| CTRI Number |
CTRI/2024/03/064355 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the treatment of Fistula in Ano (Bhagandar)by ksharsutra( medicated thread) and laying
open of fistula tract with kshar application(Alkaline Herbal paste)
|
|
Scientific Title of Study
|
A comparative clinical effect of Chedankarma followed by Ksharkarma and Ksharsutra threading in the management of low anal fistula |
| 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 Hetal Nakrani |
| Designation |
Ph.D. scholar and Associate Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya Nadiad |
| Address |
OPD No 136
Department of Shalya Tantra
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9998289058 |
| Fax |
|
| Email |
hetalnakrani136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Kapadiya |
| Designation |
Assistant Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya Nadiad |
| Address |
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9998289058 |
| Fax |
|
| Email |
manisha.kapadiya15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Kapadiya |
| Designation |
Assistant Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya Nadiad |
| Address |
OPD No 136
Shalya tantra Deparment
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9974047713 |
| Fax |
|
| Email |
manisha.kapadiya15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda Pharmacy
J S Ayurveda Mahavidhyalaya and P D patel Ayurveda Hospital
Collage Road
Nadiad |
|
|
Primary Sponsor
|
| Name |
Dr Hetal Nakrani |
| Address |
J S ayurveda mahavidhyalaya and P D Patel Ayurveda Hospital college Road nadiad |
| 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 Hetal Nakrani |
P D patel Ayurveda Hospital and J S Ayurveda College |
OPD No 136
Shalya Tanra
P D patel Ayurveda Hospital College Road Nadiad
Kheda
GUJARAT |
9998289058
hetalnakrani136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAGANBHAI ADENVALA MAHAGUJARAT UNIVERSITY Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: BAGANDARAH, (2) 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 | - | Group B | (Procedure Reference: Susgrut Samhuta Chikitsa Sthan 17, Procedure details: Kshrasutra application under
L.A. The fistulous tract will be flushed with Ksharjala daily. Ksharsutra will be changed through rail road method every week till fistula track is healed. )
(1) Medicine Name: Varunadi kwatha , Reference: Sharanghar Sanhita Madhyam Khanda) , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 1 Months(2) Medicine Name: Triphala Guggulu , Reference: Sharangdhara Samhita Madhayam Khand 7/82-83, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(ml), Frequency: tds, Duration: 1 Months(3) Medicine Name: Panchavalakala Kwatha, Reference: Sharangdhara Samhita, Madhyama khanda 2/149, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1(NA), Frequency: bd, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | Group - A | (Procedure Reference: Sushrut samhita Chikitsa Sthan 7 /4, Procedure details: Chedankarma followed by Tikshna Apamarga Kshara will be applied under L.A then covered by a gauze piece & left for approximately 30 seconds, later flushed with lemon juice followed by normal saline. Dressing was done with dry gauze soaked in normal saline. Daily dressing of post fistulotomy with Kshaplota till complete wound Healed
)
(1) Medicine Name: Varunadi Kwatha, Reference: Sharanghar Sanhita Madhyam Khanda, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 1 Months(2) Medicine Name: Triphala Guggulu , Reference: Sharangdhara Samhita Madhayam Khand 7/82-83, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of linear low anal
2. Intersphincteric and Transphincteric fistula-in-ano will be included.
3. Patients having signs and symptoms of Bhagandara like Pidika, Vedana, Srava and Kandu in Gudapradesha will be included.
4. Patients medically fit for surgery will be included.
|
|
| ExclusionCriteria |
| Details |
1. Patients with age below 18 years and above 70 years
2. High anal fistula
3. Complex fistula in ano with multiple tracts and abscess (MRI Grade, II, IV to V)
4. Horseshoe fistula
5. Crohn’s disease
6. Ulcerative colitis
7. Uncontrolled Diabetes Melitus
8. Uncontrolled Hypertension
9. Cardiovascular disease i.e., Ischemic heart disease, Myocardial Infarction, CCF etc
10. Pregnant and lactating female
11. Malignancy of anorectum or other organs
12. Rectal prolapse
13. Hepatitis B, Tuberculoses, HIV & VDRL positive cases
|
|
|
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 |
1. Healing of fistulous tract
2. The assessment of the relief signs and symptoms will be done based on a gradation scoring pattern and as per specially prepared research Performa The suitable statistical tests paired and unpaired student t-tests will be applied |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved quaily of life patients |
1 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "69"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| Date of Study Completion (India) |
30/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ksharsutra application in fistula in ano takes upper hand in the various
surgical modalities available for the treatment of this ano-rectal condition
but it is associated with excrutiating pain while changing the ksharsutra
and sometimes due to long duration of treatment patient’s compliance is
less and many dropouts during treatment.This study proposes
management of fistula in ano by laying open the tract (Chedankarma)
followed by cauterization (kshar karma This is a clinical study to compare the efficacy of Chedakarma followed by ksharkarma and ksharsutra ,
wherein 69 patients diagnosed with Low anal Fistula in ano wias be selected from the surgery OPD ,
Shalyatantra Department at JSAM, Nadiad and randomly divided into two group .
In Group A(n=36) -Fistulotomy with Kshar application and in Group B(n=33)= ksharsutra
application was done.
Pain in post-operative period , discharge and wound size was be assesed |