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.

The effect of a topical application of Diltiazem or a combination of Diltiazem and Lidocaine in various anal conditions.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000356

Enrollment

150

Registered

2009-06-15

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: Diltiazem 2% Gel: Digital application of 2.5 cm gel strip. To be applied locally thrice daily for 20 days. Control Intervention1: Diltiazem 2% gel + Lidocaine 2% gel: Digital applicati

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse event reportingTimepoint: At Days 5,10 And At The End Of The Study;Change in resting anal sphincter pressures from baseline 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	—

Countries

India

Contacts

Public ContactDr Sanjay Maroo

Troikaa Pharmaceuticals Limited

sanjaymaroo@troikaapharma.com079-26856242

Outcome results

None listed

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