| CTRI Number |
CTRI/2025/05/087540 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy Of Kushthadi Ointment In The Management Of Post Operative Fistulectomy Wound compared to Povidone Iodine |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Kushthadi Ointment In The Management Of Post Operative Fistulectomy Wound As Compared With Povidone Iodine 10 percent Ointment |
| 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 Sunil Dhavale |
| Designation |
Ph. D. Scholar |
| Affiliation |
Yerala Medical Trust Ayurveda mahavidyalaya |
| Address |
Shalya Tantra OPD No. 2, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210.
Thane
MAHARASHTRA
410210
India |
| Phone |
9221528099 |
| Fax |
|
| Email |
m2d2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Dhavale |
| Designation |
Ph. D. Scholar |
| Affiliation |
Yerala Medical Trust Ayurveda mahavidyalaya |
| Address |
Shalya Tantra OPD No. 2, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210.
Thane
MAHARASHTRA
410210
India |
| Phone |
9221528099 |
| Fax |
|
| Email |
m2d2810@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Principal and Professor |
| Affiliation |
erala Medical Trust Ayurveda mahavidyalaya |
| Address |
Shalya Tantra OPD No. 2, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210.
Thane
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210. |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Dhavale |
| Address |
Dr. Sunil Dhavale Shalya Tantra OPD, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210 |
| 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 Sunil Dhavale |
Yerala Medical Trust Ayurveda Mahavidyalaya |
Shalya Tantra OPD, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210.
Shalya Tantra OPD, Yerala Medical Trust Ayurveda mahavidyalaya, Sector - 4, Kharghar, Navi Mumbai - 410210.
Thane
MAHARASHTRA |
09221528099
m2d2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research, Dr. G. D. Pol Foundations Institute for Research and Post graduate Studies in Ayurveda, Kharghar, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushthadi Churna - Ointment, Reference: Sushruta Samhita Chikitsa Sthana - Bhagandara Chikitsa, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine | POVIDONE IODINE 10% Ointment application - Twice a day - 28 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult of any gender
All post-operative fistulectomy wound |
|
| ExclusionCriteria |
| Details |
1. Wound involved with TB, malignancy
2. Infections like HIV, HbsAg Syphilis
3. Uncontrolled Diabetic wound |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - Assessment of Relief in symptoms of Bhagandara such as Shool, Strava, Shotha, Sparshasahatva and gandha |
- Baseline, Day 7, Day 14, Day 21 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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
|
Two arm, Open labeled, randomized comparative clinical study Study setting- Clinical study Selection of patients- Selection of Patients from the IPD and OPD of the concern Institute fulfilling POST OPERATIVE FISTULECTOMY WOUND will be done as per inclusion and assessment criteria from OPD will be enrolled in this study. There will be 70 number of patients either gender from ShalyaTantra OPD/IPD of concerned institute, divided into 2 groups Groping of patients- 1) Study group : 35 Patients. 2) Control group : 35 Patients. Study population- Patients of POST OPERATIVE FISTULECTOMY WOUND fulfilling the inclusion criteria Duration of study- 28 days Follow up during study- Day 0, Day 7, Day 14, Day 21 & 28 Day from the initiation of the study. After permission of ICE and BORS- Prepared case record form will used. Informed consent from patients will be taken. |