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.
Nausea;
Heartburn;
Epigastric pain;
Abdominal discomfort aggravated/relieved by meals;
None
Parallel
Oral Aroeira
DrugActive 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
DrugComparator Group omeprazole, 1 20mg capsule + 1 placebo tablet, once a day, for a period of 4 weeks.
Complete relief dyspeppsia symptom
Assessment of the proportion of participants with complete relief of dyspeptic symptoms. Complete relief of symptoms will be considered if the scores obtained in items #3, #5 and #7 of the ROME III questionnaire are lower than or equal to their respective reference values for the diagnosis of each symptom of functional dyspepsia.
Life quality Improvement
Assessment of the proportion of improvement in quality of life using the SF-36 quality of life questionnaire, taking into account the domains "Functional capacity", "Limitation due to physical aspects", "Pain", "General health status", "Vitality ", "Social aspects", "Emotional aspects" and "Mental health" generating a continuous numerical variable (between 0 and 100, where 0 is bad and 100 is good) corresponding to each domain.
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Infan Industria Quimica Farmaceutica Nacional
Lead sponsor
Hospital Universitário Oswaldo Cruz
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
