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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01880398
Other study ID # 2468
Secondary ID
Status Completed
Phase N/A
First received June 9, 2013
Last updated December 23, 2013
Start date June 2011
Est. completion date October 2012

Study information

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

Clinical Trial 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.


Description:

A 48 years old female patient, came with complaints of painful discharging boil at left side of Perianal region with pain.

She gave a surgical history of incision and drainage for gluteal abscess done in before four month. On local examination Patient had discharging sinus at 3 o' clock position on left side of Perianal region. Before planning the treatment other aetiologies were ruled out.

Diagnosis was confirmed by Fistulogram, suggestive of high anal fistula with internal opening in the anal canal. Under spinal anaesthesia probing was done. 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 tributaries. Length of the tract was 9cm.

Then Kshar 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 Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.

The total period of Kshar Sutra treatment was 5 month. 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 rediation. The alkalinity of Kshar Sutra was 9.2ph.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date October 2012
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 48 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of Fistula in ano without tributeries.

Exclusion Criteria:

- Multiple fistula and associated ano rectal conditions

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
India Government Ayurved Hospital Nagpur 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 Efficacy of Kshar sutra in Fistula in ano Cutting and healing of the Fistula track. 5month Yes
Secondary Recurrence of Fistula in ano By observing patient for 1 year. 1year Yes
See also
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Completed NCT05660876 - Fistulotomy Versus Fistulotomy With Marsupialization N/A
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