CompletedPhase 4

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

Pakistan110 participantsStarted 2025-03-17

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for the study: * Age 18 to 65 years (to exclude elderly patients with different treatment responses). * Diagnosis of acute anal fissure based on clinical examination (symptom duration ≤6 weeks). * Willingness to participate in the study and provide written informed consent. * Availability for follow-up visits during the study period. * No prior use of GTN or Nifedipine for anal fissure within the past one month. * Presence of at least one of following symptoms: Anal pain, Bleeding during or after defecation and Difficulty in defecation Exclusion Criteria: * Participants will be excluded if they meet any of the following criteria: * History of chronic anal fissure (\>6 weeks duration) or prior anal fissure treatment within the past month. * Pregnant or breastfeeding women. * Known allergy or hypersensitivity to Glyceryl Trinitrate (GTN) or Nifedipine ointments. * History of cardiovascular diseases or contraindications to GTN or Nifedipine (e.g., hypotension, severe heart disease). * Presence of severe systemic diseases (e.g., uncontrolled diabetes, renal failure, autoimmune disorders) or conditions that may affect wound healing or medication tolerance. * Use of other topical treatments for anal fissure within the past month. * Secondary anal fissures associated with conditions e.g crohn's disease, tuberculosis, syphilis, HIV and other systemic diseases * Previous anal surgery (includin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Healing Rate at 4 Weeks

Timeframe: 4 weeks

Trial details

NCT IDNCT06859554

SponsorHafiz Muhammad Hamza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-10

View on ClinicalTrials.gov More Acute Anal Fissure trials