Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 31, 2025
December 1, 2025
11 months
May 24, 2025
December 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in dyspeptic symptom
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
At baseline and then at week 4 and 8 after randomization
Secondary Outcomes (5)
See the effect of trifluoperazine compared to first line treatment only
At baseline and then at week 4 and 8 after randomization
See the effect of amitriptyline compared to first line treatment only
At baseline and then at week 4 and 8 after randomization
Compare the effects of amitriptyline and trifluoperazine
At baseline and then at week 4 and 8 after randomization
Adverse events
Through study completion, an average of 1 year
Persistence of symptom improvement or recurrence of dyspeptic symptoms
At week 12 after randomization
Study Arms (3)
Amitriptyline
ACTIVE COMPARATORTab. Amitriptyline 10 milligrams at night along with first line treatment 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.
Trifluoperazine
ACTIVE COMPARATORTab. Trifluoperazine 1 milligrams twice daily along with first line treatment 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.
Control Group
NO INTERVENTIONFirst line treatment only for 12 weeks
Interventions
Tablet Trifluoperazine 1 milligrams twice daily will be given to patients along with standard first line treatment 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.
Tablet Amitriptyline 10 milligrams at night will be given to patients along with standard first line treatment 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dhaka Medical College
Dhaka, 1000, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2025
First Posted
June 6, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 31, 2025
Record last verified: 2025-12