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Trial record 4 of 59 for:    "Genital Diseases, Female" | ( Map: India )

Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment (Bhagandar)

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ClinicalTrials.gov Identifier: NCT01864473
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr.Nita Mahadevrao Kedar, Government Ayurved College and Hospital

Brief Summary:

Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an ancient surgical problem. It was commonly described even in the Vedic period. The description of Bhagandara, with the full text of its managements, can be gathered from the Sushruta Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina etc.

Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment due to probability of recurrence after surgery. The present treatment modality Kshar Sutra has been found effective and as adjuvant therapy by avoiding recurrence.


Condition or disease Intervention/treatment Phase
Vaginal Fistula Other: Kshar Sutra Not Applicable

Detailed Description:

A 42 years old female patient , come to the Shalyatantra O.P.D. of Government Ayurved Hospital,Nagpur with complaints of recurrent discharging boil at right side of Perianal region along with pain and discomfort in October 2010.

She gave a surgical history of incision and drainage for gluteal abscess done in year 2008 and after six month. The same complaint recurred after next six month .On local examination Patient had discharging sinus at 9 o clock position on right side of Perianal region. Before planning the treatment other etiologies like tuberculosis, diabetes mellitus , HIV or trauma were ruled out.

For the conformation of diagnosis Fistulogram was performed suggestive of low anal fistula with posterior internal opening. So under spinal anaesthesia probing was done. But it came to know that the track was directed upward in vagina and it had not any other opening in anal canal. Length of the tract was 7cm.

After conformation of vaginal fistula the track was cleaned with betadine and Hydrogen peroxide. The Kshar Sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. Patient was advice for Seitz bath with lukewarm water. 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 two month. The track cut trough and simultaneously healed. It was observed that healing rate was slow as compare to cutting rate. In this patient. The patient was observed for a period of two year to check for recurrence.

The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euphorbia Nerrifolia)latex which has quality of cutting and Haridra (Curcuma Longa) which is used as a antiseptic. This combination of drugs on the thread helps in debridement and simultaneously healing.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Case Study of Vaginal Fistula Managed by Kshar Sutra, a Minimal Invasive Treatment.
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Kshar Sutra Other: Kshar Sutra
The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euforbia Nerrifolia) which has quality of cutting and Haridra (Curcuma longa) which is used as a antiseptic. This combination of medicine on the thread helps in debridement and simultaneously healing of track. After conformation of vaginal fistula the track was cleaned with betadine and Hydrogen peroxide. The Kshar Sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. Patient was advice for Sitz bath with lukewarm water. The Kshar Sutra was changed weekly.
Other Name: Medicated thread




Primary Outcome Measures :
  1. Efficacy of Ksharstra in Vaginal Fistula [ Time Frame: 1year ]
    Efficacy of Ksar Sutra in the management of Vaginal Fistula.


Secondary Outcome Measures :
  1. Recurrence of Vaginal Fistula [ Time Frame: 1year ]
    Efficacy of Kshar Sutra in Vaginal Fistula and its recurrence.



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Ages Eligible for Study:   42 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • without any major illness like Diabetes, Hypertension, Asthma, Tuberculosis, and without multiple track.

Exclusion Criteria:

  • with Major illness, multiple Fistulas, associated anorectal conditions

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): NCT01864473


Locations
India
Dr.Nita Mahadevrao Kedar
Nagpur, Maharashtra, India, 440024
Sponsors and Collaborators
Government Ayurved College and Hospital
Investigators
Principal Investigator: Nita M Kedar, M.S.(Ayu) Government Ayurved Hospital

Additional Information:
Responsible Party: Dr.Nita Mahadevrao Kedar, Associate professor, Government Ayurved College and Hospital
ClinicalTrials.gov Identifier: NCT01864473     History of Changes
Other Study ID Numbers: 1234
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Dr.Nita Mahadevrao Kedar, Government Ayurved College and Hospital:
Fistula , Bhagandar

Additional relevant MeSH terms:
Fistula
Vaginal Fistula
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female