Comparing Amitriptyline and Trifluoperazine Effects on Functional Dyspepsia Symptoms Treatment Safety and Symptom Improvement Over 12 Weeks

What this Trial Is About

Researchers are evaluating the effects of amitriptyline and trifluoperazine in improving symptoms of functional dyspepsia, a digestive disorder. This clinical trial aims to compare these two drugs against a control group receiving standard first-line treatment, while also assessing the safety by tracking patient-reported side effects. The study seeks to answer whether these drugs affect symptoms and what medical problems may occur during treatment. Participants will be randomly assigned to one of three groups one receiving amitriptyline 10 milligrams at night plus standard treatment, another receiving trifluoperazine 1 milligram twice daily plus standard treatment, and a control group receiving only the standard first-line treatment diet, lifestyle changes, and proton pump inhibitors. The drug treatments last for 8 weeks, followed by 4 additional weeks where all groups continue only the standard treatment. During the 12-week study, participants will visit the hospital every 4 weeks to assess their dyspeptic symptoms using a 5-point Likert Scale at baseline, week 4, week 8, and week 12. Researchers will document any adverse events reported by patients throughout the study. The main outcome measured is the change in dyspeptic symptoms, with additional comparisons between the drug groups and control group, as well as monitoring symptom persistence or recurrence after treatment.

Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia