Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure.

Fistula in Ano Clinical Trial

— Bhagandar  

Official title:

Case Study of Fistula in Ano Managed by Kshar Sutra, Para Surgical Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880398
• Other study ID #: 2468
• 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

• Fistula
• Fistula in Ano
• Rectal Fistula

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

External Links

•   Fistula in ano