Efficacy of Apamarga Kshara Sutra ligation in figure of eight technique in fistula in ano

Phase 2

Not yet recruiting

• Conditions: Anorectal fistula. Ayurveda Condition: BAGANDARAH,

• Registration Number: CTRI/2025/03/082825
• Lead Sponsor: Jammu institute of Ayurveda and Research

Brief Summary

Conservative treatment of fistula in ano is not at all successful because of its callus nature . Even today when modern surgery is at its peak , fistula in ano is still a  challenge for the surgeons for its prolonged  healing period , post operative complications and incidence of recurrence . Management of anorectal disorders with Ayurveda is becoming more popular especially in fistula in ano . Kshara sutra is a medicated thread that works on the principle of cutting the tract, scrapping the unhealthy granulation tissue and healing of the tract.

The Bailey’s and love short practice of surgery has, in its 25 th edition , included kshara sutra  as a treatment method for fistula in ano while describing various methods for its treatment.

Moreover, when this kshara sutra ligation will be done in figure of eight technique  it may significantly reduce the duration of healing period of the tract of fistula , thus aiding speedy recovery.

Fistula in ano has two openings one internal opening and one external opening. with the help of probing, the internal opening and tract of the fistula is identified and kshara sutra ligation is done. but in this new figure of eight technique, one extra opening in the middle of the external and internal openings of the tract of fistula will be created. Then with the help of a malleable probe kshara sutra ligation in the figure of eight technique will be done. This new figure of eight technique may reduced the duration of the healing of the tract of fistula significantly when compared to classical kshara sutra ligation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-18
• Study Start: 2025-04-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients diagnosed with fistula in ano 2.
• Patients reluctant to modern surgical technique 3.
• Age group 18 to 60 years of age 4.
• Low anal fistua.

Exclusion Criteria

• Patients of less than 18 years of age and more than 60 years of age 2.
• High anal fistula 3.
• Patients suffering from fistula in ano associated with tuberculosis diabetes COPD or any other systemic ailment 4.
• Trans sphincteric high anal fistula 5.
• Patients with positive result of any viral marker test 7.
• Patients with Hb below 10 gm/dl 8.
• Pregnancy 9.
• Unwilling patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain	Baseline | After 7th day,14th day,21st day,28th day till complete healing of fistula tract
2. Burning sensation	Baseline | After 7th day,14th day,21st day,28th day till complete healing of fistula tract
3. Discharge	Baseline | After 7th day,14th day,21st day,28th day till complete healing of fistula tract
4. Itching	Baseline | After 7th day,14th day,21st day,28th day till complete healing of fistula tract
5. Inflammation	Baseline | After 7th day,14th day,21st day,28th day till complete healing of fistula tract

Secondary Outcome Measures

Name	Time	Method
Assessment of unit cutting time & length of tract	Baseline, 1 week, 4 weeks

Trial Locations

Locations (1)

Jammu institute of Ayurveda and Research; 🇮🇳 JAMMU, & KASHMIR, India

Jammu institute of Ayurveda and Research

🇮🇳JAMMU, & KASHMIR, India

Dr Shreya Sharma

Principal investigator

7051354235

shreyasharma1897@gmail.com