| CTRI Number |
CTRI/2025/01/079461 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Ksharasutra ligation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of fistula in ano with the help of Yavakshara Ksharasutra. |
|
Scientific Title of Study
|
Single arm clinical study of Yavakshara Ksharasutra in management of Bhagandara vis-a-vis fistula 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 Netraj Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalyatantra OPD no 03 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9405509251 |
| Fax |
|
| Email |
netraj.suryawanshi-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalyatantra OPD no 03 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822376169 |
| Fax |
|
| Email |
umesh.vaidya@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalyatantra OPD no 03 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822376169 |
| Fax |
|
| Email |
umesh.vaidya@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Dhankawadi, Katraj, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Dr Netraj Suryawanshi |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalyatantra, Dhankawadi, Katraj, Pune-411043 |
| 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 Netraj Suryawanshi |
Bharati Vidyapeeth (Deemed to be university) college of Ayurved and hospital |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Shalyatantra OPD no 03 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA |
9405509251
netraj.suryawanshi-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
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 | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Chakradatta commentary, Procedure details: Under all aseptic precautions Yavakshara ksharasutra will be ligated and Ksharasutra will be changed every week.)
(1) Medicine Name: Yavakshara, Reference: Charaka Samhita Sutrasthana 27/305-306, Route: Rectal, Dosage Form: Kshara, Dose: 1(NA), Frequency: od, Duration: 7 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as case of Bhagandara(fistula in ano specially low level fistula). |
|
| ExclusionCriteria |
| Details |
Patients suffering from Bhangandara(Fistula in ano), associated with uncontrolled DM, Hypertension, HIV, HbsAg and history of tuberculosis.
Patients with multiple fistula, haemorrhoids,
Pregnancy will be excluded from study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in length of tract |
7th, 14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete healing of fistular tract |
7th, 14th and 21st day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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 initiated after getting clearance from Institutional Ethics Committee. The research study will be registered in Clinical Trial Registry of India. This study is single arm clinical study. Patient will be selected as per inclusion/exclusion criteria. There will be all patients having characteristics according to inclusion criteria. Once the patient is enrolled tests will be done accordingly and after explaining procedure and taking written informed consent procedure will be done. Follow up will be taken on every 7th day during the treatment. Discontinue criteria If subject rejects treatment if any adverse drug reaction/patient did not come for follow up or any aggravated symptoms. |