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IRCT20221016056190N1 IRCT 2023-01-15 Shahid Beheshti University of Medical Sciences bismuth- containing quadruple and high-dose dual therapy in eradication of Helicobacter pylori infection نام اختصاری مهار کننده پمپ پروتون یا Proton Pump Inhibitors سه حرف PPI است. Comparison of high-dose dual therapy and bismuth- containing quadruple therapy as a standard first line treatment in eradication of Helicobacter pylori infection 2021-03-21 anticipated 200 Complete https://irct.ir/trial/66382 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selection of patients with Helicobacter pylori infection was done in a non-randomized manner and their division into two intervention groups was done randomly (using a table of random numbers) after considering confounding variables.In the table of random numbers, the direction of reading the table numbers was determined from the top and the left side, and then even numbers were considered for the intervention of the first group and odd numbers were considered for the intervention of the second group. And the second was specified. 2 Eradication of Helicobacter pylori infection. Intervention 1: Intervention group: The first intervention group was treated with four standard medicines containing bismuth, including amoxicillin (1 gram 30 minutes after breakfast and dinner), pantoprazole (20 mg 30 minutes before breakfast and dinner), metronidazole (1 gram 30 minutes after breakfast and dinner), bismuth sub Citrate (240 mg 30 minutes before breakfast and dinner) is placed for 14 days. Intervention 2: Intervention group: The second intervention group is treated with two high-dose drugs including amoxicillin (1 gram 30 minutes after each meal including breakfast, lunch and dinner) and pantoprazole (40 mg 30 minutes before breakfast and dinner) for 14 days. Yes - There is a plan to make this available What will be shared: Study data related to the main outcome and side effects reviewed after de-identification of subjects can be shared with other researchers When: 6 months after the results are published To whom: Researchers of academic and scientific institutions Conditions: The use of documentation and data analysis for other scientific research is allowed for other researchers Where to obtain: By email to the following address abasimaryam1989@yahoo.com Maryam Abbasi How to obtain: After the request of the researchers, if at least 6 months have passed since the publication of the results, the data file will be sent after checking for use in the research Comments:
public Maryam Abbasi
Unit 9 , No 21, Valizadeh St, Gisha Ave ,Tehran, Iran
Tehran Iran (Islamic Republic of) 1447973850 +98 21 8827 9679 Abasimaryam1989@yahoo.com Shahid Beheshti University of Medical Sciences scientific Maryam Abbasi
Unit 9 , No 21, Valizadeh St, Gisha Ave ,Tehran, Iran
Tehran Iran (Islamic Republic of) 1447973850 +98 21 8827 9679 Abasimaryam1989@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with chronic gastritis with or without improved PUD caused by Helicobacter pylori Helicobacter pylori (+) determined by any of the rapid urease test and histopathology, urease breath test, fecal antigen test Patients who have not received Helicobacter pylori eradication treatment 18 years 75 years Both Allergy to the drugs used in the study Use of PPIs, H2 receptor antagonists, antibiotics, bismuth or probiotics in the last 4 weeks before entering the study Smoking and alcohol abuse The presence of underlying disease or conditions such as liver disease, cardiovascular disease, lung disease, metabolic disease, or malignant tumor that may affect the study Pregnant or lactating female patients Performing esophageal or gastric surgery procedures in the past Incomplete follow-up or low acceptance capacity of patients in treatment during the study B98.0 هلیکوباکتر پیلوری به عنوان عامل بیماری ها که در فصل های دیگر طبقه بندی می شود Treatment - Drugs Treatment - Drugs Intervention group: The first intervention group was treated with four standard medicines containing bismuth, including amoxicillin (1 gram 30 minutes after breakfast and dinner), pantoprazole (20 mg 30 minutes before breakfast and dinner), metronidazole (1 gram 30 minutes after breakfast and dinner), bismuth sub Citrate (240 mg 30 minutes before breakfast and dinner) is placed for 14 days. Intervention group: The second intervention group is treated with two high-dose drugs including amoxicillin (1 gram 30 minutes after each meal including breakfast, lunch and dinner) and pantoprazole (40 mg 30 minutes before breakfast and dinner) for 14 days. Eradication of Helicobacter pylori infection. Timepoint: 4 weeks after receiving two treatment regimens, the eradication rate of Helicobacter pylori in two groups is compared. Method of measurement: Laboratory method of testing Helicobacter pylori antigen in stool. does not have Approved 2021-10-12 Ethics committee of Shahid beheshti University of Medical Sciences No.21 ,Valizadeh St, Gisha Ave, Tehran, Iran tehran Tehran Iran (Islamic Republic of)