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.

Changes in resting Anal Sphincter Pressure following topical application of a combination of Diltiazem and Lignocaine as compared to Topical Diltiazem and Lignocaine alone - a randomized double blind study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000758

Enrollment

Registered

2009-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Anal Fissure

Interventions

Intervention1: Topical Diltiazem gel (2%)+ Topical Lignocaine gel (2%): Two formulations may be mixed and applied to the affected area Control Intervention1: Topical Diltiazem + Placebo: Two formulati

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in baseline resting anal sphincter pressureTimepoint: At 1 & 5 hours post application	—

Secondary

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

Troikaa Pharmaceuticals Limited

vijayajaiswal@troikaapharma.com079-26856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026