CClinicalTrials.gg
CompletedNCT01880398BhagandarUpdated Dec 24, 2013

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

An observational study in Fistula in Ano, sponsored by Government Ayurved College and Hospital. Completed at 1 site in India. Open to female participants aged 48 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-24.

Sponsored by Government Ayurved College and Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1
Ages
48 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fistula in Ano

Keywords

  • FIstula in ano; Bhagandar
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 1 is below the median of 94 across 50 observational studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Government Ayurved College and Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Government Ayurved Hospital

Inclusion criteria

  • Diagnosis of Fistula in ano without tributeries.

Exclusion criteria

Exclusion Criteria:

  • Multiple fistula and associated ano rectal conditions
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherKshar 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.

    Also known as: Medicated Thread

06

What researchers measure

Primary outcomes

  1. Efficacy of Kshar sutra in Fistula in ano

    Cutting and healing of the Fistula track.

    Time frame: 5month

Secondary outcomes

  1. Recurrence of Fistula in ano

    By observing patient for 1 year.

    Time frame: 1year

07

Study locations

1 site
  • Government Ayurved Hospital
    Nagpur, Maharashtra 440015, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01880398
Lead sponsor
Government Ayurved College and Hospital
Responsible party
Dr.Nita Mahadevrao Kedar (Associate professor, Government Ayurved College and Hospital) — Principal investigator
First posted
Jun 19, 2013
Start date
Jun 2011
Primary completion
Oct 2011
Completion
Oct 2012
Last update
Dec 24, 2013

Study contacts

Nita M Kedar, M.S.(Ayu)
principal investigator · Government Ayurved Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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