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โ† Trials
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Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

RecruitingPhase 2, Phase 3Ages 18 Years - 60 YearsAllMd. Moktadirul Hoque Shuvo
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In plain words

What the trial is, and whether it could suit you

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 ke

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Tablet Amitriptyline 10 milligrams
  • Tablet Trifluoperazine 1 milligrams twice daily
  • Standard First-Line Therapy
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Where

1 site
Dhaka Medical College
Dhaka, Bangladesh
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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