Original Research

Clinical Efficacy of pilief Tablet and Ointment in Piles and

Fissure-in-ano
Sanjay Kumar Gupta1, Tukaram Sambhaji Dudhamal2, Madhav Singh Baghel3, Panchakshari Patil4
Dept. of Shalyatantra, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar 1, 2, 3
4
Senior Research Fellow (SRF), AYU International Journal, IPGT&RA, Gujarat Ayurved University, Jamnagar
Corresponding Authors Email: drtsdudhamal@gmail.com

Abstract
In ano-rectal disorders, incidences of piles and fissures are increasing in Indian population due to the western
lifestyle. In surgery many methods are available for curing ano-rectal disorders but nowadays demand of Ayurveda
and herbal preparation are increasing in society. In this study, Arshonyt forte tablet and ointment were tried in
management of piles and fissure-in-ano. The study was open prospective interventional in which patients of piles
(n = 37), acute / chronic fissures (n=14) and piles with fissures (n=12) were selected from the study centre. Two
tablets of pilief forte orally twice a day and Arshonyt ointment applied per rectal twice a day in appropriate
quantity for two weeks. The patients were assessed by a weekly interval for relief in sign and symptoms. The
obtained results were analyzed and encouraging results were observed after completion the treatment. Study
concluded that pilief forte tablet and ointment have been potential to cure piles (to be second grade) and fissure-
in-ano (acute and chronic).
Key words : Ayurveda, Piles, Fissure-in-ano, Tablet pilief, pilief ointment

Annals Ayurvedic Med. 2014:3 (3-4) 81 -
87 Introduction
Hemorrhoids is one of the common anorectal disorder
which equally affects men and women.[1] The worldwide
prevalence of hemorrhoids is said to be around 4.4%
and incidences are increased with age. The pregnancy is
also a predisposing risk factor for the development of
symptomatic hemorrhoids in females.[2] The symptoms
of piles are bleeding, pain, protrusion of piles and
perianal itching. Conservative medical treatment of
hemorrhoids includes use of fiber supplements; lifestyle
modifications may include relieving constipation,
avoiding straining, proper fluid intake, better anal
hygiene, and sitz baths.[3] If not respond to conservative
measures, rubber band ligation, sclerotherapy, infrared
coagulation, and criosurgery are some OPD
procedures.[4] Surgery i.e., hemorrhoidectomy for
hemorrhoids is indicated in fourth grade when
symptoms of bleeding, pain, and prolapsed
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec,
2014
piles compromise quality of life. In this context
Sushruta also explained four types of treatment
modalities like Bheshaj, (Medicine), Ksharakarma (Use
of Kshara / Ksharasutra), Agnikarma
(Cauterization) and Shastrakarma (Surgery)
according to the nature of Arsha (piles) which also
include surgery as last option.[5]
Acute fissure is a superficial ulcer with a base formed
by loose connective tissue and transverse fibers of the
internal sphincter. A sentinel pile external may be present
and rarely there is a hypertrophied anal papilla internal
in case of chronic fissure. The symptoms persist for
more than six - eight weeks are considered, a case of
chronic fissure-in- ano. The chronic fissure can manage
with fissurectomy, sphincterotomy (dorsal or lateral)
with their limitations and complications with marked
impact on the quality of life.[6-7] Treatment with herbs is
known to human beings since centuries. Recently,
herbal treatments has again gotten popularity with
1
documented effects on influence of blood vessel-wall
tone, decrease of capillary permeability,

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 2

2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

improve circulation, decrease of edema and blockage of
inflammatory mediators. It has been observed that in
anorectal disorders such as hemorrhoids and fissures,
twin treatment which includes oral (systemic) and
topical administration of phytomedicines offers a
significant and faster relief resulting in improved quality
of life. So the study has been planned to evaluate the
efficacy of pilief forte tablet and ointment in cases of
piles and fissure in ano.
Materials and Methods
This study was an open prospective interventional study
of four weeks. Patients having complaints of piles and
fissures were selected from the outpatient department
and in patient department of the study center. Detailed
clinical history, physical and local per rectal findings was
recorded in clinical research proforma.
Inclusion criteria
Patients of either gender between age of 20 to 70 years
having first, second and third grade hemorrhoids and
acute as well as chronic fissure-in-ano were included in
the study.
Exclusion criteria
Patients of congenital rectal polyp, anal stenosis, forth
degree hemorrhoids and complicated hemorrhoids like
thrombosed piles, strangulated piles etc. were excluded.
Patients of piles or anal fissure associated with fistula-
in- ano, ano rectal abscess were excluded from study.
Patients having systemic diseases like cardiovascular,
renal, hepatic, neurological were excluded. Unwilling
patients and anemic patients (Hemoglobin % < 7gm %)
were also excluded from the study.
Ethical Clearance: Institutional Ethics Committee:
PGT/ 7-A/ Ethics/ 2011 12/2087/Agenda no.-3/3
dated 05.09.2011.)
Ingredients of trial drugs: pilief tablet and ointment are
manufactured and supplied by Charak Pharma Pvt. Ltd.,
Mumbai having ingredients as mentioned in table-1 and
table 2.
Drug’s administration (dose and duration)
Tablet: Oral two tablets twice a day for two
weeks.
Ointment: Per rectal applications of ointment twice a
day in appropriate quantity. The ointment was applied
inside the anal canal with the help of an applicator or
index finger.
Does and Don’t: Patients were advised to consume
fiber rich diet, green vegetables, plenty of water, and
buttermilk. Patients were advised to avoid spicy, non-
vegetarian diet, oily and junk foods. A daily morning
walk for half an hour was also advised.
Assessment criteria: Efficacy was assessed at the end
of two and four weeks of treatment as reduction in
intensity of following sign and symptoms based on
gradations.
1- Inflammation
2- Bleeding per rectum 3- Ano- rectal pain
4- Itching per ano
5- Prolapsed of piles
Overall assessment

Investigations 76-100%, were considered : Complete remission

Routine hematological investigations such as Hb% 60-75%, were considered : Marked improvement
(hemoglobin), TLC (Total leucocyte count), DLC
(Differential leucocyte count), BT (Bleeding time), CT 40-59%, were considered : Moderate improvement
(Clotting time), ESR (Erythrocyte sedimentation rate), 21-39%, were considered : Mild improvement
AST (Aspartate aminotransferase), ALT (Alanine
aminotransferase), Alkaline phosphatase, Blood urea and Up to 20%, were considered : Unchanged
serum creatinine were done at baseline and at the end of
Statistical analysis: Statistical tests such as ‘student
the study.
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 3
2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet
paired ‘t’ test’ and ‘Wilcoxon signed rank test’ applied
to assess the result.

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 4

2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

Observations and Results 82.99% relief in pain by the second week. Among 54
In this study, out of 63 patients, 45 patients were males patients, with pain in ano; 16 patients got complete
and 18 were females. Male predominance was found relief from pain by first week and 25 patients got
higher might be due to reporting of more male patients complete relief from pain after second week. The
to the anorectal department. 42 patients were between reduction in perianal itching in first week was 60.98%
20-40 years of age group and remaining in age group while 84.76% in second week. Among total 28 patients
between 41- 70 years, which showed that most of the of itching per ano; 12 patients got complete relief from
patients were middle of the age group. 12 patients itching in first week and 10 patients got complete relief
reported family history of piles although assuming this from itching after the second week. Protrusion of piles
small sample studies it is difficult to say that piles and was reduced by 40.59% at the end of first week and
fissures are hereditary disease. History of same disease 47.52% at the end of second week. Among total 49
reported by 33 patients might be due to recurrence patients of piles; in three patients piles were reduced by
nature of the anorectal disorders. Out of 63 patients 33 the first week and 10 patients got complete reduction of
patients had irregular bowel habits; 47 patients piles by completion of second week (Table 3).
complained of constipation and hard stools. The In hemotological investigations total leucocyte count
constipation and irregular bowel movement are the main and neutrophil count was found decreased and
etiological factors of piles and fissure. lymphocyte count was increased with stratistical
On local per rectal examination, 49.21% patients had significance (Table 4). But the changes found are in
normal peri-anal skin. Among all patients, 41.27% physiological limit. The biochemical investigations and
patients were diagnosed as a case of acute/chronic rest hematological investigations showed insignificant
fissure-in-ano; 40.81% patients were having external changes (Table 5). So with these findings it can be said
piles. 59.19% patients had internal piles. Patients with that pilief ointment and tablet might be helpful to control
second degree piles were observed maximum (65.31%) per rectal congestion and control the infection
because in this stage a patient suffered from per rectal respectively.
bleeding as well as congestion of the piles may lead to Overall Assessment
anorectal discomfort which brings the patients to
surgeon. At base line 85.71% patients had pain in ano, Overall effect of therapy showed that 74.60% patients
69.84% patients bleeding per rectum and 44.44% got complete remission. Hence it can be said that the
patients had been itching per ano. patients of piles and fissure in primary stage is managed
with pilief forte tablet and ointment (Table-6).
Effect of therapy
Discussion
After first week treatment, 54.75% relief was seen in
inflammation and at the end of the second week 80.45% The present study of pilief forte tablet and pilief
reduction in inflammation was observed. Bleeding per ointment was designed to evaluate the efficacy of twin
rectum was reduced by 62.29% after the first week and treatment in management of piles and fissure-in ano.
by 92.00% after second week. Among 44 patients with The study planned with herbal tablet and ointment
bleeding per rectum; total 20 patients got complete which had been an anti-inflammatory, antioxidant and
cessation in bleeding during first week and 18 patientsastringent potential of their herbal ingredients.
got complete cessation in bleeding by second week; in Statistically highly significant results were obtained in
remaining six patients complete cessation of bleeding patients of second degree piles and fissure-in-ano. In
per rectum was not observed but the quantity and cases of acute and chronic fissure-in-ano fissure healed
frequency was quite reduced. completely within two weeks. In cases of internal piles
highly significant result was seen in features of bleeding
Pain in ano was reduced by 57.22% after first week and per rectum and peri-anal itching irrespective of the
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 5
2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet
decrease in size of piles. The healing of fissure bed
and congestion of piles showed a

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 6

2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

highly significant result. cellulitic waste. The seeds of Cyamopsis tetragonoliotous

In maximum patient significant reduction in

inflammation, pain, congestion of piles and cessation of
bleeding per rectum was observed after two weeks. In
fissure cases the fissure bed healed effectively with
combined formulation of local application of pilief
ointment and oral intake of pilief forte tablet. This
formulation showed an anti- inflammatory, analgesic
and healing effect of combined formulation. These
findings are strongly supported by significant reduction
in the total leukocyte counts towards the normal in
maximum patients on completion of treatment for two
weeks. In one pregnant patient with second degree piles,
encouraging results were obtained without any adverse
effect. In efficacy parameters the relief was 80.45% in
inflammation, 92.00% in bleeding per rectum, 82.99%
in ano-rectal pain and 60.98% in itching per ano.
Overall cured rate was 75% in cases of piles and
fissure-in ano without adverse effect.
A major component of a safe and effective therapy for
hemorrhoids, often overlooked, is the use of plant
extract. Several plant extracts have been shown to
improve microcirculation, capillary flow and vascular
tone and strengthen connective tissue of a perianal
region. Ano- rectal and cutaneous tissues exposed to
injury react so that water molecules contained within
cells are altered and extracellular tissues are injured.
These injured tissue results in the formation of a number
of noxious free radicals who leads to ano-rectal diseases
with symptoms pain, inflammation, swelling and
itching. The ingredients of pilief reduced local
inflammation and free-radical damage. When pilief
ointment applied locally astringent herbs strengthen the
veins and reduce bleeding. They cause coagulation of
proteins in the cells of the lining of the anal canal. This
action promotes dryness of the skin, which in turn helps
in relieving burning, itching and pain. The astringent
effect of herbs helps to heal mucous membranes and
exposed tissue of a anal canal.[8]
Mode of action of pilief forte tablet

The ingredient Cyamopsis tetragonolobus (L.) Taub. is

a source of fiber which facilitates faster elimination of
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 7
2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet
contain a big endosperm which consists large amount convenient for consumption without adverse effect.
of polysaccharide of galactose and mannose facilitating
to relieve constipation.[9] In Ayurveda classics, Melia
azadirachta L. and Acacia catechu Willd. are said to
be Krimighna (antimicrobial); so helpful in controlling
infection and related disorders and in this way it
promot absorption of food and elimination of waste
properly.[10] Terminalia chebula Retz. and Aloe
barbadensis Miller. having laxative property and
known to relieve constipation which is a foremost cause
of anorectal disorders. Plumbago zeylanica is well
known herb for Agnideepan (appetizer) and
Amapachan (digestive) which are also helpful to
correct bowel habit.[11] For ano-rectal disorders like
piles and fissure, indigestion and loss of appetite are
the main causative factors which are relieved
significantly with these ingredients.

Mode of action of pilief ointment

pilief ointment contains Curcuma longa L. which has

been found effective in healing of the fissure ulcer and
congestion of piles due to its wound healing and
antibacterial activity.[12-13] Other contents are Melia
azadirachta and Acacia catechu which are described as
Krimighna (antimicrobial) in Ayurved classic and
topical application of these two ingredient might have
acted to control the local infection and promoted the
healing. The antibacterial and antifungal potential of
leaf extracts of Acacia catechu is due to its high
terpene contents known to relieve local infection. The
extract of Acacia catechu is effective against Gram-
positive and Gram-negative bacteria as well as against
Candida albicans fungus.[14] Aloe barbadensis is
soothing in nature so helpful to relieve burning pain in
ano and it also has antibacterial activity helps to curtail
anorctal infection.[15] Glycyrrhiza glabra
L. is proven for its healing properties by reducing
mucosal congestion; so it helped in healing of fissure-
in-ano as well as pile masses.[16-17]

Conclusion

The study was concluded that pilief forte tablet and

pilief ointment have been potential to cure piles of up to
second degree and cases of acute as well as chronic
fissure-in-ano. The formulation is easy to use and
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 8
2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

Conflict of Interest: Nil peroxidation as key factors. International

Jornal of Biological chemistry. 2009; 3:
Acknowledgement: The financial support of Charak 111-118.
Pharma Pvt. Ltd., Mumbai to conduct this clinical trial
was greatly appreciated. 9.

References
1. Janicke D, Pundt M. Anorectal disorders.
Emerg Med Clin North Am. 1996; 14: 757-88.
2. Avsar AF, Keskin HL. Haemorrhoids during
pregnancy. Journal of Obstetrics &
Gynaecology. 2010;30( 3):231-237.
3. Billingham RP, Isler JT, Kimmins MH, Nelson
JM, Schewitzer J, Murphy MM.The Diagnosis
and Management of Common Anorectal
Disorders; Curr Probl Surg. 2004; 41(7): 586-
645.
4. Surgery of the Anus, Rectum and Colon. By,
John Goligher with collaboration of Herbort
Duthie, Horold Nixon. A.I.T.B.S. Publishers
and Distributors; 2002. p. 131-34.
5. Sushruta Samhita, Sushruta,
Nibandhasangraha Dalhan commentary,
Yaddavji Trikamji Acharya, Chikitsa sthan
Arsha Chikitsa (6:3), Chaukh- ambha
Orientalia, Varanasi, 2009, p. 430.
6. Hosseini SV, Sabet B, Amirkolaee MN,
Bolandparvaz S. A Randomized Clinical Trial
on the Effect of Oral Metronidazole on Wound
Healing and Pain after Anal Sphincterotomy
and Fissurectomy. Archives of Iranian
Medicine. 2008;11(5): 550-552.
7. Memon AS, Siddiqui FG, Hamad A.
Fissurectomy with Posterior Midline
Sphincterotomy for Management of Chronic
Anal Fissure. Journal of the College of
Physicians and Surgeons Pakistan. 2010; 20
(4): 229-233.
8. Odukoya OA, Sofidia MO, Ilori OO, Gbededo
MO, et al. Hemorrhoid therapy with medicinal
plants: Astringency and inhibition of lipid
Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 9
2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet
http://en.wikipedia.org/wiki/Guar accessed on dated
3.2.14
10. Dravyaguna Vignyan. By, Priyavat Sharma.
Part-II, Chapter-2 Chakshushyadi Varga,
Chaukhambha Bharati Academy; 2006. p.150
&160.
11. Dravyaguna Vignyan. By, Priyavat Sharma.
Part-II, Chapter-5 Dipanadi Varga,
Chaukhambha Bharati Academy; 2006. p. 359-
361.
12. Purohit SK, Solanki R, Mathur V, Mathur M.
Evaluation of Wound Healing Activity of
Ethanolic Extract of Curcuma longa Rhizomes
in Male Albino Rats. Asian J. Pharm. Res.
2013; 3(2): 79-81.
13. Kundu S, Biswas TK, Das P, Kumar S, De
DK. Turmeric (Curcuma longa) Rhizome
Paste and Honey Show Similar Wound
Healing Potential: A Preclinical Study in
Rabbits. International Journal of Lower
Extremity Wounds. 2005; 4(4): 205-213
14. Negi BS, Dave BP. In Vitro Antimicrobial
Activity of Acacia catechu and its
Phytochemical Analysis. Indian J Microbiol.
2010; 50(4): 369- 374.
15. Barandozi FN. Antibacterial activities and
antioxidant capacity of Aloe vera. Org Med
Chem Lett. 2013; 3: 5.
16. Irani M, Sarmadi M, Bernard F, Gholam H E,
Bazarnov HS, Leaves Antimicrobial Activity of
Glycyrrhiza glabra L. Iranian Journal of
Pharmaceutical Research. 2010; 9 (4): 425-
428.
17. Das D, Agrawal SK, Chandola HM. Protective
effect of Yashtimadhu (Glycyrrhiza glabra)
against side effects of radiation/chemotherapy
in head and neck malignancies. AYU. 2011;
32(2): 196-199.
Source of Support : Nil
Conflict of Interest : None

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 10

2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

Table- 1 Composition of pilief Forte Tablet:

Sr.no. Ingredients Sanskrit Name Form Quantity

1. Cyamopsis tetragonoliotous Guar Powder 25mg
2. Melia azadirachta Neem Extract 200mg
3. Acacia catechu Khadira Extract 200mg
4. Aloe barbadensis Kumari Extract 175mg
5. Terminalia chebula Haritaki Extract 150mg
6. Plumbago zeylanica Chitraka Extract 100mg

Table-2 Composition of pilief Ointment

Sr. no. Ingredients Form Quantity

1. Curcuma longa Haridra — 75mg

2. Melia azadirachta Neem Extract 200mg
3. Acacia catechu Khadira Extract 200mg
4. Aloe barbadensis Kumari Extract 175mg
5. Glycyrrhiza glabra Yashtimadhu Extract 150mg

Table -3: Effect of Therapy: (Wilcoxon Signed rank test)

(n=63)
Chief Assessment Mean Score Mean % Relief W n p
complaint Duration BT AT Diff.
Inflammation 1st Week 1.79 0.81 0.98 54.75  1832 61 < 0.001
2nd Week 1.79 0.35 1.44 80.45  1711 58 < 0.001
Bleeding per rectum 1st Week 1.75 0.66 1.09 62.29  666 36 < 0.001
2nd Week 1.75 0.14 1.61 92.00  946 43 < 0.001
Pain in ano 1st Week 1.94 0.83 1.11 57.22  1275 50 < 0.001
2nd Week 1.94 0.33 1.61 82.99  1409 53 < 0.001
Itching per ano 1st Week 1.64 0.64 1.00 60.98  351 26 < 0.001
2nd Week 1.64 0.25 1.39 84.76  300 24 < 0.001
Size of pile 1st Week 2.02 1.20 0.82 40.59  820 40 < 0.001
2nd Week 2.02 1.06 0.96 47.52  946 43 < 0.001

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 11

2014
 Gupta SK et.al. : Clinical Efficacy of pilief Tablet

Table-4: Effect on hematological investigations: (paired ‘t’ test)

Hematological Mean Mean % SD SEM t p Signifi-

Investigation BT AT Diff Change cance
Hb% 12.46 12.58 -0.12 0.97  0.76 0.096 -1.260 0.213 > 0.05
TLC 6880.65 6556.45 324.19 4.71  1183.87 150.35 2.156 0.035 < 0.05
Neutrophils 60.05 57.90 2.15 3.57  6.47 0.82 2.613 0.011 < 0.05
Lymphocyte 33.68 35.36 -1.68 4.98  5.68 0.72 -2.327 0.023 < 0.05
Eosinophil 3.73 3.87 -0.15 3.89  2.52 0.32 -0.453 0.652 > 0.05
Monocytes 2.63 2.40 0.23 8.56  1.26 0.16 1.411 0.163 > 0.05
ESR 20.90 18.84 2.07 9.88  15.87 2.02 1.024 0.310 > 0.05
BT 1.64 1.65 -0.01 0.35  0.39 0.05 -0.112 0.911 > 0.05
CT 3.79 3.88 -0.09 2.28  0.55 0.07 -1.231 0.223 > 0.05

Table-5: Effect on biochemical investigations: (paired ‘t’ test)

Biochemical Mean score Mean % change SD SEM t P Significance

investigation BT AT Diff
FBS 86.03 87.27 -1.24 1.44  13.41 1.70 -0.729 0.469 > 0.05
AST 20.76 18.87 1.89 9.09  10.63 1.35 1.398 0.167 > 0.05
ALT 23.57 23.45 0.11 0.48  6.66 0.85 0.134 0.894 > 0.05
Blood Urea 24.57 24.16 0.40 1.64  7.50 0.95 0.423 0.674 > 0.05
Sr. Creatinine 0.97 0.99 -0.015 1.49  0.16 0.020 -0.711 0.480 > 0.05
Alkaline
Phosphatase 63.68 63.21 0.47 0.73  19.20 2.44 0.192 0.849 > 0.05

Table-6: Overall effect of therapy:

(n=63)

Sr. No. Overall Effect No. of patients Percentage (%)

1. Complete remission (76-100%) 47 74.60

2. Marked Improvement (60-75%) 07 11.11
3. Moderate Improvement (40-59%) 06 09.52
4. Mild Improvement (21-39%) 01 01.59
5. Unchanged (up to 20%) 02 03.18

Annals of Ayurvedic Medicine Vol-3 Issue-3-4 Jul.-Dec, 12

2014