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

Fistula in Ano Clinical Trial

— Bhagandara  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954225
• Other study ID #: 1314
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 26, 2013
• Start date: February 2006
• Est. completion date: September 2006

Study information

• Verified date: September 2013
• Source: Government Ayurved College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
India	Anand Surgical Hospital	Amravati	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Government Ayurved College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1&1/2 month	Yes
Secondary	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.	1year	Yes

External Links

•   Fistula in ano