| CTRI Number |
CTRI/2025/07/090201 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
JATAYADI GHEE AND DURVADI GHEE IN ANAL FISSURE GIVE COMPLETE RELIEF |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF JATAYADI GHRITA PICHU AND DURVADI GHRITA PICHU IN PARIKARTIKA W.S.R FISSURE IN ANO |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipin Kumar |
| Designation |
PG Scholar |
| Affiliation |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UP |
| Address |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP Farrukhabad UTTAR PRADESH 209602 India |
| Phone |
8795651095 |
| Fax |
|
| Email |
drvipinkrishna@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ravindra G Varma |
| Designation |
Professor and HOD |
| Affiliation |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UP |
| Address |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP Farrukhabad UTTAR PRADESH 209602 India |
| Phone |
9036563856 |
| Fax |
|
| Email |
ravivarma3856@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vipin Kumar |
| Designation |
PG Scholar |
| Affiliation |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UP |
| Address |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BEWAR ROAD FATEHGARH FARRUKHABAD UP Farrukhabad UTTAR PRADESH 209602 India |
| Phone |
8795651095 |
| Fax |
|
| Email |
drvipinkrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Babu singh jay singh Ayurvedic medical College and hospital farrukhabad uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Vipin Kumar |
| Address |
SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABAD UP |
| Type of Sponsor |
Other [Private Ayurvedic medical College ] |
|
|
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 Vipin Kumar |
Shri Babu singh jay singh ayurvedic medical College and hospital |
Department of PG Studies in SHALYA TANTRA OPD NO. 11 Farrukhabad UTTAR PRADESH |
08795651095
drvipinkrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sushruta samhita , Procedure details: Gudapicu ) (1) Medicine Name: DURWADI ghrita, Reference: Shasrayogam , Route: Rectal, Dosage Form: Ghrita, Dose: 10(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sushruta samhita , Procedure details: Gudapicu) (1) Medicine Name: Jatayadi ghrita , Reference: Shasrayogam , Route: Rectal, Dosage Form: Ghrita, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient Diagnosed With Parikartika Fissure in ano
Patient of either sex,aged between 18years to 50 years.
Patient of Multiple Fissure in Anal Canal.
Lactating Mother. |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete wound healing. |
2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, burning sensation reduction, improvement in quality of life. |
2weeks |
|
|
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 1 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="3" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Fisssure uIn Ano is a most troubling and painfull condition that aafect great majority of population and occurs at any age irrespective of gender having prevalence rate 30 to 40 % of total ano rectal disease. This study contains toatal number 40 Patients divided into 2 groups, having 20 patients each. Patient will be selected according to inclusion and exclusion criteria and will be registered in selected case Proforma. Picchu will be given for 7 days and follow up will be done afte 7 days with Jatayadi ghrita and Durvadi ghrita picchu in Parikatika (Fissure in Ano) . |