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IRCT20200915048726N3 IRCT 2023-11-25 Mazandaran University of Medical Sciences Comparing the efficacy of the bismuth-based quadruple therapy containing a high dose of metronidazole with a concomitant regimen containing clarithromycin for eradicating Helicobacter pylori infection Comparing the efficacy of the bismuth-based quadruple therapy containing a high dose of metronidazole with a concomitant regimen containing clarithromycin for eradicating Helicobacter pylori infection 2023-12-23 anticipated 200 Complete https://irct.ir/trial/73688 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly randomized into blocks of 6 and 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 (Bismuth-containing quadruple and B: Concomitant quadruple), will be available to the analyzer. Therefore, the analyzer is not aware of the type of drugs received in each group. 2-3 H. pylori infection. Intervention 1: Intervention group: The A group (high dose metronidazole): amoxicillin 1 gr BD, metronidazole 1 gr BD, bismuth 240 mg BD, and pantoprazole 40 mg BD for 14 days. Intervention 2: Intervention group: The B group (concomitant): amoxicillin 1 gr BD, metronidazole 500 mg BD, clarithromycin 500 mg BD, and pantoprazole 40 mg BD 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 Deputy of Research and Technology of the University of Mazandaran University of Medical Sciences (via automation application or e-mail address, ebrahimnejad@mazums.ac.ir). How to obtain: The applicant submits a request for documents or data files related to this trial (which contain the applicant's e-mail address or mailing address) to the Deputy of Research and Technology of the University of Mazandaran University of Medical Sciences (via automation application or e-mail address, ebrahimnejad@mazums.ac.ir). If approved, this request will be referred to the responsible author of the project, Dr. Arash Kazemi. Then the data will be sent to the declared address. Comments:
public Arash Kazemi
Imam Khomeini Hospital., Razi Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 4977 arash_6z@yahoo.com Mazandaran University of Medical Sciences scientific Arash Kazemi
Imam Khomeini Hospital., Razi Ave
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 4977 arash_6z@yahoo.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 Intervention group: The A group (high dose metronidazole): amoxicillin 1 gr BD, metronidazole 1 gr BD, bismuth 240 mg BD, and pantoprazole 40 mg BD for 14 days Intervention group: The B group (concomitant): amoxicillin 1 gr BD, metronidazole 500 mg BD, clarithromycin 500 mg BD, and pantoprazole 40 mg BD for 14 days Helicobacter pylori eradicating. 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 2022-10-18 Imam Hospital of Sari - Mazandaran University of Medical Sciences (Research Ethics Committee) Imam hospital, Razi street Sari Mazandaran Iran (Islamic Republic of)