Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age 18 years or more

• Patients with FD diagnosed according to ROME IV criteria

• Patients who are willing to sign informed written consent

Locations
Other Locations
Bangladesh
Dhaka Medical College
RECRUITING
Dhaka
Contact Information
Primary
Md. Moktadirul Hoque Shuvo, MBBS
kdshuvo1430@gmail.com
+8801788450963
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 150
Treatments
Active_comparator: Amitriptyline
Tab. Amitriptyline 10 milligrams at night
Active_comparator: Trifluoperazine
Tab. Trifluoperazine 1 milligrams twice daily
No_intervention: Control Group
First line treatment only
Related Therapeutic Areas
Sponsors
Leads: Md. Moktadirul Hoque Shuvo

This content was sourced from clinicaltrials.gov