| CTRI Number |
CTRI/2026/01/102535 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Shodhan Dravya Coated Ksharsutra in the Treatment of Bhagandar (Fistula-in-Ano) |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of classical ksharsutra and ksharsutra coated with shodhan dravya in the management of bhagandar w.s.r. to fistula in ano: an open-label randomized trial |
| 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 Ajitkumar Barot |
| Designation |
PG Scholar |
| Affiliation |
Shree Swaminarayan ayurvedic college kalol |
| Address |
Department of shalyatantra Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist
Gandhinagar 382725 GUJARAT India
Gandhinagar
GUJARAT
382725
India
Gandhinagar
GUJARAT
382725
India |
| Phone |
8141390068 |
| Fax |
|
| Email |
barotajit9316@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Ramole |
| Designation |
M.S(SHALYATANTRA) HEAD OF DEPARTMENT |
| Affiliation |
Shree Swaminarayan ayurvedic college kalol |
| Address |
Department of shalyatantra Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist
Gandhinagar 382725 GUJARAT India
Gandhinagar
GUJARAT
382725
India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana Ramole |
| Designation |
M.S(SHALYATANTRA) HEAD OF DEPARTMENT |
| Affiliation |
Shree Swaminarayan ayurvedic college kalol |
| Address |
Department of shalyatantra Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist
Gandhinagar 382725 GUJARAT India
Gandhinagar
GUJARAT
382725
India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic college and Hospital Ahmedabad Mehsana Highway AT and PO saij TA kalol DIST Gandhinagar 382725 GUJARAT |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic college kalol |
| Address |
Faculty of Ayurveda Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar
382725 GUJARAT India |
| Type of Sponsor |
Private 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 Ajitkumar Barot |
Premswarupa Swami Ayuvedic Multispeciality Hospital |
OPD 006 Department of Shalyatantra
Gandhinagar
GUJARAT |
8141390068
barotajit9316@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shree Swaminarayan Ayurvedic college and Hospital Kalol |
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 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र Pradhan Karma | (Procedure Reference: Chakrapani Datta. (n.d.). Chakradatta: Arshadhikara, Shloka 148 (P. H. Bajpayee, Trans., 3rd ed., p. 66). Chaukhambha Sanskrit Sansthan, Procedure details: shodhana dravya coated ksharsutra ligation in bhagandar(anal fistula))
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Chakrapani Datta. (n.d.). Chakradatta: Arshadhikara, Shloka 148 (P. H. Bajpayee, Trans., 3rd ed., p. 66). Chaukhambha Sanskrit Sansthan, Procedure details: classical apamarga ksharsutra ligation in bhagandar (anal fistula))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Low anal fistula in ano , upto length 5cm
Diagnosed cases of bhagandar(fistula in ano)
Patient willing to consent and follow protocol
Willing to come for regular follow-up
|
|
| ExclusionCriteria |
| Details |
Patients aged below 18 and above 60 years.
Tubercular ,crohn’s or malignant fistula.
Hiv and immunocompromised patient
Patient who on long term steroid or unfit for surgery
High anal fistula and horse-shoe fistula.
Complicated fistula in ano( fistula with piles and other anorectal diseases)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1Reduction in unit cutting time(Patients treated with the Shodhan Dravya-coated Ksharsutra are expected to show a significantly shorter cutting time compared to those treated with the classical Ksharsutra.)
2Accelerated wound healing
(Faster and more complete wound healing is anticipated in the group receiving the coated with sodhan Dravya Ksharsutra)
|
upto heal or 45 to 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical validation of Ayurvedic innovation |
MONTHLY FOLLOW UP FOR 6 MONTHS TO ASSESS RECCURENCE AND ADVERSE EFFECT |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
26/02/2026 |
| 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="0"
Months="11"
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
|
Bhagandara, known as fistula-in-ano in modern medicine, is a chronic anal condition marked by a pus-discharging tract between the anal canal and perianal skin. Ayurveda classifies it among the Ashta Mahagada, highlighting its complex and recurrent nature. Modern treatments for fistula like fistulectomy and fistulotomy have limitations, Ayurveda offers Ksharsutra therapy—a para-surgical method using a medicated thread prepared with herbal alkaline drugs. This thread, traditionally coated with Snuhi latex, Apamarga Kshara, and Haridra, is effective in excising, cleaning, and healing the tract. However, it may cause discomfort and delayed healing in some patients. Recent innovations suggest modifying the Ksharsutra with Vranashodhana Dravyas to enhance healing, reduce pain, and improve outcomes. A comparative clinical study is proposed to evaluate the benefits of this modified approach in managing Bhagandara more effectively. Ksharsutra therapy, an Ayurvedic para-surgical method, offers benefits like minimal recurrence, sphincter preservation, and simultaneous cutting and healing. However, the classical Apamarga Ksharsutra may cause local irritation, prolonged healing, and discomfort in some patients. Enhancing the Ksharsutra with wound-cleansing (Vranashodhana) herbs may address these issues. A clinical study is essential to evaluate whether the modified Ksharsutra improves healing time, reduces discomfort, and lowers recurrence ultimately aiming to refine treatment protocols and enhance patient outcomes in Ayurvedic management of Bhagandara. |