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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.

Phase 4
Completed
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
Inclusion Criteria

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)

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. 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
NameTimeMethod
Change in baseline resting anal sphincter pressureTimepoint: At 1 & 5 hours post application
Secondary Outcome Measures
NameTimeMethod
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.
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