Amitriptyline versus Trifluoperazine for functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dhaka Medical College
  Dhaka, Bangladesh Recruiting

Study contacts

• Study coordinator: Md. Moktadirul Hoque Shuvo, MBBS
• Email: kdshuvo1430@gmail.com
• Phone: +8801788450963

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pain Reprocessing Therapy for Functional Dyspepsia

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• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

  This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07772167

• Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers

  Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.

  Recruiting at 3 sites Universiteit Antwerpen · Edegem and 2 other locations · NCT07770126

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

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  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh

  This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.

  Recruiting Bangladesh Medical University · Dhaka · NCT07694778

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.