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Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

NCT07008235 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-07

No results posted yet for this study

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

DRUG

Tablet Amitriptyline 10 milligrams

Tablet Amitriptyline 10 milligrams at night will be given to patients along with first line treatment (diet+lifestyle+PPI) 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 first line treatment (diet+lifestyle+PPI) 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.

DRUG

Standard First-Line Therapy

The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.

Sponsors & Collaborators

  • Md. Moktadirul Hoque Shuvo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008235 on ClinicalTrials.gov