EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double - blind study of 200 male and female volunteers with gastritis diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from October 2019 to July 2020. .

Hypothesis:

As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolius raddi), associated with amoxicillin and clarithromycin, for the treatment of patients diagnosed with gastritis and dyspeptic symptoms has similar efficacy and safety (non-inferior) and/or superior efficacy and safety to traditional therapy based on the use of omeprazole-associated antibiotic therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infan Industria Quimica Farmaceutica Nacional
• Collaborator: Hospital Universitário Oswaldo Cruz
• Treatments: Amoxicillin; Omeprazole

Criteria

Inclusion criteria: Patients who:

• Report dyspeptic symptoms (nausea, heartburn, epigastric pain, aggravated / relieved abdominal discomfort, and early satiety); Confirmação Have gastritis and H pylori confirmed by upper digestive endoscopy and pathological examination;

• are between 18 and 80 years old;

• Understand and sign the Informed Consent Form.

Exclusion criteria: Patients who:

• Are being treated with proton pump inhibitor, non-steroidal anti-inflammatory drugs and / or H2 receptor blockers in the month prior to enrollment for clinical study.

• Are pregnant or lactating.

• Have intestinal obstruction, gastrointestinal surgery in the last thirty days, *Barrett's esophagus.

• Make use of reflux stimulating drugs.

• With Zollinger-Ellison Syndrome,

• Have active bleeding.

• Are currently in use or have recently used oral / venous antibiotics (within the last six weeks).

Patients whose biopsy from upper digestive endoscopy is negative for H. pylori will also be excluded.