Amitriptyline versus Trifluoperazine for functional dyspepsia
Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
This trial will test whether adding low‑dose amitriptyline or trifluoperazine to standard treatment helps adults with functional dyspepsia feel better over 8 weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Dhaka Medical College Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT07008235 on ClinicalTrials.gov |
What this trial studies
Adults with functional dyspepsia will be assigned to one of three groups: amitriptyline 10 mg at night plus standard first‑line therapy, trifluoperazine 1 mg twice daily plus standard therapy, or standard therapy alone for 8 weeks. Symptom changes and patient‑reported adverse events will be recorded to compare benefit and safety between the groups. After the 8‑week treatment period, all groups will be followed according to the protocol described by the investigators. The trial focuses on symptomatic improvement using established dyspepsia criteria and routine safety monitoring.
Who should consider this trial
Good fit: Adults aged 18 or older with symptoms meeting Rome IV criteria for functional dyspepsia who can give informed consent and attend study visits are ideal candidates.
Not a fit: Patients with structural upper GI disease, major medical or psychiatric comorbidities, current use of antidepressants or antipsychotics, prior hypersensitivity to the study drugs, or needing contraindicated co‑medications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding one of these low‑dose neuromodulators could reduce dyspepsia symptoms and improve daily comfort for patients.
How similar studies have performed: Low‑dose tricyclics such as amitriptyline have shown benefit in some functional GI disorder studies, while trifluoperazine is less well studied for functional dyspepsia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Dhaka
- Dhaka Medical College — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Md. Moktadirul Hoque Shuvo, MBBS
- Email: kdshuvo1430@gmail.com
- Phone: +8801788450963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.