To compare the efficacy and safety of the combined application of topical diltiazem and lignocaine gel as compared to either drugs alone in the management of anal fissures
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients of Chronic Anal Fissures
- Registration Number
- CTRI/2008/091/000280
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in symptoms of pain, itching and bleeding recorded on a visual analogue scoreTimepoint: At baseline and at the end of 2, 4, 6 weeks of therapy
- Secondary Outcome Measures
Name Time Method Global assessment of treatment by Physician and patients as: Excellent/ Good/ Fair/ PoorTimepoint: At the end of week 6 (end of study);Healing of the anal fissure assessed clinicallyTimepoint: At the end of week 6 (end of study)