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EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA
Sponsor: Infan Industria Quimica Farmaceutica Nacional
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.
Official title: EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN PARTICIPANTS DIAGNOSED WITH FUNCTIONAL DYSPEPPSIA: A RANDOMIZED AND DOUBLE-BLIND STUDY
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
474
Start Date
2025-03
Completion Date
2027-03
Last Updated
2024-04-29
Healthy Volunteers
No
Conditions
Interventions
Oral Aroeira
Active Group oral Aroeira (Schinus terebinthifolia Raddi), 1 tablet of 640 mg + 1 placebo capsule, once a day, for a period of 4 weeks.
Omeprazole 20Mg Capsule
Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.