ifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine for treatment of Anal Fissure

Not Applicable

Not yet recruiting

• 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

Study Timeline

• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Not 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