Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
NCT ID: NCT07008235
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2025-07-01
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amitriptyline
Tab. 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.
Tablet Amitriptyline 10 milligrams
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.
Trifluoperazine
Tab. 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.
Tablet Trifluoperazine 1 milligrams twice daily
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.
Control Group
First line treatment only for 12 weeks
No interventions assigned to this group
Interventions
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Tablet Amitriptyline 10 milligrams
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.
Tablet Trifluoperazine 1 milligrams twice daily
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria
* Patients who are willing to sign informed written consent
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Md. Moktadirul Hoque Shuvo
OTHER
Responsible Party
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Md. Moktadirul Hoque Shuvo
Principal Investigator
Locations
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Dhaka Medical College
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Md. Moktadirul Hoque Shuvo, MBBS
Role: primary
Other Identifiers
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IRB-DMC/2025/38
Identifier Type: -
Identifier Source: org_study_id