Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tablet Amitriptyline 10 milligrams, Tablet Trifluoperazine 1 milligrams twice daily, Standard First-Line Therapy.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Tablet Amitriptyline 10 milligrams
Tablet Amitriptyline 10 milligrams at night will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. - Drug Tablet Trifluoperazine 1 milligrams twice daily
Tablet Trifluoperazine 1 milligrams twice daily will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. - Drug Standard First-Line Therapy
The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.
Primary outcome measures
- Change in dyspeptic symptom [Time frame: At baseline and then at week 4 and 8 after randomization]
Secondary outcome measures (5)
- See the effect of trifluoperazine compared to first line treatment only [Time frame: At baseline and then at week 4 and 8 after randomization]
- See the effect of amitriptyline compared to first line treatment only [Time frame: At baseline and then at week 4 and 8 after randomization]
- Compare the effects of amitriptyline and trifluoperazine [Time frame: At baseline and then at week 4 and 8 after randomization]
- Adverse events [Time frame: Through study completion, an average of 1 year]
- Persistence of symptom improvement or recurrence of dyspeptic symptoms [Time frame: At week 12 after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Dhaka Medical College — Dhaka
Identifiers
NCT: NCT07008235 · IRB-DMC/2025/38