Clinical Trial of Ksharsutra in The Management of Fistula in ANO

Abstract

Background: Fistula-in-ano is a common anorectal condition with significant morbidity. Conventional surgery (fistulectomy/fistulotomy) often requires hospitalization, carries risks of recurrence (0.7–26.5%) and anal incontinence (5–40%), and involves painful postoperative care. Ksharsutra, an ancient Ayurvedic technique using a medicated thread (coated with Euphorbia neriifolia latex, Achyranthes aspera ash, and Curcuma longa), offers a non-surgical alternative.

Objective: To compare the efficacy of Ksharsutra therapy versus conventional surgery in healing time, recurrence, and complications.

Methods: Randomized controlled trial of 502 patients with fistula-in-ano. Patients were stratified by fistula type (subcutaneous, low anal, high anal) and randomized to Ksharsutra (n=265) or surgery (n=237). Ksharsutra was applied outpatient under local anesthesia and changed weekly until healing. Surgery involved fistulectomy or excision with secondary intention healing. Follow-up lasted one year post-healing.

Results: Complete healing occurred in 100% of patients in both groups. Median healing time was longer with Ksharsutra (8 weeks) than surgery (4 weeks; P<0.01), though similar by 40 weeks (92% vs 98%). Recurrence at one year was significantly lower with Ksharsutra (4%) than surgery (11%). Mild anal incontinence occurred in 5% (Ksharsutra, mostly transient) vs 9% (surgery, mostly permanent). Ksharsutra caused transient local burning and discharge; surgery caused postoperative pain requiring analgesics. No systemic side effects occurred with Ksharsutra.

Conclusion: Despite slower initial healing, Ksharsutra provides better long-term outcomes with lower recurrence and incontinence rates. As an ambulatory, outpatient, cost-effective procedure requiring no hospitalization, it is a safe and effective alternative to surgery, especially for poor-risk patients.

KEYWORDS: Fistula-in-ano, Ksharsutra, Ayurvedic treatment, Conventional surgery, Fistulectomy, Randomized controlled trial, Healing time, Recurrence rate, anal incontinence, Medicated thread, Euphorbia neriifolia, Achyranthes aspera, Curcuma longa, Ambulatory treatment, Outpatient procedure