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Effects of Flupentixol-Melitracen as an Add-on Therapy in Functional Dyspepsia: A Randomized, Double-Blind, Placebo-controlled Trial

Effects of Flupentixol-Melitracen as an Add-on Therapy in Functional Dyspepsia: A Randomized, Double-Blind, Placebo-controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260325001
Enrollment
100
Registered
2026-03-25
Start date
2026-03-21
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Effects of Flupentixol-Melitracen as an add-on therapy in functional Dyspepsia patient who already recieve PPI and prokinetics Functional dyspepsia Flupentixol-Melitracen Overall symptom relief Quality of life

Interventions

dose: 0.5 mg of Flupentixol and 10 mg of Melitracen as fixed drug combination duration: 2 weeks mode of administration: oral daily dose
Flupentixol-Melitracen

Sponsors

Faculty of medicine, Khon Kaen university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70 years. 2. Diagnosed with functional dyspepsia according to the Rome IV diagnostic criteria, without alarm features. Participants must also have: - Normal upper gastrointestinal endoscopy findings, and - No evidence of Helicobacter pylori infection within 1 year prior to enrollment in the study. 3. Patients who continue to experience symptoms despite receiving treatment with a proton pump inhibitor (PPI) and prokinetic agents for at least 8 weeks prior to enrollment in the study. 4. Able to read, write, and communicate in Thai. 5. Normal findings on physical examination.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity or contraindication to flupentixol-melitracen 2. History of using nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant medications within 1 month prior to enrollment in the study 3. Presence of symptoms suggestive of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS) that may interfere with establishing a clear diagnosis 4. Pregnant or breastfeeding women 5. History of cardiovascular diseases, including cardiac arrhythmia or myocardial ischemia, within 3 months prior to enrollment in the study 6. Presence of other severe comorbid conditions, such as end-stage renal disease, end-stage liver cirrhosis, malignancy, or other serious illnesses 7. Use of anxiolytics or antidepressant medications within 3 months prior to enrollment in the study or current use of such medications 8. Patients with untreated narrow-angle glaucoma

Design outcomes

Primary

MeasureTime frame
Overall symptom relief at 2 weeks after the intervention subjective question

Secondary

MeasureTime frame
Functional dyspepsia symptoms assessment at 2 weeks after the intervention GOS questionnare,Quality of life assessment at 2 weeks after the intervention SF-NDI questionnare

Countries

Thailand

Contacts

Public ContactChalida Krataithong

Khon Kaen university

chalikr@kku.ac.th0951588165

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: May 1, 2026