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IRCT20210518051335N1 IRCT 2021-10-28 Mazandaran University of Medical Sciences Evaluation and comparison of the efficacy of triple therapies regimens containing esomeprazole and different doses of amoxicillin and bismuth for eradicating Helicobacter pylori infection in Sari EAB Evaluation and comparison of the efficacy of triple therapies regimens containing bismuth with high dose and different doses of amoxicillin for eradicating Helicobacter pylori infection 2021-12-22 anticipated 200 Complete https://irct.ir/trial/58449 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients are randomly randomized into blocks of 10 patients by a computer program and entered into the corresponding group of pre-prepared sets of numbers, respectively, Blinding description: Depending on the diagnosis, patients will undergo eradication study and treatment, but will not be informed of the type of treatment (receiving the first group or the second group). The information of the patients of the two groups, with a non-specific name that is a definition of the study groups (for example, groups A and B) and only the main researcher knows the definition (B: high dose group and A: medium-dose group), will be available to the analyzer. Therefore, the analyzer is not aware of the type of drugs received in each group. 2 H. pylori infection. Intervention 1: High dose group: Patients receive amoxicillin 1 gr tds, bismuth 240 mg tds and omeprazole 40 mg bid for 14 days. Intervention 2: Medium dose group: Patients receive amoxicillin 750 mg tds, bismuth 240 mg tds and omeprazole 40 mg bid for 14 days. Yes - There is a plan to make this available What will be shared: All data can be shared when participants are not identifiable When: Ability to access data 6 months after publishing the results To whom: The data will be available to academic researchers and non-academic physicians Conditions: Perform other analyzes and extract more results Where to obtain: Please refer to the e-mail address of the responsible author How to obtain: Submit a request to the Deputy of research and technology of the University / Refer the request to the relevant author of the project Comments:
public Hafez Tirgar Fakheri
Razi St. - Imam Khomeini Hospital, Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 7176 hafezfakheri@gmail.com Mazandaran University of Medical Sciences scientific Hafez Tirgar Fakheri
Razi St. - Imam Khomeini Hospital, Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 7176 hafezfakheri@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients have H. pylori eradication indication based on endoscopic evidence Patients with positive Rapid urease test Patients with positive histology of H. pylori infection 18 years no limit Both Age under 18 years Reluctance to participate in the study Pregnancy and lactation Patients taking concomitant anticoagulants, corticosteroids or ketoconazole. Patients with a history of gastric surgery Patients with a history of heart failure, lung disease, chronic kidney failure, liver disease (cirrhosis or chronic hepatitis for any reason), or a history of cancer Consumption of alcohol in any amount The presence of any type of malignancy History of drug allergy to the drugs in this study History of H. pylori eradication regimens at any time before this study B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs High dose group: Patients receive amoxicillin 1 gr tds, bismuth 240 mg tds and omeprazole 40 mg bid for 14 days. Medium dose group: Patients receive amoxicillin 750 mg tds, bismuth 240 mg tds and omeprazole 40 mg bid for 14 days. H. pylori eradication. Timepoint: At least the eighth week after starting treatment. Method of measurement: stool examination. Drug compliance rate. Timepoint: 8th week of study. Method of measurement: questionnaire. Severity of drug side effects. Timepoint: 8th week of study. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2021-01-27 Imam Hospital of Sari - Mazandaran University of Medical Sciences (Research Ethics Committee) Imam hospital, Razi street ساری Mazandaran Iran (Islamic Republic of)