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

Launched by HAFIZ MUHAMMAD HAMZA · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two ointments, Glyceryl Trinitrate (GTN) and Nifedipine, to see which one works better for healing acute anal fissures, a painful condition that can cause discomfort during bowel movements. The trial aims to find out which ointment helps relieve symptoms more effectively and has fewer side effects. Adults aged 18 to 65 who have been diagnosed with an acute anal fissure (lasting less than six weeks) and experience symptoms like anal pain, bleeding, or difficulty going to the bathroom may be eligible to participate.

Participants in the trial will apply the assigned ointment twice a day for four weeks and will attend follow-up visits to check on their symptoms and any potential side effects. To join, individuals must not have used GTN or Nifedipine in the past month and should not have any serious health conditions that could interfere with the study. This research is important as it could help identify the best treatment option for this common but uncomfortable condition, ultimately improving patient care.

Gender

ALL

Eligibility criteria

• 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 (including lateral internal sphincterotomy).
• • History of recurrent anal fissures (\>2 previous episodes in the past year).
• • Inability to comply with study requirements or follow-up visits.