CTRI/2023/08/056066
Completed
Phase 3
AN OPEN SINGLE ARM SINGLE CENTRIC CLINICAL TRIAL TO DETERMINE THE THERAPEUTIC EFFECTIVENESS OF PUN SUDAR THYLA THIRI IN THE MANAGEMENT OF POUTHIRAM (FISTULA IN ANO) - PSTT for Pouthiram
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: K605- Anorectal fistula
- Sponsor
- ational Institute of SIddha
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age: 18 to 60 years.
- •2\.Patients having the clinical features of the following
- •Pain and swelling in the perianal region
- •Pus and or blood discharge from perianal and anal region.
- •Skin irritation.
- •Perianal abscess.
- •3\.Sex: Male, Female and Transgender.
- •4\.Fistula tract length within 4 cm.
- •5\.According to St James University Hospital Classification, Grade I and II will be included.
- •6\.Patient who are willing to undergo Kaarathiri therapy.
Exclusion Criteria
- •1\.K/c/o Tuberculosis
- •2\.K/c/o Hepatitis B \& C.
- •3\.K/c/o Haemophilia and bleeding disorders.
- •4\.H/o Pregnancy \& Lactation.
- •5\.The patient who has uncontrolled diabetes (HbA1C more than 7\.6\) will be treated for diabetes and after the confirmation of good control he/she will be included for this study.
- •6\.K/c/o coronary heart diseases and other cardiac ailments.
- •7\.K/c/o AIDS, Syphilis.
- •8\.K/c/o Crohn’s disease.
- •9\.K/c/o High anal fistula and complicated fistula
- •10\.K/c/o Rectal prolapse
Outcomes
Primary Outcomes
Not specified
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