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

NCT04069286 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2024-04-29

No results posted yet for this study

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.

Conditions

  • Dyspepsia

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.

Sponsors & Collaborators

  • Hospital Universitário Oswaldo Cruz

    collaborator UNKNOWN

  • Infan Industria Quimica Farmaceutica Nacional

    lead INDUSTRY

Principal Investigators

  • Severino B Santos, PhD · Hospital Univeristário Oswaldo Cruz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-07-31
Completion
2027-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069286 on ClinicalTrials.gov