Efficacy and Safety of GTN vs. Nifedipine in Acute Anal Fissure: A Clinical Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

May 10, 2025

Study Completion Date

May 10, 2025

Conditions
Acute Anal FissureAnal PainAnorectal DisordersSphincter Spasm
Interventions
DRUG

Glyceryl Trinitrate (GTN) 0.2% Ointment

Participants will apply 0.2% Glyceryl Trinitrate (GTN) ointment to the anal region twice daily for four weeks. GTN functions as a nitric oxide donor, reducing internal anal sphincter tone to improve blood flow and promote fissure healing. The study aims to assess its effectiveness in symptom relief, fissure healing, and associated side effects such as headaches and dizziness.

DRUG

Glyceryl Trinitrate (GTN) 0.4% Ointment

Participants will apply 0.4% Glyceryl Trinitrate (GTN) ointment twice daily for four weeks. This increased concentration aims to determine dose-dependent efficacy and adverse effects in treating acute anal fissures. GTN acts by relaxing smooth muscle, decreasing sphincter tone, and enhancing mucosal blood flow to promote healing.

DRUG

Nifedipine 0.2% Ointment

Participants will apply 0.2% Nifedipine ointment twice daily for four weeks. Nifedipine, a calcium channel blocker, reduces sphincter tone by inhibiting calcium influx into smooth muscle cells, leading to improved fissure healing. This arm will assess its effectiveness in symptom relief and healing rates, with a focus on side effects such as local irritation or hypotension.

DRUG

Nifedipine 0.5% Ointment

Participants will apply 0.5% Nifedipine ointment twice daily for four weeks. This higher concentration is used to evaluate whether increased potency provides superior symptom resolution and healing rates compared to 0.2% Nifedipine. The study will also assess any potential adverse effects, including local irritation, dizziness, and hypotension.

Trial Locations (1)

051

Federal Government Polyclinic (Postgraduate Medical Institute), Islamabad

All Listed Sponsors
collaborator

Federal Government Polyclinic (Postgraduate Medical Institute)

OTHER

lead

Hafiz Muhammad Hamza

OTHER