Clinical trial NCT07008235: Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
Official title: Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Functional Dyspepsia
Keywords: Functional Dyspepsia
Amitriptyline
Trifluoperazine
Lead sponsor: Dhaka Medical College
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or more
* Patients with FD diagnosed according to ROME IV criteria
* Patients who are willing to sign informed written consent

Exclusion Criteria:

* Structural lesion in endoscopy and positive H. pylori status
* History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease
* Major medical and psychiatric disorders
* Previous history gastrointestinal surgery
* 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

Primary outcomes:
measure: Change in dyspeptic symptom
timeFrame: At baseline and then at week 4,8, and 12 after randomization
Secondary outcomes:
measure: See the effect of trifluoperazine
timeFrame: At baseline and then at week 4,8, and 12 after randomization
measure: See the effect of amitriptyline
timeFrame: At baseline and then at week 4,8, and 12 after randomization
measure: Compare the effects of amitriptyline and trifluoperazine
timeFrame: At baseline and then at week 4,8, and 12 after randomization
measure: Adverse events
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College
Study officials:
References: