NCT04069286

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

EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN PARTICIPANTS DIAGNOSED WITH FUNCTIONAL DYSPEPPSIA: A RANDOMIZED AND DOUBLE-BLIND STUDY

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Sponsor: Infan Industria Quimica Farmaceutica Nacional · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The initial proposal of the project was a prospective, comparative and double blind study between aroeira and omeprazole together with antibiotic treatment for patients diagnosed with gastritis caused by Helicobacter pylori, whose dosage of aroeira (Schinus terebinthifolia Raddi) was 1 tablet of 640 mg, every 12 hours for 4 weeks and omeprazole was 1 capsule of 20 mg, 12/12h, for 4 weeks. Due to Anvisa requirements, and taking into account the current rationale for gastritis related to this infection, we analyzed that a project with gastritis without the association with H. pylori would not be ideal. So, we are proposing a comparative study with the same drugs (aroeira versus omeprazole) in evaluating the complete relief of dyspeptic symptoms in Dyspepsia Functional. In this new proposal, the N will be 474 participants, maintaining a 1:1 ratio. Research participants will be those who report at least 1 of the 5 dyspeptic symptoms (nausea, heartburn, pain epigastric pain, abdominal discomfort aggravated/relieved by meals and feeling of early satiety) with onset more than 6 months, lasting at least 3 months and excluding other diagnoses by upper digestive endoscopy (EDA). Our primary objective will be "Compare the effectiveness of oral mastic (Schinus terebinthifolia Raddi) versus omeprazole in relieving complete description of the symptoms of functional dyspepsia. The secondary objectives will be: 1. Evaluate the improvement in the quality of life of participants with dyspeptic symptoms within each treatment (before and afterwards) and between aroeira versus omeprazole at the end of treatment; 2. Evaluate complaints within each treatment (before and after) and between oral mastic versus omeprazole at the end of the treatment treatment; 3. Evaluate possible adverse events to treatment with oral mastic versus omeprazole therapy reported by the participant. Clinical Trial Protocol Oral Aroeira medicine (Schinus terebinthifolia Raddi) Version 03 of 14-June-2023 HB-F3-01/2019 Sponsor: INFAN - Indústria Química Farmacêutica Nacional S/A The dosage of this study will be: 1 tablet of oral Aroeira (Schinus terebinthifolia Raddi) of 640mg, once a day, at least period of 4 weeks, and omeprazole, 1 capsule of 20mg, once a day, for a period of 4 weeks.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-07-01
• Completion: 2027-03-01
• First posted: 2019-08-28
• Last updated: 2024-04-29