CTRI/2026/01/100395 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On:
05/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda Surgical/Anesthesia
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical study to compare two Ayurvedic surgical methods (Modified Ksharasutra therapy and IFTAK technique) for the treatment of trans-sphincteric fistula-in-ano.
Scientific Title of Study
Evaluation of Modified Conventional Ksharasutra Therapy and IFTAK for the management of Riju Bhagandara an open label randomized controlled clinical 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 Hema
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
C block, 5th floor, department of shalya tantra, All India Institute of Ayurveda, Gautampuri, New Delhi C block, 5th floor, department of shalya tantra, All India Institute of Ayurveda, Gautampuri, New Delhi New Delhi DELHI 110059 India
Phone
09971160515
Fax
Email
drhemasinha@gmail.com
Details of Contact Person Scientific Query
Name
Dr Hema
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
C block, department fo shalya tantra, All india institute of ayurveda, gautampuri, new delhi C block, department fo shalya tantra, All india institute of ayurveda, gautampuri, new delhi New Delhi DELHI 110059 India
Phone
09971160515
Fax
Email
drhemasinha@gmail.com
Details of Contact Person Public Query
Name
Dr Hema
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
C block, department fo shalya tantra, All india institute of ayurveda, gautampuri, new delhi C block, department fo shalya tantra, All india institute of ayurveda, gautampuri, new delhi New Delhi DELHI 110059 India
Phone
09971160515
Fax
Email
drhemasinha@gmail.com
Source of Monetary or Material Support
C block All India Institute of Ayurveda gautampuri New Delhi 110076
Primary Sponsor
Name
Self
Address
Department of shalya tantra C block All India Institute of Ayurveda Gautampuri Awas New Delhi
(Procedure Reference: susuruta chikitsa, Procedure details: Interception of FIstulous track with application of ksharasutra followed by Triphala Guggulu & Jatyadi taila )
2
Intervention Arm
Procedure
-
kShArasUtra, क्षारसूत्र
(Procedure Reference: susutruta chikitsa , Procedure details: Modified Conventional Ksharasutra therapy followed by Triphala Guggulu & Jatyadi taila )
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Diagnosed cases of trans sphincteric anal fistula (Clinically and radiologically confirmed fistula (Trans-sphincteric Fistula in Ano) (ICD 10 code K 60.3) St. James University Hospital Classification Grade 3) aging between 20-60 years irrespective of demographic data.
Patients up to ASA criteria II.
Patients willing to consent for enrolment in the study.
ExclusionCriteria
Details
patient unfit for surgery
fistula secondary to other disease
TB Uncontrolled HTN DM Crohns disease Ulcerative colitis osteolyelitis Ca Rectum Ca Colon
BLeeding disorder
Pregnancy and lactation mother
patient positive for viral markers
patient unwilling for follow up
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Primary Outcome
Healing of the fistulous track with absence of discharge and closure of external opening will be made by clinical examination and imaging (if required)
Secondary Outcome
Assessment of Functional Outcome by Using Wexner Continence Score and Anorectal Manometry in before and 4 weeks of post-healing.
Assessment of pain in between group.
Four weeks
Secondary Outcome
Outcome
TimePoints
Secondary Outcome
Assessment of Functional Outcome by Using Wexner Continence Score & Anorectal Manometry in before & 4 weeks of post-healing.
Assessment of pain in between group.
Four weeks
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)
31/01/2026
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="3" Months="0" 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 - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
Who will be able to view these files? Response - Researchers who provide a methodologically sound proposal.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response (Others) -
For how long will this data be available start date provided 01-02-2026 and end date provided 02-01-2040? Response - Beginning 9 months and ending 36 months following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
trial Title: A Randomized Controlled Clinical Trial Comparing the Efficacy of Modified Conventional Ksharasutra Therapy (MC-KST) and Interception of Fistulous Track with Application of Ksharasutra (IFTAK) in the Management of Riju Bhagandara (Trans-sphincteric Fistula-in-Ano).
1. Scientific Abstract
Trans-sphincteric fistula-in-ano (Riju Bhagandara) remains a surgical challenge due to high recurrence rates and the risk of anal incontinence.1 While traditional Ksharasutra (medicated seton) therapy is effective, it often involves long treatment durations and patient discomfort. This prospective, randomized, two-arm clinical trial aims to compare two advanced application techniques: Modified Conventional Ksharasutra Therapy (MC-KST) and Interception of Fistulous Track with Application of Ksharasutra (IFTAK). The study will evaluate which method provides faster healing, better functional outcomes, and higher patient compliance.
2. Objectives
Primary: To compare the efficacy of MC-KST and IFTAK in achieving complete healing of the fistulous track.
Secondary: To compare functional outcomes, specifically anal continence (via Wexner Score and Anorectal Manometry), post-operative pain (VAS scale), and treatment duration.
Setting: Department of Shalya Tantra, All India Institute of Ayurveda (AIIA), New Delhi.
Participants: 20 patients (10 per group) aged 20–60 years diagnosed with trans-sphincteric fistula (St. James Hospital Grade 3).
Intervention (Group A - MC-KST): Dissection of the track at the inter-sphincteric groove, interception of the track, and application of Apamarga Guggulu Ksharasutra from the interception site to the internal opening.
Intervention (Group B - IFTAK): Linear vertical incision, interception of the proximal part of the track at the external sphincter level, and application of Ksharasutra from the interception to the infected anal crypt.
Ancillary Care: Both groups will receive Triphala Guggulu, Panchvalkal Kwath sitz baths, and Jatyadi Taila dressings.
4. Inclusion & Exclusion Criteria
Inclusion: Confirmed trans-sphincteric fistula-in-ano; ASA Grade I or II; patients providing informed consent.
Exclusion: Fistulae secondary to Crohn’s disease, Tuberculosis, or malignancy; patients with uncontrolled diabetes/hypertension, bleeding disorders, or viral markers (HIV, HBV, HCV).
5. Outcome Measures
Primary Outcome: Complete healing time (Unit Healing Time) and clinical closure of the track (absence of discharge/external opening).
Secondary Outcome: Functional status measured by Wexner Continence Score and Anorectal Manometry; pain assessment using the Visual Analogue Scale (VAS).
Follow-up: Monthly assessments for a period of 6 months post-healing to monitor for recurrence.
6. Statistical Analysis
Data will be analyzed using IBM SPSS version 25. Normality will be checked via Shapiro–Wilk test. Differences within groups will be assessed using independent "t" tests and repeated measure ANOVA. A p-value of $leq 0.05$ will be considered statistically significant.