Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07008235
PHASE2/PHASE3

Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Sponsor: Md. Moktadirul Hoque Shuvo

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-07-01

Completion Date

2026-06

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

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.

Locations (1)

Dhaka Medical College

Dhaka, Bangladesh