EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS
EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS
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.
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 3, double-blind, randomized, unicenter, clinical trial for patients who are diagnosed
 with H pylori gastritis and have associated dyspeptic symptoms seen at the Oswaldo Cruz
 University Hospital Gastroenterology Outpatient Clinic in Recife / PE, Brazil. October 2019
 to July 2020.

 In order to verify the hypothesis that treatment with oral Aroeira, amoxicillin and
 clarithromycin has similar (not inferior) and/or superior efficacy and safety than treatment
 with omeprazole, amoxicillin and clarithromycin, a sample of 200 patients was defined,
 keeping the proportion 1: 1, which will be divided into two groups:

 1. Test group with 100 patients undergoing treatment with:

 oral Aroeira (Schinus terebinthifolius Raddi, 640mg / tablet) 1 tablet every 12 hours +
 amoxicillin 2 500mg tablets every 12 hours + clarithromycin 1 tablet 500mg every 12
 hours for 14 days.

 2. Control group with 100 patients undergoing treatment with:

 omeprazole 1 20mg tablet every 12 hours + amoxicillin 2 500mg tablet every 12 hours +
 clarithromycin 1 tablet 500mg every 12 hours for 14 days.

 At the beginning of the study, patients will answer the sociodemographic questionnaire, which
 includes identification data, concomitant presence of chronic diseases and time of onset of
 symptoms. Patients will also respond to the symptom questionnaire. At the time of upper
 digestive endoscopy and pathological examination, which will be performed before and after
 treatment completion, patients will have their results graded endoscopically, using the
 Sydney criteria and according to the Sydney Histological Classification. After performing the
 second upper digestive endoscopy and pathological examination, professionals will be
 instructed to answer questionnaires to evaluate the endoscopic and histological response to
 treatment. At the end of treatment, patients will respond to a specific treatment response
 questionnaire.
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.