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

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ClinicalTrials.gov Identifier: NCT01880398
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Dr.Nita Mahadevrao Kedar, Government Ayurved College and Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Fistula in Ano Other: Kshar Sutra

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Case Study of Fistula in Ano Managed by Kshar Sutra, Para Surgical Procedure
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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 Name: Medicated Thread


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Kshar sutra in Fistula in ano [ Time Frame: 5month ]
    Cutting and healing of the Fistula track.


Secondary Outcome Measures :
  1. Recurrence of Fistula in ano [ Time Frame: 1year ]
    By observing patient for 1 year.


Eligibility Criteria
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Ages Eligible for Study:   48 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Government Ayurved Hospital
Criteria

Inclusion Criteria:

  • Diagnosis of Fistula in ano without tributeries.

Exclusion Criteria:

  • Multiple fistula and associated ano rectal conditions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880398


Locations
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India
Government Ayurved Hospital
Nagpur, Maharashtra, India, 440015
Sponsors and Collaborators
Government Ayurved College and Hospital
Investigators
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Principal Investigator: Nita M Kedar, M.S.(Ayu) Government Ayurved Hospital
More Information
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Responsible Party: Dr.Nita Mahadevrao Kedar, Associate professor, Government Ayurved College and Hospital
ClinicalTrials.gov Identifier: NCT01880398    
Other Study ID Numbers: 2468
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013
Keywords provided by Dr.Nita Mahadevrao Kedar, Government Ayurved College and Hospital:
FIstula in ano; Bhagandar
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases