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

Completed

Brief Summary: Several treatment modalities have been studied for acute and chronic anal fissure, and topical calcium channel blockers (CCB) showed promising results in treatment of anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for anal fissure after multiple studies showing their benefits compared to different agents or modalities.

Till date there have been no study to our knowledge comparing the two drugs in a blinded trial, so this prospective randomized study is designed to compare the quality of life of patients with acute or chronic anal fissure before and 6 weeks after the topical treatment with diltiazem or nifedipine ointment

Recruitment & Eligibility

Inclusion Criteria

with a definitive diagnosis of anal fissure.

Exclusion Criteria

History of reaction to topical agents.
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.

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 trial	6 weeks

Secondary Outcome Measures

Name	Time	Method
1)To assess the complaints of perianal irritation/itching during the course of 6-week therapy.	2)Any adverse events due to systemic absorption of topical drugs.

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳South, DELHI, India
Dr Piyush Mishra
Principal investigator
01126593360
drpmishra28@gmail.com