| CTRI Number |
CTRI/2025/01/079594 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study effect of aaradvadhadi ksharsutra in bhagandara. |
|
Scientific Title of Study
|
A randomised controlled clinical study of Aragvadhadi Ksharsutra and Apamarga Ksharsutra in the management of Bhagandara. |
| 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 Akanksha Dasila |
| Designation |
PG Scholar (Shalya tantra) |
| Affiliation |
Bharti vidyapeeth deemed to be university, college of ayurved, pune |
| Address |
Department of shalya tantra, 2nd floor, Bharti vidyapeeth deemed to be university, college of ayurved, dhankawadi, educational campus, satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8126774009 |
| Fax |
|
| Email |
akanksha.dasila-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Rokade |
| Designation |
Asso. Prof, dept of shalya tantra, B.V(D.U) C.O.A, Pune |
| Affiliation |
Bharti vidyapeeth deemed to be university, college of ayurved, pune |
| Address |
Department of shalya tantra, 2nd floor, Bharti vidyapeeth deemed to be university, college of ayurved, dhankawadi, educational campus, satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822552223 |
| Fax |
|
| Email |
bharat.rokade@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Rokade |
| Designation |
Asso. Prof, dept of shalya tantra, B.V(D.U) C.O.A, Pune |
| Affiliation |
Bharti vidyapeeth deemed to be university, college of ayurved, pune |
| Address |
Department of shalya tantra, 2nd floor, Bharti vidyapeeth deemed to be university, college of ayurved, dhankawadi, educational campus, satara road, Pune
MAHARASHTRA
411043
India |
| Phone |
9822552223 |
| Fax |
|
| Email |
bharat.rokade@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Department of shalya tantra college of ayurveda bharti vidyapeeth deemed to be university |
|
|
Primary Sponsor
|
| Name |
Department of shalya tantra, college of ayurved , bharti vidyapeeth deemed to be university |
| Address |
college of ayurved , bharti vidyapeeth deemed to be university, Dhankawadi, satara road, Pune, 411043 |
| 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 Akanksha Dasila |
Bharti vidyapeeth deemed to be university college of ayurveda and hospital |
Department of shalya tantra IPD fourth floor, Shalya ipd procedure room, pune, maharashtra
Pune
MAHARASHTRA |
8126774009
akanksha.dasila-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth(Deemed to be university), College of Ayurved ethics committee, Pune [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Su chi 17/32, Procedure details: Ksharsutra ligation every 7 th day till complete cutting of tract.)
(1) Medicine Name: Aajragvadhadi kshar, Reference: Su chi 17/32, Route: Rectal, Dosage Form: Kshara, Dose: 1(NA), Frequency: sos, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having low level fistula |
|
| ExclusionCriteria |
| Details |
Patients having bleeding disorders
patient on anti coagulation drugs and ca rectum
Pregnant women
Chronic or acute ulcerative collitis
Intestinal and pelvic malignancies
Veneral diseases and HIV
Multiple fistulae originating mainly due to tuberculosis
Crohn’s disease
Uncontrolled DM
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in length of tract. |
Centimeter per 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of fistula tract |
4 to 5 weeks |
|
|
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)
|
01/02/2025 |
| 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)
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
|
The study will be conducted after obtaining permission from the Institutional Ethics Committee and will be registered in CTRI, India. • As per Inclusion / Exclusion criteria patient will be selected. • Whole research procedure and aim will be clearly informed to patients and consent form will be signed and CRF will be filled. • Conduct of procedure: Patient will be examined in OPD on the day of first visit with necessary Investigations. After Investigations and deemed fit the patient will be counselled for enrollment in the study. • Procedure will be explained to the patient that ksharsutra will be applied and tied to the fistula, and is kept for one week, the kshar sutra will be changed weekly. any unexpected risk occur during the trial as an outcome of research purpose. All the possible care will be taken by hospital till patient is normalized. • Some subjects might experience symptoms like pain, burning Sensation,Itching etc, in such a case, cause will be found out and proper treatment will be advised. • Patient will be observed and if patient is not following the treatment protocol or not willing to continue treatment can be considered as a drop out. |