Health Condition 1: K929- Disease of digestive system, unspecified Health Condition 2: null- Irritable bowel syndrome
Conditions
Interventions
Intervention1: Mebeverine: Controlled release Mebeverine Hydrochloride (200 mg) administered orally twice daily before meals for 8 weeks.
Control Intervention1: Placebo: MuLtivitamin capsule(BECADEXAM
Sponsors
Department of Pharmacology
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bowel movements per day - average of last 7 daysTimepoint: baseline 4 weeks 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS QoL Score.Timepoint: baseline 4 weeks 8 weeks;Subjective assessment of severity of abdominal cramps on a 3 point scale.Timepoint: baseline 4 weeks 8 weeks;Treatment emergent adverse events.Timepoint: 4 weeks 8 weeks | — |
Countries
India
Contacts
Public ContactDR AVIJIT HAZRA
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
Outcome results
None listed