Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

NCT07008235 | Recruiting Phase 2 DMC

• 1 other identifier: IRB-DMC/2025/38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 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.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia; Amitriptyline; Trifluoperazine; Neuromodulator; DGBI; Disorders of Gut Brain Interaction; ROME IV; 5-point Likert Scale; Tricyclic antidepressant; Phenothiazine; Antipsychotic; Dyspepsia

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. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.

  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

EXPERIMENTAL

Tab. Amitriptyline 10 milligrams at night along with first line treatment (diet+lifestyle+PPI) 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 Amitriptyline 10 milligrams

Trifluoperazine

EXPERIMENTAL

Tab. Trifluoperazine 1 milligrams twice daily along with first line treatment (diest+Lifestyle+PPI) 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: Tablet Trifluoperazine 1 milligrams twice daily

Control Group

ACTIVE COMPARATOR

The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.

Drug: Standard First-Line Therapy

Interventions

Standard First-Line Therapy DRUG

The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.

Control Group

Tablet Trifluoperazine 1 milligrams twice daily DRUG

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.

Trifluoperazine

Tablet Amitriptyline 10 milligrams DRUG

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.

Amitriptyline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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, 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

Sponsors & Collaborators

• Md. Moktadirul Hoque Shuvo: lead

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Md. Moktadirul Hoque Shuvo, MBBS

CONTACT

+8801788450963; kdshuvo1430@gmail.com

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: May 7, 2026

Record last verified: 2026-05

Locations

BA (1)