A clinical trial to study the effects of two thread sutures, herbal medicated thread and non medicated thread (seton) in patients with fistula-in-ano during the treatment with minimally invasive (Blunt edge fistulectomy) surgery.

Randomized triple-blind parallel groups, active controlled clinical trial to evaluate the efficacy and safety of Herbal Medicated Thread in minimally invasive surgical management (Blunt edge fistulectomy) of fistula-in-ano.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000264

Enrollment

160

Registered

2009-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Simple and complex types of fistula-in-ano.

Interventions

Intervention1: Herbal Medicated Thread: Size of the threads used are no.10 and no.1. Control Intervention1: Non-medicated Thread(seton): size of the threads used are no.10 and no.1.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients of ageing above 18 years, who belongs to type-I or type-II of A.S.A. Risk Class. only. 2. Patient with disease of Fistula in ano. 3. Patients ready to give a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women. 2. Patient with history of positive antibody test for HIV. 3. Any other condition that in the opinion of of the investigator would make the patient unsuitable for enrolment.

Design outcomes

Primary

Measure	Time frame
Remission of fistula-in-ano.Timepoint: 6-weeks for simple fistula-in-ano, and 12-weeks for complex fistula-in-ano.	—

Secondary

Measure	Time frame
Adverse Events, And Reccurence Of Fistula-in-ano.Timepoint: 12-weeks for simple fistula-in-ano, and 12-months for complex fistula-in-ano.	—

Countries

India

Contacts

Public ContactNishat Fatima

PGIMER Dr RML Hospital

syedhabeeb_1@yahoo.co.in9953164000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026