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IRCT20230314057717N2 IRCT 2023-06-21 Shahid Beheshti University of Medical Sciences The effect of the quadruple regimen containing rosuvastatin on the improvement of stomach infection Effectiveness of Rosuvastatin ‐containing quadriple regimen in eradication of Helicobacter pylori infection compared to the standard four-drug regimen in Helicobacter pylori positive patients 2023-07-06 anticipated 156 Complete https://irct.ir/trial/70657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to intervention and control treatment groups will be done through Sealed Envelope online software. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis, Blinding description: This study will be blinded for patients, evaluator of drug outcomes and analysis. In this way, patients do not know in which group they are receiving medicine. Also, the evaluator does not know which patient has received which drug regimen during the examination of drug side effects and the rate of recovery of patients. Finally, the data is provided to the analyst in a coded form, and he does not know which data is related to which patient. 3 Helicobacter pylori. Intervention 1: Intervention group: Patients in this group received rosuvastatin tablets (20 mg) once a day in addition to quadruple therapy (amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg)). will receive for 1 month. The drug regimen will be provided to the patient in the form of a drug package. Intervention 2: Control group: Patients in this group will take a quadruple regimen including amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg) twice a day for 14 days. The drug regimen will be provided to the patient in the form of a drug package for a period of 14 days. Yes - There is a plan to make this available What will be shared: Regarding the release of data, only data related to the consequences of taking drugs can be released. Other patient information will not be reported When: After the publication of the article To whom: Researchers, students and professors Conditions: The data can be used if information is provided regarding the method of analysis, if the principle of referencing is observed Where to obtain: Send an email to the corresponding author Dr. Amir Sadeghi Amirsadeghimd@yahoo.com How to obtain: Send the request to the responsible author via email and explain the details of the required data and mention the reason and how to use it Comments:
public Shahrzad Salimi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 sharzad.salimi6969@gmail.com Shahid Beheshti University of Medical Sciences scientific Amir Sadeghi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2540 amirsadeghimd@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmation of H. pylori infection in patients by standard diagnostic methods Age above 18 years Willingness to participate in the study 18 years no limit Both Patients are currently being treated with a four-drug regimen B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group received rosuvastatin tablets (20 mg) once a day in addition to quadruple therapy (amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg)). will receive for 1 month. The drug regimen will be provided to the patient in the form of a drug package. Control group: Patients in this group will take a quadruple regimen including amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg) twice a day for 14 days. The drug regimen will be provided to the patient in the form of a drug package for a period of 14 days. Helicobacter pylori eradication. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: Endoscopy or fecal antigen test. Occurrence of drug side effects. Timepoint: 14 days after the start of the intervention. Method of measurement: Physical examination. Shahid Beheshti University of Medical Sciences Approved 2023-05-30 Ethics Committee of Shahid Beheshti University of Medical Sciences Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)