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Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment

NCT01864473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-06-04

No results posted yet for this study

Summary

Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an ancient surgical problem. It was commonly described even in the Vedic period. The description of Bhagandara, with the full text of its managements, can be gathered from the Sushruta Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina etc.

Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment due to probability of recurrence after surgery. The present treatment modality Kshar Sutra has been found effective and as adjuvant therapy by avoiding recurrence.

Conditions

  • Vaginal Fistula

Interventions

OTHER

Kshar Sutra

The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euforbia Nerrifolia) which has quality of cutting and Haridra (Curcuma longa) which is used as a antiseptic. This combination of medicine on the thread helps in debridement and simultaneously healing of track. After conformation of vaginal fistula the track was cleaned with betadine and Hydrogen peroxide. The Kshar Sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. Patient was advice for Sitz bath with lukewarm water. The Kshar Sutra was changed weekly.

Sponsors & Collaborators

  • Government Ayurved College and Hospital

    lead OTHER_GOV

Principal Investigators

  • Nita M Kedar, M.S.(Ayu) · Government Ayurved Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
42 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864473 on ClinicalTrials.gov