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Diltiazem Gel or Ointment, Which One is a Better Choice for Anal Fissure?

Diltiazem Gel Verus Diltiazem Ointment in Alleviating the Symptoms of Chronic Anal Fissure; a Randomized Clinical Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141116019971N5
Enrollment
70
Registered
2021-02-07
Start date
2021-01-19
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Anal fissure. Anal fissure

Interventions

Intervention 1: Intervention group: The first group will receive topical jel diltiazem 2% produced by Sobhan daroo co. two times per day q 12 hours. Intervention 2: Control group: The second group wil

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Symptoms of anal fissure (pain, bleeding, burning, or itching) in the last six weeks. Finding one of the following signs on examination: visible sphincter fibers at the fissure base, anal papillae, sentinel piles, and indurated margins.

Exclusion criteria

Exclusion criteria: Past history of anal surgery Current consumption of other topical or oral medication for anal fissure. History of allergic reaction to diltiazem. History of cardiovascular problems including sick sinus syndrome, heart block, arrhythmia, bradycardia, heart failure, and cardiomyopathy. Hypotension (systolic blood pressure < 90 mmHg). History of chronic liver failure. Current consumption of antihypertensive drugs. Pregnancy and breast feeding. Failure to obtain informed consent.

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: Before treatment and four weeks treatment. Method of measurement: Visual analog scale.

Secondary

MeasureTime frame
Itching. Timepoint: Before treatment and four weeks treatment. Method of measurement: Inquiring the patient about presence or absence of itching.;Bleeding. Timepoint: Before treatment and four weeks treatment. Method of measurement: Inquiring the patient about presence or absence of bleeding.;Side effects including hives, hypotension, vertigo, palpitation, light headedness. Timepoint: Four weeks post-treatment. Method of measurement: Inquiring the patient about presence or absence of side effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Karimialavijeh

Tehran University of Medical Sciences

drkarimi86@gmail.com+98 21 6634 8500

Outcome results

None listed

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