Study of controlled release mebeverine in irritable bowel syndrome in comparison to placebo.

Phase 4

Completed

• Conditions: Health Condition 1: K929- Disease of digestive system, unspecifiedHealth Condition 2: null- Irritable bowel syndrome

• Registration Number: CTRI/2018/03/012897
• Lead Sponsor: Department of Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1)Patients having recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months.

2)Patients having loose or watery stool more than three per day.

Exclusion Criteria

Female patients who are pregnant or breast-feeding.

Patients having infrequent bowel movements(less than 3 per week)

Patients having hard or lumpy stools

Patients strain during defaecation

Patients who have been treated with mebeverine within 4 weeks prior to study

Patients with history of hypersensitivity to Mebeverine.

Patients suffering from debilitating chronic diseases including frankly uncontrolled diabetes and advanced malignancy.

Patients suffering from frankly immunocompromising disorders such as HIV/AIDS.

Patients on systemic antimicrobials, corticosteroids or any other medication known to influence disease symptoms currently or within last 4 weeks.

Patients suffering from alcoholism, substance abuse or psychiatric disorders that are liable to make them unreliable trial subjects.

Patients without adequate caregiver support at home who can supervise daily oral administration as well as any adverse side effects. Any other condition which, in the opinion of the investigators, is likely to substantially increase the risk of non- adherence or the possibility of confounding of results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified