drugset / Trial / NCT04069286
EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA
Phase 3
Not yet recruiting
474 enrolled
Infan Industria Quimica Farmaceutica Nacional
Hospital Universitário Oswaldo Cruz · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a prospective, randomized, double - blind study of 474 male and female volunteers with dyspeppsia diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from March 2025 to March 2027. Hypothesis: As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolia Raddi) for the treatment of participants diagnosed with functional dyspepsia efficacy not inferior to therapy based on the use of omeprazole.
Timeline
- Start
- 2025-03
- Primary completion
- 2026-07
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aroeira | Unknown | 640 mg | Oral |
| Comparator | Omeprazole | Other / unclassified | 20 mg | Oral |