Actively Recruiting
Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
Led by Md. Moktadirul Hoque Shuvo · Updated on 2026-05-07
120
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or more
- Symptoms of dyspepsia consistent with ROME IV criteria
- Willingness to sign informed written consent
You will not qualify if you...
- Structural lesions found in upper GI endoscopy or positive CLO test
- Scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
- History of cancer, significant liver or biliary disease, hypertension, diabetes, chronic kidney disease, thyroid disorder, or major psychiatric disorders
- Previous gastrointestinal surgery
- Use of drugs for other medical conditions that cause dyspepsia or interact with amitriptyline or trifluoperazine
- Current treatment with antidepressants or antipsychotics
- History of hypersensitivity, adverse effects, or ineffectiveness with amitriptyline or trifluoperazine
- Contraindications to amitriptyline or trifluoperazine
- Age over 60 years
- Pregnancy or breastfeeding
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Trial Site Locations
Total: 1 location
1
Dhaka Medical College
Dhaka, Bangladesh, 1000
Actively Recruiting
Research Team
M
Md. Moktadirul Hoque Shuvo, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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