- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954225
Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study (Bhagandara)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maharashtra
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Amravati, Maharashtra, India, 444605
- Anand Surgical Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient without any major illness. Fistula in ano without tributaries ano without complication.
Exclusion Criteria:
- Multiple fistula and associated ano rectal conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Udumbara sutra
The Udumbara Sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.
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The Udumbara sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of Udumbara sutra in the management of Fistula in ano.
Time Frame: 1&1/2 month
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The Udumbara Sutra has good potential in the management by cutting and healing of Fistula in ano because it's less alkaline nature
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1&1/2 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of Udumbara Sutra in avoiding recurrence of Fistula in ano
Time Frame: 1year
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Use Udumbara Sutra is found to be very effective in avoiding recurrence.
There is no recurrence after one year.
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1year
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Collaborators and Investigators
Investigators
- Principal Investigator: Nita M Kedar, M.S.(Ayu), Associate Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1314
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