ifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine for treatment of Anal Fissure
Not Applicable
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2022/04/042081
- Lead Sponsor
- AIIMS Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
with a definitive diagnosis of anal fissure
Exclusion Criteria
1. History of reaction to topical agents.
2. Recurrent anal fissures
3. Associated condition or disease such as severe anaemia, cancer, fistula, abscess, Crohnâ??s disease, HIV related anal ulcer, tuberculosis ulcer, leukemic ulcer, pregnancy, third and fourth degree haemorrhoids, and Diabetes mellitus
4. History of surgical treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact on quality of life using REALISE score of patients with anal fissure comparing Nifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine in a double blind randomized controlled trialTimepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method 1)To assess the complaints of perianal irritation/itching during the course of 6-week therapy. <br/ ><br>2)Any adverse events due to systemic absorption of topical drugs. <br/ ><br>Timepoint: 3 weeks and 6 weeks