Clinical trial NCT01954225: Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study
Official title: Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula in Ano
Keywords: Fistula in ano
Bhagandara
Udumbara sutra
Lead sponsor: Government Ayurved College and Hospital
Sponsor class: OTHER_GOV
First posted: 2013-10-01
Enrollment: 1
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Use of Udumbara sutra in the management of Fistula in ano.
timeFrame: 1&1/2 month
Secondary outcomes:
measure: Use of Udumbara Sutra in avoiding recurrence of Fistula in ano
timeFrame: 1year
Other outcomes:
Locations:
city: Amravati
country: India
facility: Anand Surgical Hospital
state: Maharashtra
Study officials:
affiliation: Associate Professor
name: Nita M Kedar, M.S.(Ayu)
role: PRINCIPAL_INVESTIGATOR
References: