A Randomized Comparative Clinical Study to Evaluate the Efficacy of JatyadiGhrita and Kampillakadi Taila Suppositories in the Management of Acute Fissure-in-Ano.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduction in pain during defecation (Visual Analogue Scale score)
Study Overview
Brief Summary
In this Randomized Comparative Clinical study, 60 patients with fissure in Ano (Guda Vidaran) will be enrolled after meeting the necessary criteria and informed consent. In Group A, 30 patients would be treated with Jatyadi Ghrita Suppositories, prepared by mixing jatyadi ghrit with cocoa butter in it, given as a Daily dose of 1 suppository per anal after the defecation, And in Group B would also have 30 patients, who would receive Kampillakadi Taila Suppositories prepared by the same method as Jatyadi ghrita suppositories, with the same dose of medication and intervals. Before starting the treatment, all patients would be tested for essential investigation to ensure they meet the study’s requirements and informed consent will be taken.
The effectiveness of the treatments will be measured by Pain Assessment Criteria in VAS readings from 1 to 10 by questionnaire. After the treatments, the results will be analyzed statistically
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Symptoms of pain during defecation, bleeding per rectum, and visible linear ulcer, between Age group of 20-40 years, of either gender.
- •Patients willing to undergo trial.
Exclusion Criteria
- •Age: below 20 years or above 40 years | Sex: both male and female] Patients who are diagnosed with conditions such as anal fistula, anorectal abscess, or Grade III–IV haemorrhoids will be excluded from the study.
- •Individuals with immunosuppressive or systemic disorders, including Type 2 Diabetes Mellitus, HIV infection, Syphilis, Hepatitis B, Hepatitis C, Tuberculosis, or Crohn’s disease, will not be considered eligible.
- •Patients with a history of anorectal or other malignancies, as well as pregnant or lactating women, will also be excluded.
- •Furthermore, any patient deemed unsuitable for the investigational drug or with a known hypersensitivity or adverse reaction to the drug will not be included in the trial.
Outcomes
Primary Outcomes
Reduction in pain during defecation (Visual Analogue Scale score)
Time Frame: 1st- 0 Day | 2nd- After completion of Trial | 3rd- 1 Month after completion of follow up after trial
Secondary Outcomes
- 1, Reduction in bleeding per rectum.(2, Improvement in local inflammation signs (Tenderness).)
Investigators
Dr Bittu
Institute For Ayurved Studies and Research Shri Krishna AYUSH University