A comparative clinical study on the Effectiveness of Nishadi sutra against Apamarga ksharasutra in Bhagandara.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- 1.Unit cutting time- assessed by weekly measurement of sutra length
Study Overview
Brief Summary
In this study Nishadi sutra mentioned in Basavarajeeyam is compared with
Apamarga ksharasuthra, the standard one, in its cutting effect along with pain and burning sensation. 46 participants,selected from the OPD and IPD of Salyatantra, Government Ayurveda College Hospital, Tripunithura satisfying the inclusion and exclusion criteria will be allocated to both trial and control group .Nishadi sutra is applied in the study group and Apamarga ksharasutra in the control group. Assessment of cutting effect is done by calculating Unit cutting time(UCT) . Length of thread is measured on every 7 th day during thread change. Assessment of pain, burning sensation will be based on the Visual Analogue Scale and grading by Paul O Madson and Peter respectively and both are assessed from the first day of application and on every 7th day of thread change. The observations thus obtained will be analysed using a suitable statistical method.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Low anal fistula diagnosed by clinical examination Participants with age group of 18-60 years Participants with informed written consent.
Exclusion Criteria
- •Fistula associated with Ulcerative Colitis, Crohn’s disease, Colorectal carcinoma, Tuberculosis.
- •Fistula in participants with HIV, Hepatitis B or Veneral diseases.
Outcomes
Primary Outcomes
1.Unit cutting time- assessed by weekly measurement of sutra length
Time Frame: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
2. Reduction in pain(VAS scale)
Time Frame: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
3.Reduction in burning sensation assessed through grading.
Time Frame: assessed properly on its change on 7th day. Later on, all outcome variables will be assessed weekly on 7th, 14th, 21st,28th, 35th, 42nd, 49th, 56th, 63rd, 70th,77th and 84th days.
Secondary Outcomes
- Reduction in pain(VAS scale)(Reduction in burning sensation assessed through grading.)
Investigators
Vaisali K S
Government Ayurveda College,Trippunithura.