Evaluation of Modified Conventional Ksharasutra Therapy and IFTAK for the management of Riju Bhagandara an open label randomized controlled clinical trial

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.

3. Methodology & Study Design

• Trial Design: Randomized, Parallel Group, Prospective, Interventional Trial.
• 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.