The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fissure in Ano; Diarrhea

Treatments: Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Study type: Interventional

Funder types: Other

Identifiers

NCT05091775

98-01-01-21181

Details and patient eligibility

About

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.

Full description

The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath)

Placebo Comparator group

Description:

Patients in the first group underwent for 14 consecutive days treatment with diltiazem gel 2 times a day, a basin of warm water 2 times a day and drink daily 8-12 a glass of water will be placed with a placebo suppository.

Treatment:

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)

Experimental group

Description:

Patients in the second group or treatment group will be treated with diltiazem gel topically 3 times a day for 14 consecutive days, pelvis of warm water 2 times a day and drink daily 8-12 glasses of water plus Asacol anal suppository (mesalazine) are taken 1 piece every night.

Treatment:

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease