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

Primary Purpose

Vaginal Fistula

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Kshar Sutra
Sponsored by
Government Ayurved College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Fistula focused on measuring Fistula , Bhagandar

Eligibility Criteria

42 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • with Major illness, multiple Fistulas, associated anorectal conditions

Sites / Locations

  • Dr.Nita Mahadevrao Kedar

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Kshar Sutra

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of Ksharstra in Vaginal Fistula
Efficacy of Ksar Sutra in the management of Vaginal Fistula.

Secondary Outcome Measures

Recurrence of Vaginal Fistula
Efficacy of Kshar Sutra in Vaginal Fistula and its recurrence.

Full Information

First Posted
May 23, 2013
Last Updated
June 1, 2013
Sponsor
Government Ayurved College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01864473
Brief Title
Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment
Acronym
Bhagandar
Official Title
Single Case Study of Vaginal Fistula Managed by Kshar Sutra, a Minimal Invasive Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Ayurved College and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A 42 years old female patient , come to the Shalyatantra O.P.D. of Government Ayurved Hospital,Nagpur with complaints of recurrent discharging boil at right side of Perianal region along with pain and discomfort in October 2010. She gave a surgical history of incision and drainage for gluteal abscess done in year 2008 and after six month. The same complaint recurred after next six month .On local examination Patient had discharging sinus at 9 o clock position on right side of Perianal region. Before planning the treatment other etiologies like tuberculosis, diabetes mellitus , HIV or trauma were ruled out. For the conformation of diagnosis Fistulogram was performed suggestive of low anal fistula with posterior internal opening. So under spinal anaesthesia probing was done. But it came to know that the track was directed upward in vagina and it had not any other opening in anal canal. Length of the tract was 7cm. 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 Seitz bath with lukewarm water. The Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed. The total period of Kshar Sutra treatment was two month. The track cut trough and simultaneously healed. It was observed that healing rate was slow as compare to cutting rate. In this patient. The patient was observed for a period of two year to check for recurrence. The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euphorbia Nerrifolia)latex which has quality of cutting and Haridra (Curcuma Longa) which is used as a antiseptic. This combination of drugs on the thread helps in debridement and simultaneously healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Fistula
Keywords
Fistula , Bhagandar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kshar Sutra
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Kshar Sutra
Other Intervention Name(s)
Medicated thread
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of Ksharstra in Vaginal Fistula
Description
Efficacy of Ksar Sutra in the management of Vaginal Fistula.
Time Frame
1year
Secondary Outcome Measure Information:
Title
Recurrence of Vaginal Fistula
Description
Efficacy of Kshar Sutra in Vaginal Fistula and its recurrence.
Time Frame
1year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: without any major illness like Diabetes, Hypertension, Asthma, Tuberculosis, and without multiple track. Exclusion Criteria: with Major illness, multiple Fistulas, associated anorectal conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nita M Kedar, M.S.(Ayu)
Organizational Affiliation
Government Ayurved Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Nita Mahadevrao Kedar
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440024
Country
India

12. IPD Sharing Statement

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

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