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CompletedNCT01954225BhagandaraUpdated Oct 1, 2013

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

An interventional study of Udumbara Sutra in Fistula in Ano, sponsored by Government Ayurved College and Hospital. Completed at 1 site in India. Open to male participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2013-10-01.

Sponsored by Government Ayurved College and Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
5 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Fistula in Ano

Keywords

  • Fistula in ano
  • Bhagandara
  • Udumbara sutra
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 1 is below the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Government Ayurved College and Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Multiple fistula and associated ano rectal conditions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Other
    Udumbara sutra

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

    Other: Udumbara Sutra

Interventions

  • OtherUdumbara Sutra

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

    Also known as: Medicated Thread

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1&1/2 month

Secondary outcomes

  1. 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.

    Time frame: 1year

07

Study locations

1 site
  • Anand Surgical Hospital
    Amravati, Maharashtra 444605, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01954225
Lead sponsor
Government Ayurved College and Hospital
Responsible party
Dr.Nita Mahadevrao Kedar (Associate professor, Government Ayurved College and Hospital) — Principal investigator
First posted
Oct 1, 2013
Start date
Feb 2006
Primary completion
Apr 2006
Completion
Sep 2006
Last update
Oct 1, 2013

Study contacts

Nita M Kedar, M.S.(Ayu)
principal investigator · Associate Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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