CTRI/2008/091/000280
Completed
Phase 4
A double blind comparative randomized study evaluating the efficacy and safety of combined application of topical diltiazem and lignocaine as compared to topical dilitazem and lignocaine alone in the management of anal fissures
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients of Chronic Anal Fissures
- Sponsor
- Troikaa Pharmaceuticals Limited
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult patients aged between 18 \- 60 years.
- •2\.Patients with a diagnosis of chronic anal fissure
- •3\.Patients with symptoms persisting after 2 weeks of standard management (diet, laxatives, Sitz\-baths)
Exclusion Criteria
- •1\.Patients having anal fistulas or anal fissure of various causes such as Crohn disease, anal suppuration, abscesses,
- •2\.Patients with associated acute haemorrhoidal attacks
- •3\.Patients having anal or perianal cancer
- •4\.Patients who have been surgically treated previously
- •5\.Pregnant women
- •6\.Patients of hypertension / IHD on oral CCBs.
- •7\.Known hypersensitivity to either dilitiazem or lignocaine
- •8\.Pregnant women /lactating mother
- •9\.Patients talking CCB, Nitrates, vasodilator
- •10\.Patients with HIV infection
Outcomes
Primary Outcomes
Not specified
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