NCT07008235

Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Md. Moktadirul Hoque Shuvo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are: Does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only. Participants will: Take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Tablet Amitriptyline 10 milligrams	Tablet Amitriptyline 10 milligrams at night will be given to patients along with standard first line treatment of functional dyspepsia for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks.
DRUG	Tablet Trifluoperazine 1 milligrams twice daily	Tablet Trifluoperazine 1 milligrams twice daily will be given to patients along with standard first line treatment of functional dyspepsia for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-06
• Last updated: 2025-12-31

Locations

1 site across 1 country: Bangladesh