NCT07008235 Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
| NCT ID | NCT07008235 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Md. Moktadirul Hoque Shuvo |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-07-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07008235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07008235 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07008235 currently recruiting?
Yes, NCT07008235 is actively recruiting participants. Contact the research team at kdshuvo1430@gmail.com for enrollment information.
Where is the NCT07008235 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT07008235 clinical trial?
NCT07008235 is sponsored by Md. Moktadirul Hoque Shuvo. The trial plans to enroll 120 participants.