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

NCT01864473 | Completed

• 1 other identifier: 1234
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fistula , Bhagandar

Outcome Measures

Primary Outcomes (1)

• Efficacy of Ksharstra in Vaginal Fistula

  Efficacy of Ksar Sutra in the management of Vaginal Fistula.

  1year

Secondary Outcomes (1)

• Recurrence of Vaginal Fistula

  1year

Study Arms (1)

Kshar Sutra

OTHER

Other: Kshar Sutra

Interventions

Kshar Sutra OTHER

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.

Also known as: Medicated thread

Kshar Sutra

Eligibility Criteria

• Age: 42 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• without any major illness like Diabetes, Hypertension, Asthma, Tuberculosis, and without multiple track.

You may not qualify if:

• with Major illness, multiple Fistulas, associated anorectal conditions

Sponsors & Collaborators

• Government Ayurved College and Hospital: lead

Study Sites (1)

Dr.Nita Mahadevrao Kedar

Nagpur, Maharashtra, 440024, India

Location

MeSH Terms

Conditions

Vaginal Fistula; Fistula

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nita M Kedar, M.S.(Ayu)

  Government Ayurved Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

IN (1)