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CLINICAL RESEARCH PROTOCOLS

FOR
TRADITIONAL HEALTH SCIENCES
(AYURVEDA, SIDDHA, UNANI, SOWA RIGPA AND OTHERS)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA


Department of AYUSH, Ministry of Health & Family Welfare
Government of India, New Delhi
www.ccras.nic.in
Publisher

Central Council for Research in Ayurveda and Siddha


Department of AYUSH
Ministry of Health and Family Welfare, Government of India
J.L.N.B.C.E.H.Anusandhan Bhavan, 61-65, Institutional Area
Opposite D-Block, Janakpuri, New Delhi – 110058
E-mail: ccras_dir1@nic.in, Website: www.ccras.nic.in

© Central Council for Research in Ayurveda and Siddha, New Delhi


2009

Note: Reproduction/Translation/Citation of any part of this publication are welcome with


due acknowledgement of the Council for academic and research purpose. No citation for
commercial purpose is permitted.

Cover Page Designed by : Dr. N. Srikanth, Assistant Director (Ay.)

Printed at : Pearl Offset Press Pvt. Ltd., 5/33, Kirti Nagar Industrial Area, New Delhi - 110 015
Tel. 011-25159312, 41424700, 41424800
FOREWORD

Ayurveda and Siddha have been in vogue in this country from the earliest times, serving
the medical needs of most of our people. These systems were developed by ancient scholars on
the basis of their own philosophy, oriental methodologies and practices prevalent in that era and
have popularized and almost completed it in all aspects as a system of medicine. The advent of
foreign invasion and cross interaction had definite impact on these systems.

The worldwide interest in the use of natural products and plant-based remedies had led to
different situations developing in different countries. In countries with a strong foundation of
traditional medicine such as India and China, nationally recognized parallel traditional systems have
run for long periods, along with Western medicine with varying degrees of acceptance, integration
and assimilation.

During the last decade, use of traditional medicine has expanded globally and has gained
popularity. It has not only continued to be used for primary health care of the poor in developing
countries, but has also been used in countries where conventional medicine is predominant in the
national health care systems. With the tremendous expansions in the use of Ayurveda and Siddha
world wide, the safety and efficacy as well as quality control of herbal medicines and traditional
procedure-based therapies have become important concerns for both health authorities and the
public. Various practices of traditional medicine have been developed in different cultures in
different regions without a parallel development of international standards and appropriate methods
for evaluating Ayurveda and Siddha systems of Medicine. Like other systems of ancient India
learning Ayurveda was discovered through most suitable sources (Pramanas) viz. (1) Pratyaksha
(direct perception), (2) Anumana (logical inference), (3) Aptopadesa (verbal and authentic
documentary testimony) and (4) Yukti (experimental evidence) etc.

In modern medicine, a clinical trial is almost always undertaken to test the efficacy of
pharmaceutical products (drugs, devices etc.) and some times to study the efficacy of ‘non-
therapeutic interventions’. The global acceptance of modern system of medicine as a whole is
because it has been reviewed systematically by modern scientific parameters. Similar scientific
evidences through clinical trials are the need of time, to make the traditional medical systems
scientifically acceptable by all.

While designing the research trials it would be appropriate to understand differences


between Ayurveda/ Siddha and Contemporary Modern System of Medicine. The differences are
mainly due to the basic approach to Health and Diseases; perception and also epistemological.
The Ayurveda is holistic in approach, in diagnosis, prognosis as well as management of diseases.
Holistic approach of Ayurveda is indeed good and welcome in clinical practice (for the ‘patient’
and the ‘society’). However, this approach has considerable difficulties and even challenges the

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scientists to devise parameters and design suitable models for clinical studies/trials. The pursuit of
a better understanding of the facts and phenomena in Ayurveda and Siddha, through scientific
research will be able to fill this gap.

Only using the modern scientific tools without considering the holistic concepts of traditional
medical system, may sometimes lead to inappropriate conclusions. This is high time to create the
scientific evidences on Ayurvedic principles and practices taking into the consideration of basic
principles and philosophies embodies in the literature and correlating them with the modern
scientific concepts, which will rightly convey and translate the merits of Ayurveda and other
traditional systems of medicine.

The Central Council for Research in Ayurveda and Siddha has been engaged in scientific
research in Ayurveda and Siddha since more than past three decades and executing research
adopting the integrative protocols. I appreciate the involvement of scholars from various reputed
organizations like Indian Council of Medical Research, All India Institute of Medical Sciences, Lady
Harding Medical College, NIMHANS, Bangalore and other institutes while drafting and finalizing
the protocols.

The views and endorsement of experts from both Ayurveda and Allopathic systems
enriched the protocols providing a good scope of integrative research for creating scientific
evidence.

As research methodology is a continuously evolving subject, one should always consult the
current updates and modify the protocols and formats as per the needs from time to time. This
document would greatly serve as basic reference material for scientists and scholars who are
involved in clinical research in Ayurveda, Siddha and other traditional systems of medicine.

I appreciate the efforts of CCRAS in bringing out this document and would certainly
receive a warm welcome from scientists and scholars engaged in traditional medicine research.

(Dr. C.D. Tripathi)


Professor and Head
Department of Pharmacology
Vardhman Mahavir Medical College
& Safdarjung Hospital
New Delhi

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PREFACE

Research is essential for development of any science. This is even more necessary in
respect of ancient sciences like Ayurveda and Siddha. The various schemes and initiatives of
Government of India led to establishment of a National body “Central Council for Research in
Indian Medicine and Homeopathy (CCRIMH) in 1969. The Central Council for Research in
Ayurveda & Siddha was started in 1978 as a successor to CCRIMH, for research in Ayurveda
and Siddha.
The Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry
of Health & Family Welfare, Government of India is an apex Nodal Body in India for the
formulation of Research in Ayurveda and Siddha on scientific lines. The research activities of
CCRAS include Literary Research, Drug Research, Clinical Research including Nutraceuticals
Research, Cosmeceutical Research and Bio-medical instrumentation and Reproductive and Child
Health Care Research. The Council has been carrying out its research activities through the
network of the peripheral institutes across the country and also in collaboration with various
National and International academics and Research Organizations.
The Council is executing research studies on scientific lines as per the prevalent guidelines
with Ayurveda and Siddha related part so as to make it integrative in nature. The Council has
currently undertaken execution of clinical trials on more than 30 priority areas on phased manner
adopting the current norms of drug development process viz. pre-clinical standardization/toxicity
studies and phased clinical trials.
The integrative research protocols and Case Report Forms (CRFs) incorporating basic
principles of Ayurveda and current requirement and methodology of research etc. have been
developed from time to time through extensive consultative process involving high profile experts
in the field of Ayurveda and Allopathic system of medicine from reputed institutes viz. AIIMS,
ICMR, CSIR, NIMHANS and so on.
Dissemination of these methodologies by publishing the formats of selected diseases along
with protocols, Case Report Forms (CRFs) would help the scientists, academicians, PG and

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Ph.D. scholars etc. who wish to conduct research on different diseases/conditions in developing
protocols and serving as a basic reference material. However, the specific protocol could be
developed by individuals suitable to their needs based on the specific objectives.
There has been a great need for a comprehensive compendium of Protocol formats and
Case Report Forms (CRFs) for ready reference of research scholars, scientists etc. Keeping this
in view the Council is publishing the present compendium and I am convinced that this will be of
immense help not only for researchers more so ever to the Post Graduate and Doctorial
Scholars.
I am highly thankful to Dr. C. D. Tripathi, Professor & Head, Deptt. of Pharmacology,
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi for sparing his valuable
time by offering suitable suggestions that has made this document more authentic and scientific.
I greatly appreciate the scientists of CCRAS, expert members of task force whose efforts
made this work possible. I also appreciate Dr. M.M. Sharma, Dr. B.S. Sharma, Mr. Upendra
Singh & Mr. Narender Singh from publication section for their tireless efforts in bringing out this
publication, Mr. Gaurav Kumar and Mr. Prasanto Choudhary, Data Entry Operators for secretarial
assistance.

New Delhi (Prof. G.S. Lavekar)


Director General
CCRAS

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CHIEF EDITOR

Prof. G.S. LAVEKAR


Director General
Central Council for Research in Ayurveda and Siddha, New Delhi

EXPERT REVIEWER

Dr. C.D. TRIPATHI


Professor & Head
Department of Pharmacology
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi

EDITOR

Dr. M.M. PADHI


Deputy Director (Technical)
Central Council for Research in Ayurveda and Siddha, New Delhi

PROGRAMME COORDINATOR

Dr. N. SRIKANTH
Assistant Director (Ay.)
Central Council for Research in Ayurveda and Siddha, New Delhi

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CORE SCIENTIFIC GROUP

Dr. M.M. Rao Dr. Sulochana Bhat


Deputy Director (Ay.) Assistant Director (Ay.)
CCRAS, New Delhi CCRAS, New Delhi
Dr. Sobran Singh Dr. T. Anandan
Assistant Director (Ay.) Assistant Director (Siddha)
CCRAS, New Delhi Central Research Institute (Siddha) Chennai
Dr. Adarsh Kumar Dr. G. Ganapathi Raman
Assistant Director (Ay.) Ex. Asst. Director (Siddha)
CCRAS, New Delhi CCRAS, New Delhi
Dr. G.C. Bhuyan R.K. Singhal
Research Officer (Ay.) Statistical Officer
CCRAS, New Delhi CCRAS, New Delhi
Dr. Sarada Ota Dr. M.K. Jha
Research Officer (Ay.) Ex. Research Officer (Medicine)
CCRAS, New Delhi CCRAS, New Delhi
Dr. Banamali Das Dr. B. Venkateshwarlu
Research Officer (Ay.) Research Officer (Ay.)
CCRAS, New Delhi CCRAS, New Delhi
Dr. M.M. Sharma Dr. K. Prameela Devi
Research Officer (Ay.), Research Officer (Ay.)
CCRAS, New Delhi CCRAS, New Delhi
Dr. B.S. Sharma Dr. S.K. Vedi
Research Officer (Ay.), Research Officer (Ay.)
CCRAS, New Delhi CCRAS, New Delhi
Dr. S.K. Meher Dr. K. Bharati
Research Officer (Ay.), Assistant Director (Ay.)
CCRAS, New Delhi IIHM, Hyderabad
Dr. A.C. Kar Dr. Galib
Ex. Asst. Director (Ay.) Ex. Research Officer (Ay.),
CCRAS, New Delhi CCRAS, New Delhi

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TASK FORCE OF EXPERTS FROM REPUTED
INSTITUTES

All India Institute of Medical Sciences, New Delhi

Dr. M.V. Padma Prof. S.K. Sharma


Additional Professor Head of Department
Department of Neurology Department of Medicine
AIIMS Ansari Nagar AIIMS Ansari Nagar
New delhi-110029 New Delhi – 110029
Prof. Y.K. Gupta Dr. S.C. Mahaptra
Head of Department Professor
Department of Pharmacology Department of Physiology
AIIMS Ansari Nagar AIIMS Ansari Nagar
New Delhi - 110029 New Delhi – 110029
Dr. Nikhil Tandon Dr. Jasbir Kaur
Addl. Professor Endocrinology Asst. Professor
AIIMS New Delhi – 110029 Dr. R.P. Centre for Ophthalmic Sciences
AIIMS New Delhi – 110029
Prof. K.K. Talwar Dr. Monoranjan Mahapatra
Prof.& HOD, Cardiology Assoc. Professor Endocrinology
AIIMS Ansari Nagar AIIMS New Delhi – 110029
New Delhi – 110029
Dr. Suneeta Mittal Prof. Anita Panda
Professor & HOD Dr. R.P. Centre for Ophthalmic Sciences
Department of Obstetrics and Gynaecology AIIMS Ansari Nagar
AIIMS Ansari Nagar New Delhi – 110029
New Delhi – 111029

Indian Council for Medical Research, New Delhi


Dr. Neena Valecha Dr. Nandani Kumar
Deputy Director Ex. Deputy Director General
Malaria Research Centre (ICMR) ICMR
New Delhi Ansari Nagar
New Delhi – 110029

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Dr. Arvind Pandey Dr. Abha Rani Aggarwal
National Institute of Medical Statistics Scientist E
ICMR Head Quarters Campus, Ansari Nagar National Institute of Medical Statistics
New Delhi – 110029 ICMR Head Quarters Campus
Ansari Nagar
New Delhi – 110029

Banaras Hindu University, Varanasi

Prof. R.G. Singh, Prof. Dr. Manjari Dwivedi


Department of Nephrology Department of Prasuti Tantra & Stree Roga
Banaras Hindu University Institute of Medical Science (Ayurveda),
Varanasi – 221005 Banaras Hindu University
Varanasi – 221005
Prof. Dr. P.V. Tiwari Prof. I.S. Gambhir
Department of Prasuti Tantra & Stree Roga Department of Medicine
Institute of Medical Science (Ayurveda) Institute of Medical Sciences
Banaras Hindu University Banaras Hindu University
Varanasi – 221005 Varanasi – 221005

Vallabh Bhai Patel Chest Institute, Sir Ganga Ram Hospital, Delhi
University of Delhi, Delhi

Prof. Ashok Shah Dr. S.C. Manchanda


Department of Respiratory Medicine, Department of Cardiology
Vallabh Bhai Patel Chest Institute Sir Ganga Ram Hospital
University of Delhi, Delhi Rajinder Nagar, Delhi – 110060

Ayurvedic & Siddha Experts

Dr. S.K. Mishra Dr. B.V. Sathe


Ex. Advisor (Ay.) 30/2, 4 Erandvan
Department of ISM&H Flat No. C-1, Vihar Society
Ministry of Health & Family Welfare Near Mahendle Garage
Govt. of India Pune - 411004

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Dr. S.M. Sathe Dr. G. Veluchamy
Plot No. 9 Ex. Director CCRAS,
Gananjay Society Unit – 1 New Delhi
Azad Nagar, Kothrud
Pune – 411038

Dr. K.D. Sharma


Ex. Deputy Director (Technical)
CCRAS, New Delhi

TECHNICAL SUPPORT

Dr. Seema Jain, Dr. Syed Hissar,


Senior Research Fellow (Ay.), Research Officer (Medicine),
CCRAS, New Delhi CCRAS, New Delhi
Dr. Senthilvel, Dr. Selvarajan,
Research Officer (Siddha), Research Officer (Siddha),
CCRAS, New Delhi CCRAS, New Delhi
R.K. Rana, Dr. Babita Yadav,
Statistical Assistant, Senior Research Fellow (Ay.),
CCRAS, New Delhi CCRAS, New Delhi
Richa Singhal, Dr. Suprabhat Bhardwaj,
Senior Research Fellow (Statistics), Senior Research Fellow (Ay.),
CCRAS, New Delhi CCRAS, New Delhi

Dr. Nikhil Jirankalgikar


Senior Research Fellow (Ay.),
CCRAS, New Delhi

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INDEX

Sl. No. Subject Page


Forward III
Preface V
1. Section – I Respiratory System 1
1. 1.1 Allergic Bronchitis (Kasa) 5
2. 1.2 Bronchial Asthma (Tamaka shwasa) 33
2. Section – II Gastro intestinal System 61
1. 2.1 Irritable Bowel Syndrome (Kaphaja pravahika) 65
2. 2.2 Intestinal Helminthes Krimi roga (Gandupada krimi) 87
3. 2.3 Gall Stone Disease (Pittashmari) 111
4. 2.4 Sero conversion of HBsAg (carriers) (Yakrit vikara) 133
3. Section – III Joint Disorders 149
1. 3.1 Osteoarthritis-Knee Joint (Sandhi-vata) 153
2. 3.2 Rheumatoid Arthritis (Amavata) 185
3. 3.3 Osteoporosis (Asthisausirya) 231
4. Section – IV Ano-rectal Disorder 245
1. 4.1 Fissure-in-Ano (Parikartika) 249
2. 4.2 Piles (Arsha) 273
3. 4.3 Fistula-in-Ano (Bhagandara) 293
5. Section – V Nervous System 313
1. 5.1 Hemiplegia (Pakshaghata) 317
2. 5.2 Migraine (Ardhavabhedaka) 341
3. 5.3 Mental Retardation (Manasa Mandata) 357
4. 5.4 Sciatica (Gridhrasi) 387
5. 5.5 Anxiety Neurosis (Manodvega) 415

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6. Section – VI Metabolic Disorders 437
1. 6.1 Obesity (Medoroga) 441
2. 6.2 Diabetes Mellitus (Madhumeha) 459
7. Section – VII Eye Disorders 479
1. 7.1 Cataract (Linganasha) 483
2. 7.2 Dry Eye Syndrome (Shushkakshipaka / Parishuskha 501
Netra)
3. 7.3 Allergic Conjunctivitis (Kaphaja abhishyanda) 519
8. Section – VIII Connective Tissue Disorders 535
1. 8.1 Deep Vein Thrombosis 539
9. Section – IX Geriatric Disorders 557
1. 9.1 Rejuvenation (Rasayana) in healthy elderly persons 561
2. 9.2 Rejuvenation (Kaya kalpa) in healthy elderly persons 593
10. Section – X Reproductive System 615
1. 10.1 Menopausal Syndrome 619
2. 10.2 Dysfunctional Uterine Bleeding 643
3. 10.3 Dysmenorrhoea (Kashtartava) 661
11. Section – XI Cardio Vascular System 701
1. 11.1 Essential Hypertension (Uchcharaktachapa) 705
2. 11.2 Chronic Stable Angina (Hridroga) 727
12. Section – XII Urinary System 745
1. 12.1 Urolithiasis (Mutrashmari) 749
13. Section – XIII Vector Borne Diseases 769
1. 13.1 Kala-Azar 773
2. 13.2 Filariasis (Shleepada) 801
14. Section – XIV Haematological Disorders 827
1. 14.1 Iron Deficiency Anaemia (Pandu) 831
2. 14.2 Sickle Cell Anemia 865

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15. Section – XV Immune System 883
1. 15.1 HIV Infected Persons 887
16. Section – XVI Disorders of Skin 911
1. 16.1 Psoriasis (Kitibha) 915
17. Section – XVII Reproductive and Child Health Care 941
1. 17.1 AYUSH AG TAB during Pregnancy 943
2. 17.2 AYUSH PG TAB in edema during pregnancy 958
3. 17.3 AYUSH B.R. Leham for immunity in infants 973
4. 17.4 AYUSH PK-Avaleha in preventing postpartum 985
complications and puerperial care.
5. 17.5 AYUSH SS-Granules to ensure quality & quantity of 996
breast milk
18. Section – XVIII Clinical Safety of some 1007
Ayurveda and Siddha Drugs
1. 18.1 Clinical safety of herbo-mineral and metallic preparation 1011
(Rasamanikya Rasa)
2. 18.2 Clinical safety of herbo-mineral and metallic preparation 1049
(Vasantakusumakara Rasa).
19. Section – XIX Annexure 1085
1. 19.1 Case Report Form for determination of 1087
Prakriti/Udaliyal/Mizaj

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XVIII
RESPIRATORY SYSTEM

SECTION - I

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MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC
FORMULATION IN THE TREATMENT OF KASA
(BRONCHITIS)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF KASA (BRONCHITIS)

I. BACKGROUND
Kasa (Bronchitis)1is prevalent all over the world and certainly most common acute disease
of lungs. It is characterized by inflammation of brochial tubes and is much more common in
childhood and after middle age. Attacks are much more likely to occur in the winter and spring
seasons. The disease commonly commences with symptoms of an acute respiratory infection and
a slight sore throat. In the course of a day or so it affects the trachea and larger bronchi with
feeling of soreness behind the sternum, tightness in the chest, frequent and mainly dry cough and
a rise in temperature. The voice becomes husky. The sputum is initially thick and scanty but later
on becomes more copious, mucopurulent and more easily to cough ups. In the cases of great
severity, there is a severe bronchitis affecting the larger and smaller tubes, a high rising temperature
(104o – 105o F), severe dyspnoea, cyanosis, and prostration. The sputum may be streaked with
blood. Especially at extremes of life death may occur, or recovery will be taking 4-8 weeks.
According to modern medicine, bronchitis may follow exposure to cold. In majority of cases there
is an infection of upper respiratory tract. A number of drugs including antibiotics are available for
the successful treatment of the disease but recurrence of the condition, development of bacterial
resistance against drug is now a days common. Besides of these number of side effects, adverse
effects of antibiotic therapies have been reported time to time. So it is better to seek for a safe
and effective alternative treatment for the cure.
The disease is very well described in Ayurveda and a number of drugs have been
mentioned. Vyaghriharitaki is one of the classical compound drugs which has been in practice since
ancient times for its successful treatment. A protocol is designed here with special reterence
Vyaghriharitaki which may be principally utilized for management with suitable ammendments.

References
1. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Sutra Sthana, Chapter 25, Verses 40
2. Savill’s System of Clinical Medicine- revised and edited by E.C.Warner, 14th edition, page No. 183- 186
3. Davidson’s Principle and Practice of Medicine 18th Edition pages 339
4. Charaka Samhita; Chaukhamba Publication, Varanasi; 2nd Edition; Chikista Sthana, Chapter 18, Verses 10
&133
5. www.emedicinehealth.com

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II. OBJECTIVES
1. To evaluate the clinical efficacy of Vyaghriharitaki in the cases of Kasa (bronchitis)
2. To validate the clinical efficacy of Ayurvedic drug Vyaghriharitaki on the scientific
parameters in the patients of Kasa (bronchitis)
3. To evaluate the safety of Vyaghriharitaki in the patients of Kasa (bronchitis).
III. CENTRES
CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE & METHODS
Sample size — 120 (60 patients in each group)
Design of the study — Open clinical study.
Drug/Dosage/Duration
Group – A — Vyaghriharitaki without restriction of pathyapathya
(Restrictions related to diets and life style).
Group – B — Vyaghriharitaki with restrictions of pathyapathya
Dose & Duration — 2.5 gm B.D. for 1 (one) month
Total period — 1 year and 6 months to complete the study
V. CRITERIA FOR INCLUSION
1. Patients of either sex with Age between 15 years to 60 years
2. Cases with confirmed diagnosis by signs/symptoms/lab findings of bronchitis.
3. Duration of illness not more than 6 months.
4. Repeated attacks of bronchitis
5. Smokers.
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and more than 60 years
2. Cough associated with other respiratory disorders like Bronchial carcinoma, Bronchial
Asthma, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung
disease, tropical pulmonary eosinophilia, Loffler`s disease, Allergic Bronchopulmonary
Aspergillosis etc.
3. Diabetes Mellitus, Hypertension and other serious cardiovascular disorders.

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4. Severe renal/Hepatic disease
5. HIV positive cases
6. Pregnant/lactating mother
7. Any other serious systemic disease.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
effect / event which requires urgent treatment or if patient by own wants to withdraw from the
study, such subjects may be withdrawn from the trial and managed by the Principal Investigator
accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Screen of the patient will be recorded as per the proforma (Form I). The full details of
history and physical examination of the patients will be recorded as per the proforma (Forms II).
Clinical assessment will be done before treatment, at 15 days of treatment period and at the end of
the treatment as per proforma - III. The laboratory investigations will be carried out before and after
treatment as recorded as proforma - IIIA. Adverse events will berecorded in the proforma - IV.
IX. STATISTICAL ANALYSIS
Data collected will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the score of clinical signs and symptoms and laboratory findings and safety
evaluation will be made on the basis of serial recording of the adverse events if any and Liver and
Kidney function tests as PROFORMA II B and III.
XI. TRIAL MONITORING AND STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in). The monitoring of progress of the trial will also be undertaken by
CCRAS Hqrs. New Delhi.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial centre for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.

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B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board, any life threatening conditions whether
they are perceived to be study related or not. The Board will decide whether the adverse
effects warrant discontinuation of the study protocol or not. Protocols will be written and
approved for the treatment of study related adverse events about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit will be paid to each subject as an incentive.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at C.C.R.A.S. Hqrs. and Central Research Institute
(Ay.), New Delhi. The investigators and technicians will be detailed about the clinical trial conduct
and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Therapeutic Efficacy & Safety of Vyaghriharitaki in the
management of Kasa (Bronchitis)
Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
PATIENT INFORMATION SHEET

What is the study about?


Kasa (Bronchitis) is prevalent all over the world and certainly most common acute disease
of lungs. It is characterized by inflammation of bronchial tubes and is much more common in
childhood and after middle age. Attacks are much more likely to occur in the winter and spring
season of the year. The disease commonly commences with symptoms of an acute respiratory
infection and a slight sore throat. In the course of a day or so it affects the trachea and larger
bronchi with feeling of soreness behind the sternum, tightness in the chest, a frequent and mainly
in dry cough and a rise in temperature. The voice becomes husky. The sputum is initially thick and
scanty but later on becomes more copious, mucopurulent and more easily to cough ups.
The available treatment for bronchitis in modern medical science like antibiotics, anti
tussives, expectorants, bronchodilators etc. made tremendous success in providing instant or
symptomatic relief but there are certain side effects of these drugs. In Ayurveda, many drugs seem
to possess better curative effect in the cases of Kasa (bronchitis) that have been in practice since
years successfully.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 1 month to complete. During this
period, you are expected to visit the hospital 3 times for clinical and/or pathological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, X-ray, blood and urine samples will also be taken. If you are found eligible,
you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc. are
noticed during the treatment period, this should be brought to the notice of the Principal
Investigator.

To be translated into regional language.

10
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 15 to 60 years

2. Both the sexes irrespective of caste/religion.

3. Uncomplicated cases of bronchitis.

4. Repeated attacks of bronchitis.

CRITERIA FOR EXCLUSION Yes (1) No (0)

5. Age below 15 years and above 60 years.

6. Cough associated with other respiratory disorders


like Bronchial carcinoma.

7. Bronchial Asthma, Bronchiectasis, cases of tuberculosis,

8. Interstitial lung disease/occupational Lung disease, tropical

9. Pulmonary eosinophilia, Loffler s disease, Allergic


Bronchopulmonary Aspergillosis etc

11
10. Diabetes Mellitus and Hypertension and other
serious cardiovascular disorders.

11. Severe renal/Hepatic disease

12. Pregnant/lactating mother

A patient is eligible for admission to the trial

If Sl.No.1-4 is ‘Yes’ and Sl.No.5-12 are ‘No’

If admitted, Sr. No. of the Subject: _________________________


No. of packets issued: _________________________

Date: __________________ Signature of the investigator: ___________________

12
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

10. Income (per capita per month in Rs.): ____________________________


of the participant and Head of the family

Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)

11. Cough (Dry/Productive)

13
12. Sputum - Thick and scanty/Mucoid/
Mucopurulent/Streaks with blood

13. Dyspnoea

14. Wheezing

15. Chest Pain

16. Tightness in chest

17. Fever

18. Sore throat

19. Onset of disease Acute (1) Chronic (2)

20. Previous episodes Yes (1) No (0)

21. Treatment given so far: Traditional Medicine (1) Modern Medicine (2)

PERSONAL HISTORY

22. Diet Veg (1) Non-veg (2)

23. Sleep Normal (1) Duration in hours______________________

Abnormal(2) Duration in hours______________________

24. Constipation Yes (1) No (0)

25. Addiction Yes (1) No (0)

a). Smoking

If yes specify: (a) Quantity [packs]:__________________

(b) Total Duration in years: ____________

b). Tobacco Yes (1) No (0)

If yes specify: (a) Quantity [packs]:__________________

(b) Total Duration in years: ____________

14
c). Alcohol Yes (1) No (0)

If yes specify: (a) Quantity (ml)_________

(b) Total Duration in years_______________

d). Any other (specify)________________

26. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja(6)

Sannipataj (7)

27. Manasa Prakriti: Satwika (1) Rajasa (2) Tamasa (3)

PHYSICAL EXAMINATION

28. Built Lean (1) Medium (2) Heavy (3)

29. Gait Normal (1) Abnormal (0)

30. Body weight _________Kg.

31. Height in cms._________

32. Body temperature ____________o F

33. Blood pressure (in sitting posture of right upper limb):

Systolic _______mm/Hg Diastolic _______mm/Hg

34. Pulse rate__________/min. (Radial pulse of right upper limb)

35. Respiration rate _________/min.

Present (1) Absent (0)


36. Pallor

37. Jaundice

38. Koilonychia

39. Cyanosis

40. Lymphadenopathy

15
SYSTEMIC EXAMINATION

41. Digestive system Normal(1) Abnormal(0)

If Abnormal, specify abnormalities_________________________

42. Abdomen Palpable (1) Not palpable (2)

i) Liver

ii) Spleen

Normal (1) Abnormal (2)

43. CNS

If abnormal, specify abnormalities_____________________________

44. CVS with chest

If abnormal, specify abnormalities_____________________________

45. Uro-genital system

If abnormal, specify abnormalities_____________________________

46. Respiratory system

If abnormal, specify abnormalities_____________________________

SAMPRAPTI (PATHOGENESIS)

Vata (1) Pitta (2) Kapha (3)

47. Anubandhya dosha

48. Anubandh dosha

49. Avaraka dosha

50. Ksheen dosha

51. Ksheen dhatu Rasa (1) Rakta (2) Mamsa(3)

Meda(4) Asthi (5) Majja (6)

Shukra(7) Ojas (8)

16
52. Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra (7) Ojas (8)

53. Stages of disease (Roga Kriya Kala)

Sanchaya(1) Prakopa(2) Prasara (3)

Sthan Sanshray (4) Vyakti (5) Bheda (6)

Srotas Pareeksha

54. Pran vaha srota

Alpa Alpa Swasa (Shortened Breathing) (1)

Atisrama Swasa (Increased respiration rate) (2)

Abhikshana Swasa (Chyne stroke breathing) (3)

Kupit Swasa (Vitiated breathing) (4)

Sashula swasa (Dyspnoea with pain) (5)

55. Udakavaha srota

Jihva sosha (Dryness of tongue) (1)

Oustha sosha (Dryness of lip) (2)

Talu sosha (Dryness of palate) (3)

Kantha sosha (Dryness of throat) (4)

Kloma sosha (Excessive thirst) (5)

Trishna (Thirst) (6)

56. Annavaha srota

Anannabhilasha (Lack of desire for food) (1)

Aruchi (Anorexia) (2)

17
Avipaka (Indigestion) (3)

Chhardi (Vomitting) (4)

57. Rasa Vaha srotas

Mukha vairsya (Bad taste in mouth) (1)

Arasajnata (Tastelessness) (2)

Hrillasa (Water brash) (3)

Gaurava (Feeling of heaviness) (4)

Tandra (Stupor) (5)

Anga marda (Body ache) (6)

Jwara (Fever) (7)

Pandu (Anaemia) (8)

Avsada (Depression) (9)

Klibya (Loss of libibo) (10)

Karshya (Emaciation) (11)

Agnimandya (Diminished appetite) (12)

58. Rakta vaha srotas

Pidika (Boils) (1)

Rakta Pitta (Bleeding from any of the orifice) (2)

Mukha Pak (Stomatitis) (3)

Vidradhi (Abscess) (4)

Charma roga (Skin disease) (5)

Kamala (Jaundice) (6)

18
59. Mamsavaha srotas

Arubud (Tumour) (1)

Aljee (Phlyctenular conjunctivitis) (2)

Gandamalaa (cervical lymphadenitis) (3)

Upji (Epiglotis) (4)

Adhimamsa (Protruberance of flesh/cancer/cyst) (5)

Putimamsa (decayed flesh/gangrene) (6)

60. Medo vaha srotas

Maladhikya (Excess of excreta) (1)

Hastapada daha (Burning sensation in the palm and sole) (2)

Hastapada suptata (Numbness of the palm and sole) (3)

Tandra (Stupor) (4)

Dehachikkanta (Greasiness of the skin) (5)

Alasya (Lethargy) (6)

61. Asthivaha srotas

Adhyasthi (Hypertrophy of bone) (1)

Adhidanta (Redundant tooth) (2)

Dantshoola (Toothache) (3)

Asthi shoola (Bone pain) (4)

Kesha, loma, nakha, samshru vikara (5)


(Any defects of hair, hair follicles, nails and mustaches)

62. Majja_vaha srotas

Parva shoola (Pain in the Interphalangeal joints) (1)

Bhrama (Vertigo/Giddiness) (2)

19
Moorchh (Syncope) (3)

Mithyajnana (Illusion) (4)

63. Shukra_vaha srotas

Klaivya (Sterility / impotence) (1)

Aharshan (Loss of erection) (2)

Garbha pata (Abortion) (3)

Santam Vikriti (Congenital deformity of the children) (4)

64. Manovaha srotas

Manovibramsha (1)

Budhivibramsha (2)

Sanjna Vibhramsha (3)

Smritivibhramsha (4)

Bhaktivibhramsha (5)

Sheelavibhramsha (6)

Chesta Vibhramsha (7)

Acharavibhramsha (8)

65. Artava vaha srotas

Anartava (Amenorrhoea) (1)

Vandhyatva (Sterility) (2)

66. Mutra vaha srotas

Bahumutra (Polyuria) (1)

Atibadhata (Urination with obstruction) (2)

Prakop-mutra (Defective Urination / Difficulty (3)


in micturition)

20
Alpaalpa (Scanty urination) (4)

Aabhikshna (Constant / repeated urination) (5)

Bahulamutrata (Urine with prostatic secretion) (6)

Sashool amutrata (Painful micturition) (7)

67. Pureeshavaha srotas

Alpaalpa Pureesha (Scanty defecation) (1)

Sashoola Pureesha (Painful defecation) (2)

Atidrava Pureesha (Diarrhoea) (3)

Atigrathita yukta Pureesha (Scybala) (4)

68. Sweda vaha srotas

Aswedan (Loss of perspiration) (1)

Atiswedana (Profuse sweating) (2)

Parushya (Roughness of the skin) (3)

Lomaharsha (Thrill) (4)

Aangaparidaha (Burning sensation in the body) (5)

Date: _______________ Signature of the investigator: ______________________

21
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0, 15, 30 days)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.
1. AIRE (ACQ)* ASTHMA CONTROL QUESTIONN
a. On average, during the past week, how often were you woken by your asthma during the
night?
i. Never (0)

ii. Hardly ever (1)

iii. A few times (2)

iv. Several times (3)

v. Many times (4)

vi. A great many times(5)

vii. Unable to sleep because of asthma’


b. On average, during the past week, how bad were your asthma symptoms when you wok up
in the morning?
i. No symptoms (0)

22
ii. Very mild symptoms (1)

iii. Mild symptoms (2)

iv. Moderate symptoms (3)

v. Quite severe symptoms (4)

vi. Severe symptoms (5)

vii. Very severe symptoms (6)

c. In general, during the past week, how limited were you in your activities because of your
asthma?
i. Not limited at all (0)

ii. Very slightly limited (1)

iii. Slightly limited (2)

iv. Moderately limited (3)

v. Very limited (4)

vi. Extremely limited (5)

vii. Total limited (6)

d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?
i. None (0)

ii. A very little (1)

iii. A moderate amount (2)

iv. Quite a lot (3)

v. A great deal (4)

vi. A very great deal (5)

e. In general, during t he past week, how much of t he time did your wheeze?
i. Not at all (0)

23
ii. Hardly any of the time (1)

iii. A moderate amount of the time (2)

iv. A lot of the time (3)

v. Most of the time (4)

vi. All the time. (5)

f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
i. None (0)

ii. 1-2 puffs most days (1)

iii. 3-4 puffs most days (2)

iv. 5-8 puffs most days (3)

v. 9-12 puffs most days (4)

vi. 13-16 puffs most days (5)

vii. More than 16 puffs most days.(6)

To be completed by a member of the clinic staff.


8. FEV1 prebronchodilator……………….. 0 > 95% predicted
1 95-90%
FEV1 % predicted…………………….. 2 89-80%
3 79-70%
FEV1 % predicted………………….… 4 69-60%
5 59-50%
6 <50% predicted
PHYSIOLOGICAL ASSESSMENT (To be monitored fortnightly.)
9. Blood pressure Systolic (mm Hg.)/Diastolic (mmHg.):
10. Pulse rate (per minute)
11. Temperature

24
12. Respiratory rate (per minute)
13. FEVI (Spirometery) —————————————————— (% 0f predicted value)
14. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE

Good control (1) Poor control (2)

15. VAS (Visual Analogous Scale)

Red Zone (1) Yellow Zone (2) Green Zone (3)

Serious trouble with Mild Trouble with No Trouble with


Asthma Asthma Asthma

16. Overall impression of well-being by the Subject:

Improved (1) No change (2) Deteriorated (3)

17. Status of the patient:

Continuing (1)

Drop out (2)

Reason a) self withdrawn by the patient (1)

b) Physician wants to withdrawn the patient (2)

Date: ______________ Signature of Investigator __________________

25
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM IIIA - ADVERSE EVENTS RECORD FORM
(0, 15, 30 days)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

ADVERSE EVENTS

Do the patients have any symptoms with medication in trial groups? Yes (1) No (0)

Please complete all sections & enter l approximate information in numbers in open boxes
1 2 3 4

Adverse
Experience

Date started

Date

26
Time

Date stopped
Pattern

Isolated-1
Intermittent-2
Continuous-3
Severity

Mild-1
Moderate-2
Severe-3
*Mild-No interference with usual activity. *Moderate-Significant interference with usual
activities. *Severe-Prevents usual activities.
Serious*
Yes-1
No-2
Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient
hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.
Relationship to study
medication

Unrelated-1
Possible-2
Probable-3

27
Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs
could have been produced by the patients clinical stage, intermittent illness, trauma, accidents
etc:

Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;

Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patients clinical state.

28
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
FORM IV– LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at
‘0’ week and Kidney, Liver function tests 0th, 15th and 30th day only)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

Urine Examination

7. Routine____________

8. Microscopic___________

Blood Examination

9. DC: P (%) ________ L (%) ________ E (%) ________ M (%) ________B (%) _______

10. Hb (g/dl) _________.

11. ESR (1st hour.)(mm) __________

12. Blood Sugar:

Fasting (mg./dl) _______________

PP. (mg. /dl) _______________

13. Uric acid (mg./dl) _____________

29
Kidney function tests (Sl.No.14 & 15)

14. B. Urea (mg. /dl) _______________

15. S. Creatinine (mg. /dl) ______________

Liver function tests (Sl.No.16 to 22)

16. Total proteins (g. /dl) _______________

17. Albumin (g. /dl) _______________

18. Globulin (g. /dl) _______________

19. A/G Ratio _______________

20. S. Bilirubin (mg. /dL)

Total

Direct

Indirect

21. SGPT. (IU/L)

22. SGOT (IU/L)

23. Alk. Phosphates (KA units) _______________

24. X-ray chest PA View (‘0’ WEEK only)

25. ECG (0, 4 week & if symptoms suggest sos)

26. Any other Remarks _________________________________________________

Date: ________________ Signature of the Investigator: _______________________

30
ASSESSMENT OF SAFETY AND THERAPEUTIC
EFFICACY OF SHIRISHADI KWATHA IN THE
MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

31
Blank

32
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY AND THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SHWASA)

I. BACKGROUND
Tamaka Shwasa1 (Bronchial asthma) is prevalent all over the world. It is characterized
by chronic airway inflammation and increased airway responsiveness resulting in symptoms of
wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow
limitations usually reverses spontaneously or with treatment. The available treatment in modern
medical science like bronchodilators, steroids even in the form of inhalers and leukatriens modifiers
have made tremendous success in providing instant or symptomatic relief in Bronchial asthma. But
there is recurrent acute exacerbation and remissions and treatment has many side effects like
nausea, vomiting, tremor, huskiness of voice, disturbance of hypothalamus – pituitary –adrenal axis.
In Ayurveda, Shireeshadi kwatha (3) which has been in practice as well as has shown
anti-asthmatic effect in the clinical studies conducted in BHU, Varanasi & in clinical units of Central
Council for Research in Ayurveda and Siddha, Department of ISM & H, Ministry of Health &
Family Welfare, New Delhi.
The toxicity studies done at the Industrial Toxicology Research Center(CSIR), Lucknow,
December, 2002 report showed no acute and sub-acute toxicity of Shirisadi kwath at the dose of
2500 mg. per Kg. Single dose (acute oral) and 200 ml. per kg. per day (subacute oral 1ml=0.5
mg.) in mice.

References
1. Davidson’s Principle and Practice of Medicine 19th Edition pages 513-521
2. Charaka Samhita, Chikitsa Sthana, Hikka swasha, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath,
Choukhamba Orientalia, Varanasi
3. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 51, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
4. Harrison’s Principle of Internal medicine: 15th Edition pages 1456-1460
5. Annual Reports, P.R.U., Haffkine Institute, Bombay
6. Annual Report, P.R.U., L.H.M.C., New Delhi.

33
II. OBJECTIVE
Primary Objective:
To evaluate the comparative efficacy of Shireeshadi kwatha & sustained-release
theophylline in the mild persistent asthma.
Secondary Objective:
To evaluate the safety of Shireeshadi kwatha in the patients of mild persistent asthma.
III. CENTRE: CCRAS centers in collaboration with other centers
IV. SAMPLE SIZE AND METHODS
Sample Size: 250 (125 patients in each group)
Treatment:
A. Pre-treatment period:
There will be wash out period of two week (any oral bronchodilators should be
withdrawn gradually in both groups and patients in both groups will be allowed to take beta-2
agonist inhalation s.os.).
B. Treatment period:
1. Trial drugs:
i) Shirishadi Kwatha(Decoction)
Shirishadi kwatha (50 gm.) contains Albizzia Lebbeck (Shirish) , Solanum Surattence
(Kantkari), Adhatoda Vasica leaves (Vasa), Hedychium Spicatum (Shati) and equal in quantity.
Method of preparation of decoction: 50 gm. powder should be mixed in 400 ml of
water and reduced to 100 ml. by boiling on low flame and constant stirring. It should then be
filtered.
Dose & Duration: 100 ml in three divided doses daily for ninety days
2. Control Drug: theophylline sustained release tablet.
Dose: 400mg orally after dinner once daily.
Salbutamol inhaler 100 mcg.2 puffs sos is allowed if patient may feel acute
Breathlessness in both groups in pretreatment & treatment period. If patients ave
constipation, patient can take Vyaghri Haritaki 3-6 gm. with lukewarm water.
Design of the study – randomized controlled clinical study.

34
Duration of the study – 3 months drug therapy.
Period of Study: 3 months drug treatment period. Total duration will be 1 years to
complete the trial. Recruitment of the patients up to seven months, treatment period for three
months in both groups and data will be analyzed in next two months.
V. CRITERIA FOR INCLUSION
1. Age between 18 years to 40 years.
2. Both the sexes with equal distribution with or without rhinitis.
3. Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6
months.
4. Asthmatics who meet reversibility criteria (15% improvement in FEV I after beta-2
agonist inhalation).
5. Symptoms/exacerbation (Wheeze, cough and breathlessness) greater than weekly and less
than daily in frequency.
6. Night symptoms > twice per month but less than once a week.
7. FEV1 > 80% of the predicted value.
8. Never smokers.
VI. CRITERIA FOR EXCLUSION
1. Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
2. FEV<80%.
3. Age below 18 years and more than 40 years
4. Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis,
Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis,
interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia, Loffler
s disease & Allergic Bronchopulmonary Aspergillosis etc
5. Diabetes Mellitus and Hypertension.
6. Severe renal/Hepatic disease
7. HIV positive cases
8. Pregnant/lactating mother
9. Patient who need Salbutamol inhaler daily.

35
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per the
proforma (Forms I & IA). Clinical and physiological assessment will be done before treatment
and fortnightly during treatment period and at the end of the treatment. The laboratory
investigations will be carried out as per recorded in the proforma.
IX. STATISTICAL ANALYSIS
Data collected on scores of ACQ (ANNEX-1) & VAS (ANNEX-2) based on which
progress of treatment will be analyzed using appropriate statistical tools.
X. CRITERIA FOR ASSESSMENT
The assessment of progress & outcome of treatment are assessed on the basis of
improvement in the score of ASTHMA CONTROL QUESTIONNAIRE (Anexxure-1) and VAS
(ANNEX-2) and safety evaluation will be made on the basis of serial recording of the adverse
events and Liver and Kidney function tests as per recorded in the proforma II B and III.
XI. TRIAL MONITORING AND DATA ANALYSES
The monitoring of progress of the trial and data analysis will be undertaken by CCRAS,
Hqrs., New Delhi.
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating Center’s should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial. The study will be
conducted in accordance with Good Clinical Practice. This incorporates principles laid down in
the Declaration of Helsinki.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs…../- per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th, 75th and 90th days (7 times).
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory

36
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

37
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Safety & Therapeutic Efficacy of Shireeshadi kwatha in the
management of Mild Persistent Asthma (Tamaka Swasa).

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

38
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
PATIENT INFORMATION SHEET

What is the study about?


The available treatment for bronchial asthma in modern medical science like broncho-
dilators, steroids even in the form of inhalers have made tremendous success in providing instant
or symptomatic relief but there is recurrent acute exacerbation and remission. In Ayurveda, many
drugs seem to possess a anti asthmatic effect of which Shirishadi Kwatha that have been in
practice as well as have shown anti-asthmatic effect have been taken up for the study.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 3 months to complete. During this
period, you are expected to visit the hospital 6 times for clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, ECG and an X-ray, Blood and urine samples will also be taken. This is to
make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 3 months.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

39
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the person: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________

CRITERIA FOR INCLUSION Yes (1) No (0)

7. Age between 18 years to 40 years

8. Both the sexes with equal distribution with or without rhinitis.

9. Mild persistent cases of Asthma (as per WHO


GINA Guideline) of duration more than 6 months.

10. Asthmatics who meet reversibility criteria


(15% improvement in FEV I after Beta-2 agonist inhalation.)

11. Symptoms/exacerbation (Wheeze, cough and breathlessness)


greater than weekly and less than daily in frequency.

12. Night symptoms > twice per month.

13. FEV1 > 80% of the predicted value.

40
14. Ever smoker.

CRITERIA FOR EXCLUSION Yes (1) No (0)

15. Mild intermittent, Moderated persistent, severe


persistent to severe Asthma.

16. FEV<80%

17. Age below 18 years and more than 40 years

18. Dyspnoea due to other disease like Left ventricular


failure, COPD (Chronic Bronchitis, Emphysema),
Upper respiratory tract obstruction, Bronchiectasis,
cases of tuberculosis, interstitial lung disease/occupational
Lung disease, tropical pulmonary eosinophilia etc.

19. Uncontrolled Diabetes Mellitus and Hypertension.

20. Any other systemic disorder

21. HIV positive cases

22. Pregnant/lactating mother

23. Asthmatics that need daily Salbutamol inhaler.

A patient is eligible for admission to the trail

If Sl.No.7-14 is ‘Yes’ and Sl.No.15-23 are ‘No’

Date: ____________ Signature of the Investigator______________

41
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

8. Occupation: Desk work(1) Field work (2) Student (3)

Housewife (4) Others (5)

Indicate nature of work: ...........................................................................

9. Income per capita per month (in Rs.)

Less than Rs.5000/- (1) More than Rs.-5000/- (2)

Chief complaint with duration (if any) in months

Present (1) Absent (0) If present,


then duration
10. Breathlessness

42
11. Paroxysm of breathlessness

12. Wheezing

13. Cough

14. Expectoration of sputum

15. Nasal symptoms

16. Tightness in chest

17. Night symptoms

Yes (1) No (0) No. of attack


Per month

a). Breathlessness,

b). Wheezing

c). Awakening in the night)

Present (1) Absent (0) If present,


then duration

18. Skin allergy

History of Present illness:

19. History of Nasal symptoms

Yes (1) No (0)

1. Sneezing

2. Running nose

3. Blocked nose

4. Post nasal drip

5. History of throat clearing

If yes then specify: ...............................................................................................

43
Treatment History

Yes (1) No (0)

20. Traditional/Homeopathic Medicine

21. Modern Medicine

History of Past illness:

Yes (1) No (0)

22. History of skin allergy

23. Repeated colds

If yes indicate frequency of attack in months……………………………..

24. Family History of Asthma Present (1) Absent (0)

If present then specify:

Parents (1) Sibling (2) Both (3)

Personal History:

25. Diet: Veg (1) Non-Veg (2)

26. Any food/drink aggravated the symptoms Yes (1) No (0)

If yes, specify: ……………………………………………

27. Sleep Satisfactory (1) Unsatisfactory (2)

28. Constipation No (0) Yes (1)

History of Environmental

Yes (1) No (0)

29. Tobacco smoking exposure

If yes specify whether it aggravated the symptoms or not: …………………………

44
30. Tobacco chewing

If yes specify: (a) Quantity _____________

(b) Total duration in years: _____________

31. Betel chewing

32. History of alcohol intake:

Occasional (1) : 1

Regular (2) : 2

Never (3) : 3

33. Prakriti:

Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja (6)

Sama (7)

Physical Examination

34. Height (cm): ____________

35. Weight (kg) ____________

36. B.M.I
{ Weight (kg.)
Height (meters) 2 } ____________

37. Pulse (per min) ____________

38. Blood Pressure (mm Hg) ____________

39. Body temperature (o F) ____________

40. Respiration rate (per min) ____________

41. Cyanosis ____________

42. Clubbing nails ____________

45
43. Edema ____________

Absent (0) Present (1)

44. Pallor

45. Lymphadenopathy

If present, specify General(1) Local (2)

(Area)__________

Systemic Examination

46. Respiratory System Normal(1) Abnormal (2)

Shape of chest:

Auscultation

Ronchi: Present (1) Absent (2)

47. CVS Normal (1) Abnormal (2)

If abnormal, details____________________________________________

48. Appetite Normal (1) Abnormal (2)

If abnormal, details ______________________________________________

Date: …………….. Signature of Investigator: ……………………………….....

46
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
FORM III -CLINICAL AND PHYSIOLOGICAL ASSESSMENT
(0, 15, 30, 45, 60, 75, 90 days)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________

SYMPTOMS: The following clinical symptoms (Serial no 1-5) along with question on beta
–2 agonist use and another on FEV1% predicted are noted as per ACQ.

ASTHMA CONTROL QUESTIONNAIRE (ACQ)*

a. On average, during the past week, how often were you woken by your asthma during the
night?

i. Never (0)

ii. Hardly ever (1)

iii. A few times (2)

iv. Several times (3)

v. Many times (4)

vi. A great many times (5)

47
vii. Unable to sleep because of asthma’ (6)

* To be translated in Regional language

b. On average, during the past week, how bad were your asthma symptoms when you wok up
in the morning?

i. No symptoms (0)

ii. Very mild symptoms (1)

iii. Mild symptoms (2)

iv. Moderate symptoms (3)

v. Quite severe symptoms (4)

vi. Severe symptoms (5)

vii. Very severe symptoms (6)

c. In general, during the past week, how limited were you in your activities because of your
asthma?

i. Not limited at all (0)

ii. Very slightly limited (1)

iii. Slightly limited (2)

iv. Moderately limited (3)

v. Very limited (4)

vi. Extremely limited (5)

vii. Total limited (6)

d. In general, during the past week, how much shortness of breath did you experience because
of your asthma?

i. None (0)

ii. A very little (1)

iii. A moderate amount (2)

48
iv. Quite a lot (3)

v. A great deal (4)

vi. A very great deal (5)

e. In general, during the past week, how much of the time did your wheeze?

i. Not at all (0)

ii. Hardly any of the time (1)

iii. A moderate amount of the time (2)

iv. A lot of the time (3)

v. Most of the time (4)

vi. All the time. (5)

f. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?

i. None (0)

ii. 1-2 puffs most days (1)

iii. 3-4 puffs most days (2)

iv. 5-8 puffs most days (3)

v. 9-12 puffs most days (4)

vi. 13-16 puffs most days (5)

vii. More than 16 puffs most days. (6)

* To be completed by a member of the clinic staff.

8. FEV1 prebronchodilator…………………..…… 0 > 95% predicted

1 95-90%

FEV1 % predicted….…………….……........ 2 89-80%

3 79-70%

49
FEV1 % predicted………………………...... 4 69-60%

5 59-50%

6 <50% predicted

PHYSIOLOGICAL ASSESSMENT (To be monitored fortnightly.)

9. a. Blood pressure

i. Systolic (mmHg.)

ii. Diastolic (mmHg.)

b. Pulse rate (per minute)

c. Temperature

d. Respiratory rate (per minute)

e. FEVI (Spirometery): ___________________________

(% 0f predicted value)

10. Overall clinical assessment by the Doctor on the basis of ASTHMA CONTROL
QUOTIONNAIRE

Good control (1) Poor control (2)

11. VAS (Visual Analogous Scale)

Red Zone (1) Yellow Zone (2) Green Zone (3)

Serious trouble with Mild Trouble with No Trouble with


Asthma Asthma Asthma

50
12. Overall impression of well-being by the Subject:

Improved (1) No change (2) Deteriorated (3)

13.. Status of the patient:

Continuing (1)

Drop out (2)

Reason a) self withdrawn by the patient (1)

b) Physician wants to withdrawn the patient (2)

Date: ______________ Signature of Investigator __________________

51
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM III A - ADVERSE EVENTS RECORD
(0, 15, 30, 45, 60, 75, 90 days)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address Permanent postal address with phone number and email if any.
_______________________________________________________________________
_______________________________________________________________________

ADVERSE EVENTS

8. Does the patient have any symptoms with medication in trial group? Yes(1) No(0)

Please complete all sections & enter l approximate information in numbers in open boxes

1 2 3 4

Adverse
Experience

52
Date started

Date

Time

Date stopped

Pattern

Isolated-1

Intermittent-2
Continuous-3

Severity

Mild-1

Moderate-2
Severe-3

*Mild-No interference with usual activity. *Moderate-Significant interference with usual


activities. *Severe-Prevents usual activities.

Serious*

Yes-1

No-2

Serious ADE is defined as fatal, life-threatening, permanently, disabling requires inpatient


hospitalization or as a congenital anomaly, cancer or overdose. If yes, please till serious
Adverse experiences report form provided. In case of Serious adverse event sponsor should
be informed immediately telephonically.

53
Relationship
to study
medication

Unrelated-1
Possible-2
Probable-3

Unrelated: A reaction that does not follow a reasonable temporal sequence from the
administration of the drug; or a known adverse reaction pattern of the suspected drugs could
have been produced by the patients clinical stage, intermittent illness, trauma, accidents etc:

Possible: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug but could have been produced by the patients
clinical stage or other modes of therapy administered to the patients;

Probable: follows a reasonable temporal sequence from administration of the drug; follows a
known response pattern to the suspected drug; that could not be reasonably explained by the
known characteristics of the patient's clinical state.

54
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF SAFETY& THERAPEUTIC EFFICACY OF SHIRISHADI
KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA
(TAMAKA SWASA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(Before and after the treatment except Sl.No.23 which is to be done at ‘O’
week and Kidney, Liver function tests O, 6th and 12th week only.)

1. Centre: ………………..……….

2. Sr. No. of the subject: ……………………………........…………………………………

3. Name of the Subject: ...........................................................................................................

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Date of Assessment ___________________

7. Urine Examination

Routine____________ Microscopic___________

8. C (Cells/Cmm.)_____________________

9. DLC: P(%)______ L(%)______ E (%)______ M (%)______ B (%)______

10. Absolute Eosinophil count ————————————

11. Hb (g/dl): __________

12. ESR (1st hour.)(mm) __________

13. Blood Sugar:

Fasting (mg./dl) __________

PP. (mg./dl) __________

14. Uric acid (mg./dl)_____________

55
Kidney function tests (Sl.No.14 & 15)

15. B. Urea (mg./dl) _______________

16. S. Creatinine (mg./dl) _______________

Liver function tests (Sl.No.16 to 22)

17. Total proteins (g./dl) _______________

18. Albumin (g./dl) _______________

19. Globulin (g./dl) _______________

20. A/G Ratio _______________

21. S. Bilirubin(mg./dL)

Total: ___________

Direct: ___________

Indirect: ___________

22. SGPT. (IU/L)

23. SGOT (IU/L)

24. Alk. Phosphates(KA units) _______________

25. X-ray chest & PNS(‘0’ WEEK only)

26. ECG(0, 12 WEEK & if symptoms suggest SOS)

27. Any other Remarks: ______________________________________________

Date: ……………. Signature of the Investigator: ………………………........

Place: ……………

56
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-1: ASTHMA CONTROL QUESTIONNAIRE 1

SYMPTOMS: The following clinical symptoms (Serial no 1-5) alongwith question on beta –2
agonist use and another on FEV1% predicted are noted as per ACQ.

Please answer Question 1-6


1. On average, during the past week, how often were you woken by your asthma during the
night?
0. Never (0)
1. Hardly ever (1)
2. A few times (2)
3. Several times (3)
4. Many times (4)
5. A great many times (5)
6. Unable to sleep because of asthma’ (6)
2. On average, during the past week, how bad were your asthma symptoms when you woke
up in the morning?
0 No symptoms (0)
1 Very mild symptoms (1)
2 Mild symptoms (2)
3 Moderate symptoms (3)
4 Quite severe symptoms (4)
5 Severe symptoms (5)
6 Very severe symptoms (6)
3. In general, during the past week, how limited were you in your activities because of your
asthma?
0 Not limited at all (0)

57
1 Very slightly limited (1)
2 Slightly limited (2)
3 Moderately limited (3)
4 Very limited (4)
5 Extremely limited (5)
6 Total limited (6)
4. In general, during the past week, how much shortness of breath did experience because of
your asthma?
0. None (0)
1. A very little (1)
2. A moderate amount (2)
3. Quite a lot (3)
4. A great deal (4)
5. A very great deal (5)
5. In general, during the past week, how much of the time did your wheeze?
0. Not at all (0)
1. Hardly any of the time (1)
2. A moderate amount of the time (2)
3. A lot of the time (3)
4. Most of the time (4)
5. All the time. (5)
6. On average, during the past week, how many puffs of short-acting bronchodilator (e.g.
Ventorlin) have you used each day?
0. None (0)
1. 1-2 puffs most days (1)
2. 3-4 puffs most days (2)
3. 5-8 puffs most days (3)
4. 9-12 puffs most days (4)

58
5. 13-16 puffs most days (5)
6. More than 16 puffs most days.
To be completed by a member of the clinic staff.
7. FEV1 prebronchodilator……………...... 0 > 95% predicted
1 95-90%
FEV1 % predicted…….……….....… 2 89-80%
3 79-70%
FEV1 % predicted………………...... 4 69-60%
5 59-50%
6 < 50% predicted
Patients are asked to recall their symptoms & short-acting beta-2 agonist use during the previous
week. All seven questions as mentioned in ACQ are scored on a seven point scale (0=good
control,6=poor control) ,and the overall score is the mean of seven responses.

1: Elizabeth F.Juniper, Paul M et al. Am J Respir Crit Care Med Vol 162 pp1330-34, 2000

59
PROTOCOL FOR ASSESSMENT OF THERAPEUTIC EFFICACY OF
SHIRISHADI KWATHA IN THE MANAGEMENT OF TAMAKA SHWASA
(BRONCHIAL ASTHMA)
Annexure-II

Name of Centre: ___________________________________________________________

Name: ___________________________________ Age: _________ Gender: __________

Date:-________ C.R No. _________

VISUAL ANALOGUE SCALE (VAS)1

Red Zone (1) Yellow Zone (2) Green Zone (3)

Serious trouble with Mild Trouble with No Trouble with


Asthma Asthma Asthma

Scale: 100 mm long 2

Green zone 80 mm-100 mm “No trouble with asthma” 2

Yellow zone 79 mm-50 mm “Mild trouble with asthma” 2

Red zone Below 50 mm “Serious trouble with asthma”2

References
1. J. Asthma 2003; 40:27-39
2. National Heart, Lung, and Blood Institute, Publication No.97-4051, Expert Panel Report II, 1997.

60
GASTRO INTESTINAL SYSTEM

SECTION - II

61
Blank

62
CLINICAL VALIDATION OF BILWAMAJJA CHURNA
IN KAPHAJA PRAVAHIKA (IBS)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

63
Blank

64
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)

I. BACKGROUND
Kaphaja Pravahika1 (vis-à-vis Irritable bowel syndrome) is a disease of the
Purishavaha srotas, caused due to excessive intake of unctuous and heavy foods and is
characterised by the association of excessive mucous in the stool along with abdominal pain,
discomfort and bloating.
According to allopathic system of medicine Irritable bowel syndrome (IBS) is a blanket
term for a variety of diseases causing discomfort in the gastro-intestinal tract. It is a functional
bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of
bowel habits in the absence of any organic cause. In some cases, the symptoms are relieved by
bowel movements. Certain psychological conditions are also more common in those with IBS.
Treatments for IBS includes attempt to relieve symptoms, including dietary adjustments, medication
and psychological interventions. Patient education and a good doctor-patient relationship are also
important.
Owing to the complications and adverse effects of current modern medication to manage
such condition, need is felt for search of safe /effective Ayurvedic oral dosage forms with scientific
parameters. Keeping the gravity of the situation and the public health needs in view, the council has
initiated scientific studies on Bilwamajja Churna, a promising herbal drug that is being successfully
prescribed by Ayurvedic physicians without any side effects since centuries in Kaphaja Pravahika
(IBS).
II. OBJECTIVE
To assess the effect of Bilwamajja Churna in reducing the signs and symptoms of Kaphaja
Pravahika (IBS)

References
1. Charaka Samhita, Chikitsa Sthana, Chapter–17, Vidyotini Hindi Vyakhya by Pt. Kashinath, Choukhamba
Orientalia, Varanasi
2. Ambika Dutta Sashtri (1989), Susruta samhita (text with Hindi commentary), Uttara Tantra Chapter 40,
VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
3. Harrison’s Principle of Internal medicine: 17th Edition, Vol – 1, Page: 970

65
III. CENTERS
CCRAS identified Centers
IV. SAMPLE SIZE AND METHODS
No. of Groups : One
Sample size : 30 Subjects per center
Trial Drug /Dosage /Duration : Bilwamajja churna 3 gms twice daily after
food for 30 days with warm water for 30
days and follow-up for another 15 days
without medicine.
Design of the study : Open trial
Total period of the study : One year
Follow up study: : For a period of 15 days at the interval of
7 days after completion of the therapy.
V. CRITERIA FOR INCLUSION
1. Age between 15 and 60 years
2. History of frequent passing of little quantity of stool along with mucous and tenesmus.
3. The frequency of passing of stool should be 3 times or more in 24 hours.
4. Stool examination should be positive either with E.H. cyst or E.coli or both.
VI. CRITERIA FOR EXCLUSION
1. Age below 15 years and above 60 years.
2. Stool test negative for E.H. cyst and/or E.coli.
3. Mixed infection with other parasites like round worms, hook worms etc.
4. Complicated with tuberculosis, malignancy or hepatic abscess.
5. Associated with other grave systemic diseases like cardiac disorders, jaundice, diabetes
mellitus etc.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial, if any serious condition or any serious adverse events which
requires urgent treatment or if subjects themselves want to withdraw from the study, such subjects
may be withdrawn from the trial.

66
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening and history along with physical examination of the subjects will
be recorded as per case report form I & II respectively. Clinical and physiological assessment in
form III and laboratory investigations in form IV will be done at 0, 15th & 30th days.
Consolidated data on periodical observation will be recorded in case report form-V.
IX. ASSESSMENT CRITERIA :

Sl. Frequency of passing of stool Grade Score


No. motions per 24 hours
1 Up to Two Zero 0
2 3-5 I 2
3 6-8 II 4
4 9 & above III 6

Sl. Tenesmus / Abdominal pain Grade Score


1 Mild (Tolerable by the patient) Zero 0
2 Moderate (Twisting pain in abdomen
but not rolling type) I 2
3 Severe (Un tolerable and rolling type) II 4

Sl. Bloating Grade Score


1 Present Zero 0
2 Absent I 2

Sl. Stool examination for parasite Grade Score


(E.H / E.Coli)
1 Present Zero 0
2 Absent I 2

67
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail (ccras_stat@nic.in).
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Institutional Ethical Committee (IEC): The proposal will be placed before
Institutional Ethical Committee (IEC) of trial center for getting clearance certificate before the
project is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in case of
any adverse events occur. The data will be reviewed for every 20 participants included into the
study and administered the trial drugs. The research team will report immediately to the PI and
Data Monitoring Board, any life threatening conditions whether they are perceived to be study
related or not. The Board decides whether the adverse effects warrant discontinuation of the study
protocol. Protocols will be written and approved for the treatment of study related adverse events
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……./- per visit will be paid to subject selected in the study.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
1. Stool:
Routine & Microscopic
E.H. Cyst & E. Coli

68
Mucous
Occult blood
Ingested Vegetable particles
2. Urine:
Routine & Microscopic
3. Blood:
TLC
DC
Hb%
ESR
FBS
Mx Test

69
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician about the purpose of
the clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical validation of bilwamajja churna in kaphaja pravahika (IBS)”

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

70
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
PATIENT INFORMATION SHEET

What is the study about?


Kaphaja Pravahika (which is consider as Irritable bowel syndrome as per allopathic
system of medicine) is a disease of the Purishavaha srotas, caused due to excessive intake of
onctuous and heavy foods and is characterised by the association of excessive mucous in the stool
along with abdominal pain, discomfort and bloating.
According to allopathic system of medicine Irritable bowel syndrome (IBS) is a blanket
term for a variety of diseases causing discomfort in the gastro-intestinal tract. It is a functional
bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of
bowel habits in the absence of any organic cause. In some cases, the symptoms are relieved by
bowel movements. Certain psychological conditions are also more common in those with IBS.
Owing to the complications and adverse effects of current modern medication to manage
such condition, need is felt for search of safe /effective Ayurvedic oral dosage forms with scientific
parameters. Keeping the gravity of the situation and the public health needs in view, the council has
initiated scientific studies on Bilwamajja Churna, a promising herbal drug, which is being
successfully prescribed by Ayurvedic physicians without any side effects since centuries in Kaphaja
Pravahika (IBS).
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately one month (30 days). During
treatment period, you are expected to visit the hospital three times i.e. on 0,7th, 15th and 30th day
for clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc. are
noticed during the treatment period, this should be brought to the notice of the Principal
Investigator.

To be translated into regional language.

71
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 15 to 60 years

2. History of frequent passing of little quantity of stool

3. along with mucous and tenesmus.

4. The frequency of passing of stool should be 3 times

5. or more for 24 hours

6. Stool should be positive either with E.H. cyst or

7. E. Coli or both

CRITERIA FOR EXCLUSION Yes (1) No (0)

8. Age below 15 years and above 60 years

9. Stool test negative for E.H. cyst and/or E.coli

72
10. Mixed infection with other parasites like round worms,
hook worms etc

11. Complicated with tuberculosis, malignancy or hepatic abscess.

12. Associated with other grave systemic diseases like cardiac


disorders, jaundice, diabetes mellitus etc

A patient is eligible for admission to the trail

If Sl.No.1-4 is ‘Yes’ and Sl.No.5-12 are ‘No’

Date: __________________ Signature of the investigator: ___________________

73
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: …………………………...............…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

10. Annual Income of the family Rs.

Less than Rs.60, 000/- (1) More than Rs.60, 000/- (2)

Total number of members sharing the income:

11. History of previous treatment

12. History of present illness:

74
Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)

13. Frequent passing of stool

14. Tenesmus

15. Passing of stool with mucous

16. Abdominal pain

17. Bloating

18. Alteration of bowel habits

19. Previous episodes

20. Onset of disease Acute (1) Chronic (2)

21. Treatment given so far:

Traditional Medicine (1) Modern Medicine(2)

PERSONAL HISTORY

22. Diet Veg (1) Non-veg (2)

23. Digestion (Agni) Proper (1) Improper (2)

24. Sleep Normal (1) Disturbed (2)

25. Addiction Yes (1) No (0)

If yes, specify ……………………………………………………………………..

26. Bowel habit Regular (1) Irregular (2)

If irregular, specify …………………………………………………………………….

27. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja(6)

Sannipataj (7)

75
28. Manasa Prakriti: Sattva (1) Rajas (2) Tamas (3)

Sattva-Rajas(4) Rajas-Tamas(5) Sattva-Tamas (6)

Sama (7)

PHYSICAL EXAMINATION

29. Built Lean (1) Medium (2) Heavy (3)

30. Gait Normal (1) Abnormal (2)

31. Body weight _________Kg. Height in cms. ____________

32. Body temperature ____________oF

33. Blood pressure (in sitting posture of right upper limb):

Systolic _______mm/Hg Diastolic _______mm/Hg

34. Pulse rate__________/min. (Radial pulse of right upper limb)

35. Respiration rate _________/min.

Present (1) Absent (0)

36. Pallor

37. Jaundice

38. Koilonychia

39. Lymphadenopathy

SYSTEMIC EXAMINATION

Normal (1) Abnormal (2)

40. Digestive system

If Abnormal, specify abnormalities_________________________

41. CNS

If abnormal, specify abnormalities_________________________

76
42. CVS with chest

If abnormal, specify abnormalities_____________________________

43. Uro-genital system

If abnormal, specify abnormalities_____________________________

44. Respiratory system

If abnormal, specify abnormalities_____________________________

45. Abdomen Palpable (1) Not palpable (2)

i) Liver

ii) Spleen

Normal Abnormal

SAMPRAPTI (PATHOGENESIS)

Vata (1) Pitta (2) Kapha (3)

46. Anubandhya dosha

47. Anubandh dosha

48. Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra (7) Ojas (8)

49. Srotas: Rasavaha (1) Raktavaha(2) Mamsavaha (3)

Medovaha(4) Annavaha(5) Purishavaha (6)

Mutravaha(7)

Date: _______________ Signature of the investigator: ________________________

77
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 7th, 15th, 30th day)
Separate form should be used on each visit
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........………………………….………

4. Name ...................................................................... Age ..................... Sex .......................

5. Date of Assessment ..............................................................................................................

Chief complaints with duration (in days) Yes (1) No (0) if yes, Duration
(in days)

6. Frequent passing of stool

7. Tenesmus

8. Passing of stool with mucous

9. Abdominal pain

10. Bloating

11. Alteration of bowel habits

12. Other symptoms ( if any)

Any other, specify______________________________________

Date: ______________ Signature of investigator___________________

78
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
(On Day 0, 7th, 15th, 30th day)
CASE REPORT FORM IV-PERIODICAL OBSERVATION AND LABORATORY
ASSESSMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment

8. Stool examination

Routine Microscopic

Ova/Cyst

Mucous,

Vegitative cells

9. Urine Examination

Routine Microscopic

Blood

10. TC (Cells/Cu. mm.): _______________

11. DC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)

79
12. ESR (mm / 1st hour.) __________

13. Hb (g/dl) ____________________

Liver function tests

14. S. Bilirubin

• Total (mg/dl)

• Direct (mg/dl)

15. SGPT (IU/L)

16. SGOT (IU/L)

17. S. Alkaline phosphatase (U/L)

18. S. Proteins (Total) (g/dl)

• Albumin (g/dl)

• Globulin (g/dl)

Renal function tests

19. Blood urea (mg/dl)

20. S.Creatinine (mg/dl)

Specific Investigations:

21. Stool culture

22. Mx Test

23. FBS

Date: _____________ Signature of investigator _______________________

80
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF BILWAMAJJA CHURNA IN KAPHAJA
PRAVAHIKA (IBS)
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment

Sl Subjective/ objective 0 day/BT 7th dayDt. 15th dayDt. 30th day/AT


Parameters Dt. Dt. Dt. Dt.
1. Frequent passing of
stool
2. Tenesmus
3. Passing of stool with
mucous
4. Abdominal pain
5. Bloating
6. Alteration of bowel
habits
7. Adverse reactions
Burning sensation in Not
abdomen applicable
Nausea Not applicable

81
Diarrhoea Not applicable
Skin rashes Not applicable
8. TC (Cells/Cu. mm.) Not applicable
9. DCLLLL P _____% P _____% P _____%
L _____% Not L _____% L _____%
E _____% applicable E _____% E _____%
10. ESR (mm / 1st hour.) Not
applicable

Sl Subjective/ 0 day/ 7th day 15th day 30th day/


objective BT Dt. Dt. Dt. AT Dt.
Parameters
11. Hb (g/dl)
12. Liver function
tests
13. S. Bilirubin

a. Total
(mg/dl) Not Not
b. Direct applicable applicable
(mg/dl)
14. SGPT (IU/L)
15. SGOT (IU/L)
16. S. Alkaline
phosphatase
(U/L)
17. S. Proteins
(Total) (g/dl)
18. Albumin (g/dl)
19. Globulin (g/dl)
20. Renal function
tests
21. Blood urea Not Not
(mg/dl) applicable applicable

82
22. S. Creatinine
(mg/dl)
23. Urine
Examination
Routine Not
applicable
Microscopic Not
applicable
24. Stool
Examination
Occult Blood Not Not
applicable applicable
Ova/Cyst Not Not
applicable applicable
Mucous Not Not
applicable applicable
Vegetative Not Not
cells applicable applicable

8. Overall clinical assessment

Improved (1) No change (2) Deteriorated (3)

9. Overall impression of well being by the Subject:

Improved (1) No change (2) Deteriorated (3)

10. Status of the subject:

Completed (1)

Drop out (2) Reason: _____________________________

Died (3) Cause: _______________________________

Date: ______________ Signature of investigator ______________

83
Blank

84
MULTICENTRIC OPEN CLINICAL TRIAL OF
PALASABEEJA CHURNA IN KRIMI ROGA
(GANDUPADA KRIMI)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

85
Blank

86
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)

I. BACKGROUND
Krimi Roga (Intestinal nematode infections)1 is the most common ailment which affect one
fourth to one third of the world’s population. Of these, the Gandupada Krimi (intestinal
roundworm-Ascaris lumbricoides) is the most common. Worldwide, 1.4 billion people are
infected with a lumbricoides. While the vast majority of these cases are asymptomatic, infected
persons may present with pulmonary or gastrointestinal complaints.
The rate of complications secondary to Ascariasis ranges from 11-67%, with intestinal and
biliary tract obstruction representing the most common serious sequelae. Although infection with A
lumbricoides is rarely fatal, it is responsible for an estimated 8,000-100,000 deaths annually,
mainly in children. Ascariasis predominates in areas of poor sanitation and is associated with
malnutrition, iron-deficiency anemia, and impairments of growth and cognition.
Owing to the gravity of the signs, symptoms and rate of complications caused by Ascaris,
it is need to explore and re-establish the efficacy of classical drug Palashbeeja Churna in oral
dosage form to treat the patients affected with Gandupada Krimi (A lumbricoides).
II. OBJECTIVES
1) To see the clinical efficacy of Palashbeeja Churna in the management of Gandupada
Krimi Roga (Ascariasis).
2) Observe the clinical safety of Palashbeeja Churna in the subjects affected by the
Gandupada Krimi (A lumbricoides).

References
1. Charaka Samhita, Vimana Sthana Chapter– 7, Vidyotini Hindi Vyakhya by Vd. Ambikadatta Shastry,
Choukhamba Orientalia, Varanasi
2. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
3. Davidson’s Principles and practice of Medicine, 18th Edition, 1999, Published by Harcourt Brace and
Company, pp173-174
4. Diagnosis and Treatment of diseases in Ayurveda based on Ayurveda saukhyam of Todaranand, Part-II
by Bhagawan Dash & Lalit Kashyap, 1982, pp-286
5. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi

87
III. CENTRE
Identified CCRAS Institutes.
IV. SAMPLE SIZE AND METHODS
Sample size : 40 subjects per centre
Trial Drug /Dosage /Duration : Palashbeeja Churna 750 mg-3 gm
(Dragee form) twice daily before meal for
fifteen (15) days with honey.
Design of the study : Open observational
Total period of the study : 1 year (recruitment of Subjects up to the
end of 6th Month, continuation of trial
therapy till end of 8th Month, last 4
months for compilation of data and
Statistical analysis)
V. CRITERIA FOR INCLUSION
1. Age between 5 to 20 years of either sex.
2. Presence of signs and symptoms caused by A. lumbricoids
3. Positive ova of Ascaris in the stool
4. No history of other parasitic infestation
VI. CRITERIA FOR EXCLUSION
1. Age less than 5 years and more than 20 years.
2. Negative ova of Ascaris in the stool
3. Other parasitic infestation like hook worm, giardia, EH cyst, etc.
4. Any concomitant disorder of the liver, kidneys, heart, lungs or others
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients himself want to withdraw from the study, such
subjects may be withdrawn from the trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case report form I & II. Clinical and physiological assessment in form III and

88
laboratory investigations in forms IV A, B, C will be done at 0, 8th & 15th days respectively.
Consolidated data on periodical observation will be recorded in case Report form V at 15th day.
IX. CRITERIA FOR ASSESSMENT
Changes in the signs and symptoms and absence of ova of Ascaris will be considered for
assessing the outcome of the treatment on 8th and 15th day. The safety parameters (liver and kidney
function) will be assessed at 0 and 45th day.
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board if, any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 8th day, and 15th day. (3 times)

89
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

90
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Multicentric open Clinical trial of Palasabeeja Churna in Krimi Roga
(Gandupada Krimi)”.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

91
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
PATIENT INFORMATION SHEET

What is the study about?


Krimi Roga (Intestinal nematode infections) is the most common ailment which affect one
fourth to one third of the world’s population. Of these, the Gandupada Krimi (intestinal
roundworm-Ascaris lumbricoides) is the most common. Worldwide, 1.4 billion people are
infected with A lumbricoides. While the vast majority of these cases are asymptomatic, infected
persons may present with pulmonary or gastrointestinal complaints.
The rate of complications secondary to Ascariasis ranges from 11-67%, with intestinal and
biliary tract obstruction representing the most common serious sequelae. Although infection with A
lumbricoides is rarely fatal, it is responsible for an estimated 8,000-100,000 deaths annually,
mainly in children. Ascariasis predominates in areas of poor sanitation and is associated with
malnutrition, iron-deficiency anemia, and impairments of growth and cognition.
Owing to the gravity of the signs, symptoms and rate of complications caused by Ascaris,
it is need to explore and re-establish the efficacy of classical drug Palashbeeja Churna in oral
dosage form to treat the patients affected with Gandupada Krimi (A lumbricoides).
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 15 days. During treatment period,
you are expected to visit the hospital three times i.e. on 0, 8th, and 15th day for clinical and
physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on trial treatment for 15 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

92
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 15 to 60 years

2. Presence of signs and symptoms caused by A. lumbricoids

3. Positive ova of Ascaris in the stool

4. No history of other parasitic infestation

CRITERIA FOR EXCLUSION Yes (1) No (0)

5. Age less than 5 years and more than 20 years.

6. Negative ova of Ascaris in the stool

7. Other parasitic infestation like hook worm, giardia,


EH cyst, etc.

8. Any concomitant disorder of the liver, kidneys,


heart, lungs or others.

93
A patient is eligible for admission to the trail

If Sl.No.7-10 is ‘Yes’ and Sl.No.11-14 are ‘No’

If admitted, Sr. No. of the Subject: ________________

Date: __________________ Signature of the investigator: ____________________

94
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY & SAFETY OF
VYAGHRIHARITAKI IN THE MANAGEMENT OF KASA (BRONCHITIS)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address: Permanent postal address with phone number & E-mail if any.
..............................................................................................................................................
..............................................................................................................................................

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

10. Income per capita per month in Rs.: ____________________________

11. History of previous treatment

95
12. HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)

a) Jvara (Fever)

b) Vivarnata (Discoloration)

c) Shoola (Abdominal pain)

d) Hridroga(Cardiac disorders)

e) Sadana(Fatigue)

f) Bhrama(Giddiness)

g) Bhaktadwesha (Anorexia)

h) Atisara (Diarrhoea)

i) Swasa krichhrata (Dyspnea)

j) Hrillasa (Nausia)

k) Avipaka (Indigestion)

l) Anaha (Tympanitis)

m) Karshya (Cachexia)

n) Onset of disease Acute (1) Insidious (2)

o) Previous episodes Yes (1) No (0)

p) Duration of disease

q) Treatment given so far: Traditional Medicine (1) Modern Medicine (2)

13. PERSONAL HISTORY Yes (1) No (0)

a) Smoking

b) Non-Vegetarian diet

c) Alcoholic

96
c. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja(6)

Sannipataj (7)

14. PHYSICAL EXAMINATION

a) Built Lean (1) Medium (2) Heavy (3)

b) Gait Normal (1) Abnormal (2)

c) Body weight _________Kg.

d) Body temperature ____________oF

e) Blood pressure (in sitting posture of right upper limb):

Systolic_______mm/Hg Diastolic _______mm/Hg

f) Pulse rate__________/min. (Radial pulse of right upper limb)

g) Respiration rate _________/min.

Present (1) Absent (0)

h) Pallor

i) Jaundice

j) Koilonychia

k) Lymphadenopathy

15. SYSTEMIC EXAMINATION

Normal (1) Abnormal (2)

a) CVS with chest

If Abnormal, specify abnormalities_________________________

b) CNS

If abnormal, specify abnormalities_________________________

97
c) Digestive system

If abnormal, specify abnormalities_____________________________

d) Uro-genital system

If abnormal, specify abnormalities_____________________________

e) Respiratory system

If abnormal, specify abnormalities_____________________________

f) Abdomen Palpable (1) Not palpable (2)

i) Liver

ii) Spleen

16. SAMPRAPTI (PATHOGENESIS)

Vata (1) Pitta (2) Kapha (3)

a) Anubandhya dosha

b) Anubandh dosha

c) Avaraka dosha

d) Ksheen dosha

e) Ksheen dhatu Rasa (1) Rakta(2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra(7) Ojas (8)

f) Dushya (Involved) Rasa (1) Rakta(2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra(7) Ojas (8)

98
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
(On Day 0, 8th, and 15th)
Separate form should be used on each visit
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………….……………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment: .............................................................................................................

Chief complaints with duration (in days) Yes (1) No (0) Duration
(in days)

8. Jvara (Fever)

9. Vivarnata (Discoloration)

10. Shoola (Abdominal pain)

11. Hridroga (Cardiac disorders)

12. Sadana (Fatigue)

13. Bhrama (Giddiness)

14. Bhaktadwesha (Anorexia)

15. Atisara (Diarrhoea)

99
16. Swasakrichhrata (Dyspnea)

17. Hrillasa, Chhardi (Nausia, Vomiting)

18. Avipaka (Indigestion)

19. Anaha (Tympanitis)

20. Karshya (Cachexia)

21. Adverse reaction: Present (1) Absent (0)

i. Burning sensation in abdomen

ii. Nausea

iii. Diarrhoea

iv. Skin rashes

v. Any other, specify______________________________________

22. Overall clinical assessment:

Improved(1) No change(2) Deteriorated(3)

23. Overall impression of well being by the Subject:

Improved(1) No change(2) Deteriorated(3)

24. Status of the patient:

Continuing (1)

Drop out (2) Reason: _____________________________

Died (3) Cause: _______________________________

Date: ______________ Signature of Investigator ___________________

100
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 0)
FORM IV-A – LABORATORY INVESTIGATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment: .............................................................................................................

Urine Examination

8. Routine: _____________

9. Microscopic: ______________

Stool examination:

10. Routine: _____________

11. Microscopic: ______________

12. Occult Blood: ___________

13. Ova/Cyst (Ova of A.lumbricoids): ____________

Blood

14. TC (Cells/Cmm.) _______________

101
15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)

16. ESR (mm / 1st hour.) __________

17. Hb (g/dl) ____________________

Liver function tests

18. S. Bilirubin (mg/dl): _____________________

19. SGPT (IU/L) : _____________________

20. SGOT (IU/L) : _____________________

21. S. Alkaline phosphatase (KA unit) : _____________________

22. S. proteins (gm/dl) : _____________________

Renal function tests

23. Blood Urea (mg/dl) : _____________________

24. S. Creatinine (mg/dl) : _____________________

Date: _____________ Signature of Investigator __________________________

102
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 08)
FORM IV-B – LABORATORY INVESTIGATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment: .............................................................................................................

Stool:

8. Ova (A. lumbricoids)/Cyst

Date: _____________ Signature of Investigator __________________________

103
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
(On Day 15)
FORM IV-C – LABORATORY INVESTIGATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment: .............................................................................................................

Urine Examination

8. Routine: _________________________________

9. Microscopic: _________________________________

Stool examination

10. Routine: _________________________________

11. Microscopic: _________________________________

12. Occult Blood: _________________________________

13. Ova/Cyst (Ova of A.lumbricoids) : _________________________________

Blood

14. TC (Cells/Cmm.) _______________

104
15. DC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)

16. ESR (mm / 1st hour.) __________

17. Hb (g/dl) ____________________

Liver function tests

18. S. Bilirubin (mg/dl) : _________________________________

19. SGPT (IU/L) : _________________________________

20. SGOT (IU/L) : _________________________________

21. S. Alkaline phosphatase (KA unit) : _________________________________

22. S. proteins (gm/dl) : _________________________________

Renal function tests

23. Blood urea (mg/dl) : _________________________________

24. S. Creatinine (mg/dl) : _________________________________

Date: _____________ Signature of Investigator __________________________

105
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF PALASABEEJA CHURNA IN
KRIMI ROGA (GANDUPADA KRIMI)
CASE REPORT FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment: .............................................................................................................

Sl. Subjective/ objective 0 day/BT 8th day 15th day/AT


No Parameters Dt. Dt. Dt.
1. Jvara (Fever)
2. Vivarnata (Discoloration)
3. Shoola (Abdominal pain)
4. Hridroga (Cardiac disorders)
5. Sadana (Fatigue)
6. Bhrama (Giddiness)
7. Bhaktadwesha (Anorexia)
8. Atisara (Diarrhoea)
9. Swasakrichhrata (Dyspnea)
10. Hrillasa, Chhardi (Nausia,
Vomiting)
11. Avipaka (Indigestion)

106
12. Anaha (Tympanitis)
13 Karshya (Cachexia)
14. Adverse reaction
Burning sensation in abdomen
Nausea
Diarrhoea
Skin rashes
Any other
15. TC (Cells/Cmm.)
16. DC P _____% P _____% P _____%
L _____% L _____% L _____%
E _____% E _____% E _____%
M _____% M _____% M _____%
B _____% B _____% B _____%
17. ESR (mm / 1st hour.)
18. Hb(g/dl)
19. Ova(A. lumbricoids) in the
stool
20. Liver function tests
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
21. Renal function tests
Blood urea (mg/dl)
S. Creatinine (mg/dl)

107
Overall clinical assessment

Improved (1) No change (2) Deteriorated (3)

Overall impression of well being by the Subject:

Improved (1) No change (2) Deteriorated (3)

Status of the Subject :

Continuing (1)

Drop out (2) Reason: ______________________________

Died (3) Cause: _______________________________

Date: ______________ Signature of Investigator ___________________

108
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS
ALONGWITH SAINDHAVA, KALAMI SHORA AND
NAUSADARA IN ONE GROUP VIS-A-VIS PATHAR
CHATTI SWARAS ALONGWITH IKSHUARAKA AND
KALI MIRCH IN THE MANAGEMENT OF
PITTASHMARI (GALL STONE)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

109
Blank

110
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONG WITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONG WITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)

I. BACKGROUND
Ayurvedic literature describes ‘Ashmari’ primarily as a disease of urinary tract. Vataj, Pittaj,
Kaphaj and Shukraj these four types of Ashmaris are described in general. No specific etiology or
treatment has been mentioned Pittashmaris. However, the existence of ‘Pitteshu Iva Rochna go’ is
considered Sushruta in Nidana Sthana Chapter III and Chikitsa Sthana Chapter VII describes
Ashmaris etiology and treatment respectively. The entire description belongs to the Ashmaris or
urinary tracts. Gall stones are usually found in the gall bladder, but in 20 percent of cases, stones
may be present in the bile duct. Most of the times, it is the one sone amongst which is
responsible for patient’s sufferings (Bailey & Love’s)1.
The factors responsible for the formation of gall stones may be:
- Metabolic
- Infective
- Bile Stone
The effects and complications of gall stones may be:
(i) Stone in gall bladder
- Silent stones
- Flatulent dyspepsia
- Gall stone colic
- Acute cholecystitis

References
1. Harisson’s Principles of internal medicine, Volume-1, 14 th Edition, International Editions, 1998,
Published by McGraw-Hill Companies Inc .pp1208-1209
2. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi

111
- Chronic cholecystitis
- Carcinoma
(ii) In the bile ducts
- Obstructive jaundice
- Acute/recurrent poncreatitis
- Cholangitis
(iii) In the intestine
- Acute intestinal obstruction
TYPE OF GALL STONES
The gall stones may be:
- Cholesterol
- Pigment stones (12% of gall stones)
- Mixed stones (majority 80-82% of gall stones)
A fat fertile, female of forty is an easy victim to the disease.
The incidence of gall-stone rises with diabetes mellitus, raised serum triglycerides,
pregnancy, obesity, patients taking clofibrate, oestrogen replacement therapy and contraceptive
pills. Patients with cirrhosis liver and hemolytic anemia have more chances of pigment stones.
Modern therapy advocates surgery/lithotripsy in most of the cases. However
chenodeoxycholic acid (10-15 mg./Kg./day) or Ursodeoxycholic acid 8-10 mg./Kg./day) may be
given to dissolve gall stone in 50-70% of the cases within 2 years. Recurrence can occur on
discontinuation of the therapy.
The patient of cholelithiasis-cholecystitis may present as acute cholecystitis or chronic
cholecystitis. The patients to be taken for Ayurvedic research may be of chronic cholecystitis.
II. OBJECTIVE
No significant contribution has been made to the treatment of Pittashmari (Gall Stone) in
Ayurvedic science, yet there are different claims. It has been considered worthwhile to find out the
effect of some claimed and popular Ayurvedic medicines, practiced to remove stone. The present
study is launched with a view to:
Study the disease incidence, Clinical picture and disease pattern of Pittashmari (Gall
Stones).

112
See the effect of Vijaura Nimbu swaras + saindhava + Kalami Shora + Nausadara + Ela
combination of radiologically/ultrasonographically proved cases of Pittashmari (Gall Stone).
See the effect of Pathar Chatti swaras + Ikshuraka Kshara + Kali Mirch in the diagnosed
cases of Pittashmari (Gall Stone)
To study comparatively the effect of treatments in group (ii) and (iii).
III. CENTRE :
CCRAS identified Centres
IV. SAMPLE SIZE & METHODS
No of Groups: 2
No of patients in each group: 20
(Patients to be randomly allocated to different treatment groups)
Treatment:
Group I: Vijaura Nibu swarasa — 750 ml.
Saindhava — 20 gm.
Kalami Shora — 10 gm.
Nausadara — 10 gm.
Ela — 10 gm.
Mixed and filtered — 20 ml. thrice a day for 30 days

Group II: Pathar Chatti swarasa — 10 ml


Ikshuraka Kshara — 1 gm.
Kali Mirch — 4 in number
(1 such thrice daily with water) for 30 days)
Type of Study: Single blind

Period of Study: 30 days

Follow up; For a period of 3 months on a regular interval of two weeks

113
V. CRITERIA OF INCLUSION
1) Age > 10 years < 60 years
2) Sex-either-sex
3) Chronicity: Disease note older more than 5-7 years.
4) Murphy’s sign: Pain/Catch in deep breath when the fingers are pressed below right coastal
cartilage.
5) Patients of chronic cholecystitis/silent gall stones
6) Obese/non-obese
7) High lipid/normal lipid
8) Clinical feature of chronic cholecystitis with positive murphy’s sign.
9) Gall stone observed by definite investigative procedures e.g.
- Plain X-ray abdomen
- Oral cholecystogram
- Ultrasonography
- Endoscopic retrograde cholangiography and percutaneous hepatic cholangiography

VI. CRITERIA OF EXCLUSION


1. Acute cholecystitis
2. Acute pancreatitis
3. Carcinoma of gall bladder
4. Biliary enteric fistula
5. Diabetes mellitus
6. Pregnancy
7. Severe pain/fever/typhoid
8. Persistent
9. Jaundice
10. Empyema/septicaemia/shock

114
11. Patients on steroids
12. Patient with polyarteritis
VII. CRITERIA FOR WITHDRAWAL:
1. Discontinuation of treatment during the trial
2. Development of any complications
3. Aggravation of the disease symptoms
4. Any side effect of the drug
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations- urine routine and
microscopic, stool examination, blood sugar fasting & pp, lipid profile, x-rays: plain x-ray
abdomen, oral cholecystogram, ultrasonography,endoscopic retrograde, cholangiography will be
recorded before drug administration, at the end of treatment (Form-III)
IX. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after 3 months of regular treatment as per the
proforma. However, the patients are to be reviewed after every two weeks.
1. Good Response: Complete disappearance of signs and symptoms with no complications
and considerable regression in the size of the stone/complete disappearance of the stone.
2. Fair response: 50% and above relief in symptomatology with some regression in the size
of the stone.
3. Poor response: 25% and above relief in symptomatology with no change in the size of the
stone.
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi

115
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centers should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted along with project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.

116
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as
a subject in the clinical trial on evaluation of vijaura nibu swaras alongwith saindhava,
kalami shora and nausadara in one group vis-a-vis pathar chatti swaras alongwith
ikshuaraka and kali mirch in the management of pittashmari (gall stone).
Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

117
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
PATIENT INFORMATION SHEET

What is the study about?


Research is going on to find a suitable natural product for the treatment of Pittashmari (Gll
stone). You are invited to participate in such a study in which you will receive either Ayurvedic
trial drugs or control drug for 30 days.
The aims of the present study are
• To see the effect of Vijaura Nimbu swaras + saindhava + Kalami Shora +
Nausadara + Ela combination of radiologically/ultrasonographically proved cases of
Pittashmari (Gall Stone).
• See the effect of Pathar Chatti swaras + Ikshuraka Kshara + Kali Mirch in the
diagnosed cases of Pittashmari (Gall Stone)
• To study comparatively the effect of treatments in group (ii) and (iii
• Total 100 patients from this and other hospitals will be taking part in this study.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately six months to complete. After this
period, you are expected to visit the hospital every fortnight. The interval between the first and
second visit will be around 15 days.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination. ECG, Blood and urine samples will also be taken. This is to make sure that
you are eligible for the study.
One week later, at your second visit, if you are eligible, you would be put on trial treatment
for 30 days. You may receive either trial drug or control drug for 30 days. You should follow life
style modifications (Diets Advice, Exercise) as given along with information Sheet
From the first visit onwards, you will be required to fast overnight before attending each visit.
Blood and urine samples will be taken at every visit. At each visit, you will be supplied with
sufficient quantity of drug to last until your next visit.

118
What happens at the end of the study?
The trial treatment will be stopped at the end of 30 days. You will be put back on an
appropriate treatment available in the market.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment.
When you can leave the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
If you are found eligible, you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

119
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE).
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Patient of chronic cholecystitis/Silent gall stone

2. Clinical features of chronic cholecystitis

3. Murphy’s sign positive

4. Chronicity < 5 – 7 years

5. Age > 10 yrs. < 60 yrs.

6. Sex – either sex

7. Obese/Non-obese

8. High lipid/Normal lipid

120
CRITERIA FOR EXCLUSION Yes (1) No (0)

9. Acute cholecystitis

10. Acute pancreatitis

11. Carcinoma of gall bladder

12. Diabetes mellitus

13. Pregnancy

14. Colic/Typhoid/Jaundice

15. Biliary enteric fistula

16. Empyema/Septicaemia/Shock

17. Patient on steroids

18. Patients of polyarteritis

A patient is eligible for admission to the trail

If Sl. No. 1-8 is ‘Yes’ and Sl. No. 9-18 are ‘No’

Date: ………………….. Signature of the Investigator: ………………………

121
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM II – HISTORY

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the patient …………………………….....……… Age ………… Sex ………...

4. Address : ..............................................................................................................................

5. Date of Admission : Date of Discharge :

6. Group No. First (1) Second (2)

Third (3) Fourth (4)

7. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

8. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

9. Total income of the family (in Rupees)

Total family members:

Income per capita per month (in Rupees)

122
10. Religion Hindu (1) Muslim (2) Christian (3)

Parsi (4) Others (5)

11. Marital status Married (1) Unmarried (2) Divorcee/ (3)


separated

CHIEF COMPLAINTS WITH DURATION (IN MONTHS)

Present (1) Absent (0) Duration

12. Pain abdomen

13. Dullache in Present hypochondrium

14. Distension (abdomen)

15. Fullness belching/retching

16. Nausea

17. Fever

18. Jaundice

HISTORY OF PRESENT ILLNESS

19. Onset of disease Acute(1) Insidious (2)

20. Duration of disease(in months)

21. Factors aggravating the disease/chief complaints: ……….……………………………….....


..........……………………………………………………………………….……………

22. Factors relieving main complaints ………………………………………………………….


..........………………………………………………………………………………………

23. History of past illness, having relation with present illness

Yes (1) No (0)

If yes, specify…………………………………………………………….........……………

H/o Pancreatitis/Liver disease/Typhoid/Lipid disorders/Obesity

H/o Operation

123
H/o Treatment-hepatotoxic drugs/oestrogens/steroids

FAMILY HISTORY IF ANY

Yes (1) No (0)

24. Carcinoma

25. Diabetes mellitus

26. Polyarteritis

27. Liver disease

28. Obese/Lipid disorders

If yes specify……………………………………......….…………………………………….

PERSONAL HISTORY

29. Diet Veg (1) Non-veg (2) Lacto-ova Veg (3)

30. Sleep Good(1) Disturbed (2) Insomnia (3)

31. Emotional Stress Yes (1) No (0)

32. Addiction Yes (1) No (0)

If yes, specify………………………………………………………………………............

33. Sharirika Prakriti: Vataaj (1) Pittaj (2) Kaphaj (3)

Vataja-Kaphaj(4) Vataj-Pittaj (5) Pittaj-Kaphaj (6)

Sannipataj (7)

34. Manas Prakriti Sattava (1) Rajas (2) Tamas (3)

Sattava Rajas(4) Sattava Tamas(5) Rajas Tamas (6)

Sama (7)

PHYSICAL EXAMINATION

35. Built Lean (1) Medium (2) Heavy (3)

124
36. Gait Normal (1) Abnormal (2)

37. Body weight (in Kg.)

38. Blood pressure (Systolic)

39. Blood pressure (Diastolic)

40. Pulse

41. Respiration rate

42. Anaemia Present (1) Absent (0)

43. Jaundice Present (1) Absent (0)

44. DIGESTIVE SYSTEM

P/A – Soft Yes (1) No (0)

Non-tender

Liver Yes (1) No (0)

Palpable

Tender

Gall Bladder Yes (1) No (0)

Palpable

Tender

Spleen Yes (1) No (0)

Palpable

SYSTEMIC EXAMINATION Normal (1) Abnormal (2)

45. C.V.S. (With Chest)

If abnormal, specify abnormalities……………………………………….............…………..

46. C.N.S

If abnormal, specify abnormalities………………………………………………...............

125
47. Digestive system

If abnormal, specify abnormalities…………………………………………………..

48. Uro-Genital system

If abnormal, specify abnormalities…………………………………………………..

49. Respiratory system

If abnormal, specify abnormalities…………………………………………………..

SAMPRAPTI (PATHOLOGENESIS) OF THE DISEASE ACCORDING AYURVEDIC


CONCEPT

50. Dosa Vata (1) Pitta (2) Kapha (3)

51. Dushya (Involved) Rasa (1) Rakta (2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra (7) Ojas (8)

52. State of disease (Roga Kriya Kala)

Sanchaya(1) Prakopa(2) Prasar (3)

Sthansamshraya (4) Vyakti (5) Bheda (6)

RAKTA VAHA SROTAS Yes (1) No (0)

Pidika

Rakta Pitta (Bleeding)

Mukhapak

Vidradhi (Abcess)

Kamla

PURISHA VAHA SROTAS Yes (1) No (0)

Atibadha Purisha

Atidhrava Purisha

126
Scantly stool

Excessive faecal matter

Painful defecation

Increased frequency of defecation

LAB INVESTIGATION

Microscopic

1. Urine

Routine

2. Blood

(i) Hb%

(ii) TLC

(iii) DLC

(iv) ESR

BIOCHEMICAL

Microscopic

(1). Urine

Routine

(ii) Lipid profile

(iii) HDL

(iv) LDL

(v) VLDL

(vi) S. CHOLESTEROL

(vii) Serum Triglycerides

127
X-RAY

(i) Plain X-ray abdomen

(ii) Oral cholecystogram

(iii) Ultrasonography

(iv) Endoscopic retrograde cholangiography

Provisional Diagnosis

Final Diagnosis

Medical Management

Principal Drug Therapy

Dose

Vehicle

Diet

Summary of findings

Results Good Response (1) Fair Response (2)

Poor Response (2) No Response (4)

Drop out (5) LAMA (6)

Date: ……………… Signature of the Investigator: ………………………...

128
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM III– CLINICAL ASSESSMENT

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the patient …………………………….....……… Age ………… Sex ………...

4. Address : ..............................................................................................................................

5. Date of Admission : Date of Discharge :

6. Group No. First (1) Second (2)

Third (3) Fourth (4)

CLINICAL PARAMETERS

(A). SUBJECTIVE YES (1) NO (0)

Pain abdomen

Fullness/belching/wretching

Nausea/Vomiting

Fever

Dullache in right hypochondrium

Abdominal distention/epigastric discomfort

(B). OBJECTIVE YES (1) NO (0)

Jaundice

Hyprochondriac tenderness

Date: _____________ Signature of the Investigator: _______________

129
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF VIJAURA NIBU SWARAS ALONGWITH
SAINDHAVA, KALAMI SHORA AND NAUSADARA IN ONE GROUP VIS-A-VIS
PATHAR CHATTI SWARAS ALONGWITH IKSHUARAKA AND KALI MIRCH
IN THE MANAGEMENT OF PITTASHMARI (GALL STONE)
CASE REPORT FORM IV – LABORATORY INVESTIGATION

1. Blood Sugar: Fasting

Post Prandial

2. E.S.R.

3. Lipid Profile

- HDL

- LDL

- VLDL

- S. Cholesterol

- Serum Triglycerides

4. X-RAYS Before treatment After treatment

- Plain X-ray abdomen

- Ultrasonography

- Oral Cholecystogram

Date: ______________ Signature of the Investigator: ______________________

130
CLINICAL STUDY ON SERO CONVERSION OF HBs
Ag (CARRIERS) WITH CODED AYURVEDIC
FORMULATION ‘AYUSH-LIV’

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

131
Blank

132
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’

I. BACKGROUND
Hepatitis B1 is one of the major diseases of mankind and is a serious global public health
problem. It is preventable with safe and effective vaccines that have been available since 1982.
Hepatitis B Virus (HBV) is the most versatile of the hepatotropic Viruses. HBV can produce (1)
Acute hepatitis (2) Chronic non progressive hepatitis (3) Progressive chronic disease ending in
cirrhosis (4) Fulminant hepatitis with massive liver necrosis and (5) an a symptomatic carrier with
or without progressive disease. It has been documented by the WHO that world wide, there are
over 400 million hepatitis ‘B’ carriers, of which 42 million are in India alone. These carriers are at
200 times greater risk of developing serious liver complication including cirrhosis and liver cancer.
An HBV carrier is one who had hepatitis B in his blood for more than six months. A
carrier usually has no signs or symptoms of HBV but remains infected with the virus for years or
for a life time and is capable of passing the disease on to others. Sometimes HBV carriers will
spontaneously clear the infection from their bodies, but most will not. Any one who has not cleared
the virus after six months and has elevated liver enzymes is considered to have chronic hepatitis.
This means, the virus is infecting living liver cells and damaging them. Scar tissue called cirrhosis
replaces the damaged cells. The build up of Cirrhosis causes the liver to become hard and bumpy
and distorts the blood flow through this vital organ.
Characteristics of a HBs Ag Carrier state:
Carriers usually have no history of acute hepatitis and no clinical features of liver disease.
All of them have HBs Ag in blood. Some have HBe Ag and Anti HBe. Most of them have
normal liver function tests. Prognosis is uncertain. Virus can be carried for years. Some develop
chronic hepatitis and others are at increased risk of developing cirrhosis and hepato cellular
carcinoma.
Transmit ion of infection:
Hepatitis B Virus is transmitted by contact with blood or body fluids of an infected person
in the same way as human immuno-deficiency Virus (HIV). However HBV is 50 to 100 times
more infectious than HIV.

References
1. Harrison’s Principle of Internal Medicine 15th Edition

133
The Hepatitis B Virus (HBV) gets transmitted through
1. Prenatal (From mother to baby at the birth)
2. Child to child transmission
3. Unsafe injections and transfusions
4. Sexual contact
Hepatitis B virus is not spread by contaminated food or water and cannot be spread
casually in the work place.
Viral markers:
Chronic HBV infection is marked by the presence of HBs Ag) in the blood. At times the
Hbe Ag and Anti Hbe is also present. Presence of Hbe Ag indicates active viral replication.
Presence of Anti Hbe implies that replication is occurring at much lower level or that viral DNA
has become integrated into host Hepatocyte DNA.
PCR: Polymerase chain reaction can show HBV DNA in the blood, implying that viral
replication is occurring. This is essentially needed for formulating the treatment protocol..
Based on serological markers, hepatitis B carriers are classified into two categories super
carriers and simple carriers.
Super carrier: Those who have HBe Ag in their blood and are in the early stage of the
carrier state are very highly infectious. Very minute amount of serum or blood from such carriers
can transmit the infection. They have high titres of HBs Ag and DNA Polymerase in their blood.
Simple carrier: Very common type with no HBe Ag and a low level of HBs Ag in the
blood. HBV DNA Polymerase is negative. Simple carrier transmits the infection only when large
volumes of blood or serum are transferred as in blood transfusion. Simple carrier represents the
later stage of the carrier state.
Interferon is one of the drugs of choice for use in Chronic hepatitis B infection. Clinical
utility of interferon is limited by substantial adverse effects such as Flu like symptoms. Fatigue,
visual disturbances, Neuro toxicity, Neutropenia , Hypo tension etc.
As per Ayurvedic texts several plant drugs are known for its hepato protective, anti
hepatotoxic and anti-viral properties. A coded drug Ayush-Liv with four herbal ingredients having
above mentioned properties is selected to explore the possibilities of these drugs in combination in
the clearance of Hepatitis-B Virus.
II. OBJECTIVES
1. To study the efficacy of the Ayush-Liv formulation to get the viral marker, Hbs Ag sero
negative.

134
2. To study the efficacy of Ayush-Liv formulation in maintaining the liver parameters within
normal limits.
III. CENTERS
CCRAS identified Centers
IV. SAMPLE SIZE & METHODS
Sample size: 30 cases
Type of Study: Open trial
Trial Drug /Dosage /Duration
Group I - Allopathic drug + placebo (60 days)
Group II - Allopathic drug + AYUSH-LIV (two Caps, 550mg each twice
a day after food with water).
Type of study : Placebo controlled study
Period of study: Two months for each case and Post study surveillance screening
for one month. Total duration will be two years to complete the
study.
Follow Up : One follow up will be carried out after three months of completion
of the treatment.
V. CRITERIA FOR INCLUSION
1. Age between 18-60
2. HBs Ag positive in blood (Eliza test)
3. Normal liver function test [Serum bilirubin total<1 mg, Serum bilirubin direct <0.2mg,
Serum bilirubin indirect) <.0.8mg, SGOT<=40, SGPT<=40, SAP<13 KA Unit
4. Total protin <5.6>8.5 gm,
5. Albumin >4<6.7 gm
6. Total Globulin >1.2<2.9 gm
VI. CRITERIA FOR EXCLUSION
1. Age below 18 and above 60 years.
2. Viral markers positive for Anti HBc (IgG,IgM) Anti HBs, HBeAg, anti HBe
3. History of Jaundice during last two years

135
4. Abnormal Hematological cell count
5. Drug addicts
6. Alcohol addicts
7. Serum bilirubin total>1 mg, Serum bilirubin direct>0.2mg, Serum bilirubin
Indirect >.0.8 mg., SGOT>40 , SGPT>40, SAP>13 KA Unit
8. Total protein >5.6<8.5 gm,
9. Albumin <4>6.7 gm
10. Total Globulin <1.2>2.9 gm
VII. CRITERIA FOR WITHDRAWAL
i) If any increase in LFT parameters is observed in subsequent investigations the case will be
withdrawn.
ii) A case will be withdrawn from the study if there is development of any major ailments or
clinical symptoms of Jaundice.
iii) Patients failure to report for follow up or irregular medication (discontinuation for seven
days or above)
Patients withdrawn from the study will be managed by the Investigators.
VIII. ROUTINE EXMINATION AND ASSESSMENT
The full details of history and physical examination of patients will be recorded as per the
Proforma (Form I &IA). Clinical assessment will be done before drug administration, every
fortnightly till the completion of the treatment. The laboratory investigations will be recorded before
drug administration, every month till the end of treatment and at the end of follow-up. [Form III].
Eliza Test for HBs Ag : Every month and at the end of follow-up
Anti HBc, anti HBs : At the time of inclusion
Hbe Ag and anti HBe
LFT : Before treatment and every month till the end of
treatment and at the end of follow-up.
IX. CRITERIA FOR ASSESSMENT
If HBs Ag becomes sero negative during treatment or after completion of the treatment it
will be considered a successful outcome of the treatment. 40% difference in the success rate
between the placebo ant the treatment group will be considered significant outcome.

136
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit will be paid to subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

137
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL STUDY ON SERO CONVERSION OF HBs Ag (CARRIERS) WITH
CODED AYURVEDIC FORMULATION ‘AYUSH-LIV’
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on healthy carriers of hepatitis ‘B’ with herbal compounds.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

138
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
PATIENT INFORMATION SHEET

What is the study about?


Hepatitis ‘B’ virus (HBV) is the most Versatile of the hepato tropic viruses. It can
produce acute or chronic; progressive or non progressive hepatitis and exists in a carrier state
permanently with or without progressive disease. It has been documented by the WHO that
world wide there are over 400 million hepatitis ‘B’ carriers of which 42 million are in India alone.
These carriers are 200 times greater risk of developing serious liver complication including cirrhosis
and liver cancer. As per Ayurvedic literature several plant drugs are known for its hepato
protective, anti hepato toxic and antiviral properties. So a few drugs such as Katuki (Piccrorhiza
kurroa), the present study is aimed to evaluate role of selected Ayurvedic drugs in clearance of
Virus B infection in healthy carriers. You are invited to participate in this study where you will be
provided this drug. The previous observations in clinical and experimental studies have shown
promising effect of these drugs in the treatment of Viral Hepatitis. About 100 healthy carriers from
this hospitals and cases referred from other hospitals will be taking part in this study.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately three months to complete (two months
for treatment and another one month for follow-up study). During this period, you are expected to
visit the hospital three times. The interval between the first, second and third visit will be one
month.
Before you start treatment, during the first visit to the OPD, you will undergo a complete
physical examination, Blood and urine samples will also be taken and also tested for all the viral
markers for Hepatitis ‘B’. This is to make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for two months. The daily
dosage will be two Caps of 550mg each twice daily. At each visit, you will be supplied with
sufficient quantities of drugs to last until your next visit.

To be translated into regional language.

139
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
CASE REPORT FORM I - SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR SELECTION Yes (1) No (0)

1. Age between 18-60

2. HBs Ag positive in blood (Eliza test)

3. Serum bilirubin total<1 mg

4. Serum bilirubin direct <0.2mg

5. Serum bilirubin indirect) <.0.8mg.

6. SGOT<=40 mg

7. SGPT<=40 mg

8. SAP<13 KA Unit

9. Total protin <5.6>8.5 gm

10. Albumin >4<6.7 gm

11. Total Globulin >1.2<2.9 gm

140
CRITERIA FOR EXCLUSION Yes (1) No (0)

12. Age below 18 and above 60 years.

13. Anti HBc Positive

14. Anti HBs Ag Positive

15. Anti HBeAg Positive

16. HBe Ag Positive

17. History of Jaundice during last two years

18. Hematological cell count

19. Drug addicts

20. Alcohol addicts

21. Serum bilirubin total>1 mg

22. Serum bilirubin direct>0.2mg

23. Serum bilirubin indirect >.0.8mg

24. SGOT>40 mg

25. SGPT>40 mg

26. SAP>13 KA Unit

27. Total protin >5.6<8.5 gm,

28. Albumin <4>6.7 gm

29. Total Globulin <1.2>2.9 gm

30. Cases undergoing treatment for any


other serious illness

A patient is eligible for admission to the trail

If Sl.No.1 – 11 is ‘YES’ and Sl.No.12 – 30 are ‘No’

If admitted: Subject’s Serial No. __________ No. of packets issued: ___________

Date: ____________ Signature of the Investigator: ______________________

141
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Housewife (3) Others (4)

Indicate nature of work: ...........................................................................

10. Income

Total Members in the family : ___________________________________________

Total Income in the family : ___________________________________________

Per capita income : ___________________________________________

142
History of Past Illness Yes (1) No (0)

11. Jaundice

12. Major or minor surgery With blood transfusion

If yes, indicate amount of blood transfusion _____________________

13. I.V. Fluids

Any injection

14. Intramuscular

If yes, indicate number of injections taken_______________________

15. Intravenous

If yes, indicate number of injections taken_______________________

16. Any history of drug abuse

If yes, provide details about drugs and mode of consumption _______

17. Previous treatment for Jaundice

If yes, provide details regarding time and period of illness__________

Personal History

18. Marital status Married (1) Unmarried (2) Widow (3)

Widower (4) Divorced (5)

19. Sexual orientation Heterosexual (1) Homosexual (2)

Bi-sexual (3) Others (4)

Addiction

20. Alcohol No (0) Yes (1)

If yes specify (a) Quantity per week (ml) ______________

(b) Total Duration in years_______________

143
21. Any other, specify: ___________________________________________________

Physical Examination

22. Height (cm) ____________


23. Weight (kg) ____________
24. Pulse (per min) ____________
25. Blood Pressure Systolic(mm Hg)____________
26. Blood Pressure Diastolic (mm Hg) ____________
27. Respiration rate( per min) ____________
Systemic examination Normal (1) Abnormal (2)

28. CVS

If abnormal details___________________________________________

29. Respiratory system

If abnormal, details ___________________________________________

30. CNS

If abnormal, details ___________________________________________

31. Digestive system

If abnormal, details ___________________________________________

32. Uro-genital system

If abnormal, details ___________________________________________

Clinical Symptoms Absent (0) Present (1)

33. If any

If Present, specify____________________________________________

No. of packets issued: _______________________________________

Date:____________ Signature of the Investigator: ______________________

144
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON HEALTHY CARRIERS OF
HEPATITIS ‘B’ WITH CODED AYURVEDIC FORMULATION AYUSH-LIV
(0th, 1st & 2nd Month)
CASE REPORT FORM III – CLINICAL ASSESSMENT

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Period of Assessment: Initial (0) 1st Month (1) 2nd Month (2)

CLINICAL ASSESSMENT Yes (1) No (0)

9. Fever

10. Anorexia

11. Nausea

12. Vomiting

13. Yellow tint of the sclera

14. Dark coloured urine

15. Clay coloured stools

16. Malaise

Date: __________ Signature of the Investigator__________________

145
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL STUDY ON SERO CONVERSION OF HBs Ag
(CARRIERS) WITH CODECD AYURVEDIC FORMULATION AYUSH-LIV
(0, First & Second Month)
CASE REPORT FORM IV– LABORATORY INVESTIGATIONS

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Period of Assessment: Initial (0) 1stMonth (1) 2ndMonth (2)

Urine Examination (Microscopic)

9. Sugar: ___________________

10. Albumin: ___________________

11. Deposits: ___________________

Blood

12. TLC (Cells/Cmm.)_____________________

13. DLC: P (%)________ L (%)________ E (%)________M (%)________ B (%)________

14. Hb(g/dl): ________________

15. ESR (1st hour.)(m.m.): ________________

16. Blood Sugar-Fasting (%): ________________

146
17. Blood Sugar – PP (mg. /dl): ________________

18. S.Cholesterol (mg./dl): ________________

19. HDL (mg. /dl): ________________

20. LDL (mg. /dl): ________________

21. Triglycerides (mg. /dl): ________________

22. B. Urea (mg. /dl): _______________

23. S.creatinine (mg. /dl): _______________

24. Urea (mg. /dl): _______________

25. SGOT: _______________

26. SGPT: _______________

27. Serum bilirubin tota: _______________

28. Serum bilirubin direct (mg) _______________

29. Serum bilirubin indirect (mg.) _______________

30. Alk.Phosphatase(KA units) _______________

31. Total protin ( gms) _______________

32. Albumin (gms) _______________

33. Total Globulin (gm) _______________

34. HBsAg _______________

Physiological Parameters

35. Systolic Blood Pressure (mm of Hg) ____________________

36. Diastolic Blood Pressure (mm of Hg) ____________________

37. Weight (Kg) ____________________

38. Any other Remarks

Date: ____________ Signature of the Investigator: ____________________

147
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148
JOINT DISORDERS

SECTION - III
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150
COMPARATIVE CLINICAL EVALUATION OF
PHANCHKARMA VERSUS PHYSIOTHERAPY IN
PATIENTS OF SANDHIVATA (OSTEOARTHRITIS) -
KNEE JOINT

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

151
Blank

152
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT

I. BACKGROUND
Panchakarma is a textual classical and authentic treatment procedure of Ayurveda. Our
ancient sages and scholars like Charaka and Vagbhatta have attributed a lot of potential benefits
to Panchkarma practices. The aim of the study is to see the effect of Panchakarma in group I
patients of Sandhivata (Osteoarthritis) and to compare the results with known physiotherapy
treatment in the patients of group II. This Physiotherapy treatment is usually referred to by doctors
of various Systems of Medicines1.
II. OBJECTIVE
Comparative clinical evaluation of Panchkarma versus Physiotherapy in patients of
Sandhivata (Osteoarthritis) - knee joint, with selected clinical parameters.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Type of study : Open trial
Level of study : OPD/IPD
Number of Groups : Two Groups
Sample Size : 30 (15 patients in each group)

References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chikitsa Sthana, Chapter – 28,
Chaukhambha Sanskrit Sansthan, 5th edition, Varanasi, 2001
2. Clare Jinks, Kelvin Jordan Measuring the population impact of knee pain and disability with the
Western Ontario and McMaster Universities Osteoarthritis Index. Pain 2002: 100, 55-64.
3. Gail D Dyele, Stephen C Allison, Robert L Matekel. Physical Therapy treatment effectiveness for
osteoarthritis of the knee: A randomized comparison of supervised clinical exercise and manual therapy
procedures versus a home exercise program. Physical Therapy 2005: 85, 12, 1301-1317.
4. Effects of repetitive shortwave diathermy for reducing synovitis in patients with knee osteoarthritis: An
ultrasonographic study Physical therapy 2006: 86, 2, 236-244.

153
Drug/Dosage/Duration:
Group-I Panchkarma Group:
• Local application of Pancaguna Taila 10-15 ml each joint, thrice a day
• Nadi Sweda with Dashmoola Kwatha for 15 minutes, followed by rest for 15
minutes.
The above mentioned Panchkarma treatment will be given for 4 weeks in the hospital
followed by 2 weeks Pancaguna Taila application at home.
Group-II Physiotherapy Group:
• Exercise Protocol for 4 weeks continuously in the hospital which will consist of
Manual Therapy, Stretching, Strengthening, and Range of Motion Exercises, followed
by exercises at home for another 2 weeks.
• Associated with above treatment, shortwave diathermy (a type of thermal therapy) for
initial 2 weeks (6 days/ week).
Duration of treatment : 4 weeks in both the groups
Follow up period : After 2 wks
V. CRITERIA FOR INCLUSION
1. Age between 40 years to 70 years.
2. Sex-Either sex
3. Patients with Primary Osteoarthritis – knee joints (single or both knees)
4. Kellgren Lawrence (Radiological scale) of e” 2.
Note: Patients taking Ayurvedic/Allopathic NSAIDs orally may be included in the study but the
treatment may be considered as basal treatment and it should not be altered during the trial.
VI. CRITERIA FOR EXCLUSION
1. Age less than 40 years or more than 70 years.
2. Patients with skin allergies/skin diseases
3. Patients with Pott’s spine/infections/other systemic diseases
4. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic
Arthritis, SLE.
5. Patients with Diabetes/Hypertension

154
6. Bed ridden patients
7. Patients using local Anti-inflammatory medicine other than the research drugs.
8. Patients taking active Allopathic/Homeopathic treatment.
9. Low backache with or without radiation to legs.
10. Patients with metallic implants.
11. Subjects having any deformity of knee, hip or back.
12. History of bony or soft tissue injury to knee joint.
VII. CRITERIA FOR WITHDRAWAL
During the course of treatment, if any serious condition or any serious adverse events
occurs or pain/stiffness/swelling increases, or if subject himself/herself wants to withdraw from the
study, such subjects may be withdrawn from the study.
VIII. ROUTINE EXAMINATION/ASSESSMENT:-
Inclusion into study - 0 day
1st assessment - 14th day
2nd assessment - 28th day
3rd assessment - 42nd day
Assessment Chart – annexed in case record form.
(Based on visual analogue scale).
Radiography-I
To diagnose the patients (at or before day 0) at the time of inclusion.
Radiography-II
To be compared with Radiography-I at the time of final assessment i.e. 45th day.
However much radiographical changes are not expected.
Result expectations:
30 to 35% improvement is expected in treatment groups.
However 10 to 20% improvement may also be there in placebo group.
IX. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
155
X. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XI. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of study and
put in a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team will
report immediately to the PI and Data Monitoring Board if, any life threatening conditions whether
they are perceived to be study related or not. The Board decides whether the adverse effects
warrant discontinuation of the study protocol. Protocols will be written and approved for the
treatment of study related adverse events.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.
Counseling about life style:-
During the research period, the patient should maintain uniform life style or basal life style
(what he was adopting in general). Over exercise, over strain, riding bicycle, going upstairs or
sitting in squatting positions may seriously alter the results.

156
To Check the drug compliance
The packing of the oil should be proper with no mark over the bottle so as to avoid bias.
At each visit, patient must bring his/her medicine bottle and submit it to the researcher so that the
consumption of medicine may be checked.
Expected medicine requirement for 42 days
Oil requirement for 6 weeks (42 days):
One application on one joint = 10-15 ml x 3 times a day
= 30-45 ml.
In case of two joint involved 60 - 90ml per day.
Let us take average of 50ml per day per patient.
Thus total oil requirement for 42 days for 15 patients will be = 50 x 42 x 15
= 32 liters
Medicine requirement for 4 weeks (28 days):
Dashmoola required per day per patient = 50 gms
Requirement for 28 days for 1 patient = 50 x 28
= 1400 gms
Thus total medicine required for 28 days for 15 patients = 50 x 28 x 15
= 21kg
PHYSIOTHERAPY TREATMENT
1. Patient Exercise Program: Strengthening Exercises

Exercise Performance Repetitions


Static quad Perform daily Hold each contraction for 6 s
sets in knee Patient is positioned fully supine or with a
extension supine supported on elbows with the 10-s rest between repetitions
knee in full extension. Patient contracts Repeat 10X
the quadriceps femoris muscle and
pushes the knee down while maintaining
the foot in full dorsiflexion.

157
Standing Perform 3 X per week Hold each contraction for 3 s.
terminal knee Patient stands with a resistive band or a Repeat 10X
extension cuff from a weighted pulley mechanism Increase resistance as
behind a slightly flexed knee. Patient tolerated
contracts the gluteal and quadriceps
femoris muscles to fully straighten the hip
and knee

Closed-chain Patient performs one of the following


progression, activities 3X per week.
ordered from Patient should progress to the most
least to challenging activity that he or she can
mostchallen- successfully complete with minimal or no
ging pain

1. Seated Patient is seated holding a resistive band Hold each contraction 3 s


legpresses in both hands. Patient places his or her with knee as straight as
foot against the band, then straightens possible. Slowly return to
the knee by pushing the foot down and starting position and repeat for
forward by contracting the gluteal and a 30 s bout.
quadriceps femoris muscles Progress to bands of
increasing resistance and
additional bouts

2. Partial Patient stands with arm support as Hold each contraction 3 s


squats weight needed with hips and knees as
lessenedwith Patient performs a partial squat, keeping straight as possible. Repeat for
arm support the knees centered over the feet. Return 30 s Progress to full body
as needed to standing by contracting the quadriceps weight without
femoris and gluteal muscles support and additional bouts

3. Step-ups Patient stands in front of a low step. Slowly repeat for 30 s


Patient places foot of involved leg on Progress to increased height of
step and brings body over foot to stand the step and additional bouts.
on the step. Use as little push-off Alternate legs if both knees
assistance from the contralateral foot as are involved
possible. Step down with the
contralateral foot

158
2. Patient Exercise Program: Stretching Exercises

Exercise Performance Repetitions

Standing calf Perform daily Hold for 30 s and repeat 3X


stretch Patient stands with the heel of the foot
on the ground behind the patient; the
toes point straight ahead. The patient
leans forward until a moderate pull is
perceived in the calf musculature. The
patient may use his or her arms for
support against a wall or furniture as
needed

Supine Perform daily Hold for 30 s and repeat 3X


hamstring Patient is positioned supine with the Clinical observation: if
muscle stretch contralateral lower extremity maintained radicular symptoms are
as straight as possible. The ipsilateral hip produced, decrease or
is flexed to 90° eliminate the ankle dorsiflexion
The knee is straightened and the or the intensity of the stretch
proximal lower leg supported with the
hands until a moderate pull is perceived
in the posterior thigh and calf The
ipsilateral ankle should be dorsiflexed

Prone Perform daily Hold for 30 s and repeat


quadriceps Patient is positioned prone with both 3XClinical observation:
femoris hips and knees. A strap is placed around hamstring muscle cramping
muscle stretch the ipsilateral ankle and brought may occur if the patient
posteriorly and superiorly over the attempts to actively bend the
ipsilateral shoulder. The patient grasps knee; to reduce this possibility,
the strap in the ipsilateral hand and always use the strap to
bends the knee by straightening his or passively flex the knee
her elbow and pulling on the strap. The Maintain a gentle stretch and
knee is progressively flexed until a gentle comfortable position for the
stretch is perceived in the anterior thigh lumbar spine. Hard stretching
will frequently create lumbar
symptoms in this population

159
3. Patient Exercise Program: Range of Motion Exercises

Exercise Performance Repetitions


Knee in mid- Perform daily Two 30-s bouts with 3-s hold
flexion to full- Performed once daily at end range
extension Patient is positioned supine or supine Clinical observation: these
supported on elbows Knee is brought exercises work best if
to 45° of flexion with the ipsilateral foot performed on a smooth
sliding on the surface that the patient is surface such as a hardwood
lying on. The knee is then fully extended or linoleum floor or if a sliding
with a strong quadriceps femoris muscle board is used
contraction against any limitation to full
knee extension.

Knee in mid- Performed once daily Two 30-s bouts with 3-s hold
flexion to full- Patient is positioned supine or supine at end range.
flexion supported Clinical observation: pain with
on elbows Knee is brought to full flexion end-range knee flexion may
with assistance of the upper extremities be due to degenerative
or a strap A gentle challenge to end- meniscal tears
range flexion is sustained. Over-pressure to end range
should be applied with
caution.

Stationery Performed once daily 5 min, increase time as


bicycle Knees should be at nearly full extension tolerated
at bottom of pedal stroke Clinical observation: some
patients are intolerant of the
stationary bicycle, and clinical
judgment is required to
continue the activity.

160
4. Common Knee Impairments Addressed by Manual Therapy

Impairment Manual Intervention Typical Delivery


Loss of knee Manual mobilization through range of Mobilization grades III and
extension motion (ROM) and knee extension at IV to III++ and IV++ 2–6
end range bouts of 30 s per manual
Knee extension technique
Knee extension with valgus or abduction Clinical observation: this
Knee extension with varus or adduction manual intervention may
provide near-immediate
decrease of symptoms and
may be approached with
relatively more vigor than
knee flexion

Loss of knee Manual mobilization through ROM and Mobilization grades of III-
flexion knee flexion at end range and IV- to III+ and IV+ 2–6
Knee flexion bouts of 30 s per manual
Knee flexion plus medial (internal) technique
rotation Clinical observation: pain with
end-range knee flexion may
be due to degenerative
meniscal tears; end-range
techniques should be
utilizedwith caution.

Loss of Manual mobilization of the patella in 5°– Mobilization grades of IV to


patellar glides 10° of knee flexion IV++ 2–6 bouts of 30 s per
Medial manual technique.
Lateral Clinical observation: some
Caudal patients may be intolerant of
Cephalad even slight compressive forces
over the patella; therapist
hand placement is Important.

Muscle Manual stretches at end length of the Sustained manual stretches of


tightness muscle 12–30 s duration repeated 1–
Quadriceps femoris 3 times per muscle.

161
Hamstrings Clinical observation: the
Gastrocnemius lumbar spine should be
Adductors manually stabilized and
Iliopsoas protected during all extremity
Tensor fasciae latae and the iliotibial stretches, particularly hip
band flexor stretches; many of
these patients also will have
arthritic changes in the spine,
and symptoms can be
increased without care in
positioning.

Soft tissue Soft tissue mobilization Circular fingertip and palm


tightness Suprapatellar and peripatellar regions pressure mobilization at the
Medial and lateral joint capsule depth of the capsule or
Popliteal fossa. retinaculum for 1–3 bouts of
30 s per area.
Clinical observation: the soft
tissue work in the popliteal
fossa seems to work best
when performed slowly with
occasional sustained positions
of 10–12 s, this technique
works well when combined
with the manual mobilizations
into knee extension.

5. Method of Delivery of Short Wave Diathermy


Position of patient: supine lying with a pillow below the knee joint.
Method used: capacitive method using pad electrodes.
Electrode placement: Contra planar across the medial-lateral aspect of the knee.
Intensity: the intensity should be adjusted to produce a sensation of mild warmth in the
patient. Patient is made to appreciate the warmth by asking him/ her to blow at the hand.
The degree of warmth felt at the knee should be same as that felt at the hand.
Duration: 20 minutes.

162
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Comparative clinical evaluation of phanchkarma versus physiotherapy in patients of
sandhivata (osteoarthritis)-knee joint”.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

163
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
PATIENT INFORMATION SHEET

What is the study about?


Panchakarma is a textual classical and authentic treatment procedure of Ayurveda. Our
ancient sages and scholars like Charaka and Vagbhatta have attributed a lot of potential benefits
to Panchkarma practices. The aim of the study is to see the effect of Panchakarma in groupI
patients of Sandhivata (Osteoarthritis) and to compare the results with known physiotherapy
treatment in the patients of group II. This Physiotherapy treatment is usually referred to by doctors
of various Systems of Medicines.
Expected duration of the subject participation
An Ayurvedic physician along with a physiotherapist will take a brief history of the subject
and reveal him/her the facts about the benefits and side effects of the procedure. The volunteer
will be subjected to:
Local application of Pancaguna Taila 10-15 ml each joint, thrice a day, Nadi Sweda with
Dashmoola Kwatha for 15 minutes followed by rest for 15 minutes in group I.
The above mentioned Panchkarma treatment will be given for 4 weeks in the hospital
and then followed by 2 weeks Pancaguna Taila application at home.
In group II, Exercise Protocol for 4 weeks continuously in the hospital (consisting of
Manual Therapy, Stretching, Strengthening, and Range of Motion Exercises), followed by
exercises at home for another 2 weeks.
With above treatment, shortwave diathermy (a type of heat- therapy) for initial 2 weeks (6
days/ week) will be associated.
The benefits that might be expected from the out come of the research to the subject
The patients suffering from Sandhivata / OA, selected from CRIA will serve the cause of
science by participating in the study. We may be able to re-establish the facts and science of
Ayurveda already in use by our ancestors for last 2000 years. This treatment is expected to reduce
pain and swelling of the affected joints. The additional benefits that the subject may get that his/her
related investigations will be done free of cost .Apart from this the functional status of the patient
will improve.

164
Any risk to the subject associated with the study
Though the side effects are not very common, however in rare cases patient might develop
allergy with the oil. At times local irritation/ skin burn may happen during heat application.
Maintenance of the confidentiality of records
The records of the study will be kept confidential to protect volunteer’s privacy.
Compensation of subjects for disability or death resulting from injury
Not applicable
Freedom of individual to participate and to withdraw from research at anytime
without penalty or loss of benefits to which the subject would otherwise be entitled
Subjects will be free to withdraw from the study at any stage without assigning any reason,
without penalty or loss of benefits to which he/she would otherwise be entitled.

To be translated into regional language.

165
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – 1 SCREENING
Before Treatment
(Please tick  wherever is applicable)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

7. Group No. First (1) Second (2)

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 40 years to 70 years.

2. Sex-Either sex

3. Patients with Primary Osteoarthritis – knee joints


(single or both knees)

4. Kellgren Lawrence (Radiological scale) of ≥ 2.

CRITERIA FOR EXCLUSION Yes (1) No (0)

8. Age less than 40 years or more than 70 years.

9. Patients with skin allergies/skin diseases

10. Patients with Pott’s spine/infections/other systemic diseases.

166
11. Patients with systemic conditions such as Gouty
Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.

12. Patients with Diabetes/Hypertension

13. Bed ridden patients

14. Patients using local Anti-inflammatory medicine other


than the research drugs.

15. Patients taking active Allopathic/Homeopathic


treatment.

16. Low backache with or without radiation to legs.

17. Patients with metallic implants.

18. Subjects having any deformity of knee, hip or back.

19. History of bony or soft tissue injury to knee joint.

A patient is eligible for admission for treatment

If Sl. No. 1 – 4 is ‘Yes’ and Sl. No. 5 – 19 are ‘No’

If admitted, Sr. No. of the Subject: __________________

Date: ___________ Signature of the Investigator: ___________________

167
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – II HISTORY
Before Treatment
(Please tick  wherever is applicable)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Group No. First (1) Second (2)

9. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

10. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Constant sitting/standing for long hour (5)

Indicate nature of work: ...........................................................................

11. Family income per months in Rs.

168
12. Total family members:

13. Marital status: Single (1) Married (2) Separated (3)

Widow (4) Widower (5)

History of present illness

14. Onset of disease Acute (1) Insidious (2)

15. Duration of disease (in months)

16. Factors aggravating the disease/chief complaints __________________________

17. Factors relieving main complaints ______________________________________

18. History of past illness, having relation with present illness : Yes (1) No (0)

If yes, Specify______________________________________________________

History of past illness:

19. History of trauma/ Injury Yes (1) No (0)

If yes, specify: ________________________________________________________

20. Undergone Treatment before Yes (1) No (0)

Family History:

21. Diet: Veg (1) Non-veg (2) Lacto-ova veg(3)

Fish-veg (4)

22. Sharirika Prakriti: Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja (5) Pittaja-Kaphaja(6)

Sannipataj (7)

23. Manas Prakriti : Sattva (1) Rajas (2) Tamas (3)

Sattva-Rajas(4) Rajas-Tamas(5) Sattva-Tamas (6)

Sama (7)

169
Chief complaints with duration:

24. PAIN

Name of joints involved:

Duration

Increased by exertion Yes/ No Yes (1) No (0)

Relieved by taking rest Yes/ No Yes (1) No (0)

Pain at rest Yes/No Yes (1) No (0)

Radiating to other parts Yes/No Yes (1) No (0)

25. STIFFNESS

Name of joints involved:

Duration

Morning stiffness Yes (1) No. (0)

Lasting for an hour or so Yes (1) No. (0)

26. SWELLING

Name of joints involved:

Duration

27. RESTRICTED MOVEMENTS

Name of joints involved:

Duration

Crepitus Yes/No Yes (1) No. (0)

Duration

28. VARIATION IN PAIN

Climate

Season

170
Day/night

Rest/movement

Walking/exertion

Other relations if any

GENERAL EXAMINATION OF THE PATIENT

29. G.C.: _____________________________

30. Pulse: _____________________________

31. B.P. : _____________________________

32. Respiratory Rate: _____________________________

33. Body weight: _____________________________

34. Pallor Present/Absent

35. Icterus Present/Absent

36. Oedema Present/Absent

37. Lymphadenopathy Present/Absent

38. Pigmentation Present/Absent

39. Deformity Present/Absent

SYSTEMIC EXAMINATION OF THE PATIENT

40. Gastro Intestinal System: _____________________________

41. Cardio Vascular System: _____________________________

42. Respiratory System: _____________________________

43. Central Nervous System: _____________________________

44. Genito Urinary System: _____________________________

45. Reticulo Endothelial System: _____________________________

171
Samprapti (pathogenesis) of the disease according to Ayurvedic concept:

46. Dosa Vata (1) Pitta (2) Kapha (3)

Anubandhya dosha

Anubandh dosha

Avaraka dosha

Ksheen dosha

47. Dushya (Involved) Rasa (1) Rakta (2) Mamsa (3)

Meda (4) Asthi (5) Majja (6)

Shukra (7) Ojas (8)

Date: ____________ Signature of the Investigator: ______________________

172
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
CASE REPORT FORM – III LABORATORY INVESTIGATION
(Please tick  wherever is applicable)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: …………………………….........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

8. Group No. First (1) Second (2)

9. Date of Assessment :

INVESTIGATIONS PROFORMA

10. Blood Pathology

• TLC: _________________________

• DLC: _________________________

• ESR: _________________________

• Hb %: _________________________

11. Blood Bio-chemistry

• RA Factor: _________________________

• Serum calcium: _________________________

• Serum Alkaline phosphatase: _________________________

173
• Blood Urea: _________________________

• Serum Uric Acid: _________________________

• Blood-Sugar Fasting/PP: _____________/____________

• Others: _________________________

12. Radiology

• Soft Tissue swelling: _________________________

• Effusion: _________________________

• Osteoporosis: _________________________

• Erosion Cart/Bony: _________________________

• Deformity: _________________________

• Ankylosis: _________________________

• Reduced joint space: _________________________

DRUG TREATMENT GROUP-I/II

Medicine Dose & frequency Duration

SIDE EFFECTS/UNTOWARD EFFECTS IF ANY

174
ASSESSMENT OF TRIAL
Grade 0 = No Symptoms
Grade 1 = Mild Symptoms
Grade 2 = Symptoms Sufficient to Cause Distress/Difficulty in performing routine work
Grade 3 = Symptoms very severe/ patient unable to perform his routine work.

Symptoms Before Treatment After Treatment


(Severity Grades) (Severity Grades)

0 1 2 3 0 1 2 3

Pain

Tenderness

Swelling

Stiffness

Fatigue

Restricted Movement

Deformity

Before Treatment After Treatment

Walking Time
(Seconds)

Grip Power (mm/Hg)

Pressing Power
(mm/Hg)

ESR(mm/Hr)

Hb (Gm %)

175
WOMAC OSTEROARTHRITIS INDEX
SECTION A
PAIN

How much you have had …………………..

1. When walking on a flat surface?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

2. When going up or down stairs?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

3. At night while in bed? (i.e. – pain that disturbs your sleep)

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

4. While sitting or lying down?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

5. While standing?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

176
SECTION B
STIFFNESS

How much you have had …………………..

6. How severe has your stiffness been after you first woke up in the morning?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

7. How severe has your stiffness been after sitting or lying down or while resting leter in the
day?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

177
SECTION C
PHYSICAL FUNCTION

How much you have had …………………..

8. When going down the stairs?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

9. When going up the stairs?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

10. When getting up from a sitting position?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

11. While standing?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

12. When bending to the floor?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

178
13. When walking on a flat surface?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

14. Getting in or out of a car, or getting on or of a bus?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

15. While going shopping?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

16. When putting on your socks or stockings?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

17. When getting out of bed?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

18. When talking off your socks or stockings?

Visual Analogue Scale

1 2 3 4 5 6 7 8 9 10

179
APPENDIX

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA


COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT
KELLGREN– LAWRENCE RADIOGRAPHIC GRADING SCALE OF
OSTEOARTHRITIS OF TIBIO FEMORAL JOINT.

Grade of osteoarthritis Description

0 No radiographic findings of osteoarthritis.

1 Minute osteophytes of doubtful clinical significance.

2 Definite osteophytes with unimpaired joint space.

3 Definite osteophytes with moderate joint space narrowing.

4 Definite osteophytes with severe joint space narrowing and


subchondral sclerosis.

180
RECEIPT

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA


COMPARATIVE CLINICAL EVALUATION OF PHANCHKARMA VERSUS
PHYSIOTHERAPY IN PATIENTS OF SANDHIVATA (OSTEOARTHRITIS)-
KNEE JOINT

Received an amount of Rs 500/ (Five hundred only) from the institute as traveling expenses
for traveling to and fro the Institute for 4 weeks so as to participate in the above mentioned
research,

Signature or thumb impression: _____________________

Date: _________ Name of the Subject: ____________________________

Signature of the investigator with date: _______________________________

Signature of the Accounts Officer with date: ___________________________

181
Blank

182
CLINICAL VALIDATION OF GUGGULU, SHUNTI &
GUDUCHI IN RHEUMATOID ARTHRITIS

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

183
Blank

184
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS

I. BACKGROUND
Rheumatoid arthritis1 is a chronic multisystem disease characterized by persistent
inflammatory synovitis, usually, involving peripheral joints in a symmetric distribution. The potential
of synovial inflammation to cause cartilage destruction and bone erosions & subsequent changes in
joint integrity is the hallmark of the disease.
Exact etiology is unknown. Although recent work has focused on the possible role of
super antigens produced by a number of microorganism including staphylococci, streptococci and
mycoplasma arthritidis, other possible etiology mechanism in RA include a breakdown in normal self
tolerance leading to reactivity to self antigens in the joint such as type-II collagen or loss of
immuno regulatory control mechanism resulting in polyclonal ‘T’ cell activation. Superantigens are
protein with the capacity to bind to HLA-DR molecules and particular Vâ segments of the
heterodimetric T cell receptor and stimulate specific T cell expressive the Vâ gene products.
Of all the potential environmental triggers, the one only clearly associated with the
development of RA is cigarette smoking. Rheumatism arthritis effect females in three times more
than males it generally occurs in late third or fourth decade of their life spans.
The Ayurvedic treatment of Amavata - Rheumatoid arthritis is being increasingly recognized
as an alternate approach to its treatment. The modern treatment of this disease is not very
satisfactory and is often attended with serious reactions. As such efforts are being persistently
made for this dreadful disease. An important aspect of Ayurvedic treatment is its easy availability
and abundance of its ingredients.
According to Ayurveda some of etiological factors such as Viruddhahara (Improper &
irregular dietary habits), Viruddhachesta (Improper Physical and Psychological activities),
Mandagni, Sedentary habits and exercise immediately after food are said to be responsible for
the origin of Amavata.

References
1. Harrison’s Principle of Internal medicine: 15th Edition Page: 2083, Vol-II.
2. Madhav Nidana, Chapter 25,

185
Various studies on Amavata-Rheumatoid arthritis have been published in the JRAS and
other scientific journals. Some of the important publications dealing with development of diseases,
the Ayurvedic concepts of its etiopathogenesis, the dietetic management and effect of certain
therapies are presented in this compilation on Amavata.
The Agnimandhya-Grahani Dosa has been considered to be the main factor in pathogenesis
of this disease in Ayurveda. Certain studies have been conducted and reviewed to assess the
gastro-intestinal function. The findings indicate impaired secretion of gastric acid secretion, deranged
liver function and reduced intestinal absorption.
The cardinal features of Amavata are swelling and pain like scorpion bite over the joints
like hands and legs (especially knee, ankle wrist, metacarpals and metatarsals). Based on the
cardinal feature and other associated features, many effective regimens are described in Ayurvedic
classics.
Owing to the gravity of the situation, a need is felt for searching the safe /effective
Ayurvedic formulations to reduce the symptoms. Keeping all these view in consideration and the
public health needs, the council intends to initiate scientific studies on well known and safe classical
Ayurvedic formulation that is being successfully prescribed by Ayurvedic physicians without any
side effects since centuries.
For the present study, coded Ayurvedic drug like AYUSH-RA tab. and AYUSH-RA oil
have been taken to assess its clinical safety and efficacy.
II. OBJECTIVES
To study the effect of Guggulu, Shunti & Guduchi in rheumatoid arthritis
III. CENTRES
CCRAS identified Centres
IV. SAMPLE SIZE AND METHODS
Sample Size : 50 cases in each center
Trial period : 18 months
Design of the study : Open observational Trial.
Drug & dosage : Tab. AYUSH-RA 2gm twice daily after food and
AYUSH - RA oil for external application 2 to 3
time daily.
Duration of the study : 45 days drug therapy with a follow up for 15
days without drug.

186
Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 15 days of
treatment.
V. CRITERIA FOR INCLUSION
• Age between 35 - 65 years of either sex
• Presence of any four of the following seven criteria (according 1987, revised criteria of
American College of Rheumatology)
(a) Morning stiffness: Stiffness in and around joints lasting one hour before maximal
improvement (More than 6 week’s duration).
(b) Arthritis of three or more joints (at lest three joint area, observed by Physician
simultaneously having pain with soft tissue swelling or joint effusion, not just bony
over growth) (More than 6 weeks duration).
(c) Arthritis of Hand joints (More than 6 weeks duration).
(d) Symmetric arthritis (More than 6 week’s duration).
(e) Presence of Rheumatoid Nodules
(f) Serum Rheumatoid factor- positive
(g) Typical Radiographic changes of arthritis on PA view of hand & wrist radiograph
that must include erosions or unequivocal bony decalcification adjacent to involve
joints.
VI. CRITERIA FOR EXCLUSION
1. Age below 35 and above 60 years.
2. Patients who develop secondary complication of RA e.g. Pleuro-pericardial disease,
severely damaged joint with bed ridden patients.
3. Any other serious illness e.g. Hepatic/ renal failure.
4. Patient with diagnosed other arthritis like Gouty arthritis, tuberculosis arthritis etc.
5. Patient receiving any other method of treatment.
VII. CRITERIA FOR WITHDRAWAL
The cases with following complications will be withdrawn from the study.
1. Aggravation of the disease during the course of the trial period.
2. Discontinuation of the treatment during trial.

187
3. Development of any serious complications requiring change in the treatment.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
• The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA).
• Clinical assessment will be done and recorded on ‘0’ day, 15th day, 30th day, 45th day
and 60th day.
• Laboratory investigation will be done before and after treatment i.e. on ‘0’and 45th day.
IX. METHOD OF ASSESSMENT OF TREATMENT
The changes in the subjective and objective parameters before and after the treatment shall
be considered for assessment of the safety and efficacy the drug.
1. Clinical Assessment
Clinical assessment will be done (symptoms graded from 0 to 3) and recorded on the
zero day (i.e. one day before administering the trial drug), after completion of the treatment period
(i.e. on 45th day of the treatment) and on the final day of the follow-up (i.e. on 60th day).
Joint pain:

Sl. Severity of Pain Grade Score


1 No pain Zero 0
2 Pain occasional, can be managed I 2
without drug
3 Pain frequent and can be managed II 4
with some pain killer
4 Pain persistent and unmanageable III 6
even with drugs

Morning stiffness:

Sl. Morning stiffness Grade Score


1 No stiffness Zero 0
2 Early morning stiffness upto 30 minutes I 2
3 Early morning stiffness more than 30
minutes and less than 45 minutes II 4
4 Morning stiffness more than 45 minutes III 6

188
Tenderness:

Sl. Tenderness Grade Score


1 No tenderness Zero 0
2 Tender but bearable I 2
3 Tender and winced II 4
4 Tender winced and withdraw III 6

Swelling:
The circumference of swollen Proximal inter Phalangeal joints (PIPj) and big / major joints
are measured with simple measuring methods (soft & thin tape). (only a maximum of 3 PIPj & 3
major joints are to be measured indicating the names of the joints measured for the follow-up)

Swelling:

Sl. Severity of Swelling Grade Score


1 No swelling/not making the bony Zero 0
land marks of joints
2 Just covering the bony prominences I 2
3 Considerably above the land marks II 4
may be with positive fluctuation.
4 III 6

Sl. Name of the involved Measurement in mm.


joint Zero day 45th day 60th day
1
2
3
4
5
6

189
2. Functional assessments
Apart from this walking time in seconds, gripping power, pressing power using inflated mercury
manometer and writing time before treatment and once in every 15 days would be recorded till
the completion of the treatment.
a) Functional tests: To have an objective view of the improvements in the functions of the
affected joints, periodical functional tests have been done (Loxton, et al. 1952 and By-
waters et.al.,1950)
• Walking time: Patients were asked to walk a distance of 150 ft. and time taken has
been recorded.

Sl. Walking time in seconds


Zero day 45th day 60th day
1
2
3
4
5

Sl. Walking time in seconds Grade Score


1 Zero 0
2 I 2
3 II 4
4 III 6
5 IV 8

190
• Grip power: Patients were asked to squeeze the inflated cuff up to 50 mmHg of the
sphygmomanometer and the grip power has been recorded in m.ms. of mercury depending
upon the rise of mercury column.

Sl. Grip power (in mm Hg.)


1 Right hand Left hand
2 Zero day 45th day 60th day Zero day 45th day 60th day
3
4

Sl. Grip power Grade Score


1 If the scale shows between Zero 0
50-55 mmHg
2 between 56 - 65 mmHg I 2
3 between 66 - 75 mmHg II 4
4 between 76 - 85 mmHg III 6
5 86 mmHg & above IV 8

• Pressing power: Similarly when the patient presses the same inflated cuff up to 50 mmHg
against a table then it is recorded as pressing power.

Sl. Pressing power (in mm Hg.)


1 Right hand Left hand
2 Zero day 45th day 60th day Zero day 45th day 60th day
3
4

191
Sl. Grip power Grade Score
1 If the scale shows between Zero 0
50-55 mmHg
2 between 56 - 65 mmHg I 2
3 between 66 - 75 mmHg II 4
4 between 76 - 85 mmHg III 6
5 86 mmHg & above IV 8

ASSESSMENT ON BIO-CHEMICAL CHANGES


ESR and C-reactive proteins will be done before, monthly and after the treatment.

Sl. ESR (mm/1st hr) Grade Score


1 <20 Zero 0
2 21 to 40 I 2
3 41 to 60 II 4
4 61 to 80 III 6
5 >80 IV 8

ASSESSMENT OF SEROLOGICAL CHANGES


R.A. test (Latex fixation test) and Serum C-reactive protein will be done before monthly
and after treatment. The radiological changes will be assessed before and after treatment.

Sl. R.A. factor Grade Score


1 Negative Zero 0
2 Positive I 2
3 Strongly positive II 4

192
X. STATISTICAL ANALYSIS
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail for analysis
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by EC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB)
at Hqrs will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ………. /- per visit will be given i.e., on the 1st day of
recruitment after screening, 15th day, 30th day 45th day and 60th day.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

193
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical validation of guggulu, shunti & guduchi in rheumatoid arthritis.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

194
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
PATIENT INFORMATION SHEET

What is the study about?


Arthritis is a vague and common terminology which literally means inflammation of the
joints. There are many types of arthritis which are generally grouped into three i.e. infective,
immunological and Degenerative. Arthritis is a global problem since the generation of mankind.
The incidence is on increase as a consequence of the fact developing science and technology,
which makes the man immobile even in midst of his comforts. The sedentary life style predisposes
more. India is no exception. Rheumatoid arthritis falls under immunological disorders. It s a
disabling disease and the disability is so great that suffers become physically crippled and becomes
invalid in family and society. It occurs in all climates, on all ethnic groups in the world in
developing countries it is estimated that 3% of the population is suffering. It affects the female
three times more than males. It generally occurs in late third or fourth decade of their life spans
and finally cripples the sufferers with deformities. Ayurvedic system also recognizes this clinical
entity as Amavata.
The coded drug AYUSH-RA tab. and AYUSH-RA oil are to be tried in Rheumatoid
arthritis.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 60 days. During this period, you are
expected to visit once in a 15 days during drug treatment and follow up period.
Before you start the treatment, clinical assessment and the Biochemical tests will be carried
out. If your diagnosis is confirmed and if you are a fit case you will be subjected to this study for
the period of 60 days. You will be supplied with the sufficient quantity of medicines to last until
your next visit i.e. once in every 15 days. The clinical assessment and the laboratory investigations
will be done before and after treatment for the therapeutic efficacy of the drug.

To be translated into regional language.

195
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)
CASE REPORT FORM-I: SCREENING

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Postal Address ………………………….....………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 35 - 65 years

2. Presence of any four of the following seven criteria


(according 1987, revised criteria of American
College of Rheumatology)

(a) Morning stiffness: Stiffness in and around joints


lasting one hour before maximal improvement
(More than 6 week’s duration).

(b) Arthritis of three or more joints (at lest three joint


area, observed by Physician simultaneously having
pain with soft tissue swelling or joint effusion, not
just bony over growth) (More than 6 weeks duration).

(c) Arthritis of Hand joints (More than 6 weeks duration).

(d) Symmetric arthritis (More than 6 weeks duration).

196
(e) Presence of Rheumatoid Nodules

(f) Serum Rheumatoid factor- positive

(g) Typical Radiographic changes of arthritis on PA


view of hand & wrist radiograph that must include
erosions or unequivocal bony decalcification adjacent
to involve joints.

CRITERIA FOR EXCLUSION Yes (1) No (0)

3. Age below 35 and above 65 years.

4. Patients who develop secondary complication


of RA e.g. Pleuroperi cardial disease, severely
damage joint with bed ridden patients.

5. Any other serious illness e.g. Hepatic/ renal failure.

6. Patient with diagnosed other arthritis like Gouty arthritis,


tuberculosis arthritis etc.

7. Patient receiving any other method of treatment.

If Yes to Sl. No. 1 & 2 and No to Sl. No. 3 to 7 above, admit the subject to the trial.

If admitted, subject serial No. __________________

No. of packets issued: _________________________

Date:____________ Signature of the Doctor _______________________

197
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE REPORT FORM II – HISTORY

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

Total income of the family (in Rs.) ...........................................................

198
HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

10. Pain in Joints

If present, specify three major and three minor joints

11. Swelling in joints

If present, specify three major and three minor joints

12. Morning stiffness

13. Tenderness

14. Fever

FUNCTIONAL ASSESSMENT

15. Walking time (in seconds) __________________

16. Grip power in mm Hg:

Left hand Right hand

17. Pressing power in mm Hg

Left hand Right hand

18. Onset of disease Acute (1) Insidious (2)

19. Previous episodes Yes (1) No (0)

20. Duration of disease (in days)

Personal History:

21. Diet: Veg (1) Non-veg (2) Lecto-veg (3)

199
Addiction

22. Smoking Yes (1) No (0)

If yes specify: (a) Quantity [packs] _____________________

(b) Total Duration in years ________________

23. Tobacco Yes (1) No (0)

If yes specify: (a) Quantity_______________________

(b) Total Duration in years____________

24. Alcohol Yes (1) No (0)

If yes specify: (a) Quantity (ml) _________

(b) Total Duration in years_______________

25. Any other (specify) ________________

26. Menstrual history: Regular (1) Irregular (2)

If irregular, Specify___________________________

27. Duration of menstruation: Up to 5days (1) 5-7 days (2)

More than 7 days(3)

28. Quantity Normal (1) Abnormal (2)

If abnormal, Specify__________________________________

29. Prakriti: Vata (1) Pitta (2) Kapha(3)

Vata-Kaphaj (4) Vata-Pittaja (5) Pittaja-Kaphaja(6)

Sannipataj (7)

Physical Examination

30. Height: ___________________

31. Weight: ___________________

200
32. Pulse (per min) ____________

33. Blood Pressure (mm Hg) ___________

34. Body temperature (o F) _____________

35. Respiration rate (per min) _____________

36. Abnormal breathing sounds, specify____________

Systemic examination Normal (1) Abnormal (2)

37. CVS

If abnormal, details_____________________________________________

38. CNS

If abnormal, details ______________________________________________

39. Respiratory system

If abnormal, details ______________________________________________

40. Digestive system

If abnormal, details ______________________________________________

41. Urogenital system

If abnormal, details ______________________________________________

42. Vision

If abnormal, details ______________________________________________

Date: ______________ Signature of Investigator: ______________________

201
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE REPORT FORM III - CLINICAL ASSESSMENT
(On 0th Day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

8. Pain in Joints

If present, specify three major and three minor joints

9. Swelling in joints

If present, specify three major and three minor joints

10. Morning stiffness

11. Tenderness

12. Fever

202
FUNCTIONAL ASSESSMENT

13. Walking time (in seconds) __________________

14. Grip power in mm Hg

Left hand Right hand

15. Pressing power in mm Hg

Left hand Right hand

Date: ______________ Signature of Investigator: _________________________

203
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN


RHEUMATOID ARTHRITIS

CASE REPORT FORM III - CLINICAL ASSESSMENT

(On 15th Day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Assessment:

HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

7. Pain in Joints

8. If present, specify three major and three minor joints

9. Swelling in joints

10. If present, specify three major and three minor joints

11. Morning stiffness

12. Tenderness

13. Fever

204
FUNCTIONAL ASSESSMENT

14. Walking time (in seconds) __________________

15. Grip power in mm Hg

Left hand Right hand

16. Pressing power in mm Hg

Left hand Right hand

Date: ______________ Signature of Investigator: _________________________

205
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN


RHEUMATOID ARTHRITIS

CASE REPORT FORM III - CLINICAL ASSESSMENT

(On 30th Day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Assessment:

HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

7. Pain in Joints

8. If present, specify three major and three minor joints

9. Swelling in joints

10. If present, specify three major and three minor joints

11. Morning stiffness

12. Tenderness

13. Fever

206
FUNCTIONAL ASSESSMENT

14. Walking time (in seconds) __________________

15. Grip power in mm Hg

Left hand Right hand

16. Pressing power in mm Hg

Left hand Right hand

Date: ______________ Signature of Investigator: _________________________

207
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN


RHEUMATOID ARTHRITIS

CASE REPORT FORM III - CLINICAL ASSESSMENT

(On 45th Day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Assessment:

HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

7. Pain in Joints

8. If present, specify three major and three minor joints

9. Swelling in joints

10. If present, specify three major and three minor joints

11. Morning stiffness

12. Tenderness

13. Fever

208
FUNCTIONAL ASSESSMENT

14. Walking time (in seconds) __________________

15. Grip power in mm Hg

Left hand Right hand

16. Pressing power in mm Hg

Left hand Right hand

Date: ______________ Signature of Investigator: _________________________

209
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA

CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN


RHEUMATOID ARTHRITIS

CASE REPORT FORM III - CLINICAL ASSESSMENT

(On 60th Day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Assessment:

HISTORY OF PRESENT ILLNESS:

Chief complaints with duration (in days)

Yes (1) No (0) Duration


(in days)

7. Pain in Joints

If present, specify three major and three minor joints

8. Swelling in joints

If present, specify three major and three minor joints

9. Morning stiffness

10. Tenderness

11. Fever

210
FUNCTIONAL ASSESSMENT

14. Walking time (in seconds) __________________

15. Grip power in mm Hg

Left hand Right hand

16. Pressing power in mm Hg

Left hand Right hand

Date: ______________ Signature of Investigator: _________________________

211
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
FORM IV – LABORATORY INVESTIGATIONS
(0th day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Stage of Assessment

Initial 4th week 8th week 12 th seek

9. Urine Examination:

Routine____________ Microscopic___________

10. Stool examination

Routine _____________ Microscopic____________

Ova/Cyst____________ Occult Blood____________

Blood Examination

11. TC (Cells/Cmm.): ______________________

12. DC P (%)______ L(%) ______ E(%)______M (%)_____B(%)______

13. Hb (g/dl) ____________________________

212
14. ESR (1st hour.)(mm) ____________________

15. Blood Sugar – PP (mg./dl): _______________

16. B.Urea (mg./dl): _____________________

17. S.Creatinine (mg./dl) _______________

18. Uric acid (mg./dl) ______________

19. C. Reactive protein _____________

20. RA factor (Latex fixation test)_____________

21. SGOT _________________

22. S.G.P.T _________________

23. S. Alkaline phosphatase ________________

24. Serum Bilirubin. ________________

25. X-ray chest PA view_________________

26. ECG 12 leads _________________

27. X-ray hand/foot/ limbs (before & after treatment) _________________

28. Any other Remarks _________________________________________________

213
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
FORM IV – LABORATORY INVESTIGATIONS
(60th day)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Stage of Assessment

Initial 4th week 8th week 12 th seek

9. Urine Examination:

Routine____________ Microscopic___________

10. Stool examination

Routine _____________ Microscopic____________

Ova/Cyst____________ Occult Blood____________

Blood Examination

11. TC (Cells/Cmm.): ______________________

12. DC P (%)______ L(%) ______ E(%)______M (%)_____B(%)______

13. Hb (g/dl) ____________________________

214
14. ESR (1st hour.) (mm) ____________________

15. Blood Sugar – PP (mg./dl): _______________

16. B.Urea (mg./dl): _____________________

17. S.Creatinine (mg./dl) _______________

18. Uric acid (mg./dl) ______________

19. C. Reactive protein _____________

20. RA factor (Latex fixation test)_____________

21. SGOT _________________

22. S.G.P.T _________________

23. S. Alkaline phosphatase ________________

24. Serum Bilirubin. ________________

25. X-ray chest PA view_________________

26. ECG 12 leads _________________

27. X-ray hand/foot/ limbs (before & after treatment) _________________

Any other Remarks _________________________________________________

215
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
CASE RECORD FORM V
CONSOLIDATED DATA ON PERIODICAL OBSERVATIONS

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

Sl Subjective/ 0 day/BT 15th day 30th day 45thday 60th day


Tobjective Dt. Dt. Dt. Dt. Dt.
Parameters
Yes No Yes No Yes No Yes No Yes No
(1) (0) (1) (0) (1) (0) (1) (0) (1) (0)
1. Pain in joints
2. Swelling in
joints
3. Morning
stiffness
4. Tenderness
5. Fever
6. Walking time
(in second)
7. Grip power
in mm Hg

216
8. Pressing power
in mm Hg
9. Other Associated Symptoms if Any [Specify]

10. Adverse reactions


11. Burning Not
sensation in applicable
abdomen
12. Nausea Not
applicable
13. Diarrhoea Not
applicable
14. Skin rashes Not
applicable
15. TC (Cells/Cu.
mm.)
16. DC (%) 13. P 13. P
14. L Not Not Not 14. L
15. E applicable applicable applicable 15. E
16. M 16. M
17. B 17. B
17. ESR (mm / Not Not Not
1st hour.) applicable applicable applicable
18 Hb (g/dl)
(Cyanomet
hamoglobin
method)
19. C. Reactive
protein
20 RA factor (Latex
fixation test)
21. Liver function tests
22. S. Bilirubin

217
23. Total (mg/dl)
24. Direct (mg/dl)
25. SGPT (IU/L)
26. SGOT (IU/L)
27. S. Alkaline Not Not
phosphatase Applicable Applicable
(U/L)
28. S. Proteins
(Total) (g/dl)
29. Albumin (g/dl)
30. Globulin (g/dl)
31. Renal function tests
32. Blood urea Not Not
(mg/dl) applicable applicable
33. S. Creatinine
(mg/dl)
34. Urine Examination
Routine Not Not
Albumin (g/dl) applicable applicable
Globulin (g/dl)
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells
35. Stool Examination
Occult Blood Not Not
applicable applicable
Ova/Cyst Not Not
applicable applicable
Microscopic
RBC Not Not
Pus Cells applicable applicable
Epithelial Cells

218
7. Overall clinical assessment

Improved (1) No change (2) Deteriorated (3)

8. Overall impression of well being by the Subject:

Improved (1) No change (2) Deteriorated (3)

9. Status of the subject:

Continuing: (1)

Drop out (2) Reason: _____________________________

Died (3) Cause: _______________________________

Date: ______________ Signature of the investigator ___________________

Name of the investigator ______________________

219
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – I
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 1st visit – 0 day and taken back on 2nd visit –15th day)

Registration No. of participant .....................................................................................................

Name of the participant ..................................................................................................................

Please come for next visit on ................................. (Date and time is to be filled by the Investigator)

Instructions to trial participant

• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.

• Please return the empty strip after taking medicine along with the compliance report duly
filled.

• Please come with empty stomach and bring breakfast along with you during next visit.

Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put  Please enter Please put  Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
1.
2.
3.
4.
5.

220
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

Name of the participant .....................................................................

Date: ...........................................

Signature or Thumb impression of the participant ........................................

Signature of the Investigator with date ..........................................

221
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – II
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 2nd visit – 16th day and taken back on 3rd visit –30th day)

Registration No. of participant .....................................................................................................

Name of the participant ..................................................................................................................

Please come for next visit on ................................. (Date and time is to be filled by the Investigator)

Instructions to trial participant

• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.

• Please return the empty strip after taking medicine along with the compliance report duly
filled.

• Please come with empty stomach and bring breakfast along with you during next visit.

Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put  Please enter Please put  Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
16.
17.
18.
19.
20.

222
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.

Name of the participant .....................................................................

Date: ...........................................

Signature or Thumb impression of the participant ........................................

Signature of the Investigator with date ..........................................

223
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – III
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 3rd visit – 31st day and taken back on 3rd visit –45th day)

Registration No. of participant .....................................................................................................

Name of the participant ..................................................................................................................

Please come for next visit on ................................. (Date and time is to be filled by the Investigator)

Instructions to trial participant

• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.

• Please return the empty strip after taking medicine along with the compliance report duly
filled.

• Please come with empty stomach and bring breakfast along with you during next visit.

Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put  Please enter Please put  Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
31.
32.
33.
34.
35.

224
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.

Name of the participant .....................................................................

Date: ...........................................

Signature or Thumb impression of the participant ........................................

Signature of the Investigator with date ..........................................

225
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DRUG COMPLIANCE REPORT FORM – IV
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
(To be filled by the trial participant)
(To be issued on 3rd visit – 46th day and taken back on 4th visit – 60th day)

Registration No. of participant .....................................................................................................

Name of the participant ..................................................................................................................

Please come for next visit on ................................. (Date and time is to be filled by the Investigator)

Instructions to trial participant

• Please take tab. AYUSH-RA 2 gm. twice a day after food with a glass of luke warm water
(approx. 250 ml.) maintaining 12 hours gap in between.

• Please return the empty strip after taking medicine along with the compliance report duly
filled.

• Please come with empty stomach and bring breakfast along with you during next visit.

Day Date Morning dose (around 9 AM) Evening dose (around 9 PM)
Please put  Please enter Please put  Please enter
mark after the time mark after the time
taking the taking the
medicine medicine
46.
47.
48.
49.
50.

226
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.

Name of the participant .....................................................................

Date: ...........................................

Signature or Thumb impression of the participant ........................................

Signature of the Investigator with date ..........................................

227
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL VALIDATION OF GUGGULU, SHUNTI & GUDUCHI IN
RHEUMATOID ARTHRITIS
RECIEPT

Received an amount Rs ____________________ (Rupees_______________________ only)


from_________________________ (name) Institute/unit/center_________________ (station)
on _________________________________________________________________ (date) for
visit no.____________________________________

Date: _______________ Name of participant: ______________________


Sl. No. _________________

Signature or Thumb impression: _____________


Signature of the Investigator: _______________

Signature of Account’s Personnel /Office Personnel

Signature of the Director/In charge

228
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL
FOR THE TREATMENT OF OSETOPOROSIS

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

229
Blank

230
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
TREATMENT OF OSETOPOROSIS

I. BACKGROUND
Pommer coined the term osteoporosis in 1885, which literally means increased porosity of
Bones.
It is described as a systemic skeletal disease characterized by low bone mass and micro
architectural detoriation of bone tissues with a consequent increase in bone fragility and susceptibility
to fracture. The magnitude of the problem has not been fully understood and the incidence of
osteoporosis is highly increased due to increased life span and greater awareness of the disease
since 1980 (Rosen et al, 1997). In recent study the following observations were made.
1) Osteoporosis1 occurs both in males and females in India.
2) Osteoporotic fractures occur more commonly in Indian males than females.
3) Osteoporotic fractures occur 10-20 years earlier in Indian men and women compared to
west (Wali, T.P. etal)
Certain factors like Genetic, personal life style factors like smoking, alcoholism lower
intake of calcium, non-exposure to sunlight and certain diseases predispose this disease.
In Ayurveda under the heading “Asthi kshaya” many signs and symptoms described can
closely be correlated with this clinical entity. This has also been treated with herbal and herbo
minerals since very remote past. In recent years the advancement in the field of Phytochemistry
and clinical trials, it has been evinced the role of certain herbals like Cissus quardrangularis in the
treatment of bone fracture. The phytochemical studies have also established the presence of
phytosterol, phytoestrogen and calcium. Embica officinalis is an anti-oxidant and thereby stabilizes
Vitamine-D metabolites or their conjugates present in the primary ingredient. Further it is
considered to promote collagen metabolism by virtue of its Vitamine-C like activity. Now
combination of Asthi Shrankhala( Cissus quardrangularis) and Amalki( Embica officinalis ) is
being taken up for study.

References
1. Harisson’s Principles of internal medicine, Volume-1, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1208-1209
2. Bhaisajya Ratnavali, Chaukhamba Sanskrit Samsthan, Varanasi

231
In modern medicine this disease is managed with, Hormone replacement therapy and also
with calcium and Vitamin ‘D’ which is considered as anti resorptive and stimulator of Bone turn
over. But these drugs do have side effects like nausea, vomiting and diarrhea. In this contest the
natural calcium, which is safe, less toxic, and does not have any side effect will be taken for
study.
II. OBJECTIVES:
To assess the therapeutic efficacy of an Ayurvedic coded trial drug AYUSH B-caps in the
treatment of osteoporosis in comparison with standard control drug Calcium with Vitamin- D3.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE & METHODS
Groups : Two – trial and control [50 (25 male and 25 female) cases
in each group (Control drug will be made similar to trial
drug and one placebo draggee will be prescribed after
dinner)
Group-I : Trial drug
Group-II : Control drug
Trial Design : Double blind randomized
Drug/Dosage/Duation:
Trial drug : Coded drug AYUSH B –Two caps 500 mg each twice a
day.
Control drug : Control drug 500 mg twice a day.
Duration of : One year
Treatment
Period of Study : One year for each case.
Total duration : will be Two years to complete the study.
V. CRITERIA FOR INCLUSION
1. Age: Patients of both sexes above 45 years and up to 70 years.
2. B.M.D. T. Score below – 1.5

232
The cases for carrying out BMD T Score will be screened with the following targeted
patients:
1. Post menopausal woman with early menopause (40 years and below) and familial
prevalence.
2. Patients with osteopenia or spinal deformities on spine-x-rays.
3. Patients on long-term cortico steroids for more than six months.
4. Patients with history of osteoporosis related fractures.
VI. CRITERIA FOR EXCLUSION
1. Age below 45 and above 70
2. T. Score below –1.5
3. Primary Hyper parathyroidsim
4. Thyrotoxicosis
5. Addison’s disease
6. Cushing syndrome
7. Rheumatoid arthritis
8. Malabsorption syndrome
9. Chronic liver diseases
10. Organ transplantation
11. Chronic renal failure
12. Prolonged immobilization
13. Diabetes (Uncontrolled)
14. Cases undergoing treatment for osteoporosis
15. Cases undergoing treatment for any other serious illness.
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial there may be certain potential adverse threats like Kidney
stones, hypocalcaemia with renal insufficiency (milk alkali syndrome) and interference of calcium
with other essential nutrients. If any other side effects and other symptoms are observed then the
trial drugs will be withdrawn and will be treated symptomatically.

233
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Clinical assessment will be done (O), at the end of 1st, 2nd and every subsequent month
till the completion of treatment (Form 2). The Lab investigations (Biochemical markers) will be
recorded before drug administration (O month) and after every two months till the completion of
trial (0, 2nd, 4th, 6th, 8th, 10th and 12th months i.e. the end of the treatment). The B.M.D. will be
done before and after the completion of the treatment.
IX. CRITERIA FOR ASSESMENT
30% or more in B.M.D. T. Score (above –1.5 level) increase will be considered as
significant improvement. .
X. STATISTICAL ANALYSIS
Data on BMD T-Score will be analyzed using appropriate statistical tools. (Null
Hypothesis: There is no significant difference between the BMD T-score in the treated group and
control group).
XI. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, HQ’s Office New Delhi will monitor the progress of the trial
XII. ETHICAL REVIEW
Clearance certificate from Institutional Ethical Committee (IEC) or Head of the Institution
should be obtained before the Project is initiated. IEC/Head of the Institution should submit
patient’s information sheet and informed consent form along with project proposal for approval.
Both of these forms should be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.

The change between two BMD can be expressed in the form of (%) percentage between two measurements
or by absolute change in gm/cm between two measurements.
Percentage change is calculated as I BMD – II BMD x 100
I BMD
= (%) percentage change.
Absolute change is calculated as I BMD – II BMD

Absolute change

234
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ___________ per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the trial at CCRAS Hqrs. The investigators and technicians will be detailed
about the clinical trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

235
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR DOUBLE BLIND CLINICAL TRIAL FOR THE
TREATMENT OF OSETOPOROSIS
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Double blind clinical trial for the treatment of Osetoporosis”.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

236
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL FOR THE TREATMENT OF
OSETOPOROSIS
PATIENT INFORMATION SHEET

What is the study about?


Osteoporosis is characterized by increased fragility and susceptibility to fracture. It is a
disease very common and there is increase in its incidence due to increased life span and
advancement in health delivery system. Osteoporotic fractures occur 10-20 years earlier in Indian
men and women compared to west. The life style changes have also bearing on the predisposition
of this disease. In Ayurveda system also the management is done through herbal medicines and
this clinical entity can be correlated with Asthi Kshaya. The drugs which are used for the treatment
of Osteoporosis some time causes side effects. In Ayurveda the efficacy of herbal drugs like Asthi
Shrankhala and Amalki have been observed in clinical trials.and now these drugs are being takenup
for study with modern medicine calcitrol in 100 cases (50 each group)
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately one year to complete. During this
period, you are expected to visit the hospital thirteen times. The interval between the first and
second visit will be around one month. After it, you are required to visit once in a month till the
completion of the treatment.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, BMD Test (Bone Mineral Density). This is to make sure that you are eligible
for the study.
If you were found eligible, you would be put on trial treatment for one year. The daily
dosage will be 500mg twice. At each visit, you will be supplied with sufficient quantities of drugs
to last until your next visit. On completion of the treatment B.M.D. will be done again to asses the
effect of the treatment. Bio-chemical investigations will also be carried out one in every two
months.

To be translated into regional language.

237
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN
THE TREATMENT OF OSETOPOROSIS
CASE REPORT FORM I – SCREENING
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Age between 45 and 70 years of either sex

2. Bone Mineral Density (B.M.D.)

CRITERIA OF EXCLUSION Yes (1) No (0)

3. Age below 45 and above 70

4. Primary hyper parathyroidsim

5. Thyrotoxicosis

6. Addison’s T. Score >-1.5 and <.4

7. Cushing syndrome

8. Rheumatoid Arthritis

9. Mal-absorption syndrome

10. Chronic liver diseases

238
11. Organ Transplantation

12. Chronic renal failure

13. Prolonged immobilization

14. Uncontrolled Diabetes

15. Cases undergoing treatment for osteoporosis

16. Cases undergoing treatment for any other serious illness

If ‘Yes’ to 1 and 2 & ‘No’ to 3 – 16 above, admit the subject to the trial. If admitted,

Subject serial No. ____

No. of packets issued: _________________________

Date:____________ Signature of the Doctor ___________________

239
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSETOPOROSIS
CASE REPORT FORM II – HISTORY

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address ……………………………………..……………..........…………………………

8. Educational status: Illiterate (1) Read and Write(2) Primary School (3)

Middle School (4) High School (5) College (6)

Other (specify) (7) I.N.A. (8)

9. Occupation: Desk work(1) Field work (2)

Field work with physical labour (3)

Field work with intellectual (4)

Indicate nature of work: ...........................................................................

Addiction No (0) Yes (1)

10. Smoking

If yes specify: (a) Quantity (packs) _______________

(b) Total Duration in year’s _________

240
11. Tobacco

If yes specify: (a) Quantity ________________

(b) Total Duration in year’s _________

12. Alcohol

If yes specify: (a) Quantity (in ml/day) _________--_____

(b) Total Duration in year’s _________--_____

13. Prakriti: Vata (1) Pitta (2) Kapha (3)

Vata-Kaphaj(4) Vata-Pittaja(5) Pittaja-Kaphaja(6)

Sannipataj (7)

Physical Examination

14. Height (cm) ____________

15. Weight (kg) ____________

MEDICAL HISTORY No (0) Yes (1)

16. Pathological Fracture(After the age of 40 yrs or more)

If yes indicate: Date_______ Site__________ History of pain before fracture_________

17. Family History of Osteoporosis

If yes indicate relationship_______________________________________

18. Spinal Deformity

If yes indicate site_________ Date from which suffering__________

Menstrual History (For female patients): No (0) Yes (1)

19. Age in years at Menarche

20. Duration of menstrual period in days

21. Interval of menstrual period

22. Age in years at onset of menopause

241
SURGICAL HISTORY No (0) Yes (1)

23. Abdominal Surgery

24. Hysterectomy

25. Oophorectomy

26. Orthopedic Surgery

Drugs used (having bearing on Osteoporosis) No (0) Yes (1)

27. Steroids

If yes indicate duration (in months) _______ Doses_______

28. Anti convulsive

If yes indicate duration (in months) _______ Doses________

29. HRT Heparin/Warfarin

If yes indicate duration (in months) _______ Doses________

Clinical Symptoms No (0) Yes (1)

30. Skeletal Pain

If yes indicate Region______________ Duration in months ________

31. Kyphosis

32. Other clinical symptoms

If yes, specify (Symptoms & Duration) ________________________________________

33. Type of pain Acute (1) Chronic (2)

Date:_______________ Signature of the Investigator_________________

242
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSETOPOROSIS
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Month of Assessment :

Initial (0) 1st month (1) 2nd month (2)

3rd month (3) 4th month (4) 5th month (5)

6th month (6) 8th month (7) 9th month (8)

10th month (9) 11thmonth (10) 12th month (11)

Clinical Symptoms No (0) Yes (1)

9. Skeletal Pain

If yes indicate Region______________ Duration in months ________________

10. Kyphosis

11. Other clinical symptoms

If yes, specify (Symptoms & Duration) _______________________________________

12. Type of pain Acute (1) Chronic (2)

Date: ___________ Signature of the Investigator _______________________

243
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC FORMULATION IN THE
TREATMENT OF OSTEOPOROSIS
CASE REPORT FORM IV-A – LABORATORY INVESTIGATIONS

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Month of Assessment :

Initial (0) 2nd month (1) 4th month (2)

6th month (3) 8th month (4) 10th month (5)

12th month (6)

9. Serum Calcium__________________________________(mEg / 100 cc)


BONE TURNOVER
10. Alkaline phosphate________________________________(King & Amstrong units)
(Bone specific)
11. Osteo calcin (BGP) ________________________________(King & Amstrong units)
12. Procollagen peptides________________________________
BONE RESORPTION
13. Pyridinium cross links and some of________________________________
Type – I Collagen Break down products in serum
14. Serum Tartarate resistant________________________________________
Acid phosphatase

Date: _____________ Signature of the Investigator: ______________

244
ANORECTAL DISORSERS

SECTION - IV

245
Blank

246
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE
MANAGEMENT OF FISSURE-IN-ANO (PARIKARTIKA)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

247
Blank

248
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA1)

I. BACKGROUND
An Anal Fissure is a tear in the skin around the opening of the Anus1. It can cause sharp
pain, especially when opening the bowels. Anal Fissure is thought to be a common disorder for
which many people do not seek medical advice. The internal anal sphincter is thought to play a
key role in the development of an Anal Fissure. This is one of two muscles that control the
opening of the anus. Both muscles need to relax in order to pass a stool. Unlike the exterior anal
sphincter, which can be tensed or relaxed voluntarily, there is no voluntary control of the internal
sphincter. Because of the pain of a fissure, the internal anal sphincter may go into spasm - causing
a raised pressure within the anus. This excess pressure makes it harder to pass a stool, making
constipation worse, and contributing to a vicious circle. The spasm of the internal anal sphincter
can also restrict the blood supply to the anal skin, which reduces its ability to heal.
The condition Parikartika has been mentioned in the Ayurvedic literature as one of the
fifteen kinds of disorders which may result from an injudicious use of purgatives owing to the
ignorance of the physician or of the patient. Improperly done virechana karma (purgatives)
aggravates the Vata & Pitta that gives rise to a sort of cutting, sawing pain in the anus, penis,
umbilical region and the neck of the bladder (Vasti). The omission of flatus is arrested the Vayu
lies incarcerated in the abdomen and relish for food vanishes.
Application of Creams or Ointments that contain local anaesthetics (eg lidocaine) or
steroids (eg hydrocortisone) and an injection of outline toxin (Botox), anal dilatation,
sphincterotomy, and fissurectomy (chronic fissure) are usually in practice. But these procedures
have sometimes associated with some complications like post operative anal stenosis, sphincter
incontinence etc. To overcome such problems and to provide cheap, simple, ambulatory and
effective treatment, different treatment modalities have been kept on trial on the basis of the
treatment mentioned in the ancient literature and also based on the preliminary work done in the
management. Earlier workers have tried Kaseesadi Taila Vasti, Jatyadi Ghtrita per rectal
application, hot sitz bath and a laxative, taking lead from the ancient classics especially descriptions
described about the use of Picchavasti and Anuvasana Vasti in the treatment of parikartika.
Though different regimens have proved to be efficacious in the treatment of fissure-in-ano, patients

References
1. Charak Siddhi sthana 6/29

249
feel difficulty in pushing of Kaseesadi Taila in to the anal canal. Sometimes there was an
immediate spillage of oil after pushing due to spasm of the sphincter. More over it was found
difficult to assess which procedure was more effective in the combined therapy of pushing of oil
and application of ghee manually per rectally. In order to see the efficacy of various procedures
individually, it was thought to try different therapeutic regimens in present study beside the
development of a novel method of dilatation of anal canal to see the effect of different procedures
/ drugs in the management of fissure-in-ano.
II. OBJECTIVES
• To provide symptomatic relief in shorter duration
• To provide healing to the fissure-in-ano
• To find out a simple, amble, safe & cost effective therapeutic regimen or procedure in the
management of fissure-in-ano
III. CENTRES
CCRAS identified Centers.
IV. SAMPLE SIZE AND METHODS
Sample size : 40 subjects per centre
Trial Drug /Dosage :
Group: I
• Triphala churna; 5gm with warm water daily at bedtime for 28 days
• A novel method of Anal dilatation for 07 days
• Hot Sitz bath for 28 days Anal dilatation:
A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.
The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:
Day 1 : 5ml

250
Day 2 : 7ml
Day 3 : 10ml
Day 4 : 15ml
Day 5 : 20ml
Day 6 : 20ml
Day 7 : 20ml
Group: II
• Triphala churna; 5gm with warm water daily at bed time for 28 days
• Anal dilatation with Jatyadi Ghrita for 07 days
• Hot Sitz bath for 28 days
Anal dilatation:
Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal Canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal Canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.
Group: III
• Triphala Churna; 5gm with warm water daily at bed time for 28 days
• Hot Sitz bath for 28 days
• Application of Jatyadi Ghrita (P/R) (without dilatation) for 07 days
Application of Jatyadi Ghrita (P/R)
The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal Canal without applying much pressure in the Canal.
The same procedure is to be carried out for seven days.

251
Duration of the trial : Total six weeks: (28 days as per the schedule
given under each group and last two weeks
follow-up without any medication.
Design of the Study : Open trial
V. CRITERIA FOR INCLUSION
Selection of cases : Any age of either sex with complains of Pain with or without
bleeding per rectum during and/or after the defecation with or without other symptoms like, itching,
discharge, constipation, with /or without pain are examined and confirmed by peri-anal
examination are admitted for the study.
The cases are randomly selected irrespective of age, sex, chronicity, Prakriti and type of
fissure.
VI. CRITERIA FOR EXCLUSION
The cases associated with malignancy were excluded from the study.
VII CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition or any serious adverse
events which requires urgent treatment or if patients themselves want to withdraw from the study,
such subjects may be withdrawn from the trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case record form I & II. Clinical and physiological assessment in form III and
laboratory investigations in forms IV will be done regularly.
IX. CRITERIA OF ASSESSMENT
Since the pain is the main symptom in Fissure-in-ano, a total number of days taken to
heal the ulcer with alleviation of pain and associated symptoms are noted and results are assessed
in the following manner.

Sl. Response Response Description


Duration
1 Complete < 7 days When there is complete relief in pain during/after
Response defecation without any bleeding within 7 days of the
therapy started. No recurrence thereafter up to 6 weeks
of the follow-up.

252
2 Partial 08 – 14 When there is complete relief in pain during/after
Response days defecation without bleeding after 7 days but before 14
days of the therapy and no recurrence thereafter up to 6
weeks of the follow-up.
3 Poor 15 – 21 Complete relief in pain after 14 days but before 21 days
Response days of the treatment without bleeding and recurrence
thereafter up to 6 weeks of the follow-up.
4 No 22 days & When there is any relief in pain or partial relief or relief
Response above in pain after 22 days of the therapy and/or recurrence
thereafter.
5 Drop-out Drop-out Discontinuation of the treatment during the trial due to
development of any complications & aggravation of the
disease.

X. STATISTICAL ANALYSIS
Data on intensity of pain, duration of pain will be tabulated and analysed by using
appropriate statistical methods.
However the data of each case will have to be communicated on completion of trial
therapy to the Statistical Officer of CCRAS through e-mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
The progress of the trial will be monitored by field visits by monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal for
approval by IEC. Both will be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB)
at Hqrs. will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur. The data will be reviewed as every 20
participants entered the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions whether they
are perceived to be study related or not. The Board decides whether the adverse effects warrant

253
discontinuation of the study protocol. Protocols will be written and approved for the treatment of
study related adverse events
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.______ /- per visit i.e., on the 1st day of recruitment after
screening, 3rd week, & 6th week (3 times)
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed Tabs /Government Institutes under
intimation to this Council observing requisite codal formalities.

254
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________

CONSENT BY SUBJECT

I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.

I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.

I, exercising my free power of choice, hereby give my consent to be included as a subject


in the clinical trial on “Multi centric open Clinical trial on the management of Fissure-in-
ano (Parikartika).”

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

255
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
PATIENT INFORMATION SHEET

What is the study about? What is an Anal Fissure?


An anal fissure is a small tear in the lining of the Anal Canal. This type of tear may
develop in adults from passing hard or large stools during bowel movements. Anal Fissure is also
common in infants between 6 and 24 months. Anal Fissures are less likely to develop in older
children.
An Anal Fissure may cause you to experience pain and bleeding. More than 90 percent
heal without surgery, and you can use topical creams or suppositories to provide relief as they
heal. Anal fissures that fail to heal may become chronic and cause considerable discomfort. Certain
Ayurvedic formulations and procedures were proved to be effective in the management of fissure-
in-ano.
What are signs and symptoms of an anal fissure?
The main signs and symptoms of an anal fissure include:
• Pain or burning during bowel movements that eases until the next bowel movement
• Bright red blood on the outside of the stool or on toilet paper or wipes after a
bowel movement
• Itching or irritation around the anus
• A visible crack in the skin around the anus
When to see a doctor?
See your doctor if you have pain during bowel movements or blood on stools or toilet
paper after a bowel movement.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately six weeks. During treatment period,
you are expected to visit the hospital daily from day one to seven days then on 14th, 21st, 28th,
35th & 42nd day.

256
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for six weeks.
At each visit, you will be supplied with sufficient quantities of drugs to last until your next
visit. If any adverse reactions like skin allergy, nausea, vomiting and palpitation/tremor etc., noticed
during the treatment period, this should be noticed to the doctor who is treating you.

To be translated into regional language.

257
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE RECORD FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)
CASE REPORT FORM-I: SCREENING

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..………………………………………

CRITERIA FOR INCLUSION Yes (1) No (0)

1 Pain or burning sensation during or after defaecation

2 Bleeding per rectum during or after defaecation

3 Associated with Itching or irritation around the anus

4 A visible crack in the skin around the anus (Fissure-in-ano)

5 Bright red blood on the outside of the stool or on the toilet paper

6 Constipated bowels

CRITERIA OF EXCLUSION:

7 History of malignancy

A patient is eligible for admission to the trail

If Sl. No. 1 – 6 is ‘Yes’ and Sl. No. 7 are ‘No’

If recruited, subject serial No: ______________

Date: __________________ Signature of the investigator: _______________________

258
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment:

8. Address ……………………………………..……………..........…………………………

9. Educational status: Illiterate 1 Read and Write 2 Primary School 3

Middle School 4 High School 5 College 6

Other (specify) 7 I.N.A. 8

10. Occupation: Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work: ...........................................................................

11. Family income per month in Rs. Rs. Income per capita in Rs.

12. Religion: Hindu 1 Muslim 2 Sikh 3

Christian 4 Parsi 5

13. Dietary Pattern: Vegetarian Non-Vegetarian

259
14. Likes: __________________________________________________________________

15. Habits: Smoking Drinking Chewing Pan

Tobacco

HISTORY Yes (1) No (0) Duration


(in days)

16. Chronic illness:

17. Allergy:

18. Surgery:

19. Communicable diseases

FAMILY HISTORY

20. Type of family: Nuclear No. of persons:

Joint: No. of persons:

Yes (1) No (0)

21. Diseases: Chronic illness:

Hypertension:

Diabetes:

Genetic disorders:

If yes, specify: __________________________________________________

Psychiatric disorder:

Other:

22. History of recent delivery (in case of female): ___________________________________

HISTORY OF PRESENT COMPLAINTS Yes (1) No (0)

23. Pain or burning sensation during or after defaecation

24. Bleeding per rectum during or after defaecation

260
25. Associated with Itching or irritation around the Anus

26. A visible crack in the skin around the Anus (Fissure-in-ano)

27. Bright red blood on the outside of the stool or on


the toilet paper

28. Constipated bowels

29. Medication: Yes (1) No (0)

a. Whether received any treatment previously

b. Any surgical interventions made for any disease

CLINICAL EXAMINATION Yes (1) No (0)

General Examination

30. Blood Pressure: TPR:

31. Height

32. Weight

33. Chest : Auscultation: Heart: Lungs:

34. Abdomen:

35. Extremities - Inspection: Clubbing of fingers

Pedal Oedema: Varicose veins:

Local / Peri-anal Examination:

1. Condition of skin around anus:


12 0
2. Condition of the fissure :

Acute Chronic

Presence of Sentinel pile : Yes / No


90 30
Position of the fissure o clock position:
60
No. of fissures :

261
3. Digital examination

Tenderness Present / Absent

Sphincter tone:

Hyper tonic /Normal /Hypo tonic

Any mass palpated in the canal

4. Anoscope/Proctoscopic examination (not in Acute cases)

Treatment:

Group: I

• Triphala churna: 5gm with warm water daily at bed time for 28 days

• A novel method of Anal dilatation for 07 days

• Hot Sitz bath for 28 days Anal dilatation:

A self retaining Foley’s rubber catheter no. 18 is smeared with 2% lignocaine jelly and
inserted in the Anal canal up to 4 cm. from the tip and on the first day the bulb is inflated with 5
ml of water and gently pull the catheter downward till it sustains maximum resistance and the
catheter is allowed to stay in position for one minute. Then the water is withdrawn from the bulb
and the catheter is removed from the Anal canal. After removing the catheter the patient is given
hot sitz bath for two minutes. The catheter is sterilized properly and reused in the same patient for
next sittings.

The procedure remains unchanged except in the increase in the volume of the water from
5ml to different volumes as indicated below:

Day 1 : 5ml

Day 2 : 7ml

Day 3 : 10ml

Day 4 : 15ml

Day 5 : 20ml

Day 6 : 20ml

262
Day 7 : 20ml

Group: II

• Triphala churna; 5gm with warm water daily at bed time for 28 days

• Anal dilatation with Jatyadi Ghrita for 07 days

• Hot Sitz bath for 28 days

Anal dilatation:

Take sufficient quantity of Jatyadi Ghritam in a sterile bowl. Initially the little finger (goved)
is well smeared with the Ghritam and gently inserted in the Anal canal watching the resistance
produced by the sphincter. Care should be taken to push the finger always against the non-ulcer
wall of the Anal canal and inwards. After the little finger is inserted in to the canal allow to remain
the finger in the canal for one minute. Then the finger is withdrawn slowly and then index finger is
inserted following the same principle and wait for two minutes. Then index and middle fingers are
inserted together and kept for three minutes in the canal. Care should be taken that the fingers
and the anal canal are well lubricated with the Ghritam. After the procedures are completed the
patient is allowed hot sitz bath for three minutes. The same procedure is to be carried out for
seven days.

Group: III

• Triphala churna; 5gm with warm water daily at bed time for 28 days

• Hot Sitz bath for 28 days

• Application of Jatyadi Ghrita (P/R) (without dilatation) for 07 days

Application of Jatyadi Ghrita (P/R)

The patient is first asked to take hot sitz bath then with the help of gloved little finger the
Jatyadi Ghritam is applied gently in the Anal canal without applying much pressure in the canal.
The same procedure is to be carried out for seven days.

Remarks:

Signature of the Investigator

263
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE REPORT FORM III -PERIODICAL OBSERVATION AND ASSESSMENT
CASE REPORT FORM III – CLINICAL ASSESSMENT
(From day one to seventh day and subsequently on 14th, 21st, 28th, 35th &
42nd day)
Separate form should be used on each visit
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Day of Assessment: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, 28th, 35th & 42nd day

CLINICAL ASSESSMENT CHART: (Mention ‘Y’ for Yes, ‘N’ for No)

FOLLOW UP
Symptoms & Signs: Initial First month Second month Third month
Abdominal pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda

264
- Bheda
- Sula
Low back pain
-Day of onset
-Intensity
-Relief after passage
of clots
-Nature of pain
-Toda
- Bheda
- Sula
Pain in lower limbs
Nausea / Vomiting
Constipation
Giddiness
Tenderness on palpation
Breast tenderness
Diarrhea
Headache
Fainting

Drug Compliance Chart: 100% 75-99% 50-74% <50%


1.
2.
3.
Complications if any:
Outcome of Trial:
13. Status of the patient:
Completed:
Drop out: Reason: ____________________________
Died: Cause______________________________

Date: Signature of the Investigator

265
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MLTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE - IN ANO (PARIKARTIKA)
CASE REPORT FORM IV - A - LABORATORY INVESTIGATIONS
(On Day 1)
(Enter a in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the Subject: ...........................................................................................................

4. Date of Birth: Age (in yrs.) :

5. Address ................................................................................................................................

6. Date of Assessment :

7. Urine Examination

Routine: _______________________ Microscopic: ___________________

8. Stool examination

Routine: _______________________ Microscopic: ___________________

Occult Blood: __________________ Ova/Cyst: ___________________

Blood Examination

9. TLC (Cells/Cmm.): _______________

10. DLC: P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)

11. ESR (mm / 1st hour.) __________

12. Hb (g/dl) (Cyanmethaemoglobin method) ____________________

13. General Blood Picture for morphology of RBC ______________________

Normocytic Normochromic /Microcytic Hypochromic /Macrocytic Normo/hypochromic

266
Liver function tests

14. S. Bilirubin (mg/dl)

15. SGPT (IU/L)

16. SGOT (IU/L)

17. S. Alkaline phosphatase (KA unit)

18. S. proteins (gm/dl)

Renal function tests

19. Blood urea (mg/dl)

20. S. Creatinine (mg/dl)

Date: _____________ Signature of investigator _______________________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
(On Day 35)
CASE RECORD FORM IV-PERIODICAL OBSERVATION AND ASSESSMENT
FORM IV-B – LABORATORY INVESTIGATIONS

(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address: ...............................................................................................................................

8. Date of Assessment:

9. Hb (g/dl) (Cyanomethaemoglobin method) ____________________

10. General Blood Picture for morphology of RBC ______________________

Normocytic Normochromic /Microcytic Hypochromic /Macrocytic Normo/hypochromic

Date: _____________ Signature of investigator _______________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTI CENTRIC OPEN CLINICAL TRIAL ON THE MANAGEMENT OF
FISSURE-IN-ANO (PARIKARTIKA)
CASE RECORD FORM V-CONSOLIDATED DATA ON PERIODICAL
OBSERVATIONS
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ……………………………........…………………………………

4. Name of the Subject: ...........................................................................................................

5. Gender: Male (1) Female (2)

6. Date of Birth: Age (in yrs.) :

7. Address: ...............................................................................................................................

8. Date of Assessment:

Sl Subjective/ objective 0 day/BT 15th day 30th day 45thday/AT


Parameters Dt. Dt. Dt. Dt.
1. M.C.V. (Fl)
2. Serum iron (ìg/dl)
3. Serum ferritin (ìg/dl)
4. Hb (g/dl) (Cyanomet
haemoglobin method)
5. PCV (%)
6. General Blood Picture
for morphology of
RBC
Normocytic
Normochromic

269
Microcytic Hypochromic

Macrocytic Normo/
hypochromic
7. Liver function tests
S. Bilirubin (mg/dl)
SGPT (IU/L)
SGOT (IU/L)
S. Alkaline phosphatase
(KA unit)
S. Proteins (gm/dl)
8. Renal function tests
Blood urea (mg/dl)
S.Creatinine(mg/dl)

9. Overall clinical assessment

Improved No change Deteriorated

10. Overall impression of well being by the Subject:

Improved No change Deteriorated

Status of the patient:

Continuing

Drop out Reason: _____________________________

Died Cause: _______________________________

Date: ______________ Signature of investigator _________________________

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COMPARATIVE CLINICAL EVALUATION OF SELECT
AYURVEDIC TREATMENT MODALITIES IN THE
MANAGEMENT OF ARSHA

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

271
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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA

I. BACKGROUND
Concept of Arsha as described in Ayurveda is quite wider. ‘Arsha’ includes a variety of
conditions pertaining to Ano-rectal and other parts/organs of the body. Present study includes
conditions pertaining to Ano-rectal Arsha. Only Sushruta has described four fold methods of
treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.
Medical/conservative treatment includes various Ayurvedic medicines which decrease intra-
abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other
Oils/like Kashishadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used
medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi
churna etc. Locally Kashishadi tila and inflammatory conditions Jatyadi taila are prescribed.
In certain other cases Ksarakarma and Ksharasutra are used effectively. Plain thread
ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids
on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shastrakarma are some other
methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine)
treatment is the most suitable treatment in the Arsha of:
• Rectal origin
• History of mild/moderate bleeding
• Small, negligible or invisible haemorrhoidal mass
• Associated with diarrhoea/dysentery

References
1. Baily and Love – Short practice of surgery, 24th Edition, 2004, Arnold Publication, London
2. Charaka Samhita, Chikitsa Sthana, Arsha Chikitsa, Chapter–15, Vidyotini Hindi Vyakhya by Pt.
Kashinath, Choukhamba Orientalia, Varanasi
3. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi
4. Ambika Dutta Sashtri(1989) Susruta samhita (text with Hindi commentary) Nidana Arshonidana
2nd Chapter, Chi. 6th Chapter, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.

273
It is safe and easily available method to prescribe medicines and patient’s acceptability is
good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.
Piles (haemorrhoids – internal haemorrhoids arise in the upper Anal Canal and lower rectum form
the internal various haemorrhoidal plexus. They enlarge to involve the skin-lined lower Anal Canal
and the external haemorrhoidal venous plexus to become visible externally.
Bright red bleeding is common as is prolapse of the piles on defecation, discomfort,
mucuous discharge and partial incontinence. The patient is investigated by proctoscopy and tehn
by sigmoidoscopy to ensure that no other lesion is responsible for the bleeding. Symptomatic piles
are treated on an out patient basis by injection of sclerosant or by rubber band ligation.
Haemorroide ctomy is reserved for more severe cases.
II. OBJECTIVE
Bhesaja, Ksarakarma, Raktavasecana, Agnikarma and Sastrakarma are the measure
adopted to treat Arsha Roga (Haemorrhoids) as described in Ayurvedic texts. The present study
is aimed at reducing the effect of some Ayurvedic medicines oral and local upon Gudarsh (Piles)
in various groups for comparison. The therapy so planned is non-invasive and may give relief to
a patient while keeping him active (at O.P.D. levels).
III. CENTRES:
Identified centres of CCRAS,New Delhi .
IV. SAMPLE SIZE AND METHODS:
Sample Size : 90 patients (30 patients in each group)
Trial Drug/Dosage/Duration
Group I : Kankayan Vati : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Kaseesadi Taila : 2 ml locally before defecation
Group II : Kravyadi Rasa : 500 mg thrice a day
Triphala Churna : 5 gm at bed time
Kaseesadi Taila : 2 ml locally before defecation
Group III : Kankayan Vati : 500 mg thrice a day
Kravyadi Rasa : 500 mg thrice a day along with
Abhayarishta : 15 ml thrice a day
Kaseesadi Taila : 2 ml locally before defecation

274
Diet
Normal diet
Design of the study – Single blind open trial.
Duration of the Study - 21 days drug therapy with a follow up for every 15 days upto 3
months
V. CRITERIA FOR INCLUSION
1) Age > 5 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Bleeds/does not bleed
6) Ano-rectal Arsha only/pertaining to Ano-rectal
7) Pile mass palpated/seen by P/R exam or proctoscopy
VI. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool
3) Corrhosis liver-portal hypertension
4) Tuberculosis/Diabetes/Systemic disease
5) Bleeding diathesis
6) Multiple haemorrhoids/externo-internal haemorrhoids
VII. CRITERIA FOR WITHDRAWAL
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any side effect of the drug
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of screening, history and physical examination of the subjects will be
recorded as per case report form I & II. Clinical and physiological assessment in form III and

275
laboratory investigations i.e. Urine Routine & Microscopic, Stool Routine & Microscopic, TLC,
DLC, ESR, Hb%, B.T., C.T., P.T., Blood Sugar Fasting &PP, Proctoscopy, Sigmoidoscopy will
be done.
IX. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after three months of regular treatment. However
the patients are to be reviewed after every 15 days.
Good Response
Complete disappearance of known symptomatology in absence of any other complication
with considerable regression in the size of pile mass.
Fair response
50% and above relief in presenting symptomatology of the disease with no/negligible
change in the size of pile mass.
X. TRIAL MONITORING AND STATISTICAL DATA ANALYSIS
Progress of the study can be mentioned by the clinicians by P/R exam or proctoscopy.
Improvement in symptoms can also be assessed and the data analyzed statistically.
XI. ETHICAL REVIEW:
Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along with project
proposal for approval by IEC.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.…… /- per visit.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term training will be provided to the Investigators and Laboratory personnel
involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and technicians
will be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following Codal formalities.

276
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Comparative Clinical Evaluation of select Ayurvedic Treatment
Modalities in the Management of Arsha”.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

277
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
PATIENT INFORMATION SHEET

What is the study about?


Concept of Arsha as described in Ayurveda is quite wider. ‘Arsha’ includes a variety of
conditions pertaining to Ano-rectal and other parts/organs of the body. Present study includes
conditions pertaining to Ano-rectal Arsha. Only Sushruta has described four fold methods of
treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.
Medical/conservative treatment includes various Ayurvedic medicines which decrease intra-
abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other
oils/like Kashishadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used
medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi
churna etc. Locally Kashishadi tila and inflammatory conditions Jatyadi taila are prescribed.
In certain other cases Ksharakarma and Ksharasutra are used effectively. Plain thread
ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids
on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shgstrakarma are some other
methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine)
treatment is the most suitable treatment in the Arsha of:
• Rectal origin
• History of mild/moderate bleeding
• Small, negligible or invisible haemorrhoidal mass
• Associated with diarrhoea/dysentery
It is safe and easily available method to prescribe medicines and patient’s acceptability is
good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.
Piles (haemorrhoids – internal haemorrhoids arise in the upper Anal Canal and lower rectum form
the internal various haemorrhoidal plexus. They enlarge to involve the skin-lined lower anal canal
and the external haemorrhoidal venous plexus to become visible externally.
Bright red bleeding is common as is prolapse of the piles on defecation, discomfort,
mucuous discharge and partial incontinence. The patient is investigated by proctoscopy and tehn
by sigmoidoscopy to ensure that no other lesion is responsible for the bleeding. Symptomatic piles
are treated on an out patient basis by injection of sclerosant or by rubber band ligation.
Haemorroide ctomy is reserved for more severe cases.

278
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 90 days. During treatment period,
you are expected to visit the hospital six times i.e. on 15th, 30th, 45th, 60th, 75th and 90th day for
clinical and physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on trial treatment for 90 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

279
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM I – SCREENING

1. Name of the patient ....................................................... Age .................. Sex ...................

. Address: ..............................................................................................................................
..............................................................................................................................

2. Centre

3. Code No. (of clinical trial)

4. Group No. First Second

Third Fourth

CRITERIA FOR INCLUSION YES NO

5. Age > 5 years

6. Ano-Rectal Arsha (Haemorrhoids)

7. Arsha seen on P/R proctoscopy

8. Bleed/does not bleed

9. Painful/Painless

10. Fresh/Previously operated

CRITERIA FOR EXCLUSION YES NO

11. Patient with malignancy

12. Incontinence of stool

13. Cirrhosis liver-portal hypertension

14. Tuberculosis/Diabetes/Systemic disease

15. Bleeding diathesis

280
16. Multiple haemorrhoids/externo internal haemorrhoids

17. Cardiac disease/neurological disease

A patient is eligible for admission to the trial

If Sl. No. 5 to 10 is ‘Yes’ and Sl. No. 11 to 17 are ‘No’

Date: _______________ Signature of the Investigator: ____________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM II – HISTORY

1. Name of the patient ....................................................... Age .................. Sex ...................

2. Address: ..............................................................................................................................

3. Date of Admission Date of Discharge

4. Centre

5. Code No. (of clinical trial)

6. Group No. First Second

Third Fourth

7. Educational status: Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

8. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

9. Total income of the family (in Rupees)

10. Total family members

11. Income per capita per month (in Rupees)

12. Religion Hindu Mulsim Christian

Parsi Others

282
13. Marital status Married Unmarried Divorcee/
separated

Chief complaints with duration (in months)

Present Absent Duration

14. Pain

15. Swelling

16. Tenderness

17. Itching

18. Indurations

19. Bleeding Mild Moderate

Before defecation With defecation

After defecation

20. Type of pain Pricking Cutting Throbbing

Burning Itching Mixed

HISTORY OF PRESENT ILLNESS

21. Onset of disease Operated Non-operated

22. Duration of disease

23. Location of pile mass O’clock position

24. Size of pile mass

25. Sentinel tag/Thrombotic pile

FAMILY HISTORY, IF ANY YES NO

26. Hypertension

27. Diabetes mellitus

28. Piles

283
29. Tuberculosis

30. Others

If yes specify………….......………………………….…………………………………….

PERSONAL HISTORY Yes No

31. Smoking

32. Obesity

33. Non-vegetarian

34. Alcoholic

35. Spices intake

36. Emotional stress

37. Bowel habit

38. Sharirik Prakriti

Vataja Pittaja Kaphaja

Vata Kaphaja Vata Pittaj Pitta Kaphaj

Sannipataj

39. Manas Prakriti

Sattva Rajas Tamas

Sattva-Rajas Sattva-Tamas Raja-Tamas

Sama

PHYSICAL EXAMINATION

40. Built Lean Medium Heavy

41. Body weight (in Kg.)

42. Blood pressure (Systolic)

284
43. Blood pressure (Diastolic)

44. Pulse

45. Respiration

SYSTEMIC EXAMINATION

46. Pulse rate

47. Oedema C.V.S.

GASTRO INTESTINAL TRACT Present Absent

48. Hepatomegaly

49. Sleenomegaly

50. Tumour/Lump

51. Portal hypertension

SAMPRAPTI (PATHO GENESIS) OF THE DISEASE ACCORDING AYURVEDIC


CONCEPT

52. Dosh Vata Pitta Kapha

53. Dushya Rasa Rakta Mamsa

Meda Asthi Majja

Shukra

54. State of disease (Roga kriya kala)

Sanchaya Prakopa Prasar

Sthanasamshraya Vyakti Bheda

Date: _______________ Signature of the Investigator: _________________________

285
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM III -PERIODICAL OBSERVATION AND CLINICAL
ASSESSMENT
(On Day 0, 15 days, 30 days, 45 days, 60 days, 70 days and 90 days)
Separate form should be used on each visit
(Enter a  in the appropriate box)

1. Code No. (of clinical trial)_____________________


2. Centre________________________________
3. Sl. no. of the subject ____________________
4. Name __________________________________________Age________ Sex_________
5. Date of Assessment _________________________
Chief complaints with duration (in days) Present Absent Duration
6. Pain
7. Swelling
8. Tenderness
9. Itching
10. Indurations
11. Bleeding Mild Moderate
Before defecation With defecation
After defecation
12. Type of pain Pricking Cutting Throbbing
Burning Itching Mixed
If yes, specify_________________________

Date: _______________ Signature of the Investigator: ___________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM IV- LABORATORY ASSESSMENT

1. Code No. (of clinical trial)_____________________

2. Centre________________________________

3. Sl. no. of the subject ____________________

4. Name __________________________________________Age________ Sex_________

5. Date of Assessment _________________________

6. Urine Examination

Routine Microscopic

7. Stool examination

Routine Microscopic

Occult Blood Ova/Cyst

Blood

8. TLC (Cells/Cu. mm.) _______________

9. DLC - P _____ (%) L _____ (%) E ______ (%) M _____ (%) B ______(%)

10. ESR (mm / 1st hour.) __________

11. Hb (g/dl) (Cyanomethamoglobin method) ____________________

Liver function tests

12. S. Bilirubin

• Total (mg/dl)

• Direct (mg/dl)

287
13. SGPT (IU/L)

14. SGOT (IU/L)

15. S. Alkaline phosphatase (U/L)

16. S. Proteins (Total) (g/dl)

• Albumin (g/dl)

• Globulin (g/dl)

Renal function tests

17. Blood urea (mg/dl)

18. S.Creatinine (mg/dl)

19. Blood Sugar

• Fasting

• Post prondial

20. S. Cholesterol

Special Tests

(i) Proctoscopy

(ii) Sigmoidoscopy

Date: _____________ Signature of investigator _________________________

288
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF SELECT AYURVEDIC
TREATMENT MODALITIES IN THE MANAGEMENT OF ARSHA
CASE REPORT FORM I – SCREENING OF THE CASES

1. Name of the patient…………………………....…….. Age …………….. Sex ……...........

2. Centre

3. Code No. (of clinical trial)

4. Group No.

INITIAL During Treatment

15 Days 30 Days 45 days 60 days 70 days 90 days

CLINICAL PARAMETERS

Pain

Swelling

Tenderness

Itching

Indurations

Bleeding

LAB INVESTIGATIONS

Stool for occult blood

Note: Severity of the symptoms may be graded as I, II and III grades as per positively in
increasing order (mild 1, moderate 2 and severe 3)

* To be done at the beginning and at the end of the study.

289
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290
COMPARATIVE CLINICAL EVALUATION OF
KSHARASUTRA VIS-À-VIS APPLICATION OF KSHARA
VATI IN THE MANAGEMENT OF BHAGANDARA
(FISTULA-IN-ANO)

Drug: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

291
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292
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)

I. BACKGROUND
Bhagandara1 (Fistula in ano), Arsha (haemorrhoids) and Gudavidara (Parikartika) are some
ano rectal torturesome diseases. Among these, Bhagandara is one of the most painful diseases. It
is a disease of ano rectum which is characterized in humans by single or multiple sinuses with
purulent discharge. It is an obnoxious condition.
This is a field where modern surgery could not help much as extensive excision of the
fistulous tract result into a wide open wound with slow healing rate. Chances of wound infection,
non-healing and recurrences are high. Application of Ksharasutra in the management of fistula-in-
ano showed encouraging results (Deshpande et al 1989). The patients can abstain from
psychological trauma and extensive surgery.
Patients can undergo treatment without paralyzing their routine work.
Kshara Vati is also found to help in such cases. Thus it is important to evaluate the result
after a comparative study.
II. AIMS AND OBJECTIVE
Medical management of diseases in Ayurveda is quite popular. However, there are diseases
which can be treated by para-surgical methods in better way. Management of Bhagandara by
Ksharasutra is one such example. Thus the present study is proposed with a view to:
1. Study the disease pattern of Bhagandara (Fistula in ano)
2. To evaluate the effect of Ksharasutra application in the management of Bhagandara
(Fistula in ano)
3. To compare it with the effect of Kshara Vati (applied 7 times in 21 days) in the
management of Bhagandara (Fistula in ano)

References
1. Sushruta Nindan 4th cheptar.

293
III. SAMPLE SIZE AND METHODS
Sample Size : 60 cases
No of Groups : 2 (30 patients in each group) (Patients to be randomly
allocated to different treatment groups)
Type of Study : Single blind
Level of Study : O.P.D.
Period of Study : 21 days in Kshara Vati
In Ksharasutra group according to disease
Dose Schedule
(i) Ksharasutra application depends upon the severity and depth of fistula.
(ii) Kshara Vati will be applied seven times at the interval of every two days.
Note: Renewal of Ksharasutra will be decided by the research workers looking
after the problem.
Diet
Normal diet
IV. CRITERIA OF INCLUSION
1) Age preferably above 8 to 10 years
2) Sex-either-sex
3) Fresh/previously operated
4) Painful/painless
5) Discharging/non-discharging
6) Purulent/non-purulent
7) Tender/non-tender
8) All cases of fistula in ano
V. CRITERIA OF EXCLUSION
1) Patients with malignancy
2) Incontinence of stool/stricture of anus
3) Tuberculosis/Diabetes/Systemic disease/infections

294
4) Bleeding diathesis
5) Fistula connected with other organs like urethra vagina etc.
VI. CRITERIA FOR ASSESSMENT
Assessment will be done as per proforma after 21 days of regular treatment in group
treated with Kshara Vati. However in case of Ksharasutra application it depends upon the disease
and physicians perception.
VII. CRITERIA FOR ASSESSMENT OF RESULTS
1. Good Response:
Complete disappearance of known symptomatology
• absence of any other complication
• Normal healing of the wound
2. Fair response:
50% and above relief in presenting symptomatology of the disease
• Absence of complications
• Healing of the wound more than 75%
3. Poor response:
25% to 50% relief in symptomatology + some improvement in the wound
4. No response
No relief in symptomatology or otherwise
VIII. CRITERIA FOR WITHDRAWAL
(i) Discontinuation of treatment during trial
(ii) Development of any complication
(iii) Aggravation of the disease symptoms
(iv) Any toxicity/local reaction of Sutra/Vati
IX. STATISTICAL ANALYSIS
Data of clinical symptoms, physiological parameters and laboratory parameters will be
tabulated and analyzed by using appropriate statistical methods. The data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail for analysis

295
X. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored through field visits by monitoring unit of
CCRAS. Data analysis will be undertaken at the Monitoring Unit of CCRAS.
XI. ETHICAL REVIEW:
Ethical Committee (IEC): The proposal will be placed before Ethical Committee
(IEC) of trial center for getting clearance certificate before the project is initiated.
Patient’s information sheet and informed consent form will be submitted along with
project proposal for approval by EC. Both will be maintained in duplicate with one copy
given to the patient at the time of entry to the trial.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit i.e., on the 1st day of recruitment after
screening and at the end of 7th, 14th, 21st and 30th day of months. (5 times)
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs., New Delhi. The investigators and
technicians will be detailed about the clinical trial conduct and laboratory procedures in order to
maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS

Microscopic
Urine
Routine

Microscopic
Stool Cyst
Routine
Ova
Stool: - For Occult Blood
Sputum: - A.F.B. (To exclude Koch’s if required)

296
Fasting
Blood Sugar
PP

Blood: - TLC, DLC, ESR, Hb%, B.T., C.T., P.T.


X-rays: - Barium enema (as required)
- Fistulo-graphy
Special test: - Proctoscopy
- Sigmoidoscopy

297
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Comparative clinical evaluation of ksharasutra vis-à-vis application
of kshara vati in the management of bhagandara (fistula-in-ano)”.

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

298
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA-IN-ANO)
PATIENT INFORMATION SHEET

What is the study about?


Bhagandara (Fistula in ano), Arsha (haemorrhoids) and Gudavidara (Parikartika) are some
ano rectal torturesome diseases. Among these, Bhagandara is one of the most painful diseases. It
is a disease of ano rectum which is characterized in humans by single or multiple sinuses with
purulent discharge. It is an obnoxious condition.
This is a field where modern surgery could not help much as extensive excision of the
fistulous tract result into a wide open wound with slow healing rate. Chances of wound infection,
non-healing and recurrences are high. Application of Ksharasutra in the management of fistula-in-
ano showed encouraging results (Deshpande et al 1989). The patients can abstain from
psychological trauma and extensive surgery.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 21 days. During treatment period,
you are expected to visit the hospital three times i.e. on 0, 8th, 15th and 22nd day for clinical and
physiological assessment.
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on trial treatment for 21 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

299
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CASE REPORT FORM I – SCREENING

1. Name of the patient ....................................................... Age .................. Sex ...................

2. Address: ..............................................................................................................................

3. Centre

4. Code No. (of clinical trial)

5. Group No. First Second

Third Fourth

CRITERIA FOR SELECTION YES NO

1. Age above 8 – 10 years

2. Either sex

3. Fresh/Previously operated

4. Painful/Painless

5. Discharging/Non-discharging

6. Purulent/Non-purulent

7. Tender/Non-tender

8. All cases of fistula in ano

CRITERIA FOR EXCLUSION YES NO

9. Patient with malignancy

10. Incontinence of stool/stricture of anus

11. Tuberculosis/Diabetes/Systemic disease/Infections

12. Bleeding diathesis

300
13. Fistula connected with other organs like Urethra vagina etc.

A patient is eligible for admission to the trail

If Sl. No. 1 – 8 is ‘Yes’ and Sl. No. 9 – 13 are ‘No’

Date: _______________ Signature of the investigator: ___________________

301
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM II – HISTORY

1. Name of the patient ....................................................... Age .................. Sex ...................

2. Address: ..............................................................................................................................

3. Date of Admission Date Discharge

4. Centre

5. Code No. (of clinical trial)

6. Group No. First Second

Third Fourth

7. Educational status: Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

8. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

Total iincome of the family (in Rupees)

Total family members

9. Income per capita per month (in Rupees)

10. Religion Hindu Mulsim Christian

Parsi Others

302
11. Marital status Married Unmarried Divorcee/
separated

Chief complaints with duration (in months)

Present Absent Duration

12. Pain

13. Burning

14. Swelling

15. Tenderness

16. Itching

17. Indurations

HISTORY OF PRESENT ILLNESS

18. Onset of disease Acute Insidious

19. Duration of disease (in months)

20. Factors aggravating the disease/chief complaints………….....……………………………...

......…………………………………………………………………………………………

21. Factors relieving main complaints…………………………………………………………...

..……………………………………………………………………………………………

22. History of past illness, having relation with present illness

Yes No

If yes, specify…………………………………………………………………………

Treatment given so far: Modern Ayurvedic Any other

VARIOUS SURGERY DONE YES NO

23. Open + Drainage

24. Drainage + Saucerization

303
25. Excision

26. Saucerization + Wiring

27. Excision + Grafting

No. of times surgery done: Once Twice more than twice

Date of last surgery

FAMILY HISTORY IF ANY YES NO

28. Hypertension

29. Diabetes mellitus

30. Ano Rectal disease

31. Tuberculosis

32. Others

If yes specify…………………………….......……….…………………………………….

32. Sharirik Prakriti

Vataja Pittaja Kaphaja

Vata-Kaphaja Vata-Pittaj Pitta-Kaphaj

Sannipataj

33. Manas Prakriti

Sattva Rajas Tamas

Sattva Rajas Sattva Tamas Rajas Tamas

Sama

PHYSICAL EXAMINATION

34. Built Lean Medium Heavy

35. Gait Normal Abnormal

304
36. Body weight (in Kg.)

37. Blood pressure (Systolic)

38. Blood pressure (Diastolic)

39. Pulse

40. Respiration

Present Absent

41. Anaemia

42. Jaundice

43. Lymphadenopathy

SYSTEMIC EXAMINATION

Normal Abnormal

44. C.V.S. (With Chest)

If abnormal, specify abnormalities…………………………………………………..

45. C.N.S

If abnormal, specify abnormalities…………………………………………………..

46. Digestive system

If abnormal, specify abnormalities…………………………………………………..

47. Uro-Genital system

If abnormal, specify abnormalities…………………………………………………..

48. Respiratory system

If abnormal, specify abnormalities…………………………………………………..

305
SAMPRAPTI (PATHO GENESIS) OF THE DISEASE ACCORDING AYURVEDIC
CONCEPT

49. Dosha Vata Pitta Kapha

50. Dushya Rasa Rakta Mamsa

Meda Asthi Majja

Shukra

51. State of disease (Roga kriya kala)

Sanchaya Prakopa Prasar

Sthanasamshraya Vyakti Bheda

LOCAL EXAMINATION

52. Inspection

1). Condition of skin near fistula YES NO

Normal

Inflamed

Indurated

External piles/tags

Discolouration of skin

2). Opening

No. Position (Clockwise) Distance from anal verge in Cm.

3). Digital Examination

Fissure Yes No

Thrombotic piles Yes No

Sphincteric tone Normal

Hypertonic

306
Hypotonic

Prostate Normal Enlarged

4). Type of discharge

(i) Blood (ii) Pus (iii) Faecal material (iv) Urine (v) Gas

5). Probing

Location of Fistula Towards

Depth of Fistula Cms.

Character of Fistula

(i) Blind ext. (ii) Blind int.

(iii) Complete (iv) Bilateral

(v) Radial (vi) Curved

(vii) Horse shoe (viii) Straight

6). Proctoscopy YES NO

1. Presence of pile

2. Inflammation

3. Location of int. opening

7). Sigmoidoscopy

1. Done 2. Not done

If done then………………………………………………………………………….

Yes No

A. Ulceration

B. Bleeding

C. Mucous

307
8). Biopsy

1. Done 2. Not done

CLASSIFICATION OF FISTULA

53. Modern view

1. Low cutaneous

2. Sub. Mucous

3. Low anal

4. High anal

5. Ano rectal

6. Pelvi rectal

54. Ayurvedic view

1. Shataponak (Vataja)

2. Ushragreeva (Pittaja)

3. Parisravi (Kaphaja)

4. Shambukartava (Sannipataja)

5. Unmargi (Agantuja)

Provisional Diagnosis

Final Diagnosis

Principal Drug Therapy

Date: ………………….. Signature of the Investigator: ………………………..

308
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM III – CLINICAL ASSESSMENT

1. Centre………………………………………………………………………………………
2. Code No. (of clinical trial)
3. Patient No.
4. Group No.
INITIAL Days after starting therapy

7th day 14th day 21st day 30th day

5. Pus-discharge
6. Induration
7. Inflammation
8. Pain
9. Burning sensation/itching
10. Bleeding

ASSESSMENT OF UNIT CUTTING TIME OF FISTULOUS TRACT

UNIT CUTTING TIME TOTAL NO. OF DAYS


INITIAL LENGTH IN CMS.
(OF FISTULA)

Date: ………………………... Signature of the Investigator: ………………

309
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
COMPARATIVE CLINICAL EVALUATION OF KSHARASUTRA VIS-À-VIS
APPLICATION OF KSHARA VATI IN THE MANAGEMENT OF
BHAGANDARA (FISTULA IN ANO)
CASE REPORT FORM IV– INVESTIGATION

1. Centre………………………………………………………………………………………
2. Code No. (of clinical trial)
3. Patient No.
4. Group No.

Investigation Time of after 7 days after 14 days after 21days after month
Admission

Microscopic
5. Urine
Routine

6. Urine Glucose

Microscopic
7. Stool Cyst
Routine
Ova

8. Stool: for Occult blood


9. Haematology: TLC
DLC
ESR……………(1 Hr.)…………..mm. (2 Hr.)…………..mm.

310
10. Biochemistry
Fasting
11. Blood Sugar
PP

Bariumenema (if required)


Fistulogram
Proctoscopy
Sigmoidoscopy (if required)

Date: ………………………... Signature of the Investigator: ………………………..

311
Blank

312
NERVOUS SYSTEM

SECTION - V
Blank

314
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC
TREATMENT IN THE MANAGEMENT OF
PAKSHAGHATA

Treatment modalities : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

315
Blank

316
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA

I. BACKGROUND
Paksaghata (hemiplegia) is a major disabling disease of mankind. The terms Paksaghata,
Parsavadha and Ekangaroga are synonyms of the same disease and are used in classical
treatises in various contexts. Caraka has classified it as Nanatmaja vata vyadhi caused due to
vitiation of Vata dosa and considered it as a Maharoga from the point of prognosis – difficult to
cure. According to the concept, the disease affects the Madhyama roga marga and disrupting the
functions of Sira, Snayu, Kandara etc. According to modern terminology, hemiplegia is the
sequelae of pathological events which take place in the central nervous system, may be due to
different factors such as cerebro-vascular accidents neoplasm, infections etc. where in paralysis
will be common symptom. Ayurveda has a definite pattern of treatment for such conditions. The
line of treatment includes Snehana, Svedana and Panchakarma therapy. The Snehana and
Svedana therapy mentioned in the classics are used as preparatory mearues for Sodhana therapy.
(Caraka Samhita Chikitsa 28-100, Susrut Chikitsa 5-19). This Council has taken up this
problem for research and different methods of therapy used in clinical practice are taken up for
intensive evaluation of their efficacy of samana therapy alongwith Panchakarma therapy. A series
of clinical studies to evaluate the effect of herbo-mineral preparation and application of Sastikasali
pindasveda with Brihat Masa Taila alongwith Panchakarma therapy has shown that these
therapies are giving significant results and found effective in relieving hypertenic (stiffness) of
muscles and to improve the functional ability of the affected limb (P.K.N. Namboodiri et al,
2000, Management of Hemiplegia by Panchakarma & Samana therapy CCRAS). The objective
of present study is to evaluate the effect of samana &panchakarma therapies with and without
internal medication in the management of Paksaghata1.
II. OBJECTIVES
To assess the efficacy of Ayurvedic treatment in the management of Pakshaghata.

References
1. Charak Chikitsa 28 Ch. (Vata Vyadhi Chikitsa)

317
III. CENTRE
CCRAS identified Centers.
IV. SAMPLE SIZE AND METHODS
Sample Size : 100 patients (50 in each in group, two groups)
Treatment
A. Sodhan Chikitsa
1. Snehapana - Murchita tila taila (maximum 7 days)
2. Svedana - Vaspa Sveda (3 days)
3. Virecana - Eranda Taila (1 day)
4. Samsarjana - 7 days
5. Abhyanga - Brihat masa Taila (7 days)
6. Yogabasti (8 days) (a) Anuvasana – Morchitataila (240ml) [1st, 3rd, 5th,
7th, 8th] (Oil Enema –Dose 240ml)
(b) Asthapana – [2nd, 4th, 6th]
(Decoction Enema – Dose 960ml)
Erandamula Kvatha (480 ml.)
Morchitataila (240ml)
Honey – 180 ml
Satahva – 24 gm
Saindhava – 12 gm
** One Day Rest
7. Nasya Kshirabala taila - 3 times (Potency) (7 days)
** One Day Rest
B. Samana therapy
Internal _ Ekangavirarasa (250 mg twice daily)/ Placebo (250 mg.) BD.
Externally – 1. Morchitataila (50ml) (Abhayanga)
2. Sastikasali pinda Sveda – 14 days

318
Design of Study: Randomized double blind placebo controlled study.
1. All the patients will be provided with the Sodhana therapy for 35 days.
2. After completion of Sodhana therapy patients will be devided into two groups. One group
will receive trial drug in the dose of 250 mg. twice daily for 30 days along with
Abhyanga for 30 days and Sastikasasli pinda sveda for 14 days. The other group will
receive placebo in the dose of 250 mg. twice daily for 30 days along with Abhyanga for
30 days and Sastikasasli pinda sveda – for 14 days. Oral drug as well as Abhyanga
and Sastikasasli pinda sveda will run simultaneously.
Period of Study: Six months of each case. Total duration will be two and half years to complete
the study.
Follow Up: One follow up will be carried out at the end of 6th month.
V. CRITERIA FOR INCLUSION
1. Age: More than 20 years and less than 70 years.
2. Duration of illness more than 6 months but less one year.
3. Patients of stable one time stroke with hemiparesis or hemiplegia with or without facial
paralysis.
4. Patients with non-progressive neurological disease causing Para paresis (plegia) such as
- Compressive mydopathy (operated)
- Non-compressive (post-viral, denyclinating, post traumatic, vascular)
5. Motor deficit should be 3/5 or less (MRC Grade).
6. Spasticity of a scale of 3 or more (Ashwarth Scale)
7. Medically stable
8. Fully conscious and oriented
9. Normal Higher mental functions
VI. CRITERIA FOR EXCLUSION
1. Age less 20 and more than 70 years.
2. Progressive Neurological diseases.
3. Pregnancy & lactation.
4. Insulin dependent diabetis mellitus (IDDM)

319
5. Impaired sensorium
6. Recurrent strokes.
7. History of Renal and liver diseases
8. Cases undergoing treatment for any other serious illness.
VII. CRITERIA FOR WITHDRAWAL
A patient may be withdrawn from the study on account of the following.
1. Recurrent attacks of strokes.
2. Development of any major ailments, side effects necessitating institution of new modalities
of treatment.
3. Worsening of symptoms.
4. Patient failure to report for follow-up or irregular medication.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before the therapy, at the end of
5th week, end of 9th week, end of 6th month (Form III). The lab investigations will be recorded
before therapy, end of 5th week, end of 9th week and at the end of follow up (6th month)
(Form IV).
IX. CLINICAL ASSESSMENT:
MOTOR PARALYSIS
a). Clinical muscle strength testing – MRC Grading:
0. - Nil
1. - Flicker of movement.
2. - Movement with gravity eliminated.
3. - Movement against gravity.
4. - Movement against minimal resistance
5. - Movement against maximum resistance.
b). ADL (Activities of Daily Living) Score
c). Dynamometers – for measuring isometric strength.

320
Spasticity:
A. Clinical
a. -Ashworth Scale Score:
0. - No increase in tone
1. - Slight increase producing a catch when a joint is moved in flexion or extension.
2. - More marked increase in tone, but joint easily flexed
3. - Considerable increase and passive movements difficult.
4. - Affected part rigid in flexion or extension.
b. -Spasm Score:
0. - No spasms
1. - Mild spasms induced by stimulus
2. - Spasms occurring less than 1 per hour
3. - Spasms occurring more than 1 per hour
4. - Spasms occurring more than 10 per hour
c. - Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
B. Biomechanical Techniques:
Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the
muscles across a joint.
- Wartenberg’s pendulum or the “drop” test.
- With an electrogoniometer to record the changes in the knee joint angle.
- Relaxation index.

321
X. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trail will be monitored by field visits by Monitoring unit of CCRAS.
Data analysis will be undertaken at the Monitoring Unit of CCRAS
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and Safety Monitoring Board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELLING EXPENSES
A consolidated amount of Rs……../- per visit will be paid to the subject.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multicentric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological / Biochemical, Radiological / Sonography etc.)
which are not available at research Institutes will be referred to any reputed/Government Institutes
under intimation to this Council following codal formalities.

322
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHAT
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________

Name: ____________________________

CONSENT BY SUBJECT
The attending physician, the purpose of the clinical trial and the nature of drug treatment
and follow-up have informed me to my satisfaction, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the, “Double blind clinical trial of Ayurvedic treatment in the management of pakshaghat”.

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

323
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHAT
PATIENT INFORMATION SHEET

What is the study about?


Pakshaghata (hemiplegia) is a major disabling disease of mankind. The terms Pakshaghata,
Parsavadha and Ekangaroga are synonyms of the same disease and are used in classical treatises
in various contexts. Caraka has classified it as Nanatmaja vyadhi caused due to vitiation of Vata
dosa and considered it as a Maharoga from the point of prognosis – difficult to cure. According
to the concept, the disease affects the Madhyama roga marga and disrupting the functions of Sira,
Snayu, Kandara etc.
According to modern terminology, hemiplegia is the sequelae of pathological events which
take place in the central nervous system, may be due to different factors such as cerebro-vascular
accidents neoplasm, infections etc. where in paralysis will be common symptom. Ayurveda has a
definite pattern of treatment for such conditions. The line of treatment includes Snehana, Svedana
and Panchakarma therapy. The Snehana and Svedana therapy mentioned in the classics are used
as preparatory mearues for Sodhana therapy. (Caraka Samhita Chikitsa 28-100, Susrut Chikitsa
5-19). This Council has taken up this problem for research and different methods of therapy used
in clinical practice are taken up for intensive evaluation of their efficacy of samana therapy
alongwith Panchakarma therapy. A series of clinical studies to evaluate the effect of herbo-mineral
preparation and application of Sastikasali pindasveda with Brhat Masa Taila alongwith
Panchakarma therapy has shown that these therapies are giving significant results and found
effective in relieving hypertenic (stiffness) of muscles and to improve the functional ability of the
affected limb (P.K.N. Namboodiri et al, 2000, Management of Hemiplegia by Panchakarma &
Samana therapy Snamaa and Panchakarma, CCRAS). The objective of present study is to
evaluate the effect of samana & panchakarma therapies with and without internal medication in the
management of Paksaghata.
However, considering the eco- climatic changes traces of certain unwanted substances may
lead to untoward effects. Thus this project is undertaken to assess the clinical safety in subjects
receiving Ayurvedic preparations.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 1 month to complete. During this
period, you are expected to visit the hospital 3 times (0, 15 and 30 days) for clinical, biochemical
and physiological assessment.

324
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done. If you are found eligible, you would be put on treatment for 1 month.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the

Date: ______________ Principle Investigator:____________________________________

To be translated into regional language.

325
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..…………..........……………………………

CRITERIA OF INCLUSION Yes (1) No (0)

1. Age: More than 20 years and less than 70 years

2. Duration of illness more than 6 months, but less one year

3. Patients of stable one time stroke with Hemiparesis or


hemiplegia with or With out Facial Paralysis.

4. Patients with Non Progressive Neurological diseases

5. Motor deficit –3/5 or less[MRC Grade]

6. Spacticity of a scale of 3 or more (Ashworth scale)

7. Medically Stable, fully conscious & oriented

8. Normal Higher Mental Functions

CRITERIA FOR EXCLUSION Yes (1) No (0)

9. Age less than 20 years and more than 70 years

326
10. Progressive Neurological diseases

11. Pregnancy & lactation

12. IDDM

13. Impaired Sensorium

14. Recurrent strokes

15. History of Renal & Liver Diseases

16. Cases undergoing treatment for any other serious illness

A patient is eligible for admission for treatment

If Sl. No. 1 – 8 is ‘Yes’ and Sl. No. 9 – 16 are ‘No’

Dated:____________ Signature of the Doctor _________________________

327
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM II – HISTORY PROFORMA

1. Centre : ........................................

2. Code No. (of clinical trial)

3. Sr. No. of the Subject : _______________________

4. Name of the patient ....................................................... Age .................. Sex ...................

5. Address: ..............................................................................................................................

6. Date of Admission Date of Discharge

7. Educational status: Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

8. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

9. Family income per month in Rs.

10. Total Family members :

Chief complaints with duration (in months)

Present (1) Absent (0) Duration


(in months)

11. Paralysis/Weakness of upper limb

12. Paralysis/Weakness of lower limb

328
13. Difficulty for locomotion

14. Rigidity

15. Flacidity

16. Spasm

17. Numbness

18. Head ache

19. Difficulty in speech

20. Pain in either half of the body

21. Incontinence/retention of urine

22. Incontinence/retention of Motion

23. Facial Palsy

24. 26. Other complaints, if any (Specify) ______________________________

25. History of serious illness in the past (if any):___________________________

Personal History

26. Diet: Veg 1 Non-veg 2

27. Bowel habits Regular 1 Irregular 2

Addiction

28. Smoking No 1 Yes 2

If yes specify: (a) Quantity (packs per day) _______________

(b) Total Duration in year’s ______________

29. Tobacco No 1 Yes 2

If yes specify: (a) Quantity per day_________

(b) Total Duration in years____________

329
30. Alcohol No 1 Yes 2

If yes specify: (a) Quantity per week (ml)_________

(b) Total Duration in years_______________

31. Any other(specify)________________

Family History No (0) Yes (1)


32. Hemiplegia

33. Hypertention

34. Cardio vascular disease

35. Other, specify____________________________________________________

36. Prakriti: Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6

Sannipataja 7

37. Physical Examination

38. Built Lean 1 Medium 2 Heavy 3

39. Gait Normal 1 Abnormal 2

40. Height (cm) ________________________

41. Weight (kg) ________________________

42. Pulse (per min) ________________________

43. Blood Pressure Systolic(mm Hg) ___________

44. Blood Pressure Diastolic (mm Hg) ___________

45. Respiration rate( per min) ______________

46. Body Temperature ______________

330
Systemic examination Normal (0) Abnormal (1)

47. CNS

If abnormal details_____________________________________________

48. Respiratory system

If abnormal, details ______________________________________________

49. CVS

If abnormal, details ______________________________________________

50. Digestive system

If abnormal, details ______________________________________________

51. Urogenital system

If abnormal, details ______________________________________________

Dated: ________________ Signature of the Investigator_________________

331
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM III – CLINICAL ASSESSMENT
(0th, 5th, 9th Weeks and 6th Month)

1. Centre : ........................................

2. Code No. (of clinical trial)

3. Sr. No. of the Subject : _______________________

4. Name of the patient ....................................................... Age .................. Sex ...................

5. Address: ..............................................................................................................................

6. Date of Birth Age (in years)

7. Date of Assessment

8. Stage of Assessment: Initial 0 3rd Week 1

11th Week 2 6th Month 3

Clinical Symptoms Absent(0) Present(1)

9. Paralysis/Weakness of upper limb

10. Paralysis/Weakness of lower limb

Visual Analogue Scale

11. Improvement in locomotion 0____________________________________10

12. Numbness(VAS) 0____________________________________10

13. Improvement in speech 0____________________________________10

14. Incontinence / retention of urine 0____________________________________10

15. Incontinence / retention of Motion 0____________________________________10

16. Facial Palsy 0____________________________________10

332
OBJECTIVE PARAMETERS

MOTOR PARALYSIS

17. Clinical muscle strength testing – MRC Grading:

0. - Nil

1. - Flicker of movement.

2. - Movement with gravity eliminated.

3. - Movement against gravity.

4. - Movement against minimal resistance

5. - Movement against maximum resistance.

18. ADL (Activities of Daily Living) Score

19. Dynamometers – for measuring isometric strength.

20. Spasticity

CLINICAL PARAMETERS

21. Ashworth Scale Score:

0 - No increase in tone

1 - Slight increase producing a catch when a joint is moved in flexion or extension.

2 - More marked increase in tone, but joint easily flexed

3 - Considerable increase and passive movements difficult.

4 - Affected part rigid in flexion or extension.

22. Spasm Score:

0 - No spasms

1 - Mild spasms induced by stimulus

2 - Spasms occurring less than 1 per hour

3 - Spasms occurring more than 1 per hour

4 - Spasms occurring more than 10 per hour

333
23. Reflex Score:
0 - Absent
1 - Flicker/elicitable only on reinforcement
2 - Diminished knee/normal other DTR (deep tendon reflexes)
3 - Normal knee/hyperreflexia of other DTR
4 - Clonus – illsustained
5 - Sustained clonus
BIOMECHANICAL TECHNIQUES

(Biomechanical techniques evaluate changes in the phasic and tonic reflex activity of the muscles
across a joint.)

24. Wartenberg’s pendulum or the “drop” test

25. With an electrogoniometer to record the changes in the knee joint angle.

26. Relaxation index.

27. Overall clinical assessment by the investigator:

Improved 1 No change 2 Deteriorated 3

28. Overall impression of well-being by the Subject:

Improved 1 No change 2 Deteriorated 3

Deteriorated 4

29. Status of the patient:

Continuing 1

Drop out 2 Reason: _____________________________

Died 3 Cause: _______________________________

Date: ______________ Signature of the Investigator: ______________________

334
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND CLINICAL TRIAL OF AYURVEDIC TREATMENT IN THE
MANAGEMENT OF PAKSHAGHATA (HEMIPLEGIA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(0th, 5th, 9th week and 6th month)

1. Centre : ........................................

2. Code No. (of clinical trial)

3. Sr. No. of the Subject : _______________________

4. Name of the patient ....................................................... Age .................. Sex ...................

5. Address: ..............................................................................................................................

6. Date of Birth Age (in years)

7. Date of Assessment

8. Stage of Assessment: Initial 0 3rd Week 1

11th Week 2 6th Month 3

Urine Examination

A. Routine:

9. pH _______

10. Specific gravity_________

Absent (0) Present (1)

11. Sugar

12. Albumin

13. Bile Salt

14. Bile pigment

335
B. Microscopic ______________________________

Blood Examination

15. Hb (g/dl) _______________

16. ESR (1st hour)(mm) _______________

17. TC (Cells/Cmm.) _______________

18. DC: P(%)_____ L(%) _____ E(%)_____ M (%)_____ B(%)_____

19. PCV (%) _______________

20. Blood Sugar – PP(mg./dl)_______________

21. Cholesterol (mg./dl) _______________

22. HDL (mg./dl) _______________

23. LDL (mg./dl) _______________

24. S. Triglycerides (mg./dl) _______________

25. B. Urea (mg./dl) _______________

26. S. Creatinine (mg./dl) _______________

27. Uric acid (mg./dl) _______________

28. Total proteins (gm./dl) _______________

29. Albumin(gm./dl) _______________

30. Globulin(gm./dl) _______________

31. A/G Ratio _______________

32. SGOT _______________

33. SGPT _______________

34. Total Bilirubin _______________

336
Serum Electrolytes

35. Na+ ______________________

36. K+ _______________________

37. Cl- ______________________

38. X-ray Chest: [0 Month only] ___________________________________

39. ECG [0 Month & 6 month] ____________________________________

40. CT Scan [0 Month only] ____________________________________

Date: ______________ Signature of Investigator: _________________________

337
Blank

338
ASSESSMENT OF THERAPEUTIC EFFICACY OF
AYUSH-M NASAL DROPS AND AYUSH-M CAPSULE IN
THE MANAGEMENT OF MIGRAINE WITH OUT
AURA (ARDHAVA BHEDAKA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

339
Blank

340
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BHEDAKA)

I. BACKGROUND
Migraine1 (Ardhava Bhedaka) is as old as civilization, occupying 16% among clinical
classification of headaches, has become a challenging problem to the present day physician1&2. It
is a paroxysmal disorder characterized in its fully developed form by visual and/or sensory
phenomena in an aura associated with or followed by unilateral headache and vomiting. While this
definition is satisfactory of ‘Classical’ Migraine, there are many patients who never experience an
aura and in whom the headache is always bilateral; the single most characteristic and constant
feature is that migraine is a paroxysmal disorder, i.e., the headaches occur in attacks, separated by
intervals of freedom. It is described as a separate clinical entity in the classics of Caraka and
Susruta while Vagbhata included this condition in the classification of Vatajashiroroga. A clinical
study conducted on 20 cases migraine to evaluate the effect of Nasya Karma with fresh leaf juice
extracted from Acalypha indica Linn. (Haritamanjari,) along with internal medication of
Panchagavya ghrta (Astanga Hradya, Uttara Tantra 7/18) revealed significant clinical
improvement.
II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-M coded nasal drops and Ayush-M capsule
in the management of Migraine without aura.

References
1. Peter J Goadsby et al, Diagnosis and management of migraine, Selections from BMJ Vol.12 July,
1996 pp 456-460.
2. Classification Committee of the International Headache Society. Classification and diagnostic
criteria for headache disorders, cranial neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-
96.
3. Srikanth N. et al, Clinical study on the role of Nasyakarma and Ghritapana in the management
of Arddhavabhedaka vis-à-vis Migranous headaches, Aryavaidyan Vol.XIX, No.3, Fe-Apr.2001
: 166-171.

341
III. CENTRE
Central Research Institute (Ay.), New Delhi
IV. SAMPLE SIZE AND METHODS
Sample Size : 30 cases
Design of the study – Open trial
Treatment
a. Snehana: Local application of Til oil around nose followed by local mridu swedana(mild
fomentation) as poorva karma
b. Ayush-M Nasal drops {containing equal parts of Acalypha indica Linn. (Haritamanjari,)
and Glycyrrhiza glabra (Yasti madhu) – 3-drops in each nostril after poorva karma for
7 days.
c. Ayush-M (Glycyrrhiza glabra (Yasti madhu)- Two capsules (500 mg) twice a day with
water for two months
Duration of the study- Two months drug therapy with a follow up for one month without drug.
Period of Study: Three months for each case. Total duration will be one year to complete the
trial.
Follow – Up: One follow-up will be carried out after one month of the completion of
treatment.
V. CRITERIA FOR INCLUSION
1. Age between 20 years and 60 years
2. Both the sex
3. Patient with five or more attacks of Migraine(headache) without Aura lasting for 4-72
hours presenting with a) at least two of the features viz. i) unilateral, ii) Pulsating, iii)
Moderate to severe, iv) Aggravated by movement and b)at least one of the features viz.
i) Nausea, ii) Photophobia, iii) Phonophobia (Classification Committee of the International
Headache Society. Classification and diagnostic criteria for headache disorders, cranial
neuralgias and facial pain, Cephalagia 1988 (suppl.7): 1-96..}
VI. CRITERIA FOR EXCLUSION
1. Age below 20 and above 60 years
2. Less than five attacks of Migraine without Aura.

342
3. Clinically diagnosed cases of
a.. Tension headache
b. Cluster headache.
c. Idiopathic stabbing headache
d. Exertional headache.
e. Headache due to systemic infection.
f. Drug induced headache
4. Organic brain lesions
5. Systemic disorders
6. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the Performa (Forms I & II). Clinical assessment will be done before drug administration, at the
end of 1st month, 2nd month during treatment and at the end of 3rd month during follow up (Form
III). Required laboratory investigations will be carried out to exclude cases as specified in the
criteria for exclusion. Form-IV)
IX. CRITERA FOR ASSESMENT OF RESULT OF TREATMENT
Disappearance of headache and presenting clinical features i.e. (i) Unilateral, (ii) Pulsating,
(iii) Moderate to severe nature, (iv) Aggravated by movement, (v) Nausea, (vi) Photophobia &
(vii) Phonophobia will be considered as significant improvement.
X. STATISTICAL ANALYSIS
Data on clinical symptoms, duration of attack and frequency of attack will be tabulated
and analysed using appropriate statistical tools.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi

343
XIII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Institutional
Ethical Committee (IEC) of trial center for getting clearance certificate before the project
is initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by IEC.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at Hqrs
will carefully monitor the data and side effects during the period of study and put in a
place where by prompt reporting of adverse events occur and take appropriate steps in
case of any adverse events occur. The data will be reviewed for every 20 participants
included into the study and administered the trial drugs. The research team will report
immediately to the PI and Data Monitoring Board 1) any life threatening conditions
whether they are perceived to be study related or not. The Board decides whether the
adverse effects warrant discontinuation of the study protocol. Protocols will be written and
approved for the treatment of study related adverse events
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit will be paid to subject selected for trial.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the trial at
CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Hematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

344
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator ___________
Name: ____________________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Assessment of Therapeutic Efficacy of Ayush-M Nasal Drops and Ayush-
M capsule in the management of Migraine with out Aura (Ardhava Bhedaka )

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

345
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
PATIENT INFORMATION SHEET

What is the study about?


Migraine (Ardhava Bedhaka) is as old as civilization, occupying 16% among clinical
classification of headaches, has become a challenging problem to the present day physician. Thee
is no satisfactory treatment available, since no drug is clearly superior then its potential side effect
are also considered A clinical study conducted on 20 cases migraine to evaluate the effect of
Nasya Karma with fresh leaf juice extracted from Acalypha indica Linn. (Haritamanjari,) along
with internal medication of Panchagavya ghrta (Astanga Hradya, Uttara Tantra 7/18) reveled
significant clinical improvement. Keeping the potential of Ayurveda into consideration, the present
study is aimed at evaluating an effective and safe remedy for the management and prevention of
migraine.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 3 months to complete (2 months for
treatment and another one month for follow-up study). During this period, you are expected to visit
the hospital three times, once in a month during drug treatment and once at the end of 3rd month
during follow up.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, Blood and urine samples will also be taken. This is to make sure that you
are eligible for the study.
If you are found eligible, you would be put on trial treatment for two months.
Initially for seven days nasal drops will be given to you for installation in nostril as per
guidelines issued by physicians. Daily dose of oral treatment consist of two 500 mg.
capsules twice a day for two months.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit.

To be translated into regional language.

346
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM I - SCREENING

1. Centre: ………………..……….

2. Code No. (of clinical trial)

3. Name of the subject: ………………………………........…………………………………

4. Gender: Male (1) Female (2)

5. Date of Birth: Age (in yrs.) :

6. Address ……………………………………..…………..........……………………………

CRITERIA OF INCLUSION Yes (1) No (0)

1. Age below 20 years & upto 60 years

2. Both the sex

3. Five or more attacks of migraine (headache) without


Aura lasting for 4-72 hours

4. Presence of two or more of the following features

i) unilateral,

ii) Pulsating,

iii) Moderate to severe

iv) Aggravated by movement and

5. Presence of one or more of the following features

i) Nausea,

ii) Photophobia,

347
iii) Photophobia

CRITERIA FOR EXCLUSION Yes (1) No (0)

6. Age below 20 and above 60 years

7. Less than five attacks of Migraine without Aura

Clinically diagnosed cases of (S.No. 8 – 16)

8. Tension headache

9. Cluster headache

10. Idiopathic stabbing headache

11. Exert ional headache

12. Headache due to systemic infection

13. Drug induced headache

14. Organic brain lesions

15. Any systemic disorders

16. Cases undergoing treatment for any other serious illness

A patient is eligible for admission to the trial

If Sl. No. 1 to 5 is ‘Yes’ and Sl. No. 6 to 16 are ‘No’

If admitted, Sr. No. of the Subject: _____________________

Date: _______________ Signature of the Investigator: ___________________

348
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE RFPORT FORM II - HISTORY

1. Centre : ........................................

2. Code No. (of clinical trial)

3. Sr. No. of the Subject : _______________________

4. Name of the patient .............................................................................................................

5. Gender Male 1 Female 2

6. Address: ..............................................................................................................................

7. Date of Birth Age (in years)

8. Educational status: Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

9. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

Exposed to allergens like dust, chemicals : ..............................................

Field work with physical labor : ..............................................................

Indicate nature of work : .........................................................................

10. Total Family members :

11. Income per capita per month in rupees :

349
Chief complaints with duration Present (1) Absent (0)

12. Five or more attacks of Migraine (headache)


Aura lasting for 4-72 hours

13. Clinical features

14. Unilateral headache

15. Pulsating,

16. Moderate to severe

17. Aggravated by movement

18. Nausea

19. Photophobia,

20. Phonophobia

21. Average frequency of attacks of migraine per month

Zero One Two Three More than Three

22. Average duration of attacks of migraine (hours)

Less than five hours five to ten hours more than 10 hours

Personal History

23. Diet: Veg 1 Non-veg 2 Lecto-veg 3

24. Sleep: Normal (1) Duration in hours :____________

Abnormal (2) Duration in hours :____________

If Abnormal specify ______________________________________

No (0) Yes (1)

(a) Initiation:

(b) Maintenance:

(c) Freshness in the morning:

350
25. Anxiety

26. Constipation

Addiction

27. Smoking No 1 Yes 2

If yes specify: (a) Quantity [packs] ________________

(b) Total Duration in years ____________

28. Tobacco No 1 Yes 2

If yes specify: (a) Quantity__________

(b) Total Duration in years____________

29. Alcohol No 1 Yes 2

If yes specify: (a) Quantity (ml)_________

(b) Total Duration in years_______________

30. Any other(specify)________________

31. Prakriti:

Vataj 1 Pittaj 2 Kaphaj 3

Vataja-Kaphaj 4 Vata-Pittaj 5 Pitta-Kaphaj 6

Sannipataj 7

32. Systemic examination: Normal 1 Abnormal 2

If abnormal, specify abnormalities __________________________________________

Date: _______________ Signature of Investigator: _________________________

351
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
[0, end of the Ist Month, IInd Month, IIIrd Month]

1. Centre : ........................................

2. Code No. (of clinical trial)

3. Sr. No. of the Subject : _______________________

4. Name of the patient .............................................................................................................

5. Gender: Male 1 Female 2

6. Address: ..............................................................................................................................

7. Date of Birth Age (in years)

8. Date of Assessment

Clinical Symptoms Present (1) Absent(0)

9. Unilateral headache

10. Pulsating headache

11. Nausea

12. Photophobia

13. Phonophobia

14. Frequency of attacks during last one month

Zero One Two Three More than Three

15. Duration of migraine attacks (hours):

Less than five hours five to ten hours more than ten hours

352
16. Adverse reaction: Yes 1 No 2

If yes, details:_______________________

17. Overall impression of well-being by the Subject:

Improved 1 No change 2 Deteriorated 3

18. Status of the patient:

Continuing 1

Drop out 2 Reason: _____________________________

Died 3 Cause: _______________________________

Date: ________________ Signature of the Investigator: ______________________

353
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(BEFORE TREATMENT)

1. Centre : ........................................
2. Code No. (of clinical trial)
3. Sr. No. of the Subject : _______________________
4. Name of the patient .............................................................................................................
5. Gender: Male 1 Female 2
6. Address: ..............................................................................................................................
7. Date of Birth Age (in years)
8. Date of Assessment
9. Urine Examination: Routine____________ / Microscopic___________
10. TC (Cells/Cmm.)_____________________
11. DC: P (%)______ L (%)______ E (%)______ M (%)______B (%)______
12. Hb (g/dl) ______________
13. ESR (1st hour.)(mm) ______________
14. Blood Sugar – PP (mg./dl)______________
15. B. Urea (mg./dl) ______________
16. S. Creatinine (mg./dl) _______________
17. Uric acid (mg./dl) _______________
18. Lipid profile ______________
19. Liver function tests ______________

Date: ______________ Signature of Investigator _________________________

354
DOUBLE BLIND PLACEBO CONTROLLED
CLINICAL EVALUATION OF “AYURVEDIC CODED
DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

355
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356
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
DOUBLE BLIND PLACEBO CONTROLLED CLINICAL EVALUATION OF
“AYURVEDIC CODED DRUG (AYUSH MANAS)” IN THE MANAGEMENT OF
“MANASA MANDATA (MENTAL RETARDATION)”

I. BACKGROUND
Manasa mandata is a condition in which the normal growth of the child is affected and
this could be equated with mental retardation due to various reasons. According to Ayurveda this
deficiency occurs due to beeja dosha where the parents of the child might have had incompatible
and improper diet and habits, during and before their conjugation. According to ayurvedic
concepts vata or vayu (bodily bioforce) is the self-generating and self-propagating energy, which
is responsible for the conduct, regulation and integration of all vital functions and the structures of
the body. This vital force when imbalanced due to the above factors affects the development of
fetus and ends up with serious deformities to the child. Because if vata is in imbalanced stage,
definitely child will become mentally and/or physically abnormal. Ayurveda has mentioned the role
of doshaja (both sareeraka & manasika) and ajantuja factors in development of the disease
pathogenesis. The rajoguna &tamoguna (manasika dosha) along with vata, pitta, & kapha
(sareeraka dosha) will play an important role for the development of this disease.
Severity of Mental Retardation
Depending on the severity of intellectual impairment ICD –10 classifies the mental
retardation in to following degrees.
F 70 Mild mental retardation IQ of 50-69
F 71 Moderate mental retardation IQ of 35-49
F 72 Severe mental retardation IQ of 20-34
F 73 Profound mental retardation IQ < 20
The Intelligence quotient (IQ) score is used in the measurement of intelligence. IQ tests are
designed in such a fashion that an average individual gets a score of 100. As mentioned earlier, an
IQ of less than 70 is the criterion for falling in the range of mental retardation. Common IQ tests
that are used in India are Binet Kamat Test (BKT), Vineland Social Maturity Scale (VSMS),
Development Assessments scale for Indian Infants (DAS II), Seguin Form Board (SFB) and Malin
Intelligence Scale for Indian Children (MISIC).
II. OBJECTIVE
To study the efficacy of Ayush Manas for one year, in children with mental retardation in
terms of improving their intellectual function as measured by the IQ or SQ.

357
III. SAMPLE SIZE &METHODS
Study design: 12 months prospective double blind placebo controlled design is proposed. Patients
while e & f are optional / to selected patients.
Sample Size: Sample size would be 60 in active drug arm and 60 in the placebo group.
Drug/Dosage/ Duration
The subjects will be randomized to ayush Manas and placebo in a 1:1 ratio with
approximately 60 patients assigned to each group. Active treatment will be given for one year.
The drug Ayush Manas (250/tab) will be given at a dose of 2 tablets tid with water, which
contains equal parts of brahmi, manduka parni, jyothishmathi and ashwagandha.
Study procedures
Subjects will visit the investigator six times during the trial. The initial visit is screening phase
(visit 0), and subsequently after 1 to 4 weeks of initial wash out period (visit 1), after 3 months
(visit 2), 6 months (visit 3), 9 months (visit 4), 12 months (visit 5) and 6th visit will be at 15th
month. Visit 0 will be considered as the screening, visit I will be considered, as the baseline visit
where the trial begins and visit 5 will be the end of active treatment. On visit 1(base line visit), the
investigator after ensuring compliance with inclusion and exclusion criteria will propose the study to
the patient and obtain informed consent for each subject from the parent or guardian. A complete
medical history will be obtained. This will include patient demographics, significant past and present
illness or surgical procedures, concomitant medication data and VSMS – Malin’s version. A
physical examination will be done and include the recording of height, weight heart rate and blood
pressure. Diagnosis of Mental Retardation will be made according to VSMS – Malin’s version
criteria for Mental Retardation. Laboratory investigations will be done as per CRF (case recording
file) at base line (visit 1), after 3 months (visit 2) and at the end of the active treatment (visit5).
IV. CRITERIA FOR INCLUSION
1. Children of either sex aged in between 6 to 13 years.
2. Children with mild to moderate Mental Retardation.
V. CRITERIA FOR EXCLUSION
Children with a history of peptic ulcer disease, any gastric or duodenal surgery,
gasterointestinal (GI) bleeding or other GI disorders.
1. Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac
or hematological disorders.
2. Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2
mg/dl, SGOT, SGPT >2times uppr limit of normal; serum bilirubin or Alkaline phosphatase
>1.5 times upper limit of normal.

358
3. Subject’s guardian who cannot be relied upon to comply with the test procedures or are
unwilling to give informed consent.
4. The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4
weeks prior to study entry.
5. The Children has likelihood of requiring treatment during the study period with drugs not
permitted by the study protocol.
6. The Children with a history of recent and clinically significant drug abuse.
7. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia,
thrombocytopenia etc.
8. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to
return for follow-up visits, and unlikelihood of complete study.
9. Children in whom another investigational drug was used with in 3 months prior to entry in
this study.
10. Children with mental retardation suffering with active epilepsy (H/o attack in last 3 months).
11. Children to whom Binet Kamat Test (BKT) can’t be administered for any reason such as
speech delay, severe hyperkinesias etc.
VI. CRITERIA FOR WITHDRAWAL
A discontinuation occurs when an enrolled subject ceases participation in the study,
regardless of the circumstances, prior to completion of the study. The reason for withdrawal
should be recorded in the CRF, dated and signed. Efforts should be made to ascertain the reason
for discontinuation.
Discontinuation can be due to:
1. Non-compliance with the study medications and specified visits
2. Serious clinical events requiring specific treatment
3. At subject’s/ guardian’s request.
The final evaluation required by the protocol at the end of the study, will be performed at
the time of study discontinuation.
VII. ROUTINE INVESTIGATION AND ASSESSMENT
The following laboratory tests will be performed on at base line (visit 1), after 3 months
(visit 2) and at the end of the active treatment (visit5).

359
The laboratory tests include:
Hematology: Hemoglobin, haematocrit, RBC count, TLC, DLC, platelet count, erythrocyte
sedimentation rate (ESR), bleeding time, clotting time, prothrombin time.
Biochemistry: Total bilirubin, SGPT, SGOT, alkaline phosphotase, creatinine, blood sugar,
serum protein and albumin.
Urinanalysis: Albumin, microscopic haematuria, Urine for abnormal metabolites.
The laboratory test results will be recorded in CRF.
VIII. CLINICAL ASSESSMENT
Using study instruments in each visit will assess all Children who fulfill the inclusion and
exclusion criteria and whose parent/guardian provides written informed consent.
Instruments - a. Detailed clinical proforma for Mental Retardation
b. Binet Kamat Test (BKT)
c. Vineland Social Maturity Scale (VSMS) – Indian adaptation by Malin
d. Maladaptive Behavior Scale (Part II of ABS of AAMR)
e. Seguin Form Board (SFB)
f. Malin’s Intelligence Scale for Indian Children (MISIC)
a, b, c & d will be administered to all the patients while e & f are optional / to selected patients.
SAFETY RECORDING
a. Adverse Events
All adverse events observed or reported by patients will be recorded in the CRF with
information about severity (i.e., whether mild, moderate or severe) and possible relation to the
study medication. Any serious adverse effects must be notified immediately to the study monitor.
b. Safety Measures
Safety evaluation will perform by recording clinical adverse events at randomization
(baseline) and at the subsequent clinical visits. Further adverse events will be classified according
to their type, severity and possible relationship to treatment. At Visit 1 the subject’s medical history
will be recorded. At monthly visits vital signs (body temperature, pulse, blood pressure) will be
recorded and a physical examination will be performed (Abnormal Lab reports listed in appendix
3).

360
IX. TRIAL MONITORING AND DATA ANALYSIS
A qualified statistician will perform the statistical analysis. All available data will be used in
the analysis. In general all statistical tests will be performed at the 5% level of significance.
X. ETHICAL REVIEW
Ethics Committee: The study will be performed in accordance with the principles stated
in the Declaration of Helsinki (enclosed Appendix 2). Ethical approval of the study protocol will
be obtained from the Ethics committee at institutions where the study will be conducted before the
study is undertaken. The opinion of the Ethics Committee should be dated and given in writing.
Whenever possible, the names and titles of the members attending the Ethics Committee meeting
should be appended. The approval must clearly identify the protocol and other documents
submitted for review, by title and study code.
XI. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 1st, 2nd, 3rd month (4 times)
XII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators involved in the
multicentric trial at CCRAS Hqrs. New Delhi. The investigators will be detailed about the clinical
trial conduct and laboratory procedures in order to maintain the uniformity.
XIII. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Haematological /Biochemical, etc.), which are not available
at research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

361
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”
PATIENT INFORMATION SHEET

What is the study about?


The research study in which patient participation is suggested aims to assess the efficacy
and safety of a new drug called AYUSH MANAS, a herbal product.
Currently no available drug has proven efficacy to improve the overall intellectual
functioning. Many patients seek alternative methods of treatment (complementary medicine). There
is thus a definite need to scientifically assess some of these treatment modalities. Though there are
no published data available on the efficacy of these herbs in mental retardation, the long claimed
usage in complementary medicine in India, claimed efficacy in mental performance, the apparent
safety profile makes it worthwhile studying in a placebo controlled randomized double blind trial.
The individual components of AYUSH MANAS have been studied in India & abroad in
various institutes in open clinical trials for disorders of the nervous system, memory improvement,
and development of immunity.
Explanation of procedures to be followed
Study procedure
I agree to return to this institute for examinations and evaluations of my child’s response to
treatment. At this initial visit my child’s medical and psychiatric history, current condition and
eligibility to enroll in this study will be evaluated. Approximately 5 more visits will be required to
assess my child throughout this study. Visits will take approximately one or two hours.
During these visits, a complete clinical assessment including physical examination,
psychological tests, & behavior rating scales, compliance with therapy and reporting of any
adverse reactions will be recorded.
Laboratory tests will be performed on first, second and last visits.
My child will be receiving either AYUSH MANAS or placebo (inactive drug). Neither my
physician nor I will know what medication my child is receiving. The physician will however be
able to obtain this information, quickly if needed.
Expected duration of the study and number of patients expected to participate
My child will be one of 120 patients who will participate in this study. The study
medication will be administered orally daily for a period of one year.
Possible risks
Based on our clinical experience the drugs included in AYUSH MANAS have shown no
side effects for short and long-term therapy.

362
Problems and side effects, which are not known at this time, could occur. I will be told of
any changes in the way the study will be done and of any newly identified risks to which my child
may be exposed.
I shall inform the physician about any illness that my child may have suffered in this study
period and the treatment required for it.
Patient participation
Participation in this study is entirely voluntary. If I do not desire to enroll my child for the
study the child’s treatment will continue as per the routine of the institute.
Possible benefits of the study
The costs of the all tests, examinations and medical care required as a part of this study
are to be provided free of cost to me. My child may respond favorably to treatment and others
may benefit from the overall conclusions to be drawn from the results of this study. There is no
guarantee that my child will benefit from participating in this study.
Withdrawal from this study
The investigator in charge of this study can remove my child from the study without my
consent based on his/her judgment to improve my child’s medical care or my failure to follow the
study schedule.
Compensation
If my child is injured as a direct result of taking part in this study, I understand that
medical treatment and other related costs should be made available by CCRAS, New Delhi.
Right to withdraw from the study
I am free to leave this study at any time without giving any reason. My decision of not
participating in this study or to leave the study in between shall not affect my child’s future medical
care.
Confidentiality
The records obtained during the study as well as related health records will remain strictly
confidential at all times. However, I understand that these will need to be made available to
CCRAS, New Delhi, to other doctors/scientists of this study and if required to the drug regulatory
authority. The information disclosed will remain confidential. The results of the treatment, including
laboratory tests, photographs may be published for scientific purposes provided my child’s identity
is not revealed.
Data protection: Use of data collected from this study
My child’s personal data, which may be sensitive, will be collected and processed only for
research purposes in connection with this study. By taking part in this study, I agree not to restrict
the use of any data even if I withdraw.

363
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF “AYURVEDIC CODED DRUG
(AYUSH MANAS)” IN THE MANAGEMENT OF “MANASA MANDATA
(MENTAL RETARDATION)”
WRITTEN INFORMED CONSENT FORM
(By parent/guardian of the patient)

I,…………………………………………………………………………………………Father/
Mother/Guardian of………………………………………, exercising my free power of choice
give my consent on my as well as my child’s behalf to be included in this study on one-year
prospective double blind placebo controlled clinical evaluation of “Ayurvedic coded drug (AYUSH
MANAS)” in the management of “Manasa Mandata (Mental Retardation)”. I have read, or had
read to me, the above information before signing this consent form. I have been provided ample
opportunity to ask questions and have received answers that fully satisfy those questions. I have
been informed to my satisfaction by the attending physician the nature and purpose of the study.
I understand that the clinical details and information recorded as part of the study will be
kept confidential.
I am also aware of my right to withdraw out of this study at any time during the course of
the study without having to assign the reason for doing so.

Signature of the Father/Mother/Guardian Date: ________________

Signature of the Physician Date: ________________

Signature of impartial witness Date: ________________

To be translated into regional language.

364
CENTRAL COUNCIL FOR RESEARCH IN A YURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – I SCREENING
(Enter a  in the appropriate box)

1. Name of the patient : ______________________________________________________


2. Address: _______________________________________________________________
_______________________________________________________________
3. Centre: _______________________________________________________________
4. Code No. (of clinical trial)
5. Patient No. ______________________________________________________________
6. Group No. First Second
Third Fourth
CRITERIA OF INCLUSION Yes (1) No (0)
1. Age between 5-16 years of either sex 1 0
2. Duration of disease up to 10 years 1 0
3. Presence of cardinal symptoms of diseases 1 0
CRITERIA OF EXCLUSION
4. Age below 5 and above 16 years 1 0
5. Duration more than 10 years 1 0
6. Patients with uncontrolled epilepsy, hyperkinesis, 1 0
psychosis, tuberculosis and organicity
7. Others (specify)_________________________________________
A patient will be admitted for treatment,
If ‘Yes’ to 1 – 3 and ‘No’ to 4 – 7 above
No: _ _ _ _ _ _ _ _ _ _ _ _

Date: _____________ Signature of the Investigator _______________________

365
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
ASSESSMENT OF THERAPEUTIC EFFICACY OF AYUSH-M NASAL DROPS
AND AYUSH-M CAPSULE IN THE MANAGEMENT OF MIGRAINE WITH
OUT AURA (ARDHAVA BEDHAKA)
CASE RFPORT FORM II - HISTORY

1. Name of the patient : ______________________________________________________

2. Address : _______________________________________________________________
_______________________________________________________________

3. Date of Admission Date of Discharge

4. Centre : __________________________________________________________________

5. Code No. (of clinical trila) :

6. Patient No.

7. Group No. First 1 Second 2

Third 3 Fourth 4

8. Age in patient in years : _______________

9. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

10. Occupation

Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work…………………………….................................

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Total income of the family in rupees : .......................................................

11. Total Family members :

12. Income per capita per month in rupees :

Chief complaints with duration Yes (1) No (0)

13. Delayed milestones 1 0

14. Speech handicap 1 0

15. Seizures 1 0

16. Mental age not proportional with chronological age 1 0

17. Adaptive behavior Impaired 1 Not impaired 0

18. Hyperactivity present 1 absent 0

19. Maladaptive signs (tick if present)

Twitches & tics


Silly giggling
Dribbling of the saliva
Destructive & harmful
Inopportune laughing/crying/shouting
Fixed eyes
Lack of personal hygiene
History of present illness:

20. Onset of disease Acute 1 Insidious 2

21. Duration of disease ______________

22. Treatment given so far :

Ayurvedic medicine 1 Modern medicine 2 Unani 3

Homoeopathy 4 Siddha 5 Mixed 6

367
Medicines given ________________________ Results obtained ______________________

23. Factors aggravating the disease/chief complaints ___________________________________

24. Factors relieving main complaints_______________________________________________

25. History of past illness having relation with present illness

Yes 1 No 2

If yes, specify _____________________________________________________________

Family History if any Yes (1) No (0)

26. Mental disease 1 0

27. Mental retardation 1 0

28. Consanguineous marriage 1 0

Personal History

29. Diet: Veg 1 Non-veg 2 Lacto-ova veg 3

30. Sleep: Good 1 Disturbed 2 Insomnia 3

31. Emotional stress Yes 1 No 2

32. Bowel Habit Regular 1 Constipation 2 Loose motion 3

33. Addiction Yes 1 No 2

If yes, specify _____________________________________________________________

34. Prakriti

Vataj 1 Pittaj 2 Kaphaj 3

Vataja-Kaphaj 4 Vata-Pittaj 5 Pitta-Kaphaj 6

Sannipataj 7

368
35. Manas Prakriti

Sattva 1 Rajas 2 Tamas 3

Sattva-Rajas 4 Sattva-Tamas 5 Rajas-Tamas 6

Sama 7

Physical Examination:

Build Lean 1 Medium 2 Heavy 3

36. Body weight Kg: _________________

37. Blood Pressure (Systolic): _________________

38. Blood Pressure (Diastolic): _________________

39. Body temperature: _________________

40. Respiration: _________________

Present (1) Absent (0)

41. Cyanosais 1 0

42. Anaemia 1 0

43. Jaundice 1 0

44. Pigmentation 1 0

45. Clubbing of fingers 1 0

46. Deformities 1 0

47. Lymphadenopathy 1 0

Systemic examination Normal (1) Abnormal (2)

48. CVS with chest 1 2

If abnormal, specify abnormalities_______________________________________________

49. CNS 1 2

If abnormal, specify abnormalities__________________________________

369
50. Digestive System 1 2

If abnormal, specify abnormalities__________________________________

51. Urogenital System 1 2

If abnormal, specify abnormalities__________________________________

Samprapti (Pathogenesis) of the disease

52. Anubandhyashareerikadosha Vata 1 Pitta 2 Kapha 3

53. Anubandhashareerika dosha Vata 1 Pitta 2 Kapha 3

54. Anubandhya manasika dosha Rajas 1 Tamas 2

55. Anubandhamanesika dosha Rajas 1 Tamas 2

56. Ksheena shareerika dosha Vata 1 Pitta 2 Kapha 3

57. Ksheena manasika dosha Rajas 1 Tamas 2

58. Stages of disease (Rogakriya kala)

Sanchaya 1 Prakopa 2 Prasara Sthanasamshraya 3

Vyakti 4 Bheda 5

SROTAS PAREEKSHA

59. Pran Vaha Srota

Alpa Alpa Swasa (Shortened Breathing) 1

Atisrama Swasa (Increased respiration rate) 2

Abhikshna Swasa (Chyne stroke breathing) 3

Kupita Swasa (Vitiated breathing) 4

Sashula swasa (Dyspnoea with pain) 5

60. Udakavaha Srota

Jihva sosha (Dryness of tongue) 1

370
Oustha sosha (Dryness of lip) 2

Talu shosha (Dryness of palate) 3

Kantha shosha (Dryness of throat) 4

Kloma shosha (Excessive thirst) 5

Trishna (Thirst) 6

61. Annavaha Srota

Anannabhilasha (Lack of desire for food) 1

Aruchi (Anorexia) 2

Avipaka (Indigestion) 3

Chhardi (Vomitting) 4

62. Ras Vaha Srotas

Mukha vairsya (Bad taste in mouth) 1

Arasajnata (Tastelessness) 2

Hrillasa (water brash) 3

Gaurava (Feeling of heaviness) 4

Tandra (Stupor) 5

Anga marda (Body ache) 6

Jwara (Fever) 7

Pandu (Anaemia) 8

Avsada (Depression) 9

Klaibya (Loss of libido) 10

Karshya (Emaciation) 11

Agnimandya (Diminished appetite) 12

371
63. Rakta Vaha Srotas

Pidika (Boils) 1

Rakta Pitta (Bleeding from any of the orifice) 2

Mukha paka (Stomatitis) 3

Vidradhi (Abscess) 4

Charma raga (Skin disease) 5

Kamala (Jaundice) 6

64. Mamsa Vaha Srotas

Arubuda (Tumour) 1

Aljee (Phlyctenular conjunctivitis) 2

Gandamalaa (cervical lynphadenitis) 3

Upjivihika (Epiglotitis) 4

Adhimamsa (Protruberance of flesh/cancer/cyst) 5

Putimamsa (decayed flesh/gangrene) 6

65. Medo Vaha Srotas -

Maladhykya (Excess of excreta) 1

Hastapada daha (Burning sensation in the palm and sole) 2

Hastapada suptata (Numbness of the palm and sole) 3

Tandra (Stupor) 4

Dehachikkanata (Greasiness of the skin) 5

Alasya (Lethargy) 6

66. Asthi Vaha Srotas -

Adhyasthii (Hypertrophy of bone) 1

372
Adhidanta (Redundant tooth) 2

Dantshoola (Toothache) 3

Asthi shoola (bone pain) 4

Kesha, lorna, nakha, samshru vikara 5


(Any defects of hair, hair follicles, nails and mustaches)

67. Majja Vaha Srotas -

Parva shoola (Pain in the Interphalangeal joints) 1

Bhrama (Vertigo/Giddiness) 2

Moorchh (Syncope) 3

Mithyajnana (Illusion) 4

68. Shukra vaha srotas -

Klaivya (Sterility/impotence) 1

Aharshan (Loss of erection) 2

Garbha pata (Abortion) 3

Santana vikriti (Congenital deformity of the children) 4

69. Manovaha srotas

Manovibramsha 1

Budhivibramsha 2

Samjavibramsha 3

Smritivibramsha 4

Bhktivibramsha 5

Sheelavibramsha 6

Chesta vibramsha 7

Acharavibramsha 8

373
70. Artava vaha srotas -

Anartava (Amenorrhoea) 1

Vandhyatva (Sterlity) 2

71. Mutra-vaha srotas -

Bahumutrata (Polyuria) 1

Atibadhta (Urination with obstruction) 2

Prakop mutra (Defective Urination/Difficulty in micturition 3

Alpaalpa (Scanty urination) 4

Aabhikshna (Constant/repeated urination) 5

Bahulamutrata (Urine with prostatic secreation) 6

Sashoola mutrata (Painful micturition) 7

72. Pureeshavaha srotas -

Alpaalpa pureesha (Scanty defecation) 1

Sashoola pureesha (Painful defecation) 2

Atidrava pureesha (Diarrhoea) 3

Atigrathita yukta pureesha (Scybala) 4

73. Sweda vaha srotas -

Aswedan (Loss of perspiration) 1

Atiswedana (Profuse sweating) 2

Parushya (Roughness of the skin) 3

Lomaharsha (Thrill) 4

Aangaparidaha (Burning sensation in the body) 5

374
74. Investigations

Clinical assessment

75. Provisional diagnosis Final diagnosis

76. Medical management

77. Principle drug therapy

Drug Dose Vehicle Diet

Duration of treatment

78. Summary of findings

79. Results: Good response 1 Fair response 2

Poor response 3 No response 4

Dropout 5 LAMA 6

Death 7

Date:____________ Signature of Investigator___________________________

375
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION)
CASE REPORT FORM – III INVESTIGATION

1. Name of the patient: ________________________________________________________

2. Address: _______________________________________________________________
_______________________________________________________________

3. Centre: __________________________________________________________________

4. Code No. (of clinical trial):

5. Patient No.

6. Group No. First 1 Second 2

7. Age of patient in years: _____________________________________________________

Investigations

Investigations At the time of admission At the time of discharge

8. URINE: Routine & Microscopic

9. Stool: Macroscopic & Microscopic

HAEMA TOLOGICAL INVESTIGATIONS

10. HB %

11. T.L.C. (in thousands/Cmm)

12. D.L.C.

Polymorphs :..... .....%

Lymphocyte :..... .....%

Basophil : . . . . . . . . . . %

Eosinophil : . . . . . . . . . . %

376
13. E.S.R. : 1 Hr . . . . . . . mm

: 2 Hr . . . . . . . mm

Biochemistry:

14. Total proteins (gm % )

15. Alkaline phosphatase . . . . . . . . . IU/L

16. S.G.O.T . . . . . . . . . IU/L

17. S.G.P.T . . . . . . . . . IU/L

18. S. Bilirubins . . . . . . . . . mg/100 ml

19. Urea . . . . . . . . . mg/100 ml

20. S. Creatinine . . . . . . . . . mg/dl

Special Tests

21. Urinary catecholamines

22. CT Scan for Head

23. EEG

Note: Only such investigations are to be undertaken for which facilities exist in the Institutes/
Centres/Units themselves, unless exempted.

24. Objective test

(i) Binet Kamat test

(ii) Seguin Form Board Test

(iii) Vineland Social Maturity Scale

377
INFORMED CONSENT (APPENDIX 1)

Informed consent will be obtained from each subject in the prescribed format prior to
performance of any study related procedures: before physical examination, laboratory screening or
any other investigational procedure and before administration of any study related medication. The
investigators will give each subject full information about the nature, meaning and importance of the
study and a description of the procedures to be followed by the investigator in accordance with
Declaration of Helsinki (Appendix 2). They will further be given a description of any foreseeable
risks and discomforts. Subjects will also be told that they have the right to opt out of the trial at
any time without having to give reasons and without prejudice to further treatment. Each subject
will be given a copy of the subject information sheet and will be given sufficient time to consider
the implications of the study before deciding whether or not to participate in the trial.
The subject and the investigator must sign the informed consent form. At this time the
subject must have legal capacity and be able to comprehend the nature, meaning, importance and
risks of the study and to make up his mind accordingly. If the subject is illiterate, an impartial
witness (a person, who is independent of the trial and who cannot be unfairly influenced by people
involved in the trial) will attend the informed consent form in a language known to the subject.
Signed informed consent means the explicit acceptance that the Investigator(s), the sponsor and,
possibly, the regulatory authorities, will know about the individual’s data.

Note: In the above Subject means parent’s Legal guardian.

378
DECLARATION OF HELSINKI (APPENDIX 2)

Introduction
It is the mission of the physician to safeguard the health of the people. His or her
knowledge and conscience are dedicated to the fulfillment of this mission.
The Declaration of Geneva of the World Medical Association binds the physician with the
words, “The health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act only in the patient’s interest when providing
medical care which might have the effect of weakening the physical and mental condition of the
patient.”
The Purpose of biomedical research involving human subjects must be to improve
diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and
pathogenesis of disease.
In current medical practice most diagnostic, therapeutic or prophylactic procedures involve
hazards. This applies especially to biomedical research.
Medical progress is based on research, which ultimately must rest in part on
experimentation involving human subjects.
In the field of biomedical research a fundamental distinction must be recognized between
medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical
research, the essential object of which is purely scientific and without implying direct diagnostic or
therapeutic value to the person subjected to the research.
Special caution must be exercised in the conduct of research, which may affect the
environment, and the welfare of animals used for research must be respected.
Because it is essential that the results of laboratory experiments be applied to human
beings to further scientific knowledge and to help suffering humanity, the World Medical
Association has prepared the following recommendations as a guide to every physician in
biomedical research involving human subjects. They should be kept under review in the future. It
must be stressed that the standards as drafted are only a guide to physicians all over the world.
Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their
own countries.
I. Basic Principles
Biomedical research involving human subjects must conform to generally accepted scientific
principles and should be based on adequately performed laboratory and animal experimentation
and on a thorough knowledge of the scientific literature.

379
1. The design and performance of each experimental procedure involving human subjects should
be clearly formulated in an experimental protocol which should be transmitted for
consideration, comment and guidance to a specially appointed committee independent of the
investigator and the sponsor provided that this independent committee is in conformity with
the laws and regulations of the country in which the research experiment is performed.
2. Biomedical research involving human subjects should be conducted only by scientifically
qualified persons and under the supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a medically qualified person and
never rest on the subject of the research, even though the subject has given his or her
consent.
3. Biomedical research involving human subjects cannot legitimately be carried out unless the
importance of the objective is in proportion to the inherent risk to the subject.
4. Every biomedical research project involving human subjects should be preceded by careful
assessment of predictable risks in comparison with foreseeable benefits to the subject or to
others. Concern for the interests of the subject must always prevail over the interests of
science and society.
5. The right of the research subject to safeguard his or her integrity must always be respected.
Every precaution should be taken to respect the privacy of the subject and to minimize the
impact of the study on the subject’s physical and mental integrity and on the personality of
the subject.
6. Physicians should abstain from engaging in research projects involving human subjects unless
they are satisfied that the hazards involved are believed to be predictable. Physicians should
cease any investigation if the hazards are found to outweigh the potential benefits.
7. In publication of the results of his or her research, the physician is obliged to preserve the
accuracy of the results. Reports of experimentation not in accordance with the principles laid
down in this Declaration should not be accepted for publication.
8. In any research on human beings, each potential subject must be adequately informed of the
aims, methods, anticipated benefits and potential hazards of the study and the discomfort it
may entail. He or she should be informed that he or she is at liberty to abstain from
participation in the study and that he or she is free to withdraw his or her consent to
participation at any time. The physician should then obtain the subject’s freely-given informed
consent, preferably in writing.
9. When obtaining informed consent for the research project the physician should be particularly
cautious if the subject is in a dependent relationship to him or her or may consent under
duress. In that case the informed consent should be obtained by a physician who is not
engaged in the investigation and who is completely independent of this official relationship.

380
10. In case of legal incompetence, informed consent should be obtained from the legal guardian
in accordance with national legislation. Where physical or mental incapacity makes it
impossible to obtain informed consent, or when the subject is a minor, permission from the
responsible relative replaces that of the subject in accordance with national legislation.
Whenever the minor child is in fact able to give a consent, the minor’s consent must be
obtained in addition to the consent of the minor’s legal guardian.
11. The research protocol should always contain a statement of the ethical considerations involved
and should indicate that the principles enunciated in the present Declaration are complied
with.
II. Medical Research Combined with Professional Care (Clinical Research)
1. In the treatment of the sick person, the physician must be free to use a new diagnostic and
therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health
or alleviating suffering.
2. The potential benefits, hazards and discomfort of a new method should be weighed against
the advantages of the best current diagnostic and therapeutic methods.
3. In any medical study, every patient—including those of a control group, if any—should be
assured of the best proven diagnostic and therapeutic method.
4. The refusal of the patient to participate in a study must never interfere with the physician-
patient relationship.
5. If the physician considers it essential not to obtain informed consent, the specific reasons for
this proposal should be stated in the experimental protocol for transmission to the independent
committee (I, 2).
6. The physician can combine medical research with professional care, the objective being the
acquisition of new medical knowledge, only to the extent that medical research is justified by
its potential diagnostic or therapeutic value for the patient.

381
ABNORMAL LABORATORY RESULTS (APPENDIX 3)

SI.No. Laboratory Test Clinically Moderate Marked


relevant abnormality abnormality
direction (%) (%)
1. Haemoglobin (Hb) Decrease 10(5) 25(10)
2. Haematocrit Decrease 10(5) 25(10)
3. RBC Either 10(5) 25(10)
4. White cell (TLC) Either 10(5) 25(10)
5. Platelet Decrease 10(10) 25(25)
6. Creatinine Increase 10(5) 50(50)
7. Glucose Either 10(20) 50(50)
8. Total bilirubin Increase ≥1.5xULN ≥2.0xULN
9. AST/ALT Increase ≥1.5xULN ≥3.0xULN
10. Alkaline phosphatase Increase ≥1.2xULN ≥1.5xULN
11. Abnormal laboratory
value follow-up

Patients with markedly abnormal tests at the end of treatment period should be followed
up to satisfactory resolution.
ULN is defined as the upper limit of normal, depending on whether the pretreatment
baseline was normal or abnormal.
The follow up of abnormal laboratory tests described in the CRF will be recorded
accordingly.

382
SCHEDULE OF ASSESSMENTS (APPENDIX 4)

Assessment Screening Double Blind Treatment Follow Up


Visit No. 0 1 2 3 4 5 6
Inclusion/Exclusion X - - - - - -
criteria
Medical History X - - - - - -
BKT X - - - - X X
VSMS X - X X X X X
Part II of ABS of X - X X X X X
AAMR
SFB X - X X X X X
MISIC X - X X X X X
Pulse/BP/Weight/Height X X X X X X X
Physical Examination X X X X X X X
Clinical Lab. Evaluation X - X - - X -
Study drug accountability - X X X X X -

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384
SAMANA THERAPY VIS-A-VIS PANCHAKARMA
THERAPY IN THE MANAGEMENT OF GRIDHRASI
(SCIATICA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

385
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386
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)

I. BACKGROUND
Pain starting from the gluteal region and spreading down the back of the lower limb and
radiating upto the foot is the main symptom of the Gridhrasi (Sciatica). There will be a limp gait
and difficulty in sitting. If pain is severe, the patient may not be able to move from bed. The pain
increases by coughing or sneezing. The patient suddenly seized with immobilizing and shooting pain
down the leg, starting from lower back.
The disease mostly affects the early and middle aged people. Occupations like heavy
weight lifting, continuous pressure on the back etc. are also main causative factors.
ETIOPATHOGENESIS
According to Ayurveda, in Gridhrasi1, the main vitiated Dosha is Vata. In Ashtanga
Hridaya and Sushruta Samhita, the descriptions of Gridhrasi are identical. However, Caraka’s
description differs. It classifies Gridhrasi into two types namely Vataja and Vatakaphaja.
Caraka’s description is very much similar to modern concept. According to Ayurvedic concepts
also, the origin of the disease is at Katipradesha (Lumbo - Sacral region).
Inspite of the fact that the spinal diseases are difficult to be cured, sciatic pain is not so
much harmful as other neurological conditions. Ayurvedic concept of treatment for Gridhrasi
(Sciatica) is more effective and suitable as compared to modern mode of treatment. On prolonged
use also, there is no side effect with Ayurvedic regimen of treatment. Several single and compound
herbal preparations like Bhallataka (Tripathy et. al., 1965). Nirgundi (Jain et. al., 1976) and
Hingutriguna Taila (Prem Kishore et. al., 1986) etc. have shown good response in the
management of Gridhrasi (Sciatica).

References
1. Charaka Samhita, Chikitsa Sthana Chapter– 28, Vidyotini Hindi Vyakhya by Vd. Ambikadatta
Shastry, Choukhamba Orientalia, Varanasi
2. Harrison’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by Mc Graw-Hill CompaniesInc.pp1208-1209
3. Ambika Dutta Sashtri (1989) Susruta samhita (text with Hindi commentary) Nidana Sthana,
Chapter – 1, VIIth Edition Chaukhamba Sanskrit Series Office, Varanasi.
4. Bhaisajya Ratnavali, Krimiroga Chikitsa Prakarana, Chaukhamba Sanskrit Samsthan, Varanasi

387
Since inception, Indian Institute of Panchakarma has been concentrating Clinical
Research Trials on Gridhrasi in order to find out an effective line of treatment. Several Single and
Compound Ayurvedic preparations had been tried. Following are the main drugs in which Clinical
Trials have been already conducted in past. All the trials have shown significant result in the
management of Gridhrasi cases.
Typical pain radiation, caused due to irritation of the 4th and 5th lumber and 1st sacral
roots, from the sciatic nerve extending mainly down the posterior aspect of the thigh and posterior
and lateral aspects of the leg is termed as Sciatica. Twinkling, paresthesia and numbness of or
sensory impairment of the skin, soreness of the skin and tenderness along the nerve also
accompanies the classic sciatic pain and on physical examination reflex loss, weakness, atrophy,
fascicular twitching and occasionally stasis oedema may occur is the motor fibres of the anterior
root are involved.
Mild attacks least for a week or two. Other cases happen to be more chronic and
provide a history of remitting attacks. Favorable cases, rested absolutely on hard bed, may
recover with 4 – 6 weeks but recurrences are frequent. Foot drops seldom recovers completely.
Pelvic tractions help in some cases with disc lesions. Massage, spinal exercise and heat application
provide comfort and hence are useful. If there is no improvement by providing bed rest and there
are recurrent disabling attacks, surgical removal of the disc is suggested.
II. OBJECTIVES
The study aims to assess the Comparative Clinical Evaluation of Dasamoola Bala Kwatha
(Internal) along with Dasamoola Bala Taila (Internal and External) in one group and
Panchakarma Therapy with its different procedures in another group in the management of
Gridhrasi (Sciatica). The drug Dasamoola and Bala are well known for their Vatahara
properties.
III. CENTER:
CCRAS identified Centers
IV. SAMPLE SIZE AND METHODS:
Sample Size: 100 cases
No of Groups: Two groups
Trial Drug/Dosage/Duration
Group – I: Samana Chikitsa
a). Dasamoola Bala Taila – 10 ml. to 15 ml. thrice daily X 14 days.
i). Dasamoola Bala Kwatha – 10 – 15 ml. thrice daily X 14 days.

388
ii). Nirgundi Patrapotala Sweda after Abhyanga with Dasamoola Bala
Taila X 14 days.
b). Virechana X 1 day with Eranda Taila 30 ml., after completing the
Patrapotala Sweda

Group – II: Panchakarma Therapy


a). Snehapana with Dasamoola Bala Taila for 7 days
b). Vashpa Sweda X 3 days
c). Viechana with Eranda Taila X 1 day
d). Samsarjana Karma X 7 days
e). Vaitarana Vasti X 7 days
No of Patient in each Group: 50 cases in each group
(Random allocation of selected cases in two different trial groups)
Type of Study: Single blind
Duration of Study: Samana Chikitsa for a period of 22 days while Panchakarma
Chikitsa will continue for a total period of 25 – 26 days.
Follow Up: For a period of three months on a regular interval of fortnight, either with
postal correspondence or on personal appearance of the patient at the field station where
he/she has been registered for the trial.
V. CRITERIA FOR INCLUSION
1. Age — 20 to 70 years
2. Sex — Either sex
3. Duration of illness — Upto 2 years
4. Radiating pain, starting from the gluteal region towards, the foot
5. Tenderness of the Sciatic Nerve course
6. Severe pain on squatting
7. Sensory change
8. Non-involvement of Urinary Bladder and Rectum
9. Positive straight leg raising sign

389
VI. CRITERIA FOR EXCLUSION
1. Age below 20 years and above 70 years
2. Duration of disease more than 2 years
3. Monoplegia
4. Paraplegia
5. Hip joint arthritis
6. T.B. Spine/Hip
7. Pelvic pathology
8. Traumatic lesion in lumbo - sacral region
VII. CRITERIA FOR WITHDRAWAL
1. Left against medical Advise (LAMA)
2. Development of complications due to presenting illness or otherwise
3. Aggravation of symptoms
Pronounced toxic side effects
VIII. ROUTINE EXAMINATION AND ASSESSMENT
Screening of the patient will be recorded as per case record form - I. Detailed clinical
history and physical examination of each patient will be recorded as per Part – II of the Proforma
annexed. Pathological, Biochemical and other relevant investigations will be carried out as per Part
– III of the proforma. The assessment of the results will be done according to effect of the Trial
Groups on each of the sign and symptom. Each sign and symptom is graded and a numerical
value is given for assessment of results. (as per case record form III).
Following criteria has been fixed for Routine Examination and Assessment.
1. Pricking pain 6
2. Pulling pain 6
3. Stiffness 3
4. Tenderness of sciatic trunk 6
5. Straight leg raising test/positive 54
jugular vein pressure test
6. Ankle jerk 2

390
7. Knee jerk 2
8. Plantar reflexes 2
9. Pressing power 3
10. Muscle wasting 3
11. Walking speed 3
12. Sensory impairment 2
13. Posture 8

Total 100

Symptoms were suitably graded to assess the degree of involvement. The assessment chart
is annexed at Part – IV of the Proforma.
IX. CRITERIA FOR ASSESSMENT
Result of treatment will be graded as follows:
1. Good Response : Complete relief in presenting symptomatology of the disease.
2. Fair Response : 75% and above relief of signs and symptoms.
3. Poor Response : 50% to 74% relief of signs and symptoms
4. No Response : No response in presenting clinical symptomatology of disease or
otherwise.
X. TRIAL MONITORING AND DATA ANALYSIS
The progress of the study will be monitored by team comprising of Clinicians, Pathologists,
Biochemists, Radiologists and Statisticians.
XI. STATISTICAL ANALYSIS
Before treatment and after treatment, data signs/symtoms and other parameters taken into
account for diagnosis and assessment of result of treatment will be tabulated and analyzed using
suitable statistical methods.
XII. TRIAL MONITORING AND DATA ANALYSIS
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.

391
XIII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
XIV. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XVI. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

392
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________

Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Samana therapy vis-a-vis panchakarma therapy in the management
of gridhrasi (sciatica)”

Date:___________ Name of the Subject:_____________________________

Signature or Thumb impression_____________________

Date:___________ Name of witness: _______________________________

Signature or Thumb impression: _____________________

Relationship ___________________________________

To be translated into regional language.

393
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
SAMANA THERAPY VIS-A-VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
PATIENT INFORMATION SHEET

What is the study about?


Pain starting from the gluteal region and spreading down the back of the lower limb and
radiating upto the foot is the main symptom of the Gridhrasi (Sciatica). There will be a limp gait
and difficulty in sitting. If pain is severe, the patient may not be able to move from bed. The pain
increases by coughing or sneezing. The patient suddenly seized with immobilizing and shooting pain
down the leg, starting from lower back.
The disease mostly affects the early and middle aged people. Occupations like heavy
weight lifting, continuous pressure on the back etc. are also main causative factors.
According to Ayurveda, in Gridhrasi, the main vitiated Dosha is
Vata. In Ashtanga Hridaya and Sushruta Samhita, the descriptions of Gridhrasi are
identical. However, Caraka’s description differs. It classifies Gridhrasi into two types namely
Vataja and Vatakaphaja. Caraka’s description is very much similar to modern concept.
According to Ayurvedic concepts also, the origin of the disease is at Katipradesha (Lumbo -
Sacral region).
Inspite of the fact that the spinal diseases are difficult to be cured, sciatic pain is not so
much harmful as other neurological conditions. Ayurvedic concept of treatment for Gridhrasi
(Sciatica) is more effective and suitable as compared to modern mode of treatment. On prolonged
use also, there is no side effect with Ayurvedic regimen of treatment. Several single and compound
herbal preparations like Bhallataka (Tripathy et. al., 1965). Nirgundi (Jain et. al., 1976) and
Hringutriguna Taila (Prem Kishore et. al., 1986) etc. have shown good response in the
management of Gridhrasi (Sciatica).
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approxim. Samana Chikitsa for a period of 22 days
while Panchakarma Chikitsa will continue for a total period of 25 – 26 days.
During treatment period, you are expected to visit the hospital for clinical and physiological
assessment.

394
Before you start treatment, during the first visit to the clinic, you will undergo a
complete physical examination, required objective tests and laboratory investigations will
also be done.
If you are found eligible, you would be put on treatment for Samana Chikitsa for
a period of 22 days while Panchakarma Chikitsa will continue for a total period of 25 –
26 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

395
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Name of the patient: .................................................... Age: ................. Sex: ...................

2. Address: ...............................................................................................................................

3. Centre:

4. Code No. (of clinical trial)

5. Patient No.

6. Group No

CRITERIA FOR INCLUSION Yes (1) No (0)

7. Age between 12 – 70 years 1 0

8. Sex – Either sex 1 0

9. Duration of illness upto 2 yrs. 1 0

10. Regarding pain starting from gluteal region 1 0

11. Tenderness of sciatic nerve course 1 0

12. Severe pain on squatting 1 0

13. Positive straight leg raising sign 1 0

CRITERIA FOR EXCLUSION Yes No

14. Age below 12 and above 70 years 1 0

15. Duration of the disease more than 2 years 1 0

396
16. Monoplegia 1 0

17. Paraplegia 1 0

18. Hip joint arthritis 1 0

19. T.B. Spine/Hip 1 0

20. Pelvic pathology 1 0

21. Traumatic lesion in lumbosacral region 1 0

Date: ________________ Name of Investigator: _____________________

397
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Name of the patient : ............................................................ Age ............ Sex .................

2. Address : ..............................................................................................................................

3. Date of Admission Date of Discharge

4. Centre :

5. Code No. (of clinical trial)

6. Patient No.

7. Group No

8. Age of Patient (in years)

9. Educational status:

Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

10. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

Total income of the family (in Rs.) ...........................................................

11. Total Family members :

12. Income per capita per month in rupees :

398
13. Religion: Hindu 1 Muslim 2 Sikh 3

Christian 4 Parsi 5

Chief Complaints with Duration (as indicated in days)

Present Absent Duration

14. Sphik sula/Katisula/Prishta sula 1 0

15. Urasula (Pain on back of thigh) 1 0


(Sciatic Course)

16. Janghasula (Pain in calf muscle) 1 0

17. Padasula (Pain in foot) 1 0

18. Pain on raising from squatting 1 0

19. Thota (Pricking pain) 1 0

20. Graha (Pulling pain) 1 0

21. Spandana (Twitching) 1 0

22. Walking difficulty 1 0

23. Stambha (Stiffness) 1 0

24. Supti (Numbness) 1 0

25. Nidranasa (Distrubed sleep) 1 0

History of Present Illness

26. Onset of disease Acute 1 Insidious 2

Duration of disease (in days)

27. Treatment given so far: Ayurvedic medicine 1 Modern medicine 2

Unani 3 Homoeopathy 4

Any other, specify: .......................................................................................................................

Spell out the medicines given and results obtained: ......................................................................

399
28. Factors aggravating the disease/chief complaints

Drug 1 Diet 2 Cold Climate 3

Tropical Climate 4 Damp climate 5 Sea shore 6

Positive factors may be spell out: ....................................................................................

29. Factors relieved main complaints

Drug 1 Diet 2 Cold Climate 3

Tropical Climate 4 Damp climate 5 Sea shore 6

Positive factors may be spell out: ....................................................................................

Yes No

30. Past illness, having relation with present illness 1 0

If yes, specify .......................................................................................................................

31. Hypertension 1 0

32. Diabetes mellitus 1 0

33. Bronchial Asthma 1 0

34. Cancer 1 0

35. Cardio vascular disease 1 0

36. Tuberculosis 1 0

Others (specify) ....................................................................................................................

Personal History

37. Diet Veg. 1 Non-Veg 2 Lacto-Ova Veg. 3

38. Sleep Good. 1 Distrubed 2 Insomnia 3

39. Emotional stress Yes 1 No 2

40. Bowel habit Regular 1 Constipation 2 Hard Stool 3

Loose Stool 4

400
41. Dependency Yes 1 No 2

If yes, specify: ......................................................................................................................

42. Prakriti

Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6

Sannipataja 7

43. Manas Prakriti

Sattva 1 Rajas 2 Tamas 3

Sattva-Rajas 4 Rajas-Tamas 5 Sattva-Tamas 6

Sama 7

Physical Examination

44. Built Lean 1 Medium 2 Heavy 3

45. Gait Normal 1 Abnormal 2

If abnormal, specify abnormalities: ........................................................................................

46. Body weight (in Kgs.)

47. Blood pressure (Systolic)

48. Blood pressure (Diastolic)

49. Body temperature

50. Pulse

51. Respiration

Present Absent

52. Cynosis 1 0

53. Anaemia 1 0

54. Jaundice 1 0

401
55. Pigmentation 1 0

56. Clubbing of fingers 1 0

57. Deformities 1 0

58. Lymphadenopathy 1 0

If any, specify .......................................................................................................................

Systemic Examination

Present Absent

59. C.V.S. with chest 1 0

If any, specify .......................................................................................................................

60. C.N.S. 1 0

If any, specify .......................................................................................................................

61. Respiratory system 1 0

If any, specify .......................................................................................................................

62. Digestive system 1 0

If any, specify .......................................................................................................................

63. Uro-Genital system 1 0

If any, specify .......................................................................................................................

Local Examination

Yes No

64. Tenderness on sciatic trunk 1 0

65. Straight leg raising test 1 0

(Sakthi ulkshepa vaishamya) 1 0

66. Defective posture (Dehavakrata) 1 0

402
67. Sensory impairment 1 0

68. Stiffness (Stambha) 1 0

69. Swelling (Sotha) 1 0

70. Muscle wasting (Mamsa sosha) 1 0

Samprapti (Pathogenesis) of the disease according to Ayurvedic Concept

71. Anubandhya dosha – Vata: Vyana 1 Samana 2 Apana 3

72. Anubandha dosha – Kapha: Kledaka kapha 1

73. Dushya: Rasa 1 Mamsa 2 Asthi 3

Snayu 4 Kandara 5

SROTAS PARIKSHA

Mamsa Vaha Srotas: Yes No

74. Arubuda 1 0

75. Alajee (Phlyetenular conjunctivitis) 1 0

76. Ganda mala (Cervical lymphadenitis) 1 0

77. Upajihvika (Epiglotitis) 1 0

78. Adhimamsa (Protuberance of flesh/cancer/cyst) 1 0

79. Putimamsa (decayed flesh/Gangrenous) 1 0

Rasa Vaha Srotas

80. Mukha vairasya (Bad taste in mouth) 1 0

81. Arasyata (Tastelessness) 1 0

82. Hrillasa (Water in mouth) 1 0

83. Gaurava (Feeling of heaviness) 1 0

84. Tandra (Drowsiness) 1 0

403
85. Angamarda (Body ramps) 1 0

86. Jwara (Fever) 1 0

87. Pandu (Anaemia) 1 0

88. Avasada (Depression) 1 0

89. Klavya (Loss of libido) 1 0

90. Karshya (Emaciation) 1 0

91. Agnimandya (Diminished appetite) 1 0

Provisional Diagnosis:

Final Diagnosis:

Medical Management:

Principal Drug Therapy:

Dose —

Vehicle —

Diet —

Summary of findings:

102.Results:

Good Response 1 Fair Response 2


Poor Response 3 No Response 4
Drop out 5 LAMA 6
Death 7

Date: Signature of Investigator


Counter Signature of Head of Deptt.

404
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
NEW DELHI
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
PROFORMA
CASE REPORT FORM III – CLINICAL ASSESSMENT

1. Name of the patient : ............................................................ Age ............ Sex .................

2. Address : ..............................................................................................................................

3. Centre :

4. Code No. (of clinical trial)

5. Patient No.

6. Group No

Parameters to Initially at the 1st 2nd 3rd Follow up


be taken for time of Assessment Assessment Assessment
assessment admission – 15 days – 30 days – 45 days
(1) (2) (3) (4) (5) (6)

Clinical Parameters:

(A). Subjective symptoms

1. Pricking pain

Absent — 0

Mild — 2

Moderate — 4

Severe — 6

405
2. Pulling Pain

Absent — 0

Mild — 2

Moderate — 4

Severe — 6

3. Stiffness

Absent — 0

Mild — 1

Moderate — 2

Severe — 3

(B). Subjective signs:

a. Tenderness of the sciatic nerve

Grade – I (Patient says there is tenderness) — 2

Grade – II (Patient winces) — 4

Grade – III (Winces & withdraws the affected limb) — 6

b. Straight leg raising test (in degrees)

0 — 54

10 — 48

20 — 42

30 — 36

40 — 30

50 — 24

60 — 18

70 — 12

406
80 — 6

90 — 0

c. Ankle jerk

Present — 0

Exaggerated — 1

Absent — 2

d. Knee jerk

Present — 0

Exaggerated — 1

Absent — 2

e. Planter

Present — 0

Up going — 1

Absent — 2

f. Pressing power

a). Upto 10 Kg. — 3

b).10 to 20 Kg. — 2

c). 20 to 25 Kg. — 1

d). 25 and above — 0

g. Muscle wasting

Thigh:

a). Difference of 2.5 – 3.5 cm. — 0.5

b). Difference of 3.5 – 4.5 cm. — 1

c). Above 4.5 cms. — 1.5

407
Calf:

a). Difference of 1 – 1.5 cm. — 0.5

b). Difference of 1.5 – 2 cm. — 1

c). Above 2 cms. — 1.5

Measurement:

25 cm. above the medical mallcolus — R

— L

20 cm. above the knee joint line — R

— L

h. Walking speed (Time taken to cover 20 meters)

a). Upto 20 seconds — 0

b). 21 to 40 seconds — 1

c). 41 to 60 seconds — 2

d). Above 60 seconds — 3

i. Sensory impairment — 2

j. Posture — 8

a). No Complaint — 0

b). Patient can walk without difficulty but experienced — 1


difficulty from getting up form squatting posture

c). Difficulty to squat — 2

d). Difficulty in climbing upstairs — 3

e). Limping gait — 4

f). Can stand on both limbs but with pain — 5

408
g). Can stand without touching the affected limb — 6
on the floor

h). Can sit on bed without support but with pain — 7


and difficulty

i). Lying in bed with pain affected limb flexed by — 8


a supportive pillow

Total numerical value 100

Foot Note: Any abnormalities in Lab. Parameters recorded at the time of admission that may
be considered during the assessment of the progress of the case and also during
follow up period.

Modern Diagnosis

409
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA & SIDDHA
NEW DELHI
SAMANA THERAPY VIS – A – VIS PANCHAKARMA THERAPY IN THE
MANAGEMENT OF GRIDHRASI (SCIATICA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(Enter a  in the appropriate box)

1. Name of the patient : ............................................................ Age ............ Sex .................

2. Address : ..............................................................................................................................

3. Centre :

4. Code No. (of clinical trial)

5. Patient No.

6. Group No

Investigations at At the time of After 10 days 20 days 30 days


admission
(1) (2) (3) (4) (5)

Date of sample taken:

Present Absent (P) (A) (P) (A) (P) (A)

7. Sugar 1 0 1 0 1 0 1 0

8. Albumin 1 0 1 0 1 0 1 0

9. Bile Salt 1 0 1 0 1 0 1 0

10. Bile Pigment 1 0 1 0 1 0 1 0

11. Microscopy 1 0 1 0 1 0 1 0

410
Stool:

12. Ova 1 0 1 0 1 0 1 0

13. Cyst. 1 0 1 0 1 0 1 0

14. Occult 1 0 1 0 1 0 1 0

Hematological Investigations:

15. Hb%

16. T.L.C.

17. Polymorph

18. Lymphocyte

19. Basophil

20. Monocyte

21. Eosinophil

22. E.S.R.

Biochemistry:

23. Blood Glucose

24. Urea

25. Serum Cholesterol

(P) (A) (P) (A) (P) (A) (P) (A)

26. VDRL 1 0 1 0 1 0 1 0

27. X-ray spine 1 0 1 0 1 0 1 0


(AP & Lateral view)

28. Pelvis 1 0 1 0 1 0 1 0

If abnormal, specify abnormalities .........................................................................................

411
BLANK

412
CLINICAL EVALUATION OF HERBAL PREPARATIONS
IN THE MANAGEMENT OF MANODVEGA
(ANXIETY NEUROSIS)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

413
BLANK

414
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)

I. BACKGROUND
Life is a conglomerate of body (Shareera), faculties (Indriya), mind (Satva), and soul
(Aatma). Any of these cannot be isolated and studied separately. So seers of Ayurveda express
that the term ‘Shareera’ refers body including five senses and mind.
As mind is a dual faculty (Ubhayendriya) or sensory-motor faculty (J’nana-Karmendriya),
it perceives and responds. Even the physical well being is reflected in mind, so is the illness. This
made the terms happiness (Sukha), and misery (Dukha), synonyms of health and illness. The
influence of mind cannot be ruled out in origin, existence or cure of any condition of any disease.
When allowed to persist for long time the psychic and somatic disorders get combined with each
other.
Chittodwega/ Manodwega is one of the Manasika Vikara mentioned in Ayurvedic
literature. The symptoms of this disease can be assumed mostly similar with the generalized
anxiety disorder (GAD). GAD is a disorder requires the presence of unrealistic or excessive
anxiety and worry, accompanied by symptoms from three of four categories: (1) motor tension, (2)
autonomic hyperactivity, (3) vigilance and scanning, and (4) apprehensive expectation. The anxious
mood must continue for at least a month.
The Ayurvedic principle of synthesis of mind, body and soul to consider man as integrated
whole one, would help to treat mental disorders effectively. Medhya rasayanas and Satvavajaya
chikitsa are such a measures, which can be utilized for the treatment of Chittodwega/
Manodwega1.
In Chittodwega/ Manodwega2, when the mind is afflicted with anxiety, fear, agitation etc.
this leads to worry, apprehension, depression, psychological arousal as anger, irritability and
ultimately lead to disturbance in personal, familial and social harmony.

References
1. Charaka Samhita with Ayurveda Dipika commentary of Chakrapanidatta, Chaukhambha Sanskrit
Sansthan, 5th edition, Varanasi, 2001
2. Sushruta Samhita with Nibandha Sangraha commentary of Dalhana and Nyayachandrika
commentary of Gayadasa, Chaukhambha Orientalia Varanasi, 6th edition, 1997.
3. Harrison: Principals of Internal Medicine Vol. II, 13th edition (International edition).

415
Anxiety disorders3 are among the most prevalent psychiatric condition in the world.
Further, studies have persistently shown that they produce inordinate morbidity, utilization of health
care services, and functional impairment. Recent studies also suggest that chronic anxiety disorder
may increase the rate of cardiovascular-related mortality. Hence, clinicians in psychiatry and other
specialties must make the proper anxiety disorder diagnosis rapidly and initiate treatment.
Ayurveda provides rational means for the treatment of many disorders, which are
considered to be obstinate and incurable in other systems of medicine.
II. OBJECTIVES
To evaluate the anti-anxiety effect of an ayurvedic compound drug in patients suffering with
manodwega.
To evaluate efficacy & safety of ayurvedic compound drug in manodwega patients
The efficacy of ayurvedic compound drug for six weeks have been studied on manodwega
in terms of relieving from the symptoms pridictable through ayurvedic clinical parameters &
hamilton’s rating scale for anxiety neurosis.
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample Size : 24 patients in each group (2 groups).
Trial period : 45 Days
Design of the study : Sequential crossover design and double blind method are
adopted.
Drug & dosage : The Ayurvedic compound consists of Mandukaparni
(Centella asiatica), Yasti (Glycyrrhiza glabra), Jatamamsi
(Nardostachys jatamansi) in the ratio of suspended in the
Kshirabala Thaila. The daily dose of Ayurvedic drug is
3gms. / Day in 3 divided doses. Each capsule contains
500mgs of drug i.e.Mandukaparni (120mg), Yasti (120mg.)
Jatamamsi (240mg.) and ksheerabala taila (3 drops).
The daily dosage of diazepam is 15mg. /day also in three
divided doses. The placebo is plain starch powder.

Duration of the study : 45 days drug therapy with a follow up for 7 days.

416
Study period : 1 year to complete study.
Follow – Up : The follow-up will be carried out after 7 days of treatment.
V. CRITERIA FOR INCLUSION
1. Age between 16-45 years of either sex
2. Presence of cardinal features of manodwega
3. Onset between 8weeks to 2 years
4. Ambulatory and co-operative
VI. CRITERIA FOR EXCLUSION
1. Age below 16 yrs. and above 45 yrs.
2. Duration of the disease – below 8weeks and above 2years.
3. Exhibiting psychotic symptoms
4. Factors interfering with concentration and communication
5. Hypertension
6. Diabetes
7. Any other systemic diseases
VII. CRITERIA FOR WITHDRAWAL
1. If patient does not follows the instructions.
2. Any complication developed during the course of trial.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
A detailed clinical and social history is taken. The patients assessed on the basis of clinical
parameters and Hamilton’s anxiety rating scales.
IX. METHOD OF ASSESSMENT OF TREATMENT
1. Clinical Symptomatic Relief
2. Psychological parameters
3. Hamilton’s anxiety rating scale
X. STATISTICAL ANALYSIS:
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have

417
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.100/- per visit i.e., on the 1st day of recruitment after
screening, 8th day, 15th day and so on upto 45th day (weekly once).
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I am willing to undergo any risk for inclusion in
this study.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on “Clinical evaluation of herbal preparations in the management of
Manodvega (Anxiety Neurosis)”.

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

419
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
PATIENT INFORMATION SHEET

What is the study about?


Chittodwega/ Manodwega is one of the Manasika Vikara mentioned in Ayurvedic
literature. The symptoms of this disease can be assumed mostly similar with the generalized
anxiety disorder (GAD). GAD is a disorder requires the presence of unrealistic or excessive
anxiety and worry, accompanied by symptoms from three of four categories: (1) motor tension, (2)
autonomic hyperactivity, (3) vigilance and scanning, and (4) apprehensive expectation. The anxious
mood must continue for at least a month.
The Ayurvedic principle of synthesis of mind, body and soul to consider man as integrated
whole one, would help to treat mental disorders effectively. Medhya rasayanas and Satvavajaya
chikitsa are such a measures, which can be utilized for the treatment of Chittodwega/Manodwega.
In Chittodwega/ Manodwega, when the mind is afflicted with anxiety, fear, agitation etc. this
leads to worry, apprehension, depression, psychological arousal as anger, irritability and ultimately
lead to disturbance in personal, familial and social harmony.
Anxiety disorders are among the most prevalent psychiatric condition in the world. Further,
studies have persistently shown that they produce inordinate morbidity, utilization of health care
services, and functional impairment. Recent studies also suggest that chronic anxiety disorder may
increase the rate of cardiovascular-related mortality. Hence, clinicians in psychiatry and other
specialties must make the proper anxiety disorder diagnosis rapidly and initiate treatment.
Ayurveda provides rational means for the treatment of many disorders, which are
considered to be obstinate and incurable in other systems of medicine.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 45 days.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, required objective tests and laboratory investigations will also be done.
If you are found eligible, you would be put on trial treatment for 45 days.

420
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

421
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – I SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Name of the patient: .................................................... Age: ................. Sex: ...................

2. Address: ...............................................................................................................................

3. Centre:

4. Code No. (of clinical trial)

5. Patient No.

6. Group No

Yes (1) No (0)

1. Age between 16-45 years of either sex

2. Cardinal features of udvega present

3. Onset between 8 weeks and 2 years

4. Ambulatory and co-operative

CRITERIA FOR EXCLUSION Yes (1) No (0)

5. Hypertension

6. Diabetes

7. Any other systemic disease

8. Age less than 15 years and more than 45 years

9. Duration of illness less than 1 month and more


than 2 years

422
10. Exhibiting psychotic symptoms

11. Factors interfering with concentration and


communication

A patient is eligible for admission to the trail

If Sl. No. 1 – 4 is ‘Yes’ and Sl. No. 5 – 11 are ‘No’

Date: ______________ Signature of the Investigator: ______________________

423
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – II ADMISSION

1. Name of the patient : ...........................................................................................................

2. Address : ..............................................................................................................................

3. Date of Birth: Age (in yrs.) :

4. Patient No.

5. Date of Admission Date of Discharge

6. Centre :

7. Code No. (of clinical trial)

8. Age of Patient (in years)

9. Group No.

10. Educational status:

Illiterate Read and write Primary

Middle school High school College

Others (specify) INA

11. Occupation Desk work Field work

Field work with physical labour

Field work with intellectual

Indicate nature of work…………………………….................................

12. Total income of the family (in Rs.) ...........................................................

13. Total Family members :

424
14. Income per capita per month in rupees :

Chief Complaints with duration (in days) : Yes (1) No (0)

15. Free floating anxiety

16. Fear

17. Vague aches and pains

18. Panic attacks

19. Difficulty in concentration

20. Psychosomatic symptoms (tick if present)

Depersonalisation

Tremors and tics ____________

Profuse sweating ____________

Dryness of mouth ____________

Throat choking ____________

Chest constriction ____________

Palpitation ____________

(Organicity must be ruled out)

History of Present Illness

21. Onset of disease Acute 1 Insidious 2

22. Duration of disease (in days)

23. Treatment given so far: Ayurvedic medicine 1 Modern medicine 2

Unani 3 Homoeopathy 4

Siddha 5 Mixed 6

24. Factors aggravating the disease / chief complaints


_______________________________________________________________________

425
25. Factors relieving main complaints

_______________________________________________________________________

26. History of past illness, having relation with present illness. Yes 1 No 0

If yes, specify _________________________

27. History of previous episodes. Yes 1 No 0

If yes, specify _________________________

Family History, if any Yes (1) No (0)

28. Mental retardation

29. Mental disease

30. Anxiety neurosis

Personal History

31. Diet Veg Non-veg Lacto-ova veg

32. Sleep Good Disturbed Insomnia

33. Emotional stress Yes 1 No 2

34. Bowel habit Regular 1 Constipation 2 Loose 3

35. Addiction Yes 1 No 2

If yes, Specify _______________________________________

36. PRAKRITI :

Vataj 1 Pittaj 2 Kaphaj 3

Vata-kaphaj 4 Vata Pittaj 5 Pitta- Kaphaj 6

Sannipataj 7

426
37. MANAS PRAKRITI :

Sattva 1 Rajas 2 Tamas 3

Sattva Rajas 4 Sattva- Tamas 5 Rajas-Tamas 6

Sama 7

Physical examination

38. Build Lean 1 Medium 2 Heavy 3

39. Gait Normal 1 Abnormal 2

40. Body weight (Kg)

41. Blood pressure (Systolic)

42. Blood pressure (diastolic)

43. Body temperature

44. Pulse

45. Respiration

Present (1) Absent (0)

46. Cyanosis

47. Anaemia

48. Jaundice

49. Clubbing of fingers

50. Deformities

51. Lymphadenopathy

Systematic examination Normal Abnormal

52. C.V.S. with chest 0 1

If abnormal, specify abnormalities ____________________________________________

427
53. CNS 0 1

If abnormal, specify abnormalities ____________________________________________

54. Digestive system 0 1

If abnormal, specify abnormalities ____________________________________________

55. Uro-genital system 0 1

If abnormal, specify abnormalities ____________________________________________

Samprapti (Pathogenesis) of the disease according to Ayurvedic concept.

56. Anubandhya Shareerikadosha Vata 1 Pitta 2 Kapha 3

57. Anubandhashareerika Vata 1 Pitta 2 Kapha 3

58. Anubandhya-manasikadosha Rajas 1 Tamas 2

59. Anubandhya-manasikadosha Rajas 1 Tamas 2

60. Ksheena shareerikadosha Vata 1 Pitta 2 Kapha 3

61. Ksheena manasikadosha Rajas 1 Tamas 2

62. Ksheena dhatu (indicate) Rasa 1 Rakta 2 Mamsa 3

Meda 4 Asthi 5 Majja 6

Shkra or Artava 7 Oja 8

63. Dooshya Rasa 1 Rakta 2 Mamsa 3

Meda 4 Asthi 5 Majja 6

Shkra or Artava 7

64. Stages of disease : Sanchaya 1 Prakopa 2 Prasara 3

Sthanasamsraya 4 Vyakti 5

Bheda 6

428
Srotas Pareeksha

65. Pran vaha srota

Alpa Alpa Swasa (Shortened Breathing) 1

Atisrama Swasa (Increased respiration rate) 2

Abhikshana Swasa (Chyne stroke breathing) 3

Kupit Swasa (Vitiated breathing) 4

Sashula swasa (Dyspnoea with pain) 5

66. Udakavaha srota

Jihva sosha (Dryness of tongue) 1

Oustha sosha (Dryness of lip) 2

Talu sosha (Dryness of palate) 3

Kantha sosha (Dryness of throat) 4

Kloma sosha (Excessive thirst) 5

Trishna (Thirst) 6

67. Annavaha srota

Anannabhilasha (Lack of desire for food) 1

Aruchi (Anorexia) 2

Avipaka (Indigestion) 3

Chhardi (Vomitting) 4

68. Rasa Vaha srotas

Mukha vairsya (Bad taste in mouth) 1

Arasajnata (Tastelessness) 2

Hrillasa (Water brash) 3

429
Gaurava (Feeling of heaviness) 4

Tandra (Stupor) 5

Anga marda (Body ache) 6

Jwara (Fever) 7

Pandu (Anaemia) 8

Avsada (Depression) 9

Klibya (Loss of libibo) 10

Karshya (Emaciation) 11

Agnimandya (Diminished appetite) 12

69. Rakta vaha srotas

Pidika (Boils) 1

Rakta Pitta (Bleeding from any of the orifice) 2

Mukha Pak (Stomatitis) 3

Vidradhi (Abscess) 4

Charma roga (Skin disease) 5

Kamala (Jaundice) 6

70. Mamsavaha srotas

Arubud (Tumour) 1

Aljee (Phlyctenular conjunctivitis) 2

Gandamalaa (cervical lymphadenitis) 3

Upji (Epiglotis) 4

Adhimamsa (Protruberance of flesh/cancer/cyst) 5

Putimamsa (decayed flesh/gangrene) 6

430
71. Medo vaha srotas

Maladhikya (Excess of excreta) 1

Hastapada daha (Burning sensation in the palm and sole) 2

Hastapada suptata (Numbness of the palm and sole) 3

Tandra (Stupor) 4

Dehachikkanta (Greasiness of the skin) 5

Alasya (Lethargy) 6

72. Asthivaha srotas

Adhyasthi (Hypertrophy of bone) 1

Adhidanta (Redundant tooth) 2

Dantshoola (Toothache) 3

Asthi shoola (Bone pain) 4

Kesha, loma, nakha, samshru vikara 5


(Any defects of hair, hair follicles, nails and mustaches)

73. Majja_vaha srotas

Parva shoola (Pain in the Interphalangeal joints) 1

Bhrama (Vertigo/Giddiness) 2

Moorchh (Syncope) 3

Mithyajnana (Illusion) 4

74. Shukra_vaha srotas

Klaivya (Sterility / impotence) 1

Aharshan (Loss of erection) 2

Garbha pata (Abortion) 3

Santam Vikriti (Congenital deformity of the children) 4

431
75. Manovaha srotas

Manovibramsha 1

Budhivibramsha 2

Sanjna Vibhramsha 3

Smritivibhramsha 4

Bhaktivibhramsha 5

Sheelavibhramsha 6

Chesta Vibhramsha 7

Acharavibhramsha 8

76. Artava vaha srotas

Anartava (Amenorrhoea) 1

77. Vandhyatva (Sterility) 2

78. Mutra vaha srotas

Bahumutra (Polyuria) 1

Atibadhata (Urination with obstruction) 2

Prakop-mutra (Defective Urination / Difficulty 3


in micturition)

Alpaalpa (Scanty urination) 4

Aabhikshna (Constant / repeated urination) 5

Bahulamutrata (Urine with prostatic secretion) 6

Sashool amutrata (Painful micturition) 7

79. Pureeshavaha srotas

Alpaalpa Pureesha (Scanty defecation) 1

Sashoola Pureesha (Painful defecation) 2

432
Atidrava Pureesha (Diarrhoea) 3

Atigrathita yukta Pureesha (Scybala) 4

80. Sweda vaha srotas

Aswedan (Loss of perspiration) 1

Atiswedana (Profuse sweating) 2

Parushya (Roughness of the skin) 3

Lomaharsha (Thrill) 4

Aangaparidaha (Burning sensation in the body) 5

81. Investigations

82. Provisional Diagnosis Final Diagnosis

83. Medical management

84. Principle drug therapy

Drug Dose Vehicle

Diet

85. Duration of treatment

86. Summary of findings

87. Results : Good response 1 Fair response 2

Poor response 3 No response 4

Drop-out 5 LAMA 6

Death 7

Date : Signature of Investigator

433
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE
MANAGEMENT OF MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM - III INVESTIGATIONS
Name : ...............................................................................................................................................
Age : ............................... Sex : .................. Date: ......................................................
Investigations Before starting After 45 days
treatment
URINE (24 hour sample)
1. 17 – hydroxyl-cortico steroids
2. 17- keto-steroids
3. Vanillyl mandelic acid (VMA)
4. Routine
HAEMATOLOGICAL INVESTIGATIONS :
5. Hb _________________ gm/dl
6. T.L.C. (in thousand/Cmm)
D.L.C
7. Polymorphs ________________ %
8. Lymphocyte ________________ %
9. Basophil ________________ %
10. Monocyte ________________ %
11. Eosinophill ________________ %
12. E.S.R. 1 hr ________________ mm
2 hr ________________ mm
BIOCHEMISTRY :
13. Blood Glucose (Random) _____________ mg/dl
14. Urea _____________ mg/dl
15. Blood lactic acid estimation if possible
16. S. Creatinine _____________ mg/ dl
17. ECG

434
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF HERBOMINERAL PREPARATIONS IN THE MANAGEMENT OF
MANODVEGA (ANXIETY NEUROSIS)
CASE REPORT FORM – IV PERIODICAL OBSERVATION & ASSESSMENT
Centre : ...................................................................... Date: ......................................................................................
Code No: ................................................................... Sr. No. of the subject: ...........................................................
Subject‘s Name: ......................................................... Sex: .................................................. Age: ...........................

Parameters Initial At the end of 45 days


Clinical Parameters

435
a. Subjective symptoms
1. Hamilton’s anxiety rating scale
2. Taylor’s manifest anxiety scale
b. Objective test
1. Work output (cancellation of 9s)
2. Perceptual discrimination
(Closing the Cs into Os)
3. Psychomotor performance tests
a. Hand precision (Finger dexterity test)
b. Hand steadiness (Steadiness tester)
c. Speed of response (Tapping board)
Blank

436
METABOLIC DISORDERS

SECTION - VI
Blank

438
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND
PLACLINICAL TRIAL OF VYOSHADI GUGGULU IN
THE MANAGEMENT OF OBESITY (MEDOROGA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

439
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440
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)

I. BACKGROUND
Obesity (Medoroga) is a condition in which there is an excessive accumulation of fat in the
body. Framingham study showed that a 20% excess over the desirable body weight clearly
poses risk to health. This disease is a metabolic disease generally occurs in affluent societies. It is
associated with increased mortality by predisposing to the development of important diseases like
diabetes, hypertension, atherosclerosis, heart disease, arthritis, infertility etc. and diminishes the
efficiency and happiness of those affected.
Because of imbalance between energy intake and expenditure, the excess fat accumulates
in the body. Although no satisfactory etiological classification of obesity is well defined but number
of factors are known to be associated with its development. Obesity is most prevalent in middle
age, but it can occur at any stage of life. It is prevalent in high socio-economic group. There are
certain professions in which obesity is common. Familial tendency exists in many cases.
Endocrine factors and energy imbalance are also responsible for the obesity. There are certain
drugs which cause obesity like steroids, oral contraceptives, phenothiazine, insulin etc.
The following complications generally occur in this disease viz. - psychological and sexual
problems, mechanical disabilities, osteoarthrosis of knee, hip, lumbar spines, abdominal and
diaphragmatic hernias and varicose veins, exertion dyspnoea, metabolic disorders like non-insulin
dependent, diabetes mellitus (NIDDM), hyperlipidaemia, gall stones, hyperuricaemia and
cardiovascular disorders. Low cardia output increases susceptibility to hypertension and IHD.
The current line of management in modern medicine is not giving satisfactory response in
the treatment of obesity. At this juncture it becomes essential to explore the efficacy of certain
Ayurvedic drugs in the management of obesity. Guggulu is one of major ingredient of the trial drug
of this project, on which many scientific research studies, (experimental and clinical both) have
been conducted establishing its hypocholestraemic, anti-obesity and anti-atherosclerotic effect.
II. OBJECTIVE
The aim of the present study is to assess the efficacy of Vyoshadi guggul in the
management of obesity.
III. CENTRES
CCRAS identified centers.

441
IV. SAMPLE SIZE AND METHODS
No. of Groups — Two
No. of patients in each group — 60
Sample Size — 120 (60 subjects in each group)
Drug/Dosage/Duration:
Drug — Vyoshadi Guggulu
Dosage — 1gram (2 capsules of 500 mg. each)
two times a day.
Duration — 6 months
Design of the study — Randomised Double blind placebo
controlled study.
Duration of the study — 6 months drug therapy with a
follow up for 3 months without
drug.
Total period of study — 9 months
V. CRITERIA FOR INCLUSION
1. Age above 25 years and below 60 years of either sex
2. Presence of obesity, i.e., weight is more than 20 % excess of the desirable weight
according to height, sex and age(according to annexed height and body weight table) Or
Age adjusted BMI above 85th percentile (Indian standard)
3. WHR i.e., Waist Hip Circumference ratio >0.95 in males and >0.8 in females
VI. CRITERIA FOR EXCLUSION
1 Age below 25 years and above 60 years
2. Obesity secondary to or associated with Hypothyroidism, hypertension, Diabetes mellitus,
hyperlipidemia or Cushing’s syndrome.
3. Any concomitant serious disorder of the liver, kidneys, heart, lungs or other organs.
4. Pregnancy and Lactation.
5. Person undergoing treatment for any other serious illness.

442
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial, if any serious complication develops which requires urgent
treatment with other drugs and therapies, such subjects may be withdrawn from the trial. The
Investigator shall mention the probable cause of withdrawal.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the Case Record Form (Forms I & IA). Clinical assessment will be done before drug
administration (0), at the end of 1st month, 3rd month and 6th month during treatment and at the
end of 9th month follow up (Form II). The laboratory investigations will be recorded before
drug administration, at the end of three month, at the end of treatment (6 months) and at the end
of follow-up.(9th month) [Form III] .
IX. FOLLOW UP
Follow-up will be carried out for 3 months after completion of treatment.
X. STATISTICAL ANALYSIS
Clinical symptoms and laboratory parameters will be analyzed using appropriate statistical
methods.
XI. TRIAL MONITORING
Monitoring unit of CCRAS Headquarters, New Delhi will monitor the progress of the trial.
Data analysis will be undertaken by the Monitoring unit at CCRAS headquarter.
XII. ETHICAL REVIEW
A. Institutional Ethical Committee (IEC): The proposal will be placed before Ethical
Committee (IEC) of trial center for getting clearance certificate before the project is
initiated. Patient’s information sheet and informed consent form will be submitted along
with project proposal for approval by EC. Both will be maintained in duplicate with one
copy given to the patient at the time of entry to the trial.
B. Data and Safety Monitoring Board (DSMB): A Data and safety monitoring board
(DSMB) at Hqrs. will carefully monitor the data and side effects during the period of
study and put in a place where by prompt reporting of adverse events occur. The data will
be reviewed as every 20 participants entered the study and administered the trial drugs.
The research team will report immediately to the PI and Data Monitoring Board if, any
life threatening conditions whether they are perceived to be study related or not. The
Board decides whether the adverse effects warrant discontinuation of the study protocol.
Protocols will be written and approved for the treatment of study related adverse events.

443
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs……. /- per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

444
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the investigator ___________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the, “Multicentric double blind pre-clinical trial of vyoshadi guggulu in the management of obesity
(medoroga).

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

445
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
PATIENT INFORMATION SHEET

What is the study about?


Ayurveda has a very comprehensive approach for the management of Obesity. The present
study aims at evaluating selected Ayurvedic formulation for its efficacy in Obesity. You are invited
to participate in this study where you will be provided with a combination of Vyoshadi gugulu in
the dose of 1 gm. (2 capsules of 500mgms each) two times a day. There have been earlier trials
too showing the efficacy of similar formulation. About 360 persons with Obesity shall be included
in this trial for which 3 big hospitals from different parts of the country are participating in the trial.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 9 months to complete(6months of
medication and thereafter 3 months of follow up). During this period, you are expected to visit the
hospital five times. Six visits shall have to be undertaken one initially when you are included in the
trial, then after one month, after 2 months, after 4th month, after 6th month and after 9th month.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, ECG and an X-ray, Blood and urine samples will also be taken. This is to
make sure that you are eligible for the study.
If you are found eligible, you would be put on trial treatment for 6 months. The daily
dosage will be 500 mg twice daily. At each visit, you will be supplied with sufficient quantities of
drugs to last until your next visit.

To be translated into regional language.

446
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM I - SCREENING
(Please tick  wherever is applicable)

1. Centre: ______________________________

2. Name of the subject: ______________________________________________________

3. Address : _______________________________________________________________

4. Centre: ______________________________

5. Date of Birth: Age (in yrs.) :

6. Code No. (of clinical trial)

7. Group No. First 1 Second 2

CRITERIA OF SELECTION Yes (1) No (2)

1. Age between 25-60 years

2. WHR i.e., Waist Hip Circumference ratio >0.95 in males


and >0.8 in females

3. Presence of obesity, i.e., weight is more than 20 %


excess of the desirable weight (according to annexed
height and body weight table)

Or

Age adjusted BMI above 85th percentile (Indian standard)

CRITERIA FOR EXCLUSION Yes (1) No (2)

4. Age below 25 and above 60 years

5. Endocrine disorders

447
6. Diabetes mellitus

7. Hyper-tension

8. Pregnancy and Lactation

9. Malignancy

10. Athletes or body builders having muscular hypertrophy

11. Cardiac illness

12. Person undergoing treatment for any other serious illness

A patient is eligible for admission to the trial

If Sl.No.1-3 is ‘Yes’ and Sl.No.4-12 are ‘No’

If admitted, Subject’s Serial No. ____________

No. of packets issued: _____________________

Date: ____________ Signature of the Investigator: ________________

448
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM IA – HISTORY

1. Centre: ______________________________

2. Sr. No. of the subject: ____________________________________________________

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Centre: ______________________________

6. Date of Birth: Age (in yrs.) :

7. Code No. (of clinical trial)

8. Group No. First 1 Second 2

9. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

10. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work…………………………….................................

Total income of the family (in Rs.) ...........................................................

11. Total Family members :

12. Income per capita per month (in Rs.) :

449
Chief complaint with duration (if any) in days

Absent (0) Present (1) Duration

13. Polyphagia

14. Polydipsia

15. Excess sweating

16. Excess sleep

17. Body fatigue

18. Loss of libido

19. Palpitation/dyspnoea on exertion

Personal History

20. Diet Veg. 1 Non-veg. 2

21. Sleep Good 1 Disturbed 2 Insomnia 3

22. Emotional stress: No 0 Yes 1

23. Bowel habit: Regular 1 Irregular 2

24. Prakriti: Vataja 1 Pittaja 2 Kaphaja 2

Vata-kaphaja 2 Vatapittaja 2 Pitta-Kaphaja 2

Sannipataja 2

25. Addiction No 0 Yes 1

If yes, Specify__________________________________________

PHYSICAL EXAMINATION

26. Built: Lean 1 Medium 2 Heavy 3

27. Gait Normal 0 Abnormal 1

28. Body weight (Kg.) _________________________

450
29. Body height (in cm.) _________________________

30. Skin fold thickness(Triceps) _________________________

31. Blood pressure (Systolic) _________________________

32. Blood pressure (Diastolic) _________________________

33. Pulse _________________________

34. Respiration _________________________

Absent (0) Present (1)

35. Cyanosis

36. Anaemia

37. Jaundice

38. Lymphadenopathy

SYSTEMIC EXAMINATION Absent (0) Present (1)

39. C.V.S. (with Chest)

If abnormal, specify abnormalities_________________________________

40. C.N.S.

If abnormal, specify abnormalities_________________________________

41. Digestive system

If abnormal, specify abnormalities___________________________________

42. Uro-Genital system

If abnormal, specify abnormalities___________________________________

43. Respiratory System

If abnormal, specify abnormalities___________________________________

451
Samprapti (pathogenesis) of the disease according to Ayurvedic concept

44. Dosa Vata Pitta Kapha

Anubandhya dosha

Anubandh dosha

Avaraka dosha

Ksheen dosha

45. Dushya (Involved): Rasa Rakta Mamsa

Meda Asthi Majja

Shukra Ojas

Srotas Pariksha

46. Medo vaha srotas

Maladhikya (Excess of excreta) 1

Hastapada daha (Burning sensation in the palm and sole) 2

Hastapada suptata (Numbness of the palm and sole) 3

Tandra (Stupor) 4

Dehachikkanta (Greasiness of the skin) 5

Alasya (Lethargy) 6

47. Garbhapata (Abortion) Absent (0) Present (1)

48. Santana vikriti Absent (0) Present (1)


(Congenital deformity in the children)

Date: ____________ Signature of the Investigator: ______________________

452
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC DOUBLE BLIND PRE-CLINICAL TRIAL
OF VYOSHADI GUGGULU IN THE MANAGEMENT OF OBESITY
(MEDOROGA)
CASE REPORT FORM II – CLINICAL AND ANTHROPOMATRIC ASSESSMENT
(0, 1, 3, 6, 9th months)

1. Centre: ______________________________

2. Sr. No. of the subject: ____________________________________________________

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Centre: ______________________________

6. Date of Birth: Age (in yrs.) :

7. Code No. (of clinical trial)

8. Group No. First 1 Second 2

9. Date of Assessment :

Clinical Symptoms Absent (0) Present (1)

10. Polyphagia

11. Polydipsia

12. Excess sweating

13. Excess sleep

14. Body fatigue

15. Loss of libido

16. Palpitation/dyspnoea on exertion

453
Anthropometric assessment

17. Body weight (Kg.) _________________________

18. Skin fold thickness(Triceps) _________________________

19. Status of the patient:

Continuing (1)

Drop out (2) Reason: _____________________________

Died (3) Cause: _______________________________

Date: ______________ Signature of the Investigator: ______________________

454
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC DOUBLE BLIND CLINICAL TRIAL OF VYOSHADI
GUGGULU IN THE MANAGEMENT OF OBESITY (MEDOROGA)
(0, 3rd , 6th AND 9th MONTH)
FORM III – LABORATORY INVESTIGATIONS

1. Centre: ______________________________

2. Sr. No. of the subject: ____________________________________________________

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Centre: ______________________________

6. Date of Birth: Age (in yrs.) :

7. Code No. (of clinical trial)

8. Group No. First 1 Second 2

9. Date of Assessment :

10. Urine Examination

Routine____________ Microscopic___________

11. Stool examination

Routine ____________ Microscopic____________

Ova/Cyst ___________ Occult Blood____________

12. TC (Cells/Cmm.)_____________________

13. DC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) ________

14. Hb (g/dl) _________

15. ESR (1st hour mm) __________

455
16. PCV (%) _______________

17. Blood Sugar – PP (mg./dl) _______________

18. S. Cholesterol (mg./dl) _______________

19. HDL(mg./dl) _______________

20. LDL (mg./dl) _______________

21. S. Triglycerides (mg./dl) _______________

22. B. Urea (mg./dl) _______________

23. S. Creatinine (mg./dl) _______________

24. Uric acid (mg./dl) _______________

25. Total proteins (gm./dl) _______________

26. Albumin (gm./dl) _______________

27. Globulin (gm./dl) _______________

28. A/G Ratio _______________

29. Acid Phosphates (KA units) _______________

30. Alk. Phosphates (KA units) _______________

31. E.C.G: [ 0 Month only]

32. X-ray Chest: [ 0 Month only ] _____________________________________________

33. T3: _________ T4 : __________ TSH: ___________

34. Any other Remarks _____________________________________________

Date: _____________ Signature of the Investigator: ______________________

456
RANDOMISED DOUBLE BLIND CONTROLLED
CLINICAL TRIAL OF AYUSH-DIAB IN CONTROLLING
BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

457
Blank

458
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS

I. BACKGROUND
Diabetes is a metabolic disorder; a comparable condition of Madhumeha specifically an
abnormality in the way of the body utilizes glucose, due to an absolute or relative deficiency of the
hormone insulin or resistance by the body tissues to the action of insulin.
Conventional modern medicine provides a number of drug of choice for controlling the
blood sugar level in the patients of diabetes mellitus type-2. However, with the prolonged
treatment doses of the drugs often needs to be increased to control the blood sugar level and a
time comes when patient has to be switched over to insulin. Such patients become cases of insulin
dependent diabetes mellitus. With a view to help the suffering community there is a need to find a
safer drug, which can be used to control the blood sugar level and such drug can be used safety
for longer periods.Ayurvedic classics provide references on herbal and herbo-mineral preparations
which can be safely used in controlling the blood sugar level in the patients of diabetes mellitus.1
II. OBJECTIVE
To study the effect of Ayurvedic formulation in controlling blood sugar level of the patients
suffering with Type-2 Diabetes mellitus.
III. CENTRE
Identified Centres of CCRAS

References
1. Harrison’s Principle of Internal Medicine 15th Edition Page 2109-2135.
2. The Expert Committee on the Diagnosis and classification of Diabetes Mellitus : Report of the
Expert Committee on Diagnosis Classification of Diabetes Mellitus, Diabetic care 1997;
207:1183-97.
3. Siddharth N Shah, Asshit Shah, API Text Book of Medicine 5th Edition Page-1460.
4. Vaisajya Ratnawali, Saptam Sanskaran 2040 Page 812.

459
IV. SAMPLE SIZE AND METHODS
Sample Size-100
Total Number of group-Two
Total number of patients in each group-50
Level of study-OPD
Treatment:
A. Dietary regimen: Patient will be advised to restrict their dietary schedule and do
light exercises (like brisk walking for two kms. per day, swimming, jogging etc.
during treatment).
B. Trial drug:
1. Ayush-DIAB 500 mg dragees BD with water half hrs before meals (Capsule
Ayush-DIAB contained extracts of Meshashringi (leaves) one part+ Amra Beeja
Majja one part + Karvelaka Beeja one part + Jambu Beeja one part + Silajeeta
one part) for six months.
Diet: - Patients will be advised to take their diet as described in Patient information sheet
and do brisk walking/jogging or light exercise for half hour daily..
2. Standard control: Glimepiride 1mg OD ½ hour before meal.
Duration of the study: Six months (total duration of the study 2 years)
Duration of medication - Six months
Total duration of study – 2 years
V. CRITERIA FOR INCLUSION
1. Age between 30 years to 65 years
2. If yes in any of the three
Blood sugar – Fasting > 126 and =< 200 mg/dl or
PP > 200 mg/dl and <= 350 mg/dl or
Glycated haemoglobin > 7% and <10%
3. Recently diagnosed (< 6 Month) cases of Type-2 Diabetes mellitus not taking any anti
Diabetic drug.

460
VI. CRITERIA FOR EXCLUSION
1. Age below 30 and above 65 years.
If yes in any of the three
Blood sugar – Fasting =< 126 and > than 200 mg/dl or
PP=< 200 mg/dl >350 mg/dl or
Glycated haemoglobin<=7% and =>10%
2. Malignant and accelerated hypertensive
3. CVS disorder (CAD)
4. Pregnant woman and planning to be pregnant within six months
5. Lactating mother
6. Secondary Diabetes mellitus
7. Patient under going regular treatment for Diabetes or any other severe illness
8. CNS disorder e.g. encephalopathy
VII. CRITERIA FOR WITHDRAWAL
The investigator shall withdraw the patients from the study if
1. Fasting blood sugar rises to >200 mg. /dl. Or post prandial blood sugar level increases
to>350 mg./dl and are not controllable within fifteen days.
2. Any serious complication develops which requires urgent treatment with any other drug/
therapy?
The investigator will mention the probable cause of withdrawal and provide possible
medical treatment to manage the illness.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per the
proformae (Forms I & IA). Clinical and physiological assessment will be done before drug
administration and after every two weeks. The laboratory investigations will be recorded before drug
administration, after every two weeks (blood Sugar only) and at the end of treatment (Form-III)
IX. CRITERIA FOR ASSESSMENT
If during treatment or after treatment fasting Blood sugar becomes<126 mg. /dl. and post
prandial Blood sugar< 200mg./dl. and HbA1c < 7% it will be treated as successful outcome of
the treatment.

461
X. STATISTICAL ANALYSIS
Data on Fasting/Post prandial blood sugar and HbA1c will be analyzed using appropriate
statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSES
The progress of the trial will be monitored by CCRAS Hqrs. New Delhi consisting of one
expert each of allopathy and Ayurveda besides one outside expert. Data analysis will be
undertaken at the Monitoring Unit CCRAS Hqrs. New Delhi
XII. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. The investigators and technicians will
be detailed about the clinical trial conduct and laboratory procedures in order to maintain the
uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

462
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS
CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the Investigator: ___________
Name of Investigator: ________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the clinical trial on Randomized Controlled Clinical Trial of Ayush-DIAB Capsules in the
Controlling Blood Sugar Level in Type 2 Diabetes mellitus.

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

463
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLIND CONTROLLED CLINICAL TRIAL OF
AYUSH-DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2
DIABETES MELLITUS
PATIENT INFORMATION SHEET

What is the study about?


Research is going on to find a suitable natural product for the treatment of Type-2
Diabetes mellitus. You are invited to participate in such a study in which you will receive either
Ayurvedic trial drugs or control drug for 24 weeks.
The aim of the present study is to assess the anti-diabetic effect of these drugs in the
management of Type 2 Diabetes mellitus patients.
Total 100 patients from this and other hospitals will be taking part in this study.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately six months to complete. After this
period, you are expected to visit the hospital every fortnight. The interval between the first and
second visit will be around 15 days.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination. ECG, Blood and urine samples will also be taken. This is to make sure that
you are eligible for the study.
One week later, at your second visit, if you are eligible, you would be put on trial treatment
for 24 weeks. You may receive either trial drug or control drug for 24 weeks. You should follow
life style modifications (Diets Advice, Exercise) as given along with information Sheet.
From the first visit onwards, you will be required to fast overnight before attending each
visit. Blood and urine samples will be taken at every visit. At each visit, you will be supplied with
sufficient quantity of drug to last until your next visit.
What happens at the end of the study?
The trial treatment will be stopped at the end of 24 weeks. You will be put back on an
appropriate treatment available in the market.

464
Are there any risks?
Both trial and control drugs may cause hypoglycemia (very low blood sugar) in some
cases. The symptoms of hypoglycemia are sweating, drowsiness, nausea, confusion and in-
coordination. In case of such symptoms, you should immediately take sugar, glucose/biscuits and
milk/fresh lime juice/orange juice with sugar and report to the doctor.
What are the alternatives?
Your doctor will be pleased to explain to you the available alternative treatment to control
your blood sugar?
When you leave can the study?
Your participation in the study is entirely voluntary. You can choose to leave the study at
any time. Your decision to leave the study will not affect your medical care or relationship with
your doctor.
Your doctor may decided that you should not continue in the study if, a) your blood sugar
becomes very high or very low, b) you start on insulin or other medication that affect blood sugar,
c) you take part in any other trial.
What is the cost of the study?
All medication and tests to be done during the study will be free of charge.
If you do not want to participate, you are free to do so. It will not affect your medical
care or relationship with your doctor in any way.
What happens now if you decided to take part?
You will asked to sign a consent form saying that you have been given information about
the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
DIET REGIMEN:
To take 25 cal/kg per day (Moderate work)
Protein 0.8 gm/kg per day
Total Fat < 30% of calories (Saturated fat < 10% polyunsaturated fat < 10% of calories)
Cholesterol < 300 mg per day
Dietary fibre 50 gm per day (atleast)
Common salt < 5 gm. per day

465
Saturated fat & cholesterol are found in e.g. Ghee, Vanaspati, Dalda, Palm, Coconut oil.
These contain highly saturated fat. Patient should be advised to take less saturated fat and
cholesterol.
Poly unsaturated fat take Sun flower oil, Soyabene oil, Olive oil which contained
unsaturated fat should be taken 3 small tea spoonful / day.
Milk : Three cup daily double tone
Whole Cereal: 90 gm daily. [old samarice, kodo, java, wheat with husk]
Vegetable : 250 gm daily [padwal, karaila, methi, pumpkin, brinjal, beans]
Dal : 400 ml. daily [Moong, Masoor, Kulthi, Arhar, Garam]
Fruits : 200 gm. Daily [Apple,Guava & Pappaya]
Spices : [Ginger,coriander,cardamom]
DO’NT
To avoid smoking.
To avoid Fasting.
To avoid sweets, honey, sugar, jaggery, cold drinks, fruit juice, avoids fruits e.g. Mango,
Sharifa, Grapes, Chiku, Banana, Khajur, potato,turnip & beetroot

To be translated into regional language.

466
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM I - SCREENING

1. Centre: ______________________________

2. Name of the subject: ______________________________________________________

3. Sr. No. of the Subject : ____________________________________________________

4. Address : _______________________________________________________________

5. Date of Birth: Age (in yrs.) :

6. Code No. (of clinical trial)

7. Gender Male 1 Female 2

CRITERIA OF INCLUSION Yes (1) No (2)

1. Age between 30 years to 65 years

2. If yes in any of the three

Blood sugar – Fasting > 26 and =< 200 mg/dl or

PP > 200 mg/dl and<= 350 mg/dl or

Glycated haemoglobin>7% and <10%

3. Recently diagnosed (< 6 Months)

Cases of Type-2 Diabetes mellitus

Not taking any hypoglycemic drug or insulin.

CRITERIA FOR EXCLUSION Yes (1) No (0))

4. Age below 30 and above 65 years.

467
5. If yes in any of the three

Blood sugar – Fasting =< 126 and > than 200 or

PP=< 200 mg/dl >350 mg/dl or

Glycated haemoglobin<=7% and =>10%

6. Malignant and accelerated hypertensive

7. CVS disorder (CAD)

8. Pregnant woman or the women planning to be pregnant


in next six months

9. Lactating mothers

10. Secondary Diabetes mellitus

11. Patient under going regular treatment for Diabetes or


for any other severe illness

12. CNS disorder e.g. encephalopathy

A patient is eligible for admission

If ‘Yes’ to S.No.1 – 3 & ‘No’ to 4 – 12

If admitted:

Sl. No. of the subject ____________

No. of packets issued____________

Date:____________ Signature of the Investigator _____________

468
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM II – HISTORY

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ____________________________________________________

4. Name of the subject: ______________________________________________________

5. Address : _______________________________________________________________

6. Gender Male 1 Female 2

7. Date of Birth: Age (in yrs.) :

8. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

9. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work…………………………….................................

10. Total Family members :

11. Income per capita per month (in Rs.) :

12. Religion : Hindu 1 Muslim 2 Sikh 3

Christian 4 Parsi 5

469
Chief complaint with duration (if any) in days

Absent (0) Present (1) Duration

13. Polyuria (Excessive Urine)

14. Polyphagia (Excessive Hunger)

15. Polydipsia (Excessive Thirst)

16. Exhaustion/Tiredness

17. Loss of body weight

18. Body ache

19. Giddiness

20. Polyneuritis(Numbness / Tingling)

21. Visual disturbance

22. Others

If Yes specify: _____________________________________

Personal History

23. Diet Veg. 1 Non-veg. 2 Lecto-veg 3

24. Presence of anxiety No 0 Yes 1

25. Constipation No 0 Yes 1

Addiction

26. Smoking No 0 Yes 1

If yes specify: (a) Quantity [packs]: ________________

(b) Total Duration in year’s ________________

27. Tobacco No 0 Yes 1

If yes specify: (a) Quantity: ________________

(b) Total Duration in years ________________

470
28. Alcohol No 0 Yes 1

If yes specify: (a) Quantity (in ml/day): ________________

(b) Total Duration in years ________________

29. Any other(specify) _____________________

30. Prakriti: Vata 1 Pitta 2 Kapha 3

Vata-kaphaj 4 Vata-pittaja 5 Pitta-Kaphaja 6

Sannipataj 7

Physical Examination

31. Height (cm) ____________

32. Weight (kg) ____________

33. Pulse (per min) ____________

34. Blood Pressure (in sitting position)

Systolic_________________(mm Hg)

Diastolic ________________(mm Hg)

35. Body temperature (o F) _____________

36. Respiration rate (per min) _____________

37. Signs of dehydration and oedema, if any____________________

SYSTEMIC EXAMINATION Absent (0) Present (1)

38. CVS

If abnormal, details _______________________________________________________

39. CNS

If abnormal, details _______________________________________________________

471
40. Digestive system

If abnormal, details _______________________________________________________

41. Uro-Genital system

If abnormal, details _______________________________________________________

42. Respiratory system

If abnormal, details _______________________________________________________

Date: ____________________ Signature of Investigator ___________________

472
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM III - CLINICAL & PHYSIOLOGICAL ASSESSMENT
[Before Treatment & Fortnightly During Treatment]

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the subject: ____________________________________________________

4. Name of the subject: ______________________________________________________

5. Address : _______________________________________________________________

6. Gender Male 1 Female 2

7. Date of Birth: Age (in yrs.) :

8. Date of Assessment :

Chief complaint with duration (if any) in days

Absent (0) Present (1) Duration


(in days)

9. Polyuria (Excessive Urine)

10. Polyphagia (Excessive Hunger)

11. Polydipsia (Excessive Thirst)

12. Exhaustion/Tiredness

13. Bodyache

14. Giddiness

15. Polyneuritis (Numbness / Tingling)

473
16. Visual disturbance

17. Others

If Yes, specify: ___________________________________________________________

Physiological Assessment

18. Weight (in Kgs.) ______________

19. Blood Pressure (in sitting position)

Systolic_________________ (mm Hg)

Diastolic ________________ (mm Hg)

Date: ______________ Signature of Investigator: _________________________

474
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
RANDOMISED DOUBLE BLINDCONTROLLED CLINICAL TRIAL OF AYUSH-
DIAB IN CONTROLLING BLOOD SUGAR LEVEL IN Type 2 DIABETES
MELLITUS
CASE REPORT FORM IV- LABORATORY INVESTIGATION

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the subject: _____________________________________________________

4. Name of the subject: _______________________________________________________

5. Address : _______________________________________________________________

6. Gender Male 1 Female 2

7. Date of Birth: Age (in yrs.) :

8. Date of Assessment :

Urine Examination

Routine

9. Sugar ____________

10. Albumin ____________

11. Deposits ____________

Microscopic

12. Pus cell ____________(hpf)

13. RBC ____________(hpf)

14. Cast ____________(hpf)

Stool examination

15. Routine ____________

475
Microscopic

16. Ova ____________

17. Cyst ____________

18. Occult Blood__________

Blood

19. TC (Cells/Cmm.): ____________

20. DC: P(%)_____ L(%)_____ E(%)_____ M(%)_____ B(%)_____

21. Hb (g/dl) ____________

22. (1st hour.) ____________

23. Blood Sugar- Fasting/PP (mg./dl)____________/____________

24. Glycosylated) HbA1c (to be done before treatment


after three months and end of treatment)

25. Blood Urea (mg. /dl) ____________

26. S.Creatinine (mg./dl) ____________

27. Uric acid (mg./dl) ____________

LIPID PROFILE

28. Serum total Cholesterol (mg./dl) ____________

29. S. Triglycerides (mg./dl) ____________

30. HDL (mg./dl) ____________

31. LDL (mg./dl) ____________

32. VLDL (mg/dl) ____________

LIVER FUNCTION TEST

Serum Bilirubin

33. Total (mg/dl) ____________

476
34. Direct (mg/dl) ____________

35. SGOT (IU/L) ____________

36. SGPT (IU/L) ____________

37. Alk.Phosphatase (KA units) ____________

38. Total proteins (gm./dl) ____________

39. Albumin (gm./dl) ____________

40. Globulin (gm./dl) ____________

41. A/G Ratio ____________

Serum Electrolytes

42. Sodium(mEq/L) ____________

43. Potasium(mEq/L) ____________

Sl.No.9 – 43 will be done before and after treatment except Sl.No. 23 (Blood Sugar) which
will be done before treatment and fortnightly during treatment period. HbA1c will be repeated
after three months also.

Date: ______________ Signature of Investigator__________________________

477
Blank

478
EYE DISORDERS

SECTION - VII
Blank

480
CLINICAL EVALUATION OF AYUSH-CT DROPS AND
AYUSH-CT CAPSULE IN IMPROVING THE QUALITY
OF VISION AND PREVENTION OF PROGRESS IN
SENILE IMMATURE CATARACT (LINGANASA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

481
Blank

482
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)

I. BACKGROUND
Senile cataract (Linganasa1) is a disease of common occurrence in all geographical areas
and in all races. The incidence, however, is distinctly more in tropical countries. The two factors
peculiar to tropical circumstances and responsible for this high incidence are higher concentration
of actinic rays in tropical sunlight, and the nutritional deficiency factors so significant in these areas.
It can be generally stated that in developing tropical countries, the age of 50 years and above is
considered a cataractogenous age and the degree of incidence increases as the age advances. It
is safe to assume that 60% people develop cataract by the age of 60 years. 70% by the age of
70 years, 80% by 80 years and 90% by 90 years of age. It was estimated that 55% of total or
partial blindness was due to cataract in some stage of its formation. Of these, the incidence in
rural areas was 70% and in Urban areas 30%. Similarly, the incidence in males was 64.4% as
compared to 35.6% in females. It is rare in persons under 50 and these disturbances occur in (a)
impaired semi permeability of the capsule, (b) increased insoluble proteins, and (c) less effective
auto-oxidative system.
The current lines of management include various surgical methods. There is no definite
medical treatment for this condition in the patients where surgical treatment is not suitable (like
uncontrolled diabetes, cardiac disorders and so on.) Ayurvedic literatures have recorded many
single drugs and compound formulations for the treatment of Linganasa/Timira. (Cataract) .Drugs
like Punarnava, Amalaki, Palasha etc. possess various pharmacological actions like Chakshushaya
(Improves visual acuity), Timira hara (Effective managing various disorders of vision) besides its
Rasayana action that prevents free radical damage i.e. anti-oxidant effect1.

II. OBJECTIVE
To evaluate the therapeutic efficacy of Ayush-CT Drops and Ayush-CT Capsule In
improving the quality of vision and Prevention of progress in senile immature cataract

References
1. Ambika Dutta Sashtri (1989) Susruta Samhita (text with Hindi commentary) Uttara Sthana, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi

483
III. CENTRE
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample size : 50 cases
Trial Drug /Dosage /Duration
1. Ayush-CT Drops {Distillate (Ark) of equal parts of Punarnava and
Palashamoola} two drops three times a day and Ayush-CT Capsule (Extract of
equal parts of Punarnava and Amalaki) 500mg. two capsules BD for 4months
2. Placebo- Distilled water two drops three times a day and glucose capsules 500mg.
two capsules BD for 4 months
Design of the study : Double blind Randomized controlled trial
Duration : Four months drug therapy with a follow up for two months
without drug.
Period of Study : Six months (Four months drug therapy and two months
follow-up) for each case. Total duration will be two years
to complete the trial.
Follow – Up : One follow-up will be carried out after two months of the
completion of treatment.
V. CRITERIA FOR INCLUSION
1. Age above 50 years and up to to 80 years
2. Both the sex
3. Immature cataract (confirmed by ophthalmoscopy, retinoscopy/iris shadow presence)
With any one or both of the symptoms
• Disturbance in vision (diplopia,polyopia,holes etc)
• Diminished visual acuity
VI. CRITERIA FOR EXCLUSION
1. Age below 50and above80 years
2. Mature cataract
3. Sluggish pupil reaction

484
4. Hypertension
5. Diabetes mellitus
6. Glaucoma
7. Any other illness causing notable visual morbidity
8. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & IA). Clinical assessment will be done during treatment (Form II). The
laboratory investigations will be carried out before and after the treatment.
IX. STATISTICAL ANALYSIS
Data on disturbance in vision and diminished visual acuity will be analyzed using
appropriate statistical methods.
Improvement in visual acuity (Using near vision and distance vision chart-Snellen’s test
type) and disappearance of symptoms of disturbances in vision (Clinical assessment) will be
considered as significant, besides status of cataract examined through ophthalmoscopy, retinoscopy
and Iris shadow tests.
X. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
XI. ETHICAL REVIEW
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as

485
every 20 participants entered the study and administered the trial drugs. The research team
will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.……. /- per visit will be paid to subjects
selected.
XIII. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XIV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

486
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the trial on “Clinical Evaluation Of Ayush-CT Drops And Ayush-CT Capsule In improving the
quality of vision and Prevention Of Progress in senile immature cataract”

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

487
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
PATIENT INFORMATION SHEET

What is the study about?


Senile cataract (Linganasa) is a disease of common occurrence in all geographical areas
and in all races. The incidence, however, is distinctly more in tropical countries. The two factors
peculiar to tropical circumstances and responsible for this high incidence are higher concentration
of actinic rays in tropical sunlight, and the nutritional deficiency factors so significant in these areas.
It can be generally stated that in developing tropical countries, the age of 50 years and above is
considered a cataractogenous age and the degree of incidence increases as the age advances. It
is safe to assume that 60% people develop cataract by the age of 60 years. 70% by the age of
70 years, 80% by 80 years and 90% by 90 years of age.
The current lines of management include various surgical methods. There is no definite
medical treatment for this condition in the patients where surgical treatment is not suitable like
uncontrolled diabetes, cardiac disorders and so on. Ayurvedic literatures have recorded many
single drugs and compound formulations for the treatment of Linganasa/Timira. Drugs like
Punarnava, Amalaki, Palasha etc. possess various pharmacological actions like Chakshushaya
(Improves visual acuity), Timira hara (Effective in managing various disorders of vision) besides its
Rasayana effects that prevents free radical damage i.e. anti-oxidant effect.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately six months to complete ( four months
for treatment and another two months for follow-up study). During this period, you are expected
to visit the hospital six times, once in a month during drug treatment and once at the end of 6th
month during the follow up.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, Blood and urine samples will also be taken. This is to make sure that you
are eligible for the study.
If you are found eligible, you would be put on trial treatment OR placebo therapy
for four months. Daily dose of oral treatment consist of two 500-mg. capsules twice a day
along with eye drops two drops three times a day for four months

488
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be informed to the
Principle Investigator.

To be translated into regional language.

489
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Sr. No. of the Subject : ____________________________________________________

5. Address : _______________________________________________________________

6. Date of Birth: Age (in yrs.) :

CRITERIA FOR EXCLUSION Yes (1) No (2)

1. Age above 50 years up to to 80 years

2. Both the sex

3. Immature cataract (confirmed by ophthalmoscopy,


retinoscopy/iris shadow presence) With any one or
both of the symptoms

4. Disturbance in vision (diplopia,polyopia, holes etc/


Diminished visual acuity)

CRITERIA FOR EXCLUSION Yes (1) No (2)

5. Age below 50and above 80 years

6. Mature cataract.

7. Sluggish pupil reaction

490
8. Diabetes mellitus

9. Glaucoma

10. Hypertension

11. Person undergoing treatment for

12. Any other serious illness

If yes, specify: __________________________________________________

13. Any other illness causing notable visual morbidity

If yes, specify: __________________________________________________

A patient is eligible for admission to the trail

If ‘YES’ to 1 – 4 and ‘NO’ to 5 – 13

If admitted, subject serial No: _________

No. of packets issued: _______________

Date: ____________ Signature of Investigator: _________________________

491
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM II- HISTORY
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male 1 Female 2

6. Date of Birth: Age (in yrs.) :

7. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

8. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work…………………………….................................

9. Income per capita per month (in Rs.) :

Chief complaint with duration (in month) Yes (1) No (2)

10. Disturbance in vision

If Yes, duration in months _________________

492
11. Diplopia

If yes, duration in months __________________

12. Polyopia

If yes, duration in months _________________

13. Holes

If yes, duration in months _________________

14. Any other visual disturbances

If yes, (specify): __________________

Duration in months: _______________

15. Diminished visual acuity

If yes, details* &duration in months _________________

Visual acuity (Snellen’s test type)

Distant vision:

16. Right Eye: ___________

17. Left Eye: ___________

18. Both Eyes: ___________

Near vision:

19. Right Eye ___________

20. Left Eye ___________

21. Both Eyes ___________

22. History of cataract in family Yes (1) No (0)

If Yes, relation with patient _________________

493
23. Prakriti Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6

Sannipataja 7

EXAMINATION OF THE EYE

24. General examination Normal 1 Abnormal 2

If abnormal, specify abnormalities ____________________________________

Lens (Medoashrita patala)(ophthalmoscopy)

25. Colour: Gray Brown Transparent

26. Opacity: Central Peripheral Total

27. Position Normal 1 Displaced 2

28. Iris shadow Present 1 Absent 2

Vitreous Present (1) Absent (2)

29. Degenerative changes

30. Opacity

Pupil (Dristi mandal) Normal (1) Abnormal (2)

31. Size

Reaction Present (1) Absent (2)

32. Direct

33. Consensual

34. Retina (Asthiashrita patala)

If abnormal, specify ___________

Visual acuity (Snellen’s test type)

Distant vision:

494
35. Right Eye ___________

36. Left Eye ___________

37. Both Eyes___________

Near vision:

38. Right Eye ___________

39. Left Eye ___________

40. Both Eyes___________

Glasses (Correction)

Right Eye Left Eye


Vision Sph Cyl Axis Vision Sph Cyl Axis Vision
41. NV
42. DV

Tonometry (Schitoz’s)

Intraocular pressure*

43. RE ________ mm/Hg

44. LE ________ mmHg

* 6-21 Normal

Date: ____________ Signature of Investigator: _________________________

495
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0, end of 1st, 2nd, 3rd, 4th, 5th & 6th month)
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

Present (1) Absent (0)

7. Disturbance in vision

8. Diplopia

9. Polyopia

10. Holes

11. Any other visual disturbances (specify)

If Present, Specify___________________________

Visual acuity (Snellen’s test type)

Distant vision:

12. Right Eye ___________

13. Left Eye ___________

496
14. Both Eyes ___________

Near vision:

15. Right Eye ___________

16. Left Eye ___________

17. Both Eyes ___________

18. Adverse reaction: Yes (0) No (1)

If yes, details: _______________________

19. Status of the patient:

Continuing (1)

Drop out (2) Reason:_____________________________

Date: ______________ Signature of Investigator: ___________________

497
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH-CT DROPS AND AYUSH-CT CAPSULE
IN IMPROVING THE QUALITY OF VISION AND PREVENTION OF
PROGRESS IN SENILE IMMATURE CATARACT (LINGANASA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
PHYSIOLOGICAL PARAMETERS
(Before the treatment)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment :

8. Urine Sugar _____________________________________________________________

9. Blood Sugar - PP (mg./dl)

Date : __________________ Signature if Investigator : ___________________

498
CLINICAL EVALUATION OF THE EFFECT OF
TARPANA AYUSH-DE EYE DROPS, AYUSH-DE
CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA/PARISHUSKHA
NETRA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

499
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500
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)

I. BACKGROUND
In certain conditions, there is insufficiency of lubrication of eye and the conjunctiva
becomes dry. Deficiency in any components of tear film, results in dryness of the eye, due to the
appearance of dry spots on the corneal and conjunctival epithelium. Sushruta considered
shushkakshipaka as an individual disease and classified under sarvagata netra rogas. Even though
there is no separate entity such as Parishushka netra in classics, authors of different texts
mentioned the above condition while describing the therapeutic procedure adapted for the
management of eye disease. Conditions like Ativishushka netra, Ashrusrava rahita netra,
Asnigdha netra are mentioned in Nibandha samgraha (one of the commentaries on Sushruta
Samhita.)
There are many conditions which cause dryness of the eyes. Hypofunction of lacrimal
glands (eg. sjogren’s syndrome, sarcoidosis, lymphoma, leukemia amyloidosis.), mucin deficiency
(e.g. vitamin A deficiency), conjunctival scarring, (e.g. trachoma, Stevans Johnson syndrome,
pemphigold, chemical burns, chronic bacterial or viral conjunctivitis, irradiation and miscellaneous
causes such as mumps, deficient blinking etc.).
(Kapha is responsible for sanigdhatwa (oiliness) sthiratwa (structrual and functional integrity
of body systems) by means of its qualities like gurutwa and shitatwa.) Tarpaka kapha, one of the
five varieties of Kapha, situated in siras is responsible for the integrity of sense organs
(akshitarpana). According to Dalhana, the term aksha refers to sense organs like netra. Collective
function tear film components can be correlated with the function of the tarpakakapha.
Clinical studies conducted with topical and internal use of Ghrita prepared with the Haridra
and Daruharidra has shown significant improvement in subjective parameters like Dryness,
Redness, Photophobia etc. Pharmacological actions such as chaksushya (conducive to vision),
netrya (conducive to eye), netra ruja hara (analgesic ophthalmic action) are attributed to haridra,
daruharidra and ghrita from which the formulation under taken for the study was prepared. The
response obtained after the clinical study could be well understood with the above
pharmacological actions ascribed to various ingredients 1&2

References
1. Dry Eye Syndrome and its management – A clinical study, JRAS, Vol.XXII, No.1-2, (2001)
pp.17-24.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi.
3. Sushruta Uttarasthana Chapter 9/18-22

501
II. OBJECTIVE
To evaluate the effect of Ayush-DE drops and Akshi tarpana in dry eye syndrome
(shushkakshipaka / parishuskha netra)
III. CENTRE
CCRAS identified Centres
IV. SAMPLE SIZE AND METHODS
No. of groups : Four groups
No of patients in each group : 25
Type of Study : Open
Level of Study : OPD/IPD
Period of Study : 4 months (3 months treatment and one
month follow up Study with Distilled
Water)
Treatment:
Group-I
1. Akshi Tarpana with Ayush-DE Ghrita {prepared with equal parts of Yashtimadhu
(Glycerrhiza glabra)} for five days.
2. Installation of Ayush-DE drops {Yashtimadhu (Glycirrhiza glabra)} three drops
three times a day for three months.
Group-II
Installation of Ayush-DE drops {prepared with Yashtimadhu (Glycirrhiza glabra)} three
drops three times a day for three months.
Group-III
Artificial tears for three months (conventional)
Group IV
Autoserum (optional)
Procedure of tarpana
Local application of tila taila around the eye orbit followed by mild sudation will be given
as purvakarma. Concentric boundary should be made around each orbit with paste of masha
choorna (Powder of Phaseolus mungo). 20 ml of lukewarm medicated ghee should be filled and
allowed to retain in the boundary for twenty minutes. After the prescribed period, ghrita will be
removed with cotton pads followed by removal of the boundary.

502
V. CRITERIA FOR INCLUSION
1. Dryness of the Eye with or without
a) Sandy and scratchy feeling
b) Pain / pricking sensation
c) Photophobia
d) Mild reddness/ Mild blepharitis
e) Less flow of tears even when exposed to irritant odour and fumes
f) Foreign body sensation
g) Mild reddness
2. Age between 20-40 years
3. Tear film break-up time less than 10 seconds
4. Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on
the cornea.
5. Schimers tests positive < 10 mm (exact measurement)
6. Chronicity upto six months.
VI. CRITERIA FOR EXCLUSION
1. Age below 20 years above 40 years
2. Chronicity above 6 months.
3. Corneal ulcer
4. Degenerative condition of conjunctiva
5. Extra ocular and intra ocular infections
6. Contact Lens users
7. Systemic disease causing Dry Eye Syndrome (Physicians remarks)
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravate, which requires urgent treatment, such subjects may be withdrawn from the trial and
managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history including any associated diseases and physical examination of the
patients will be recorded as per the Proforma (Forms I & II). Clinical assessment will be done

503
before drug administration on every 15th day during the treatment and at the end of 3rd month
during follow up (Form III). Required laboratory investigations will be carried out to exclude
cases as specified in the criteria for exclusion. (Form-IV)
IX. CRITERIA FOR ASSESSMENT
Relief in subjective parameters viz. dryness, pain, redness, foreign body sensation and
improvement in tear film breakup time, Schimers tests will be considered as significant response.
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through e-
mail.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by CCRAS HQrs. New Delhi. Data analysis
will be undertaken at the Monitoring Unit CCRAS HQrs. New Delhi
XII. ETHICAL REVIEW
Each Institutional Ethical Committee (IEC) of participating centre’s should give
clearance certificate before the project is initiated. Patient’s information sheet and
informed consent form should be submitted alongwith project proposal for approval by
IEC. Both should be maintained in duplicate with one copy given to the patient at the
time of entry to the trial.
XIII. TRAVELLING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs.------/ per visit i.e., on the 1st day of recruitment after
screening, 15th, 30th, 45th, 60th day & end of 3rd month (6 times)
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

504
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical evaluation of the effect of tarpana and eye drops in the management of dry eye
syndrome (shushkakshipaka / parishushka netra)”

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

505
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
PATIENT INFORMATION SHEET

What is the study about?


In certain conditions, there is insufficiency of lubrication of eye and the conjunctiva
becomes dry. Deficiency in any components of tear film, results in dryness of the eye, due to the
appearance of dry spots on the corneal and conjunctival epithelium. Sushruta considered
shushkakshipaka as an individual disease and classified under sarvagata netra rogas. Some clinical
studies on this condition revealed promising results in managing this condition. The present study
aims at evaluating effect of topical and internal medication in the management of dry eye syndrome.
Approximately 50 patients will be included in the trial.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately4months to complete (3 months of
medication and thereafter 1 month follow up). During this period, you are expected to visit the
hospital initially for five days for Tarpana. During the trial you are expected to visit 8 times, at an
interval of every 15 days in first 3 months and at the end of 4th month.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination; required objective tests will also be done.
If you are found eligible, you would be put on trial treatment for 30 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be inforrmed to
the Principle Investigator.

To be translated into regional language.

506
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS IN THE MANAGEMENT OF DRY EYE SYNDROME
(SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM – 1 SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Subject Name : ......................................................... Age ................ Sex .........................

2. Centre : ...................................

3. Code No. (of clinical trial) :

4. Patient No.

5. Group No. First 1 Second 2

Third 3 Fourth 4

CRITERIA FOR SELECTION Yes No

1. Dryness of the Eye with or without

2. Sandy and scratchy feeling

3. Pain / pricking sensation

4. Photophobia

5. Mild redness/ Mild blepharitis

6. Less flow of tears even when exposed


to irritant odor and fumes

7. Foreign body sensation

8. Mild redness

9. Age between 20-40 years

507
10. Tear film break-up time

11. Rose Bengal staining showing devitalized


epithelium of conjunctiva and mucus plaques
on the cornea. (Value)

12. Schimers tests positive (Value)

13. Chronicity upto 6 months

EXCLUSION CRITERIA Yes No

14. Age below 20 years above 40 years

15. Chronicity above 2 years

16. Corneal ulcer

17. Vitamin-A deficiency

18. Degenerative condition of conjunctiva

19. Extra ocular and intra ocular infections

A patient is eligible for admission to the trail

If Sl. No. 1-13 is ‘Yes’ and Sl. No. 14-19 are ‘No’

Date ______________ Signature of Investigator____________________

508
COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM -II HISTORY
(Enter a  in the appropriate box)

1. Subject Name : ......................................................... Age ................ Sex .........................

2. Address : ..............................................................................................................................

3. Date of Asmission : ................................................ Date of Discharge ...............................

4. Centre : ...................................

5. Code No. (of clinical trial) :

6. Patient No.

7. Group No. First 1 Second 2

Third 3 Fourth 4

8. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

8. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

1. Environment : __________________

2. Income 10, 000 & >

10, 000 & <

509
Chief complaint with duration (in month)

Present (1) Absent (2) Duration

9. Dryness of the eye

10. Sandy and scratchy feeling

11. Pain / pricking sensation

12. Photophobia

13. Mild redness/ Mild blepharitis

14. Less flow of tears even when exposed


to irritant odour and fumes

15. Foreign body sensation

16. Mild redness

17. Others specify: ......................................................................................................................

HISTORY OF PRESENT ILLNESS

18. Onset of disease Acute 1 Insidious 2

19. Duration of disease (in months):

PERSONAL HISTORY

20. Diet Veg 1 Non-veg 2 Lacto-ova veg 3

21. Sharirik Prakriti (please see separate attached sheet)

Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6

Sannipataja 7

PHYSICAL EXAMINATION: Normal Abnormal

If abnormal, specify abnormalities ____________________________________________

510
SYSTEMIC EXAMINATION:

Normal Abnormal

If abnormal, specify abnormalities ____________________________________________

EXAMINATION OF THE EYE

Vision examination

Normal Abnormal

If abnormal, specify_______________________________________________________

Movement

Normal Abnormal

If abnormal, specify_______________________________________________________

Lacrimal System Normal Abnormal

(ashruyantra)

If ‘abnormal’ specify, ______________________________________________________

Conjunctiva (bulbar)

Congestion (GRADE 0-5) _________________________________

Oedema (GRADE 0-5) _________________________________

Haemorrhage (GRADE 0-5) _________________________________

Redness (GRADE 0-5) _________________________________

Nodule (GRADE 0-5) _________________________________

Conjunctiva (tarsal)

Tarsal scarring (GRADE 0-5) _________________________________

Fllicles (GRADE 0-5) _________________________________

Others (GRADE 0-5) _________________________________

511
Sclera (Sukla mandala)

Change in colour (GRADE 0-5) _________________________________

Pigmentation (GRADE 0-5) _________________________________

Nodule (GRADE 0-5) _________________________________

Congestion (GRADE 0-5) _________________________________

Cornea (Krishna mandala)

Lusture Normal Lustureless

Vascularisation Sensation 1 Present Absent 2

Reduced 3

Epithelial status Tearfilm meniscus Defect / erosion / desquamated

Tear film break-up test _________________________________

Rose Bengal staining _________________________________

Shchimer tests _________________________________

Date: ______________ Signature of Investigator ___________________

512
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM III - CLINICAL ASSESSMENT
(0 day, 15th, 30th, 45th, 60th, days & end of 3rd month)
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Dryness of the eye (GRADE 0-5) _______________________

8. Sandy and scratchy feeling(GRADE 0-5) _______________________

9. Pain / pricking sensation (GRADE 0-5) _______________________

10. Photophobia (GRADE 0-5) _______________________

11. Redness/ Mild blepharitis (GRADE 0-5) _______________________

12. Less flow of tears even when exposed to _______________________


irritant odors and fumes (GRADE 0-5).

13. Foreign body sensation (GRADE 0-5) _______________________

14. Redness (GRADE 0-5) _______________________

15. Others (specify) Present 1 Absent 2

513
Clinical Tests

15. Tear film break-up test: ______________________________

16. Rose Bengal staining: ______________________________

17. Shchimer tests: ______________________________

18. Status of the patient: Continuing 1 Drop out 2

Reason: ____________________________________________

Date: ______________ Signature of Investigator ___________________

514
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSHKA NETRA)
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS AND
PHYSIOLOGICAL PARAMETERS
(Sl.No.5 to 17will be done at 0 & 15th day and 18-20 at the end of 1st, 2nd month,
3rd and 4d month)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment :

8. TLC (Cells/Cmm.): ___________________

9. DLC: P (%) _______ L (%) _______ E (%) _______ M (%) _______ B (%) _______

9. Hb (g/dl): ___________________

10. Platelet: ___________________

11. ESR (1st hour.) (mm): ___________________

12. Blood Sugar Fasting & PP (mg./dl): ___________________

13. B. Urea (mg./dl): ___________________

14. S. Creatinine (mg./dl): ___________________

15. Liver function tests (SGOT/SGPT): ___________________

16. Lipid profile: ___________________

Date: ______________ Signature of Investigator ___________________

515
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516
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS
IN SIMPLE ALLERGIC CONJUNCTIVITIS
(KAPHAJA ABHISHYANDA)

Drug : Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

517
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518
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN SIMPLE
ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)

I. BACKGROUND
Allergic conjunctivitis1 is commonly occurring ocular problem in day-to-day ophthalmic
practice. Apart from phlyctenular conjunctivitis as a manifestation of endogenous allergy and spring
catarrh an exogenous allergy, the conjunctiva may react to many other sensitizing factors viz.
external, physical or chemical. Allergy as a cause of conjuctival congestion has however been
exaggerated. (Anything which does not fall into the description of a specific condition and any
condition show aetiology is undermined is often attributed to allergy.) This evasive diagnosis is
further supported by the favorable response of the conjuctival congestion to steroids (Dhanda et
al. 996).
Current line of management advocates the use of topical steroids/ decongestant drops/
Mast Cell Stabilizers along with anti-histamine agents, is found unsatisfactory and temporary,
should be repeated only during exacerbations, besides their adverse effects (Anonymous, 1996).
At this juncture it becomes essential to explore safe effective drug which could effectively tackle
such conditions. Ayurvedic literatures have recorded more than 60 plant drugs useful in the
treatment of various eye disorders. Daruharidra (Berberis aristata DC.), one of such agents has
potent anti-inflammatory and anti-allergic action.
[Netrarujahara (Analgesic ophthalmic action), Netrakanduhara (anti-allergic action),
Kaphajabhisyandahara (Effective in allergic ocular conditions) (SrikanthN.2000).] Berberine, an
alkaloid isolated from B. aristata and its salt berberine hydrochloride produced depressant effect
on histamine, 5-HT and Bradykinin. It exhibited anti-inflammatory property on acute, sub-acute
and chronic models of inflammation. Clinical application of berberine in chronic trachoma patients
by intraconjuctival injection proved highly effective. The effect confirmed by scientific studies, that
revealed “Berberine may prove practical remedy for large scale use in trachoma patients. Berberine
in a dose of 0.5 mg per egg protected 50-75% chick embryos from the lethal effect of the
trachoma organisms inoculated into the yolk sac”. The results supported the ancient Ayurvedic
claims on the use of the plant B. aristata in eye diseases and clinical report on the efficiency of
berberine in trachoma. (Bhatnar1970, Halder 1970,Imaz 1977, Verma. RL.1993, Anonymous

References
1. Ambika Dutta Sashtri (1989) Sushruta samhita (text with Hindi commentary) Uttara Sthana, VIIth
Edition Chaukhamba Sanskrit Series Office, Varanasi.
2. Actions & uses of indigenous ophthalmic drugs, Chaukhamba Sanskrit Pratisthan, New Delhi

519
1996) it may be concluded that the decoction of the Daruharidra may be successfully employed
in the management of acute and chronic conjunctivitis of varied aetiology.
A clinical study of 52 cases of Allergic conjunctivitis was conducted to evaluate the effect
of a potent Anti- inflammatory, and Anti- Allergic Indigenous Ophthalmic Drug -Daruharidra
(Berberis aristata DC.). Topical administration (Aschyotana) with decoction of root bark of
Daruharidra (Berberis aristata DC.) was scheduled for 5 days and Aschyotana procedure was
repeated for the same period at an interval of 7days.Follow up observation was done for one
month. This study reveled that the scheduled therapy is highly valuable in the management of
allergic conjunctivitis of varied aetiology. The response obtained may be explained with the anti-
allergic, anti-inflammatory, antibacterial, properties attributed to the drug (Bhatnar1970, Halder
1970, Imaz 1977, Sabir 1976, Verma. RL. 1993, Anonymous 1996) besides its Netrarujahara
(Analgesic Ophthalmic action), Kaphajabhisyandahara (effective in allergic ocular conditions), and
Netrya (Conducive to Eye) actions.
II. OBJECTIVE
To evaluate the effect of Ayush –AC eye drops in simple Allergic Conjunctivitis (Kaphaja
Abhishyanda)
III. CENTRE
Central Research Institute (Ay.), New Delhi
IV. SAMPLE SIZE AND METHODS
Sample Size _ 90 patients (2 Groups)
Design of the study – Randomized Control Trial
Trial Drug /Dosage /Duration
Ayush-AC Eye Drops {containing equal parts of Daruharidra (Berberis aristata) and
Sirisha (Albizia libeck)} three times a day for 15 days.
Control - Distil water + preservative used in the drug
Duration of the study - 1½ months including 15 days drug therapy with
a follow up for one month without drug.
Period of Study - 15 days for each case. Total duration will be one
year to complete the trial.
Follow – up - One follow-up will be carried out after one week of
the completion of treatment.
V. CRITERIA FOR INCLUSION
1. Patients presenting with cardinal features of allergic conjunctivitis viz.
• Redness

520
• Itching
• Lacrimation
• Irritation
• Photophobia.
2. Age >10 yrs.
3. Conjunctival smear negative for bacterial/viral (optional)/fungal infection.
VI. CRITERIA FOR EXCLUSION
1. Age below 10 yrs
2. Conjunctival smear showing evidence of infection.
Clinically diagnosed cases of
3. Infective conjunctivitis
4. Parasitic infestation
5. Contact Lens users
VII. CRITERIA FOR WITHDRAWAL
During the course of the trial treatment, if any serious condition develops/ symptoms
aggravates, which requires urgent treatment, if no response after one week of treatment such
subjects may be withdrawn from the trial and managed by the Principal Investigator accordingly.
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before drug administration on 15th
day during drug therapy and 30th day & 45th during follow up (Form III). Required laboratory
investigations i.e. Stool examination (3 samples), TC (Cells/Cmm.), DC (P, L, E, M and B),
Absolute eosinophil, Hb% (g/dl), ESR (1st hour.) (mm), Blood Sugar – random (mg./dl,
Conjunctival swab for light microscopy and C&S evaluation will be carried out to exclude cases
as specified in the criteria for exclusion. (Form-III)
IX. CRITERA FOR ASSESSMENT
Disappearance of Redness, Itching, Lacrimation, Irritation and Photophobia will be
consider ed as significant out come of the treatment.
X. STATISTICAL ANALYSIS
Data on clinical symptoms and objective tests before and after the treatment will be
tabulated and analyzed using appropriate statistical tools. However, the data of each case will have
to be communicated on completion of trial therapy to the Statistical Officer of CCRAS through
e-mail.

521
XI. TRIAL MONITORING AND DATA ANALYSIS:
CCRAS, Hqrs, New Delhi will undertake the monitoring of progress of the trial and data
analysis.
XII. ETHICAL REVIEW:
A. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC)
of trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project proposal
for approval by EC. Both will be maintained in duplicate with one copy given to the
patient at the time of entry to the trial.
B. Data and safety monitoring board: A Data and safety monitoring board (DSMB) at
Hqrs. will carefully monitor the data and side effects during the period of study and put in
a place where by prompt reporting of adverse events occur. The data will be reviewed as
every 20 participants entered the study and administered the trial drugs. The research
team will report immediately to the PI and Data Monitoring Board if, any life threatening
conditions whether they are perceived to be study related or not. The Board decides
whether the adverse effects warrant discontinuation of the study protocol. Protocols will be
written and approved for the treatment of study related adverse events.
XIII. TRAVELING EXPENSES FOR RESEARCH SUBJECTS
A consolidated amount of Rs. ______/- per visit.
XIV. TRAINING TO INVESTIGATORS AND PERSONS INVOLVED
Short-term two-day training will be provided to the Investigators and Laboratory
personnel involved in the multi-centric trial at CCRAS Hqrs. and Central Research Institute (Ay.),
New Delhi. The investigators and technicians will be detailed about the clinical trial conduct and
laboratory procedures in order to maintain the uniformity.
XV. LABORATORY INVESTIGATIONS
The Laboratory Investigations (Pathological/Biochemical, etc.), which are not available at
research Institutes should be conducted at identified reputed labs /Government Institutes under
intimation to this Council following codal formalities.

522
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a subject
in the “Clinical Evaluation of Ayush –AC Eye Drops in simple Allergic Conjunctivitis (Kaphaja
Abshyanda)”

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

523
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
PATIENT INFORMATION SHEET

What is the study about?


Allergic conjunctivitis is commonly occurring ocular problem in day-to-day ophthalmic
practice. Apart from phlyctenular conjunctivitis as a manifestation of endogenous allergy and spring
catarrh an exogenous allergy, the conjunctiva may react to many other sensitizing factors viz,
external, physical or chemical. Experimental and clinical studies revealed that drugs undertaken in
the study viz. Daruharidra and Sirisha have significant effect of in the management of allergic
disorders including allergic conjunctivitis. The present study aims at evaluating effect of [Ayush-AC
capsules &] Ayush-AC drops in the management of allergic conjunctivitis.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 22 days to complete (15 days of
medication and thereafter one week of follow up). During this period, you are expected to visit
the hospital three times at the interval of one week.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, blood samples will also be taken to make sure that you are eligible for the
study.
If you are found eligible, you would be put on trial treatment for 15 days.
At each visit, you will be supplied with sufficient quantities of drugs to last until
your next visit. If any adverse reactions like skin allergy, nausea, vomiting and
palpitation/tremor etc., noticed during the treatment period, this should be noticed to the
Principle Investigator.

To be translated into regional language.

524
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL EVALUAT ION OF THE EFFECT OF TARPANA AYUSH-DE EYE
DROPS, AYUSH-DE CAPSULES IN THE MANAGEMENT OF DRY EYE
SYNDROME (SHUSHKAKSHIPAKA / PARISHUSKHA NETRA)
CASE REPORT FORM – 1 SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre : ...................................

2. Code No. (of clinical trial) :

3. Subject Name : ....................................................................................................................

4. Date of Birth : Age (in yrs.) :

5. Address : ..............................................................................................................................

CRITERIA FOR INCLUSION Yes (1) No (2)

1. Patients presenting with cardinal features of


allergic conjunctivitis viz.

• Redness,

• Itching,

• Lacrimation,

• Irritation

• Photophobia.

2. Age >10 yrs

3. Conjunctival smear negative for bacterial/viral


(optional)/fungal infection.

CRITERIA FOR EXCLUSION Yes (1) No (2)

4. Age below 10 yrs

525
5. Conjunctival smear showing evidence of infection.

6. Infective conjunctivitis

7. Parasitic infestation

8. Contact Lens users

A patient is eligible for admission to the trail

If Sl. No. 1 – 3 is ‘Yes’ and Sl. No. 4 – 8 are ‘No’

If admitted: Serial No._______________ No of Packet issued_________________

Date ___________________ Signature of Investigator:____________________

526
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
Case Report form-II history
(Enter a  in the appropriate box)

1. Centre : ...................................

2. Code No. (of clinical trial) :

3. Subject Name : ....................................................................................................................

4. Patient No.

5. Date of Birth : Age (in yrs.) :

6. Address : ..............................................................................................................................

7. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

8. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work ...........................................................................

9. Total family members :

10. Income per capita per month in rupees :

527
Chief complaint with duration (in month)

Present (1) Absent (2) Duration

11. Redness

12. Itching

13. Photophobia

14. Lacrimation

15. Irritation

16. HISTORY OF PRESENT ILLNESS

I. Onset of disease Acute 1 (1) Insidious 2 (2)

II. Duration of disease (in months)

III. Factors aggravating the disease/chief complaints ______________________________

IV.Factors relieving main complaints __________________________________________

V. History of past illness, having relation with present illness : Yes No

If yes, Specify____________________________________________________________

VI. Contact with pets _____________________________________________________

17. PAST HISTORY Yes (1) No (2)

I. Working in agriculture field

II. Contact with pets

III. Hay fever, asthma, eczema

IV. Use of hair dye

V. Use of systemic antibiotics (Sulphanomides)

18. PERSONAL HISTORY

19. Diet: Veg 1 Non-veg 2 Lacto-ova veg 3

Fish-veg 4

528
20. Sharirik Prakriti: Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 5

Sannipataja 7

21. Manas Prakriti : Sattva 1 Rajas 2 Tamas 3

Sattva-Rajas 4 Rajas-Tamas 5 Sattva-Tamas 6

Sama 7

22. EXAMINATION OF THE EYE (NETRA PARIKSHA)

I. Vision

II. Palpebral fissure (Vartma sukla sandhi) Wide 1 Narrow 2

III. Eyeball (Akshigolaka)

(a) Size Normal 1 (1) Microphthalmos 2 (2) Big 3

IV.Lids (Vartma)

(a) Position Normal 1 Drooping 2

(b) Thickness Present 1 Absent 2

(c) Inflammatory signs Present 1 Absent 2

(d) Lashes

Misdirection Present 1 Absent 2

Scantiness Yes 1 No 2

(e) Lidmargin

Ectropion Yes 1 No 2

Entropian Yes 1 No 2

V. Lacrimal System Normal 1 Drooping 2


(ashruyantra)

If ‘abnormal’ specify, ___________________

529
VI. Conjunctiva (bulbar) Yes (1) No (2)

Congestion

Conjunctival/CCC

Oedema

Hemorrhage

Redness

VII. Conjunctiva (tarsal) Yes (1) No (2)

Nodule

Others Yes

VIII. Sclera (Sukla mandala) Yes (1) No (2)

Change in colour

Pigmentation

Nodule Yes

Congestion

IX. Cornea (Krishna mandala) Present (1) Absent (2)

(a) Opacity

(b) Oedema

(c) Vascularisation

(d) Epithelial status

(e) Keratitis

Normal (1) Abnormal (2)

X. Anterior Chamber

If abnormal, specify: .............................................................................................................

530
XI. Iris (Mamsa ashrita patala)

If abnormal, specify: .............................................................................................................

XII. Vitreous

If abnormal, specify: .............................................................................................................

Lens (Medoashrita patala)

(a) Opacity Present Yes (1) No (2)

Normal (1) Abnormal (2)

XIII. Pupil (Dristi mandal)

If abnormal, specify: .............................................................................................................

XIV. Retina (Asthiashrita patala)

If abnormal, specify: .............................................................................................................

XV. IOP (Digital)

If abnormal, specify: .............................................................................................................

Date: _____________ Signature of the Investigator: ______________________

531
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH –AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
CASE REPORT FORM III - CLINICAL ASSESSMENT

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7 Redness (Grade 0-5) _________________________________________

8 Itching, (Grade 0-5) _________________________________________

9 Photophobia. (Grade 0-5) _________________________________________

10 Lacrimation, (Grade 0-5) _________________________________________

11 Irritation (Grade 0-5) _________________________________________

12 Adverse reaction: _____________________________________________________

If yes, details____________________________________________________________

13 Overall impression of well-being by the Subject:

Improved (1) No change (2) Deteriorated (3)

14 Status of the patient:

Continuing (1)

Drop out (2) Reason: _____________________________

Died (3) Cause: ______________________________

Date: ______________ Signature of Investigator__________________________

532
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR CLINICAL EVALUATION OF AYUSH – AC EYE DROPS IN
SIMPLE ALLERGIC CONJUNCTIVITIS (KAPHAJA ABHISHYANDA)
CASE REPPOT FORM IV – LABORATORY INVESTIGATIONS
(Before treatment)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment :

8. Stool examination

Routine ____________ Microscopic____________

Ova/Cyst____________ Occult Blood____________\

9. TC (Cells/Cmm.)_____________________

10. DC: P (%)_______ L (%) _______ E (%)________ M (%)________ B (%)_______

11. Absolute Eosinophils

12. Hb (g/dl): _______________

13. ESR (1st hour.) (mm) _______________

14. Blood Sugar – Randomized (mg./dl) _______________

15. Conjunctival swab for light microscopy and C & S evaluation

Date: _____________ Signature of the Investigator: ______________________

533
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534
CONNECTIVE TISSUE DISORDER

SECTION - VIII
Blank

536
CLINICAL TRIAL ON EVALUATION OF EFFECT OF
JALAUKAVACHARANA IN DEEP VEIN THROMBOSIS

Treatment modality: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

537
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538
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS

I. BACKGROUND
Presence of thrombosis1 within a deep vein and accompanying inflammatory response in
the vessel wall is termed as thrombosis of deep vein. Most important consequences of deep vein
thrombosis is pulmonary embolism. More than 90% of pulmonary embolism arise from deep vein
thrombosis (William F.; Baker Jr., 1998) Pulmonary embolism has mortality of 18.3% without
treatment (Kemp PM, Traror D Batty V. et.al., 1996). Once the deep vein thrombosis occurs,
the risk of pulmonary embolism is high in first 72 hrs.
Risk factors for Deep Vein Thrombosis: Virchow triad of venous stasis, intimal injury and
hypercoagulable state was described in 1856 but still hold some truth.Extensive autopsy and clinical
studies have shown that 95% pulmonary embolism arise from deep vein thrombosis in the lower
limbs. Indwelling catheter in upper extremity veins like superior vena cava and right ventricle can
induce thrombosis.
Prevention of pulmonary embolism is the most important aim of treating the patient with
deep vein thrombosis. Prophylaxis is achieved by drug like heparin, LMW heparin or oral
anticoagulant and physical method like intermittent leg compression and graduated compression
stocking. In the early phase thrombolytic maybe useful in clot lysis.
Due to high cost of thrombolytics and LMW Heparin and bleeding and thrombo-
cytopenic side effect of heparin, the future Ayurvedic procedure Jalaukavacharana (leech
application) which has low cost and no side effect hold a strong promise for development of a
better procedure. Previous studies showed Jaloukavacharana as a promising treatment for deep
vein thrombosis. The same needs to be verified further.
II. OBJECTIVE
To evaluate the effect of Jalaukavacharana (leech application) in deep vein thrombosis.

References
1. Harisson’s Principles of internal medicine, 14th Edition, International Editions, 1998, Published
by McGraw-Hill CompaniesInc.pp1652

539
III. CENTRES
CCRAS identified centers
IV. SAMPLE SIZE AND METHODS
Sample size : 20 in each centre
Procedures of leech application:
1. Pre-operative procedure:
i Preparation of leech: Before using for blood letting, the leeches should be
purified by keeping them in water mixed with turmeric powder for some
time. Then, they should be shifted to the fresh water.
ii Preparation of patient: Thoroughly examined patient should be made to
take comfortable and convenient lying down position. The part of the
body where leech is to be applied should be cleanly washed and dried by
wiping with cotton cloth or swab. Antiseptic lotion or oil etc. should not be
used.
2. Operative procedure:
Then one or two leeches depending on the condition should be applied to the
swollen and indurated part of the limb. If the leech does not suck the blood, a drop of
milk or blood should be; put on the site. Still if leech fails to such the blood, mild prick
should be made on the skin. After the leech starts sucking the blood, it should be covered
with a wet cloth. If at biting site, pricking pain and itching appears, the leech should be
removed, if it does not leave, its mouth should be sprinkled with the turmeric powder.
3. Post operative procedure:
i Care of patient: After detachment of the leech, bleeding may continue. At
that time turmeric powder should be applied on the bleeding spot and
washed with cold water and dried by gently pressing with a gauze. Then
to enhance the healing process, Jatyadi Taila should be applied and
bandaged.
ii Care of leech: In order to make the leech fit for further use, it should be
made to vomit the sucked blood, by keeping it in the water mixed with
turmeric powder followed by holding it upside down and applying mild
pressure on the body of the leech from tail to mouth. After complete
vomiting it should be washed out with cold water and kept in the pot.
After 7 days, we can make use of the same leech for blood letting.

540
Duration of the Procedure- Application of leech will be done twice a week with an
interval of 3 days. Total duration of the procedure is 1 month.
Design of the study – Open Trial
Total period of study- 12 months
V. CRITERIA FOR INCLUSION
1. Both sexes
2. Between 25 years and 70 years.
3. Unilateral swelling of lower limb
4. Warmth and erythema over swelling
5. Tenderness over swelling
6. Calf pain (Posterior calf tenderness)
7. History of Immobilization for more than 2 weeks
8. Post menopausal hormonal replacement therapy
9. Patient with hemodynamically stable
10. Patient with positive finding of thrombosis on the basis of intravascular Doppler Study
VI. CRITERIA FOR EXCLUSION
1. Patient with hamodynamically unstable
2. Patient with Bleeding disorder
3. Patient with Respiratory failure
4. Severe CCF with EF < 30%
5. Severe uncontrolled diabetes
6. Acute MI
7. History of recent haemorrhagic stroke
8. Person undergoing treatment for any other serious illness
VII. CRITERIA FOR WITHDRAWAL
During the course of trial treatment, if any serious condition develops which requires
urgent treatment; such subjects may be withdrawn from the trial and managed by the Principal
Investigator accordingly.

541
VIII. ROUTINE EXAMINATION AND ASSESSMENT
The full details of history and physical examination of the patients will be recorded as per
the proforma (Forms I & II). Clinical assessment will be done before and after the procedure. The
laboratory investigations and the physiological parameters will be recorded before and at the end
of treatment
IX. STATISTICAL ANALYSIS
Clinical symptoms, physiological parameters and laboratory parameters will be analysed
using appropriate statistical methods.
X. CRITERIA FOR ASSESSMENT OF RESULTS
Relief in clinical signs and symptoms will be considered as significant improvement.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by Monitoring Unit and staff of CCRAS
Headquarters, New Delhi).
Data analysis will be undertaken at the CCRAS Headquarters, New Delhi.
XII. ETHICAL REVIEW
Each participating center’s Institutional Ethical Committee (IEC) should give clearance
certificate before the project is initiated. Patient’s information sheet and informed consent form
should be submitted alongwith project proposal for approval by IEC. Both should be maintained
in duplicate with one copy given to the patient at the time of entry to the trial.

542
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of treatment and follow-up, including the laboratory investigations to be
performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so. I, exercising my free power of choice, hereby
give my consent to be included as a subject in the “Clinical trial on evaluation of effect of
Jalaukavacharana in deep vein thrombosis.”

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

543
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
PATIENT INFORMATION SHEET

What is the study about?


In spite of advances in the medical as well as surgical management of deep vein
thrombosis, limited success and their complications pose major concern for scientific community.
Jaloukavacharana or application of leech on affected part is proved to be beneficial in deep vein
thrombosis. It is the mildest, safest and painless way of extracting impure blood from the vein.
After certain preoperative measures the leech is allowed to suck the blood. After the leech leaves
the part, bandaging will be done. It takes about 15 minute to complete the procedure at each
sitting.
What will you have to do?
Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 1 month to complete the treatment and
another 6 months for follow-up study). During this period, you are expected to visit the hospital
twice a week. The interval between the 1st and 2nd visit will be 3 days.
Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, Blood and urine samples will also be taken. This is to make sure that you
are eligible for the study.
If you are found eligible, you would be put on trial treatment for 1 month. At each visit,
you will be treated with the application of leeches.

To be translated into regional language.

544
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CASE REPORT FORM I – SCREENING
BEFORE TREATMENT
(Enter a  in the appropriate box)

1. Centre : ...................................

2. Code No. (of clinical trial) :

3. Subject Name : ....................................................................................................................

4. Gender Male Female

5. Date of Birth : Age (in yrs.) :

6. Address : ..............................................................................................................................

CRITERIA FOR INCLUSION Yes (1) No (0)

1. Both sexes

2. Between 25 years and 70 years.

3. Unilateral swelling of lower limb

4. Warmth and erythema over swelling

5. Tenderness over swelling

6. Calf pain (Posterior calf tenderness)

7. History of Immobilization for more than 2 weeks

8. Post menopausal hormonal replacement therapy

9. Patient hemodynamically stable

10. Patient with positive finding of thrombosis on the


basis of intravascular Doppler study

545
CRITERIA FOR EXCLUSION Yes (1) No (0)

11. Patient hamodynamically unstable

12. Patient with Bleeding disorder

13. Patient with Respiratory failure

14. Severe CCF with EF < 30%

15. Severe uncontrolled diabetes

16. Acute MI

17. History of recent haemorrhagic stroke

18. Person undergoing treatment for any other serious


illness.

A patient is eligible for admission to the trail

If Sl.No.1-10 is ‘Yes’ and Sl.No.11-18 are ‘No’

If admitted, Subject’s Serial No. ____________

Date: ____________ Signature of the Investigator ______________________

546
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
CASE REPORT FORM II – HISTORY
(Enter a  in the appropriate box)

1. Centre : ...................................

2. Code No. (of clinical trial) :

3. Subject Name : ....................................................................................................................

4. Gender Male Female

5. Date of Birth : Age (in yrs.) :

6. Address : ..............................................................................................................................

7. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

8. Occupation Desk work 1 Field work 2

Standing for long time 3

Laborious 4

Sedentary 5

Indicate nature of work ...........................................................................

Chief complaint with duration (in month)

Present (1) Absent (2) Duration

9. Unilateral swelling of lower limb

10. Warmth and erythematic over swelling

547
11. Tenderness over swelling

12. Cord like palpation over swelling

13. Cyanotic colour change over swelling

14. Paleness over swelling

15. Calf pain (Posterior calf tenderness)

History of Past illness Yes (1) No (0)

16. History of Immobilization for more than 2 weeks

17. Orthopedic procedure on hip, knee

18. History of trauma (pelvis, femur, tibia)

19. History of intake of oral contraceptive

20. Post menopausal hormone replacement therapy

21. Non-hemorrhagic stroke with immobilization

22. Hypertension

23. Diabetes

24. Tuberculosis

25. Malignancy

26. Major hospitalization/surgery during past three years

If yes, specify ___________________________________________________________

27. Other complaints if any (Specify) _____________________________________________

Personal History

28. Diet Veg 1 Non –veg 2

29. Sleep Normal 1 Abnormal 2

30. Presence of anxiety No 2 Yes 2

548
31. Constipation No 2 Yes 2

Addiction

32. Smoking No 2 Yes 2

If yes specify: (a) Quantity (packs) ________________

(b) Total Duration in years ________________

33. Tobacco No 2 Yes 2

If yes specify: (a) Quantity (packs) ________________

(b) Total Duration in years ________________

34. Alcohol No 2 Yes 2

If yes specify: (a) Quantity (in ml.): ________________

(b) Total Duration in year’s ________________

35. Any other (specify): ________________________________________

36. Prakriti Vata 1 Pitta 2 Kapha 3

Vata-Kaphaj 4 Vata-Pittaja 5 Pittaja-Kaphaja 6

Sannipataja 7

Physical Examination

37. Height (cm) ____________

38. Weight (kg) ____________

39. Pulse (per min) ____________

40. Blood Pressure Systolic(mm Hg) ___________

41. Blood Pressure Diastolic (mm Hg) ___________

42. Body temperature( o F) ___________

43. Respiration rate( per min) ___________

549
Absent (0) Present (1)

44. Anemia

45. Pallor

46. Clubbing

47. Edema

48. Deformities

If present, specify ________________

49. Lymphadenopathy

If present, specify: General 1 Local 2

(Area)__________________________________________________________________

Local Examination Absent (0) Present (1)

50. Pain in calf after dorsiflexion of foot

51. (Horranis sign)

Systemic examination Normal (0) Abnormal (1)

52. CVS

If abnormal, details ______________________________________________

53. CNS

If abnormal, details ______________________________________________

54. Respiratory system

If abnormal, details ______________________________________________

55. Per abdomen

If abnormal, details ______________________________________________

550
56. Digestive system

If abnormal, details ______________________________________________

57. Urogenital system

If abnormal, details ______________________________________________

58. Locomotor system

If abnormal, details ______________________________________________

Date:_________________ Signature of Investigator____________________

551
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
FORM III – CLINICAL ASSESSMENT
(0,………………..)
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment :

8. Month of Assessment :

Clinical Symptoms Absent (0) Present (1)

9. Unilateral swelling of lower limb

10. Warmth and erythematic over swelling

11. Tenderness over swelling

12. Cord like palpation over swelling

13. Any cyanotic color change over swelling

14. Paleness over swelling

15. Calf pain (Posterior calf tenderness)

16. Any other non-specific symptoms

If yes, Present specify_________________________

552
17. Overall clinical assessment by the Investigator:

Improved 1 No change 2 Deteriorated 3

18. Status of the patient:

Continuing 1

Drop out 2 Reason: _____________________________

Died 3 Cause: _______________________________

Date: _____________ Signature of Investigator __________________________

553
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
CLINICAL TRIAL ON EVALUATION OF EFFECT OF JALAUKAVACHARANA
IN DEEP VEIN THROMBOSIS
FORM IV– LABORATORY INVESTIGATIONS AND PHYSIOLOGICAL
PARAMETERS
(Before and after the treatment)
(Enter a  in the appropriate box)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Name of the subject: ______________________________________________________

4. Address : _______________________________________________________________

5. Gender Male Female

6. Date of Birth: Age (in yrs.) :

7. Date of Assessment :

8. Month of Assessment :

9. Hb%

10. Urine

Routine: ____________ Microscopic: ____________

9. Stool for occult blood: ____________

10. TLC: ____________

10. DLC: P (%) _______ L (%) _______ E (%) _______ M(%) _____ B (%)_______

11. ESR: ____________

12. BT: ____________

13. CT: ____________

554
14. PT: ____________

15. APTT: ____________

16. Platelet count : ____________

17. Lipid profile: ____________

18. Serum total cholesterol: ____________

19. Serum triglyceride: ____________

20. High density lipoprotein: ____________

21. Very low density lipoprotein: ____________

22. X-Ray Chest: ____________

23. ECG 12 leads: ____________

24. LFT : S.Bilirubin, SGOT, SGPT, S.Alkaline phosphatase, S.Albumin, S.Gobulin, A/G ratio

25. KFT: BUN, S.creatinine, Blood sugar, Serum Antithrombin,

26. Blood sugar

Fasting: ____________ Post Prandial: ____________

27. Serum Antithrombin

28. S.Sodium,

29. S.Potassium

30. USG:Duplex venous ultra-sonograph (B-mode) –colour droppler

31. Real time B-mode Compression Ultrasound

Date:________________ Signature of Investigator_______________________

555
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556
GERIATRIC DISORDERS

SECTION - IX
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558
MULTICENTRIC OPEN CLINICAL TRIAL OF
RASAYANA DRUGS IN HEALTHY ELDERLY PERSONS

Treatment modality: Study Code:

PROTOCOL & CASE REPORT FORMS (CRF)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA


AND SIDDHA

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS

I. BACKGROUND
The World Health Organization (WHO) has defined Health as a state of physical, mental
and social wellbeing and not only the absence of disease or infirmity. Over the years, this definition
has changed and now Health is seen as a more holistic state including spiritual component in it.
This present definition of Health by WHO closely resembles the definition laid down in Ayurvedic
texts, more than 3000 years ago. The emphasis on maintaining good health or Swasthya is crucial
to Ayurveda. Ayurveda has presented a total holistic approach for upliftment of body and mind as
well as spirit. Whatever is possible through the control of mind and prana, can be acquired
through Rasayana. Rasayana therapy1 (Rejuvenating group of medicines) aims specially at the
promotion of strength and vitality by replenishing rasa and other Dhatus. The other benefits
secured by Rasayana therapy are promotion of memory and intelligence, immunity against disease
and decay, preservation of youthfulness, lustre, complexion and voice.
Rasayana is of three types according to their effect – 1. Ajasrika (nutritional) 2. Kamya
(desirable) and 3. Naimittika (conditional) and of two types according to the methods of
application - 1. Kutipravesika (confined treatment under specified atmosphere) and 2. Vatatapika
(usual out patient treatment).
There are numerous rasayana drugs among which important ones are Amalaki, Bhallataka,
Nagabala, Pippali, Aswagandha, Shilajit and Svarnabhasma. Brahmi, Shankhapushpi, Guduchi and
Yastimadhu are particularly intellect promoting (Medhya) rasayana drugs though they also promote
physical strength.
A series of clinical and experimental studies have already been conducted to assess the
Rasayana effect of many single and compound preparations. The studies on Chyavanprasa and
Amalaki Rasayana showed significant health promotive effect in elderly volunteers. The Pippali
Ksirapaka provided significant Naimittika rasayana effect in the patients of Tuberculosis, Asthma
and Arthritis reflected through increase in body weight, nitrogen retention, serum protein and
haemoglobin.

References
1. Kasinatha Sastri (1970), Caraka samhita Part-II, First edition, The Chowkhamba Sanskrit Series
Office, Gopal Mandir Lane, P.O. Chowkhamba, Post Box – 8, Varanasi – 1, India.

561
The study on the Medhya Rasayana effect of Shankapushpi, Brahmi and Mandukaparni
showed significant improvement in neurological and psychological parameters. The effect of Brahmi
on acetylcholine, acetylase and cholinesterase has been better than Mandukaparni. Similar studies
were also conducted on Satavari and Vacha with encouraging results.
Aswagandha when administered to 106 apparently normal healthy male volunteers in the
age group of 50-59 years was found to have anti-aging effect. Another study established the
haematinic effect of Aswagandha when administered with milk for 60 days to 60 children. The
effect of another Ayurvedic compound consishting of
Shatavari, Punarnava, Bala, Guduchi, Amalaki and Yasti in 50 apparently healthy male
volunteers in the age group of 45-50 years indicated that the compound has capability of restoring
the age - related functional impairments. A series of clinical studies conducted in different institutes
revealed that Amalaki (Emblica officinalis) as an effective remedy for different gastrointestinal
problems besides its Rasayana effect.
II. OBJECTIVES
• To observe the effects of Rasayana regimen (Triphala churna 5gm OD at night and
Ashwagandha churna 5gm OD at morning daily with water for 4 months) on physical
performance, quality of life and metabolic milieu.
• To observe the clinical safety of Rasayana regimen on clinical & laboratory parameters.
• Effect of Rasayana regimen in apparently healthy elderly on
a. Physical strength
b. Balance
c. Sleep
d. Urge incontinence
e. Constipation
f. Stress level
g. Quality of life
h. Vague ache and pains/ stiffness
i. Appetite
2. Adverse effect of regimen
a. In apparently healthy elderly person with no systemic disease
b. In person with systemic disease like hypertension and drug interactions

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III. CENTRES
CCRAS identified centers.
IV. SAMPLE SIZE AND METHODS
Sample Size: 50 subjects per center (Total 250 participants)
Drug/Dosage/Duration:
Drug: Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at morning
daily with water for 4 months.
Design of the study: Multicentric open clinical trial
Duration of the study: 4 months.
V. CRITERIA FOR INCLUSION
1. Age between 50 and 70 years
2. Apparently healthy
3. Co-operative and fully conscious
VI. CRITERIA FOR EXCLUSION
1. Diabetes mellitus
2. Severe bronchial Asthma /COPD
3. Cancer
4. Dementia < 24 score
5. Any symptomatic cardiac disease
6. Chronic debilitating conditions like hepatic/ renal insufficiency (Confirmed through history/
clinical examination)
7. Any acute illness/ serious illness
8. Fever/ delirium
VII. CRITERIA FOR WITHDRAWAL
1. Any serious intercurrent illness
2. Any serious adverse effect or drug interaction

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VIII. ROUTINE EXAMINATION AND ASSESSMENT
A. The full details of history and physical examination of the patients will be recorded as per
the Case Record Forms (I & II). Clinical assessment including recording of common signs/
symptoms of suspected ADRs will be done before drug administration, at the end of 1st,
2nd, 3rd & 4th month of treatment (Form III). Laboratory investigations will be carried out
before drug administration, at the end of 2nd and 4th month of treatment (Form IV).
IX. FOLLOW - UP
Monthly follow-up will be carried out at the end of each month during the four months
treatment period.
X. STATISTICAL ANALYSIS
Clinical symptoms, physiological parameters and laboratory parameters will be analyzed
using SPSS 15.0 version with appropriate statistical methods.
XI. TRIAL MONITORING AND DATA ANALYSIS
The progress of the trial will be monitored by field visits by Monitoring Unit - CCRAS
HQ, New Delhi. Data analysis will be carried out at the Monitoring Unit.
XII. ETHICAL CLEARANCE
Each participating centre’s Institutional Ethics Committee (IEC) should give clearance
certificate before the project is initiated.
a. List of Clinical Symptoms to be taken into account for assessment using VAS (Visual
Analogue Scale):-
1. Dizziness
2. Constipation
3. Urge incontinence
4. Aching muscles
5. Joint pain
6. Joint stiffness
7. Sleep abnormality
8. Loss of appetite
9. Vague pain
10. Fatigue

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11. Generalized weakness
b. Clinical parameters to record
1. Height
2. Weight
3. Pulse rate
4. Blood pressure
Supine (diastolic/systolic__________)
Standing (diastolic/systolic__________)
Orthostatic hypotension – Yes/ No
5. Upper mid arm circumference
6. Skin fold thickness
7. BMI (body weight in Kgs./Height in meters2)
8. Waist circumference
9. Waist: hip ratio
10. Grip strength both hands
11. Get up and go test
12. Walking distance in 1 min.
13. General physical examination
c. Scores
1. Geriatric depression score
2. WHO-QOL score/ CDC score for health quality
3. HMSE (Hindi version of mental system evaluation)
4. Hamilton anxiety scale
d. Laboratory investigations
1. Complete haemogram (Complete blood picture)
2. GBP for anemia
3. Complete urine examination

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4. Serum Iron
5. TIBC
6. Plasma glucose
a. Fasting
b. Post prandial
7. Lipid profile
a. HDL
b. LDL
8. Liver function tests
a. Serum proteins
i. Albumin
ii. Globulin
b. Serum bilirubin
i. Total
ii. Direct
c. SGPT
d. SGOT
e. Serum Alkaline Phosphatase
9. Serum triglycerides
10. Serum Cholesterol
11. Serum electrolytes
12. Renal function tests
a. Blood urea
b. Serum creatinine
13. Serum uric acid
14. Serum Thyroid Stimulating Hormone (TSH)
15. Serum calcium

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16. Serum phosphates
e. Special tests
1. ECG
2. Pulmonary Function Test (PFT)
f. Marker of inflammation
1. C Reactive Proteins (CRP)
2. TNF ?
3. IL-6
g. Serum melatonin
h. Free radical system
a. Malonyl aldehyde
b. Catalase
c. Super oxide dismutase
d. Glutathione
e. Peroxidase
i. Prostate specific antigen
j. Test for insulin resistance

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
PROTOCOL FOR MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA
DRUGS IN HEALTHY ELDERLY PERSONS
WRITTEN INFORMED CONSENT FORM
CERTIFICATE BY INVESTIGATOR

I certify that I have disclosed all details about the study in the terms easily understood by
the patient.
Date: _______________ Signature of the subject: ______________
Name: ____________________________

CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory investigations
to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the trial
without having to give the reasons for doing so.
I, exercising my free power of choice, hereby give my consent to be included as a
participant in the clinical trial of Triphala churna 5gm OD at night and Ashwagandha churna 5gm
OD at morning daily with water for 4 months on the general health of the aged persons.

Date:___________ Name of the Subject:_____________________________


Signature or Thumb impression_____________________
Date:___________ Name of witness: _______________________________
Signature or Thumb impression: _____________________
Relationship ___________________________________

To be translated into regional language.

568
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
PATIENT INFORMATION SHEET

What is the study about?

Ayurveda has laid emphasis on maintenance of positive health and prevention of diseases,
besides management/ treatment of diseases. Rasayana Therapy of Ayurveda promotes health of
individuals especially elderly persons. The present study is aimed to evaluate selected Ayurvedic
Rasayana drugs for their efficacy in the promotion of health of elderly people.

You are invited to participate in this study where you will be provided with the trail drugs
and require to take Triphala churna 5gm OD at night and Ashwagandha churna 5gm OD at
morning daily with water for 4 months. Previous observations in clinical and experimental studies
have shown promising effect of these drugs in the promotion of health. About 250 healthy elderly
persons from this and other hospitals around the country will be taking part in this study.

What will you have to do?

Your doctor will explain clearly what you have to do. It is important that you follow the
instructions scrupulously. The study will take approximately 16 weeks to complete. During this
period, you are expected to visit the hospital five times. The interval between the first, second,
third, fourth and fifth visits will be four weeks (one month).

Before you start treatment, during the first visit to the clinic, you will undergo a complete
physical examination, ECG and an X-ray, Blood and urine samples, etc. will also be taken. This
is to make sure that you are eligible for the study.

If you are found eligible, you would be put on trial treatment for 16 weeks. At each visit,
you will be supplied with sufficient quantities of drugs to last until your next visit.

To be translated into regional language.

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM I - SCREENING

1. Centre : ...................................

2. Code No. (of clinical trial) :

3. Subject Name : ....................................................................................................................

4. Gender Male Female

5. Date of Birth : Age (in yrs.) :

6. Address : ..............................................................................................................................

CRITERIA FOR INCLUSION Yes (1) No (2)

1. Age between 50 and 70 years

2. Apparently healthy

3. Cooperative and fully conscious

CRITERIA FOR EXCLUSION Yes (1) No (2)

4. Diabetes mellitus

5. Severe Bronchial Asthma/ COPD

6. Cancer

7. Any symptomatic cardiac disease

8. Chronic debilitating conditions like hepatic/ renal


insufficiency (Confirmed through history/ clinical
examination/ laboratory findings*)

9. Dementia (Score <24 )

10. Any acute illness/ serious illness

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11. Fever/ delirium

A patient is eligible for admission for treatment

If Sl. No. 1 – 3 is ‘Yes’ and Sl. No. 4 – 11 are ‘No’

If admitted, Subject Serial No.: ______________

Date: ____________ Signature of the Doctor __________________

* Normal range of values for Sl. No. 8

A. Liver function tests

1. S. Bilirubin

• Total: 0.3 – 1.0 mg/dl

• Direct: 0.1 – 0.3 mg/dl

2. SGPT: 0 – 35 IU/L

3. SGOT: 0 – 35 IU/L

4. S. Alkaline phosphatase: 30 – 120 IU/L

5. S. Proteins (Total): 5.5 – 8.0 g/dl

• Albumin: 15 - 40 g/dl

• Globulin: 2.0 – 3.5 g/dl

B. Renal function tests

6. Blood urea: 15 – 40 mg/dl

7. S. Creatinine: < 1.5 mg/dl

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM II – HISTORY

1. Code No. (of clinical trial)

2. Centre :__________________

3. Sr. No. of the Subject : ___________________________________________________

4. Subject Name : __________________________________________________________

5. Gender Male (1) Female (2)

D D M M Y Y

6. Date of Birth : Age (in years.)

7. Address : ..............................................................................................................................

8. Educational status:

Illiterate 1 Read and write 2 Primary 3

Middle school 4 High school 5 College 6

Others (specify) 7 INA 8

9. Occupation Desk work 1 Field work 2

Field work with physical labour 3

Field work with intellectual 4

Indicate nature of work ...........................................................................

10. Type of living arrangement

Living alone 1

Living with his/her spouse 2

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Living with his/her family 3

Living in an old age home 4

Others (specify) 5

11. Income (per capita per month) of the participant and Head of the family
in Rs __________________________________________________________________

A. Chief complaint with duration in days

Absent (0) Present (1) Duration


in days

12. Dizziness

13. Constipation

14. Urge incontinence

15. Aching muscle

16. Joint pain

17. Stiffness

18. Sleep abnormality

19. Loss of appetite

20. Vague pain

21. Fatigue

22. Generalized weakness

B. Recurrent frequent attacks of No (0) Yes (1)

23. Fever

If yes, indicate frequency of attacks in last six months: ____________________________

24. Rhinitis/ upper respiratory tract infection

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If yes, indicate frequency of attacks in last six months: ____________________________

25. Urinary tract infections

If yes, indicate frequency of attacks in last six months: ____________________________

26. Other complaints (Specify) _________________________________________________

C. History of Past illness: No (0) Yes (1)

27. Tuberculosis

28. Major hospitalization/ surgery during past three years

If yes, specify ___________________________________________________________

D. Personal History

29. Diet: Veg (1) Non-veg (2)

Addictions Yes (1) No (0)

30. Alcohol

31. Tea/ Coffee more than 4 times a day

32. Tobacco

If Yes, Chewing (1) Smoking (2) Both (3)

33. Prakriti Vata Pitta Kapha

Vata-Kaphaj Vata-Pittaja Pittaja-Kaphaja

Sannipataj

34. Deformities Absent 0 Present 1

If present, specify _________________________________________________________

35. Lymphadenopathy Absent 0 Present 1

If present, specify, General 1 Local 2

Area __________________________________________________________________

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E. General systemic examination Normal (0) Abnormal (1)

36. Respiratory system

If abnormal, details _____________________________________________________

37. Digestive system

If abnormal, details _______________________________________________________

38. Urogenital system

If abnormal, details _______________________________________________________

39. Vision

If abnormal, details _______________________________________________________

40. Hearing

If abnormal, details _______________________________________________________

41. Locomotor system

If abnormal, details _______________________________________________________

42. Central nervous system

If abnormal, details _______________________________________________________

43. Cardiovascular system

If abnormal, details _______________________________________________________

F. Presence of any of the following symptoms

Absent (0) Present (1)

44. Burning sensation in abdomen

45. Nausea

46. Diarrhoea

47. Skin rashes

Date: ____________ Signature of Investigator _______________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III A – CLINICAL ASSESSMENT
(ON 0 DAY)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the Subject: ____________________________________________________

4. Name of the Subject: _____________________________________________________

5. Date of Assessment :

A. Clinical Symptoms Visual Analogue Scale

Absent (0) Present (1)

6. Dizziness

7. Constipation

8. Urge incontinence

9. Aching muscles (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

10. Joint pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

11. Joint stiffness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

12. Sleep abnormality (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

13. Loss of appetite (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

14. Vague pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

15. Fatigue (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

16. Generalized weakness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

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Normal (0) Impaired (1)

17. Vision

18. Hearing

19. Any other non-specific symptoms Absent (0) Present (1)

If present, specify_________________________

B. Physical Examination

20. Height (cm) _____________

21. Weight (kg) _____________

22. Pulse rate (per min) _____________

23. Body temperature (oF) _____________

24. Blood Pressure – Supine Systolic (mm Hg) _____________

25. Blood Pressure – Supine Diastolic (mm Hg) _____________

26. Blood Pressure – Standing Systolic (mm Hg) _____________

27. Blood Pressure – Standing Diastolic (mm Hg) _____________

28. Orthostatic hypertension: Yes (1) No (2)

29. Upper mid arm circumference (cm.) _____________

30. Skin folds thickness (mm) _____________

31. Grip strength (Right hand) (Kg) _____________

32. Grip strength (Left hand) (Kg) _____________

33. BMI (basal metabolic index – wt./ ht.2) _____________

34. Waist circumference (cm.) _____________

35. Waist: hip ratio _____________

36. Respiration rate (per min) _____________

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37. Get up and go test _____________

38. Walking distance in 1 min. _____________

C. Score system

39. Geriatric depression score: _____________

40. WHO-QOL Score/ CDC score for health quality: _____________

41. HMSE (Hindi version of mental system evaluation): _____________

42. Hamilton anxiety scale: _____________

D. No. of sachets issued:

a. Aswagandha Churna sachets _____________

b. Triphala Churna sachets _____________

Date: ______________ Signature of Investigator: ______________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM III B – CLINICAL ASSESSMENT
(ON 30TH DAY, 60th DAY, 90th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the Subject: ____________________________________________________

4. Name of the Subject: _____________________________________________________

5. Date of Assessment :

A. Clinical Symptoms Visual Analogue Scale

Absent (0) Present (1)

6. Dizziness

7. Constipation

8. Urge incontinence

9. Aching muscles (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

10. Joint pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

11. Joint stiffness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

12. Sleep abnormality (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

13. Loss of appetite (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

14. Vague pain (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

15. Fatigue (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

16. Generalized weakness (Absent) 0 1 2 3 4 5 6 7 8 9 10 (Severe)

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Normal (0) Impaired (1)

17. Vision

18. Hearing

19. Any other non-specific symptoms Absent (0) Present (1)

If present, specify_________________________

B. Physical Examination

20. Height (cm) _____________

21. Weight (kg) _____________

22. Pulse rate (per min) _____________

23. Body temperature (oF) _____________

24. Blood Pressure – Supine Systolic (mm Hg) _____________

25. Blood Pressure – Supine Diastolic (mm Hg) _____________

26. Blood Pressure – Standing Systolic (mm Hg) _____________

27. Blood Pressure – Standing Diastolic (mm Hg) _____________

28. Orthostatic hypertension: Yes (1) No (2)

29. Upper mid arm circumference (cm.) _____________

30. Skin folds thickness () _____________

31. Grip strength (Right hand) (Kg) _____________

32. Grip strength (Left hand) (Kg) _____________

33. BMI (basal metabolic index – wt./ ht.2) _____________

34. Waist circumference (cm.) _____________

35. Waist: hip ratio _____________

36. Respiration rate (per min) _____________

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37. Get up and go test _____________

38. Walking distance in 1 min. _____________

C. Score system

39. Geriatric depression score: _____________

40. WHO-QOL Score/ CDC score for health quality: _____________

41. HMSE (Hindi version of mental system evaluation): _____________

42. Hamilton anxiety scale: _____________

D. Presence of any adverse reactions Absent (0) Present (1) Duration


(in days)

43. Burning sensation in abdomen

45. Nausea

47. Diarrhoea

49. Skin rashes

47. Overall clinical assessment by the Doctor:

Improved 1 (1) No change 2 (2) Deteriorated 3 (3)

48. Overall impression of well-being by the Subject:

Improved 1 No change 2 Deteriorated 3

49. Status of the patient:

Continuing 1

Completed 2

Drop out 3 Reason: ______________________________________

Died 4 Cause of death: _______________________________

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D. No. of sachets issued (if continuing):

a. Aswagandha Churna sachets __________________

b. Triphala Churna sachets __________________

Date: ______________ Signature of Doctor _____________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
CASE REPORT FORM IV – LABORATORY INVESTIGATIONS
(ON 0 DAY, 60th DAY & 120th DAY)
(USE SEPARATE FORM ON EACH VISIT)

1. Centre: ______________________________

2. Code No. (of clinical trial)

3. Sr. No. of the Subject: ____________________________________________________

4. Name of the Subject: _____________________________________________________

5. Date of Assessment :

A. Complete urine examination

6. Routine _______________________________

7. Microscopic ___________________________

B. Complete blood picture and haemogram

8. Total count (Cells/Cu.mm) ______________________

9. Differential count: P ____ (%) L ____ (%) E ____ (%) M ____ (%) B ____ (%)

10. ESR (mm/ 1st hour) _______________

11. M.C.H.C. (g/dl) _______________

12. M.C.V. (fl) _______________

13. PCV (%) _______________

14. Hb (gm/dl) _______________

15. Serum iron (μg/dl) _______________

16. Total Iron Binding Capacity - TIBC (μg/dl) _______________

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C. Plasma glucose (mg/dl)

17. Fasting _______________

18. Post prandial _______________

D. Lipid profile (mg/dl)

19. HDL _______________

20. LDL _______________

E. Liver function tests

21. Serum proteins (gm/dl) Albumin ________ Globulin_________

Serum bilirubin (mg/dl). Total ________ Direct____________

22. SGOT (IU/L) ______

23. SGPT (IU/L) ______

24. Serum alkaline phosphatase (U/L)

25. Serum triglycerides (mg/dl) _______________

26. Serum cholesterol (mg/dl) _______________

F. Serum electrolytes (mmol/L)

27. Sodium____________

28. Potassium _________

29. Chlorides __________

G. Renal function tests (mg/dl)

30. Blood urea _______

31. Serum creatinine __________

32. Serum uric acid (mg/dl) _________

33. Serum thyroid stimulating hormone (μU/ml) ____________

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34. Serum calcium (mg/dl) ____________________

35. Serum phosphates (phosphorous) _________________

H. Special tests

36. ECG findings _______________________________

37. Pulmonary function test findings _____________________

I. Marker of inflammation

38. HsCRP (mg/L)_______________________________

39. TNF á (pg/ml) _______________________________

40. IL-6 (pg/ml) _________________________________

41. Serum melatonin (pg/ml) ________

J. Free radical system

42. Melonyl aldehyde

43. Catalase

44. Super oxide dismutase

45. Glutathione

46. Peroxidase

47. Prostate specific antigen ____________

48. Test for insulin resistance ___________

Date: _________________ Signature of the Investigator: ______________________

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CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA
MULTICENTRIC OPEN CLINICAL TRIAL OF RASAYANA DRUGS IN
HEALTHY ELDERLY PERSONS
DRUG COMPLIANCE REPORT FORM – I
(To be translated in to local language)

Sl. No. of Subject _____________________________________________________________


Name of Subject ______________________________________________________________
(To be filled by the trial participant)

(To be issued on 1st visit (0 day), 2nd visit (30th day), 3rd visit (60th day) and 4th visit (90th
day) and taken back on 2nd visit (30th day), 3rd visit (60th day), 4th visit (90th day) and 5th visit
(120th day))
Please come for next visit on ______________________________ (Date and time is to be
fill