To determine the effects on resting anal sphincter pressure following topical application of 2% diltiazem gel and a combination of 2% diltiazem with lidocaine gel (2%) in various anal conditions.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Chronic Anal Fissure
- Registration Number
- CTRI/2009/091/000356
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1.Adult patients of either sex aged 18 - 60 years.
2.Patients diagnosed with chronic anal fissure, hemorrhoids and patients undergoing elective anal surgery.
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 malignancy
4.Patients who have been surgically treated previously
5.Patients on oral CCBs./ nitrates/ vasodilators
6.Known hypersensitivity to diltiazem
7.Pregnant women /lactating mother
8.Patients with the history of HIV infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in baseline resting anal sphincter pressure.Timepoint: At 15, 30 and 60 minutes following topical application of study drugs.;Change in baseline resting anal sphincter pressure.Timepoint: At 15, 30 and 60 minutes following topical application of study drugs.
- Secondary Outcome Measures
Name Time Method Adverse event reportingTimepoint: At Days 5,10 And At The End Of The Study;Change in resting anal sphincter pressures from baseline <br>Timepoint: At days 5, 10 and 20.;Change in the VAS score for pain from baseline (day 1)Timepoint: At days 5, 10 & 20 post application;Local examination for local dermatological effectsTimepoint: At day 5, 10 and at the end of the study