| CTRI Number |
CTRI/2025/03/082986 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Comparative Study Of Nia VR ointment And Povidone Iodine Ointment in The Management Of Post Operative Transphincteric Anal Fistula Wound
|
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study Of Nia Vr ointment And Povidone Iodine Ointment in The Management Of Post Operative Transphincteric Anal Fistula Wound
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipika Datir |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9665536904 |
| Fax |
|
| Email |
dvd1998115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Ashok KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
National Institute Of Aayurveda |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Ashok KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
National Institute Of Aayurveda |
| Address |
Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda,Deemed to be University(DE NOVO) Joravar Singh gate Amer road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Aayurveda |
| Address |
National Institute of Ayurveda Deemed To Be University (De-Novo) Jorawar
Singh Gate Amer Road Jaipur Rajasthan – 302002 |
| 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 |
| Dipika Datir |
NIA hospital |
OPD no. 28 - National institute of aayurveda , Deemed to be university (DE NOVO) Joravar Singh Gate , Amer Road Jaipur ,Rajasthan-302002,Jaipur Rajsthan
Jaipur
RAJASTHAN |
09665536904
dvd1998115@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: NIA VR CREAM , Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 4(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: NIA VR CREAM topically used in trans sphincteric fistula in ano | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: POVIDONE IODINE OINTMENT, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 4(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -POVIDONE IODINE OINTMENT WILL BE APPLIED LOCALLY IN TRANSPHICTERIC ANAL FITULA WOUND |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of post operative partial fistulotomy (Anshik Bhedana) with Ksharasutra application between 20 to 60 yrs of age will be included in this study.
Having no any other local or systemic ailment requiring active treatment.
|
|
| ExclusionCriteria |
| Details |
Intersphincteric
Extrasphinctericor
Suprasphincteric anal fistula
Patients with other concurrent diseases requiring active treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall improvement to the wound
wound status will be assesed on the basis of subjective parameter i.e pain and gandha .Objective parameter stava and wound size . |
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the quality of life of the patient |
12 week |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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 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
|
Participants attending OPD and IPDof NIA Shalyatantra department satisfying the selection criteria will be selected. All the participants who voluntarily agree to participate and provide informed written consent for participation will be recruIted in tHe study . Total 60 participants will be selected after detail examination and divided in 2 groups of 30 patients as per study protocol.All procedures will be executed under aseptic precaution. Patient will be kept for 3 days in post operative days assessment of the outcome will be on 7, 14 ,21 28 days Patient will be followed up on every 2 nd week after completion of trial for 2 months |