Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMd. Moktadirul Hoque Shuvo

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or more

Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria

Patients who are willing to sign informed written consent

Disqualifiers

Structural lesion in Upper GI endoscopy and/or positive CLO test

Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms

History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders

Previous history of gastrointestinal surgery

Trial design

Treatments tested in this trial

  • Tablet Amitriptyline 10 milligrams
  • Tablet Trifluoperazine 1 milligrams twice daily
  • Standard First-Line Therapy

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Md. Moktadirul Hoque Shuvo

Lead sponsor

Dhaka Medical College

Sponsor institution