Comparing Acotiamide and Itopride for the Management of Indigestion

This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning. The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms. Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily. Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day. The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach. Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.

NCT Number	NCT07449689
Lead Sponsor	Aga Khan University Collaborators: The Searle Company Limited Pakistan
Conditions	Functioanl Dyspepsia, Post Prandial Distress Syndrome
Enrollment	368 participants
Start Date	2026-04
Primary Completion	2026-12 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-06