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A pilot clinical trial to know the effectiveness of Siddha Karanool (medicated thread) treatment in Anal fistula

A Pilot Clinical Trial to explore the efficacy of Siddha treatment in Powthiram (Anal fistula) using Karanool (Seton) coated with Sesame Salt, Papain and Turmeric A Chemical ablation method. - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080152
Enrollment
10
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K603- Anal fistula

Interventions

Intervention1: Sesame salt - Papaya latex Siddha Karanool therapy: Siddha medicated thread used in the management of Anal fistula. Sesame salt, Papain powder of papaya latex and Turmeric coated Seton

Sponsors

Investigator funded
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with pain and discharge continuously or intermittently Fistula in ano patients having single tract of length less than 8 cm St James University Hospital MRI Classification of Anal fistula grade I and II

Exclusion criteria

Exclusion criteria: Crohn s disease Ulcerative colitis Urogenital tuberculosis Uncontrolled metabolic disorders Intra-abdominal abscess Intestinal and pelvic malignancies Infection of pelvic bones Venereal diseases, STD/HIV

Design outcomes

Primary

MeasureTime frame
1.The temporal difference in PDAI scoring in perianal fistula from baseline to healed status will be described. As its a pilot clinical trial, Sample size has been chosen as per ICMR guidelines.Timepoint: At baseline, weekly assessments, at endpoint

Secondary

MeasureTime frame
Efficacy of Sesame Karanool therapy in perianal fistula will be documented. Improvement in the Quality of Life of the patient with anal fistula from baseline to endpoint will be measured using QOLAF-Q. Impact of duration of the fistula and tract length over the unique healing time of each patient will be described.Timepoint: Weakly assessments till the healing of fistula

Countries

India

Contacts

Public ContactDr G Sharmila

National Institute of Siddha

sharmila1121995@gmail.com8508025180

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026