I also showed a dose dependent hepatoprotective effect against oxytetracycline induced hepatic damage in ratslM. confirming its mernperoxidation whereas andrographiside had mainly brane stabilising and antioxidant proper tie^'^^. a polyherbal formulation. Histopathological lebound Na+/K+ sions of liver and lipid peroxidation were also signifi. catalase and membrane the anti-tubercular drugs in ratsi*. pre. In an in vitro study combination of Liv52 and Livl00 reduced the peroxidation effect of hydrogen peroxide in rat liver homogenate. ACP significantly improved ethanol metabolism in a rat and ALP.MEDICINAL PLANTS (NATURAL PRDUCTS) (40%) induced toxicity in isolated rat hepatocyteslJf. cathepsin 6. acid phosphatase and ribonuclease in CCI.powder form. anti-lipoperoxidant activity'".isolated from Andrographis tent and also improved the histopathological findings. 52 and Liv. probably due to better absorption of dehyde content". Liv-52 and another formu. Further studies caras silymarin with respect to its effects on reduced ried out on Jigrinc by the same group showed that it glutathione.'% demonstrated that treatment with oxidant potential of Liv. paniculatademonstrated anti-oxidant effects in CCI.triglycerides peroxidase and superoxide dismutase and lipid and lipid peroxides in the liver. Both. glucose 6 phosphate significant protection against hepato-toxic effects of dehydrogenase (GGPD).Treatment with this drug significantly reversed the changes in lipid metabolism induced by Plasmodium berghei.patic damage induced by either alcohol. 100'".'& at the National mation.the studies have shown that the aqueous form of the vented lipid peroxidation in CCI.the liquid form. (Summer) exhibited marked protection as deterhlined Administration of Liv-52. SimultanPicrorrhiza kurroa in carbon tetrachloride treated eous administrationof Liv-100with the anti-tubercumice significantly reversed the altered serum ALT.polypharmaceuticalherbal formulationcontaining 14 nism of action of Picrorrhiza kurroaappears to be its medicinal plants. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 263 . andrographolide. SGPT. induced liver dam. biThe diterpenes. significantly lowered the raised enzymes Botanical Research Institute. Results showed that aqueous extract of roots of diameter 1-3 cms. glutathione 5-transferase. carbon tetrachlorideor paracetamolin rats. by assessing serum enz)'. glutathione also reduced the levels of gamma-GTP. The results confirm der) on the hepato-protective activity of Boerrhavia the hepato-protective property of Andrographis diffusa (Punarnava)was evaluated in thioacetamide paniculata and suggest its probable role in delaying intoxicated rats. The authors have attributed its hepato-protectiveeftreated mice. SGOT.a study conducted by Rawat eta/. but not GLDH and bilirubin. total thiol. thus resulting in a return of circulatory lipoproteins towards normal. Neoandrographolide was as effective fect to its anti-oxidant property1".The protective effect of picroliv against hepatic damage caused by Plasmodium bergheiinfection in Mastomys cauchawas studied by Ramesh et alia5. The protective effect of these drugs was attributed to the enhanced supply of reduced glutathione that inhibited the deleterious process of lipid peroxidation.The effect of seasons.of collection of raw material-canbe understoodfrom cyclohexane (BHC) that ultimately leads to tumor for.The hepato-protective effect of Jigrine. It also model of chronic alcohol administrati~n'~~. was evaluated in 3 models of heeffect as a free radical scavenger and inhibitor of li. lar drugs.This suggested the antiSantra et a/. pressed hepatic enzyme activities such as hepatic arginase. rifampicin and pyrazinamide showed AST. Furthermore. reduced the increased serum transaminases. collected in May the hepatic tumorigenic conditioni3*. Jigrine significantly pid peroxidation of liver plasma membrane.nes viz. It reactivatedthe plasma and liver lipolytic enzymes.

intra-venousor oral routesIY. Cumene hydroperoxideinduced its effects by stimulating stem. with Emblica officinalis. and antibddy dependent cellula. Similarly. cycloph~sphamide. and liver superoxide dismutase activity and increased catalase activity-Theyalso decreased the frequency The protective effect of Ernblica officinalisin experi. Emblica The water extract of leaf of Ocimumsantumwas more officinalis inhibited the increase in serum amylase effective and less toxic. Microscopical examination ethanol extract.cell Active principles of Withania somniferaconsisting of Tamra-bhasma. RBC and WBC counts. UV light induced Methanolic extract (75%) of Withania somnifera (a plant belongingto the Rasayana group of drugs) sig. Tee intra-peritoneal route gave the best protection as compared to intra-muscular.Sobatum. 13. showed that the acinar cell damage and total inflam. platelet count and nificantly in 2 models of cataract i.UV light induced damage by free radicals on the bacthal dose of gamma radiatioct It 4so increased bone teria Salmonella typhimurium.Membrane stabilizers The leaf and root extracts of Vernonia lasiopus and Oral administration of Rasayana group of drugs (from Vernonia galamensisdemonstratedprominent in vitro Ayurveda) were found to significantly increase total membrane stabilising property as determined by the WBC count.erated by the reaction of photoreduced riboflavin and lowing radiation. purified from the plant Solanum trlobatum nificantly increased the WBC count in normal Balblc (Alarka) showed significant protectionin vitro against mice and reducedthe leucopenia induced by suble. Rasayana'sreduced 13. as Leaves of Ocimum sanctum delayed the onset as seen by a significant increase in haemoglobin cont well as the subsequent maturation of cataract sigcentration. bone marrow cellularitv. a known antioxidantIs2. azathioprine or prednisolone. galactosamic body weight and hemolytic antibody responses to cataract in rats and naphthalenecataract in rabbits1". induced hepatotoxicity in rats. ellagic acid. IU. DAHANUKAR eta/. Withania somnifera probably exerts oxygen1%. Withania somnifera prevented mylosuppression induced bv one or more of the following 3 compounds. it also promarrow cellularity and normalised the ratio of tected against superoxide production that was gennormochromatic to polychromatic erythrocytes fol.when administeredintra-peritoneally before a whole matory score was significantly less in dogs pretreated body exposure to 11Gy of 60 Co gamma radiation.S.of micronucleatedpolychromatic erythrocytes seen mentally induced acute necrotising pancreatitis in after whole body irradiation in mice1=. an organo-mineral compound from SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 264 .1. In these rats.. in improving the survival rate in mice.lung fibrosis in rats following whole b ~ d irradiation. 13.7. bixin and alpha-tocopherol significantly Hepatoprotectiveeffects of other medicinal plants that decreased lung collagen hydroxyproline and thus y have been evaluated in various models of liver dis. dogs has been evaluated by Thorat et al. natural killer cell percentage inhibition of RBC lysis n. cytotoxicity in gamma radiation exposed mice. as compared to aqueous caused by pancreatitis. curcumin. They also lowered serum and liver lipid peroxidation eases are given in Table 1. Oral administration of anti-oxidants viz.2. la screening of drugs that may protect against CCI. human erythrocytesiq. Measurement of urinary excretion of ascorbic acid thus serves as a parameterfor hepatoprotective effect of a drug. comparableto deprenyl.e. 12. catalase and glutathione peroxide activities in rat brain frontal cortex and striatum. A novel non-invasive parameter has been developed for by Visweswaram et al. urinary excretion of ascorbic acid is reduced. Plahts protecting against oxidative sfress radiation induced lipid peroxidationin liver1*. equimolar concentrationsof sitoindosidesVII-X and withaferin A induced a dose-related increase in superoxide dismutase. A.

The potential of Bacopa monniera as an antioxidant l The was studied by Tripathi e a/.14. effect of the alcoholic and hexane fractions of Bacopa monniera on FeSO. showed significant protection against tion of reduced glutathione.assaytb3. Rubiadin. a dihydroxy anthraquinone. but at higher concentracumene hydroperoxide inducedlipid peroxidationand tions. lowered reduced glutathione and superoxide dismutase levels in rat Liver homogenate.MEDICINAL PLANTS (NATURAL PRDUCTS) Ayurveda. a carbazole alkaloid.anti-viral. Due to a lack of ideal diffusion and evaporation from the surface it is generally difficult to assess the SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 265 . In addition. Chemotherapeutic plant products nificantly reducedmalondealdehyde (MDA) levels. Escherichia coli. isolated from an alcoholic extract of the stem bark of Clausena anisata activip. most of the work has carried out in vitro. anti-fungal and moderate insecticidal. Bacillus cereus. which was found to be largely responsible for the biological activities The alcoholic extract of dry nuts of Semecarpus anacardium(Bhal1atak)showed bactericidal activity in vitro against 3 gram negative strains (Escherichia coli. was found to be active against gram positive and 13. dysentriae. Anti-peroxidative property of Nardostachys jatamanasi(Jatamanasi) was tested in vitro by using iron induced lipid peroxidation in rat liver homogenate. Bacillus stearothermophilus. especially the leaf extract. Salmonella typhi and Proteus vulgaris) and 2 gram positive strair?s (Staphylococcus aureus and Corynebacteriumdiphtheriae). it enhanced the rate of oxidation.The degree of peroxidation was quantitated by thiobarbituric acid reactive substance (TBARS) con? tent. It also sig. Chromatographicfractionation of the stem led to the isolation of kaur-16-en-19-oicacid. anti-fungal. Bacillussubtilis. induced oxida- Substantialanti-microbial. sporicidal and cytotoxic activities were observed with the hexane extract of the stem bark of Amona glabra. an Ayurvedic drug was evalu. Sandhika. and t-butylhydroperoxide (t-BHP) in a dose depended manner.'. it only slightly protected the auto-oxidation and FeSO.14. No Plants which have shown anti-microbial. coagulase positive Sfaphylococcusaureus. alterations in biochemical and histopathologicalpa. twigs. lM. No derrnatoxic effect (irritant property) was observed in the mouse skin irritant. and cumene hydroperoxide induced lipid peroxidation was studied. The anti-oxidant property of the preparation has been found to be better than that of EDTA.The percent inhibitionwas more in the case of Fez+induced lipid peroxidation. The alcoholic fraction showed greater protection against both that inducers and the results were comparable to known antioxidants like vitamin C. anti-protozoal and anti-helminthic effects rameters was noted. Vitamin E and pbenzoquinonel".itylm.The rssults thus suggested that have been described in this section. Similarly. Standard astamra bhasma is a potent anti-oxidant drug and can says have been used by various investigators and be used in the management of lipid peroxidationln. . The acetone and alcoholic extracts of the leaves of Cassia alata showed significant in vitro anti-bactea ial activity against Staphylococcus aureus. Probable mechanism of action could be through metal chelation at the initiation level and also as a chain breaker suggesting that Bacopa monniera is a potent anti-oxidant. Both the hexane and alcoholic extracts provided protection against lipid peroxidation(the hexanefraction was more potent) suggesting that the plant does have anti-oxidantacti\. No anti-bacterial activity with any extract of either the root or seeds of Pongamia pinnatawas noted3.1. mannitol. Subsequent studies have shown that the alcoholic extracts of different parts of the plant (leaves. Iron induced 'gram negative bacteria and fungitg1. Anti-microbialagents : ated in vitro using the same model (cumene hydroperoxide) and showed significant antioxidant Clausenol. At low doses. the alcoholic extract also inhibited growth of Klebsiella pneumoniaewhereasthe acetone extract inhibited the growth of Vibrio cholerael". The responses with Bacopa monniera were found to be dose-dependent. isolated from alcoholic extract of Rubia cordifolia (rnanjistha) demonstrated significant anti-oxidant property as it prevented lipid peroxidation induced by FeSO. green fruit) also possess anti-bacterialproperties.3. Salmonella typhi and Salmonella.

anti-bacterialpropertiesof aromatic oils derived from plants using the agar cup and disc diffusion methods. Hence, Agnihotri and Vaidya lU to develhave oped a novel approach to study the anti-bacterial property of certain plants like Eugenia caryophyllus, Thymus vulgaris, Cinnamonum zeylanium and Cuminum cyminum. Volatile components of the hexane extracts of these plants were tested against standard gram positive an6 gram negative bacteria grown on agar slants and the results were expressed as percentage inhibitionof the area of the slants. Of the 4 Plants selected, Thymus vulgaris had the most prominent anti-bacterial activity.

Ricinus communis (Erand) (75%) and Lawsonia inermis (74.33%) while the minimum activity was exhibited by Jatropha curcas (lOO/~). The essential oil isolated from the leaves of Aegle marmelos exhibited significant anti-fungal a c t i h against different fungal isolates and 100% inhibition of spore germination of all the tested fungi when eval'uated~~in~ the spore germination assay. Kinetic studies showed that the inhibition was both concentration as well as time dependenttn.

Four compounds have been isolated from an extract preparedfrom the fruit rind of Terminalia belerica viz. termilignan, thannilignan (both lignans), 7-hydroxy14.2. Anti-fungalagents 3',4'-(methylenedioxy) flavone and anolignan B. All The ethanolic extract of Azadirachta indica leaves possessed demonstrable anti-HIV-1, anti-malarial, demonstrated much more significant anti- and anti-fungal activity in vitro172.1n. dermatophytic activity as compared to the aqueous extract, when tested in vitro agains?88 clinical iso- The natural xanthones isolated from the fruit hulls of lates of dermatophytes using the agar dilution tech- Garcinia mangostana showed good inhibitory activnique.The MIC90 of ethanolic extract was 100 pg/ml ity against the three phytopathogenicfungi, Fusarium whereas that of aqueous extract was 500 pglmllw. vasinfectum, Alternaria tenuis, and Dreschlera oryzae. Substitution in the A and C rinqs in the deFour Siddha drugs viz Nandhi mezhugh, Parangi rivatives of mangostin obtained by has been shown pattai choornam, Erasa kenthi mezhugu and Vaan to modify the bioactivities of the compound^"^. mezhugu (in order of efficacy) were found to have significant anti-fungalactivity when tested against 14 The petroleum ether, chloroform, acetone and ethanol ( 5 ) extracts of the leaves of Cassia alafaalso 9O strains of Candida albicansl". showed significantin vitro anti-fungal activity against Essential oil obtained from the herb of Santolina various fungi viz. Aspergillus niger; R. japonicum, chamaecyparissus showed significant anti-fungal Candida albicans, C. tropiathis and R. g l ~ t i n i s ~ ~ ~ . activity both in vitro (against 13 strains of Candida albicans) and in vivo (experimentally induced vagi- The root of Withania somnifera was found to be efnal and systemic candidiasis in mice)16', It also fective in prolonging the survival of Balblc mice inshowed activity against experimentally induced su- fected intravenously with Apergillus fumigatus. This perficial cutaneous mycoses in guinea pigs by the protective activity is probably due to the observed hair root invasion testq6*. Anti-bacterial activity was increase in phagocytosis and intracellular killing caalso observed as seen by its inhibitory effects on the pacity of peritoneal macrophages induced by treatgrowth of Staphylococcus aureus, Bacillus subtitis, ment with Withania somnifera, thus suggesting that the plant has the potential to activate macrophage BaciNus caerus and Escherichia coli. function in infectious states176. Rai 170screened 17-medicinalplants against the test pathogen, Pestalotiopsis mangiferaeand the results 14.3. Anti-viralagents revealed that 14 plants had anti-mycotic activity Although initial studies by Thyagarajan et a/, In with whereas 3-plants, vir 4rgemone mexicana, Phyllanthus amarus showed promising results in Caesalpinia bonducelraand Casia fistulaaccelerated Hepatitis B carriers, further studies have demonthe growth of the pathogen. Maximum antimycotic strated that the plant does not clear the hepatitis B activity was shown by Eucalyptusglobulus(88%) and surface antigen (HbsAg) in asymptomatic carriers of Catharanthus roseus (88%) followed by Ocimum the antigen17'. However, recently, in an in vitrostudy, sanctum (85.50%), Azadirachta indica (84.66%), the aqueous extract of Phyllanthus amarus was

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MEDICINAL PLANTS (NATURAL PRDUCTS) . Table 1 Illustrates the other plants that have been evaluated in various models of liver diseases and the parameters selected for their evaluation. PlanWPlant derived agents (Author) Methanolic extracts of the seeds of Apium graveolens Linn. and Hygrophiliaauriculata H Damaging agent (Animals)
) ) rats Thioacetamide )

Parameters of evaluation Uver functlon tests (AST, ALT, alkaline phosphatase, sorbitol dehydrogenase. glutamate dehydrogenase and.bilirubin). Hepatic triglycerides, Histopathology. Liver function tests, Histopathology. Hepatic total lipids, triglycerides, phospholipids, free fatty acids Liver function tests, Liver glycogen content. Serum cholesterol. Histopathology. Liver function tests, Histopathology. Liver function tests, Histopathology. Liver function tests (AST, ALT). Blood and hepatic giutathione levels. Hepatic lipid peroxide content Histopathology. . Liver function tests

Paracetamd

50% alcoholic extrad of

Phyllanthus embljca and its isolate. q~ercetin~~~ Garlic oilsm Swertia chiratSn

Country made liquor ingestion (rats). Paracetamd (mice) Radioc?lcium (micer CCI, (rats)

,

Ethyl acetate extract of Acacia catechu (katha) 2n Leaf extract of Glycosmis pentaphylf13 Propolis. a natural resin produced by honey bees, rich in flavonoids2" Powdered roots and aerial parts of Sjda rt~ombifolia their ague and Plant leaf suspension and methanolic extract of Trichopus ~ e y l a n i c u 3 ~ Methanolic extract of Tiichopus zeyianicus 27s

CCI, (rats) CCI, (rats) Alcohol and CCI, (rats)

C I paracetambl and C, rifampicin (rats) Paracetamol (rats)

Liver function tests. Histopathology. . Hepatic and lipid peroxide contents. Cholerectic activity

Normal rats

incubatedwith the Alexandar ceH line, a human hepatocellular carcinoma derived cell line which has the property of secretingthe Hepatitis B surface antigen (HbsAg) in the supernatant. The results demonstrated that Phyllanthus amarus was effective in inhibiting the secretion of HbsAg for 48 hrs thus proving its anti-hepatitis B virus property at the cellular level1m.

-.

Glycyrrhkaglabra (Yasthimadhu) was tested against RNA viruses like the Chandripura virus, Measles virus, Polio vaccine viruses type 1,2 and 3, Polio wild type viruses 1, 2 and 3 as well as DNA viruses like the Herpes type 1 and 2 viruses in vitro. It inhibited the DNA virus plaque formation at lower concentrations (0.608 mM) while the RNA viruses were inhibited at higher concentrations (1.216 mM) Im.
I8l

Glycyrrhizin, a triterpenoid glycoside obtained from Premanathan et a/,

carried out in vitro screening

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of mangrove plant extracts for anti-immunodeficiency virus activity. HIV infected MT4 cells were incubated with the extract and anti-viral activity was detected using tetrazolium-based colorimetric assay. Seven extractswere found to be effectivefive of which (bark of Rhizophora mucronataand leaves of Excoecaria agallocha, Ceriops decandra, Rhizophora apiculata, Rhizophoralamarckit) completely inhibitedthe virus adsorption to the cells.
14.4.Anti-protozoal agents 14.4.1. Antimalarial :

14.5. Anthelminthic agents
14.5-1. Anti-Nematodes

Kumar et a1ln studied the mechanism of action has of palasonin, the active principle of Butea frondosa seeds onAscaridia gallL Palasonin inhibited glucose uptakeand depletedthe glycogen content1" and thus the possible mechanism of A anthelminthic action s may be relatedto inhibition of energy metabolism. Both aqueous and alcoholic extracts of the leavesof SencionudicaulisBuch Hamwere found to exert antifilarial activity ,when tested against Setaria cervi (Nematoda Filarioidea).The effective concentrations differed for the aqueous and alcoholic extracts suggesting the presenceof a cuticularpermeabilitybarrier. Both extracts also demonstrated micro-filaricidal action in vitro.Their anti-filarial responses were similar to diethylcarbamazinein that they too did not block the stimulant effeot of acetylcholine on the wormlu.

Ethanolic and petroleum extracts of Artemisia japonica, Artemisia maritimia and Arlemisia nilegaricawere tested for anti-malarial activity, both in vivo and in vitro. In vivo studies were carried out in Balblc mice using the Rane test wherein all the compounds prolonged the survival time of the mice. In vitro, all 3 compounds inhibited schisont maturation in chloroquine sensitive strains of Plasmodium falciCo-administrationof Rbgulipid, a herbal formulation, parum'=. *with diethylcarbamazine therapy to patients sufferBall shaped wood scrappings soaked in 5% Neem ing from filariasis was found to decrease chyluria ir oil (Azadirachtaindica) diluted in acetone and placed these patients1". in water storage overhead tanks controlledthe breedMustafa et allwinjectedthe excretory-secretojpoding of Anopheles stephensiandAedes aegyptiin45 ucts released by the adult Setaria cervi, a bovine days1*'. Similarly, application of a cream of filarial parasite, into rabbits to raise polyvalentantiAzadimchta indicaon exposed body parts at the rate bodies.The$eantibodies can be used to detect circuof 2.0 gm/person significantly protected against lating antigens in sera by counter immuno-electroAedes, Culex and Anopheles musquitoe biesIu. phoresis and serve as a diagnostic test for filariasis. The methanolic extract of Swertia chimta was found to inhibit the catalytic activity of topoisomerase Ienzyme of Leishmania donovani. On subjecting the extract to fractionation, it yielded 3 secoiridoid glycosides, amarogentin, amarohwerin and sweroside of which amacogentin was found to be a potent inhibitor of topoisomerase I and exerted its effect by interactingwith the enzyme, thus preventing binary complex formation1-.
14.5.2. Anti-Trematode (fluke) The root tuber extract of Flemingia vestita, an indigenous medicinal plant in Meghalaya, exhibited antihelminthicactivity in vitro, against 2 species of flukes, Artyfechinostomum sufrartyfex and Fasciolopsis buski. It caused paralysis in both the spedes. Stereoscanning observations on the tegumental surfaces revealed sloughing off of most of the spines or their deformation and wrinkling and rupture of the general tegument1". 14.5.3. Agents with molluscicidalactivity

Crude 50% ethanolic extract of Parthenium hysterophorus flowers exhibited trypanocidal activy nsm ip evansi both in vitro and in ity against 7aoo a vim. Toxicity was seen only at 1g / kg doselm.

The leaf, bark, cake and oil of Azadirachta indicaand synthetic pesticides derived from the plant domonstrated both, dose and time dependent, molluscicidal activity when tested against the snails, Lymnaga

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MEDICINAL PLANTS (NATURAL PRDUCTS)

acuminata and'lndoplanorbis exustus. The cidal effect of pure azadirachtinwas greaterthen that of the synthetic mollusci~ides~~.
15. Anti-mutagenic plants

thymidine uptake studies, thus demonstrating its anti- ' cancer The anti-tumor effect of the crude extract of Centella asiatica as well as its ~artially purified fraction was studied in both, in vitro short and long term chemosensitivity test systems and in vivo tumor models. The purified fraction inhibited the proliferation of transformed cell lines of Ehrlich ascites tumor cells and Dalton's lymphoma ascites tumor cells more significantlythan the crude extract. It also significantly suppressed the multiplication of mouse lung fibroblast cells in long term culture. In vivo administration of both extracts retarded the development of solid and ascites tumors and increased the lifespan of the tumor bearing mice.Tritiated thymidine, uridine and leucine incorporation assays suggest that the purified fraction acts directly on DNA synthesis1". The methanol eluted fraction of the petroleum ether extract of the root bark of Salacia otilonga Wall showed 100% cytotoxicity on Ehrlich ascites tumor cellsM. Fresh root suspension of Janakia arayalpathra exhibited strong anti-tumor effects in mice challenged with Ehrlich Ascitic Carcinoma (EAC) cells. It prolongedthe survival of all mice and protecteda number of mice from tumor growth, probably by enhancing the activity of the immune systemtgg.

Punark, a mixture of solvent extracts of natural products, namely turmeric (Curcuma tonga), betel leaf (Piperbetel) and catechu (Acacia catechu) protected against benzo (a) pyrene inducedchromosomaldamage in human lymphocytes in vitro '=. Alcoholic extracts of tumeric oil (TD) and tumeric oleoresin (TOR) showed anti-mutageniceffect in vitro.They also demonstrated chemoprotective effect in lymphocytes of normal healthy subjects in vitrowhen tested against benzo (a) pyrene induced DNA damage. In vivo the extracts reduced DNA damage (cytogenetic damage) in oral mucosalcells of patients with oral submucous Water, oil and alcoholic extracts of nuts of Semecarpus anacardiumwere found to be anti-mutagenic when tested against benzo (a) pyrene (BZP) in the bacterial test system using Salmonella typhimurium strainsTA98 andTA100. The water ex. tract was less-effectiveas compared to the oil and alcoholic extracts. In addition, the water and alcoholic extracts showed anti-mutaginic effect when tested in lymphocyte cultures of normal healthy volunteers'". Ellagic acid, a fraction isolatedfrom Terminalia arju'na has been evaluated for it anti-mutagenic potential in TA98 and TA100 strains of Salmonella typhimurium against direct and indirect - acting mutagens. The f.raction was quite effective against S9-dependent 2AF while it showed moderate effect against NPDigg.
16. Anti-cancer plants

-

*

Withaferin A, a steroidal lactone isolated from the roots of Withania somnifera, reduced survival of V79 cells in a dose-dependent manner.The applicability of this drug as a radiosensitizer in cancer therapy needs to be exploredzo0. Banerjee etal, have studied the modulatory influence of the alcoholic'extract of leaves of Ocimum sanctum on various enzyme levels in the liver, lung and stomach of mouse. Oral treatment with the extract significantlyelevatedthe activities of cytochrome P450, cytochrome b5, arylhydrocarbon hydroxylase and glutathione S-transferaseenzvmes. all of which are important in the detoxificationof carcinogens as well as mutagens. Moreover, it also significantly elevated extra-hepatic glutathione S-transferase and reducedglutathione levels in the liver, lung and stomach. These observations suggest that the leaf extract or its active principles may have a potential role in the chemoprevention of chemicalcarcinogenesis.

The potential role of various plants in cancer therapy as either a direct anti-canceragent, chemopreventive agent, radiosensitizer or immunity enhancer is presented in the following paragraphs. Evaluation of the in vitro anti-cancer effects of bioflavonoids, viz. quercelon, catechin, luteolin and rutin against human carcinoma of larynx (Hep-2) and sarcoma 180 (S-180) cell lines showed that only luteolinand quercetin inhibited the proliferationof the cells. Luteolin caused depletion of glutathione in the cells and a decline in DNA synthesis, as seen by 3H

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S1W S. A DAHANUKAR et EL.

Studies conducted by Rao eta/, have shown that pergularinine (PgL) and tylophorinidine (TPD) isolated from Pergulada pallida are potently toxic and inhibit the growth of Lactobacillus leichmannii cells by binding to thymidylate synthetase.The binding led to significant inhibitionof thymidylate synthetase activity making them potential anti-tumor agents.

lighted the therapeutic potential of immunomodulatory angets from plant products. They have evaluated Indian medicinal plants for immunomodulatory activityz0'. The authors have also reviewed the Ayurvedic concepts of preventive health care. A list of Ayurvedic medicinal plants showing immunomodulatoryactivity has been provided which includes agents like Withania somnifera, Allium sativum, Petroleum ether.extract of Hygrophilic spinosa ex- Azadirachta indica, Piper longum, Asparagus hibitedanti-tumor activity in Ehlrich ascitic carcinoma racemosus, Glycyrrhiza glpbra, Aloe vera, Gmelina and sarcoma 160 bearing mice MS. arborea and Tinospora cordifolia. Aqueous extract of Podophyllumhexandrum, a herb Thatte and Dahanukar, *0° have described how clues from the Himalayas, demonstrated significant anti- from the description of ancient writings can lead to tumor effects when drug was tested in strainlA'mice the development of new immunostimulatoryagents. carrying solid tumors developed by transplanting The experiments carried out to prove the rasayana Ehrlich ascites tumor cells. Radioprotective effects concept of Ayuweda have demonstrated that Asparawere also seen when the drug was administrated to gus racemosus, Tinospora cordifolia and Withania mice before whole body lethal irradiation of 10 GyzM. somnifera protected animals against infections in The chemopreventive efficacy of Trianthema portulacastrum L.Aizoaceae was tested in male Sprague-Dawley rats. Hepatocarcinogenesis was induced by the potent carcinogen diethylnitrosoamine (DENA).Treatment of the rats with aqueous, ethanolic and chloroform fractions of the plant extract at a dose of 100 mgtkg once daily reduced the incidence, numerical preponderance, multiplicity and size distributipn. of visible neoplastic nodules. Morphometric evaluation of focal lesions showed a reduction in number of altered liver cell foci per square centimeter as well as of average area of individual lesion. A decrease in the percentage of liver parenchyma occupied by foci seems to suggest the anti-carcinogenic potential d the plant extract in DENA-induced f hepatocarcinogenesiszM. Pretreatmentwith Ocimum sanctumleaf extract followed by the addition of 7,12-dimethylbenzIa1anthracene (DMBA) significantly blocked the formation of DMBA-DNA adducts in primary cultures of rat hepatocytesin vitro.The viability of the cells was not adversely affected by the extractm.
17. Immune active plants

normal and immunosuppressed states induced by hemisplenectomy or surgery2j0.These plants also produced leucocytosiswith predominant neutrophilia and prevented, to varying degrees, the leucopenia induced by cyclophosphomide. They were found to activate the polymorphonuclear and monocyte-macrophage systems. Only those rasayanas which produced sweet (madhur) vipaka (Tinospora cordifolia, Asparagus racemosus, Emblica officinalis, Terminalia chebula and Withania somnifera) were found to stimulate the reticulo-endothelial system, but not those like Acorus calamus, Commiphora mukuland Picorrhiza kurroa, which produced bitter (katu) vipakaZt0. Among the immunostimulant rasayanas, Tinospora cordlfolia has been extensivelvstudied bv Dahanukar et a1z,ql. It has been found td activate ihe mononuclear cells to release cytokines like GMCSF m2 and IL-1 in a dose dependent manner "O. Whole aqueous extract of Tinospora cordifolia, standardized using HPTLC, has been evaluated as an adjuvant in clinicalconditions like obstructivejaundice, tuberculosis and cancer chemotherapy and has been found to increase the efficacy of conventional therapyti0. Active principles of Tinospora cordifolia were found to possess anticomplementaryand immunomodulatory activities. Syringin (TC-4) and cocdiol (TC-7) inhibited the in vitro immunohaemolysis of antibody coated sheep erythrocytes by guinea pig serum by inhibiting the C3-convertase of the classical

Modulation of the immune response through stimulation or suppression may help in maintaining a disease free state. Agents that activate host defence mechanisms in the presence of an impairedimmune responsiveness can provide supportive therapy to conventional chemotherapy. Upadhyap7 has high-

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MEDICINAL PLANTS (NATURAL PRDUCTS)

complement pathway.The compounds also gave rise to significant increases in IgG antibodies in serum. Both humoraland cell-mediatedimmunity were dosedependently enhanced. Macrophage activation was reportedfor cordioside (TC-2), cordiofoliosideA (TC5) and cordiol (TC-7) and this activation was more pronouncedwith increasing incubation times21a.

to have irnmunostimulatory properties in mice. It stimulated an increase in humoral antibody titres and also of antibody secreting spleen cells in the plaque forming cells assay following immunisationwith sheep erythrocytes. It also increasedthe number of perito- . neat macrophages and produced an increase in delayed hypersensitivity reaction in mice lge.

The effect of Asparagus racemosus, Tinospora The alkaloidal fraction of Boerrhiva diffusa significordifolia, Withania somnifera and Picorrhiza kurroa cantly restoredthe suppressed humoral response in on macrophage function obtained from mice treated stressed rats as observed by Mungantiwar et a1,218 with the carcinogen, ochratoxin (OTA) was evaluated wherein Boerrhiva diffusaincreasedthe suppressed with by ~hule~~l'.~reatment these plants significantly antibody titres following immunizationby sheep RBCs attenuated the OTA-induceds u ~ ~ r e s s i o nchemo- in rats subjected to restraint stress. It also signifiof tactic activity as well as IL-1 arid TNF-a production cantly reversed the depleted adrenal cortisol level by macrophages. Moreover, Withania somnifera po- and the elevated plasma cortisol level in the stressed rats, thus appearing to have a corticosteroidsparing tentiated 'macrophage chemotaxis and ~ s ~ a r a $ u s racemosus induced excessive production of TNF-a effect in experimental stress.. as compared to controls. Immune-21, a polyherbal natural'product, has been Ray etaI2l5 demonstrated that ovalbumin immunized shown to exhibit significant irnmunopotentiatingand mice treated with Azadirachta indicaleaf extract had immuno-prophylactic activity, both in vitro and in higher IgG and IgM levels and anti-ovalbumin anti- vivdq9. body titres as compared to control (humoral response). Azadirachta indica also induced cell medi- 18. Adaptogens ated response as seen from the enhancement of Adaptogen is a term used to describe agents that macrophage migration inhibition and footpad thick- increase the nonspecific resistance of organisms ness. These findings were supported by Ansari against a variety of stressors. A recent review on etal, n6.They found that Azadirachta indicapotenti- adaptogens, 211 describes the developments taking ated the antibody titres following typhoid H. antigen place in this field and the problems associated in'the immunisation and induced delayed hypersensitivity evaluation of adaptogens. following administration of tuberculin and DNCB to animals. In human volunteers, it stimulated humoral In a series of experiments the whole, aqueous standimmunity by increasing antibody levels and cell me- ardised extracts of Tinospora cordifolia, Asparagus diated immunity by increasing total lymphocyte and racemosus. Emblica officinAlis. Withania somnifera. T-cell count in 21 days. Piper longum and Terminalia chebula, were admin: istered orally to experimental animals, in a dose exOral pretreatment with leaf extract of Azadirachta trapolated from the human dose.These animals were indicareversedthe inhibitory effect of restraint stress exposedto a variety of biological, physical and chemion formation of anti-sheep RBC antibody titres in cal stressors.The plants were found to offer protecrats immunized with sheep RBC and also the intion against these stressor9I1.All the plants reversed crease in foot pad thickness. It reversed the DDT the effects of cisplatin on gastric emptying, while induced suppression of antibody response and leuTinospora cordifoliaand Asparagus racemosusalso cocyte migration inhibition in tetanus toxoid immunormalised cisplatin induced intestinal hyper-motilnized rats. Restraint stress dong with administration ity, complying to the definition of an adaptogen.They of DDT in subthreshold doses resulted in an inhibiwere found to be safe in both acute and subacute tion of the immune response. Azadirachta indica attoxicity studies. All of them produced immunostimutenuated the immunotoxicity of environmental and lation211. The type of extract (methanolic extract of xenobiotic stressorsm7. Withania somniferawas more active) and time of adRoot suspension of Janakia arayalpathrawas found ministration (the best effects were observed only if

,

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S102 S. A. DAHANUKAR et aL,

given as pre-treatment) also influenced the effects. o f these plants Emblica officinalis strengthened the defense mechanisms against free radical damage inducedduring stress.The effect of ErnWica officinalis appeared to depend on the ability of target tissues to synthesize prostaglandins. On the other hand, gastroprotective effect of Tinospora cordifolia was probably mediated through a predominantly immunostimulant mechanismas the protectionwas found to disappear on blocking the macrophage function. In normal mice, high doses of Tinospora cordifolia significantly increased apoptosis in bone marrow cells. The therapeutic doses (100-200 mglkg) were devoid of such effect. However, at the same therapeutic doses, it inducedapoptosis in malignant cells, but protected the normal bone marrow from apoptosis induced by cyclophosphamide. This variable effect of Tinospora cordifolia (of increasing or decreasing apoptosis) depending on the stressor (either cancer or cyclophosphamide) as well as the cell type (S180 or bone marrow cells) suggests its true potential as an adaptogen. It is of further interest to note that Tinospora cordifoliaincreases the bone marrow proliferative fractions at 100 and 200 mglkg doses thus leading to leucocytosis. If the dose is increased, apoptosis is observed and the leucocytosis is blunted. This apparent paradox may be due to its effects on c-myc.'a gene that causes both proliferation as well as induces apoptosis depending on the environment. It is exciting thus to hypothesise that Tinospora cordifolia may be producing some of its effects via activation of c-myc and inducing'genotypic'adaptation. Ocirnum sanctum, known to have antistress properties, was,recently studied by Sembulingam et al, 220 for its antistress effects against a different type of stress Le. noise pollution, in rats. The ethanolic extract of Ocimum sanctum reversed the changes in plasma levels of corticosterone induced by exposure to both acute and chronic noise stress, indicating the antistress property of the plant against noise. Studies have been reported in the literature to explore the possible mechanisms responsible for adaptogenic effect. For example, Panax ginseng did not modify brain and hypothalamic 5HT levels in unstressed rats, however, it attenuated restraint stress induced elevation of 5HT levelsa.

19. Nutraceutics

This is an emerging field of therapy. As we come to the end of this millennium, more and more people are getting health conscious and are looking at dietary substances for preventive or curative effects. Support towards this line of thinking from the scientific field is described in the follcwing paragraphs.
19.1. lndian spinach (Beta vulgaris)

Dietary consumption of green vegetables has been associated with protection against mutagenic and clastogenic activity of genotoxicants. Chlorophyll, present in all green plants, has been suggested to be the principal factor involved. Sarkar et a/,2a compared the clastogenic or anticlastogenic effects of crude aqueous extract of leaf of Indian spinach, (Beta vulgaris L. var. benghalensis Hort.) and equivalent amounts of chlorophyll extracted from leaf, purified chlorophyll and chlorophyllin (a sodium copper derivative). After treatment for 7 days, the mice were administered potassium dichromate, a known metallic clastogen and sacrificed 24 hrs later. Cytogenetic end points were chromosomal aberrations and damaged cells. Results showed that both crude leaf extract and chlorophyllin were nonclastoqenic and reduced the clastogenic effects of dichromate. However, chlorophyllwas clastogenic.The protective effect of the crude leaf extract was attributed to the total effect of the interaction between the different components within the leaf extract, thus neutralising the clastogenic effects of chlorophyll.
19.2.Karela (Momordia charantia)

Substitution of groundnut oil with palmolein in cereal based lactovegetarian diets provides about 30% of total fa4 calories, doubles the saturated fatty acids and reduces by half the linoleic acid confent. The hypoglycemic activity of the alcoholic extract of the pulp of Momordia charantia (Karela) was evaluated in 3 experimental models of diabetes. In the normal glucose primed rat model, it decreased plasma glucose that was not accompanied by increase in insulin secretion. No evidence of tachyphylaxis to its effects on repeated dosing was found. In streptozotocin induced diabetic rats, it improved glucose tolerance and significantly reduced plasma glucose. The extract also increased the rate of glycogen synthesis fromt4C-glucose by 4-5 fold in the liver of

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272

226 demonstratedthat both pre-treat.increase in the experi?lental group to the mic zone. diets. it did not prevent the increase in controls2n. Curry leaf (Murraya Koenigii) and Mustard similar with both treatment regimes.enolysis and gluconeogenesis ciation of increased incidence of coronary heart disease (CHD) with the high consumption of coconut The status of lipid peroxidation was investigated in and coconut oil in Kerala. LDL andVLDL cholesterol and triglycerides Ghafoorunissaet al. However. phatase activity. red palm oil is the richest natural source liver and renal function tests. nism of action of Momordia chF.cant fall in various serum lipids like total cholesterol. haernatologicalparameters. Mint leaf (Mentha s~icata) creasing the antioxidant defense Mint leaf has been shown to have significant stimuDeshpandeet a/. heart and decrease in heart rate and blood pressure and biokidney were lowered in rats administered these spechemical changes in cat heart 'Oronary artery cies. It. Glutathione levels in liver. Italso prevented the elevation Of MDA and glutathioneS-transferaseactivity showed a sharp tent and lactatedehydrogenaserelease in the ischae. had no effect on bile cholesterol. concurrent treatment offering more 19. while hydroperoxides and conjugated dienes were significantly increased in liver and heart and 16 age and sex matched healthy controls.Turmeric (Curcuma lonaa) dismutase and c'atalase activiiv was found to be in-.19. There was an increase in the concentration of hepatic glyis widespread in India. Both. areekl to alloxan induced diabetic rats Droduced a 19. Concoconut and coconut oil and saturatedfats and found centration of malondialdehydeshowed a significant that both groups did not differ in 32 CHD patients decrease.3. indicating that curcumin protects against ischaemia induced chanaes bv in.8.MEDICINAL PLANTS (NATURAL PRDUCTS) normal rats. cardi~vascular factors and membrane furictions risk in middle aged subjects.6.secretion and its composition. No histopathological powerful biological anti-oxidants and hence. has plants'. creased in liver and heart of bdth the spices adminCurcumin (from Curcuma longa) protected against istered groups. Glutathione reductase. Also. Since their consumptionof rats fed Murraya Koenigiiand Brassicajuncea.19.4. SGOT.This studv indi. of both the experimental aroups. The anti-mutagenic activity of Curcurnin has already Augusti2" in his review on the therapeutic values of been described under the section 'Anti-mutagenic onion (Allium cepa) and garlic (Allium sativum). All the results suggest that the mecha. treated rats caused a reduction in amylase activity2=. discussed the presence of many sulfur containing - - - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 273 .The effects were essentially 19. myeloperoxidase activity.(Brassica iuncea) cates that palm oil may not the deleterious effects associated with saturated fatty acids=. The Whole curry leaf (Murraya Koenigil) and mustard author further explained that the tocols present in (Brassicajuncea) fed to rats at doses equal to norpalm oil are natural biological anti-oxidantssand can mal human 'intake did not cause any adverse effect therefore augment the anti-oxidant potentialof Indian on food efficiency ratio. ruled out the asso.Fenuareek(Traonel1afoenum araecum) . however. increased HDL thostitution of palmolein oil for ground nut oil on selected lesterol in diabetic rats2ag.Edible oils signif.7. studied the effects of the subin normal rats and in addition. SGPT and alkaline phos. Onion (Allium cepa) significant protection.latory effect on the lipase activity of pancreas and ment as well as concurrent treatment of turmeric intestinal mucosa in rats.5. fibrin level and of carotenes (especially beta-carotene) which are glycosylated haemoglobin. bilirubin. glutathione peroxidase ligation. cogen and glycogenesis and a decrease in glycogA study conducted by Kumar.hntiacould be partly Administration of unroasted and roasted powdered attributedto increased glucose utilisation liver in the forms of seeds of figonella foenum graecum (fenurather than an insulin secretion effectP5. Superoxide 19. It also stimulated intestinal extract in CCI. red palm changes were observed in the livePo. plants oil can be used to preventvitamin A deficiencywhich showed significant hypoglycemicaction in rats.

UDPG dehydrogenase decreased and sev. ing in efficient permeability across the barrierszu. It increases in sulphated glycosaminoglycans in their loweredthe level ofiotal cholesterol in the heart and heart and aorta. (Piper nigrurn and longurn) verse in liver.Plex with drugs and solutes. in another studyzd4. 60th garlic protein (16% of diet) and $arlic oil (100 been shown to enhance the bioavailabilifyof various mgtkglday) exhibited significant lipid lowering effects structurally and therapeutically diverse drugs.. has may be responsible for their beneficial effectsa7. It may modulate membrane dynamics due to its easy partitioningthus helpious smellw. Garlic (Allium sativum) by 3 mgkg cisplatin in healthy mongrel dogszN.total and LDL cholesterol. the garlic may act as an apolar molecule and form apolar cornprotein is more palatable and free from an obnox. active principles mainly in the form of cysteine de. isolatedfrom garlic (Allium findings suggest that ginger could be an effective and sativum)* has been shown to be as active as gugulipid cheap anti-emetic adjunct to cancer chemotherapy. in controlling hypercholestermia. antiperoxide activity and decrease in activity of glu. Superoxide atheromatous plaques of aorta.accumulation of cholesterol.of Piperlongurn. HDL cholesterol was Garlic protein diet or daily administration of garlic oil not significantly affected.4. However. rats.liver and demonstrated platelet antiaggregatory accreased. that are responsible for the various biological activities such as anti-diabetic.3-benzodioxol-5-yl]-1-0xo-2.strated significant hypolipidaemic effects in experimotrypsin activities. Piper nigrurnandZinglber officinalis tathione peroxidase and gluthathione S-trans.9. Total cholesterol:HDL and ta 2% cholesterol fed rats controlled significantly the LDL: HDL ratios were also significantly lowered. obesity and derangement of enzyme activities in cholesteroldiet fed 19.The rial mucosa and reduced pancreatic trypsin and thy. [1-[5-[1. phospholipids and ment also reversed the lipid peroxidation and triglycerides in liver.These S-allyl cysteine sulfoxide.The high percentage of cysteine in garlic Piperine. a combination alcohol fed rats caused a significant increase in However.The effects of treatment were just the re.19. It lowered the lipoprotein lipid levels.Data in rats fed with cholesterol diet. lowered the cholesterol1 cholesterol acyl ttansferase lipolytic enzymes and phospholipid ratio and elevated the decreased HDLfecal excretion of sterols and bile acidsm.tivity2". Administration of water soluble proteins of garlic to Trikatu.19. in rabbits as measured by the alteiation of peak - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 274 . extract Of M rsi a yi tc fragrans Garlic oil stimulated lipase activity only in the intesti. rats.11. alkaline phosphatase. Even though intestinal barrier through the transcellular pathway. The acetone and 50% alcoholic extracts of Zingiber antibiotic.10. garlic also did not show mentally induced hyperlipidaemia in rabbits. Ginger (Zingiber officinalis) rivatives in onion and garlic. Myristica fragrans(nutmeg) seed cxtract administralipogenic enzymes and HMG CoA reductase and tion to hypercholesterolemic rabbits reduced both partly due to stimulatory effects on plasmaJecithin. hypocholesterolaemic and fibrinolyticm officinalis (ginger) exhibited significant anti-emetic activitv with the acetone extract beina more effective than ihe ethanolic extract against thesis induced 19. This extract also prevented the studies by these authorsm showed that the treat. cholesterol and triglycerides. Protein and the reactive disulphide group in the oil pentadienyl] piperidine].was found to decrease the bioavailability ot isoniazid ferasP.Nutmeg (Myristica fragrans) . Fecal excretion of dismutase and catalase activities in cholesterol fed cholesterol and phospholipid were significantly increased in these rabbitsz4'. The hypolipidemic obtained from intestinal everted sacs studies sugaction is primarily due to a decrease in hepatic gest that piperine is absorbed very fast across the cholesterogenesls in the treated rats. LDL any effect on bile secretion and compositionm. heart and aorta and dissolved decrease in reduced glutathione levels. Like mint. a pungent alkaloid present in Piper nigrurn Linn.The beneficial effects are partly due to its inhibitory effects on transaminases. era1 degrading enzymes increased in the aorta on treatment. It garlic oil was found to be more effective.'2. hyaluronic acid level in. A DAHANUKAR et a/.S. and Piper longurn Linn. Further ratio significantly. total cholesterol.

. Betel leaf (Piper betle) found to be active against gram-positive and gramThe influence of &o varieties of betel leaf (Piperbetle negative bacteria and fWJfim. Clausena anisata ties of the plantZ5O. ble for the analgesic and anti-inflammatory proper20.tral analyses. The animals showed marked inhibition of feed intake and loss of body weight resulting in mortalities.6. with increasing amounts of mowrah seed meal in diets. Clausenol was 19. especially 20.The latter variety also had a negative ef. Cerpegia juncea From the chloroformextract of finely chopped. B experimental rats. Air-dried roots of Camellia sinensis were extraTheir structures were established as 1-hydroxy-6.14. Iinoleic and linolenic ministered.MEDICINALPLANTS (NATURALPRDUCTS) plasma concentration (C. Ochna obtusata ' Column chromatographyof chloroform extract shadedried and powdered stem bark of Ochna obtusata afforded an orange compound. UV. levels and area under methoxy-3-methylcarbazole and 1. 20. .6-dimethoxy-3methyl carbazole. Bacopa monniem has been carried out by Garai et alzWNg. Histopathological examination revealed a gradation of damage from slight erosion of the tip of villi of intestinal mucous membrane tacomplete necrosis and destruction of it. 20.However. they have a significant stirnulatory in. BacoPa monnier' a The anti-mutagenic potential has already been de. crystallisedfrom ac20. was examined on digestive enzymes of pancreas and intestinal mucosa and on bile secretion in Three main saponins named albiziasaponins A. both the betel cant anti-inflammatoryactivityJ53. lebbeck Ambadi. amylase and disaccharidases whereas a slight ' Gas liquid chromatographic analysis of fixed oil of lowering in the activity of these intestinal enZytlleS Ocimum sanctum revealed the presence of five fatty was seen when Mysore variety of betel leaf was ad.2. Camelliasinensis clausenol and clausenine. HNMR Following are some of the studies carried out to find and MS data corresponding to Prezewalskinone-B. were isolated from alcoholic extract of the stem bark of Clausena anisata. Three new dammarane-type triterpenoid saponins. IR.7. Mowrah (Madhuca latifolia) bacopasaponins A. The Ambadi antiallergic properties of Albizia lebbeckZ4'.13.1. Linn. The results indicated that while and C were isolated from the bark of Albizia lebbeck these betel leaves do not influence bile secretion and and their structures were established through speccomposition. The other significant change was a severe vacuolar degeneration of kidney tubular cellszu. shade dried whole plant of Cer~egia luncea cerpegin has been derived which is the active principle responsible for its analgesic propertiesJ0.acids (stearic. from physical and chemical evidence and syn!hesis. scribed earlier in this chapter. palmitic.) namely. 20. demonstrated signififect on pancreatic amylase.5. designated as 20.cted by percolation with methanol at ambient SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 275 . leaf varieties have shown decreasing influence on pancreatic trypsin and chymotrypsin a c t i v i t i e ~ ~ ~ .) curve (AUC).3-ocimumsanctum lipiise. These may be responsible for the fluence on pancreatic lipase activity.acids) which in further studies. the pungent Mysore and non-pungent 20.B and C and a new damtype pseudojujubogenin glycoside* bacOpa Mowrah (Madhuca latjfolia) seeds are used as aniSaponin D have been isolated and identified by ma1feed as they 40-50% edible fat and the transand contains saponins besides protein and high level s~ectroscOpic of formations. variety of betel leaf has a positive stimulatory influence on intestinal digestive enzymes. ~h~tdchernistr~ etone which gave elemental analysis. Two new carbozole alkaloids. carbohydrates. This is probably the active principle that is responsiout the active principle of plants. Further.4. 19. oleic.Chemical characterization of the plant. the seeds were found to be toxic when administered to young and adult rats at levels of 10 to 40% in diet. respectively.

Ipomoea treated human erythrocytes and that activity was in. Santdlena chamaeccyparissus. scribed the results extractsscientific endeavours in of their of 266 botanically idenFor the benefit of the readers. identification of complex glycoproteins and typing bacteria. Rumexnepalensis. antiPYretic plants (Araucaria bidwilli. Sengupta et a/. boustanianum. and the 21.Stephania Lectins are structurally diterse. in~~lvingSpe ture tissues. commonly used by the tribals of Nilgiris. Santolina chamaeccyparissus).. Thunbe~ia fmgrans). Stephania japonica). Specific ac. Follow-up studies have been carried out on some of these plants with confirmed activity. plants with analgesic activity (Araucaria bidwilli. A D H N K R et el.Bhandary.in the state of Karnataka. Melianthus major. Araucana bidwiIIi. nal plants. Stems and leaves agents (Brachylepsis nervosa. Reviews on medicinalplants use of the flowers of lchnocarpus frutescensandthe rhizome of Hedychium coronarium in the treatment It beyond the scope ofthis chapter to IustiB review of diabetesare noteworthy.Their findings include 40 hitherto unknown medicinal uses of known medicilatedm. chromatography and hydrolysis procedures progressively yielded 3-0-p D-glucopyranoso-a-spinasterol.ulceroprotectives (Araucaria bidwilli. Malothriaperpusilla. Mirabilis jalappa.obscura. Calotropis gigantea. Stephania japonica. Bauhinia wriegata. the use of the stem sap of 21. Immunological tests indicated that all ties of Plants. Suresh. 20. lpomoea obscura. EVIDENCE BASED AYURVEDIC DRUGS 276 . tally inhibited by lactoselcellobiose(SLII) and me. diuretic plants (cystisus bit erythrocyte agglutinating activities Were specifi. Brynopsis lacinosa. The active SELECT RESEARCH PAPERS a?. They are being used by the biomedical scientists and biochemists in blood typing and stimulation of cell for chromosome analysis and gene mapping. In the roots of field grown haemostatic plants (A houstanjanum. in cell separation.(Amarantus spinosus). Human and rab.h. plants affecting~ 1 0 0 t h muscle (relaxant effect) (Amucaria bidwilli. Cell tatgeting by lectins in cancer therapy is still in its infancy.which the alcoholic in the fol'Owing paragraphs. of 1-6 week old Peanut Plant (A.-thus excelsea). chemotherapeutic Lectin activities in roots.scoparius. Toddalia asiatica). Thunbergia fragmns).~i~hty-nine extracts were shown to possess biological activity. ZP have reviewed the potential of these biomolecules in medicine. Phytolectins plants (Araucaria bidwilli. plants with local anaesthetic activity (Mirabilis jalappa).8. Bauhinia variegate. Actively growing tissues con. Santolina chamaeccyparissus. nodules. Mirabilis jalappa. jaPOnd. lp~moea obscura. Calotropis gigantea. CVS active plants (Cystisus scoparnation and sugar inhibition assays. Toddalia plants SLI was the major activity.coromandelianum. using various experimental models viz. Brachylepsis nervosa.Awal w have dearticles that have been published in the last 5 years. Cardiospermum helicacabum. Brachylepsis nervosa). Miscellaneous Calamus thwaitesii as an antifertility drug. Rubia cordifolia. AAUA temperature.. Among these.Further studies will have to be carried out to correlate these principles with the pharmacological (hypoglycaemic and ukeroprotective) activities of the plantm. have investigated the phytochemical and pharmacological activities of 25 medicinal plants. n 69 tajned mote SLll activity in comparison to the ma. anti-inflammatory plants (A. CNS-active sied plant materials from 222 species were tested for various biological activities including chemotherapeutic and pharmacological.1. Sida cordifolja. while nodules asiatica) and effect on biochemical parameters showed both activities (SLI and SLII). Seed em. Cyclea peltata. hibited by T-disaccharide. the articles are sum. plants modulating fertility (Ailanchecked by erythrocyte (human and rabbit) aggluti. Santolina chamoeccyparissus. Toddalja asiafica). Thunbergia fragrans). An interested reader may refer to them for detailed information. Malvastrum thy1 al~ha-mannoside respectively. Sobnt extraction. Stephamiajaponic~m. lberis amara. ImPomea obscura. cystisus scoparius). tivities of SLI and SLll were maximal in stem tissue conducted ethnomedical field and minimal hypocotyl.study O 98 medicinal preparations. used by the Siddis of Uttara Kannada the vegetative tissue lectins are serologically re.ius. et al. Malvastrum commandelianum.S.Ypogaea) were lpornoeaobscura). bvos and cotyledons agglutinated f~euraminidase anti-diarrhoea1plants (Bauhinia variegata. carbohydrate binding proteins that bind reversibly to specific mono-or oligosaccharides. hlalvastrum commandelianum. et a/.

ec. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 277 . globulin. extract of Hygrophilia spinosaon the haematological Sb.' in adults over 60 years of age revealed that about 47% of the elderly population uses herbal drugs. haematologicalparameters. biolaxant. uterine re. samples and antihistaminic and anti-SHT activity in tions 6 samples. Lower doses did not al. Sharathchandraand Balakrishnamurthv have studied the mode of action of Cleistanlhuscollinus. The results clear reactor and the induced activity was counted showed that weekly moderate to high dose levels using high resolution gamma ray spectrometry. a toxic plant that is frequently implicated in poisoning. thewestern & Easterncoastsof India. in benign prostatic hypertrophy showed no toxic efthe ileum.2. et al.The polyherbal drug. absolute lymphocyte count and percent lymphocytecount. peutic significance of these plants in restoring ionic Cerpegin.) have been reviewed by Johri and SingW. which is 15 times higher than bolic activity (spontaneous contractions in isolated the recommended dosP1. Zinc. a furopyridine alkaloid isolated from the balance has been discussed by the authorsm. Tinospora cordifolia. Cleistanthuscollinuscauses depletion of thioVthiol containing enzymes in most organs which results in its toxicity. also called as sahadevf.The main reasonfor herbal drug usage is the belief that these drugs have lesser side effects. uterus) in 59 samples. Co. Elemental analysis of plants drugs/formula.The chemistry. Fe. Cr. Mo. Lakshadweep and the Andaman and Nicobar Islands. bark and roots) often used as showed excitation. Rb. for their ef. the uterus and the atrium with the aim of fects as seen on morphological. The theram oral administration. gross behaviour. 'U have screened two hundred and matous tissue formation in rats. convulsions and respimedicines in the Indian Ayurvedic system have been ratory paralysisw. Vernonia cinerea. specific parts of several plants be toxic at doses above 400 mg/kg and the mice (fruits. Toxicity studies tum. oxytocic. (viz.of the medicinal herbs have been found to be rich in fected liver and kidney functions and metabolic and one or more of the elements under study. Various Indian medicinal plants viz. The effect of multiple doses of the petroleum ether Ba. Significant increase in the relativeweights of adrenals was also observed. Prostina. Vernonia amygdalina. stem.chemical and haematological changes in rats upto spasmodic activity was observed in 22 extracts. in rats4@. L . K. ionotropic and antiarrhythmic activity. analysed by Singh and Gargm for 20 elements (As. uterine relaxant activity in 16 22. Nerium andicum(Kanher) and Acorus calamus (Vacha) were Toxicity studiestarevealed that LD50 of the ethanol ~ extract of V i t leucawylonleaf was more than 3 glkg analysed for the presence of minor and trace elewhereas that of the cold aqueous infusion was 1050 ments by instrumental neutron activation analysis mgkg. Similarly.doses of 450 mglkg. Azadimchta indica. detecting any anti-spasmodic. P. Vernonia lasopiusetc.ples were irradiated with thermal neutrons in a nutions of normal mice was evaluatep. CI.The samand biochemical parameters and hepatorenalfunc. Se. Anti. Most (above 40 mg/kg) and daily high dose (8 mg/kg) af. Ocimum sanc21. similar to cyclophossixty extracts from marine organisms collectedfrom . Thiol compounds may act as antidotes. chloroformextract of Ceropegiajuncea was found to In a similar study. leaves.MEDICINAL PLANTS (NATURAL PRDUCTS) principles and resultsof these studies have also been discussed. Vernonia anthehelmintica. Br. Sc. recommendedfor use fects on 3 isolated tissues of the guinea pig namely. High doses (1500 mg/kg) significantly inhibited granuloNazarine. Cu. of the ethanolic extracts was found to (INAA). 350 mglkg for mined.elemental analysis of some herbal plants used in the control of diabetes has been done by the techniques ter them. pharmacology and traditional medicinal uses of various Vernonia species.phamidem. Administration of the juice of Lantana camara leaves to rats resulted in a significant reduction in the total protein. manganese. and sodium were signifiToddalia asiaticaand 250 mgikg for Araucaria bidwilli cantly higher in Ocimum sanctum leaves while zinc was higher in Azadimchta indica leaves. Pharmacoepidemiologicalsurvey carried out by Karandikar et al. Na. irritability. Mn. Sr and Zn) by employing INAA. Ca.body weight changes and histopathological. Concentrations of 13 elements were deterD be 1 gmlkg for Ailanthus excelsa.

Conclusion the plant products. dounew field for exploration and. Fe. at affordable rates. there is a flip side too: to quality control. taken into considerationthe advocated uses for this groupof plants as per Ayurvedic textbooks while de'signing their research protocol. In 1982. However. Any publication related to phyWe see a definite change in the pattern research topharmacology should ideally provide on the on medicinal plants. Pb.relevant to needs of our country.Very few studies. There is still a paucity of clinical products. diarrhoea. An attempt has been made by Uchil eta/" to develop a battery of standardization tests using mpdern technotogy for commonly used organometallic preparations (bhasmas) and comparethem with the Ayurvedic tests. etary modulation of diseases may emerge as an alternative mode of therapy.tuberculosis. we have indigenousimmunostimulants available. 23. a logical interpretationof the codifiedlanguage of traditional medicine also becomes a necessity in order to further promote research in this field. These data reveal the necessitv of deve\oomentot modern correlates for standardisation of kyurvedic formulationto add precision However. address the problem of drug interactions. . to detect false claims and adulteraVery few articles published in the last 5 years have tion and to predict their adverse drug reactions. AIDS and malnutrimacological activity as seen from the work On tion are some of the major problems of our country. Nutraceutics have Opened up an which are carried out in controlled. malaria. system or fertility control. Rawat et a la. Our findings are listed below : authenticationand standardisationof the plant prodThere is a growing interest in correlating phytochemi. and phytochemical properties to specific pharmacoMajority of the drugs are at the experimental stage logical activities is expected. In addition to the proper utilization of technological advances. DNA patterns and genetic control has been observed rather than concentrating merely on the gross effects induced by the plant drugs. Nl. has been paid CNS-actives cytoprOtectivel clinical studies. The elements Mn. CI. Infectionslike ing the botanical properties of plants with their phar.i ZVIDENCE BASED AYURVEDIC DRUGS . of plants for their effects on the autonomic nervous however. if any. of Neutron Activation Analysis (NAA) and Atomic Absorption Spectroscopy(AAS). and have to still undergo clinical trials. more attention Dr. Modem correlates for standardisation Wih the advances in cellular biology.Today. In future. a shift towards studyingchanges in cytosolic enzyme atiiities. The results revealed that on6 3 preparations could fulfil at least 3 of 4 criteria as described in Ayurvedic textbooks. copper content and presence of chemical groups and complexes when tested using modern correlates.S. None of them showed presence of elemental copper. di.the Indian market. cal constituents of a plant with its pharmacological ~ oall the research areas selected by the scientists t activbau3". A DAHANUKAR et of. Cd. Ca. two studies documenting .H 1 ~ these areas have not been extensivelyex~ ~ ~ ~ ~ dimensional research aimed at correlatingbotanical ploied.ble blind manner. The work done on rasayana group of plantsa\ is a good example of the above statement..ucts. all of them differ with respect to particle size. Al. . In view of this. Scientists have even started correlat. In terms of pharmacological activity. the authors have attempted to interprete the word 'rasayana'in mddern scientific terminology and have . Cu. the status has not immunOmOdulafors and plant changed. SELECT RESEARCH PAPERS G. in the near future. Zn and Hg were found to be present in different plants in various proportionsl". Here. Na. in. concurrent consumption of drugs from differcreasing trend has been noticed towards evaluation ent discipllis is a common finding. Cr.Satyavati had expressedneed for well planned. Seven preparations of copper bhasma manufactured by different companies were screened using both the methods. At the sametime a de. more co-ordinated multi. 16 years later.This understanding triggered the subsequent research work that was aimed at evaluating the immunostimulant potential of the rasayana group of plants and now. bulk densities. provided adequate information on the procedures adapted by the researchersfor quality assurance of 24.

Ramteke S et al. Goel RK. Joshi VK. Goet RK.14:83-8.lndian Ginkgo biloba.34:1204-7. 10. _SinghRK. 6.MEDICINAL PLANTS (NATURAL PRDUCTS) interaction of plant drugs with modern medicine are important from the clinician's point of v i e w . Nootropic effect of BR-16A (Mentat). Ghosal S. postnatal environmental impoverishment and hypoxia In rats. jourwhether positive or negative. Indian J Exp Biol 1996. Anxiolytic activity of Azadirachta indica leaf extract in rats. Pharmacological acdons of Pongamiapinnata seeds a preliminary study. 3. a herbal psychotropic formulation. 20. Acharya SB. Jalswal AK. Similarly. Vinekar AS. Ravishankar B. . Faruqi S. n Vaidya AB. Kulkarnl SK.35:831-6. lndian J Exp B i d 1994. JAllem Complement Med 1997. 21. Kumar A Effect offrasina. Pharmacological actions of Ables pindrow Royle leaf. Conwls Ther 1995. Kasture SB. Bhattacharya SK. . e l al. Shukla VJ. Mitra SK. (Bmhml) Indian J Pharmacd 1997:29:S359-65. Nath G. Effect of a composite lndian herbal preparation. Neuropharmacological studies on Panax ginseng. in peer-reQiewed nals. Indian J P h a r W 1997. rhizome extract. Effect of BR-16A (MentatR) on cognitive deficits in aluminium-treatedand aged rats. Bhattacharya SK. et el. therapy for the attenuation of electroconwlsive shock-induced anterograde and retrograde amnestic deficits. CIHP(1II) on avoidance learningduring endurance pettormance of rats. • 9. a 18. the need of the hour in order to provide information about and access to research work done in different laboratories of the country. Pharmaco-epidemiological study of use of herbal medicines in the elderly i Pune. Makwana HG.Acharya SB.29:258-61. Saha K. Fanrql S. Sriprada VT. Studeffects nucifera ies on pyschopharrnac~~~ical of ~ e l u h b o Gaertn. Andrade C. herbal formulation. 7. Kulkarni SD.33: 580-4. BhardwajSK. Singh RK. 32:37-43. Nlnan I. work carried out on traditional medicine is presented in conferences and is available in the conference abstract books (data of which may or may not be complete) or published in local journals. A relevant point that arose while compiling this data and needs mentionis the needfor documentation of research activities and publications of results. Kasture VS. Chakraborti A.36:187-91. Hence. - 17. Kumar A. Singh HK. these are not peer-reviewedand moreover this data is accessible to a select few. 14. e. Neuropsychopharmacologicaleffecb of the ayurvedic nootropic Bacopa monniera Llnn. et al. Srivastava KK.38:95-100. 5. Anxiolytlc activity of glnkgolic acid conjugates from. Ps~. 19. Satyan KS.The status and scope of lndian medicinal plants acting on central nervous system. Jaiswal AK. Karandikar SM. lndian J Pharmacd 1995: 27:186-8. 4. Effect of Poogamla pinnata on perturbed central cholinergic markers of cognition In experimentally demented rats.11:241-7. J Ethnopharmacoll996. Bhattacharya SK. This results in lacunae whilejudging the current status of researchon traditional medicine and leads to a false impressionthat not enough researchis being carried out in this field. Singh RK.3:327-36.30:181-5. Andrade C.1:9-11.hooharmacology (Berl) 1998. psychotropic herbal formulation. Indian J Pharmacol 1998. Balasubrarnanian R. lndian J Physiol Pharmacd 1994. J ECT 1998. 22. lyer MR. f6. et al.54:63-7. Indian J Exp B i d 1994. networkingof the various researchactivities carried out by different scientists has now become . Although. Mukheriee PK. Dhawan EN. BR-16A attenuates anterograde amnesia induced by electro-convulsive shocks in slow-learning rats. Bharati Vidyapeeth Bulletin 1997. Indian J Exp Biol 1994. Bhattacharya SK. Behaviouralstudies on BR-16A (Mentat). Slngh RK. Andrade C. 8. the documented data on adverse drug reactions of plant drugs is also sparse. REFERENCES 1. et al.32:489-91. 2. on cognitive deficits induced by prenatal undernutrition. 12. Bhattacharya SK. on experimental models of Alzhelmer's disease and centralcholinergic markers in rats. 11. . Herbal pharmaw. Effect of Lawsonla inermls on memory and behavlour mediated via monoamlne neurotransmitters. et al. Ramteke S.32:31-6. Handa SS. Attenuation of ECS-induced retrograde amnesia by using an herbal formulation. Nath G. BhattacharyaSK. Indian J Exp B i d t997. General pharmacology of Vitex leucowm Linn leaves. Bhargava VK. BhattacharyaSK. lndian J Exp Biol 1996:34:41-7. IndianJ Exp B i d 1995. an Ayurvedic .Inhibition of morphine tolerance and SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDlC DRUGS 2 79 .136:148JL.29:S340-3. 15. Pharmacological actions of Poogamia pinnata roots in albino rats. Pandit VA. lndian J Pharmacol 7997. Pal SC. 13. . lndian J Expt Bid 1998. J Basic Appl BIomed 1996:4:438.

Raj 1 Udaya HB. 35. Pharmacological actions of cerpegin. J Ethnopharmacol1998 (accepted PharmaCd 1997. 52.11:535-7.. Manocha A. Piilai KK. 7. lnvestlgations of anti-inflammatory activity of Jigrine.424-7. Singh RK. Kuikarni C.C. Anti-arthritic and anfi-Inflammatory ing of Ochna obtusata. Diwan PV.29:110-6. Saha K. David J. Evaluation of antiinflammatory activity of fatty aclds of Ocimum sanctum fixed oil. Deshpande SG. Ramaswamy S. Jnflammaphamacd Manocha A. Antinociceptive action of Azadimchta indica (neem) in mice: possible mechanisms involved. Hazeena BV.33:848-50. Ancient Scl L l e 1995. Cempegia juncea. Karunakar N Pillai KK. J Basic Appl Biomed 1996.34:12185.14:253-7. Effect of . Narayanan N. George B. Ganguli S. Goswami M. and Rhynchosia cane (Wilid. 53. for publication). Anti-pyretic hctivity of some plants in female albino rats :A preliminary report. Das SN. Subramonlam A. Ray A.' 33. etal. on pharmacokinetic proflle of sodium vaipmate and carbamazepine in normal humanvolunteers. Husain 2. ~nti-inflammatorypotential of Pongamiapinnate root extracts In experimentally Induced Inflammation In rats. Das J.40:355-8.S A. lnfiuence of gossypin on the development of acute tolerance to morphine induced antinociception. effect of a poiy-herbal drug (Ease(R)) : Its mechanism of 32. Singh S.28:116-9. Nagarajan S. fects ts ethanol exiract of Clerodendron seframm roots in 48.33:428-32. Evaluation of ocular anti-inflammatory activity of Butea Irondose. ~nflammatory pmperty of Sandhika: a compound herbal drug. et el. Alam M. 28. Suresh B. Antinociceptive antiinflammatory and antipyretic ef. Anti-inflammatory activity of the latex of Calotropls pfvcem.36:112-4. Juss in rats. Singh RK. Vernonia laslopusand Vemonia galamensis A medicinal perspective. fhi~gnanasambantham Viswanathan S.34:531-4. lndian J EXP B i d 1997. Rao KS. 50. Further study of anti-inflammatory effects of Abies pindrow. Antipyretic activity of Nelumbo nucifera rhizome extract. Husaln SZ. lndian J Exp Biol 1995. J Ethnophannacd1994. lndianJ Exp Biol 1998. Ramakrishna S. Susan T. Saha BF! Studies on the anti-inflammatory activity of rhizomes of Nelumbo nucifem (teetter). Antiinflammatory and antipyretic activity of Michellachampaca Linn. 49. action. Husain2. flower extract. 45. Goel RK. Kumar VL.41:134-8. RajasekharanS. . Biochemical modes of action of Gmeiina asisUca in inflammation. ~nii-inflammatory ( and hepatoprotective activities of Sida rhombifolia Linn.35:380-3. Joy S. . Phflother Res 1997. 25. Vimala R. chemoshodcin mice. J Ethnopharmacol 1997:57:213-7. Kaul EL. An!lpyretic activity of TBR-002. B i d 1996. 51. Chemical and pharmacological studies on flxed oil of Ocimum sanctum. Neuropharmacoiogicai studies on Fusarlum toxins-Ill :Neurochemical investigations on total toxin extracts from E moniliforme and E oxyspom. PushpangadanP. 43.Effect of Ginkgo biloba in 40. lndian J Expt B i d 1997. 34. Ancient Sci Life 1995. Latha PO. Elango K. Tripathl YB. Pandey EL. Chaurasla S Trlpathi P. lndian J Exp B i d 1996. Andrade C. Sen P.66:4Q3-6. Hamsavenl QR. 23.4:21-4. Pandey B L Anti-inflammatory activity of seed extracts of Pongamia pinnata in rat. et el. Rao M. Johri RK. Indian J Pharmacol 1995. 42.44:123-5. Vijayasekam V Pharmacological screen. Gopalakrishnan S. (white variety). lndian J Exp Biol 1998:36:418-20. Bhima RR. Thirugnanasambantham P. 39. Hota D. lxora brachiateRoxb.9. Mukherjee PK.b3:367-9.29:306-9. A herbal formulation. Khanna N. Indian J Pharmacd 1997. Pal M. Chattopadhyay RR. lndian J Exp Biol 1997.33. lndian J Exp Biol1995. lndian J Exp B i d 1995. lsmaii TS. P. IndianJ Phannacoll997.) D. lndian J Phamacol1996. ~ i s h r r SH. 41. 30. Indian J Pharmacd 1997. 44. Reddy MK. 28:84-7. et al. 47. DAHANUKAR at el. lndian J Physiol experimental animals.15:7-14. Basu N. Majumdar DK. 31 Si~prakaSam Viswanathan S. lndian J ~ h a r m a c d 1996. Margaret I. Possible biochemical mode of anti-inn'ammatoty action of Azadimchta indica A. Pandey EL.35:413-4.27:116-9. Planta Med 1997. dependence by Wthanla somnlfera in mice.lnfluence of Glnkgo biloba on the effect of anticonvulsants. 27. Majumdar DK. Yadav MR. Singh RK. Saha K. Dhanasekaran S. Viswanathan S. 40:327-8. Rtoterapia 1996. Mukhejee PK.29:198-200. Suresh Chandra J. Chatterjee S. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 280 . Singh S. Pentylenetetrazol-inducedkindling in animals: protective effect of BR-16A. 24. Sukumar E. Fitoterapkr 1995. Singh C. Res Ind 1995. 37. Antioxidant and antl. 26. 38. 38. Kuikarni SK. P.35:1310-14. Indian J Exp Bfol 1996. Vaz J. Joseph T Influenceof caffeine . Influence of Gymnema sylvestral on \nRammation.67:117-20. Indian J Dq. PillaiKK.34:275-6. a novel pyridine alkaloid from 46. lndian J Physiol PhermaCd 1998. Mengi SA.

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234. lndian J Exp Biol 1998. enzymes and fecal excretions of bile acids and sterols in Phytochemistry 1996. 239. GuptaYK. lectlns of peanut (A.. Ram A. . Singh S. Kulshrestha DK.) on digestive enzyme9 of pancreas and intestinal muwsa and on bile production in rats. 238. lndian J Exp Bid 1998. Phytochem 1995. Effpct of orally administered betel leaf (Piper belle Linn. BhargavaVK. Arihara S. Thirugnanasambantham P. lndian J Exp B i d 1995. Saraswathi G. 241. Screening of lndian plants for biological activity: Part XV. Patel K. lndian J Exp Biol 1995. Sheela CG. Effects of S-ally( cysteine sulfoxide from A~~~~~ sativum Linn and gugulipid on some 249. - . JayaramanV et al. Prevention o hyperf chdesterolemia and atherosclerosis in rabbits after supplementation of Myristlca t r a g m seed extract. Indian J Biochem Biophys 1995:32:106-8. Garg SK. Yemasaki K. hypogaea). lndian J Pharmacd 1995. Khan BA. Effect of Trigonellafoenun graecum (Fenugreek) on serum lipids in normal and diabetic rats. Kuntze). Biochemicaleffects of garlic protein dieteandgarlic oil on glycosaminoglycan metabolism in cholesterd fed rats.36:60-4. 230. Indian J Exp Biol 1995. et al. Kochupillal V.30:254-6. Bisen PS.34:72-5. Ind'ien J EW Biol lgg6. Gandhl VM.74:165-7 . Yoshikawa K. Przewalskinone-B from the stem bark of Obhna obtusata. Abraham A. 243. - 244. (0. Phytdectins: natural molecules with immense biotechnologicalpotential. Khan BA. Hypoliiidaemic I effect of Myristica tragrans fruit extract in rabbits. Suresh B. lndian J Exp B i d 1996. Zutshi U. Augusti KT. 231. 253. Antiperoxide effect of garlic protein in alcohol fed rats. Chaudhuri T Das SK. Phytochem 1996. Sheela CG. Ohtad 235.p166. Seth SD. Plate1 K.34:61-5. Achari B.55:49-53. Pahalk GK. Sharma A. 233. Ohtani K. Saponins from Albizla lebbeck. Balasubramanian S. lndian J Exp B i d 1996.43:447-9. SharathchandraJNN. lndian J Med Res 1995. hgusti KT. Bedi KL. hdian J Exp Biol1997. lndianJ Biochem Biophys. Viswanathan S. Digestive enzymes of rat pancreas and small Intestine in response to orally administered mint (Mentha spicata) leaf and garlic (Allium satiwm) oil. lndlan J Physiol Pharmecd 1995.57:93-6. SrinivasanK.33740.36:573-7. Cherlan KM. Augusti KT. 232. Vedasiromoni JR.40:155-8. Pal BC. lndian Drugs 1994. Dixlt VP. 34:634-40.MEDICINAL PLANTS (NATURAL PRDUCTS) tetrachloride-induced liver damage in rats. Aswal BS. cholesterol fed rats.33:337-41. Bhandary MJ. 252.34:444-87. Dhanasekaran S. Sharma VN. J Ethnopharmacol 1997. lndian J Pharmad 1995. Augusti KT. 246.38:1287-91. Daniel RS. Mathur R. Gautam H. lndian J Exp Bidl 1996.1 and garlic (Allium SativUm L. SivaprakasamP. Hypolipidemic effect of garlic protein substituted for casein in diet of rats cornpared to those of garlic oil. 240. Abraham A. Goel AK. Qammaranetype triterpenoid saponins from Bacopa monniera. 229. lndian J Exp Biol 1996. Mathew BC. Srinivasan K. J Elhnopharmacd 1996. 245. Gupta SK.39:407-10. Leelamma S. Ethnopharmacological studies on the medicinal plants of Nilgiris. Mahato SB.34:346-50. Khajuria 4. 242.Yamasaki K. 250. Sengupta S. 254. 251. Abraham A. 236.27:89-93. hdian J Exp Blol 1998. 248. Nagpal RK. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 287 . J lndian Chem Soc 1997. Antiperoxide effects of S-allyl cysteine sulphoxide isolated from Allium satiwm Linn and gugulipid in cholesterol diet fed rats.74. 1997. Antiemetic efficacy of ginger (Zinglber olficinale) against cisplatln-induced emesis In dogs. Augusti KT. Sharma SS.42:815-20. Mahato SB. Khan BA.27:156-60. lndian J Physiol Pharmacd 1996. Hypoglycemic action of Murreya koenigii(cuny leaf) and Brassicajuncea (mustard): mechanism of action. J lndian Chem Soc 1997.33:7526. lndian J Pharmaooll998. et al. Garai S.33:749-51. Rajamo. Bawpasaponin D a pseudojujubogeninglycoside from Bacopa monniem.102:184-7.35:103-10. K. Mulky MJ. Permeability characteristics of piperine on oral absorption an active alkaloid from peppers and a bloavailability enhancer. Rajasree CR. Therapeutic values of onion (Allium cepe L. Karen RS. KhoslaI? Gupta DD.32:340-52.). Haematological and hlstological studies after curry leaf ( M u m koenuori) and mustard (Bmssiy juncea) feeding in rats. Kumar RV. Role of Mlrrraya koenigii(curry leaf) and Brassicajuncea (Mustard) in lipid peroxidation. 149-58. 255. Kaveriappe KM. 237. 247. Leelamma S. India J Ethnopharmawl 1995~47: 256. Sengupta LK. Leelama S. Medical ethnobotany of the Siddls of Uttara Kannada district.34. Mathew BC. Toxicological evaluation of mowrah (Madhuca latitblia Macbride) seed meal. Mehrotra BN.. Effect of Trikatu (Piperlne) of the pharmacokinetic profile of isoniazid In rabbits. Chandrashekar KR. Prabhu MS.36:46-50. Lauria ? Gupta R. Singh R. Augusti KT.Vegelative tissue . Karnataka. m T. Phytochemical investigation of the roots of Camellia sinensis L. Ga&i $.

Maiti BR. todcodr d Cldstanlhus c d l f ~ An indigenous toxic : plant Indkm J ph. Prospects and pempmibes of natural plant prbducts tn medicine. - 265. 282 Samudralwar DL. Vaidya AB. Hepatoprotective effect d SwsrUa chlmta on rat Indlan J Exp Bld1997. Pharmacological . Gulati RK.29:76-81. Mohanan PV. A @ S.cbMties of ubects of MIM marine animals and plants on Wated Wuer ol the guinea pig. PardeddBM.29:4266. Hepatoprotection with Qlycosmis pentaphJdla(Retz). 260. Saralhchandra 0. NS. 289. QargAN. Handa SS.35:384-8. Minor and trace elemental determl~tlon the Indian herbal and other medidnal in 203. Qiri DK. 272. Mukherjee S. 42221-8.33:261-8. Garg AN. Indian J P h a m c d 1984.34:851-3. Agrawal SS. Pillal KK.36:385-9. Indkn JMadne Sd ?998. Pushpanqadan I? Hepatoprotective activity of T-us zeylenicus extract agalnst paracetamol-induced hepatic damage in rats.48:1059-82. Protectiwr role of propolb against alcohol carbon tetrachloride-induced hepatotoxicity in rats. Evans DA. 273. Analydr of some herbal plants from India used in the control of diabetesmeUitus by NAA and M S techniques. -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDlC DRUGS 288 . Rajasekharan S. AvailaMUty of essential tmce elements I Ayumdlc Indian nndldnal herb8 using instrumental n neutronactivation analyrlr. Nazarine F. 258.48:97101. Modern correlatesfor Ayuwedic quality control tests for Tmbhasma. Johri RK.27:499-501. Rathinam K. Sub-acutetoxicity study of a polyherbal drug ( P m t i ~ ( R ) in rats. Effect of petroleumether extract from Hygrophllaspinosaon hematdogid p a m etem and hepatorenal functions in mi-.257.26:1-12. Singh C. 268. AnterkarVDS. Humin SZ. Uchll 4 Rega NN. Anlta F. 287. Sur A. InoYan J PharrmMd 1997. Ind h J Pharmacd 1997.29:82-5. Hepatoprotectivestudies on Phflandhus m h l h Unn. Appl Radat loot 1997. 268. 274. Sen S Singh S. J ' Msd A m M e Pkvlt Sd 1997:1%744-52.33:384-9. Indian J Expt Bld 1998. 261. Subramoniarn A. Sharma M. 275. lndlan J Exp Biol 1997. and quercetin.35:13Q&9. Qupta NK. New drugs from medicinalplants: opportunities end approaches. J Assoc Phys I & 1984. Maiti S. MedMlul use#of Vemonia spedes. Mitra S. J Efhmpharmacd 1995. D w 1996. SinghV. Dahanukar SA. Modification of redlation induced changes in murine hepatlc lipidproRles by garik (Alllm safhmUnn.34:1201-3. 270. Indian J Exp Bid 1998. Qupta M. hdku. lndbn J Exp BIol1986. Hepatoprotee tive activity of ethyl acetate &act of Acada catechu.49:119-28. Ratabdi PV. Singh A. 259. h u m d a r UK. etal. Sur RK.rmncd 1997. Indian J Exp Bld 1995. 264.) unsaturated oils. eta& . Blswas NR. Indlan J Phar) Med 1998:30139-44. Gupta SS. Appl Radfat /sot 1997. Jayasekhar P. 271. BaWtrishnamurlhy R FertubatioRs in giutathlono and adenosine triphorphatase in acute oral . Hepatoprotective actMty of AHum gmwolens and Hygrophilaaurlculataagainslparacetamol and thloacetamide intoxication in rats.

without a systematic attempt to co-ordinate the work 'it1 its entirety.. 1977. these researches have been Inore in the nature of independent efforts confined to ind~vidualscientists rJr groups of scientists. has also been engaged in research on plants. SATYAVATl Indian Council of Medical Researcl't.. therefore. 1973. revealing various types of pharmacological activities irr these plants. Inspite of a large number of studies undertaken on different aspects of medicinal plants. coordinated research on ~nedicinal plants selected after careful discussion and consultation with reputed Ayurvedic/Unani physicians was made for the filst time in India by the Indian Council of Medical Research (ICMR) ill 1964. A deliberate effort to carry out an integrated.. 1969. plants to be studied were selected mainly on the basis of their actual use in the traditional systems of medicine. 1976. New Delhi. 1972). The Central Drug Research Iilstitute (CDRI). But after 1963 CDRI felt the need to have a more broad-based screening of plants for biological activity by including a number of plants on which no information was available in the traditional systems of medicine. Earlier.Arngar. nearly 10 plants out of 58 initially selected for the study. there has been a tremendous upsurge of interest and research in the field of indigenous drugs in India. . 1982). Dhawan c l nl. h A Delhi-110 029 . is fraught with difficulties ofspace and time encountered in compiling material from such widely varying journals and other publications. By this means nearly 2000 plants have been so fa1 screened by the CDKI. &n April. Following tile pioneering and monumental work of Sir Ram Nath Cliopra and colleagues in the early part of this century. had reached an advanced stage of investigation (ICMR Bulletin. 1980 . 1 9 7 7 . This was a unique experiment and during the five years course of this scheme. in operation under the ICAlR.Insari . 1974. - -- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 289 . 1970 this scheme was transferred to the then newly constituted Central Council for Research in Indian Medicine and Homoeopathy (CCKIMH). through the Composite Drug Research Scheme (CDRS). . Setty et al. Bhakuni et a/. Lucknow. These results'have been published in a series of articles {Dhar et of. Raatogi and Dhawan.. 1968.Pharmacology of NIedicioal Plants and other Natural Products G. V. 1971. Any review of literature in this area.

. 1978). 1975c). 1977a). CVithania somnifera showed beneficial effects in 30 patients of anxiety lleurpsis (Singh and Malviya... ~fiicatum revealed Essential oil of the rfiizomes of Had~hium mild tranquillising action in ratr (Dixit and Varrna. 1979). 1977). 1980) and Dcsmodium potycurpum only analgesic activity (Wahi ct al. and Dysoxylum bitacctarifcrum (Singh etal. 1978). ct a / . total alkaloids of Stephania wightii (Naziniuddeen ct a l .198 1). 1980). Other plants reported to have CNS depressant effect are Cjmbopogm citratus essential oil (Seth ct al. a large number of plants have been showh to have CNS depressant activity. Fcronia limonin root (Patel st a!.. Ippmaa carnca leaves (Bhattacharya ct al. 1973a). 1978). its extract potentiated barbi. Neuromuscular blocking activity similar to that of' d-tubocurarine. .. 1979a). coronarium and H. 1979b). Bacopa monniera Linn. I.. with CNS activity . 1982)) Elaaocar~s ganitrus fruits (Battacharya at al. t ylophorine from Tylophora indlca (Gopalakrirhnan ct of. The histamine content was lowered in the whole brain but raised in the cortex (Singh et of.. Local anaesthetic activity has been reported in Euphorbia ncrqolio (Lahon el al. Lucknow.. Tranquillising activity has been reported in Conwluulus plrnicaulis in animals (Singh et al. A new triterpenic acid isolated from Corchorw daplesms has been found to have analgesic and an tipyretic activity (Vohora ct d. . At the CDRI. 19i9) and Zizyphus jujuba (Sahu and Das. Anticonvulsant activity was found in the roots of Cichorium intibus ( Jindal et ul. 1975). SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 290 ... but milder in degree. In rats. Essential oil of Psoralca corq. Clycywhize glabra Linn.G .. Morus indica showed potent local anaesthetic and analgesic activity (Barman ct a!. . Piper r~igrum leaves (Sridharan et al.. Acacia aurirulofornnl (Sahai et al.. Important among these are Pntkirlsonia acukata (Rao. 1976). Nuciferine is a dopamine receptor antagonist with pharmacologic profile similar to that of chlorpromazine but its Hofman degradation product atherosperminine showed effects associated with d o p a h e receptor stimulation (Bhattacharya et al. ./ There has been considerable interest in plants showin3 CNS actiyity. V. Conuolwluc pluricwlis and Tinospora cordwia (four plants described in Ayurveda as "Mcdh~eRcfrapma" drugs) decreased the acetylcholine content of whole brain and cortex in stressed rats. 1977).. 1975). 1N O ) . was demonstrated in a quaternary alkaloid isocwulidins isolated from the leaves of Cocculus kurifolius (Kar et al. Epistephanine from Stephania hernandijiolia revealed significant adrenergic neuron blocking?ictivity (Ray et al. 1975).. 1977b) and in clinical studies (Singh and Mehta.lifoliashowed a direci stimulant effect on skeletal muscle similar to that of caffeire (Zutshi and Bhagwat.. SATYAVA'I'I The present report is a review of the published literature on phaxmacology of medicinal plants between 1975-81.. 19i6c).. Plant. 1979a). 1 980) and biflavonoids isolated from Taxus baccata leaves (Vohra et al... 1979).

1981). Cannabis led to significant hyperglycemia and concomitant fall in liver glycogen in rats (Soni and Gupta. I975 . on tolerance (Singh and Ilas.... A study on cognitive functions in chronic cannabis users (lid not reveal any difference between the useri and non-users (Ray rt al. the major fruit alkaloid of A. 1979). Wi!hdrawal symptoms were reported by the majority of subjects (Singh st a/. A series of studies has been carried out on the interaction 01 cannabis with CKS depressants (Singh st al.. Rats treated for 37 days with CclostnrrpaniGulota seed oil showed an enhanced learning and memory process (Karanth rt al. G~~nhizaglabra. in the rat.. 1980 . An Ayurvedic compound comprising Cmtrlla osiatica (Mandookafiarni). 1976). 1979b). 1979). 1979a).1981) In a double blind clinical trial. anJ strictamine an indole alkaloid isolated from Ustonia scholaris flowers (Bhattacharya et al... 1980b). 1980. 1978). 1978) and hypothermic activity (Singh and Das.. Ghoah and Battacharya.. Strictamine is considered to be the biogenic precursor of picntnine. which are often treated as synonymous. Dhari&aitara tailarn revealed anxiolytic effcct in rats (Srinivasan rt J. 1976) and potentiation of morphine analgesia by callnabis (Ghosh ail3 Bhattacll~rya. 1978) . 1980a). most of the CNS activity of cannabis is serotonin-mediated (Gliosli and Bhattacharya. Significant psychopharmacologicd activity has been demonstrated in the epimeric pair of 4-methoxyindolc alkaloid^ isolated from Alstonia vencnata bark (Bhattacharya ct al.. 1975b).PHARMACOLOGY O F MEDIClNAL PLANTS turate hypnosis. There studies at the Banaras Hindu University have confirmed that. while . 1979b) and copper (Singh and Das. Prolonged inhalation showed inhibition of act tylcholine release from the brain with simult?aneous activation of xrotonin and catechoIamine release (Sing11et a/. 1979). 1977) and on mechanism of anticonvulran t (Singh and Das. MAO-inhibitor activity lias also been reported in echitovenidine. vetlenata (Bhattacharya and Ray. 1978). Whilst picrimine is reported to be a cencral nervous system dqprtssant (Dutta ct al.. 1976). strictamine exhibits anti-depressant activity (Bhattacharya ct al. 1981).. Clinical study in volunteers on the effrct of chronic cannabis use did not reveal any serious harmful eEects.. CenbNa asiatica powder did not show any &t. induced depletion of acetylcholine and catecholamu~es axld l an increase in sel otonin and histamine levels in wlrolc L ain (Sing11 c! ol. Tranquillisiag effect comparable to chlorpromazine wae found in Lufa hrbrrosa extract tested in rats with septa1 lesions (Karanth rt al. Ghosh and Uhattacharya.preventing the release of serotonin and catecholamine. SELECT RESEARCH PAPERS ON EVJJJENCE BASED AYURVEDIC DRUGS 291 .by many Ayurvedic physicians-both plants showed significant . A single inhalation of marijualla fumes by rats released acetylcholine from the brain into the blood. In a comparative study between Bacoja monirra (Bruhmi) and Mandookaparni (CcntrNa asiatica). Ghosh et al.. on the general mental ability of normal children (Kuppurajm rt al. 1976). 1978e .

. Patnaik and Kohler. 1976) were other plants which showed significant hypotensive activity. Anchusa strigosa (Mahipal ct of.thri. Lucknow. 1978a) and Cundrbita maxima (Lahon ct al. Crotosparine. Plants with activity on tho cardiovascular system 1. V. more potent (Sing11 et 'nl... comparable to digoxin and ouabain with a better margin of safety (Patnaik and Dhawan. 1966. 1976). Brahmi (Centella asiatica). Kushtha (Saussurea lappa) and Jatamansi (Nardostachys jatamansi). Sarpagandfia (Rauwolfia scrpcntina). At the CDRI. a new cardenolide from Asclepias curclssavica has been shown to have cardiotonic activity in cats and guinea pigs.. HibGcus rosa sinerlsis (Dwivedi ct al. the N-methyl derivative of a proaporphine base from Croton sparsiflorus has been reported to have good hypotensive activity (Rastogi ana Dhawan. 1981). While Brolrmadiyoga showed better effect than Tagara alone. f SELECT RESEARCH PAPERS Oh hVIDENCE BASED AYURVEDIC DRUGS 292 . ~tbe plant uaed not apecitierl. IIy+olipidemic agents Ever since the first experiments on crude gum guggul which 4emonstrated l~y~olipidelnic effect in the oleoresin (Satyavati.C . Vocha (Acorur calamus)...hora mukul) itself but other plants which might have similar effect. 1976)... I969). 1978). 1978) showed cardiotonic effect. Hypotctl~iuc cardiotonic agents and A large number of plants have been screened and found to have mild to moderate degrce of hypotensive activity. 1980e). 1978. 57 of them being hypotensive and three showing cardiotonic activity. Systematic studies at the CDRI. Asclepin... alba also had a myocardial depressant effect.--- --- ----. SATYAVATI psychotropic action in rats. Mollugo ceruiana showed sustained inotropic effect perhaps mediated through autonomic receptors (Bansina th ct al. Buddleja asiatica ahowed persistent' hypotensive activity in cats and dogs whichwas found to be due to an alpha-receptor antagonistic action (Singh et al. on the effect of Tagara (Vaferiana spccics) *. Coleonol. Tiliacora raccmosa (Guha ct al. Er). E .. 1976). Satyava ti ct al. Nerium indicum (Singh el al. 1975~). ------- 2 . over 60 plants have been found to have cardlovascular system (CVS) activity. 1978). comprising 6 plants including Tagara.I. a direrpene isolated from Colcus forskohlii is the most promising hypotensive agent (Dubey et al. 1977) and Eclipta alba (Gupta at a/... chlorpromazine was superior to both (Mahal ct al. however. Piper aurantiacum (Singamma e t al. chlorpromazine and a cornpound preparation Brahmadiyoga.ra variegata (Chatterjee ct af.. A double blind clinical comparison was carried out in patients suffering fiom various types of schizophrenia (Unmada). 1981). considerableinterest has been evinced not only in gum guggul (Comm.- *Exact Uotat~icalname . Tribulus tcrrcstris (Seth and Jagadeesh. Bacoba monicra was. have shown hypolipidemic activity in three -.. 1978d). Sapindus trifoliatur (Singh et al. 19771. 1980). 11.Lucknow. 1982).

in a double blind trial.administration. 1979) and also to decrease myocardial necrosis following isoprenaline in rats (Saxena et al. mukul (gum g u g u l ) in rats (Nityanand and Kapoor. bleeding time and recalcification time but led to a rise in peptic activity and mucin content of the gastric juice (Kumar et al.. Pkrocarpus rnarsupium showed hy pocholesterolemic eKect in normal rabbits (Pandey and Sharma. The essential oil of asafoetida (Fertda o s o f e t i d a ) showed significant protection against fat-iuduced increase in plasma fibrinogen and decrease in coagulation time and a fibrinolytic activity in healthy human volunteers (Bordia and Arora. 1978).. 1976. Garlic prctreatment has been shown to reduce serum cholesterol in rabbib (Jain. Guggulu. Sharma and Sharma.. It is now under phase I1 clinics! studies.steroid constituents of C. A significant lowering of endogenous cholesterol level has been observed in rats fed capsaicin (Sambaiah ct al. 1979. It revealed a consistent hypotensive effect 1). fibrinogen and fibriuolytic activity onion was not found (Sharma and Sharma. 198 rats prolonged the clotting time. 1978). Double blind clinical study was carried out on obcse subjects with Ajush-55 (comprising h-aiuki. 1976) and rats (Pushpendran 61 al. in allother study. Triphala. 1981).. Sainani ct al.. Malhotra et 01. Guggulrpid. 1 981 ). Shilajafu and many mineral preparation). 1980).. 0nion. 1979). 1976). Chitrakomula. similar to garlic ( K u r n ~ ct al. of coronary artery d~sease as well as healthy individuals with lraction '' of A C. In experimental ~nirnals. mukul. 1979).. 1975). 197b) but was found to prevent atherosclerotic changes in r rats. Bordia and Chuttani (1979) reported an increase in fibrinolytic activity and a decline in ptatelet on adhesive index without s. naukul in patients with Type 11 l~yperlipoproteinemip. a srandardised resin fiaction of C.gr~ificanteff~ct serum cholesterol in patient.. 1979). SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 293 . lowered serum cholesterol and triglyceriies in healtliy male volunteers (Nityanand kt al.. Xityanand etal...i (Tripathi et al.. mukul. The drug also rhowed an anticoagulant activity (Mester et al. Onion was found to have hypolipidemic effect in patients of ischaunic heart disease (Shar ma et at. mukul (Nityanand and Kapur. raw garlic has been reported to lower the blood cholesterol in 'normal subjects (Bhushan rt al. Hypolipidemic effect was confirmecl in the ethyl acetate fraction of C. Clinically.. 1975b). 1979)... Clinically. However.did not show arry change in tlie blood chulesterol. 1977) and in a ketosteroid fraction in cl1ick. 1975). to have any esect on experimental atherosclerosis in rabbits (Jain. (1977) and later Kotiyal ct al. (1979) reported a hypolipidemic activity comparable to that of clofibrate in the fraction ' A ' of C. in fraction 'A' ofprtroleuln ether extract in male gerbils (Ahuja rt d. 1980) and to protect rats against isopnnalineGarlic extract feeding in induced myocardial necrosis (Saxena et al. i973. 1977) and normal subjects of the Jain community (Sainani el al.

1980a.. 1975). Kamboj and Dhawan. however. very meagre.. M~rin~apterygospnna root and Tsrminalia arjuna bark.. b. 5-hydrdxy 1 : 4 naphthoquinone) is reported to have anticoagulant and Rathinam. listed 16 plants as more active antifertility age~its. A vasoconstlictor effect has been found in Albizzia lebbeck (Tripathi and Das. 1.without effecting the body weight or serum lipids (Kuppurajan et al. 1978). Alcollolic extract of Cuminium gminum seed and Hyptis suavtolrns leaves showed potent antifertility activity while Dolichos bflorus seeds and Trianthema pentandra leaves were devoid of such activity (Garg. on the other hand. and other plants had over 60% activity (Chaudhury and Haq 1980b). Pharmacology of solasonine. Ananas comosus unripe fruit. . Embelra ribes roots and Sapindus trifolialus seeds. Butm monospuma seeds. 1977). SELECT RESEARCH P A P E G 3 N EVIDENCE BASED AYURVEDIC DRUGS 294 . auplrrta also showed abortifacient activity. Chaudhury and Haq (1980a) listed 11 plants with 103% antifertility activity in one species of animal or the other. Ethanol extract of Cychorium inpbis showed significant resorptive activity (Prakash and Mathur. 5 plants have shown anti-ovulatory activity. Sc~eening 32 botanically identified plant materials showed significant of antifertily activity in only Abrusprscatorius seeds. showed significant antifertility effect (Garg el a!. 1982). 1976). Documented clinical data on antifertility plants is. A. (Kamboj 8: Dhawan. DUUCUJ carota seeds. ICamboj and Dhawan (1982). 1982). 9 extracts of 7 plants viz. 1 1 Plants with antifertility activity 1. Research on Indian plants with antifertility activity has been exhaustively reviewed recently (Chaudhury and Haq. benzene extract of Achyrantls aspcra stem bark and Sssbania aeglyptica flowers and alcoliol extract of Woodfordta fmtirosa Aowers (Pakrashi et a / . 3 976 j Of 201 extracts of 36 plants screened. Plants with antifertility effect in the femalr Twenty eight plants and about the sarne number of isolated materials have been reported to have shown anti-implantation (interceptive) activity. (1979b). 19UOa). 1978). . Fruit extracts of Emblica OJJicinalis and Terminalia belrrica (two components of the well known 'Trt$hala' of Ayurveda) p~otectedalbino rats against myocardial necrosis induced by isoproterenol (T'ariq el al. 1931. Plumbagin (2-methyl. activity (San~hakumari a glycoalkaloid from Sdanum surratsase has been s~udicd (Basu and Lahiri. 1977). Curcuma longa rhizomes. Anti-implantation activity in mice was found in petroleum ether and chloroform extracts of Abroma augwta root. 1976) and an atherosclerotic effect in c u m i ~seeds by Rao rt al.

1978a). Piprr longurn fruits alone revealed only marginal antifertility activity in rats. 1975. 1977) and#-coumaric acid (Pakrashi and Pakrashi.1916) given in a dose of 0. . 1980b). Krishnaswami and Purushottaman. benzene extract. in this study. it inhibited pregnancy in 80% of rats (Kholkute et al. Em belin (2 : 5 dihydroxy-3-undecyl-4:4 * benzoquinane) isolated f o Embclia rrbes seeds rm was effective in rats in one series of study. Hibi. ArisWochia indica root has been studied in great detail by Pakrashi and co-workers. Piper iongum and Borax (Carbhani varanaurhadham) recommended by Ayurvedic practitioners enhanced the uterine alkaline phosphatase activity in rats and guinea pigs (Raman rt a1. ernbelin did not reveal any estrogenicor antiestrogenicaction (Krishnaswamiand Purushottaman. 1978) and Sharina st al. however. (Radhakrishnan and Alam. arhtolic acid (Pakrashi and Chakraborti. 1977) and prolong the dlestrus stage (Prakash.5 g twice daily from the 5th to 20th day but did not have any intcrceptive effect m 7 women volunteers (Joshi t t ai. in the petroleum ether and methanol extracts of the plant.. Rerultr of studies on Embrlia ribts arc also equivocal. 1978)..PHARMACOLOGY O :AIEDICINAL PLANTS I . Trianthcma portdacaslrum and bark of Morirtga olciJira did not show any antifertility erect (Rao ct d.Garg ct al. 1979). its methyl ester (Pakrashi and Saha. A combined preparation of Embrlb nbss. nbes. Icd to liver and kidney damage in mice (Pakrashi and Saha. sesquiterpene (Pakrashi and Saha. r ~ 1975. but not in another (Kholkute st al. showed significant antifertijity activity in rats (Kholkute rt al. 1976). Anti-e. (19 78) observed that biochemically embelin seems to share some but not all the e k t s of antiestrogenic compounds. however. 'Antifertility activity was demonstrated ki the root extract (Pakrashi t t al. 1977) showed anti-estrogenic activity. 1978). Both aristolic acid (Pakrashi and Chakraborty. Con trovenial results have been reported with extracts of Dapcrrs caruta seeds.. 1977). 1979a). 1976a) and perhaps altered the estrogen295 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .. Seshadri rt al..rcus rosa n'ntnds... The methyl ester. trogenic activity reported in rats (Prakash 1978b) was confided in the ethanol and benzene extracts (Prakash. 1979). Prrkash and Mathur (1979) found an estrogenic activity in a 50% ethanol extract of the plant at a low dare. (197P) or Kamboj and Dhawan (1982). w h e t w roots of Butta vulgaris. 1976) and its active constituents.. (i976) have not been 'confirmed by Prakash ct al. When mixed with E. 1978a). Further. 1980b). 1978b) and the sesquiterpene (Pakrashi and Chakraborti.r fresh leaves were found to disrupt the normal estrus cycle in rats (Prakash and Mathur. i978a) although antifertility effect was found.1979~).with a dose dependent antiestrogenic activity (Kholkute and Udupa. Ethanol and benzene extracts of Artaboty odoratiuimu. Extracts of Annona squamost weds and C u m l a reJkxa whole plant and the alcoholic attract of iota la ria juncca seeds showed antifertility effect.. Anti-implantation activity reported by ~ a and colleagues (Garg.

Among its ingredients. protein. 1980b). 197711). Steroids isolated from Ananas comosus (unripe fruits and juice) exerted abortificient effect in mice (Pakrashi and Ijaqan. 1970). The flowers but not leaves and stem of 11. 1980a). mice and rabbits. Laccardia locca (Laksha)-had an 'ulti-implantation elfect in rats. l'lumbagin (2-methyl-5-hydroxy. 1977). 1977).. a plant u s ~ dby an Adivasi population in Maharnshtra. I t has been suggested that the compound acts by exer- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 296 . 4 naptl1aqu. antiestrogenic or androgenic effect in mice (Pakrashi and Bhattacharya. 1970a. Kliolkute et al.. 1978b). 1978). sialic acid and glycogen con tents o rhe pterus and vagina (Dixit..b)..tattii flowers caused degenerative changes i l l the ovary afgsrbils alongwith a decrease in the RNA. anti-ovvlatory and abortifacient activity without any teratogenic effect in rats.. ~Iyush-17. Sida carpinifolia (methanol f extract) and Podocarpus brev~oliirs(chloroforni extract). 1. I'hysalin-X Iron1 Physalis minima had significant abortifacient effect in rats (bfahana et al. 1980). u~hereas Areca catechu has also been r e p ~ r t e d to have anti-implantation effect (Chaudhury and Haq. compound Ayurvedic preparation containing Saraca rndico. A flavanone glycoside from Curculigo orchioides was found to be a powerful uterine stimulant in several species (Sharma et al. que~cctin and hent~iacontanc) were clcvoid of any anti-lertility effect (Kholkute and Udupa. Saraca indica and its phenolic glycoside (p. a rlreca catechu. I t revealed an anti-uterotropic effect without an anti-estrogenic activity (Gllosh ef al..none) isolated from Plurnbugo zglanica showed significant anti-implantation.. although tlie mother liquor showed activity. showed antifertility activity in rats. 1978). by exerting its effect on the zygote and/or blastocyst (Gaitonde and Mabajan. fiom lle~lzcne extract of Achyranfhes aspera showed 100 per cent abortifacient effect in the rabbit at a single dose of 50 mglkg. illalvavlucyscoti. gold and sugar evinced anti-implantation effect in I ats. 1979). 1976. The compounds isolated l i l t . I t had no estrogenic. Coccus lacca.progesterone balance (Kholkute and Udupa. 1976). 1975). Oleanolic acid 3-B glucoside isolated from Randia dumetorium showed anti-implantatioll activity in rats and was found to be anti-estrogenic in action (Pillai rt al.) have been shown to be a highly potent uterine stimulant (Satyavati. Alcoholic extract of Lygodrurn Jlexosum. showed antitertility clrcct in rats (Kholkute et al. whe~:administered during 6-7 days of gestation (Pakrashi and Chnkravarti. Larica papaya (unripe fruits) showed abortifacient activity in rats (Gopalkri~tlnanand liajasekharasetty. 1956b). 1977). rosa stnensis showed significant antifertility activity (La1 el al. benzene extract (cyanidin.

4. The aqueous and alcoholic extracts of E.1982) whereas Coronaridine froni Tabarnoemontano hcyncano showed anti-implantation activity along with estrogenic activity (Mehrotra acd Kamboj. Lucknow (Khanna et al. 1977b). Contraception in the male Aristolochia indka root (chloroform fraction) rcvealcd an antispermatogenetic effect ( Pakrashi and Pakrashi. 1980). 1982). Antispermatogenetic effect of the flower extract of Hibiscus rosa sinenst3 was demonstrated in Rhinopama ki--a n6n-ac$'otd bat (Singhvi and Lal..... 1978).. 1977).. a new flavonoid from Tarminalia arjuna has shown oxytocic activity (Sharma at d. Vasicine potentiated prostaglandin-induced uterine contractions in rats (La1 and Sharma. lactation is a common practice among women in Kerala. Lactogcnic~galactogogue effect of Asfiaragur racmusus roots has been wcll documented (Satyavati at al.. A s p d y carried out on lactating micc showed that contact with jasmine (jusminum pubucais) flowers led to suppression of milk production with involution of the mammary gland. It revealed anti-ovulatory activity i n rabbits (Pakrashi and Chakrabarty. Even exposure to the smell of thtse flowers induced similar changes although to a lesser drgree (Abraham el d. 1981). Azadirachln indica leaves showcd an antifertility activity in the male mice f which was not due to inhibition o spcrma~ogencsis(Deihpande st al.. From the husk of Plantago ouata (Isapgol) a new cerbical dilator (Isaptent) has been developed by the CDRI. 1978).efitadenia raticulata showed significant lactogenic effect in rats (Anjaria rt al. Ruteafrondosa flowers and Caesalipinia bonducella seeds showrd estrogenic effect in rats (Tewari el al. n b t s fruits did nDt reveal any toxic effect on the male reproductive organs in rats (Seshadri rt al. Embafh ribes fruits administered to male bonnet m~nkeys for 3 months reduced the circulating testosterone levels without affecting normal sperrnatogenesis (Purandare et al. 197fia). 1979).. I t exerted an abortifacient effect in guinea pigs but not in rats (Gupta et al. .PHARMACOLOGY OF MEDICINAL PLANTS ting anti-lutebtrophic activity (Pakrashi and Chakrabarty. 1979). 1980). 3. Isaptent has been found to compare very favourably with the imported laminaria tent in efficacy and safcty and is much cheaper (IChlR. 1980)..e: .iaction) isolated from L. and its derivative p-coumaric acid showed an anti-prolactin effect in male mice (rakrashi rt al. an alkaloid isolated from Adhatoda vasica showed potent uterotonic activity partially mediated through prostaglandins (Gupta et ul. 1981). AntifibrinoIytic activity in the roots and phenolic glycoside (punamavoside) of Borrrhavia dzJiusa has been found useful in controlling uterine bleeding in monkeys (Srivastava st al. Bandaging the breasts with +mine flowers to suppress. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRIJGS 297 .. 1978). 1980). 1975). 1976).. 1979). Arjunalone. Vasicine. Plan!$ with lactogmic and anti-lashgenic activities S tigmaaterol (as well as an el .

.... Crewia )~ asiatica (Pakrashi and Mukherji. Coccinia ir~dica & A and Coccinia indica W vor palmata (Pillai ct a(. Ficus bcngabnsis (August. al. 1981 ct a?1 '. Cannabis extract showed consistent adverse cffe~tson the testicular function in the mice (Dixit and Lohiya. A number of leguminou9 plants of the 1a Acacia family have also been found to evince hypoglycemic activity in expe. Allium crpa or onion (Mathew and Augusti. Pterocarpus santalinus. Plant extracts with semen . 1976). 1975). pigeon (Vyas and Singh.. Pterocarpus marnrpium (Rajasekharan and Tuli... IV. 1977a). Clrrodendron phlomides (Bhattacharya and Bajpai. on account o f a no7. Azadirachta indica showed hypoglycemic as well as anti-hypergl y cemic effects in dogs with adrenaline-induced and glucose-induccd hyperglycemia (Satyanaraya~~a blurthy et el. 1975. Lucknow. Terminalia belm'ca (Tripathi et al. Spermicidal saponins from Sapindw mukrossi fruit. The CDRI. 1977a). 1977). -1 975). Of all the plants tested so far. 1980. 1975).. 1976) and onion extract (Sharma et a1 .. 1976...imental diabetes (Singh st al.. 1982). Singhal ct al. Pittosporum nilghcrensc and Polemoniurn comuleum have been characterized (Setty st a[. 1979~).-~amlating property have been taken up for in depth study at the CDRI. Gupta et al. seem to be ofgreat interest and potentiality. Schlrjbra copitota. 1982). 1979). has recently reported hypoglycemic action in Dipteracanthus prostratus. Lucknow. Singh and Bhaqdwaj 1975. 1 9 7 7 ~Arb18 murmlos (Vyas et a[. <ingiber nJzcitlals (Sharma and Shukla. Clinical efficacy of the crude drug waq demonstrated in Cinnamomum tumala (Chandola rf of. Cyanropsis tetragonoloba (Pillai et al. inufa racemosa. 198Oa). Malvavircus conzattii flower extract revealed potent anti-spcrmatogenetic activity in gerbils and house rats (Dixit.. Lucknow.. 1977). dogs (Dixit et al. P~trocarpus marsupium and its active cornponent. 1980)..1980).Gtitiamomurn tamala. 19tOc) and Pferocarpus marsufiium (Chakravarti et al. 1978). SELECT RESEARCH PAPERS ON EVlDENCE BASED AYURVEDIC DRUGS 298 . Rhur chinensis and Trichoson~hes palmatu (Rastogi and n 1 wan. hypoglycemic activity has been reported in a number of plants viz. 198%). Spermicidal activity in a number of plants has been investigatedin detail at the CDRI. 19771. (-) -epicatechin (a flavonoid). 1978) and albino mice (Verma ct of. 1976a. 1976. Augusti.el antidiabetic mechanism promoting regenera tion of the beta cells of the pancreas (Chakravar~i al. 1980). 1976) and toad :Dixit rt al. A rise in plasma insulin with a simultaneous Fall in blood sugar was demonstrated in patients of diabetes mellitus treated with Ctnnamomum tamala (Chandola et. Phnts with hypoglycemic activity In the last few years. 1980a). 1975a.

whereas from Evodia 1u. Further studies showed that i t could inhibit cholera toxin induced diarrhoea and fluid accummulation in the gastromtestinal tract ofadult raw (Sabir st a/. 1975). 1976). Antlulmintic actioiry Carica P4P(qa... A striu of plants belonging to different families have been screened in vitro against human round worms (Ascaru lumbrtcoides). Aty1osol-a new . antibacterial and antifGgal activities (Krishnaswami and Purushottaman. 1978). C'bopogon species.. 1977). Oenarrthcjawffica (Sharma rt al. Berberine hydrochloride showed potent anthelmintic effect against Sypharia obvelata in rnice in vim (Sighal. Blumc~mcmbrancea. Butro frondosa and Mimordia charantia showed anthelqintic action against Ascaridia gaNi i n v~tro (Jawahar La1 et al. Cythoclmr &rat#. c h b m f m extract of A&irqchta indica and Pmgamia glabra were fun$SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 299 . ~naphliscontrota. 1976). 1975).substituted biphenyl isolated from Aiylosia trinuvia showed antibacterial effect (Tripathi tt al.. 1982). &rbcrine inhibited chokra toxin-induced fluid accummulation in the ligated ileal loop of adult rabbits (Caitonde et al. Cwcuma longa.. 1977). Sdvia lanata and <ingiber ofuinak (Slnha et al. 1980d) and Caesalpinia crisfa seeds were effective against human ambebiasis (Tewari et al. 1977. aathelmintic. Nigtfla sativa (Agarwal et al.. 1982). revealing potent f activity in p h t r o 'the <ingibnaceae family ( Raj. while the ether extract of Shsrea robusta win. It caused potent and prolonged inhibition of the cholera tmin-ir$uced subcutaneous inflammation in rats (Akhtar et d.PHARMACOLOGY OF MEDICINAL P U T S V. 3. Laggrro aurita. 1979). Plumbagin (5-hydraxy. 1978a). Antibacterial actwity In oilro anti-bacterial activity against pathogenic gram positive and gram negative bacteria was reported in the essential oils of several plants viz. Ncem leaves (Mdia azadiraca) were found to be effective against b u w n ascariasis (Singh ct al. 1980). 2-methyl. 2.. Crude extract' of Allium sativum (garlic) had anti-bacterial effect against gram-positive and gram-negative bacteria in vitro and gram negative bacteria in the intestinal tract of poultry (Sharma et dl. Clinically... 1-4 napthoquinone) revealed anticancer. Cp~nJioadloris. Hedychiwn sjnkatum. A n t i f i p l octivitt Ether and chlorofbrm extracts of Mwnaprurimr seeds and CurIonga stem w u c found to be fungistatic. Palma rosa and Psorolea torylfolia (Zutshi et al.. antifungal and antiviral activities 1. 1977). 1980)..r~-ankendo. 197713). Sapindus tt$oiiahrs.. P l u t s with antibuterll. It significarltly inhbited the growth as well as production of enterotoxin in Eschcrichio coli (Kumar and Sharrna.two alkaloids with antibacterial activity have heen isolated (Rastogi and Dhawan. 1976).

1982).. 1977). lactones.. Vanda parviflora and <ingiber capitaturn (Rastogi and Dhawan. 1979). Cynoden dactylon. Berberine sulphate also protected chick embryos against the lethal effect of trachoma organisms (Sabir ct al.. Antileukemic constituents from Tithonia tagitiflora (Pal rt al. 4. ~Cacsilr alata (Radhakrishnan rt a[. 1980). Schiwallin. Solanum. 1982a). Of these. 1977)and the rhizornesof Curnrma amada (Ghoshet al.. e. Rg&o and Tephrosia candi& have also b u n characterized at the CDRI. Berberine chloride eye ddPs (0.. 1980~) showed p t e n t an ti-fungal activity in oitro. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Q I U T G U S . 1979a). Euphorbia. 1981).. 1976) and Cuivuma augustijJa (Banerjre e and Nigam.Lucknow (Dhawan and Rastogi.Aglaia ro~burghiana. 1976) and Saussurra Ia@a(Ray and Mazurndar. Otaa p o h m a .. 1982). Antiviral activity was found in plants of 14 major genera vir. Interferon like substances responsible for antiviral activity have been reported in nearly 17% plants screened at the CDRI. / Antiviral activiw At the CDRI.. Ipomoca. Lucknow have been isolated. Rubia cordifoliaIAdwankarat of. 1976). antiviral activity has been confirmed in several plants. Celsioside.. Other plants which have shown va$ng degrees of anti-tumor activity are Alliurn cspa (Yerkar ct d. 1977) showed potent an tifungal activity. Srnvcorpur m~cardinm(Chitnis rt al. 1982). 1981) and. 11'81). Lrm p iu ~ilgherrense (Garg and Khanna.al. 1976). Simplocos.. Pipa. auricuIaLa. 1979). Dh-s m a ( H a m rt al. Rhozp sticta (Mukhapadhyay at d. Lima.t of Alpinia &in'tiarum has been characterised as a flavonoid (Ray and Mazumdar. Cattia jstula.. An tifungal constituer.. 300 M. 1976) wcre shown'to be antifungal constituents.ip. Amabin-1 from Arnebia nobrlis inhibited mouse leukemia and rat Walker carcinosarcoma (Katti at of. Arnebin from Arnabia nobilis and lactones from many plana sllnwed antifungal activity against experimental fuhgal infection in guinea . characterised and biologidly evaluated. i. curcurnu caesia ( ~ a n a j e and Nigam. 1978... . alantolactone and isoalantolactone (Tripathi et al. Acacia. 19791. Acacin ouricul~rmis. ? ~ ~ ziqphns (Babbat rt at. Ficus. Essential oils of Curclfnra aromolica (Rao. Polygonum. Grewia hirsuta. Briddia retusa. Lucknow. Plants with anticancer activity Active constituents of 10 plants active against one or more o^ the tumora tested at CDRt.arnebin being more potent (Wahab ct at. 1978b). 1982 b). Inula racemosa yielded a number ofanti-dermatophytic constituents. Ematamia k p 8 0 ~ (Chitnis i t al. 1980) and cmodin f r ~ m Rumrx mardimus (Agarwal st at.lcidal (Mishra and Sahu. r saponin from Crhia coromandeliana has sllown high activity in Walker carcinosarcoma system but is toxic in the mouse leukemia system (Cupta' et al. Grewia. Argyrsia. C.2 %) adtninistered f a 2 weeks revealed a curative' effect in clinically positive cases of trachoma (Babbar et. 1976).. 1979). a saponin from Schima wallichii (Chandel at al.. p i t . 1976) and 0thbiologicaliy actiGe anti-tumor agents from Cocculus p~ndulns. Psychotria tnmcata..

PHARMACOLOGY OF MEDICINAL PLANTS Anti-viral.. and T-fophora indica (Sharma and S h a m . 1982). Lucknow. N p k h sfeliata (Singh i t al. A Siddha drug Linga chendooram prepared out of cinnabar showed significant antipyretic activity in rats. The CDRI. 1977). The exact identity of Rosna. has reported anti-inflammatory activity in 29 plants (Rastogi and Dhawan. Berginia ligulata (Gehlot el al. Hibi~cus rosa JinmEiS. Vanda roxburghii. The beneficial effect of Semecarpus anacmdium administered in rLe form of milk extract in various inflammatory conditions has been tonfirmed in patients of rheumatoid arthriti~ (Tripathi st al. Six such plants used as Hnsna were screened against formalin arthritis in rats and all of them revealed anti-inflammatory activity of varying degrees.... . 1978) and in plumbagin from Plumbag0 rosea in chick cmhryos. Alpinia galanga was found to be the most potent followed by P l u c k lancrolaia. Nmmm indinm (glycaide). 1977a1. Ayurveda descrities the drug ' R m a ' as the drug of choice for the treatment of arthritic conditions. 1980a). . 1980b. comparable to phenylbu tazont (Deodhar rt al. CaloPhyllum inophyllum and its xanthones (Gopalakrishnan. showed significant improvement. 1979~). Gossypin reduced initial as well as late phases of rat paw oedcma induced by carrageenin (Pafmar and Ghosh.. 1980b). 19801. Curcumin (diferuloyl methane). activities analgesic and -ti-p~etic During the perioJ under review. Tin~spor. c). Plants with ha ti-in&mmatory. 19751.. 1977a) showed potent analgesic. 1979). is not clear. Acanthus illic~oltus (Agshikar et al. 1977) aud a compour:d preparation (Am'tarishtam) with 7. 1980). VII. With& somnifcra (Singh et o f . Immunosuppressive action was demonstrated in mangostin from Garcinia mangostat~a and t~lophorine from Tylo@ora indica (Oopalirluirhnan st al. xanthone from Mmu/mso (Gopalakrishr an ct o f .. Aghia roxburghiana and <ingiber capitanum have been attributed to the presence of interferon-like proteins in them (Babbar et ol. 1980). 1980a) as also a coumarin derivative-calo~~hyllide (Bhalla rt al. and Pandya... however.9). 1977). cordfolia as the main ingredient (Pillai et al. Berberine was shown to inhibit local inflammation induced by cholera toxin in rat by means of a selective antagonim (Akbtar et al.~ cordifolia (Shah. bavachinin from Psoralea coryl~orta (Anand el al. Cytotoxic effect in mice of different degrees and nature has been reported in sesquiterpene lactone component of Parthenium hys~crophorus(Vaidya et al.. 19. anti-pyretic and anti.and anti-tumor activities of CassiaJistula.. Pendse et d. 1978)... in a double blind clinical trial on patients of 'definites rheumatoid arthritis. 1978b) and embelin from Embrlie ribs (Gupta t t d . but ~Qina"iindgericor anti-in&mmatory activity (Ghosh cf 4. .inflammatory activities in rats and mice. analgesic and anti-inflammatory activity has been reported in a number of plants viz. 19i9).. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 301 . 1976.

. 1981).. 1979). A q w u s extract of T.. ?ire equivocal..indaca prevented albumin-induced anaphylaxis in guinea pigs. 1979).. extracts of Ocimrm sawturn (Bhargava and Singh. Alcoholic extract of T8ctona grandis significantly inhibited restraint ulcers in rats and histamineinduced ulcers in guinea pigs (Pandey ct al. 1979. 1976). I . 1982). Hedy~~hium spica~um( Sharma 1975). 1982) have been found to provide relief in dyspepsia (ulcer and non ulcer). 1980c). Puri et al. Triterhnoids (ulsolic acid and lupeol) from a number of Indian plants belonging to S a ptaceaelsapindaceae famil) evinced anti-ulcer activity in rats subjected to restraint stress (Gupta et al. since the initial reports of (Shivpuri c t a f .. modified the Schultz-Dale reaction and caused leucopet~iain dogs (Haranath and Shyamala Kumari.. Prasad et al. 1975). revealed anti-stress or adaptogcnic properties.. 1975) have been found to be highly potcnt.. Alcoholic extract of and total alki~loids T.. 1976b... Recent clinical studies on 7. 198Cb). 1981).Curma longa powder fried in ghee (Jain rt d. indica have yielded equivocal ' Sheth. indicating :in immunosuppressive effect The bronchodilator. 1975... blilhania somtuzd~a (Singh et al. Card-&a turgida (Chaturvedi et al.. Plants with X ' spasmolytic/antispasmodic activity Spasmolytic or antispasmodic activity of varying degrees has been reported in a number of plants vir.. Amlaki Rasayana (Varma et al.. 1978a). indica showed non-specific antispasmodic action on isolated tissues (Dhananjayam et al. deodara. Curcumin has been thus reported . 1975). 1976) as well as anti-~llceractivities (Sinha ct al. 1978) and Daucus carota (Gambir et al. 1979).... 1979) and H1d9hium spicatum rhizome (Chaturvedi and Sharma.1975) among sesquiterpenes from C. Claumarin-a new coumarin' from Clawen a pmtaph~l/a(Patnaik et a!. Among these. ' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 302 . 1977) and Amlaki (Emblica 4fuinalis) (Chawla et al. Allohimachalol was found to be the most potent as a spasmolytic (Puri et d.. Nimbidin from Mtlia azadirachtu (Pillai ct al. . Planta with and-dcer activity Reports on the effect of curcumin on the gastric muwsa and secretion to evince ulcaogenic (Gupta et al. 1975) and branchodilator and an tibronchoconstriction effect in guinea pig ileum (Gupta. 1980) and AcalHh indua (Rarnan at al. 1982) and Altingia excelsa (Singh et al. results (Gupta st al. membrane-stabilizing and immunosuppressive efFect of T indica was confirmed in rat lung perfusion experiments (Nayampalli and . 1980. 1980). Gore stal. Tyloflhra indica has been studied extensively for its effect in bronchial asthma. Leaves of Acorur calamas (Chandra..WII.. Inula racmsa (Singh at al. 1975) brought about significant relief in bronchospasrn and other clinical signs and symptoms in patients of bronchi J a s t h m . Tinasflora cordifalia (Patcl el al. 1975). 1978) and srsquiterpenoids from Cedrus dsodara (Kar et al. ) 1968.

1978c). 1978b) and Tinospora tt cordiqfolia (Singh ct a/. Among the compound preparations tested.. ~iuretic activi~y Vitladinia australis has been attributed to vittadinoside-a of sterol glucoside isolated from the plant (Kar st al. the fresh leaves had better effect than their' cold aqueous extract on the glycoside isolated from the plant (Natu et al.. 1975b). Indigofcra tinctoria and Andrographics panicu/ah (Chaudhuri. Craeta~a nurvala has been shown to be an Ayurvedic drug of choice in the treatment of various urinal y disorders and particularly helps in the migra~ion stone and in preventing of atony of bladder. XI.. 1979) and Ricinus communis (Natu st al. 1982). Wirlhnia somnifrra.migration inhibitor (Tripathi et al... 1977b).. I t protected sensitized guinea pigs against hone serum antigen (Tripathi and Das. acting on hepatic fmnctions The Indian traditional systems of medicine claim to offer usehl remedies for a variety of hepatic diseases. 1982). It also significantly inhibited. Plant. Solanum xanthocarpum in a clinical trial on respiratory diseases showed sigm'ficant improvement in cough and expectoration without any significant reduction in airwav resistance (Jain.. C u m i s tripnus exhibited a do:e-dependm t saliuretic effect.. without affecting fhe potassium excretion (Naik rt of. in vitro.. 197%~). protected r a u against CC1.Livcrgcn. Luja echinata (Lauria st al. IVithania somnifcra (Singh et al.. 1977) have shown protection against carbon tetrachloride (CC1. Apart from a diuretic ftavone glycoside from Millingtonia hortsnsis (Kar rt al. 1981). following prostatectomy (Deshpande st al. a compound preparation (contaming Andrugraphis paninrlata). PHA-induced hlrutogenic response of human lymphocytes and in sensitized guinea pigs... 1977). also had an effect SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 303 . Nympham stellab. Mimosa pdica (Pill~i al. three new coumarins and an alkaloid wit11 diuretic activity have been isolated from Toddalia asiaticc (Rastogi and Dhawah..)-induced hepatic injury in rats. X.. 1977). had a significant cromoglycatc-like action on the mast cells and appeared to also inhibit the early proccu of sensitization and synthesis of reaginic-type antibodies (Tripathi st al. Indigojira tznctoria (Anand ct al.PHARMACOLOGY O F MEDICINAL PLANTS Albizcia kbbeck has batxi subjected to detailed study with respect to its anti-asthmatic and anti-allergic activities. JVymphaca stcllata. 1980). 1978) increased the bile flow and liver weight. apart from general pharmacological studies (Tripathi et al. it marked1y reduced the secretion of the macrophage .. Plintm with diuretic activity Diuretic activity has been reported in extracts of Cllrdiosperrnum hiicacabrm (Santakumari st ol. suggesting a ' stimulation of the microsoma1 enzymes cf the liver. 1981). 1977). Among the plants investigated in recent yeara.. In case of Ricinus commmis. 1979b). 1976). Liv-52.-induced necrosis of the liver (Singh d d. 1979a). 1975).

edic ratorativc to& o&inalir as the main ingredient. 111 a pilot study. two well known medicinal plants ' EcI$h alba and Phyllanthus niruri inactivated hepatitis surface B antigen (HBs Ag) in oitro (Thyagarajan et al. ~ c u l a t a . Punarnava whole plant paw ler pro. did not find any protective effect in the alcoholic extract of Picrorhita kurroa against CC1. Luffa ecchinata fruit juice administered as nasal drops to patients of viral hepatitis led to a reduction in serum bilirubin and SSPT.-induced hcpatoxicity in rats Kutkin. Kantikar rt at. kurroa and its constithtent organic acids (cinnamic and vanillic acids) showed significant choleetric activity in dog$ and a laxative activity in rats. along with substan tial relief in clinical symptoms lika anorexia and malaise. (1976). as compared to placebo (Kuppurajan et ol. 1977). administered for 1 year was reported to be effective *Chavan~rashis a well-known Ayur:. 1978). echinata drops in the nose. 1976). on the bile flow and liver weight in rats. the nasal ~ecretions containing 1.. however.i t s main ingredient (Chaudhuri. A random survey of Ayurvedic literature resulted in a list of nearly 90 plant expected to be beneficial in the treatment of liver diseases (Satyavati. 1980a). There was profuse rhinorrhoea following instillation of L.. total proteins and mean corpuscular haemoglobin conccntration (Venkatraghavan d al. (Das st al. X! I. the bitter glucoside of P. 1976).. for their effect on the process of ageing. Gcniforte-an Ayurvedic compound preparation.. somnifera and Rocnhavia d i b a (Punamava) to norm11 children (8-12 years of age).5 mg% bilirubin (Vaidya st al. Plants with adrptogenic and other activities Certain drugs classified in Ayurveda as '~asGana' have been tested clinical study. growth and also longevity in albino rats on stock diet which was not so marked in animals on a low protein diet (Rajagopalan el al. and r c j u v e ~ ~ r En#lica with SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 304 .s&lar to the plant A. in patients of acute viral hepatitis showed significant improvement in clinical and biochemical parameten after 2 w& of treatment (An tarkar et al... This seems to be a highly interesting and promiring field of research which might throw valuable leads in the pharmacology and therapeutics of liver diseases.not'ed a pojitive rritrogen b4ance. and a combination of W.. a well known Ayurvedic compound prepmation. The main ipgredien t of A r o p w a r h i is the plant Picrorhita kurroa (Rutki). 1978). I11 a cont~*olled Wilhania somnifera root powder administered in milk for one year showed significant improvement in several parameters in human volunteers aged 50-59 years.6-5. 1982).a wardhani. with Chavanaprash* as the major ingredient. ' A double blmd clinical trial of Aro4. In a double blind clinical trial with milk fortified with Withunia somniftm (Ashwagandha) alone. 1980). Ash ragundho showed a significant increase in body weight. 1980).

4. 1982). the consistent hypolipidemic activity of Commiphnra rnukul are but a few examples of success achieved iu exploring the pharmaco~ogical basis of the traditional clinical use of these plants in therapeutics. Others seem to be undertaking studies largely on individual initiatives. the immuno-suppressive effect of Albizzin kbbrck. 1973). The dried kernels of Myisticafrograns (nutmeg) seeds showed a marked inhibitory effect on thr biosyrithesis of prostaglandins by die rat kidneys in vivo and in uirro (Misra et al. 1978). by inhibiting prostaglandin synthesis (Fawell et ctl. In spite of all these efforts. however. T o mention a few examples. followed by those with anticancer. 198. XIII. 2. were found to have beneficial eft'ect in experimental goitre in rats (Veena Kumari el al. As in the past. 1979). The bioavailability of vasicine and sparteine were reported to be enhanced by the addition of Piper longunt (Atal..1). Certain important snd useful lea&. spasmolytic sesquiterpcnes from Gdrw deudro and spermicidal saponins &om several plants. however.PHARMACOLOGY OF AIEDICIKAL PLANTS in delaying the pathological changes characteristic of senile maculopathies in 36 ophthalmic patients (Albal and Chandorkar. Pi* chaba and Ziruibrr oflcinalis the bioavailability of rifampicin was not increased {Dahanukar et al. there is the CDRI work on identification and characterisation of chemical cor~stitutentsof plants withepromising biological activity such as coleonol -a diterpenoid from Coleus forshhki with hypotensive activity. anti-inflammatory and antimicrobial activities and others. by the addition of Trikati-a combination of Piper nigrum. there has been greater emphasis on a search for plants with CNS activity.. is the lack of clinical follow-up of the leads obtained by painstaking research. The major bottleneck. 1980). like iiidomethacin. This s ~ u d y supports the earlier reports that nutmeg might act.. 1975). (. hypoglycemic. 3. have cet tainly been obtained during the years under review. P9rr chaba was found to enhance thc bioavailability of sulphadiazine and tetracycline (Atal cl al.. Am overview The foregoisg brief accouiit of rescarch on mrQicinai plants in India in the past few years highlights certain important points and trends:1. however. 111 a cliiiical study or1 human volunteers. The novel mode ot' antidiabetic activity of Pkrocar~us marsupium..VSactivity and antifertility activity. yowever. inexpensive and safer drugs for most diseases encountered in our country still remains (o be achieved. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 305 . however. the situation regarding well-planned clinical studies of plant poducts continues to be disappointing. the ultimate goal of providing potent. Bauhinia variegatrr (Kachavar) and Jalkwnbhi (botanical identity not specified). Two plants. Scteening of plants for their pharmacological effect using a n h l models was continued and to a large extent standardiscd in major laboratories.

Well-known mlmples of Refractory Diseases are cancer. psoriasis.. it is extremely important to realize that the same ethical considerations in human research which are relevant and obligatory for modern naedicine should be applicable to research on medicinal plants and natural products (Satyavati. mental disorders including psychos. ctc. Further. disorders with an allergic cornpone11t iu their etiology (s. [here had been no con- certed etforts till recently to collect and publish the results of all scientific studies carried out on . a satisfactory or lasting remedy. The second and third volu~nes of this monograph are now under preparation. the situation calls for a serious re-appraisal. This was the objective of a ~ H Regional Group which met recently O (1980). cerebrovascular disorders like hemiplegia and paraplegia. viral disease like polionzyelitis and herpes zoster. Rexarch efforts could thus be directed to finding remedies ( i ) for the so called "Refractory Diseases" i e. metabolic disorders like diabetes mellitus. The entire research on medicinal plants at "CDKI. so far. ep. Toxicity of indigenous drugs is another area which has been largely neglected. whul these drugs are used in clinical practice as per traditional l dosage form. 1982b). anxiety neurosl.medicinal plants. those for which modern medicine has not been able tc. has also been reviewed very rece~itly Rastogi and Dhawan (1982). rheumatoid arthilitis and allied conditions. ctc.Lack o organised libratwe srrrury and ruvicw f Subsequent to the monumental publications of Sir R. urolithiasis. 1976). ~ l active principles ofplants and natural products must be subject to thk same stringent toxicity studies as for synthetic drugs. M. Mith a view tomeet the longfelt need the ICMR brought out the first volume of a comprehensive monograph on Medicinal Plants of India (Vol. K. liver disorders (including viral hepatitis). obesity. Chopra (Chopra et al. peptic ulcer. Lucknow. it would be desirable to have a "need based approach to research on traditional drugs including screening of plants for biological activit)".is.. While it is argued that there is no need for preclinical toxicity studies. hyperlipidaeinia and atherosclerosis. bronchial asthma. Ndkarni (1954).). and (ii) as supplementary measurer . malabsorption syndromes including ulctrativt colitis. skin allergies. I) in 1976 (Sqyavati et al. 1958) and Dr. eczema.g.t? well-established chemotherapy. Some by major global traditional practices have been reviewed recenly by Satyavati (1982 a). stress disorders. N. 1956. offer. drug dependence. Acknowledgement - I a n grateful for tile prompt and enthusiastic support of all the.lepsy. Plioritics in m a r c h on natural products As stressed earlier. in order to achieve results within a reasonably short period.pharmaSELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 306 .

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Bid. . and Prabhakara y a o . Setty. S. S. 47-49. s??u~I.J. Seth. S. (1980). (1980a). P. Inrlinn Med. G. t i . P... roga Homoco..P. Res.. S5ivpuri. Singh. A4ed.K. S. 3. . R Q Koili.. exp. all S k ~ r d U. A ~ : ~ ~ I ~ . P. f lndian Council of Medical Research. and Prasad. (1976). S'm. 65. P. D.21B. R.G. . K. D.. S. (1976a). 20.Shoeb. R. Res. Med. K. K .422-429. Res. Antbetic. .51t 1.. 13. Med. and Bwthwal. S.. 18. L. J. Rcs. Pharmd.. y. M. V. S. Indian J. Mirra.Singh. K. . and M.. V . (1977).. Biol. Kurnlr A. S i ~ f l N... Sharrna. P. R. P. and Blrthwal. S. - . 81-91 . 233-236. P. Gupta. and Kohli.. Kohli.Res. Toga Hgnom. N. M. S. and Kohli.zR l s . Indian Med. Indiun Med. (1980d). S. S. 96-102. S.. 7. B. (1976). N. N.149-151..Pe~dse. and Bhagwat.. Indian J. R . N. Si lz. G l .M. Y.. a ~ Pnsad. 1.. V.R.andShanna.S. Ind. S~I:'I. New Iklhi. 17-22.. P. Kamboj. P. 719276279.. 17-24. Y.~. ~ 167-168. 58-62. Eil:'~. Srivastava. D. Sil:i. R . .. V. N+th. 18 . V. Indian 3. M. 13. Siqgh. N. D.. (1977a). Indinn 3. . J3ga~Txd'lnRzo.Sirlq\. ffornwo. Res. B. D. G. K. Shukla. K. 19. and Khmna. Med.Pfiamacel. Ral'l~v. 9-14. 311 Prlk~r'l. Indian 3.V...rn1. P. Res. Srivastava. R . S. Res. and Sarnrnuel. (1980b). M. Bhandari.7... 16.l:i. K. (1976). P. and Mishra. K. L l t x 4 . Res. M. Bwl. Rcs. (1979) Indian Heart J. Medicinal Plants o India. M.. R ... K. K. V r ~ tS. ~. V. (1980~). R.Indian j'. ll.'(1978b). si 1:'l. 3. (1978~).V. C ' l z ~ l rV. Res. Indian Mcd.. . R . G ~ ? t aM. S'llrrnI. V.C. 61..R. N. Quart. 19. Mahatma. Indian J. 127. SATYAVATI Sart. C. J.. Med. 29-35... 513-515. Quart. R. . Physician India. N. S'l~rrn B.Medim Et513 B3t. D. N. P. K.A. K.. and Mabawar...7.. Sinha. and Shlirrnl. P.. 89-96. Indian Med. Si. . 3.V. (1975b).m-n1-~r. S . S i ~ : ~ n n lM.'P.. A .25-33. P. I.R. N.8 r231. and Rarotra.C.T)..Sitsramx~. Q W .. C h . (1980).231-232. Y. 314 . Ti l : ' ~ . B... M. N. S. Sizrrnx. P. Contraception. Singh. 15. J... 3. 0. .V. exp. Physhl.. Sil:'i. . (1977b). K.. Meno?.. Indian Med.. Medico. G. P. six en^. M.. 7. K V.L. 3.. . H.GI~~~. V.. M. ~ .V l t i . (1977). 250-261. .. P. K. 6% 754. (1975). V. R . K . Pfysiol Phamml. M.Radhakrirhna.. Rcs. C. 18. B. 1. N. 15. (1977a). 12. Yoga Homoeo. P. (1969). d-16.D. IGmboj. V.571578. Shanna. P. C. 53-57. R. exp. Gupt?. K. vbj.V~~'~. Mishra.~ t lA. 7. Toga R. K. R. G. Indian J. (1976).S. G. N. (1982).53-54. Indian J. Ethno Bot. P. and Prasad D. P. V... C. P. Res. Bull.R. R. C.. (1975). K g Shar~na. N. . K. and Khzlnna. (1976b). 10. 187.16. Q ~ t . K. fC3Vi. M.31. Kulshreshtha. Res. Kokate. and Venkataraghavan..Mishra.~T~K~S~~. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDJC DRUGS . Assoc. 14.. Quart.T~. K. Indian -7. N. \. B. (1975a). rl~\re. S. Singh. r..R.1. Sharma. 12. P h d . roga Hornwo. R . 11. (1978a). K .. 466.9. K. S.. P (1978). Seshldri. . Crude Dmg R~s. and Verrnl. Indian Med. 14. Setty. G. F ~ I : ' ~ .370-371. 12.V .. Sia7'1. 10. N.. P. K. (1978d). R.tO. C.. P. N. S.FIL~'I. ~ S i q ' l . 3. R . Res.~vati. and Kohli.Ylt'l.Revathi. 104-106. Shjrml. R . Res. 16. Cmde Drug Rrr 20.. Singh. S. Rrrina. .1821. 3 .Kapil. . K. Indian 3. 263-264. Gupta.272-280. Bwl. raga' Hornom.. K. I Saxcna. D 131. Gupta.and Kohli. J. 7. (1382). exp. and J3g1dmh. S'larrnl.Tripathi. S.(1976). (1980). Garg. ~ ~ ~ K Q ' L I Indian Med.. (1977).Ali. Seth.1.. vrude Dmg Res. Si :?'I. . Sethi. K. and Popli.... (1981). . A. Iniian 3. P h a r m l . ~ L ~ ~ . K. V..Nlth. 10. T ~ . S'larml. 2nd S\ukla. Cnrdc Drug.. Val.and Kohli. S. Indian 3.B. P . C. R. (1975).~. and Bhargava. R.. d 5' 17.?th%. and Bhargava. Indian 3.. K.Cmde Dmg Res. Kulshreshtha. Mittrl.

5). 17.. and Malviya. h f .. h l . 15.. Mcd.Upadhyay. Res. Tripsthi. and Sinha. K. M. 7-12. M. 14.. (1976). P.R. 3. (1976a). llukherjee. P. C.. (1975~). K.(1975). C. Agarwvd.). 12. P. P. B. Sriv3stlv. -ind Singh. 108-1 10. K. S.R.. Mehta. S. 152-154. Phnrm. 76 (Suppl. Indian 3. H. Ethnoplmmccal. (1978). Kalla. V. P. . P. A. Sinha. P h . 15.Tewari. (1977b). N... Sinha.. Updhyay. Indian 3. P.J. S . 13. Indian 3. 7. (1981). L.. Singh. If. C. K. XI.1. roga Homwa. H. (1978). 18. Inr'. Rts. R. and Van. Biol. N. 3.. hlalviya. Toga Homoeo. and P~ndcy. (1982)..h. rota Homoca. Psyckopharmacology.. Rcs. and Kohli. N. Crude Dm+y Res. I . 7. P.3. 'Rcs. (1917). P k m a d . 56. .7. (1979a). Seshadri. H. K. Singh.Janaki.. Yoga Homoeo. 50. P. J. (1979a). Singh.. (1978). and Joshi. 39. K . Indian Afcd. Rcs. 14-18. . Siqgb.. S. Indian J . C . (1978). and Das. Indian Med. hi. hI. M.. (1977~). S.. C. 119-123. 2001-2002. 326-329. M. Indian M t d . and Tripathi. Os. Yoga H m m . Gupta.. J. G. axp.zs.R. P.. Garg. and Jahan.H . K. txp. . Psychol. H.. t*. K.. C. . S. Tripsthi.P. R. Lznc'lester.. (I9PCe). U. Silq'l. Singvi. C... Rcs. V. 189-194. m d Udupa.. Tripathi. Tripathi.. 3. A. (1975 b). Sen.. 397-4C6. P. Sen.Sen. P. Rcs. 49-54. 15.K. C. C. 13. T e m r i . cxp.N. . Indim 7. 3.If. Yoga Nomom. . L.7-14. P. 13 107-108. Indian M t d . Rcs. P. Vol . K. J . J. and Chaturvedi. Rao J. H. Siqh?.and Rastogi... Indian J . Indian Mcd. R . P. .. and Mehta.and Das. 165 Tripathi.P. and Udupa. Bhattacharya S.. S.. Astedt. (1982). . Indian 3. 14. (ICiPz'. 12.iedholrn. (1979b).. K. (1977).. B. S.. B. P. 3. R. C. T.. Sikdar. 140-142. C.R. (1980). 124-130. (1977). 280-284. B.. R . Toga Homoco. (1976~). A. and Udupa. K . K. ex& Biol. S. Res. Pkarmdco!. S.385-396. K. Tewari. S. 11. P. Singh. Phytoatcmisfry. Tripathi.J. K. Singhal.. Singh.. and Dns. Indian 3. V. p.. S. K. Indian Med. P.D. H. P. Subramanizn. S. C. R. Zndinn 3. and Venkataraghavan. Agzr\rzl. (1977). 10.Sarkar. 3. S . Sarin. C. S. K . K. 18-25.). K. 3. N. R. Indian Mcd. (1977). (197. Toga. A. P. (1976). Tripathi... P. Mcd Rcs.42-47.4 J.. Rajagopalan. Thirunclakantan. B. Mathur. 51-37. K. 18. F. Enqland. PLANTS Singh. J . 339-310. Quart. $ i . J . K . ZndianJ. K. N. Srinivasan. P. hi. 15. Singhal. Soni. Singh. Indian . Bwl. Singh. N. dppl. Jain. (1978). D. P. 9. Singh. P. (1930). P. exp. and Das.. P. (1977).. P..H. 15.lchra. Singh. a d Das.. Yoga Homoco.. Indian Mtd. K. F. 52..III. Thyagarajan. R. 2CQ1-:((3 d . Rcs. N.. W . K. Tariq. H. C. Sarkar. and hfTP Press Ltrl. 18. Indian J. Mukhcrjm. cxp.Phammwl. 345-347.485. B.. .Aganval. Indian Mcd. V. 1405-1407. Z. Sinha. R a . P.... and Sundaravelu. H. 38.). 3. R. P.PHARMACOLOGY OF kfEDICINAI. K.As:f.. P. P. Biol. Singh.. Etbopharmacol. N. 14.. S. R (1979~). Toga Homoco. Indian Med. 15-18. 14. K. and Mehta. and Khanna. 1. N.Hussain. Tirumzls.. K. Sarkar. Tripathi. P h j t ~'orislr_. J. P. Singh. and Lall. 16. R. Sridharan. N. 13.I.. Indian Mcd. R. 121. hl. and Baldb. 3. H. D. P. Pafhola~y Managmunf. Rcs. and Singh. K.. and Das. 38-99. H. K. Pathak. (Ed. (1978e). Piryriol. (1976).4R-52 Singh. I n a h 3.' FELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 315 . 12. Yoga Hornom. S. I n d b Med. and Dar. P. 11. . E. A.R. G. S. 159-169. 53-54. A. A I . E. M. 190-204. Mapa. 309-316.~y. N. 83-87. 76 (Suppl. &? Homom. M. B. . A.U. and Dasgupta.. Indian 3. R. (1976). J. and D. Khanna. Gupta. S. Biol. 2 2 . Biol. S. Biol. Sinh. K. N. Res. (1979 b\. K.. Singh. Indian J . K . and D35. Ps-ychophannacolo. z ~ Fzstogj R . H.: Hafez. D. and Gupta. P. Phatmac. and Udupa.

3 Res.0 .2ls165-166. I . K. Mrd. Vyu.C. (1976). 12. a d Khan. N. 3. B.KulW. 0.and Singh.. S.. Vjidya. K. B. A. S. and Khanna. K. Vaena Kumxi. h 1 . and Bolradia. A. cq. ( 9 5 .. IdionJ. 10. 223-228. . and S. A g d . Wahi. 17) . hso..D. K. 3 Rrs. B.. 76 (Suppl. S. Yoga Homom. Ru. Rahagopalan. Gupta.). D. Y. Indiun 3. nin .. K. E t h n o w . B.a.. I n d h Md. 245. Md. 857 W. A. Md. 22-25.. (1980).P. V. 4 . K.. and Rmtogi R. P h . M. Joshi.135-137. arp. 129-131. 1 370. C. P. 63-66.Md. . K. l l . K. B. H. S.P (1978b).. U. 1946. Verm~. J. K. (1975). SU46... D. (1977). Indim3. Indian 3. C. Seshadri. Sbami. Jacob..Tandon.... C.. W. 561-564. Sn'. x. M d / . C.. . M. Velk%tsrjghavan. J. Sundenan. I d h .) e. Zr~tshi. and Udupa.P y i l Phumuc. . Ref. 3. 0. vaidya.O. 1117-1119. 815-820. Zutshi. and Khan. Singh. N.71.Singh J. K. S.. A. 3. Ravathi. K. 14. Shah. 0 . .. Stivaatatn. S. P.Biol. and Srivastava.lO. P. ' Rcs.A. R. (1977). M. Bhatia. C. M. V. T. M. D. P..l6.. (1979). I n d i d 3 . S. W ~ h r bS.H. 18.. K. and Wahi. & Md. Indim. and Sheth. A p . IndianJ .. ?% ~~~t o R s r Prolcrodron P&$y dnu & f rmd Traditional M6diCinr.andNagaampaei. Chandra. Biol. P. Sharma.ISEA/Trad. (1976). (1980).. . . 40. and Bhagwat..N. Z. Z. R. 3.I. I d a 3 Md. and Udupa K. Joshi. 14.V. R. 4 .. Indian J. r p Biol. P k m ~ d .and Santosh Kumar (1980).(1978).Toga 'Homom. Vyaa. Vohora. Sharrna.. 77-82.. N.Agarwal..Singh. Mchta.. Z. R. Vo\ora. V. Ilrs. S. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . (1976). S.. Varrm.I. N. V. K.. M. S. A. (1981). K w . S. (1982). Y. P. K. Piasad. India J .B.Tripathi. H. M. Janaki. Ru.

G. The active principle has been identified in a fewsases only.Pharmacology of Medicinal Plants* G. The long awaite7iVol. M.N. The abstracts have not been considered due to constraints of space and paucity of data in such reports. The list of plants where activity could be confirmed in a fraction is given at the end of each section. The results of 870 more plant species were reported during the period (Aswal et a/. In the present review the plants have been classified according to thsir pharmacological activities.b. 1987) where the lndian contributions have been adequately covered. 1987) is a welcome addi.. Dhawan edited a multiauthor review on status of medicinal plants research in India (Dhawan. Some plants. Marg. 1984a. PATNAIK & B.. . Unfortunately in most cases work has been restricted to the crude extracts and in many cases only preliminary findings have been reported. The plants. 1986) and anti-inflammatory plants (Chawla et a/. Panda and colleagues published comprehensive reviews on hepatoprotective (Handa et a/. appear in more than one section. A broad based screening of lndian plants for a wide range of biological :ctivities is being continued at the Central Drug Research Institute. - . Under each section if any plant has been clinically evaluated it is reported in the beginning followed by plants from which active consbtuents have been isolated and evaluated. 'CDRI Commvnlcotlcn No.K. 1986). Central Drug Research lnstifute. where only crude extracts. Anti-inflammatory activity A large number of plants has been tested for antiinfiamrnat~r~ activity and as many as 39 plants have shown promising activity. The investigation showed that many crude extracts had promising activity and fractions of 168 plants confirmed various biological activities.. Efforts have been made to cover all published papers containing significant new data. lnspite of a large number of publications a very small number of plants has been clinically evaluated.. are dealt with at the end. therefore. 1986). If we have missed any important papers we crave authors indulgence and would appreciate if the lapses are brought to our notice... Details of these have been provided at appropriate places in the following pages. Mehrotra and cl~lleagues 987) pubPlants" containing lished a compendium to the "Glossary of lndian Medicir~al updated botanical nomenclature of the medicinal plants.on and hopefully the (1 final volume will also be available soon. . Lucknow-226 001 Medicinal plants have continued to be an area of major scientific interest with the lndian investigators and a large amount of literatu~ has been published 3 in addition to some excellent reviews. 4328 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 317 . 2 of "Medicinal Plants of India" (Satyavati eta/. fractions or powdered plant material has been used. Abraham et a/. DHAWAN Division of Pharn~acology.

Curcumin is the active constituent of Curcunia longa and has been evaluated clinically as well as its mechanism of action has been analysed. The study. K. By doing so it can reduce the cell damage produced by these enzymes. 1985). 1986).. Curucumin inhibited the actwty of some proteolytic enzymes' (Soudamini. The active anti-inflammatory compounds isolated from Indian plants have diverse chemical structures. In view of these interesting activities it may be clinically evaluated in patients with arterial thrombotic events and requiring antiarthritic therapy. A furanoid hedychenone isolated from this fraction showed marked activity and had a lower ulcerogenic index than with phenylbutazone (Srimal et a/.. Like other non-steroidal anti-inflammatory agents it inhibited the synthesis of prostaglandins (Srivastava and Srimal. It was more potent than phenyl-butazone but less active than betamethasone (Frotan etal. 1983). from the hexane extract of the root of Desmodium gangeticum also had significant anti-inflammatory activity in the above mentioned test system ( ~ h o s h and Anandkumar....inflammatory activity against - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 318 . A review of the pharma-cology and clinical trial of Curcun~alonga has been published (Srimal and Dhawan. Curcumin produced stabilization of lysosomal membrane and caused uncoupling of oxidative phosphorylation. Patnaik & 6. 1983). Extracts of the rhizome of Hedychium spicatum showed marked anti-inflammatoiy activity against carrageenin induced oedeina in mice and rats.ma tory activity. Dhawan N.. 1983). A flavonoid from the alcoholic extract of central wood of Acacia catechu showed potent anti-inflammatory activity in rats (Chakravarthy etal. 1986). 3-Pglucoside isolated from the alcoholic extracts of the seeds of Randia dumatorum possessed significant anti-inflammatoryactivity in the exudative and proliferative phases of inflammation in rats (Ghosh etal. The hexane-soluble extract was found to be the most active fraction.. In adtiion it produced a dose related antithrombotic effect in mice (Srivastava et a/. 1986). The sodium salt and acetyl derivative of anacardic acid isolated from leaves of Rhus seminalata showed significant anti. 1985). 1984). The antithronibotic effect appears to Le due to its antiplatelet aggregation activity.G. The activity appears to be due to the presence of rutin and quercetin-3-galactoside in the plant. Gangetin. A 3-0-rhamnose-glucoside (rutin) was isolated from this extract and shown to be responsible for the anti-inflammatory activity (Sethuraman et a/. Anti-inflammatory doses of curi.. The aqueous extract of the leaves of Delonix eleta produced a dose dependent inhibition of carrageenin-induced rat foot oedema (Sethuraman and Sulochana.umin cause either inhibition of platelet cyclooxygenase or by some unknown mechanism inhibit the release of TXbwithout inhibiting the generation of PGI. a pterocarpan. The stem bark of Symplocos spicata yielded tr-spinasteroi which showed a significant activity a ~ i n s acute inflammation t induced by carrageenin in rats. 1983). 1988). The crude extract of the flowers of Wrightia tinctoria showed anti-inflammatory activity in the same model. in rats (Srivastava et a/. It also caused stimulation of the adrenals resulting in the release of endogenous corticoids. 1984). thus shows that curcumin has multiple sites of action accounting for its anti-inflan. 1985). A glycosidal fraction of Acacia farnesiana also inhibited the carrageenin oedema in rzts (Trivedi et a/.

Aqueous extract of the whole plant of Cuscuta chinensis showed significant inhibition of carrageenin-induced oedema in rats.5-2 gikg s. attenuation of central prostaglandin acbvrty..p. The activity has been compared with phenylt . Eclipta alba was found to possess moderate anti-inflammatory activity against carrageenin-induced paw oedema in rats (Chandra et a/. pericarp and endocarp of Sernecarpus anacardiun~ (Bhallataka) were tested for anti-inflammatory activity in rats...Pharmacology of Medicinal Flants carrageenin-induced acute inflammation and analges~cactivity in rats.d arthritis indicates its of possible usefulness in arthritic patients. The Ayurvedic use of the plant is justified by these studies. 1984). another 40% showed major improvement and the rest minor improvement (Upadhyay et al. 1) was found to be eq~~iactive 50 to mglkg of phenylbutazone and 10 mglkg of hydrocortisone agaiqst sub-acute inflammation in mice (Sudhir et a/.. The activity coilld be due to the presence of sterolttriterpenoids or flavonoids known to possess anti-inflammatory activity.j rats by i. Ninety per cent ethanolic extract and aqueous extract of Strobilanthes heyneanus produced biochemical changes in the serum and liver of rats similar to phenylbutazone. the active constituent needs to be isolated and characterised. The results indicate that the plant has effect on enzymes and metabolites involved in inflammation. 1987). The extract also possessed a cholinergic activity (Nisa eta/. The extract of Salai SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 319 .:i components of the inflammatory process are equally suppressed by the extract.. A rnacked antiarthritic activity of adjuvant-induc. 1987b).. 5-10 g of hhallataka showed complete remission in 40% patients..-?xtract the leaves of Nyctanthes arbortristis possessed significant anti-inflamnatory activity in a number of acute. The activity simulates that of nonsterokL-4 anti-inflammatory drugs. Alcoholic extracts of Crataeva nurvala fed orally has shown anti-inflammatory activity by the granuloma pouch method (CCRAS Report. 1986). The compounds exhibited a profile of activity associated wit!. quite preliminary and needs further detailed evaluation.) has anti-inflammatory activity in rats comparable to 25 mgkg of aspirin (Hukeri et a/. In an open clinical trial in rheumatoid arthritic patients.. The whole nut decoction was most eftectke. 1985). The whole nut.. showed antiThe aqueous extract of stem of Polygonuni glabru~i? inflammatory activity like betamethasone (Singh et al. The effect of these cornpounds on ':NS was also studied (Bhattacharya et a/. The aqueous extract also decreased the level of adrenal ascorbic acid (Nair et al.~tazone (Singh et a/.. The root powder (1 glkg) significantly reduced the serum a-2-macroglobulin and increased the synthesis of total serum protein in carrageenin-induced inflarnmation in rats (Agarwal et a/. 1986). However. t-. The hexane extract of Euphorbia acaulis showed a! . The nut merits further chemical and pharmacological studies. Alcoholic extract of the leaves of Withania sonrnifera (1 gl.. 1984). subacute and chronic inflammatory mc.c. 1985). and p. The petroleum ether extract of Phyllanthus fraternus (0.. 1 9 8 5 ~ )The study is . routes. 1985).'i-inflammatory activity in acute and chronic inflammatory models in mice ai7. The alcoholic .0.lels in rats including imrnunologically induced arthritis (Saxena et a/. 1986). The nut had no immuno-suppressive activity. 1985).

The active principle needs to be identified. 1986). It was devoid of ' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 320 . 1986). analgesic activity with a mild CNS depressant action (Vohora et ? 1984a). Oral administration of coconut oil extract of rhizome of Acorus calamus and leaves of Ocimum sanctum and 0 imum bascilrcum produced anti-inflammatory activity in acute t as well as chronkc models of inflammation in rats. 1984a). The effect was equally marked in the adrenalectornizedanimals. The nonsteroidal mechanism of action with no ulcerogenic activity provides the plant with an advantage over other drugs. . Casimiroa edulis (Aswal et a/. Dictamnus albus. a powder mixture of Embelica officina/is. produced significant anti-inflammatory effect against carrageenininduced paw oederna in rats. Leptorhabdosparvitlora and Viburnum odoratissirnus (Abraham et a/. Terminalia bellerica and Terminalia chebula. caprylic etc. haw an guggul (Boswellia serrata) exhibited marked anti-inflammatory activity in carrageenin-induced oedema in rats.N. 1987). The analgesic activity seems to be of non-narcotic type. Various extracts of Vitex negundo showed anti-inflammatory activity alongwith CNS activity (Ravishankar et a/. It also exhibited aspirin like analgesic and antipyretic properties (Godhwani et a\.. Some of the plants showing anti-inflammatory activity have been tested for analgesic activity as well.. It was devoid of ulcerngenic effect and had a very high LD.. In rats extracts of Leucas aspera exhibited significant anti-inflammatory activity (Reddi et a/.. In other cases crude. Several of these merit fufiher chemical and pharmacological investigations including elucidation of the mechanism of action. K.G. routes (Singh and Atal. The effect was decreased by adrenalectamy (Varde et a/. Anti-inflammatory activ-itywas also confirmed in the fractions of Antidesma gerardiana. Further work is being carried out to isolate the active constituents. There was no additwe effect of the two preparations. oleic: stearic. The preliminary findings provide a rationale for the use o i Ule plant in Ayurvedic system of medicine.. Analgesic and antipyretic activities As in the case of anti-inflammatoly activity compounds of diverse chemical structures have been isolated from plants and shown to have analgesic activity. 1986). Commiphora mukul petroleum ether extract also showed a similar activity (Sharma eta/. 1986). Most of the plants need dose dependent study.. Helenia elliptica.extracts have exhibited analgesic andlor antipyretic activity. Patnaik & 6. The tked oil obtained from the petroleum ether extract of the roots of Abutdon indicum containing a number of higher fatty acids like linoleic.. contrary to the common belief.. Other investigators have also reported that extract and aqueous suspension of Ocimum sanctum showed antiinflammatory activity against carrageenin and croton oil-induced oedema in rats. 1988).p. 1988). showed analgesic activity against z a t i c acid-induced writhing in mice but was less potent than aspirin. palmitic.value by oral and i. The alkaloidal fraction of the leaves of Solanum melongena have a marked I. The alcoholic extract of Triphala.

in addition. when administered by oral CS well as parenteral I analgesic acbvity in rats a. Petroleum ether extract of Phyllanthus fratemus (0.. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 321 . 1985~). whereas a role for interacti~~n arachidonic acid metabolism like aspirin is suggested for the other two compounds. Further. Trianthema portulacastrum.. 1984).. The methanol extract and aqueous suspension of Ocimum sanctum had aspirin-like analgesic and antipyretic properties (Godhwani et al... chrysin. detailed evaluation of the analgesic activity including the mechanism of action need to be elucidated. Certain bioflavonoids.c. aqueous extract of the stem of Polygonurn glabrunt showed morphine-like analgesic activity... morin and rotin showed analgesic activity c 3amanathan etal. 1987)...5-2 glkg s. ethanolic extracts of Trianthema potrulacastrum and Cissus quadrangularis (Singh et a/. 1986) and aqueous extract of Cuscuta chinensis (Akbar et al. In many plants. Various extracts of seeds of Vitex negundo (Ravishankac et a/. 1985).. r In addition to the anti-inflammatory activity.) had analgesic activity in mice comparable to 25 mglkg of aspirin (Hukeri et al... Alcoholic extract of Woodfordia fruticosa showed antipyretic effect against TAB vaccine-induced pyrexia in rats (Alam et a/. value (Bagi et a/. The opioid-like analgesic activity of gossipin without development of tolerance merits a detailed evaluation of selective activity on different types of opiate receptors and the possibility of using it as a morphine substitute. which merits further exploitation (Vohora et al. Semilar activities were seen with the Pterocarpan isolated from the roots (hexane extract) of Desmodium gangeticum (Ghosh and Anandkumar . Gossipin (Gossypium indicum) is known to possess analgesic activity through opiate receptors. d mice comparable routes showed a centrally act~ng to morphine (Atal et el. 1983). 1985). The oleanoiic acid 3-p-glcl -. Their active principles should be isolated. with 1985) had opioid-like activity. 1984. Potassium embelate which was prepared from embelin. 1985). 1984). Many plants have shown promising activity. lntracerebroventricular administration of calcium significantly reduced the analgesia. Most of the above plants showing aspirin like activity should be evaluated for their antipyretic property. It was devoid if antipyretic activity. 1985a). Presence of 2 carboline alkaloids harmine and harmaline has been established in this extract. but had anti-inflammatory activity (Ghosh et a/.. The defatted extract of Tribulus terrestris enhanced morphine induced analgesia (Prakash et a/.aside isolated from the alcoholic extract of the seeds of Randia dumatorunsshowed significant analgesia against thermal stimuli in rats. repeated administration of gossipin did not change its analgesic potency in mice indicating the absence of tolerance (Vswanathan etal.. The benzene extracts of Hedychium spicatum (Srimal et el..l984b). 1984). 1985) also shoded analgesic activity apart from other CNS activity. a paraquinone derived from the plant Embelia ribes.. 1986). possessed significant antipyretic activity against yeast-induced pyrexia.Pharmacology of Medicinal Plants D gross CNS effects and had a high L . 1983). It also had a cholinergic and histamine-like action (Singh et a/. 1984) showed aspirin-like analgesic activity ( ~ k b aetal.

G.K. Patnaik & 8.N. Dhawan

Antiallergic/antihistaminic activity
\

,

Treatment of asthma and other allergic diseases had been a major problem. Many drugs are recommended in the tradition21 system. However, most of these have given only symptomatic relief. A number of plants were tested for antiallergic activity and in some cases the active principle was identified. Quercetin isolated from Allium cepa exhibited bronchodilatory effect (Handa etal., 1983) and inhibited mast cell degranulation in sensitized rats similar to disodium chromoglycate (Johri eta/., 1985). Tlre latter effect could he due to a membrane stabilizing property. The use of Allium cepa in asthma may be attributed to the presence of quercetin. A similar effect on mast cells was also observed with the crude extract of seeds of Albizia lebbeck and a saponin isolated from the plant (Johri et el., 1985). Biochemical and histochemical studies of adrenal medulla of guinea pigs indicate that administration of Albizia lebbeck reduces the release of catechoiamines in response to histamine (Tripathi etal., 1983). Apart from the membrane stabilizing property, the above qctivity could also be due to an increase in the production of histaminase or histamine receptor blocking acbvity. These properties provide possible rationale for the use of the plant in the treatment of bronchial asthma. Chelidonic acid isolated from Cassia spectabilis showed antiallergic activity comparable to disodium chromoglycate, as tested by the passive peritoneal anaphylaxis method in rats (Mallaiah e l a/., 1984). Dimethyl chelidonate was found to be less active than chelidonic acid. The pure alkaloid extracted from Tinospora malabarcia markedly enhanced the anti-SRBC antibody titre. It significantly inhibited antigen-induced histamine release from the peritoneal mast cells of sensitized rats in vitro (Bhattacharya et a/. 1986). The beneficial effects of Tinospora could be because of an increase in the levels of IgG and IgM i~nmunoglobulins decrease in the mediators of hypersensitivity reactions. and In the isolated guinea pig lung preparation the glycosidal fraction ofpcacia farnesiana (2-10 mg) increased the outflow per se and antagonized the histamine-induced bronchial constriction. It also showed a vasodilatory effect in the hind limb perfusion test in dogs (Trivedi etal., 1986). The dried fruit of Piperlongurn reduced the passive cutaneous anaphylaxis in rats and prevented antigen-induced bronchial spasm in guinea pigs. It had, however, no significant effect on the histamine content of lungs, trachea and intestine or on histamine release by antigens (Dahanukar and Karandikar, 1984). The results provide an explanation for the traditional use of the plant in the porphylaxis of asthma. The steam distilled extract of fresh leaves of Ocimum sanctum was found to enhance anti-SRBC haemagglutination titre and IgE antibody titre. It significantly.inhibited the antigen-induced histamine release from the peritoneal m a ~cells of sensitized rats in vitro and also antagonized t responses to various $pasmogens on isolated guinea pig ileum. The plant extract appears to modulate humoral immune responses and it may be acting at several steps in the immune mechanism which needs further elucidation (Mediratta et ?I., 1988). The aqueous and alcoholic extracts of leaves of Rumex

SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS

Pharmacology of Medicinal Plants nepalensis showed antihistaminic and anticholinergic activity. The alcohol~c extract, in particular, was more potent (Agan,tgal et al., ' 985). The use of the plant in local allergic conditions may be attributed to the a:;tihistaminic property. Further study and fractionation of the alcoholic extrac: to isolate the active pri~ciple needed. In addition to the anti-inflammatory sctivity Leucas aspera is extracts prevented mast cell degranulation in rats (Redd; et al., 1986). On the other hand the intracutaneous skin test with the polle i grains of Prosopis luliflora and in vitio test showed signs of histamine release and allergic responses (Thakur and Sharrna, 1987).

Hypolipidaemic activity
Comrniphora mukul continues to be the most investigated plant for hypolipidaernic activity. Gugulipid, obtained from the gum resin of Commiphora mukul, feeding producsd a dose-dependent increase 'in the levels of noradrenaline and dopamine and in the activity of DBH in monkeys (Srivastava et .a/.. 1984). These findings suggest the possible lipid lowering mechanism of gugulipid. In the phase I clinical trial gugulipid was found to be completely safe. The efficacy was evaluated ir?Phase II trial in 19 patients of primary.hyperlipidaemia. It showed significant lowering of !:holesterol and/or trigly-cerides in 15 patients. All patients with familial combined hyperlipidaernia responded to the drug, while patients with familial hypercholesteraemia did not respond (Agarwal et al., 1986). This shows the action of guggul in selective patients. In another clinical study effect of gugul was seen in patients of hyperlipidaernia. The drug was found to be safe and it .markedly lowered the various lipid fractions known to be artherogenic along with a significant rise in HDL chokesterol (Verma and Bordia, 1988). Gugulipid is now being marketed as a new drug. In Il3' prelabelled mice thyroid gland culture, petroleum ether extract of Comminphora mukul significantly increased the turnover of radio-activity. Hypertrophy and hyperplasia of the thyroid gland was also observed (Singh et a/;, 1985a). This indicates that the hypolipidaemic plant can be used in the treatment of thyroid diseases. Yograj guggul (mixture of 27 plants) exhibited more marked immunodepressant effect than guggul (Commiphora mukul) (Shukla etal., 1986). Biochemical studies in rats indicate that Salai guggul (~oswellia'serrata) extracts showed hypolipidaemic activity through inhibition of cholesterol biosynthesis in the liver as with clofibrate (Zutshi etal, 1986). The powdered pulp of fruits'of Embelica ofiicinalis significantly reduced the serum cholesterol and atherosclerosis in cholesterol-fed rabbits (Thakur and Mandal, 1984). Fronl. Cicer arktinurn the antistress and antihyperlipidaemic principle was isolated and identified as pangamic acid. (Singh et a/., 1983). Fiw per cent ethanolic extract of seeds of Alfalfa (Medieago sativa) showed significant antiatherosclerotic effect assessed by the estimation of glycogen, cholesterol, triglyceride and phospholipid contents of cardiac and liver tissue. The effect was similar to clofibrate (Dixit and Joshi 1985) which could be due to decrease in intestinal absorption and increase in bile acid secretion and could be due to saponin content in the seed. The action is, however, encouraging. The

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323

G.K. Patnaik & &N. Dhawan

.

alcoholic extract also prevented the development of plaque formation and hyperlipidaemia in cholesterol fed rabbits (Dixit et a/., 1986). A significant hypolipidaemic activity was shown by Atylosia scarabaeoides in the primary screening tests (Prakash et a/., 1985). Commercial Guar seeds (Cymopsis tefragonoloba) were fed orally to guinea pigs in diet (40%. Feeding for 30 days reduced total blood cholesterol and sugar in normal and alloxan-induced diabetic animals (Srivastava et a/., 1987). Dly seed powder of Carum capticum fed orally (1% in food) for 4 weeks to rabbits significantly lowered the serum cholesterol, triglyceride and phospholipd levels. Tbc?serum cholesterolbinding reserve and HDL cholesterol showed a continuous rising pattern from the very first week (Agarwal and Pant, 1986), which indicates the potentiality of the plant as a drug. In rats intramuscular administratioit of Thevetia neriifolia significantly reduced the blood glucose, serum protein and cholesterol and elevated alkaline phosphatase (Goswami and Dutta, 1985). Further, the glycoside extract of Thevetia nen'ifolia in albino et rats stimulated synthesis of blood SLP by the osteoblast cells ( ~ o s w a m i a/., 1986). The hypothesis needs to be confirmed. In the bind brain and pituitary marked increase in ALP was als6 seen. This could be due to some trigger of release mechanism after administration of glycoside. The ethanolic extract of Aloe barbadensis fed for 2 months to dogs not only lowered the lipoproteinwt ih atherogenic properties (GLDL and LDL) but also increased the cholesterol concentration of HDL fraction which has been shown to be an important independent antiatherosclerotic factor (Dixit and Jain, 1985). In the alloxaninduced diabetic rats filtered juice of fresh red gram seeds (Cajanus cajan) was found to be hypocholesterolemic (Giri et el., 1986). The alcoholic extract of Nepeta hindostana at a dose of 20 mglkglday produced marked hypocholestremic effect in pigs. In addition, the histopathology of myocardial infarction suggested a beneficial effect of the plant (Arora, 1987). Jammun seed (Eugenia cumini) extract administered for 2 weeks to rats in addition to showing the antidiabetic effect also reduced markedly the serum cholesterol and serum triglyceride levels (Giri eta/., 1985). The active principle, however, needs to be isolated. Administration of water and ether extracts of bitter gourd (Momordica charantia) powder caused a significant fall in serum cholesterol levels simultaneously with its hypoglycaemic effect. The extracts also had a lowering effect on the body weight (Upadhayay and Pant,1986). Cabbage (Brasica var capitula) oil (100 mgikg p.0. for 30 days) produced a lowering of blood sugar and tissue cholesterol and triglyceride contents in rats (Tarfa et a/., 1988). The effect could be due to the presence of methyl cystein sulphoxide whose antihypercholesterolemic effect is known. However,the active principle needs to be isolated. Two glkg of raw garlic (Allium sativum) fed to rabbits for 30 days, on the other hand, produced a significant increase in serum cholesterol level associated with unwanted cardiac changes in ECG which were reversible on withdrawal of garlic (Gupta e l el., 1987). It will be difficult to postulate any ill effect of garlic in humans as the daily use is usually much less. However, excess use may be harmful.

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Pharmacology o f ~ e d i c i n a l Plants

Hypogiycaemic activity
Several plants which were investigatzd for hypolipidaemic activity were also assessed for hypoglycaemic activity and some plants hi~ve exhibited both effects. Plants used extensively in the traditional systems of medicine have continued to receive greater attention. A flavonoid from the ethanolic extract of wood of Acacr. I catechu showed hypoglycaemic activity (Chakravarthy et a/., 1983). Ethylaceiate extract of stem of Tinospora cordifolia showed a moderate blood sugar Lowering activity in rabbits (Mahajan and Jolly. 1985). Guar seed (Cymposis tctragonoloba) was fed orally to guinea pigs in diet (40%). Feeding for 30 d,!ys reduced total cholesterol and sugar in normal and alloxan-induced irabetic animals (Srivastava eta/., 1987). The hypoglycaemic effect of the plant may be due-to a d~recteffect (due to aminoacids content) or reduction in insulin requirement (due to galactomannan content). Different extracts of seeds of Trigonella foenumgraecurn showed significant blood glucose lowering effect in rabbits. The alkaloid-rich fraction was found to be the most active as tested by the glucose tolerance test (Jain et a/., 1987). The activity is promising and the plant needs special attention. Cabbage oil (Brasica var capitula) feeding to rats produced a good effect (Tarfa et al., 1988). reduction of blood sugar apart from hypolipida~mic In addition to the hypolipidaemic effect Jammun (Eugenia cumini) seed extrat administered for two weeks to alloxan-induced diabetic rats markedly reduced the blood sugar level (Giri et a/., 1985). In the alloxan-induced diabetic rats,'red gram (Gajanus cajan) was found to be hypoglycaemic and hypocholesteraemic. It also lowered the blood urea level. It was found to be non-toxic and had no adverse side effects (Giri et a/., 1986). This may be included in the diet of the diabetic. The effect of, water and ether extracts of bitter gourd (Momordica charantia) administered for 7, 14 and 21 days to albino rabbis revealed that no significant hypoglycaemia could be atained in the first week. From the second week, however, the effect became evident and at the end of third week it became most prominent. The plant also had a hypolipidaemic property (Upadhayaya and Pant, 1986). Dried leaf powder of Gymnema sybestre regulated the blood sugar \evels in alloxan-induced diabetic rats (Shanmugasundararn et a/., 1983). The extract produced blood sugar homoeostasis and increased the activity of the enzyme affording the utilization of glucose by insulin-dependent pathways. The pathological changes initiated in liver during hyperglycaemia are revesed by the extract. The herb is used in the control of diabetes rnellitus. The aqueous extract of the leaf antagonized hyperglycaemia in moderately diacetic rats and the effect persisted beyond 2 months after its discontinuation. It had, however, no effect in severe diabetic rats except for prolongation of survival time in the toxic group of animals (Srivastava et al., 1986). The drug induced longevity could be due to its known cardiotonic and adaptogepic characteristics produced by increasing resistance and immunity in diabetic animals. However, the exact mechanism needs elucidation. The hypoglycaemic action could be explained
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in the light of earlier reports of prevention of hypoglycaemic response of the anterior pituitary gland. Alcoholic extract of Hamiltonia suaveolens root produced significant reduction in blood sugar in normal and a less marked fall in alloxan treated rats. Similar results were observed in normal rabbits, dogs, and monkeys. The ethylacetate fraction showed an equipotent activity in normal rats. One month chronic toxicity study showed no untoward effect (Desai and Bhide.1985). Significant hypogiycaemia was observed with Afylosia scerabaeo!des (Singhal et a/., 1985). Aaueous extract of seeds of Tephrosk purpurea (60 mgkg p.0.) showed hypoglycaemic activity in normal and alloxanirduced diabetic rabbits. The effect was found to be less than that with tolbutamide in diabetic animals. The seeds were more active than the plant (Rahman et al., 1985) In rabbits aqueous suspension of seeds of Syzygium cunlini led to reduction in blood sugar level. In alloxan-treated diabetic rats the decrease was much less (Nair and Santhakumari, 1986). The mechanism of action seems to be extra-pancreatic. The crushed leaves of Munaya koenigii exhibited hypoglycaemic activity in fasting normal rabbits during the first hour itself. Simi\ar response was seen in glucose tolerance study in rabbits. ,In human volunteers a peak fall in blood sugar (25%) at 50 mglkg dose was seen 3 hour after. medication. In alloxan-induced diabetic rats the peak fall in blood sugar was seen at the fifth hour (Shanthakumari et a1.,1985). Different fractions of Swertia chirata showed blood sugar lowering activity in albino rats (Chandrasekar et al., 1987;Mukherjee and Mukherjee,l987). However, the hexane fraction was found to be most active. Probably it contains the active constituents. The fraction needs further chemical exploitation and the mechanism o f action needs to be established. The water-soluble fractions of different extracts of leaf of Bougainvillea spectabilis exhibited blood sugar lowering effects in the streptozotocin-induced diabetic rats (Sarkar et a/., 1986). Aqueous extract of a powdered indigenous preparation containing a mixture of 12 plants showed significant hypoglycaemic activity in normal and alloxan- induced diabetic dogs and alloxaninduced diabetic rats (Ainbpure etal., 1985). The individual plants need to be tested to identify the best plant and its active principle. Hypoglycaemic activity was confirmed in the fractions of the following plants: Trichosanthes dioica (Aswal et a/., 1984b), Dqdonea viscosa (Aswal et al., 1984a) and Echinops echinitus (Abraham etal., 1986). Work is being carried out to identify the active principles.

Hypotensive activity
The plants tested mostly have shown moderate to short duration of action. The experiments were done in normotensive animals. The active plants need to be tested in hypertensive animal models. The water insoluble alcoholic extract of fruits of Wthenia coagulans showed a prolonged fall in blood pressure in dogs. It also had a cardiodepressant effect (Budhiraja et a/., 1987). The effect seems to be direct. However, a new withanolide was isolated from the fruits which had a structural

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Phannacology o f Medicinal Plants resemblance with the aglycones. The compound produced a mild hypotensive effect in mediated through cholinergic receptors. A carc:iodepressant effect was also noticed (Budhiraja et a/., 1983j. Work on the plailt Coleus forskohlii led to the isolation of the hypotensive principle forskolin, which appeared initially to be an isomer of coleonol, a diterpene. The two are possibly identical compounds. It possessed antihypertensive, positive'inotrop;::, platelet aggregation inhibitory and adenylate cyclase activating proper ti:.:^ (DeSouza et al., 1983). Scoparone a naturally occurring coumarin (6,7-di~ ;methyl esculetin) in the aerial parts of Artemesia scoparia produced a marked hypotensive effect with immediate onset and lasting for 2 to 5 hours in normote:,isive anaesthetized or conscious animals. It had a good oral absorption (S-iarma, 1985). The hypotensive mechanism seems to be partly central anri partly peripheral (Sharma, 1988). The effect of scoparone on tissue catecholamine content revealed that the hypotensive activity is independent of catecholamine lowering action (Sharma, 1987). Glycosides of Abrus precatorius produced a transient rise of blood pressure associated with a fall which could be attributed to rnyocardial depressant action (Basu et a/., 1985). Essential oil of the whole plant Blumea menlbranacea produced a marked and long lasting hypotensive effect in anaesthetized dogs (Mehta et a/., 1986). The mechanism seems to be a direct vasodilation and cardiodepressant action. It had also a CNS depressant effect. However, no dose-response study was done. The active principlealso. needs to be identified. The ethanolic extract of the pulp (pericarp of fruit) of Balanites roxbiirghii showed a moderate,hypotensive effect in anaesthetized dogs and.less marked effect in cats (Rao et a1.,1986). It seemed to be mediated centrally. The aqueous extracts of Kalanchoe integra and seeds of Canavalia virosa (Mukhopadhyay et a/., 1986) also showed hypotensive activity in addition to other pharmacological effects. The alcoholic extracts of Picrorhiza kurrooa, Tecomella undulata, so la nun^ nigruh and Cichoriom intybus which are used in the management of liver disorders, showed hypotensive effect in dogs (Panday, 1985). Hypotensive activity was confirmed in anaesthetized animals in the fraction of the following plants:Eucalyptus globulus, Euphorbia madden;, Lpon~oea pescaprae, Phyllanthus gardnerianus, Prirvula denticulata, Tamarix ericoides (Aswal et al.,l984b); Coscinium fenestratum, Phytolacca acinosa (Aswal et al.. 1984a); Acacia raddiata, Etrgenia magnifolia and Tibouchitla serl~idecandra (Abraham etal., 1986). Chemical and pharmacological work is in progress to , isolate the active constituents of these plants.

.

Cardiac .stimulant activity
L i e work has been done in this area. Only one plant has shown promising cardiotonic activity but A needs detailed evaluation. Epicatechin isolated from the bark of Pterocarpus marsupium showed a cardiostimulant effect, on frog heart, mediated by adrenoceptors. A hyperglycaemic activity was also noticed in higher doses in normal rats (Chakraborthy and Gode, 1985). Apart from the

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G.K. Patnaik & B.N. Dhawan
hypotensive activity forskolin (isolated from Coleus forskohlir) also showed positive inotropic effect (DeSouza et a/., 1983). A glycosidal fraction of the whole inotropic effect on frog heart (Vohora plant Corchorus tn'dens produced p~sitive eta/., 1983). Study on the cardiovascular effects of "Rooh-afza" an indigenous preparation indicated that this mixture 0f.a number of natural .products selectively improved the coronary blood flow in laboratory animals (Gulaii et aL, 1985).

,

Diuretic activity
A nomocr of plant extracts showed promising diuretic activity. At the moment it is r:ot possible to ascertain whether this could be due to the presence of naturally occurring inorganic salts. The active material should be desalted and 'tested'. Moreover the potassium sparing nature of the plants should be established before considering them for development as drugs. A good diuretic actiwty was observed with the saponins isolated from Vigna sinensis, Vigna radiata and Vigna mungo (Sood and Bajpai, 1985). The drug "Narikel lavan" (from Cocos nucifera) produced a.diuretic activity in rats (Shukla et a1.,1985). Detailed investigationis, however, required including an elucidation of the mechanism of action. A number of plants have confirmed diuretic activity in various fractions. These are:Meconopsis aculeata, Pentapanax parasiticus, Pulicaria angustifolia, Uncaria macrophylla, Vicia pallida (Aswal et el., 1984b); Clerodendron paniculatum, Pogosten~on pubescens, Sansevieria trifasciata (Aswal et a/., 1984a): ~naphalis' n~arcescens,Elaecarpus munronii, Nepeta erisotachya, Samadera indica and Senecio corymbosus (Abraham et al,, 1986). Further . chemical and pharmacological work is being carried out to isolate the active principles and to establish the mode of action.

Hepataprotective activity
In most of the experiments carbon tetrachloride (CCI,) was used as an agent to induce hepatic damage in rats in different doses and for variable duration. The damage simulated viral hepatitis, fatty infiltration and cirrhosis. Ethanolic extract of the rhizomes of Picrorhiza kurrooa exhibited potent hepatoprotective activity in rats and mastomys .The active principle was identified as an iridoid glycoside mixture, kutkin. The kutkibfree fractions of the extract had no hepatoprotectwe activity, rather they aggravated the toxicity. Kutkin had significant activity against hepatic damage induced by galactosamine in rats and against Plasmodium berghei in mastomys, and appears to be a promisilig lead (Ansari et a/., 1988). The 50% etha~olic extract of roots and leaves of the plant Phyllanthus niruri had hepatoprotective effect on alcohol-induced liver damage on nonhepatectomized and partially hepatectomized rats (Agrawal et' a/., 1986). However, the hexane extract of the aerial parts of Phyllanthus niruri yielded triacontanal, phyllanthin and hypophyllanthin. Phyllanthin and hyp~phyllanthin

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Pharmacology of Medicinal Plants protected against CCI. Piperlongurn is included in Ayurvedic medicines against liver ailments.5 g k g p... 1985) but had nc effect on the regression of parenchyma. 1985). while triaronta::~: was protctctive against galactosamine-induced toxicity (Syamasundar et a/. of the crude drug could be mediated due to the above =onstituents. prolonged treatment with Piper longum (8-12 weeks) led to normalization of parenchymal damage..x6 days) of Andrograpt5.-induced hepatotoxicity in rabbits as indicated by a reduction of serum asparate amino-transferase and alanine aminotransferase and the histopathological examination of liver tissue.01 to 1% concentration and only GPT activity was studi~ The overall effects d. The compound restricted the fibrosis (Nirmal et al.vas prevented by (+) cyanidanol. This needs further study. Prevention of fibrosis by the plant could be due to an action of the immune process. and galactosamine induced cytotoxicity in primary cultured rat hepatocytes. Therefore. the necrotic tissue was found o persist. The possible mechanism could be like glucocorticoids es the compound is steroidal in nature. Since CCI.. 1984b)..1984a). The plant prevented the fibrous changes and promoted regeneration of parenchymal tissue (Rege et a/.s paniculata showed a significant hepatoprotective activity in CC1. ..o. leading to production of free radicals or by accumulation of the metabolites. Tinospora cordifolia improved the regression pattern and restricted fibrosis (Nirmal et. ed either by acceleration of metabolism of CCI. 1985).. The mode of action n( ?ds further study.. Alcoholic extract of the stem of this plant showed hepatoprotective effect in mice. Cyanidanol might act as a fibrinolytic agent. Piper longum (+) cyanidanot from Acacia catechu) administered orally did not show hepatoprotective effect in CC14-inducedacute damage in animals. The acute type of liver damage was not prevented by Tinospora cordifolia but the chronic type was prevented.. 1984~). Ttae study was done with 0. rats and rabbits against CCI. but it seems to have no beneficial effect per se. rather they caused aggravation of this damage. Solanum nigrum.. the active principle of Acacia catechu. The regression process was. however. failed to prevent ~ the acute type of damage in rats (Rege et al. it can be postulatedthat Tinospora cordifolia might act through membrane s!abili-zation. 1984a). produces cell membrane damage. (Singh et a/. 3-p-hydroxy~2. Tenninalia atjuna and Citrullus colocynthis administered orally to dogs exhibited SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . The aqueous leaf extract (0. Aqueous extract of the above plants (Tinospora cordifolia.. 1986). Aggrevation of acute . The effect was. The dry fruit powder of Piper longunl had no effect against the acute damage nor against the cirrhotic changes induced by CCI. 1986). However. improved by the plant by restricting fibrosis (Rege et a/.3-dihydrowithanolide obtained from :ne fruits of Withania F coagulans was found to possess marked hepatoprotectivc effect against CC14induced toxicity as evident by biochemical and histopathological studies It was found to be more active than hyqrocortisone (Budhiraja et a/.al.damaqcould have occur. less marked than Liv-52 (Dwivedi et al. The herbal drug "Livol" composed of Boerhaavia diffusa. It h o lever. The Ayurvedic use of the plant in liver ailments seems to be logical. however. The chronic type of damage induced by CCI.

The active principle was identified to be desoxyrhaponitigenin (Patnaik et a/.. It relaxed the smooth muscles of gastro-intestinal. Several coumarins were responsible for the activii. The CCI. saponins isolated from Vigna sinensis. Rheum webbianum also showed a good spasmo\ytic activity. Patneik & B. The saponin isolated from Madhuca indica and characterized as protobasic acid showed moderate spasmolytic activity on isolated guinea pig ileum preparation.N. The glycosides obtained from Symplocos spicata (Frotan et a/. The coumarins were also isolated from the hexane and ethyl acetate fractions.1985) The individual plants should be evaluated and the identification of the active principle in each plant si~ouldbe given importance. 1987). uterine respi~atory 1985. The 50% ethanol extract of the aerial parts of Heracleum thomsoni showed promising spasmolytic activity.. 1986).. 1983). This led to the testing of various plants for spasmolytic activity.. Active constituents have been isolated from sevekal plants and evaluated in detail but unfortunately none of them scores over papaverine. Spasmolytic activity Due to the rigid control over poppy cultivation alternatir!e plant sources of obtaining spasmolytic agents are being explored out world wide. 1985). Among these angelicin was found to be most active (Khan etal. Amongst these ansolactone was found to be the most potent and possessed good oral absorption (Lakshmi etal... Vigna ~adiata and Vigna mungo (Sood and Bajpai.-induced toxicity in mice and was equipotent to 10 my/kg of hydrocortisone. After further fractionation the active principles were identified as some novel furanocoumarins. Many plants are also tested as they were reported to possess this activity in the traditional use.. Angelicin showed nonspecific spasomolytic activity in a variety of in vivo and in vitro test models and was also found to be orally active. 1986).. It was found to be less potent than papaverine. The aerial parts of Corydalis meifolia yielded 13-methyl-tetrahydroprotoberberin (Cavidine) which showed a nonspecific spasmolytic activity by both parenteral and oral routes (Patnaik etal.. 1984). 1983). and vascular systems in several species (Patnaik et a/.G. 1987b). biliary. 1986). 1987a). It seems that the two properties may be complimentary.K. and Corchorus hidens (Vohora etal. induced hepatotoxicity in rats was counteracted by Eclipta alba in addition to its anti-inflammatory activity (Chandra et a/.. Maxima isoflavone isolated from Tephrosia maxima showed nonspecific antispasmodic activrty in vifm Vaximum activity was observed with isofalvona G but R was less active than papaverine (RamMurthy ef a/. urinary. Because of its good yield this novel compound merits chemical exploitation for improvement of biological activity. 1987).. the cold aqueous extract of Kalanchoe SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 330 . It was almost equipotent to papaverine. . Alcoholic extract of the leaves of Whania somnifera (1 glkg) possessed a hepatofirotective effect against CCI. The ethanolic extract of Cbusena anisata had spasmolytic activity in vitro. This plant also showed a potent antiinflammatory activity (Sudhir etal. Dhawan hepatoprotective activity as judged by the biochemical parameters (Pandey et a/.

Pharmacology o f Medkinal Plants integra (Varma et al., 1986) and essential 011from Pseudosorghum (Mehta et al., 1983) showed varying degrees of smooth muscle relaxant activity. Spasmolytic activity of a number of plant extracts was confirmed in the subsequent fractions. The plants are:Clausena indica, Corydah's meifolia, Dalbergia sisso and Rheum webbianum (Aswal et al., 1984b): Axyris amaranthoides, Coelogyne ovalis, Desmodium pseudotriquetrum and Thermopsis barbata (Aswal e t al., 1984a); Fraxinus xanthoxyloides, Milletia splendens, Saussurea albessns, Setlecio kunthianus and Toddalia asiatica (Abraham et al., 1986). Further fractionation and isolation of the active principles in the more promising plants is being carried out.

Antigastric ulcer activity
A significantamount ofdata has been reported on the antiulcer activity of banana fruit. The active variety is Muss spaientum var paradisica. The banana pulp powdar fed orally daily in a dose of 500 mglkg increased mucosal resistance as evident by significant increase in the (3H)-thymidine incorporation into mucosal cell DNA, increase in total carbohydrate content of gastric rnucosa, decrease in gastric juice DNA and protein and increase in carbohydrateiprotein ratio of gastric juice. Aspirin produced an opoosite effect (Mukhopadhyay et a/., 1987). The study suggests that the ulcer healing property of banana is by strengthening the mucosal barrier. The antiulcerogenic effect of banzna powder was also studied against aspirin-induced gastric ulcer. The potent effect seems to be again due to strengthening of the mucosal barrier. The study further indicates that the antiulcerogenic principle appears to be present in the unripe fruit and varies from season to season and place to place in the subcontinent (Goel et a/., 1985). The material is under clinical evaluation. Several steryl and acylsteryl glycosides (sitoindosides I , 11, Ill and IV) have been isolated from Musaparadisica (Ghosal and Saini, 1984; Ghosal, 1985). Sitoindoside IV augmented the synthesis cf PGI, like compounds in the gastric mucosal tissue of rat (Bhattacharya and Ghosal, 1987). The antiulcer activity of the plant could be mediated via the cytoprotective effect of PGI,-like compounds. Sioindoside IV in a dose of 100-400 uglmouse, administered for 3-7 days, produced signifi9,ant mobilization and activation of peritoneal macrophages (Chattopadhyaya et a/., 1987). This indicates probible immunostimulant activity of the ptant which needs further evaluation. Nimbidin (40 mglkg i.v.) the bitter principle from the oil of ,Azadirachta indica seed kernel, suppressed the basal as well as the histamine and carbachol stimulated gastric acid output in rats. The effect resembles that of histamine H2 receptor antagonists (Pillai and Santhakumari, 1985). The mechanism of action needs showed good further elucidation. Aqueous extract of the bark of Ficus ~acemosa anti-gastric secretory and antiulcer activity in rats. It stimulated the mucopolysaccharide secretion and inhibited the acid secretion (Pate1 and Vasavada, 1985). The results are promising and the plant needs further study.

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G.K. Patnaik & 0.N Dhawan .

CNS activity

I

A large number of plants were investigated for CNS activity. But, except for Bacopa monnieri and Fumaria indica attempts were not made to isolate the active principle. Majority of the plants, however, showed CNS depressant qctivity. The activity of the memory improving plant Bacopa monnieri has been.shown to be due to 2 saponemBarcside A and B (Singh and Dhawan, 1985). It had a facilitory effect on the newly acquired behaviour. It improved acquisition and consolidation (retention) and it detayed the extinction of the labile behaviour. The mechanism of the facilitatory action needs further investigation. The findings confirm the traditional use of the plant to improve performance in various learning situations. Fumariline, a spirobenzyl isoquinoline alkaloid isolated from seeds of Fumaria indica showed a dose (10-15 mgkg i.p.) dependent CNS depressant acthnty including anticonvulsant activity in rats. The compoulid, however, has no significant muscle relaxant activity (Kumar et al., 1986). Methanolic extract of Morus hdica produced a CNS depressant action in mice and the motor protile resembled a minor transquilizer but without muscle relaxation and anticonvulsant property (Pal etal., 1983). The essential oil from Pseudosorghum grass showed a mild tranquillizing action (Mt?hta et al.. 1983). The alkaloidal fraction obtained from the alcoholic extract of Triantheme portulacastrum (Vohora et el., 1984b), roots of Salvia haemetodes (Akbar et al., 1984), a crude glycoside fraction of Corchorus tridens (Vohora et a/.,1983), aqueous extract of Kalanchoe integra (Varma et a/., 1986), Cuscuta chinensis (Akbar et a1.,1985). Chloroform fraction of Syzygiurn cumini (Chakraborty et al., 1986), leaf (Ravishankar et al., 1985) and seed (Ravi-' shankar et al,'1986) extract of Vitex negundo and leaf extract of Azadirachta indica (Singh et a/., 1987) showed varying degree of CNS depressant activity validating their traditional use. CNS depressant activity as judged from significant potcintiation of barbitai sodium hypnosis in mice was also confirmed in various fractions of the following plants:Zingiberroseum (Aswal etal., 1984b), Cissampelos pareira, Desmodium pseudotriquetrum, Saccharum oficinarun~,Scrophularia koelzii (Aswal et a/,, 1984a); Etinocarpusnimonii and Hippophae thamnoicies (Abraham et el., 1986). Work'is being continued in the above plants to isolate and characteke the active principles.

Adaptogenic activity
Following the increased use of Panax ginseng and related species as adaptogenic agents there has been a lot of interest in the plants used in the Indian systems of medicine, particularly in the Ayurveda as Rasayanas. However, during the period under review limited work has been done an such plants and only three plants showed promising activity. Aswagandha, an Ayurvedic d ~ obtained from the roots of pthania somnifera, showed positive g anabolic effects (Varma, 1983). Two new acylsterylglucosides sitoindoside Vlt

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Pharmacology o f Medcinal Plants and Vlll isolated from the roots of Withania somnifera produced marked antistress activity in a number of test models. The activity was also potentiated by Withaferin-A, a common withanolide. The compounds had low toxicity (Bhattacharya eta/.,1987a). From Cicerarietinuni the stamina building and antistress principle has been isolated and identified as pangamic acid (d-gluconodirnethyl aminoacetic acid) (Singh et el., 1983). An Ayurvedic formulation "Alert" containing oil of Celastrus paniculatus inhibited glycogenolysis in the muscle fibre of rats. It reduced depletion of liver glycogen after swimming bouts in rats. This suggests possible antistress property of the plant as described in the Ayurveda (Kakrani et el., 1985). It is necessary to systematically study these plants employing a battery of tcst systems and to initiate developmental studies with the more promising agents.

Anticancer activity
Many plant materials have shown encouraging antitumor and cytotoxic activity in cancerous cells. However, all of these need further study to evaluate their specific* by testing these also on the normal healthy cells. An orange coloured oil obtained from the petroleum ether extract and a resinous material from the methanol extract of the nuts of Semicarpus anacardium weie found to possess antitumor property against P388 lymphocytic leukaemia in mice (Indap etal., 1983). Two closely related major constituents of Semicarpus anacardiunl, Bhilwanol-A and Bhilwanol-0, have been isolated and found to possess mild anticancer activity against P388 lymphocybc leukaemia in mice (Gudgaon etal., 1985). A cytotoxic effect of the oil of this plant is also reported (Pathak etal., 1983). The acetylattd oil per se did not have any activity but markedly potentiated the antitumour activity of different groups of anticancer drugs against P388 and sarcoma 180 systems in animals (Indap et al., 1986). The effect could be attributed to an increase in cell membrane permeabnility to the specific group of molecules. However, a detailed study to establish the mode of action is needed. The plant seems to have promising potentialw. The sesquiterpene lactone perthenin, isolated from Parthenium hysterophorus, was studied for its cytotoxic effect in vitro using cultured bovine kidney cells. It was found to inhibit macromolecular synthesis. At luglml concentration there was 50% inhibition in RNA. DNA and protein synthesis. It also markedly inhibited toe activity of key cellular enzymes (Narasimhan et al., 1985). The compound seems to have a potential antitumour activity for which it needs further evdmtion partidularly for the specific activity. Plumbagin isolated from the bark of Plumbego rosea and Plumbargo zeylanica regressed experimental tumor (Purushottaman et a1.,1985). Echitmine chloride isolated from Alostonia scholaris showed a dosedependent regression of methyl cholanthrene-induced fibrosarcoma in rats. At higher doses it was active against P388 lymphocytic leukaemia (Mohan et al., 1985). The compound needs detailed toxicity study at differenr dose levels on other tissues to ascertain the specific anticancer activity.

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Ethanolii extract of Curcuma longa and an ointment of curcumin produced marked symptomatic relief in patientswith ex?ernal cancerous lesions (Kuttan et al., 1986). Further, curcurnin was found to be cytotoxic to Dalton's lymphoma cells in v i h . It was also found to inhibit the growth of Chinese hamster ovary cells (S~udamini Kuttan, 1986). The antitumor property of curcumin needs and futther study. The inhibition of mitochondria1enzymes involved in a-tivation of carcinogens also needs to be evaluated. Several plants have been investigated for their effects on the Dalton's sdi tumor. A purified material (presumably a flavone glycoside) isolated from lxorajavanicawas st~idied its effects on solid tumor development in mice for (Nair and Panikkal, 1988). It completely prevented the formation of tumor and arrested further growth in the already formed tumor. The glycoside deserves further evaluation. An Ayurvedic drug containing the flowers of Ixora coccinea was found to retard the development of tumor and arrest the development of already formed Dalton's lymphoma as solid tumor in experimental animals (Panikkar et a/., 1986). The methanolic extract of seeds of Carum bulbocastrum produced complete cytotoxic effect on Dalton's lymphoma (John and Panikkar, 1988). A peptide of mol. wt. 5000 isolated from Mistletoe extract (Viscum album) reduced the solid tumor induced by Dalton's lymphoma ascites tumor cells . on mice. The peptide was not cytotoxic to normal lymphocytes which indicates a cell dependent toxicity (Kuttan et a/., 1988). The aqueous extract of the flowers of Crotus sativus also showed cytotoxic activity against Dalton's lymphoma in mice3(Panikkarand Majella, 1986). Alcoholic extract of whole plant Withania somn#era prevented the development of adenomas in lungs of mice induced by urethane. The extract also prevented the urethane induced decrease in body weight, mortality, leucopaenia and lymphopaenia (Singh et a/., 1986). The plant extract seems to induce a stategf nonspecific increase in resistance. Elaborate biochemical and immunological studies are indicated to provide further data. A number of plants have confirmed anticancer activity in their subsequent fractions as tested against human epidermoid carcinoma of n-asopharynxin tissue cultureand P388 lymphocyticleukaemia in mice (Aswal bt al., 1984b). These are: Agave americana, Ampelocissus tomentosa, Carpesium abrotanioides, Casearia ovata, Cassine glauca, Coleus caninus, Costus sativum, Cudrania cochinchinensis, Cyanotis cristata, Cyathea khasayana, Diplazium esculentum, Dysophylla crassicaulis, Euphorbia maddeni, Gossypium herbaceljm, Hyptis suaveolens, lnula cuspidata. lpomoea nil, Jatropha glandulifera,Junipenrs indica, Leea n~mphylla, Oplismenus burmannii, Pollia subsum bellata, Scirpus erectus and Thalictmm cultraturn.

Anti-infective activity
Many plant extracts have been tested for antibacterial, antifungal, clntivira) and antihelminthic activity, but only a few have shown promising activity.

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Pham~acology Medicinal Plants of The essential oil obtained from the leaves of Elsholtzia poljdracha showed ankcterial activity in vitro against 0. anthracis. V. cholerae, C. welchii, S. typhi, P. aeruginosa and S. lutea (Chaturvedi and Saxena, 1985). It also showed potent antifungal activity against plant pathogeniz fungi A. nidulans, A. niger and F. oxysporum (Chaturvedi et el., 1987). The alcoholic extract of leaf of Ocin~umsandun~ dilution) completely inhibited the growth of strains of M. (1:l tuberculosis (Reddy et el., 1986). The ethanolic and aqueous extracts of Phyllanthus Ratemus and Jatropha glandulifera showed antibacterial and antifungal activity. The alcoholic extract in addition had antiviral activity against Hepajitis B surface antigen (Ramachandani and Chungath, 1987). The essential oil of the root of Uvaria narum exhibited good antimicrobial and antihelminthic acti\ntyin v b (Nanda et a/., 1986). Several sesquiterpenes were isolated from the oil. The activity could be due to these sesquiterpenes. The aqueous extract of leaf of Eucalyptus laceolatus possessed strong antifungal activity against F. solani. M. chinereus, C. lunata, P.bubaki and A. sclerotiorum (Barde, 1985). The oil obtained from the leaves of lnula cuspidata showed marked antifungal activity against pathogenic fungi, in particular against A. fumigatus, in vitro (Chauhan and Saxena, 1985). Various extracts of seeds of Vernonia enthelmintica possessed significant activity against A. lumbricoides and H nane. The alcoholic extract was most potent (Singh et a/., 1985d). An . indigenous drug formulation containing onion (Allium cepa), garlic (Alljum sativum), lemon (Citrus linlon) and turmeric (Curcuma longa) and seeds of Abrus precatorious completely eliminated scabies in pigs (Dwivedi and Sharma, 1985). Many of the above plants are used in Ayurvedic medicines. Some of these need further evaluation including isolation of the active principles. Fractions of Crotalaria modurensis (Aswal et a/., 1984b), Coscinium fenestratum (Aswal et a/., 1984a), Azadirachta indica (Abraham et a/., 1986) confirmed antifungal activity. Fractions of Eucalyptus globulus (Aswal et a/., 1984b), Coscinium fenestratum (Aswal et el., 1984a), Lespedeza stenocerpa (Abraham et a/., 1986) confirmed antibacterial activity. Fractions of Carex obscura, Shopera robusta (Aswal et al., 1984a), Terminalia cheubla, Hippophae salicifolia, Syzygium megacarpus (Abraham et el., 1986) were confirmed for antiviral activii and antihelminthic activity was confirmed in fractions of Lycium barbarum (Aswal et a/., I 984b).

Antifertility activity
A review of work done upto 1981 has been published (Kamboj and Dhawan, 1982). Subsequent data from 1983 onwards on some promising plantsshowing activity in male and female animals are summarized below. The work on anti-implantation plants has been reviewed by Kamboj (1988). Various Investigators have used different species of animals and periods of drug administration. However, it is advisable to utilise standard procedures of assay (like WHO ME protocols) to draw valid conclusions and to permit evaluation of relative efficacy.

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G.K. Patnaik d B.N. .Dhawen

Plants active .in fernale:.A large number of plant extracts have shown antifertility activity in female animals, but only in 3 plants the active prindple has been identified. Most of the plants, however, possessed estrogenic activity and, therefore, have little clinical potential. Administered orally 1-5 days post coitum, to female rats the ethanolic extract and hexane, benzene and chloroform fractions of Ferulajaeschkeana prevented pregnancy. The active principle was identified as a new coumarin, ferujol.hsingle administrationof ferujol(0.6 mgkg) on day 1,2 or 3 postcoitum prevented pregnancy significantly (Singh et a/., 1985b). It was active during the preimplantation period. The compound has potent estrogenic activity which could be responsible for its contraceptive effect. Vicolide B a sesquiterpene ladone isolatedfrom Viooa indica showed marked reduction in litter size in rats treated with 50, 100 mglkg p.0. for days 8-14 or days 14-21 post coitum. The effect may be due to antiestrogenic activity or due to a direct embryo-toxicity. It was found to be devoid of progestationalactivity (Susan et el., 1986). Further, the aqueous extract of the whole plant administered in 98 or 56 times the human dose (as used by the tribal people, in Bihar) in subacute toxicity study in rats and rabbits was found to be safe as judged by biochemical and other parameters. The ethanolic extract of the aerial parts of Caesalpinia decapitata administered p.0. on days 1-8 post coitum in female hamster exhibited significant contraceptive activity but was devoid of any estrogenic activity. Further fractionation revealed that the activity was localized in the butanol and aqueous fractions (Keshri et a/., 1988). A combination of alcoholic extracts of Azadirachta indica (leaf and stem), Piper longum (fruit), €mbclia ribes (harries) and Gossypium indicum (seeds) considerably prolonged the diestrus phase of female rats (Reddy et el., 1984; Kokate et el., 1987). Ei nbelin, isolated from Embelia ribes, increased the uterine weight, total protein, total solid and ACP activity but decreased the RNA content, glycogen and ALP activity in ovariectomized rats. No biochemical changeswere observed in prcrgressive primed rats (Prakash et a/., 1986a). The results suggest that estrogenic property of the substance may be responsible for the antifertility activity of Embelia ribes. The alcoholic extract of Hibiscus rosa-sinensis controlled60% fertility in rats. The surviving foetuses showed neonatal defects. In a dose of 270 mglkg p.a. it caused 70% reduction in weight of foetus (Sethi et el., 1986). The alcoholic extracts of seed of Annona squamosa and pulp of Xeromphiq spinosa significantly prevented pregnancy in animals (Saluja and Dantani,l984). Prakash and co-workers screened 20 medicinal plants for antifertility activity rn female rats (Praksh eta1.,1986b). Among these 50% ethanolic extract of Dupatriumjunceum, Puemria tuberose and Rubus ecs pu It ili inhibited pregnanoy. .Estrogenic andlor antiestrogenic activity was observed in several plants. Some of these also exhibited antifertility activity of varyin($ degree. Acetone extract of the seeds of Foeniculumvulgare showed a dosedependent increase in the weight, nucleic acid and protein concentration inthe cervix and vagina of castrated female rats (Annusuya et a/., 1988). The results of the study suggest the anabolic nature as well as the estrogen-like effect of the plant,

*

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Pharmacologyof Medicinal Plants Neerp oil (Azadrachta indice) administered intravaginally and p.0. showed 80% foetal resorption activity in female rats (Lal et a/.. 1986). At the higher dose there was mortality indicating toxicity but even then there was incomplete antifertility effect. Similar antifertility activity was also observed by administering neem oil on selected days of pregnancy in female rats (Lal et al., 1987). The material seems .to have little clinical potential. The fractions of Leipiium capitatum exhibited estrogenic activity (Singh et a/., 1984~). Aqueous extract of the root of Moringa oleifera produced both estrogenic as well as antiestrogenic effects in rats (Chattopadhyay et a/., 1987). This could be due to the peresence of several constituentsin the extract. Hence isolation of the active constituents is neded to substantiate the reported use of the plant as an antifertility agent. The butanolic extract of Pueraria tuberose showed estrogenic activity in female rats as evident by biochemical and histological stud~es (Shukla etal., 1987a, b). Petrol and alcoholic extract of the seeds of Daucus carota administered orally showed mild antifertility effect when given 1-10 days post pregnancy in rats (Lal et a/., 1986). It was found to have estrogenic activity (Kaliwal and Ahmed, 1987). The water soluble alcoholic extract obtained from defatted powdered seed kernel of Balanites roxburghii showed antiovulatory antioesrus effects and inhibited sperm motility in rats and rabbits (Shukla et al., 1986). The butanol fraction of the aeriai parts of Acharanthes aspera given on 1-5 day of pregnancy in rats prevented pregnancy. It also showed a marked estrogenic activity (Wadhwa etal., 1986). Antifertility activity was also confirmed in fractions of Bupleurum marginaturn, Chonemorpha fragrans, Pluchea lanceolata, Pulicaria angustifolia, lpomoee pescarpae, Zingiber roseurn (Aswal et al., 1984b); Cacia farnesiana, Lepidium capitatum, Loniera japonica, Juniperus communis (Aswal et a/., 1984a) and Moringa pterygosperriia (Abraham et al., 1986). Oxytocic activity in rats was confirmed in the fractions of the following plants.Amorphophallus cor~ipanulatus, Codonopsis ovata, Deutzia corybose, Ephedra geradiana, Geranium lucidum. Gnaphalium pensylvanicum, Hippophae rhamnoides, Vicoa vestita, (Aswal et a/., 1984a); Luffa echinata, Polemonium coeruleum, Thalictrum cultraturn (Aswal et al., 1984b); Berberis pseudumbellata, Hippophae salicifolia, Lespedezajuncea, Lespedeza stenocaropa and Polygonup nepalense (Abraham etal., 1986). Most of these plants were, however, ineffective in causing abortion in pregnant animals. Isolation of the active constituents in selected plants is in progress. Plants active in male: Gossypol (Thespesia populnea) given in doses of 20, 30 and 40 mglkglday in male rats produced marked degenerative changes in the gonads. Besides testes. epididymis was also affected by tQe compound (Kaur et a/., 1988). Plumbagin isolated from the roots of Plumbago zeylanica administered daily for 60 days caused selective testicular lesions in male dogs. A reduction in the weight of testes and epididymis was observed. Inhibition of androgen dependent structures was also noticed (Bhargava, 1984). Intramuscular administration of saponin rich fraction isolated from the fruits of Sapindus triioliatus daily for 2 months caused reduction in the weight of testes

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G. 1986). The alcoholic extract of Crataeva nurvala (Varuna) given for 36 days significantly reducedthe size of arb. 1986). The plant needs further evaluation. The plant may be beneficial and clinically in the management of agalactia.. It had a prompt onset of action and a reversible effect but the duration of action was too -long for any possible therapeutic usefulness (Mukherjee et a/. The galactagogue activiG in agalactia was noticed as the seed causea a sustained rise in the milk yield v ~ h a n Panwar. like kctivity in aortic tissue. Very few detailed studii have been done with pure compounds.. The mechanism of action needs to be worked out in detail. Patnafk 6 B. inhibition of spermatogenesis and alteration in epididymal t s u (Bhargava. \t caused reversible arrest of . However. However. Concluding remarks \ This survey shows that a large number of plants has been screened for diverse type of biological activities. The flower extract of Mahtavisucus conzatti also arrested spermatogenesis and led to atrophy of secondary sex organs (Pakrashi et at.K.spermatogenesis.. The aqueous solution of kernel powder of Semecamus anacardium markedly affected the fertivi in rats. 1985). Dhawan and epkilidymis. 1984). it produced severe testicular lesions like vacuoSiaiion. 1987). Aerva lanata did not affect formation or dissolution of phosphate type urinary stones in rats (Gurumatfhava Rao et a/. The effects suggest decreased production and supply ise of androgens. There has been limited follow-up studies and in a few cases only an a&e constituent or even an active standardised fraction been obtained. Nigella sativa seeds administered to goats increased the milk production substantially. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 338 .N.fidlaly produced urinory bladder stone in rats (Report CCRAS. Oral' feeding seeds also produced a marked of 50% ethanolic extract of Syzyghm cc~m'i androgen deficiency in male r a b b i and rats (Sinha et el. 1985). katyorrhexis and atrophy of leydig cells (Singh. s Other pharmacological activities A quarternary alkaloid isolated from Co~culuslaurifolius possessed marked neuromuscular blocking activity of nondepolarizing type like dtubocurarine.. Gindarinin hydrochloride an alkaloid of Stephanie glabra possessed local anaesthetic activity like procaine (Mahatma et a/. 1987). Any agent affecting leydii cell function cannot be used as male contraceptive and hence it seems that there i no positive lead in this area available so far. nuclear pyknosis.. 1986). In rabbits root powder of lnula recemosa and Saussurea lappa administered orally showed PGE. The compound was devoid of surface anaesthetic property which may be a disadvantage. On the contrary chemical constituents have been isolated from a large number of Indian plants but most of these have not been biologically evaluated and. 1986).

ary to define priority areas and to concentrate developing new drugs from Indian plants in these conditions with a concerted multipronged effort. 1985 Singh et a/. allergy. the long time and expenses involved in studies reveiwed above. 1984d Akbar et al. necessary to evolve a comprehensive strategy to biologically evaluate isolated compounds and to quickly undertake precllnical developmental studies if new drugs are to be obtained from this important source in a reasonable time frame..g. like liver displants and orders. What should be thestrategy for the future? It will be neces . The lndian Council of Medical Research has started a large project by initiating controlled clinical studies on selected plants in diseases where satisfactory modern drugs are not available e. 1984. There have been serious discussions to evolve an? utilise alternate strategies in development of new therapeutic aids from plants used in traditional systems of Indian medicine due to limited success. Another major limitation in majority of studies has been lack of botanical authentication and any details of place and time of coliection of plant materials in most of the papers. therefore. It is.. stress and memory despair. There is a concommitant follow-up of the plant materials selected for chemical and pr~armacological these studies. ICMR has already got promising data on use of Ksharsootra in treatment of anal fistula (G.1983 Bagi et a/. 1987a Varma et a/. Carefully selec~ed specific test modelsshould be employed in these cases. bronchial asthma. not included in this review. etc. personal communicatioi ) and other trials are continuing. This is absolutely essential to ensure reproducibility of results and to reduce prcblems in follow-up studies. Iei~hm:~niasis. The progress of this project will be watched witk interest...V.1983 f Bhattacharya et al... control and diseases for which no satisfactory drugs are avaiiab'?.Pharmacology of Medicinal Plants therefore.. 1985 Singh e a/. These areas should fertility include priority areas for health care in India like malaria. filaria. ~nfective hepatitis. Satyavati. 1985 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . 'Eff~~rts need to be strengthened in studies of marine flora and fauna also! The data on the plants discussed in :?is review have been summarised as activity wise in Table 1 for ready reference Table 1 Pharmacological Activity Present it: Different Plants Name of the Plant Activity kefnrences Adaptogenic Celastrus paniculatus Cicer arietinum Withania somnifera Analgesic Abutilon indicum Cissus quadranoularis Cuscuta chinensis Kakrani et a/.

t985 Mallaiah et a/. 1984b Aswal d a/.. 1985 Aswal et al. 1983 Bhattacharya et a/. 1984a et Vohora etal. 1984b Panikkar and Maiella.. 1984 Godhwani et a/.1988 Aswal et a!.. 1986 Dahanukar and Karandikar. 1983 Handa et a/. 1985 Bhattacharya e el..N... 1984 Vswanathan et a/.. 1984 V ~ h o r a a/. 1986 Trivedi et al.. 1984 Thakur 8 Sharrna... 1984b Mohana et a/... 1984b John and Panikkar. 1984b Aswal et al. Patnaik 8 6.. 1986 Anticancer Agave americana Alstonia scholaris Ampelocissus tomentosa Carpesium abrotaniodes Carum bulbocastrum Casearia ovata Cassine glauca Coleus caninus Crotus sativus Cudrania cochinchinnesis Curcuma longa SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 340 ... 1984b Kuttan et a/.. 1986 Aswal et a \ . 1984b Aswal et al. 1987 Agarwal et a/. 1983 Johri et al.G.. 1985 Tripathi et al.. 1984b Prakash et al. 1985 Singh etal.. Dhawan contd .jTable I) Desmodium gangeticum Embelia ribes Gossypium indjcum Hedychium spicatum Ocinwm sanctum Phyllunthus fraternus Polygonum glabrum Randia dumatorum Rhus semialata Salvia haematodes Solanum melongena Trianthema portulacastrum Tribulus terrestris Vitex negundo Acasia farnesiana Albizia lebbeck Allium cepa Cessia+spectabilis Leucas aspera Ocilnum sanctum Piper longum Prosopis juliflora Rumex nepalensis Tinospora malabarics Ghosh and Ananda Kumar... 19% f Aswal et a/. 1983 Atal et el. 1984 Johri et a/. 198% Ghosh et a/... 1985 Srimal et el.... 1987 Hukerj et a/.... 1984 Reddy et a/...1985 Ravishanker et aL. 1986 Medirata et el. 1987b Akbar et a/..K.

1986 Aswal et a/..... 1984b Aswal et at..... 1983 Aswal et a/.... 1984b Aswal et a/.Pharmacology of Medicinal Plants contd . k et a/. 1984a Achyranthes aspera Wadhwa et a/. 1984b Aswal et a/. 1985 Purush . :986 Bupleurum marginatum Aswal et a/. 1984b Aswal et a/... 1984b Panikkar st a/.... 1986 Amorphophallus campannlaiils Aswal et a/. 1987 ---- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 341 . 1984b Aswal et a/.. 1986 Nair and Panikkar. 1984b Codonopsis ovata Aswal et a/. 1984b Aswal e l a/. 1984b Aswal et a/. 1984b Aswal et a/. 1984b Aswal et a/. 1987 Reddy et a/.... 1985 lndap eial. (Table 1) Cvanotis crfstata Cyathea khasvana Diplazium esculanlum Dysophylla crassicaulis Euphorbia maddeni Gossypium herbaceurn Hyptis suaveolens lnula cuspidata lpomoea nil lxora coccinea lxora javancia Jatropha glandulifera Juniperus indica Lee*arnacrophyl/a Oplismenus buramanni Parthenium hysterophorus Plumbago rosea Plunibago zevulanica Poollia subumebellata Scirpus erectus Semicarpus anacardium Thalictrum culfratum Viscurn album Withania somniferi Antifertility Soudamini and Kuttan. 1984b Kuttan et al.. 1986 Acacia farnesiana Aswal et a/.1986 Pha:. 1984b Caesalpinia decapitata Keshri et a/... 1987 Lal et al... 1988b Singh et a/. 1984 Balanites roxburghii Shukla eta/.. 1986... 1984b Narasirrbhan et a/.. 1984c Daucus carota Kaliwal and Ahmed. 1988 Chonemorpha fragrans Aswal et al. 1984b Aswal et a/.~thaman. 1986b Berberis pseudumbellata Abraham et a/. 1984b Aswal et a/. 1984 Azadirachta indica Kokate et a/. 1983.. 1985 Aswal dt a/.... 1988 Aswal et a/. 1984a Annona sqnemosa dt':ria and Dantani... 1984b Gudg-lon et a/.1985 Purush Ahaman..

1984c Singh et a/... 1986 ASWT'a a/. '1984b SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 342 . 1984b Aswal et a/. 1985b Annusuya et a/.. 1987b Abraham et a/.K. 1984a Singh et al... 1987 Sinha et a/.. 1984 Aswal et al. 1084c Prakash et a/.. Moringa pterygosperma Piper longum Pluchea lanceolata Plumbago zeylanica Polemonium coeruleum Polycjonum nepalense F'ifsraria tuberosa Pulicaria anqustifolia Rubus ellipticus Sapindus trifoliatus Semicarpus anacardium Syzigium cumini Thalictrum cultratum Thespesia populnea Wcoa indica Xeromphis spinosa Zingiber roseum Lal et el. 1987a. 1986 Aswal et a/. 1986 Saluia and Dantani. 1986b Prakash et el. 1984c Aswal et a/. 1984c Sethi et a/.... 1986a Reddy et a/... (Table 1) Deutzia corymbosa Dupatriumjunceum Embelia ribes Eghedra gerardiana Ferula jaeschkeana Foeniculum vulgare Geranium lucidum Gnaphaliumpensylvanicun~ Hibiscus rosasinensis Hippophae rhamnoides Hippophae salicifolia lponloea pescaprae Juniperus communis Lepidium capitatum Lespedeza juncea Lespedeza stenocarpa Lonicerajaponica Luffa echinata Malvaviscus conzatii Moringa oleifera svn. Patnaik & 8.G. 1984b Abraham et a/. 1986 Prakash et a/.... 1984 Aswal et al. 1988 Walia et a/. 1985 Susan et el. 1984 Aswal etal.. 1984b t Kaur et el..... 1984 Aswal et a/. 1984b Bhargava.N.. 1986 Reddy et al.. 1986 Aswal et al.. 1985 Shukla et a/. 1988 Aswal et el... 1984a Aswal et a/. 1984b Prakash et a/. 1986 Singh.. 1986 Gandhi etal. 1984a Aswal et a/. Dhawan contd.c Aswal et a/. 1986b Shukla et al....... 1984b Prakash et al. 1984c Abraham et a/.... 1984c Abraham et el.... 1986b Bhargava. 1986 Aswal et a/. 1986 Aswal et al...

1983 Trivedi et a/. 1986 Chauhan and Saxena.. 1984a 1 Dwivedi a. 1987 Ghosal. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 343 .. 1985 Dwivedi and Sharrna.. 1984a Aswal et d.d Sharma... 1984b et Reddi et a/. 1985 Abraham et a/... .. 1986 Aswal et a . 1984a Abrahem et a/. 1987 Aswal et a/. 1985 Ficus racemose Patel and Vasvada.. 1985 and Musa sapientum var paradisic Bhattacharya Ghosal. 1984b Chatunrelli and Saxena. 1986. 1985 Chaturv~:diet al.. Azadirachta indica Pillai and Santhakumari.. 1984b Barde. 1985 Abraham eta!. ~ a!. 1985 Rarnachandani 8 Chungath. 1985 Aswal et :I/.. 1987 Aswal :'a/. (Table 1) Antigastric ulcer .. 1986 Nanda et a/. 1985 Dwivedi8 Sharrna.. 1985b Chakravarthy et a/. 1986 Singh et el.. 1987 Aswal et el.. 1986 Ramachandani & Chungath. lnula cuspidata Jatropha glandulifera Lespedera stenocarpa Lycium barbarum Ocimum sanctum Phyllanthus fraternus Shoera robusta Syzygium megacarpum Terminalia chebula Uvaria narurn Vernonia anthelmintica Acacia catechu Acacia femesiana Antiinflammatory Dwivedi and Sharma.1984b A s L .Phamacology of Medicinal Plants contd. 1984 Allium cepe Allium sativum Abrus precatorius Azadirachta indlca Carex obscura Citrus Iimon Cosdnium fenestratum Crotalaria madurensis ElshoMie polystrache Eucalyptus globuls Eucalyptus lanceolatus Hippophae salicifoic. 1987 Chattopadhyav et a/. 1986 Abraham et a/. 1985 Ghosal and Saini...

1986 Ghosh and Anandakumar. 1987 Varde et a/.. 1988 Hkeri et al... 1983 Abraham et a/. 1984a .. 1986 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 344 . 1986 Saxena et el.. 1986 Srimal et a/.1985 Sethuraman and Sulochana.. 1985... 1986 Sharma et al. 1984b Abraham et a/.. 1988 Aswal et a/. 1988 Abraham et a/. 1985 Singh et a/. 1984a Somasundararn et el.. 1985c Ghosh et a/.. 1988 Godhwani et a/. 1988 Agnihotri et a/....l987 Upadhayay et a/.. 1986 Chandra etal.. 1985 Fortan et a/. 1984 Varde et a/.....1985 Srivastava and Srirnal. 1988 Singh et al..D~: Nan contd .. 1986 Nair et a/..G. (Table 1) Acorus calamus Antidesma geranliana Boswellia serrate Casimiroa edulis Clerodendron inenne Comiphora mukul Cordia obligua Crataeva nurvala Curcuma longa Cuscuta chinensis Datrrra stramonium Delonix elate ~esmodium gangeticum Dictamnus albus Eclipta alba Embelica oficinalis Euphorbia acaulis Halenia elliptica Hedychium spicatum Lawsonia inermis Lepforhabdos parvifldra Leucas aspera !Vyctanthes arbor-tristis Oci~num bascilicum Ocimum sanctum Phyllanthus fratemus Polygonum glabrum Randia dumetorum Rhus semialata Semicarpus anacardium Strobilanthes heyneanus Symplocos spicatd . Singh et a/..... 1986 Aswal et a/. 1985 Srivastava et a/. 1986 Abraham et al... 1988 Sharma et al. 1986 Reddy et al.. Terminalia bellercia Terminalia chebula Viburnum odoratissimum Varde et a / .. 1983 Sharma et a/... 1983 Bhattacharya et al. 1987 Sharma et a/. 1986a Nisa et al. 1985 Uma et a/.. 1984 Gupta et a/.N.K Patnaik & B... 1986 Srimal& Dhawan. 1987 Report CCRAE.

1984 Anbalagan and Sadique. Sudhir et al. . 1983 Cuscuta chinensis Akbar et a/.... 1987 Vohora et a/.. 1984b Tribulus terrestris Prakash et a/.... 1983 Chakravarthy and Gode. .. 1984a Erinocarpus nimonii Abraham etal. 1986 Kalanchoe integra Varma et a/. 1984a Solanum melongena Vohora etal.. 1986 Antipyretic Ocimum sanctum Trianthema portulacastrum Woodfordia fruticosa Aerva lanata Crataeva nurvala Cardiostimulant Coleus forskohlii Corchorus tridens Pterocerpus .marsupium Godhwani eta/.. 1983 Pseudosorghum Mehta et a/.. 1984a Corhorus tridens Vohora et a/.. 1986 Antiurolithiatic CNS DeSouza et a/.1986 Sethuraman eta/...Pharmacology of Medicinal Plants contd (Table 1) Vitex negundo Wmhtiria fcndoria Withania somnifera Ravishankar et a/.. I 985 Vigna mango Sood et at.... 1086 Hippophae rhamnoides Abraham et a/. 1983 Vohora eta!. 1985 Ruh-afia Gulati et a/. 1986 Fumaria indica Kumar et a/.. 1985... 1986 Trianthema protulacastrum Vohora et a/. 1985 Report CCRAS. 1984 Scrophularia koelzii Aswal et a/. 1985 Vigna radiata Sood e! al. 1984a Syzygium cumini Chakraborty et a/.. 1986 Morus indica Pal eta/. 1987 Bacopa monnieri Singh & Dhawan. 1986 Gurumadhava Rao et a/. 1985 Desmodum pseudotriquetrum Aswal et el. 1984b Alam et a/.. 1085 Azadirachta indica Singh et a/. 1983 Saccharom oficinarum Aswal et at.. 1984a Salvia haematodes Akbar et a/.....1985 Canavalia virosa Mukhopadhayay etal. 1985 - SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 345 . 1986 Cissampc?louspareira Aswal et a/. 1985.....

1986 Aswal et al. 1987 . 1986 Asi4al et al. 1984a Abraham et a/. 1985 Abraham et a/.. 1985 Pandey etal... 1984b Dwivedi et a/. 1984b Aswal et a/. 1984a Budhiraja et al.... 1984b Sood et al. 1985 Vihan and Panwar. 1984b Abraham et a/. 1984c Pandey et el. 1985 Rege et a/. 1986 Aswal et al..1985. 1988 Nirrqa! et al.. et a/. 1985 Rege et al. 1986 Pandey et al.... 1986 Sudhir et a/. 1986 Aswal et a/. 1986 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 346 ...K. 1985 Sood et el. Patnaik 8 B. Dhowan contd (Table 1) Vigne sinensis Vitex negundo Sood et a/.. 1984a Singh et a/... 1984a Aswal et a/.N.. 1984a Shukla et a/.. 1985 Rege et el. 1985 Sood et al.. 1986 Aswal et al. 1985 Pandey et a/... 1985 Ansari et a/. 1986 Symasundar etal...... 1986 Aswal. 1984a Aswal et al. 1985 Nirmal et a/.. 1984b Abram et a/. Diuretic Zingiber roseurn Acacia tortilis Anaphalis marcescens Antidesma menasu Carduus nutans Clerodendronpaniculatum Cocos nucifera Naeocarpus rnunronii Meconopsis aculeala Nepeta erisotachya Pentapanax parasiticus Pogostemon pubescens Publicaria anqustifolia Samadera indica Sensevieria tifasciata Senbecio corymbosus Uncaria macrophylla Vigna mungo Vigna radiata Vigna sinensis Nigella satjva Acacia catechu Andrographis paniculata Boerhaavia diffusa Citrullus colocynthis Eclipta alba Phyllanthus niruri Picrorhiza kumoa Piper longum Solanum nigrum Tern~inalie ariuna Tinospora cordifolia Galactopoetic Hepatoprotective W!hania coaqulans 'Wthania somnifera Nirinal et a/. 1985 Ravishankar et a/.. 1984a Abraham et a/..G....... 1987 Agrawal et a/. 1984a Aswal et a/. 1985 Chandra et a/.. 1984b Aswal et a/....

1987 Dixit and Sinha. 1987 Mirhadi and Singh. 1985 Shanmugasundaram. 1986 Santhaku~nari et a/. 1986 Tarfa et al. 1987 Dixit and Jain...... 1986b Desai and Bhide. 1986 Singh et a/. 1987 Nair and Santhakumar~. 1985 Aswal et a/. 1983 Srivastava et a/. 1986 Giri et a/.. 1986. 1985 Singhal et al.. 1984a Abraham et a/.. 1988 Giri et a/. 1986a Singh et a/... 1986 Rahman et a/.. 1985 Mahajan and Jolly..... 1988 Giri et a/.(Table 1) Acacia catechu Atylosia scarabaeoides Bougainvillea spectabilis Brasica varcapitula Cajanus cajan Cymposis tetragonoloba Dodonea viscosa Echinops echinitus Eugenia cumini Gymnema sylvestre Chakravarthy et a/. 1986 Srivastava et a/. 1986 Aganval and Pant.. 1983 Singhal et a/. 1986 Shukla et al. 1985 Gupta et al.. 1987 Aswal et a/. 1985a Hypoglycaernic Han~iltonia suaveolens Momordica charantia Murraya koeniqii Swertia chirata Svzygium cumuni Tephrosia puruprea Tinospora cordifolia Trichosanthes dioica Trigonella foenum-graecum Hypolipidaernic Allium sativam Aloe barbabadei~sis Atylosia scarabaeoides Boswellia serrata Brassia capitata Cajanus cajan Carurum capticurn Cicer arietinun~ Commiphora mukul SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 347 ...... 1985 Chandrasekar et a / . 1985 Zutshi et al.. 1983 Agawal et a/. 1984b Jain et a/. 1987 Mukherjee and Mukherjee. 1986 Tarfa et al.. 1985 Upadhayay and Pant.. 1985 Sarker et al.Pharmacology of Medicinal Plants contd .

1985. (Table 1) . 1986 Mehta et el.. 1984 Verrna and Bordia.. 1986 Upac:iyay and Pant.. 1985 Abraham et a/. 1987 Thakur and Mandal. 1984 Giri et a/. Dhawen contd.. 1984b Pandey. Local anaesthetic Muscle relaxant Stephania glabra Cocculus laurifolius Mahatma et al. 1985 DeSouza et a/. I986 Aswal et a/. 1984b Pandey. 1984a Pandey. 1983 Aswal et al. 1985 Sharma.. 1985 Dixit and Joshi. Patnaik 8 B. 1986 Aswal et a/... 1985 Aswal et a/. 1987 Hypotensive Acacia raddiane Abrus precatorius Artemisia scoparia Balanites roxburghii Blumee membranacea Canavalia virosa Cichorium intybus Coleus forskohlii Coscinium fenestratum Eucalyptus golbulus Euphorbia maddnei Eugenia manqifolia lpomoea pes-caprae Kalanchoe integra Phy!lanthus gardnerianus Phytolacca acinosa Picrorhiza kurrooa Primula denticulata Solanum nigrum Tamarix ericoides Tecomella undulata Tibouchina semidecandra Withania coaqulans .. 1985 Aswal et a/. 1986 Mukherjee et 3 1384 ! .. 1 984 b Varma et el.. 1985. 1986 Basu et a/. 1984a Aswal et al. .... 1984b Aswal et al. . 1983. 1988 Srivastava et el. Cymposis tetragonolobe Embelice oIlicinelis Eugenia cumin1 Medicaqo sativa MomomUca carantia Nepeta hindostena Thevetia neriifolia Srivastava et a/.. 1985 Abraham et a\. 1984b Abraham et el. 1986 Mukhopadhayay et a/..1988 Rao et a/. 348 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS ..G.N.K.l986 Budhiraja et a/. 1986 Pandey.... 1986 Arora. 1984b Aswal et a/.. 1987 Goswami and Dutta.

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L.. (1985). J. Sarkar. (1985a). K. 569-580. 48.K.A. 21. 22. Central Council for Research in Ayurveda and Siddha.. Ramachandani. and Tandon. Ethnbot. M. (1986). and Sarin.M. 55... N.. 230231. 517-520. Ind. 86-88. Rege. and Karandikar. J.. A. N. (1987a). Drugs. and Singh. and Saleemuddin. Shoeb... Sambantham.. S..A. K. S. M. J. 17(S). and Karandikar. Gupta. 6 . and Reddy. Rajpal. Satyavati. Res. an'b~antani. 46. Shukla. Bull. EthnoBot.. Rao..N.D.K. Medicinal Plants of India..1. R-. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 353 ... G. Pillai. Ancient Sci. Purushomtharnan. Med. Rao. . 24. M. Khan.. 28.V.R. K. 166-170.. (1987).and Gupta. 544-555. G. M.M. (1986).K..S.. S. 11. Singh. 27. Ethano-bol. Drugs. Rege. 177-188. Sharma.. Prakash. 418-421.. F'rakash.. K. G.C.A.R. (1983). 132-134. Rao. 151-155.. (1984a). Kokati. Res. G. and Gupta.N. (1985). 53. J:Med. K. 25. Mohna. N Dahanukar.G. Sid.K.T. R.R. Drugs. (1986). N. Report CCRAS'(1986)...N. 220-223'..K.K. Sid. B. P. New Delhi. T. Ind.Y. R. Sethuraman. Shanmugasundaram.. Sarnudram.K. Dahanukar. 81. M. Viswanathan.B. M. G. and Arivudai Nambi. Santhakumari. J. and Panneyvselvam. Pillai. and Mathur. Drugs. V. Nath. N.. Ind.Kashfudduj. Physiol. Pharm. Ay.O.R.. R. 4-10. 189-195. Chaudhary. J. Ind. Ecol. A.. 343. Indap. Bull. E. (1984). 7 . J.. Rawshankar. Pillai. Fitoerapia. 12. C. E3. Life. Rege.N.K. T. and Sasikala. (1385). Bull. Drugs. and Karandlkar. (1984~). P. J. 140-141. Med.G. S. and Mathur.G. (1985). and Chungath. Vankata.B. Planta Med. 58. R. S.Banudha. 25. Khan. Drugs. 22. (1987b). Shoeb. B. J.. (1986). S.. Saxena. N. lnd.C. 47-61. (1988). Ancient Sci.205-224. Dhawan. Pathak. 21.. and Prasad. R. Res. Gupta. 332-333. R. Sulochana.K. Ind.. Panneevselvam. S. R. pp. S. Comp.P. Sharrna. M.21-23. Physiol. C. C. K. J . Med.K. Sci. and Podder. B. 5. (1985).. G. (1986). D. Ramchandran. Ind. D. Nair. J. S.B.. 11. 471-475. Res. Ethanopharmacol..G.P. (1985). Drugs.. Gupta. J. M. and Karneswaran.. Patnatk. Sci. Current Sci. and Chari.. Pharmacol. M. and Sulochana.M. S. and Santhakumari. A..N.S. Ethnophaimacol. (1985). 319-330. Health Sci. S. Sethuraman. (1986). Arogye J. 168-171. R ~ s . F dkash. S.S. A. K.K.K. M.S. Chem. Calcutta. 91-97. Res. G. 57.N.G. 6. Reddy...B. and Bhatia.V.K. S. E. P. 556-568.66-77.. and Singh. (1986). New Delhi Saxena. Inst.R . Reddi.(1986b).A. Pharm.K. Ind. A.Viswanathan. Shukla. (1987).(1983). T. Tyeb. 7. (1984). S. (1984). Daqatpkar. S. Reddy. and Dhawan. Pharm. and Susan. K. 21.Pharmacology of Medicinal Plants Patnaik. and Nair. R. G. P.P.. Nair. 31-32.P.B. 7. D. K.K. Phermacol. N. Sethuraman. Life. 158-159. R. J.. V. and Sasikala. Life. (1986a). Rawshankar.. 7292. Patnaik. lnd. Ay. J. Ind. Ram Murthy... R.S. Rahkman.B.. J. Ind. M. a6-42.K.K. Das. Sci. S.O.. Ambaye. . M. 6. N. Saluja. and Patnaik.Banaudha. M. 5. Ind. Singh. N.N. and Dhawan. 134-135. Probe. 114-116.. Ind.. R. (1986). ICMR.T.K. Seth~. Mathur. 4. B. and Wali.D. ti.. Drugs. K.Patnaik.K... C. Sarnbantham.. A. Ancient Sci. Ind. Saxena. (1984).N.K.. Shukla. (1984b). N.47.

Singh J.P.P.C. Kohli.. Physiol. C. 51.. K.C. Rao. Planta Med. Gupta.V..S. B. Gupta. M. and Prakash. N. Ind..K. Ind.K..K.K. (1986). SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .G. Ra0. S. Singh. 40. M. (1986). V. G.210-212.P. M. V. Ind.. Sinha. K. and Arya..D. I. 413-417.D. (1985). Soudamini..N.P. M.. J. Alam.D.T. B. S..N. Chem.. R. Arora. Pharmacol. S...7-12.K. G. 155-164. K.P.387-394'.Sharma. (1986).P.. Mathur... 9-22. S. (1984). and Kamboj. (1986). J.P. Singh..90-100. Dhawan Sharma. J Ethnophannacol. 5. and Kuttan. Srimal. (1984a).M.. Singh.S. Amla Res. 17. Vagbhata. Pharmacol. Atal. 7. 239-242. Ind.Tank. 58. 6. ICrude Drug Res. Kaur. Srimal.3-4. A. Shukla. Wadhwa. J.L. 162. N. Int.. 31. R. and Kapoor.S. C. Singh. 714-717. M. Khanna. and D h s a n .K. Singh.Singh..M.M.. Planta Med. Tripathi... and Bajpai. R. Sriiastava.. ' Singh.K.P. Amla Res. and Angusti. (1988). 1131-1133.225-233. 56-59 .. J. 10. A. Srimal. (1983). R. (1985).218-219. R. R.K. A.. Orient J.and Srimal. and Atal. Singh. Thakur.. Joseph.P. (1985). (1986). and Hikins. Anand..C.N. G:P. and Joshi.. Saiti.. and Mandal. M. R. 17. R. . Res..K.. and Johri. M a . J. R.K..'P.B.. Y. 17. Ind. (1987b). Ind.. Sharma.N.K.(1985). Bull. Sharma. Agents Action. 50.219-223..M.. 57.. F. (1984). M..N.M. 178-179. and Garg.. and Dhawan. Srimal. Efhno-Bo! Res.7743.C. Ind. and Maheshwari. 52. 18. Patnaik 8 0. R. 53. (1987a). (1985). B. 81. 23. R. Shukla. Satti. Srivastava. Handa. Fitoterapia. Miani. 154-157.V. and Prasad. K. Sharma..O. Ed. B. G. B. (1985). Pharrnacol. Cunent Sci. . (1985). Sci. Budhiraja... D.. A. G. Current Sci.S. S.G. A. S. Diit. R. Nagarjun. 131-142. 36. H.C. and Dhawan. R. B.S. N. Current Sci.C.6769. J. Ind.Y.441-442. 16.. In: Hamdard National Foundation M~nograph. Jain. . Med. Thrombosis Res. Bull. Pun. Thakur. R.. G..R. D. C.K. m d Kamboj. (1984b).. Phannecol. Singh. R. R. Kiso. and Prakash.P. and Sharma. 86. Shukla. D. K.B. S. Mathur.L. S. J. (5987). Atv. 32-33' Thakur.K.R. and Sharma.Gupta.40-43. M. Pharmecd. 8. V.M. and Tandon. Srivastava. 87. ('988). (1985).D. B..L. 268-270. Planta Med..407-412. (1987). 8. . (1985a). Tarfa. L. N. C. and Dhawan. .. Wadhwa. L... Singh. S. Med.P.. (1988).K. J.143-147. J. Reddi.R. Singhal. V.215-223. Susan. Nath. J. R. Gupta.. G. Phanacol. (1987).N. D.C. A. Med.V. 16.N.P. Husain. Pal.. N. (1984). K.N. 24. A. K. S.G. (1987). K. R. and Mishra. J.K.J. Med.K. Bull. 22. Drugs. AnneimForsch. 5.N.O. P..612663. A.. Nltyanand. N. (1985b). Ethnophannacol.. C. H. (1987). J.K. 139-142. 49. P. Singh.Q..T. Pharmecol. J.. Soudamini. 142-146. K. J. Ind. Singh. Ind.V.. M. Gupta... pp. S. 88.... Arora... Singh. Srivastava. 41-44. Atal. 19. Gupta. and Dixit. Khanna.P. W t a . and Purushottaman.. Drugs.. (1984c). L. Junnarkar... Longia.480-481.N.S. Ind.130-133. Shukla. Fitoterapia..L.C. Ind. and Singh. 28. M. 79. 2. J.. Ethnopharmacol. Res. Biosci. T.235238. Phann. (1986). R. (1986). S. Syamasundar. and Atal. Res. S. Sudhir. R.. R.. 69-73 Sood. 6. Ind.B. R. Srhstava.K. C. Singh.. S. Sriiastava. ~y(1986).N. 14.L.P. and Bhargava.. (1985).

L. Modi. H. 20. S. S.Y:~984a). Ramaswarny. S.. and Karneswaran. Garg. 30.. Upadhyay. B. (1983). Jaiswal. and Bordia.N. Varma. (1987).. Physiol. S. Viswanathan.B. S. J. S. C K (1986).Y. Gupta.G. Tewari. India.. (1983). 176-178..R.Rao. (1986) Ind. V. Sarnbandarn.M. Ind. J.. P. M.A.70-87. 182-183. and Pant. . and Na&. 87.Pharmacology of Medicinal Plants Tripathi. S N. G.R. 525-529.T. Ind. (1984b). 26. Vet. 27.B. 25.. Singh.K. 356-360'.Singh. S.J. Singh. Vihan.. (! 985).K..S. Upadhayay. J.. 347-349. R. 469-471 Verrna. d3 Vohora. C. Naik.(1983). Planla M e d .B. . Y. Drugs. Plan!a Med.H.N.. 21. Singh. V. A.Kaur.. Zutshi. P. Singh.. S. Pharmacol. Ethnopharrnaco!.. A. and Rao.. 81.A. and Kamboj.B. Ahmad. D. S. Khan. Naqvi.. M. J. B.K.H. I.L. A. 331-336..A. M.K.. Pharrnacol. 21. 226-228'. 1nt. 11.. V. Sarin. J. J.C. G. Ind. L..S..S.B. S. Shah..N. S. M. S. Vohora. Assoc. and Tripathi. Trivedi. and Khan..T.. (1988). C r ~ ~ Drug Res. S.Y. 78-83.S. 106-108. Exp. (1988). J. Vohora. L.. (1986). (1986). Added In the proof SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 355 . 28. 352. M. Ind J. P. Diab. J.P. T. R. V..S. PharmaCO~. Pharmacol. Ind. 47. Ros.D. (1986) Rhumatism. Tripathi. 64. Ainapure.S. P.87. Varma.C. and Atal.M. 986). 231-233.S. Physiol. and Ahmed. Drugs. and Amladi. Dey. and Panwar..N. and Tripathi. Biol. S. 18.. C.P. Ind. Kumar. Ind. 23.S.. Med. and Khan.. N.S..B. 17-19 (1 Varde. Ind. S.267-268.. U.. Wadhwa.

Unit of CCRIMH. Yoga SL Honroeo.RAJASEKHARANe and S. Trivedi (1971. Vagabhatta (500 BC-900 AD) and Madhava (700 A C ) bad given a detailed clinical description of twenty varieties of Prameha as well as Pramehapideka (inflammatory conditions in diabetes). Sharma (i959) has m'cntioned in his text-book f'Dravyagmavigyana" about the Karma (action) of Plerocarpus marsupium especially Abhyantara Pachana SamsthcrSthmbhaniya. Ind.R. Beejak.. and Mehahar. 1936). a common tree growing in central and southern pass of India and Sree Lanka (Cevlone). 1970). One OF. E.llege. Res.' A ~ a n a are the Sanskrit synonyms of the etc. the ancient Ayurvedic masters like Charaka (3000 BC-500 BC). F?thasaiaL. Jarnn~ti( J & K ) ) [ Received for publication on' M e !7.12 Capsule Vijaysar is p r e p ~ t e dfrom Pferocarpus marsupium (Beejak).caused 3y viruses is established by a group of G e r an resear~ chers who creat6d a type of vir-as which destroys islets of langerhans in the pancrezs with a high degree of selectivity from x mutant of ihe enctphalomyocarditis virus. r. tonic. Bendookapuspa.Jolrt. TULI*:: ( C.. I975 ] lntroductioa From the beginning of history. According to-palaeograhy. 3. The genesis of diabetes . Mutra Vaha Samsthan-Mutra szmgrs: haniya. ~ c i ~ a l Sarjak. Su~hruta'(2200 RC-600 BC).. (Chopra et al. According to the intensity of the disease and pature of the p a t i ~ n tthey adopted "Panchakarma therapy" and advised strict "HitAhar. Med. Many centuries back the Chinese. Zhavamisra (16th century A D )has described it as a useful medicine for Prameha. Japanese acd Arabic writings also indicated the the disorders of urinary exeretion i n ~ l u d i n g sweetness of urine.Government Ayrirvedic Cc. a part of Veda gave a good clinical descripcion about Prameha (anomalies of urinary disorders) including hiadhumeha (diabetes mellitus). IN T H E TREATMENT OF MADHUMEHA (DIABETESMELLITUS) A CLINICAL TRIAL S. clesnsing. for external application in i d a m m a tion and headache etc. 1970. Wood of tbe Prerocarpus marsupium is used as astringent.. Several e?idemiolo_eical studies have pointed out the importance of environmeai i~ determining the prevalence of diabetes (Jamtt.Vihar" (diet and physical exercise). Artacus of Cappodocia (AD 30-90) was the first to introduce the name "diabetes".) and * Rcscarch Assistant ** Officer-ineharge and Principal 356 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . 11 :(2?11976 VI J A Y S A K . the famous Roman physician. Pethsar. Pterocarpus-marsupium Roxb. healing procedure or surgery. PTERO CARPUS MARSUPIUM. Recently there has been much interest in "nonketotic diabetic coma" and many attempts have been made to explain it (Watkins et al. They have also zuggested the treatment of Pramehapideka by antiseptic. Ayurveda.

and Govt. clinical featuies. Capsule Vijaysar was administered to the patients in different ddses based upon their stamina ( ~ a l a ) .2 cases. Patna. Out of 35 patients. From pharmacological investigation of one of these compounds. Banglore. 1 male and 1 female. urinary fndings and blood sugar tests were taken. Ayurveda College. Heartwood of Pterocarpus marsupiurn is taken. Materials and Methods The raw materials (heartwood of Pterocarpus marsupiurn) was obtained from the following S. is under progress. The Ghana-satva (extract) obtained is reduced to the Rasakriya Pak. 'cruched well.Rajaseklrnran arid Tuli Shah e t a ! . (1972) ha-e carried out some chemical investigations of the heartwood of Pterocarpus marsrrpiirrn Roxb. M. Ayurveda College and Hospital. Ayurveda College Pharmacy. Results Tables 2. . 2 cases females). It is boded over a \low fire. e. 60 and above. (1972) have isolated some flavalroid compounds. we may lind that the clinical trial of capsule Vijaysar with Himkashaya has considerable effect in reducing the three cardinal sy mptoms of Madhlimeha (diabetes mellitus) i. Capsule Vijaysar was p r e ~ a r e d from the heartwood of Pterocarpus mar~upiurn. named Bianol. The study of the hypoglycemic effect of this substance according to them. Gwalior. Out of the total number of the patients 35 cases were selected for detailed study. This powder is weighed (250 ~milligrams) and filled into capsules. Prabhut Mutrata (polyurea). *ge Group 20.age (Vaya) and intensity of the disease (Rogadhikya).dipped into pure aqueous solution in the-ratio of 1 : 16 (Kilogram) by weight. 3 and 4 present the details of the administration s f capsule Vijaysar with Iaimkashaya (of heartwood in 35 selected patients. For the clinickl trial the 'patients'' hLtory. Shah et a1. no significant effect on blood pressure and respiration of dog.39 40-59 Number of Patients 5 18 12 35 Male Female 5 9 7 21 9 5 60 and above TOTAI-: 14 ' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 357 . Govt. Atikshudha (polyphagia).' Units-Govt. wash:d i n pure aqueous solution. P. filtered through a clean cloth and boiled. 2 cases. male 40-49. chipped. 6 were hereditary cases (age group 20-39. Shah et al. dried under penumbra and powdered. Govt. they found that it has no anthelmintic activity on earthworms. . Central Pharmacy. Table 1 presents the details of the patients. A summary of a case in which the administration of capsule Vijaysar showed marked effect in reducing the three cardinal symptoms of diabetes mellitus is briefly presented below - Tfie details of the patients according t o age a'nd sex. Atipipasa (polydipsea).From a perusal of these Tables. Rajapipala. Jayanagar. reduced to one-fourth in volume.(1972)have isolated some c h ~ m i c a investil gations of the heartwood of Pferocarplis marsupirim Roxb.

of cases Good Fair Poor 1.S. She was advised very strict Ahar-Vihar (diet and pbysical exercise). Above 3 Nil . Prabhutmutra (Polyurea) Atipipasa (Polydipsea) Atikshuda (Polyphagia) TOTAL : 30 25 20 17 14 51 6 3 4 5 25 80 6 15 5 14 - TABLE 3. There is no family history of diabetes mellitus. of Response Group Sugar % cases Good Fair Poor 3./100ml. aged 45 years. She was treated with Capsule Vijaysar (250 mg./100 mi. 201mg. temperature was normal./lOOml. 1 and 2) shows the effect of the medicine. showed no abnormality. but in blood sugar it docs not show much successful effect. 7 3. Last few months she did not take any medicine. Table 3 - SELECT RESEARCH PAPERS O N EVIDENCE BASED AYURVEDIC DRUGS 358 . polydipsea and polyphagia of four years' duration. of Response cases Good Fair Poor ' - 1. Thus the clinical effect of the drug shows that it helps'in reducing the sugar percentage of urine gradually. 0 ~ ~ . Hg : cardiovascular and respiratory systems . with Himkashaya of the heartwood of Vijaysar. The effect of the Gzpsule Vijaysar on urine sugar Urine No. The graph (Figs. / ~ 0 16 ~ ~ . fasting blood sugar was 110 mg. According to the doctor's advice initially she had taken 20 days' insulin therapy. Diabenese.5 kilogram. in reducing Grihit Jal Rashi (water-in-take). According to the observation on 16-6-73 her urine sugar was 0. 2. to 53. ~ 11 2.1100ml.75% t o ~ ..- TABLE 4 The effect of the Capsule Vijaysar on blood sugar (fustina) Blood Sugar No. But only one'yeor back she was found a diabetic. After the insulin thCrapy the doctor advised her to take tab.Pterocarpus nlorsupiunt in the treatment of Afadliunreha TABLE 2 Effect of the Capsule vijavsar in reducing the three cardinal symptoms Response Group Complaints No. a house-wife came under observation owing to Daurbalya (general debility). Mutra Rashi (urine output) and Mutravisarjana-krama (fuequency of micturation) of the above patient... pain in legs. After one month's regular administration of the Capsule Vijaysar the patient was found tb have recovered from all the diabetic symptoms. fasting blood sugar was I50 mg. / 100 ml. pulse 761 minute regular. to 2 ( . 3. She is married and has three children. Urine sugar was reduced fram 0. Blood pressure was 125 85 mm. 301mg. 15 normal and weight was increased from 52 kg.D.1100mI.75%. & above Nil TOTAL : 23 A female.. 1 daily. Her urine sugar was 1. 121mg.25%. on 16-6-73 with the complaints of sleeplessness (Nidranash). Weight 52 kg. weight) 2 T. to 300mg. all peripheral pulsations were normal. polyurea.

Urine sugar was 1% and fasting blood 'sugar was 180 mg.1100 ml.tEe capsule Vijaysar on urine add Table 4 On blood Sugar \ (fasting). all peripheral pulsations were ' normal. dose three capsule T. he is married and has three children. pulse 74lminute regular. a police constable came under observation ou 2-5-74 with complaints of polyuren. k . blood pressure was 125185 mm. S. D. Cardiovascular and respiratory systems showed no abnormality.Rajasekharan and Tuli shows the effect.B. with Himkashaya with s t ~ i c Ahart Vihar (diet and physical exertion).of . Table 5 shows the effect of the medicine in the patient.1. TABLE 5 The efecr o the Capsule Vijaysar In reducing f the urine sugar and blood sugar ( F B S ) percentage ( Weekly records) - Alter treatment - D '11 Z \r 1st 2nd 3rd 4th 5th Before Treatment week week week week week a 0 . Hg:.t - : o W - 3- - Another case in which the administration of the Vijaysar Capsule helped 'in reducins urine sugar and blood sugar [fasting) percentages is briefly described below :-A male.75% 0. he had taken tab.. polydipsea. weight 69 kg. FIGUSE. Urine Sugar 1% 1% 0. 100m1. diabtnese. WATERdN-TAKE $ E I (AFTER TREATMENT) FIG. From a perusal of the Table it may be observed that the treatment is effective in reducing the sugar percentage in urine and blood. Initially (four years back).. He was given the treatment for one month.s . Other family members are all very healthy. aged 38 years. The patient was having normal health.-% OATE OF OBSERvAT'ON INWEEKS (AFTER TREATMENTr - FF. 359 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . 100ml.25% -Nil Nil 4 . His father was a diabetic patient.S. For the last few months he did not take any medicine. polyphagia and burning sensation (occasionally) of four years' duration. 171mg/ 160rng/'l~0mg/115mgr 180mg/ 100ml. 1OOml. 100mI.

unit. (iii) Mutraa samgrahaniya.N.Pterocarpus marsupiuna in 1he'lrhbli~elf~'oj~~adit~~t~~c1ra General observations of the administration of Capsule Vijaysar in diflerent patients are given below : Primary stages of diabetes mellitus (Nava cases) and in healthy patients Capsule Vijaysar showed encollraging effects in reducing all the diabetic symptoms gradually.(polydipsea). It is further observed that Madhumeha patients who were used to the insulin therapy or modkrn oral anti-diabetic drugs for a long time did not show significant response. progress was observed. . Director. in Capsule Vijaysar was found to be eflect~ve reducing Atipipasa ( polydipsea ) in some chronic diabetic patients. drug is related to the various factors like ~ a ~ a n i ~~a n g l o r eGo'vt. However. (Govt. (iii) Old and debilitated cases.~ y u i v e d '. Stham. Kurup. Pachan Samsthan. Gwalior. (iv) Hereditary cases (Except one). P. and ~ u t r a s a m g r a h a . M. the diet and physical exercise (Hit-Ahar-Vihar) had not shown any response to Vijaysar Capsule.and. to the bit. The age of onset of t h e diabetic manifestation in majority of the cases is in between the age group of 40 to 60 years. Some patitnts however objected . Govt. Ayurtherapy recorded some temporary relief veda College. (ii) Diabetic patients with other complications (Upadravavyadhi's). Satisfactory results were not obtained in the following types of cases : (i) Chronic diabetic patients. Kala. . Sankhyadhar. Discussion The senior authors are also thankful to From the clinical trial carried out in this EX-officer-inkhare&. Further observations are still in progress. - . the therapeutic effect of Capsule Vijaysar was found to be. central Pharmacy. The regular administration of the drug helps in gradually reducing the urine sugar percentage. ACKNOWLEDGEMENT The authors are very much grateful to Dr. It was also observed from the trials that those patients who did non rigidly follow. for his many a bhaniya (astringent) especially Abhayantara helpful suggestions and encouragements. This drug also proved incft'ective on those who inherited diabetic character and also on chronic and debriitatcd patients. S. Regular administration of the Himkashaya with. Regular administration of' Himkashaya on some chronic. Government effective as Meha-har (anti-diabetic). College. the effectiveness of t h e JJnits.d that Capsule Vijaysar produced minimal side elfects. Ayurveda College ar . Rajpipala. New Delhi.61) Meha-har (anti-diabetic). To a certain extent i t also helps in reducing the blood sugar percentage.iC(:RIMH!. niya. helped in reducing ~ t i p i p a s a .Samsthan. age-old cases. P.V.taste of the Himkashaya and as such sonie work is to be undertaken to make the same acceptable to the patients.ter . (ii I Sthambbaniya (astringent) especially in ~ b h ~ a % t a r Pachan . SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . It was 0bserve. . Central Council for Research in Indian Medicine and Homoeopathy. it was found that Capsule Vijaysar is Clinical Research Enquiry. Patna) for supplying us the except in one case) and no other remarkable heartwood of Pterocarpus marsupturn. Ayurveda cases studied through Capsule Vijaysar College Pharmacy. Vaya Satmya and Asatmya. C. Dr. Jammu. for providing the facilities. primary' failure Casbiibted in the patients who vrere addicted t a insulin therapy or modern oral anti-diabetic drugs from a longer period.dur'tliinks are also due to the four S. Govt. ~oncfus~dn From the above clinical trial. Hereditary and Hospital.

~ l i a $ t e r13. Ed. (1966) ( 1949) 5. by Athridev.. . Vol. pp. Dravyaguna Vigyan. Q I 4. 13. Chowk.Rajasekharatl and Tuli 1. "Ketonaemia in uncontrolled diabetes mellitus". XV. (1970) (1966) 'Lessons of epidemiology of diabetes'.1. Chrrpter 17 (78-121). Ed.C. Dr. Clilhitsastllanam. P. Sutrnsthanam.N. 13. Comentator. (1960) 12. H. Quilorr. Bhaskar Govind Genaker. (1966) Nid3dnstha'nam. Sushruta Samhitn. 519-20. 11. Chapter 10. SELECT RESEARCH PAPERS ON EVIDE-WE BASED AYURVEDIC DRUGS 361 . y Ed..virus induced din betes(l972) . and Mal!ins. Bislingratnn Shri Brahma Sanhar Shzs:ri. British M e d ~ c a Journal. J.. Nayyar.D~abetes". Moti La1 Banarasi Dass. Fitzgerald. Ed. B. Japan. Va~nnasl. New Delhj. Bianol. by Shri Gulabkunverba. No. R. Vidyan S Janardhanan Pillai (Sararthndeepika Vyakyan in Malayalam).. p. Best. Chapters 11. Charnkn 7. Watkins. Jarrett. "Nagarjun". Ed. (1972) 11. D. D.C. I. P. V. 12. Chikitsasthanam. Hofber Medit s. by R o b ~ r H. Sharma. Chikitsasthauam. Vo1. (1970. Further studies on Heartwood of Pterocarpus marsupiurn.Volun~e 111 (English). "Nagarjun". 1 1 pp.. A. Ayurvedic Society Jamn. chapter 6. W i l l i a ~ i ~M. Banaras.' Epoclts in the lilsto~ of d1'1betes i n '. Nnik.271. Vol. l 1. C. Chapter 4. C.. A . Chapter 6.. Shah. 213-235. 43. hladhvanidann 9.. Glossary of Indian Medicinal Plants. S. Jamnagar.11 (English'. Ed. . 111. B. Vol. Shri La1 Chandji Vaidya. Ed. 8. h. Astanga Hridayn (1957) 2. 5 2 . Clraraha Sarnhita. 1. pp. S. 210 . Varanasi. k i l l . Nidnnasthanam. (1956) 10. by ~ h o w k h u m b a Vid!a Bhawnn. . R. Publications. July. Chopra. J. by ~hO\vklla&ba Sanskrit Series. Ayurvedic Society.V. Trivedi. by Chowkhamba Vidya Bliawan. a n d Thakur. M.B. Cnl b i i i i i o i i . and Chopra..M.L..J. E d by S h r i Gulabkunverba. Publishers: Dokutarii Company Ltd.2 3 . "as. Nidanasthanam. R. ChnraL? Sam11ita..M.. by Sree Rarna Vilasam Press. Fritish Medical Journal. pp.K. Harpar and Row.

Pterocarpw n ~ a r s ~ i yiin~the~lrenf/lfentof Man'l~toirelra o ~ E=i.l ur ~ i .4 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS .

Madras Medical College : V. Gupta and Nandini K. no side-effects were reported. Hpr~haran. New Delhi Accepted June 29. Sundaram. B. it is concluded that Vdaycrrar is useful in the treatment of newly-diagnosed or untreated mild NIDDM ptients.K. A. A. Sam Philip. Collabarating Centres [According to alphabetical order of the c ~ t y givlng address o f the Department. Lato Gtntral Biostatistical Monitoring Unit.B.C.non-insulin-dependent dtabetes mellltus . R. Venhataraman. change w. Medical College Hospital : R. layabal. New Delhi : A. and the dose on whic control wna attained was 2 g of the extract in about 73 per cent of tbe patients. f i i ) Cuttuck : Department o f Endocrinology. Radhakrishna.S. Samal. Sitaram Bhartia Institute of Science w d research : M.and postprandial levels) had been attained in 67 (69%) of 97 patients studied. Chennai di Central Technical Co-ordinating Unit'. pp 24-29 Flexible dose open trial of Vijayasar in cases of newly-diagnosed non-insulin-dependent diabetes mellitus Indian Council of Medical Research (ICMR) Collaborating Centres'. Institute for Resqrch In Medical Statistics. ( r r r ) Kottayam : Department o f Medicine. Selvaraj.4 per cent at 12 wk from the initial meai of 9. Heme. Also. Central Biostatistical Monitoring Unit'. 2. Principal rnvestigator(s). Ahuja*. I l l r r n HbA.V. Sesh~ah. . Research staff of the Collaborating Cenlre]. one sus. Sunitha.c decreased significantly (P < 0. S.S. Mathai. A. both the fasting and postprandial blood glucose levels fell signifiuatly (P < 0. Kausalya and T. (I) Chennai : Department of D~abetology. Tamby. 7 Key wiirds Flexible . July 1998.iililian J Med Res 108.S. Four patients had to be withdrawn from treatment due to excwively high postprandial blood glucose levels. ICMR. V.C. Suresh. Manju. S. S.h is .Vijayasar (Prerocarpus marsupiz~m) which is I.dose open trial . 1998 A flexible dose open trial was undertaken in four centres in India to evaluate the efficacy o f an Ayurvedic drug V~ayasar(Pterocarpus marsup~um)in the treatment of newly-diagnoyd o r untreated non-insulin dependent diabetes mellitus (NIDDM). Co-lnvestigator(s). Experimental ~tudieson pgayasar by various workers1-lohave d e m o n s t r d the hypoglycaemirz The therapeutic pptions in the treatment of noninsuliwdependent diabetes mellitus (NIDDM) include dietary modification. P. by 32 and 45 mJdl at 12 wk from the initial means of 151 and 216 mgldl respectively. Among the 93 patienta wbo completed 12 wk o f treatment. K. Kumar 'since deceased SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS . Rajalakshmi. S. P. Kishore Kumar. 3 g id about 16 pe cent and 4 g i n 10 per cent of the patients.Numerous claims have been made of a variety of traditional remedies for the cure of diabetes.s obsewd in the mean levels of lipids. Medical College : K.K. 3. Daniel Rajasekar Cefitrsl Te~hnical Co-ordinating Unit for Traditional Med~c~nc Research.001) to 9. 12 wk. (rv) New Delhi . Jayakumar. ICMR Hqrs.M. control o f bleod glucose (both fasting By . Paul A.001).8 per cent No significant. oral hypoglycaemics and imulin. Chennai : S. Other laboratory parameters remained stableduring the designated treatment period of 12 wk. I Periyandavar. R.P€erocarpus mumuprum used by Ayurvedic physicians to treat diabetes mellitus and is expected to have a role specifically in the treatment of NIDDM.

It was also proposed toabtain informationmgaiding side-effects/toxicity of the drug.and the intake was tsnninated. which was comparabk to that of metformin2'.g of the exttact for the first 4 wk. ac The trial was tonductal at the Sitaram Bhartia Institateo Science and Reseuch. h4edical Colltge. Now Dolhi. If not controlled. the daily dosage w e increased to 4 g of the extract for the next 4 wk. and Medical College Hospital. the dosage was SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 364 . Thus. ptorosupin and pterostilbene which have heen shown to significantly reduce the blood glucose levels in hyperglycaemia induced by streptozotecin. Moreover.e. Newly-diagnosed or untreated NIDDM patients aged between 35 and 60 yr who gave written informed consent we* recruited for the trial. 10. other rcfiva principles are being discovered like the t h m phenolic constituents marsupsin. Ahmad et alia have shown that (-) epicatechin increases the CAMP content of the islets which is associated with increased insulin release. Other insulin-like effects on glucose metabolism and on osmotic fragility of red cells though probably through a distinct receptor have bean demonstrated by other investigatorsi9-. Tke trial tet e t rimn period was 12 wk.TpwlOF YIJAYASR W NlDDM CASES action in animals. one-fifth beingtaken at breakfast and the rest equally at lunch and dinner. Cuttack. body mass index (BMI) than 19. conversion of proinsulin to insulin and cathepsin & activity in mature and immature rat islets in vitro. fi~oyarar iumr the barki4.though it could not be reproduced by Kolb et all7. the patient was declared as a 'failure of treatments with VQqyasm. Presence of any less systemic diseases. At the end oc this' period. if the blood glucose was controlled by 2 or 3gdwe. and water stored in a tumbler made from the Yijayapur heartwood" have shown ehco~aging antidiabetic action. During treatment.c) in newlydiagnosed or mtreatd NIDDM p4tienis in a Phase I1 apen trial.marsupium was found to have proactive and restorative effects in alloxan induced dikbetic ratsi6. If the blood glucos~ was not controlled even with this dose. The trial wis initiated in Janwry a 1993. Mild diabetics with fasting blood glucose from 120 to 180 mg/dl and postprandial blood glucose from 18Q to 250 rng/dl (both venous whole blood) at the end of diet therapy were admitted t~ treatment with Yijayasur.. Mtdical College. S. Patients wem instructed to attend the clinic for assessment . Madras f and for collecting drugs weekly until the blood glucose was control!ed and fortnightly thereafter. However.C. if the blood glucose was not controlled (i. half-an-hour before a meal.15 per cent of protein and. This prompted the Indian Council of Medical Research (TCMR) to undertake a clinical trial at four c e n m acroSs the country. that dose wascontinued for the rest of the treatment period of 12 wk. if any. subsequent assessments were done fortnightly. Vijoyos~ to be self-administered daily in two was divided doses. pregnancy or lactation were considered as contraindications for inclusion in the trial. The hypoglycaemic effects have been attributed to various active principles in Yjayarm. An active principle (-) epicatechin isolated from the bark of P. If the blood glucose was not centrolled by the end of this period also. Weekly assessments were scheduled for the first four weeks and if blood glucose was brouet under coatrol. dosage and other relevant aspwts were decided bnExpert Group.25-30 per cent of unsaturated fat in the total calorie intake. drpg. Patients were started with a daily dosage of 2. Complete physical examination and relevant laboratory investigations were done on all eligible patients.B. there isxnsiderabte experimental evideace to show that Vijayasar has antidiabetic action but there is a paucity bf well conducted clinical trials b conclusively document the antidiabetic effect of Vijayasar in NIDDM patients. Chennai. fasting blood glucose level was 2 120 mgtdl or postprandial blood 11 glucose level was 2 110 mgtdl). Kottayam. The main objective of the trial was to assess the antidiabeticeffect of Vijuyrum in t w s of control of blood glucose levels and glycosylatedhaemoglobin (HbA. the daily dosage was increased to 3 g of the extract for the next 4 wk. trial design.in M r h 1995. The patients weie prescribed diet therapy for a month comprising 60-65 per cent of carbohydrate. and withdrawn from the study. Informatjon on general clinical history and dietary pattern was obtained. Clinical studies undertaken on V j y a heart~oodll-~~. The uniform protocol and proformaa.

the patient was withdrawn from the study and termed as 'failure Table I. helshe was withdrawn from detail. 124 had fasting . However. The drug was supplied to the centres through the ICMR Central Biostatistical Monitoring Unit (CBM Unit) for Traditional Medicine Research. Quality Control and Formulation of Selected Traditional Remedies/Natural Products. and undertook data processing and statistical analysis. Madhya Pradesh during November 1992. glycosylated haemoglobin (HbA. The CBM Unit distributed drugs to the participating centres. the recommended dietary schedule was were excludedfrom analysis (Table I). N L Y 1998 increased and the assessments continued to be done levels were assessed by using Student's and H ~ A . Mervai range. haemogram. To avoid adverse impact of any dietary continued treatment throughout). 1 4 (19%) dropped out of the trial at various time points during During the trial period. If at any At 12 wk. but blood glucose not controlled 159 71 Not eligible for study. 223 patients were admitted to diet therapy method of Winckers and Jacobs using 0-toluidinP at the end of which blood glucose was still not or glucose oxidation GOD3 and ~ b ~ . % Admittcd to diet thaapy 223 Dropout during did therapy 15 7 Blood glucose levels controlled 49 22 by did therapy Diet therapy completed. Vellora. If a pcitient developed any major of the remaining 97 patients is described below in ailment or side-effects. analysis : Changes in the blood glucose Status No.b colorimetricz4 or ion exchange resin2' methods.an extract (dried aqueous decoctton) of the bark of P. The approximate yield from the raw material was 8-10 per cent. - The Vijayasar raw material was collected from Matinala. and three others aberrations. bload glucose from 120-180 mgtdl and postprandial External quality control of these estimations were blood glucose from 180-250 mg/dl and were initiated done with Christian Medical College. Lucknow. scrutinized the data collected. occasions within a period of nne week. Blood glucose was estimated by the In all. Mekal hills. marsupium.INDiAN J MED RES. C 't' test and the 95 per cent confidence intervals were weekly. on treatment with Vijayasar. control of fasting blood glucose was time during treatment. weeks. The statistical significance of difference at every visit. The progress strongly advocated. nor did their anything unusual without consulting the treating initial mean levels differ from those in patients who physician. presently located at Jammu. Statistical. Chennai.from analysisi Withdrawn from study* 2 Number in analysis 97 fasting level > 180 mddl andlor postpmndial level > 250 mgldl +On accountof non-adherencetothe protocol (dosagenot increased to 3 gat 4 wk although his bbbd glucose was not controlled by 2 s dose). While blood glucose estimations were done computed. @ one patient developed severe itching and the other developed periodontal abscess requiring nugay' SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 365 . an4a thorough investigation was undertaken to study assess'if the symptoms were drug-related. Estimation of electrolytes. Patients in the study of treatmerlt' with Vijayusar. the postprandiat blood glucose observed in 72 per cent and postprandial blood level exseeded 300 mgldl on two consecutive glucose in 75 per cent of the patients (Table 11). c the ~ controlled in 159 (Table I). The voucher specimen had k e n deposited in the herbarium of the Central Drug Research Institute (CDRI). liver function tests and in proportions was determined by undertaking chirenal function tests weredone only once in four square test with continuity $&ection.c) and lipids were carried out at the end of diet therapy and at the end of 12 wk of treatment. Of these. Chandigarh. Vijaymar. patients were instructed to the 12 wk treatment period (there were no specific avoid the use of other drugs for any ailment or for complaints made by these patients. was manufactured and packaged by the ICMR Centre for Advanced Research on Standardization. due to high blood glucose levels* 35 g 124 Admitted to d ~ trial k V u t during chmothernpy 24 1 Excluded.

Table 1 1 Mean blood glucose and HbA c levels during treatment in patients who completed 12 wk of treatment* 1. Parameter No. None of the patients reported any side-effects ascribable to Vijayakar.3 Not done lls23. it was found that 35. and < 8. Four of the 97 patients had to be withdrawn from treatment because their postprandial blood glucose exceeded 300 rngldl on two consecutive occasions within a week. only 7 per cent of the patients attained control by 12 wk. Also. Among the remaining 93 patients who completed the stipulated 12 wk of treatment.1 9. A similar picture was observed for the 54 patients.c levels. . there was no appreciable change in the mean body weight of the patients ocer the 12 wk period. respectively. An attempt was made to measure the quality of life on a three-point scale for three parameters viz. respectively.c (%) 0.c 7 no change for the remaining 5 patients. t6e dose required for control was 2 g in 49 patients (by 4 wk).c 70 73 67 72 '15 69 5 *defined as < 120 mgldl for fasting blood glucose < 180 mddl for postprandial blood glucose.9 32' 45' 27-36 40-5 1 0. Ye Blood glucose Fasting Postprandial (PP) Fasting and PP HbA. By the end of treatment. the mean fasting and postprandial levels steadily decreased significantly from the initial values of 151 and 216 mgldl to 119 and 171 mgtdl.c estimation could be done initially and at the end of 12 wk of treatment for only 67 patients.OF VMAYASAR l NIDDM CASES N Control of both fasting and postprandial levels was attained in 69 per ceht of the patients.001 as cornbared to the initial value SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS + 366 . The other two symptoms. Other biochemical parameters such as serum glutamic oxaloacetictransaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) were virtuall'y unaltered. and disappeared altogether in 14 and 7 patients. capacity to do work (fatigue).c. by 12 wk of treatment (Table 111).001). showed improvement in these three parameters.4' * excluding four patients who were withdrawn from treatment because their postprandial blood glucose levels exceeded 300 mg/dl on two consecutive occasions within a week P 0. Control of blood glucose and HbA. in whom the HbA.. a marked reduction was observed in polyuria. respectively.0 13W7.7 HbA. Also.TRIAL.tU1.c at I2 wk Parameter Total patients in analysis 97 97 97 67 Control attained* No. of patients Initial Blood glucose (mgldl) Fasting Postprandial Mean SD * At4wk At8wk At 12 wk Mean decrease by 12wk 95% C1 for mean decrease 93 93 67 151*17. The HbA.4i0. no relationship was faund between the dose of Vijayasar and the changes observed in the HbA. 3g in I I patients (by 8 wk) and 4g in the remaining 7 patients (by 12 wk). The correlation coefficient between the initial and post-treatment HbA.0 171i29.2-0.5 9.2 per cent.5 per cent for HbA.c level decreased from 9. the mean HbA. 26 and 16 per cent. viz.c values was 0.0 172i26. There was a decrease in the level for 54 patients. sense of well-being and optimization of weight (tending towards normal weight). respectively.6 18B35.c level had-decreased. all 10'patients with initial polyuria had complete relief.8 to 9.6 and 8. by 12 wk of treatment. There was no change in the mean cholesterol level at the end of 12 wk of treatment andthe decreases in triglycetides (5%) and high density lipoproteins (4%) were very small and non-significant statistically.60. polyphagia and polydipsia were initially present in 21 and 7 patients. Of the three cardinal symptoms of diabetes mellitus. increase for 8 patients and Table 11. In the*group as a whole.4 Not done 12Oi31. In the case of HbA.3 216U1..c values were 8. their mean initial and final HbA.4 per cent by 12 wk of treatment (P < 0.

Paramji RP.e. lndran J Physlol Pharmucol 1959. a controlled comparative. Mehrotrs. To extend the above conclusion to all NIDDM cases. which was well tolerated. on bled sugar. We further acknowledge the sustained interest and advice of Prof. ntarsupium). In contrast. Increased tolerance to glucose was also observed in this study.V. Dhawan. Faridabad. in a pilot trial conducted by the ICMR at the All India Institute of Medical Sciences. 4 02s. among 18 NIDDM patients treated for three months with Vijayasar in a fixed daily dosage of 2 g. CBMU. flexible dose multicentric trial has been initiated at four centres. However.INDIAN 1 MED RES. the 0. S. and to assess the relative efficacy of Vijyasar vis-a-vis an allopathic drug. Raghunathan. ICMR. However. However. in fact. manufacture and supply of trial drugs. however. Botany Division. Handa. only 7 per cent of the patients attained control by 12 wk. Meerut during the conduct of the trial. eight patients (44%) attained control of both fasting and postprandial blood glucose (unpublished results). Dr is also M. 3 : 76-7. with respect to HbAlc. Sepaha and Bose" found that the extract of the Vijayasur heart-wood appeared to be effective in reducing blood glucose in only one patient.JULY 1998 Discussion In a preliminary clinical trial on 14 diabetic patients. fndran J Pharmacy 1949. Guptc. A preliminary note on the action of Pterocarpus marsuprum Roxb.S.N. Lucknow. Indian J Med Sci 1963: 17 : 501-5. The virtual absence of hypoglycaemia in the study subjects reflects its relative safety. h j i t Roy Chaudhury. and the findings of this trial will be reported in due course. B. may not have clinical References I.N. in the premtion ofbibliography on v~~~~~~ acknowledged. there was no change in the quality of life in majority of patients. Aiman R. though statistically significant.D. as also by pandey and sharma14. Ojha KN.4 per cent reduction in the mean HbA. Weacknowledge useful suggestions given throughout the period of the study by Members ofthe Task Forcc on Diabetes Mellitus and Expcrtsof the ICMRScientific Advisory Group forTraditional Medicine Research. 11 : 188 Joglekar GV. New Delhi. sense of well-being and optimization of weight did .c level. Das. 3. in contrast to the findings in healthy rabbitsz6 significance. is currently restricted to mild diabetics. those with fasting blood glucose level between 120 and 180 mg/ dl and postprandial blood glucose level between 180 and 250 mgtdl. Only 10 per cent of the patients needed a higher dose of 4g per day. and in about 73 per cent ofthese patients the required daily dose was 2g of Vijayasar (P.Venkatachalam K. i. scrutinized the manuscriot and made useful &mments. CDRJ. substantial symptomatic relief was noticed in thi three cardinal symptoms of diabetes mellitus. We would like to specially acknowledge the tireless efforts of Prof. Prof. ahm mu in the standardization. Satyavati. Lucknow in identifying and procuring the plant material is acknowledged. It may therefore be concluded that Vogyasar is useful in the treatment of newly-diagnosed or untreated NIDDM patients. we thank the patients who had participated in the trial. New Delhi. randomized. Also. 2. This study has shown that control of blood glucose (both fasting and postprandial) could be achieved in 67 of 93 newly-diagnosed or untreated NIDDM patients. the quality of life measured On a threepoint scale with Parameters such as capacity to do work (fatigue). Effect of Cymnema sylvestre and Pterocarpus marsupiuni on glucose tolerance in albino rats. lCMR HQs. former Director-General. Dr K. Officer-in-Charge. Chaudhary NY. in terms of lowering the blood gluc6se level in NIDDM patients. thrice daily for seven days. Acknowledgment We gratefully acknowledge the pivotal role played by Dr G. Gupta SS. Pandey and Sharma14reported a reduction of 16 mg/ dl in the fasting blood glucose level from an initial mean of 191 mgldl among 12 diabetics treated with Vijayasardecoction prepared daily. H~~ocholesterolaemic was effect not found in patients with diabetes mellitus in this study. Neeraj Tandon and Dr Madhu Sharma ofMonograph Unit on Medicinal plants ofIndia.lot show much improvement. This small reduction may probably be due to the shorter duration of the trial treatment. former Head. The services rendered by Dr B. SELECT RESEARCH PAPERS O N EVIDENCE BASED AYURVEDIC DRUGS 367 . Assistance rendered by Ms.K.. In a clinical trial of 35 patients. even in a large dosage of 4 g per day. Vijayasar has had a significant therapeutic effect. The response was classified by the authors as fair or good in 56 per cent of the patients in terms of urine sugar and in 34 per cent in terms of fasting blood glucose. Prof P. Effect of indigenous plant-extracts on glucose-absorption in mice. t in all^. Rajasekharan and Tulil*reported that regular administration of Vijayasar heart-wood extract for 8 wk gradually reduced the urine sugar and the fasting blood glucose. In the present study. as the coordinator of thenew disease-orientedresearch on herbal drugs. The conclusion.

CIinicalobsuvationsontheantidiabcuc pmpcnia of Ptemarpusmarruptum and Eugeniajombola~. Practrcd clmtcal biochembtry. Sliti AQ. Hypglyeacmicactivity ofherocorpwmarsupiw wood. blood ureaand serum lipids as influenced by Gurmar preparation.. Pter0capx m ~ u p i W in the treatment ofmadhumeha (diabetes rnellitus) -A clinical trid.shtra Med J 1981. Shanna PV. LMcn 1981.. an extract (dried aqueous decoction) of the heartwood of P.should read as ' %. 17. Greulich B. Effect of (-) epiubchin on CAMPwntcnt.paaogi AK. (Byah) -An experimental study. Insulin-mimctic effect of (-) epicatechin on osmotic fingility ofhuman erythrocytes. Chakravanhy BY OuptlS. Khan MM. D~ cOsu H~ ~ ~ d ~ lDE. f@ndhch das d i a k t a ntellihu. Ahmad F.Blood sugar. l RL. Studies on antihypcrglycwicactivity of some indigenous plants.J Res Indian Mrd Yoga Hmeop 1978. OodeKD. ~ h im PV. 18. Ahmad F. 27 : 388-94. Mahara. 16.~SN. Spur Tank Rod. Kicsel U. Clin Chem 1981. Gambhir SS. Panmatic bnaccll regeneration in rats by (-)epicatechin. 21.. Khan MM. 23.Evaluation ofglywsylPtcd hemoglobin in diabetic patients. IndianJMed R u I%% 55 : 166-8. Chennai 600031 1ndia" J Mcd Re4 108. of phytochemisby and hypoglycacmic actions ofPtcrcrapx maraupiw (Papilionaccae). editor. 7 : 11-2. Indian Drugs 1988. 261. Pterocarptu marsupium and Tamarfndu~i d c a in diabctca mallips. 8. J Indian Med AssoC 1956. Chaubcy M.lnd1~J~B1ol1991. A h d F. Acta Diabetol Lutina 1989: 26 :291-300. Chaubey M. 60 : 60910. Bum HF. lnstrtute for Rescarth in Medical S q l t c etpls ICMR.. JEthanopharmacd 1991. GodcKD. 35 : 71-5. Varlcy H. CheCpvt. 1971 : 938.marsupium. Insulin like activity of epicatechin. 26. Jadhav SN. Indian JPharmacol1980. Improved wlorimctric assay for glywsylated hemoglobin. I2 : 123-9. Zaid MA. J Res Indian Med Yoga Homeop 1976. an extract (dried aqueous decoctio'n) of the bark of P. ~ J. 12. CmPal Biostatlst~cdMonitoring Unit. 28 : 165-9. sCpshaGC. Suhail M.. Munich :IF Lchmanns Valag. 25 : 461-3. parkcr KM. Gowenlock AH. Van Der BO& I.. K h d i P. 6 : 2057. - 9 Jw lo.27 : 669-72. R a j w h a n n S. J Rex Indian Med 1971. 25. 20. Indian Bid 1995. LI. Chakravarthy B k Gupta S.-a Monitoring Unit.TRIAL OF VIJA Y S R IN NIDDM CASES AA 4. Diabetes 1981. Vnishwanar IP. insulin relase and wnvcrSion of pmiwul'in to insulin in immature andmhvcratislctsmv1ho. Some aspects . Trivedi CP. . W S u r g 1976. 13 : 137-9. ~ ~JD. 5. Khan MM. 22. ICMif New Leihi In the sixth para unde: ~1aterinl'g. L. s : 75960. the second-sentence T q . Khdid P. 19. t980. Reprmn! requestx : The dffiwin-chargc. ' Pande MC. Ch.. i : 1303-4.z&. Chennai & Central Technical Co-ordinating Unit. July 1998. Gupta SR. Indian J t'hysiol Pharmmd 1963. Bell M. Manickam M. A preliminary study of the hypoglycscmic action of hearWood ofPlercrarpusmarsupium Roxb. . Hypoglycaernic CReci of bark of Pterocurpw marst +urn Roxb. Observations on the dlect of some indigenous drugs on blood sugar level of nomul and diabetic rabbits. H~poglycaemic S Pterocarpw marmpium Roxh.. I / @ : 9-14. 30 : 613-7. Shanna PV. 15. 14. In :Pfeiffcr EF. Schmidt FH :Methoden dcr Harn-und Blutzu&crbcstimmung I1 Blutzuekcr. Rsstogi A Y Ki@ai JR. 13 : 126. London : William Heinemann Medical Books. Kolb H. Tijoyrum). 33 : 791-2. 24. 6. JNanvol Products I W . mmupium. Shah DS. AntihypergJymic activity of phenolics ' o m Ptercrarpur marsupium. Shiniie S Kavishwar WK. Khannade B. ~ ~ i ~ 13. ( ~ ~ : A ) h MedSurg 1975: 25 :21-4. 16 : 9-1 1. 5th ed.krabarti CH. Kdar P. Tuli SN.29:516 20.amxt 1982. Gambhir SS. (Boaka) on alloxan induced diabetes. pp 24-29 Flexible dose open trial of Yijayaar in cases of newly-diagoscd~non-insu~in-k~en&~ diabetes mellitus Indian Council of Medical Resenrch (ICh@ Collaborating Centres. Rastogi A h Kidwai JR. Kidwai JR. Pandcy MC. Khalid P. Lack of antidiabetic effectof (-) epicatechin. Pancreatic k t a a l l regeneration A novel antidiabetic mechanism of Pterocarplcr marsupium Roxb. Pandcy MC. JRes I d a n Med Yogo Horncop 1978. Shama PV. Apte IC. Hypocholcstaolaunic effect of bark of Pterocapa nuvsupium Roxb. Central Bit. Viioyruar.i~ethods (page No. 7. Rizvi SI. of Ojha J K ~ d HS.- SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 368 . Hypoglycecmic effect of bark of PterocarPus Roxb.

l<.16:240-244.~ rtccd /o~. the ac~e/.Joun~nl o/lDninrind . p o ~ ~ d e r~lrrtli.. Voidyo S b (RR R. K Surcsh Kumar.. s. Ayurveda is tlrc most popular indigenous lndian system of medicine. u~otphi~te. co~tductcd controlled trial cont/raring a liquid Ayuruedic n (hnkl) pre/. Rajagopal. T e e is a hr ~.s rrjAjurutrlir:atrciici~~m pnllinlirw cart. M.75 ml per 15 ml emulsion) are botli costly (Ils. and anilk. cated oils. the once-daily dose. the rrsul& itidicnlc that tkwr111al1 volu* o/lhe drug requ~rcd/orflecliue laxatiue aclion. Glicui Medical Col+.lltn sttrr1it.S. sniall-volumc liquid laxative would bc prefcrablc.X. ghec. 0 US. A clinical tri. dccrcascd activity. Canccr I'ain Kclicl Co~a~~~il~ce. l'lic -. a so~itlrern state o/lndia.S. 676 M II~ 503. 4 Orc& / YYX Managing Morphine-Induced Constipation: A Colltrolled Comparison of an Ayurvedic .' It is gcncrally tiiultifacto- 3.). I6 No. local discasc.Many patienu find them unpalat~ able. or otller mcdicincs. pills. and drugsnotably opioids. ~ ~ I . conrtijmlior~. RK.' In tlie I'ain and Palliative Care Clinic at tlie Calicut Medical Collegc.19995'. !+owever. tl~e tolerable taste. 21 d castor oil. As a part of an ongoing eITort to seleit a tilore ideal prcparation. Most of the patients arc bcry poor and arc not ablc to buy drugs regularly.. 1'. R 0. P Ualacliandnn and I? K Warner . Indin o I Glicul.~aratioa (hiisrakasncliam) w i t a convn~lional laxaliue table1 (Sofsm) in the ~~~c~nagmttct~t o olrioicl-ittdtrce cur~sli/rn[iun pafio~ts ad~attcedcnncn: Wough them f it1 with A was. I 1)ist.ll !*. Illdin.25 rnl. liquid laxadvcs like lactulose and crcrnaffin (milk of magnesia 11. parallill Adclres~ rq~rint requests to: 1)r. 8 U. 30% of patients have head and neck caliccr and associated dysphagia. 51 per 100 nll and Rs. Ncw Yort New York by SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 369 .tabk side c/jrcl projik. K.Sym/don Ainltng-11 Val. alternative medicine. 0. and the 141ucost tnake hlisrakasricl~anln good cl~oice /orpro/)/~ylaxir 111 ol~ioid-induced co?ufi. Key Words Cancer care.:I\ u~idcrtakcn wit11 ~ l ~ i s prc1)aratiocl to dctcl-nlillc iu c f k c t OII ol~ioid-induced co~~stipatioti. liq. 23 per 20C 1111 rcspcctively*) and are required in relatively large v o l ~ m c s . .I Pain Symptom Manage in 199S. in wliicli materials mainly of plant or animal origin arc used for preparing decoctions. Ayurveda Zi~kadtcctiort Constipation is a frcqucnt causc of distress in advanced canccr.RR). . Kotukkal (1'. a clleap. an attempt has bcc~r made to study tllc cfIicacy af an Ayurvedic prcparation. Pain and Polliatiur Cure Clinic (K. Indk.. Mirrahnel~antis a centuries-old Ayu~ucdic liquid puqativc cor~raining kinds c Ilcrbs.ILIIIICSII~ Alya Vai~lya Sala. Krrala. and Arya Cotirlipalion is a frequenl cawe o/distress in aduattced canm A paUiatiue care crt~il in Krrala. M.balion.W). CnnccrlJaiirI&lieJCo~nrrillcc. Kcrala. 1998 Publiil~cd Elscvicr. I I I I I . Formulation and Senna I? R Ramcsll. For sucli paticnu.no ~tatisticnlly signijica~rt dij/cretcce itt the a/r/rarettl degree o laxative action bclcucot the f tluo.fi~. - rial in origin and niay bc caused by poor 'dict. Kotlakkal.

d \wlio gave i ~ r f o r l n e d consent.' Lasativcs wcrc g i v c ~ as a prol ?blL 2 ~>liylacticIilcasurc to tile p a t i e n u wllu wcrc s c a d on oral t t ~ o r p l l i ~ lQr l l i c lint cirnc. A ~ n mexicane L~III~.Linn.-lid lurpvrhum(Linn. AII i t ~ t c t v a lo 2 days w s ~ I l o v v c dbel a iwcctl steps. v i e paticnts wcrc c x a i ~ l i n c d every 3 days d u r i n g the first wcck a n d qp. l l r c qudy p e r i o d was I4 days.~ 780 780 7110 780 708 780 780 780 780 780 780 780 780 7W 780 780 780 780 7W 78U fBI.) Mcrr.that 111e cxpcctaiion a n d acliievemeni~of bocvcl movcmcnt a r c widely varying par. A m caluhu Linn. T i l e cxclusion criteria arc'givcn illTablc 1. 8: d in milk bOa ml: castor uil50 mi. d e r n q r a p l ~ i c s n d drugs administcrcd a t o tire study patients are describcd.intt. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 370 . Step 1was given first a n d t h e n followvcd rap&tively by stcp 2 and stcp 3 if t l ~ c previous stcp lailcd. (me) Pippali Amnlnhi Urahhn Sjama Danthi Lhavonfht Kraduka Ku~arani Sadhoni Charm~lahua Swrncutrkm Co&ht Sikha~i lhjani Chinnnmh~t h'arnttjo U!~rhntrlti V~nthi~hhatha Ilnlt~~rtn Pipnbngurn Linn. Ctofon rigbum I. Opmulina turplrhum (L~IIII.itr~r.k g . Of tlrosc wlio c o m p l c i c d tlte study. Fifty patic11u wcrc ~:r~rdortrly allocalcd t o tllc two siudy groups (25 c a c l ~ ) b y drawing lots (saiirplirrg with rcl>lacctnc~ri).i ~ i d u y t x l coirstipation in p a t i c n u wit11 advanced catrccr. Each day's bowel movcmcntc wcre recorded ill a spccilic f o n n a t in accordance wit11 dre critcria given in Tablc 5.) S i h Mallso (wltitc) 8al<o~prmum nwntanum (Willd. c O C g r o u p rcccivcd Murahurneham (TaMc 4 : I ) tlrc o t h e r g r o u p reccivcd S o f s c m b l e u (puri~ ficd ~ n ~ c ix ~ n c t mg c o ~ l t l i n i n g12 m g a GO SCI~II~ g l ~ c ~ ~ i asecalci. Acacia sirmafa (Lour.. V U u uinfia Litltr.m d s salts).die last day o f tlie second week. (purified) '100 ml of r t ~ c mcdiiit*c i s prrparcd by 11ac rnlrontirr protcvin~ tlw k .~rncters. (1)urificd) jafmpha cum. Cu:urrumalonga Liaa. Sofscm ublec.tipateclcvctr kforc o a~td clritdrc~t tl~c irttakc or ~norplti~lc I'aticnu already utldcrgoing Aptncdic tltcral)y as sonte nrcdicincc may Ilavc a laxarivc action I'alicttu wlto rcfuse i~tfok~ttcd coarcnt aini was to conrparc efficacy o f Mirrahuru/ram wid1 that o f a cor~vcntional laxative. 85% I n g e d i c ~ ~o frhitrah(I~~dan? L Sanskrit rtntttc Ituuttical J I C I Wt. as lias bccn d o n e in sinrilar otlrcr studies.in Tables 3a at1J Sb. ~ 1 1 cdiairioser.hale Ciuiefiluln I~IIII. (black) Uiraria #cmafcd t i ~ ~ a . T l i c hxati:cs wcce adriiit~istcrcdi n tlircc steps (Tablc 4). Tliesc criteria were set o n the basis o f subjectivc feeling o f satisfaction.) MucU.l. i t 1 tllc trlatragccitctrc ol o l i o i d . A r p r h a spcdio~e Swcc. Saccharurn ~Jficr~tnrum 1jrt11. ill4 Tl~c study was conducted o n p a d c n u witli advanced carlccr aged 15 years a n d o l d e r wlio le wcrc started or1 oral n ~ o r p l i i ~ f o r ~ l r cfirst tirtic an. in view o f the fact . a i n g i t c ~ n s x c d a z t c r r i t l l per. l ~ c T dif'rcrcncc betwccn llrc plrysical forr~tso f c l ~ ctwo drugs ~rcccssitatcda n o p c ~ rtrial rather t l ~ a i ra double-blind study. r Cucvmu trigunw Roxb.ittrt. Phylbnrhur d l u n I.io~~ Criteria IttVattu i'atic~tuwitlt i t t a r t i t t a l obrtrucciott I'aticttu alrcady on laxativcr l'aiiclru r l ~ arc co~t.) S i l n hfuu?.7bbL I Exclt~. p a ~ i e n u d i e Sofscna'group cornplctcd the it1 study. 7i'nospracordi/dia (\Clilld. slur W ml. Achytanlhu orpna 1. Mninp ohftra 1a nr.kTl~ot~tr fJan#amia& h a Vcttt.~ E i g l ~ t y c r c c n t (N = 20) o f tlic p a t i c n b in p tltc Mirmkatnef~am group a n d 64% (N = IG) o f d i c . Sip* 7X&httnvi1khnl.) hlicrs c x 1la1k. .

~ l l ~ c s ic t r c s I p fuggcst a tl. Twentynine p c r c c n i (N = 5) from d l c MinokaJnJlomgroup a n d 55% (13= 6 ) froill thc Sofsena group h a d satisfactory bowcl nfbvcnicni wit11 s r p 2. Sex distribution I 2 d 25 17 A II B 6 - 10 25 Male Fcnialc 8 - 25 10 25 15 rrGshctoiy Imwvcl II~OVCI~~C~ILS. a n d 15% (N= 3) a n d 31% (N= 5) o f the respective groups did n o t have Talk 36 DkcusSioff Ayulveda literally means thc science of liic and. Details o f tllosc cases with unsatisfactory bowel movements are given in Tablc7.clli-square test).the positive and negative aspects o f life are DNS Taken by Study Patients Nurnbcr of patienu MisraLas~~ehai~~ group Morphinc dosc/24 br I5 mg 50 mg 45 mg GO mg Otlrcr n~cdicatior~s Par. Tvvo each from.5 ing 10-20 ing 20 inc I 0 SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 37 1 .blscnn group 9 10 2 4 - 8 12 0 I . o n e f r o m the hfisdam&rn g r o u p a n d four f r o m the Sofsena group d r o p p e d o u t duc to irregular laxative administration. O n e f r o m the Sokena g r o u p dropped out as I l e was getting good bowel m o v c m e n l widlout laxative (Table 8).5-25 iiog 500 III~ 20 1 S 1 19 J 4 4 I 1 2.group L)iag~icnu Carcinoi~la ollrlng Carcinoma o l tongue Carcinoma ot breast Carcinoma olesopl~agus Carcinoma oloropharynx Carcinoma or tonsil Hcpatocellular carcinoma Mulitple m)rloma Carcinoma of onry Carcinoma orcelvix Carcinoma of check Carcinoma of pehir Acuk myelogenous leukemia Age distributiol~ Y J S 1 ~""1' 7 J 3 2 2 0 I 3 I 2 I 0 I 0 I S 2 0 I 0 I - 0 25 I 4 4 25 c10 91-40 4 1-50 51-60 GI-70. A m o n g . cvcn d ~ o u g l tlic l difkrcllcc.Z.rccranrol L)iclole~~ac rodiurt~ hlr~oclo~~rainiclc Aii~itri~~tylinc Ranitidir~e Ilalopcridol I'rcdnirolor~c Dicyclo~ai~~c Dosc/24 2-5 R Irr &. a n d 24% (N= 4) from the Mirrahasneham group a n d n o n e fro111 tlie Sofsena g r o u p h a d satisfactory boivel movcment w i t h stcp 3 (Table 6). T w o f r o m LII? Misrakainelranr died d u r i n g the coursc of Ole study.those who did n o t P m p l e t e the study. b o t l i tlic groups were lost t o follow-up. 47% (N 8) fro111 t l ~ c M i r r u k a s t J ~ a m g r o and 45% (N5: 5) f r o m tllc u~ Sofseua g r o u p h a d satisfaclory bowel moveci\cnts will1 step 1. bong dlosc w i t h satisfactory k w c l movcnicnu. t+orplline was witlidrawn from two patients in the Sofsena group a n d tllesc patients were d r o p p c d fro111 tli: study. - 25 9 I2 25 10 1 SO r t ~ ~ II 10-50 III~ 17.cnd it1 favor of Muraknute/~atr~ fro111 tlic p o i n t o f view of cmucy. is 1101statistically significant ( P > O.. ( N = 17) o f the hlirrakariuhain g r o u p a n d 69% ( N = 11) o f the Sofsena g r o u p h a d satisfactory bowel movements.

T l ~ c pliar~uacokincticsa ~ i d pl~artriacodparriics o irs compo~rencs not clearly C arc u ~ ~ d c r s t o o d . .: :. ~ ~ ~ I I Oside CKCCU I I I S : ~ t i s r a c t o ~ ~ IIIOVCIIICIII LXIWCI wit11 sidc ciTccu I P ticnu oli oral ~ i i o r p l t i ~ ~ c bccausc a scientific cvaluariorl o r tllc drug using modcrt~ i ~ c ~ l i a i l ~ ology'h~andatcd t ~ c a ~ s l con~promisc.i t was well acccptcd by tlie patielits who ircrc bcncfirtcd by it.uncl of Ayurvctla arc writtc11in tlic classical 1-lintlu language of Sanskrit an J arc fiatcd to 400 U. a unique state of tlircc basic bodily hurnors (Vntn. ~ 0 1 1 1 is lcsg o. Illc i in lircl. and K@ha).tLrlrcnt is lor t l ~ c paticnt and not for tllc ailr~iclit. u ~ d l ~ c c g \~toduccs ctlcciivcl laxliivc tlic SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 372 . mltcr d r a ~ isytrlptomatlc or factorial. especially tliosc \ \ * i r l ~ clyspl~agiafroni head and luck lesions. is assut~rcdillat dle combir~aIt tion of tllc 21 I~erbstogether with castor oil. csscri~all~.~turc 1 1 tllc ~)ri~iciplcs ~)l-:icticcs 0 .e in constipated padcnts.ilta~t~cltam appcar-s to be acil11g as . tvhicli dcals \Jitli t l ~ c orderly upkccp of Iicaltll and (ii) Alhurnvrithn (paticrit's rcgi~iicn). in Evc~y ailrnclit is coricci\. vorrlltlng.l~ctl( J 1:s. and colic) I'IIII~ t lodc~arc h. 1.& about 1300 ycars old and is in the olficial FormularyP T h e ir~dividualirigredienu arc dcscribcd wid^ botanical and Ayun. Mir.llis is tltc: tllc ~ ~ c a s atlint it is co~~irnorily n swtcd t l ~ a tthe Ayurvcclic tr. This priticiplc was coniprorniscd ill dic use of tlic sarnc Ayuneedic laxative for all pa- - ~novc~ncnt: a..5 rill Alicraltnsr~el~o~~~ d1a11115.W) f19r I r i ..Altl~ougl~ ~ used as a 'pucgativc" i l l A)vrvcda. Any upset occurring to this nasccrit state of balance is manifested as an ailmcnt arid rlic tllcrapy is dircctcd to rcgai~l :rigitla\ starc.:i:t rlo~c. wliicl~is all about tlic eradication of discascs.i. S o f s e ~ ~aa .cxl~hincdl i a ulliquc \ ~ a y tliis scicncc. Pitlo.C.. wit side 9. cffccu (tnurca. Ayuwcda pcrccivcs man as an intcgral part of naturc and its approacl~to uvcll-bcirig is pllilosopl~ical principle ant1 liolistic in tccliniquc. ~ Sol[ g f scna tablct. c Tllc cost of 2. 1 .r. cornpo~icnu. constitiltiorially.i sti~riulnrit laxativc. Tl~us.cdic dcuils in a recent public a t i o ~ i . was c~nployed the cornparator.G Ayuweda liar.. 7 1 to 1 0 ~ 1111). Tlic latency of action of Sofscna is 6 1 2 hours. kvcly 1iuni. TIlc Inode of processing. tile ingrcdicnrs and 1115 indications for this formulation arc' dcscribcd ill a classic A y u y d i c litcmture callcd Asl~fnngahridajan~' wlticl~. tlte present study evaluated small closis of hfisraknsitel~nm a larati\..c.!. it is a liquitl prcparaAs lion tilat c . 'l'ltc ~~aticrtrs not col~lplai~i tlld abort1 tllc tnstc bf tlic laxative.c.t0 compared to a n observed latency pcriod of 4-6 hours in t l ~ case of ~lurknsntlrnrn. . two (i) t l ~ c Svnrilravtirhn (I~caltl~y rnarr's r c g i ~ ~ ~ c n ) . Afurnkasrrclurm is a ccnturics~ld combinatiim used in Aylllvcda as a purgati\.tn bcini is iccn to ocpupy. !uilk. .. as lrccly a\ailablc stirntrlant laxa~ivc co~uliionly used in Irldia. tl~crapy rllc rrlay vary for different paticnts displaying the sanic sylnp toms. as PaGc~iuw l ~ o had regular bo\rcl riiovclnctits wit11 Afisrkostlelraa~wcrc also satisfied \\+it11its easy adl~~inisrtatiori. be usctl ili a srnnll rlosc 1 2 .ccl as a psycl~osotnatic nlanifcstation and its cradication is fttnctional and h e g r n t i v e .

Si~.I h w ~ h al. UI itisli ~ a t i o l ~F l I I I I I I1989. Vasudcva~i sccrefor larial support. 10. glisli translation). P:M. No. 1. I'rccsuggestions arid to Mrs. Anecdotcdly. tlla Kanicsli. ~ ~ I I w . sa11111im. Kobct t 'l'wycr~ossfor tlrc vcry ttscfi11 dis- 9. T. 2. and low sidc eifcct profile.asivatliy. 3.J I'ain Symptom Manage 1996. 198G. It is tentatively concludcd from tl~isstud\that hlirtal~nrncharr~ the potential to bc uscd II. JE. Warricr I'K Nhnbiar VPK. as it nccds higher adult dosage. 16 No. 1993-1996. Twycross RC. f l ~ ~ ~ a r i k uTory tt Mrs.Lennardrjones MisicwicrJ. . and glycerine enema. cuuioris and guidarice during tlic study arid wliilc prcpariug ll1c manuscript.11:363. Murali and Dr. In comparison.5 mg q4h) that shc was m%ing. Edinburgli: Clturcllill Livingstorre.i:170. Palliative Med 1991. No. Thanks arc also duc t KO Dr. o n its own. is unpalatable and not as eKec. and Mr. hrnal~kuiiyC. continued vomiting eveh aftcr stopping Mirrakameltam. Variation in bowel Iiabit i r i two p o p uladon sa~i~plcs. ~ iS Zb ~ S ~ secics. Slic stopped vomiting aftcr discontinuing the low dose of morphine (2. dlc Toniiuladorr appcars to bc a good clioicc Furtlicr rigorous studics arc riccdcd to cstab lisll tlic prcli~riinary results prcscntcd iierc. tf Vd. Tllcy also h a n k tlic paticnu. volu~itecrs. Sykes NP. 4. C l i ~ ~ l k l i . vomiting.U as an allertlate rllenpcutic tool for niandging tnorpl~inc-inducccl constipation aid part of pallialivc carc of pticnLr with atlmnhd cancer.11 It was interesting to note diat 4 of dlc 17 patienu (24%) wlio exhibited satisfactory r e d u in tlic Misraharnel~a~n group took it only once in twp or tlirce days. Indi211rnedici~nlI ) ~ .C. n d stafT of tlic e l'alliativc Care Clinic lor ttlcir cxcclpain a r ~ d l c ~ isupport to the study.S. ~: I I C~I 'Varanari. to Dr. One oPthesc patienu had carcinoma of the tdnjil and responded well to bisacodyl5-10 mg at niglit. 1991. 'I'llcy did riot liavc bowel rriovcrr~c~it tliat wit11 dose. Br 6.5:307. castor oil. I ( E n Vo1. i r i 5 %YALIIIICS. and colicky pain. A~volut~tec~ for tllc colr~pariri~odel son of laxatives in opioid-rclatedconstipation.' 4. I~igllcr doses (1020 mi) of tile Misrakariiclrlnm have acliievcd rcsulfs in patients w l ~ o Imuo lrot s c s p d c d LO convenlional laxatives at all. 18:G6 aV ~~L~. Vicwcd from tlic perspective of palatability. cornplaining of nausea. Two patients in tlie Mirrakariieha?n group stopped tlie laxative aftcr tlic first dose.. I'rog I'nlliaGvc Csrc 199k..~ ~ l Oric~itL O I I ~ I I ~ . 4 Oclolrr IY98 'Ibblc 7 Details of Cases will1 Utrultfactory Bowel Move~rienLs 7bMc8 Details of Drormuu fro181llle Study Reas011 a) Vornitcd in step I and colic* b) N bowel movement o even wid1 step Sb Toul Jee art for dexription. 2 U I S 5 5 'All nix c W were m a n q e d mlh rcpcatcd u x ol bisacodd supporilor). Irregular luurivc admintcncion Dead8 N follow-up o Morpl~inc-dll~dnwn Good bowel rnuovcelertt nid~out laxatkc Toul action in tliis small dose. whcrcas the o t l ~ c rpaticlil wlio had hcpatoccllular carcinoma. Lack SA.css~licirsiriccrc gratitude . 1989. A clinical comparisori ol laxative iri a I~ospice. Sykes N. SELECT RESEARCH PAPERS ON EVIDENCE BASED AYURVEDIC DRUGS 373 . I C I . Uritislr Natio~bal I I . Control ol aiiriicn~ary symptoms in far advanced cancer.Ilic autliors cxl)~. cgsl cflectivencss. tivc. dcspite anticmctics. ConncU Ah4. Iiilton C. I I I I ) C I ~ ~ ~ I I IofI 500 S ~ I C ~ cics. Sykes NP. Forr~~ul~ry.utll~ KL. . Ullisl~agrac~~a S~~sl. I I ~ Cl~c lai: Ltcl. 18:ti7. Irvine G. hied J 1965:ll 1095..