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

Summary

The goal of this clinical trial is to compare the therapeutic efficacy and safety profile of Glyceryl Trinitrate (GTN) and Nifedipine ointments in the treatment of acute anal fissures in adults. The main questions it aims to answer are:

Which ointment is more effective in promoting fissure healing and symptom relief? What are the adverse effects associated with each treatment? Researchers will compare GTN and Nifedipine ointments to determine which provides better symptom resolution with fewer side effects.

Participants will:

Apply GTN or Nifedipine ointment topically twice daily for four weeks Attend follow-up visits for symptom assessment and adverse effect monitoring

Conditions

• Acute Anal Fissure
• Anal Pain
• Anorectal Disorders
• Sphincter 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.

Sponsors & Collaborators

• Federal Government Polyclinic (Postgraduate Medical Institute)

  collaborator OTHER

• Hafiz Muhammad Hamza

  lead OTHER

Principal Investigators

• Naveed Ullah Khan, Consultant surgery, HOD · Federal Government Polyclinic (Postgraduate Medical Institute)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-17

Primary Completion

2025-05-10

Completion

2025-05-10

Countries

• Pakistan

Study Locations