Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Md. Moktadirul Hoque Shuvo

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Functional Dyspepsia

Treatments: Drug: Tablet Amitriptyline 10 milligrams; Drug: Tablet Trifluoperazine 1 milligrams twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07008235

IRB-DMC/2025/38

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Amitriptyline

Active Comparator group

Description:

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.

Treatment:

Drug: Tablet Amitriptyline 10 milligrams

Trifluoperazine

Active Comparator group

Description:

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.

Treatment:

Drug: Tablet Trifluoperazine 1 milligrams twice daily

Control Group

No Intervention group

Description:

First line treatment only for 12 weeks