To compare the effect of topical application of diltiazem gel (2%) and lignocaine gel (2%) individually and in combination on resting anal sphincter pressure in a double blind study design.
- Conditions
- Health Condition 1: null- Chronic Anal Fissure
- Registration Number
- CTRI/2009/091/000758
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1. Adult patients of either sex aged 18 - 60 years.
2. Patients diagnosed with chronic anal fissure
3. Patients having symptoms (pain) present for a minimum of 6 weeks despite standard therapy (diet, laxatives, Sitz-baths)
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. Patients who are on topical therapy with lignocaine/ steroids/ calcium channel blockers
7. Known hypersensitivity to diltiazem
8. Pregnant women /lactating mother
9. Patients with HIV infection
10. Pregnant women /lactating mother
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in baseline resting anal sphincter pressureTimepoint: At 1 & 5 hours post application
- Secondary Outcome Measures
Name Time Method Change in the VAS score for pain from baselineTimepoint: At 1 & 5 hours post application;Local examination for local dermatological effects.Timepoint: On the day of treatment.;No. of adverse event, No. of patients with adverse eventsTimepoint: On the day of treatment.;Side effects reported during the studyTimepoint: On the day of treatment.