CLINICAL TRIALNot yet recruiting
EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS
All genders
Phase 2/Phase 3
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.
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Treatments or procedures
Drug
· Oral Aroeira/ Amoxicillin/ Claritromycin
Drug
· Omeprazole/ Amoxicillin/ Claritromycin
More details
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.
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This study is new. We’ll notifiy you when this trial starts recruiting.
0REPLY1 YEAR AGO