Functional dyspepsia Dyspepsia Functional dyspepsia
Conditions
Interventions
Each capsule contains 500 mg of C. longa extract powder, delivering approximately 475 mg of curcuminoids.,Placebo capsule is comparable to the intervention.
Experimental Drug,Placebo Comparator Drug
Curcumin capsule from turmeric extract,Placebo
Sponsors
Chiang Mai University
Speciality Innovations, Co., Ltd.
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 80 years, both male and female 2. Diagnosed with functional dyspepsia based on ROME IV criteria, and confirmed negative for Helicobactor pylori infection 3. Able to read and write in Thai 4. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Presence of significance underlying gastrointestinal conditions 3. History of gastrointestinal surgery 4. History or presence of immune-related disorders 5. History or presence of coagulation disorders 6. History or presence of severe comorbidities 7. History or current use of medications metabolized primarily via Cytochrome P450 enzymes 3A4, 1A2, or 2C9, 8. History or current use of antiplatelet, anticoagulant, or NSAIDs 9. History or current use of immunosuppressive agents 10. History or current use of chemotherapy 11. Known or suspected of allergy or hypersensitivity to curcumin or C. longa 12. History of vaccination within one month 13. History or current use of medication, procedures, or any products that may interfere with outcome assessments 14. History or current heavy smoking, alcohol dependence, or use of other addictive substances 15. Current participation in other clinical research studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspepsia symptoms 0, 2, 4 weeks Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom relief 0, 2, 4 weeks Questionnaire,Quality of life 0, 2, 4 weeks Questionnaire,Safety laboratory parameters 0, 4 weeks Biochemistry lab,Adverse events 0, 2, 4 weeks History taking,Serum gastrin (exploratory) 0, 4 weeks ELISA,Pharmacokinetics (exploratory) 4 weeks HPLC or LC-MS | — |
Countries
Thailand
Contacts
Public ContactNut Koonrungsesomboon
Faculty of Medicine, Chiang Mai University
Outcome results
None listed