Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Recruiting now · Phase 2/Phase 3

Conditions studied: Functional Dyspepsia

In brief

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 facts

Study ID

NCT07008235

Run by

Md. Moktadirul Hoque Shuvo

People needed

120

Starts

2025-07-01

Expected to finish

2026-06-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine
• Any patient with ongoing treatment with antidepressants or antipsychotics
• Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine
• Patients for whom Amitriptyline and Trifluoperazine are contraindicated
• Elderly patients> 60 years
• Pregnancy and breastfeeding

Where it is running

• Dhaka Medical College — Dhaka, Bangladesh (enrolling)

Full record on ClinicalTrials.gov

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