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Effect of Amitriptyline and Trifluoperazine on Patients with Functional Dyspepsia

Effect of Amitriptyline and Trifluoperazine on Patients with Functional Dyspepsia

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250612003
Enrollment
120
Registered
2025-06-12
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia Functional Dyspepsia Amitriptyline Trifluoperazine Neuromodulator Dyspepsia DGBI Disorders of Gut Brain Interaction ROME IV Tricyclic antidepressant Antipsychotic Phenothiazine

Interventions

Patients will get Tablet Amitriptyline 10 milligrams daily at night along with standard first line treatment,Patients will get Tablet Trifluoperazine 1 milligrams twice daily along with standard first
Amitriptyline,Trifluoperazine,Standard first line treatment only

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or more 2. Patients with FD diagnosed according to ROME IV criteria 3. Patients who are willing to sign informed written consent

Exclusion criteria

Exclusion criteria: 1.Structural lesion in Upper GI endoscopy and/or positive CLO test 2.Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms 3.History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders 4.Previous history of gastrointestinal surgery 5.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 6.Any patient with ongoing treatment with antidepressants or antipsychotics 7.Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine 8.Patients for whom Amitriptyline and Trifluoperazine are contraindicated 9.Elderly patients> 60 years 10.Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frame
Dyspeptic symptom improvement At week 4 and 8 5-point Likert Scale

Secondary

MeasureTime frame
Adverse events Throughout the study Patient reported adverse events,Change in Likert scale score or persistence of improvement or recurrance At week 12 5-point likert scale

Countries

Bangladesh

Contacts

Public ContactMd. Moktadirul Hoque Shuvo

Dhaka Medical College

kdshuvo1430@gmail.com01788450963

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026