Actively Recruiting
Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure
Led by American University of Beirut Medical Center · Updated on 2025-01-29
183
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
No study to date has compared topical DTZ to MEBO ointment in the treatment of anal fissure. Therefore, the present study aims to compare the efficacy and safety of DTZ to MEBO in the treatment of acute anal fissure. The investigators propose to conduct a comparative randomized clinical study. In this study, the investigators will compare patients with acute anal fissure receiving MEBO ointment vs Topical DTZ ointment vs a combination of MEBO and DTZ ointment. Hypothesis: MEBO in combination with DTZ is more effective than DTZ or MEBO alone in the treatment of acute anal fissure.
CONDITIONS
Official Title
Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 18 years and above.
- Subjects with painful anal fissure lasting 3 months or less with pain experienced at least twice a week.
- Subjects with an average worst anal pain score of 4 or higher on an 11-point scale during the last 3 days of screening.
- Subjects with a radial fissure and induration visible on anal examination.
- Willing to stop other topical treatments applied to the anal area at least 2 weeks before starting the study and during the study.
- Able to give informed consent.
You will not qualify if you...
- Subjects unwilling to be examined for anal fissure.
- Subjects who have had lateral sphincterotomy, anal stretch, hemorrhoidectomy, anal fistula surgery, or incision of perianal abscess.
- Subjects who had botulinum toxin injection in the anal area within 6 months or used glyceryl trinitrate ointment for more than 1 week within 4 weeks before screening.
- Subjects with anal fissure caused by other conditions such as drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis, or malignancy.
- Subjects with cardiovascular disease.
- Subjects allergic to diltiazem or ingredients of MEBO (sesame oil).
- Subjects taking prohibited medications or experimental agents within 8 weeks or 5 half-lives before screening.
- Subjects with gastrointestinal disorders including inflammatory bowel disease, chronic fecal incontinence, prior pelvic radiation, fixed anal stenosis or fibrosis.
- Subjects with major psychiatric or hematological illness.
- Subjects with planned hospitalization or elective treatment during the study.
- Subjects unavailable for the study duration or deemed unsuitable by the investigator.
- Patients currently taking oral therapy for anal fissure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
American University of Beirut
Beirut, Lebanon
Actively Recruiting
Research Team
E
Eman Sbaity, MD
CONTACT
M
Mohamad Hadi El Charif, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here