| CTRI Number |
CTRI/2025/08/093806 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See and compare efficacy of JatyadiGhrita and Kampillakadi Taila Suppositories (Varti) for Acute Fissure-in-Ano |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of JatyadiGhrita and Kampillakadi Taila Suppositories in the Management of 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 Bittu |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 14, Ground Floor, Institute for Ayurved Studies and Research Shri Krishna
AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
8059182469 |
| Fax |
|
| Email |
bittukhanna1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajender Singh |
| Designation |
Chairperson Shalya Tantra |
| Affiliation |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra |
| Address |
Room no 102, 1st Floor, Institute for Ayurved Studies and Research Shri Krishna
AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9416662761 |
| Fax |
|
| Email |
drrajendersingh1346@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajender Singh |
| Designation |
HOD & Chairperson of PG Department of Shalya Tantra |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room No 102 PG Department of Shalya Tantra, Institute for Ayurved Studies and Research Shri Krishna
AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9416662761 |
| Fax |
|
| Email |
drrajendersingh1346@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies & Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies & Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri Road Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Other [Self] |
|
|
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 Bittu |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
Shalya Tantra Department Room no 14, ground floor Institute for Ayurved Studies and Research, Shri Krishna Government Ayurvedic Hospital sector-08 umri road Kurukshetra
136118
Kurukshetra
HARYANA |
8059182469
bittukhanna1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillakadi Taila, Reference: Dwivraniya Chikitsaadhaya, Charaka Chikitsa Sthana, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: If the suppository is dry or slightly rigid, sterile Tila Taila or Ghrita may be applied on its surface | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Ghrita, Reference: Ashtanga Hrudaya Uttarasthana, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: If the suppository is dry or slightly rigid, sterile Tila Taila or Ghrita may be applied on its surface |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Symptoms of pain during defecation, bleeding per rectum, and visible linear ulcer, between Age group of 20-40 years, of either gender. Patients willing to undergo trial. |
|
| ExclusionCriteria |
| Details |
Age: below 20 years or above 40 years | Sex: both male and female]
Patients who are diagnosed with conditions such as anal fistula, anorectal abscess, or Grade III–IV haemorrhoids will be excluded from the study. Individuals with immunosuppressive or systemic disorders, including Type 2 Diabetes Mellitus, HIV infection, Syphilis, Hepatitis B, Hepatitis C, Tuberculosis, or Crohn’s disease, will not be considered eligible. Patients with a history of anorectal or other malignancies, as well as pregnant or lactating women, will also be excluded. Furthermore, any patient deemed unsuitable for the investigational drug or with a known hypersensitivity or adverse reaction to the drug will not be included in the trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain during defecation (Visual Analogue Scale score) |
1st- 0 Day
2nd- After completion of Trial
3rd- 1 Month after completion of follow up after trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1, Reduction in bleeding per rectum.
2, Improvement in local inflammation signs (Tenderness).
3, Patient compliance and recurrence rate during follow-up. |
1st- 0 Day
2nd- After completion of Trial
3rd- 1 Month after completion of follow up after trial |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this Randomized Comparative Clinical study, 60 patients with fissure in Ano (Guda Vidaran) will be enrolled after meeting the necessary criteria and informed consent. In Group A, 30 patients would be treated with Jatyadi Ghrita Suppositories, prepared by mixing jatyadi ghrit with cocoa butter in it, given as a Daily dose of 1 suppository per anal after the defecation, And in Group B would also have 30 patients, who would receive Kampillakadi Taila Suppositories prepared by the same method as Jatyadi ghrita suppositories, with the same dose of medication and intervals. Before starting the treatment, all patients would be tested for essential investigation to ensure they meet the study’s requirements and informed consent will be taken. The effectiveness of the treatments will be measured by Pain Assessment Criteria in VAS readings from 1 to 10 by questionnaire. After the treatments, the results will be analyzed statistically
|