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A clinical study to compare two Ayurvedic surgical methods (Modified Ksharasutra therapy and IFTAK technique) for the treatment of trans-sphincteric fistula-in-ano.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100395
Enrollment
20
Registered
2026-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K605- Anorectal fistula

Interventions

None listed

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of trans sphincteric anal fistula (Clinically and radiologically confirmed fistula (Trans-sphincteric Fistula in Ano) (ICD 10 code K 60.3) St. James University Hospital Classification Grade 3) aging between 20-60 years irrespective of demographic data. Patients up to ASA criteria II. Patients willing to consent for enrolment in the study.

Exclusion criteria

Exclusion criteria: patient unfit for surgery fistula secondary to other disease TB Uncontrolled HTN DM Crohns disease Ulcerative colitis osteolyelitis Ca Rectum Ca Colon BLeeding disorder Pregnancy and lactation mother patient positive for viral markers patient unwilling for follow up

Design outcomes

Primary

MeasureTime frame
Primary Outcome Healing of the fistulous track with absence of discharge and closure of external opening will be made by clinical examination and imaging (if required) Secondary Outcome Assessment of Functional Outcome by Using Wexner Continence Score and Anorectal Manometry in before and 4 weeks of post-healing. Assessment of pain in between group. Timepoint: Four weeks

Secondary

MeasureTime frame
Secondary Outcome Assessment of Functional Outcome by Using Wexner Continence Score & Anorectal Manometry in before & 4 weeks of post-healing. Assessment of pain in between group. Timepoint: Four weeks

Countries

India

Contacts

Public ContactDr Hema

All India Institute of Ayurveda

drhemasinha@gmail.com09971160515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026