NCT01954225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

2 months

First QC Date

September 6, 2013

Last Update Submit

September 26, 2013

Conditions

Keywords

Fistula in anoBhagandaraUdumbara sutra

Outcome Measures

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

    1&1/2 month

Secondary Outcomes (1)

  • Use of Udumbara Sutra in avoiding recurrence of Fistula in ano

    1year

Study Arms (1)

Udumbara sutra

OTHER

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

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
Udumbara sutra

Eligibility Criteria

Age5 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Multiple fistula and associated ano rectal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anand Surgical Hospital

Amravati, Maharashtra, 444605, India

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nita M Kedar, M.S.(Ayu)

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 6, 2013

First Posted

October 1, 2013

Study Start

February 1, 2006

Primary Completion

April 1, 2006

Study Completion

September 1, 2006

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations