drugset / Trial / NCT06859554
Efficacy and Safety of GTN vs. Nifedipine in Acute Anal Fissure: A Clinical Trial
Phase 4
Completed
110 enrolled
Hafiz Muhammad Hamza
Federal Government Polyclinic (Postgraduate Medical Institute) · collab
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2025-03-17
- Primary completion
- 2025-05-10
- Completion
- 2025-05-10
Publications
- Results Mustafa NA, Cengiz S, Turkyilmaz S, Yucel Y. Comparison of topical glyceryl trinitrate ointment and oral nifedipine in the treatment of chronic anal fissure. Acta Chir Belg. 2006 Jan-Feb;106(1):55-8. doi: 10.1080/00015458.2006.11679834.
- Results Wang C, Ni J, Xiong Y, Chen J, Li B, Xu L. The efficacy of diltiazem, glyceryl trinitrate, nifedipine, minoxidil, and lidocaine for the medical management of anal fissure: a systematic review and network meta-analysis of randomized controlled trials. Int J Surg. 2025 Apr 1;111(4):3020-3029. doi: 10.1097/JS9.0000000000002263.
- Results Momayez Sanat Z, Mohammadi Ganjaroudi N, Mansouri M. The Effect of Topical Nifedipine versus Diltiazem on the Acute Anal Fissure: A Randomized Clinical Trial. Middle East J Dig Dis. 2023 Apr;15(2):121-125. doi: 10.34172/mejdd.2023.330. Epub 2023 Apr 30.
- Results Shrestha SK, Thapa PB, Maharjan DK, Tamang TY. Effectiveness of 0.2% Glyceryl Trinitrate and 0.5% Nifedipine in the Treatment of Chronic Anal Fissure. JNMA J Nepal Med Assoc. 2017 Jan-Mar;56(205):149-152.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nifedipine | Other / unclassified | 0.2 % | Topical |
| Comparator | Nifedipine | Other / unclassified | 0.5 % | Topical |
| Comparator | Nitroglycerin | Unknown | 0.2 % | Topical |