| CTRI Number |
CTRI/2026/03/105813 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Manjistadi herbal ghee used as a suppository versus local application for managing anal fissures. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of manjistadi ghrita gudavarthi and manjistadi ghrita in the management of parikarthika vis-a-vis acute fissure in ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARITHA B |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8970242149 |
| Fax |
|
| Email |
harithaharry0365@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAIPRASAD S SHETTIGAR |
| Designation |
Associate professor |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8277766651 |
| Fax |
|
| Email |
eastwestpack@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HARITHA B |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8970242149 |
| Fax |
|
| Email |
harithaharry0365@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences, Manipal , 576104, karnataka, India |
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences Manipal |
| Address |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi, 576104 , karnataka ,India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HARITHA B |
Muniyal institute of ayurveda medical sciences, Manipal |
Out patient department of shalya tantra, room no.9, first floor, muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal,udupi
Udupi
KARNATAKA |
8970242149
harithaharry0365@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda and medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjistadi ghrita gudvarthi, Reference: P v sharma, chakradatta, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjistadi ghrita, Reference: P v sharma, chakradatta, Route: Rectal, Dosage Form: Ghrita, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cases of fissure in ano are taken for study.
2.Patients having acute fissure in ano with duration less than 12 weeks.
3.Patients, irrespective of religion, occupation and economic status are taken.
4.Patients of both sexes, between age group of 18 to 60 yrs |
|
| ExclusionCriteria |
| Details |
1.Patients having fissures in ano secondary to ulcerative colitis, syphilis, Crohns disease, tuberculosis.
2.Patients suffering from malignancy of any organ or ano rectum are excluded.
3.Patients suffering from chronic fissures and sentinel tags.
4.Patients with uncontrolled diabetes.
5.Patients suffering from fissure in ano are associated with conditions like hemorrhoids and fistula in ano.
6.Patients with infectious diseases like HbsAg and HIV. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, Healing of fissure |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in bleeding per rectum, Improvement in overall patient comfort, and quality of life |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fissure in ano is a longitudinal tear in the lower part of the anal canal extending from just below the dentate line to the anal verge. Initially, it involves only the epithelial layer but may later extend deeper into the anal mucosa. It commonly occurs in the posterior midline of the anal canal and is usually caused by trauma due to the passage of hard stools, followed by secondary infection. Spasm of the anal sphincter leads to severe pain during and after defecation.
The condition commonly affects young and middle-aged individuals, with a mean age of around 39.9 years. About 75% of fissures occur in the posterior midline, while 25% occur anteriorly, which is more common in women. Nearly 40% of acute fissures may progress to chronic fissures. The annual incidence is approximately 0.11%, with variations according to age and sex.
Modern treatments such as topical medications, botulinum toxin injections, and lateral sphincterotomy are available but have several limitations, including headache, recurrence, sphincter weakness, infection, and risk of fecal incontinence.
In Ayurveda, fissure in ano is correlated with Parikarthika, characterized by severe cutting pain in the anal region. Acharya Sushruta has recommended Manjistadi Ghrita for Vrana Shodhana and Vrana Ropana (wound cleansing and healing). In this study, Manjistadi Ghrita Guda Varti, prepared using Maduchhista (beeswax) as the base, is used to provide prolonged contact of the medicine with the affected area. Due to its Vrana Ropana, Vata-Pitta Shamana properties, a clinical comparative study was conducted to evaluate the effectiveness of Manjistadi Ghrita Guda Varti and Manjistadi Ghrita in the management of Parikarthika (fissure in ano). |