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NOT YET RECRUITING
NCT04069286
PHASE3

EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA

Sponsor: Infan Industria Quimica Farmaceutica Nacional

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Omeprazole 20Mg Capsule

Comparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.