Comparing Acotiamide and Itopride for the Management of Indigestion

Functional Dyspepsia (FD) is defined as gastro-duodenal symptoms occurring without any underlying systemic or metabolic disease, affecting an estimated 8.4% of the global population. Both acotiamide and itopride are established, commercially available medications known to be efficacious in managing FD. However, there is currently no direct comparison between the two drugs to help establish a universally accepted standard of care. This study is designed as a single-center, randomized, double-blind superiority trial to be conducted at the Aga Khan University Hospital in Karachi, Pakistan. The trial seeks to enroll 368 participants aged 18 to 70 who meet the ROME IV criteria for FD, specifically Postprandial Distress Syndrome (PDS). Methodology \& Procedures: Baseline Phase: Participants will undergo a 7-day baseline period in which they will discontinue any current gastrointestinal medications to clear residual effects. Randomization \& Blinding: Participants will be randomized via a computer-generated program in a 1:1 ratio to one of two treatment arms. To ensure double-blinding, the hospital pharmacy will encapsulate both acotiamide and itopride into identical opaque capsules, making them indistinguishable in taste, smell, and appearance. Intervention: The active treatment phase lasts 4 weeks. Group 1 will self-administer 100mg of oral acotiamide thrice daily before meals, while Group 2 will self-administer 50mg of oral itopride thrice daily before meals. Assessments: Symptom Severity Diary: Participants will record nine specific symptoms daily on a scale of 0-3 throughout the 5-week study duration. Overall Treatment Effect (OTE): At week 1 and week 4, participants will evaluate their symptom changes compared to baseline using a 7-point Likert scale. Quality of Life (QoL): The Short form of NPEAN dyspepsia index (SF-NDI) will be administered at the end of the baseline period (day 7) and at the end of the treatment period (week 4) to assess changes in disease-specific QoL. Safety Monitoring: Participants will be monitored for Adverse Events (AE) and Serious Adverse Events (SAE) at the week 1 and week 4 follow-up visits. All adverse events will be documented in case report forms and tracked by the Principal Investigator until resolution or stabilization, with SAEs being reported to the Ethical Review Committee.