The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure (NCT05091775) | Clinical Trial Compass
CompletedPhase 1/2
The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure
Iran140 participantsStarted 2020-06-01
Plain-language summary
Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase.
The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing.
This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.
Who can participate
Age range
18 Years – 65 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:
For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.
Exclusion Criteria:
* Recurrent fissure with skin appendage.
* Long history of constipation.
* Use of immunosuppressive drugs or corticosteroids.
* Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
* Pregnancy.
* Grade 3 and 4 hemorrhoids.
* Neurological disease.
* Obsessive-compulsive disorder.
* Previous history of anal surgery
* Skin diseases such as eczema and psoriasis.
* Sexually transmitted infections, tuberculosis.
* Mucosal prolapse.
* Anal fistula and pelvic radiotherapy.
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
1
Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)