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IRCT20220306054205N1 IRCT 2022-04-18 Rasht University of Medical Sciences The effect of two quadruple diets of amoxicillin, bismuth, levofloxacin and pantoprazole versus amoxicillin, clarithromycin, bismuth, pantoprazole in the treatment of Helicobacter pylori Comparison of two quadruple regimens of amoxicillin, bismuth, levofloxacin and pantoprazole versus amoxicillin, clarithromycin, bismuth, pantoprazole to eradicate Helicobacter pylori 2021-12-22 anticipated 196 Complete https://irct.ir/trial/62424 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is 49 quadruple blocks in random blocks. The randomization method is 49 quadruple blocks in random blocks. After adopting the sequence list of blocks, this list is enclosed in a locked envelope and sealed in the clinic nursing center Digestive research is maintained and read daily after the start of the study, and patients with inclusion criteria will receive their medication regimens according to the list, Blinding description: This study is of Open Lable type, because patients' medications are specific and have different colors and sizes. However, the researcher does not know the type of medication patients receive. 3 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere. Intervention 1: Intervention group: Patients in the intervention group will use a four-drug regimen containing levofloxacin 500 daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours and amoxicillin 1 g every 12 hours. Intervention 2: Control group: In this study, the control group of the usual treatment group of four drugs under the treatment regimen with clarithromycin 500 twice daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours and amoxicillin 1 gram every 12 hours will be given. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Afshin Shafaghi
Namjoo St. Guilan University of Medical Sciences, Rasht
Rasht Iran (Islamic Republic of) 33111-41937 +98 13 3332 8101 drafshinshafaghi@gmail.com Rasht University of Medical Sciences scientific Afshin Shafaghi
Rasht - Shahid Ansari Street - in front of Mellat Park
Rasht Iran (Islamic Republic of) 41937-13111 +98 13 3332 8101 drafshinshafaghi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) All patients tested positive for Helicobacter pylori after endoscopy no limit no limit Both B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group will use a four-drug regimen containing levofloxacin 500 daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours and amoxicillin 1 g every 12 hours. Control group: In this study, the control group of the usual treatment group of four drugs under the treatment regimen with clarithromycin 500 twice daily, pantoprazole 20 twice daily, bismuth tablets every 12 hours and amoxicillin 1 gram every 12 hours will be given. The primary outcome variable in this study is the eradication of Helicobacter pylori. To evaluate the eradication of Helicobacter pylori, urease breath test will be performed again 4 weeks after the end of treatment. If the test is negative, the treatment will be considered successful. Timepoint: 4 weeks after the end of treatment. Method of measurement: Urease breath test. Rasht University of Medical Sciences Approved 2021-03-10 Ethics committee of Guilan University of Medical Sciences Namjoo St. Guilan University of Medical Sciences, Rasht13111-41937 Rasht Guilan Iran (Islamic Republic of)