A clinical trial to compare the efficacy of Yashtimadhu Ghrita anal infiltration and Diltiazem topical application in the management of chronic anal fissure
- Conditions
- Health Condition 1: K90-K95- Other diseases of the digestive systemHealth Condition 2: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2023/05/052302
- Lead Sponsor
- CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients of either sex aged 18-60 years.
2. Patients with chronic anal fissure greater than 6 weeks of duration.
3. Willing to provide written informed consent.
1. Patients with co-morbidities such as fistula in ano, haemorrhoids, perianal abscess, clinically evident fecal incontinence, anal stenosis/fibrosis
2. Patients with inflammatory bowel disease, tuberculosis, diabetes mellitus, anemia, malnourishment caused by systemic diseases, malignancy, HIV, STDs, hepatitis B
3. Patients with uncontrolled hypertension, clinically significant renal disease, hepatic disease, cardiovascular disease, psychiatric disease
4. Fissure associated with abscess, drug-induced fissure or fissure resulting from external trauma
5. Fissure located at lateral locations and multiple fissures
6. Patients on medications hampering wound healing (corticosteroids, NSAIDs, anti-convulsants, anticoagulants, immunosuppressive agents etc.)
7. Patients using oral calcium channel blockers
8. Patients with frequent h/o headache
9. Active substance abuse
10. Known hypersensitivity to either of the trial interventions
11. Pregnant and lactating women
12.Patients who have been using either of the trial interventions prior to 30 days of randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants having complete healing of the chronic anal fissureTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse events during the study periodTimepoint: 30 days;Pain during defecationTimepoint: day 8, 15, 22, 30;Proportion of participants having complete healing of the chronic anal fissureTimepoint: after one week <br/ ><br>;Recurrence of anal fissure after complete healingTimepoint: day 60, day 90 and day 180;Time to cessation of bleedingTimepoint: day 8, 15, 22 & 30