Functional dyspepsia Dyspepsia Peppermint Oil Phytotherapy Placebos Randomized Controlled Trial Double-Blind Method
Conditions
Interventions
Participants will receive peppermint oil capsules at a dose of 187 milligrams, to be taken one capsule three times daily, 15 minutes before meals for 28 days period,Participants will receive placebo c
Active Comparator Drug,Placebo Comparator Drug
Peppermint oil,Placebo
Sponsors
Department of medicine, Phramongkutklao Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 20 and 80 years. 2. Patients presenting with symptoms consistent with functional dyspepsia according to the Rome IV criteria, with a symptom duration of at least 4 weeks. All patients must have undergone esophagogastroduodenoscopy (EGD) and tested negative for Helicobacter pylori infection. 3. Patients who provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Evidence of any organic disease that may explain the patient's symptoms 2. Patients presenting with upper gastrointestinal bleeding 3. Patients with confirmed Helicobacter pylori infection who have not received eradication therapy 4. Patients with jaundice, defined as total bilirubin greater than 2 mg per dL 5. Patients with anemia, defined as hemoglobin less than 10 g per dL 6. Patients with chronic kidney disease stage 4 or higher, defined as a glomerular filtration rate less than 30 mL per minute per 1.73 square meters 7. Patients with a history of gastric surgery, gastric bypass surgery, or gastrointestinal malignancy 8. Patients with a history of using nonsteroidal anti-inflammatory drugs, aspirin, or other antiplatelet agents within the past four weeks 9. Patients who have used proton pump inhibitors or prokinetic agents within the past two weeks 10. Pregnant women or those planning to become pregnant 11. Patients with a known allergy to peppermint or peppermint oil 12. Patients with symptoms suggestive of irritable bowel syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspepsia at day 0, day 14 and day 28 of treatment SODA (severity of dyspepsia assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life at day 0 and day 28 of treatment EQ-5D-5L questionnaire | — |
Countries
Thailand
Contacts
Public ContactPatranit Nuntasilapachai
Phramongkutklao hospital
Outcome results
None listed