NCT01880398

Brief Summary

Background: Fistula in ano is one of the most common diseases of the ano rectal region. Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature. Commonly prevalent surgical treatment for anal Fistula, that is "Fistulectomy" does not provide successful cure for the disease, post operative complications and recurrences being common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus) with Ksharsutra was practiced by Sushruta (1000-600B.C.) . Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various types of Fistula.

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 all trials

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

June 9, 2013

Last Update Submit

December 23, 2013

Conditions

Keywords

FIstula in ano; Bhagandar

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Kshar sutra in Fistula in ano

    Cutting and healing of the Fistula track.

    5month

Secondary Outcomes (1)

  • Recurrence of Fistula in ano

    1year

Study Arms (1)

Kshar Sutra

The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph.

Other: Kshar Sutra

Interventions

The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph.

Also known as: Medicated Thread
Kshar Sutra

Eligibility Criteria

Age48 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Government Ayurved Hospital

You may qualify if:

  • Diagnosis of Fistula in ano without tributeries.

You may not qualify if:

  • Multiple fistula and associated ano rectal conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Ayurved Hospital

Nagpur, Maharashtra, 440015, 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)

    Government Ayurved Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 9, 2013

First Posted

June 19, 2013

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations