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Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study (Bhagandara)

Primary Purpose

Fistula in Ano

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Udumbara 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 Fistula in Ano focused on measuring Fistula in ano, Bhagandara, Udumbara sutra

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient without any major illness. Fistula in ano without tributaries ano without complication.

Exclusion Criteria:

  • Multiple fistula and associated ano rectal conditions.

Sites / Locations

  • Anand Surgical Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Udumbara sutra

Arm Description

The Udumbara Sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.

Outcomes

Primary Outcome Measures

Use of Udumbara sutra in the management of Fistula in ano.
The Udumbara Sutra has good potential in the management by cutting and healing of Fistula in ano because it's less alkaline nature

Secondary Outcome Measures

Use of Udumbara Sutra in avoiding recurrence of Fistula in ano
Use Udumbara Sutra is found to be very effective in avoiding recurrence. There is no recurrence after one year.

Full Information

First Posted
September 6, 2013
Last Updated
September 26, 2013
Sponsor
Government Ayurved College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01954225
Brief Title
Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study
Acronym
Bhagandara
Official Title
Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
September 2006 (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
The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara' has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra has been found effective due to its action of proper drainage of pus from the fistula that leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano. Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne management of Fistula in ano.
Detailed Description
A 5 year male child, come with complaints of painful discharging boil at left side of perianal region and pain with surgical history of incision and drainage for gluteal abscess done before six month. On local examination Patient had discharging sinus at 8 o' clock position on right side of Perianal region. Before planning the treatment other aetiologies were ruled out. Under short general anaesthesia diagnosis was confirmed by probing as Fistula in ano. Internal opening of Fistula was confirmed by injecting Methylene Blue dye through external opening. The track was directed upward in the anal canal without any tributary. Length of the tract was 3cm, suggestive of low anal fistula. Then Udumbara Sutra was tied covering the entire underlying track for cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. The Udumbara Sutra was changed skilfully by weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed. The total period of Udumbara Sutra treatment was 1,1/2 month. The track cut through and simultaneously healed. The patient was observed for a period of 6 month to check for recurrence. The Sutra or Medicated seton was a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata), which has quality of cutting and healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula in Ano
Keywords
Fistula in ano, Bhagandara, Udumbara sutra

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
Udumbara sutra
Arm Type
Other
Arm Description
The Udumbara Sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.
Intervention Type
Other
Intervention Name(s)
Udumbara Sutra
Other Intervention Name(s)
Medicated Thread
Intervention Description
The Udumbara sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.
Primary Outcome Measure Information:
Title
Use of Udumbara sutra in the management of Fistula in ano.
Description
The Udumbara Sutra has good potential in the management by cutting and healing of Fistula in ano because it's less alkaline nature
Time Frame
1&1/2 month
Secondary Outcome Measure Information:
Title
Use of Udumbara Sutra in avoiding recurrence of Fistula in ano
Description
Use Udumbara Sutra is found to be very effective in avoiding recurrence. There is no recurrence after one year.
Time Frame
1year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient without any major illness. Fistula in ano without tributaries ano without complication. Exclusion Criteria: Multiple fistula and associated ano rectal conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nita M Kedar, M.S.(Ayu)
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anand Surgical Hospital
City
Amravati
State/Province
Maharashtra
ZIP/Postal Code
444605
Country
India

12. IPD Sharing Statement

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Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study

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