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IRCT20171230038142N20 IRCT 2020-09-19 Esfahan University of Medical Sciences Sequential Therapy versus Quadruple Therapy for Helicobacter pylori Eradication Sequential Therapy versus Quadruple Therapy for Helicobacter pylori Eradication 2020-07-22 anticipated 174 Complete https://irct.ir/trial/50950 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the samples are selected in an accessible manner, according to the entry and exit criteria, from the patients referred to the gastrointestinal clinic of Al-Zahra Hospital in Isfahan.Then, for allocation to two groups of quadruple and sequential, the selected patients are allocated to blocks with a volume of 4 by block random allocation method.In this way, blocks of volume 4, are formed based on the variables of sex and weight, and then within each block, half of the people in the quadruple group and half of the people in the sequential group are included, in order to maintain the balance of the number of participants in each group.In this study, 42 quadruple blocks and one hexagonal block were considered and the method of allocating samples was randomly substituted so that if heterogeneity in terms of matched groupings is observed in the final result, by creating a random sequence, the samples are again repeat and corrected. 3 Helicobacter pylori. Intervention 1: Intervention group:quadruple group: 87 patients with Helicobacter pylori infection who were indicated for treatment were selected. They then received a quadruple diet with PPI + bismuth + amoxicillin + metronidazole for 14 days. The drugs are made by Sobhan Company from Iran. Intervention 2: Intervention group: sequential group: 87 patients with Helicobacter pylori infection who were indicated for treatment were selected. They will then receive a sequential diet, including PPI and amoxicillin for 5 days, followed by PPI and clarithromycin and tinidazole for 5 days. The drugs are made by Sobhan Company from Iran. Yes - There is a plan to make this available What will be shared: Information will be provided to applicants after anonymity and one year after the publication of the results. When: one year after the publication of the results To whom: Doctors, infectious disease specialists Conditions: Comparison of current drug regimens with other regimens Where to obtain: Send email to a.hakamifard@gmail.com How to obtain: Send email to a.hakamifard@gmail.com Comments:
public Atusa Hakami Fafd
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 a.hakamifard@med.mui.ac.ir Esfahan University of Medical Sciences scientific Atusa Hakami Fafd
Al-Zahra Hospital, Sofah Boulevard.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 a.hakamifard@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Ulcerative peptic ulcer disease based on upper gastrointestinal endoscopy 18 years no limit Both Having any of the following diseases: MALT, Zollinger-Ellison syndrome, various types of gastrointestinal cancers, liver or kidney diseases, other infections that require antibiotics, immunodeficiency diseases. History of upper gastrointestinal surgery History of Helicobacter pylori eradication or history of PPI use of antibiotics or probiotics (artificial or natural) during the past 4 weeks B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group:quadruple group: 87 patients with Helicobacter pylori infection who were indicated for treatment were selected. They then received a quadruple diet with PPI + bismuth + amoxicillin + metronidazole for 14 days. The drugs are made by Sobhan Company from Iran. Intervention group: sequential group: 87 patients with Helicobacter pylori infection who were indicated for treatment were selected. They will then receive a sequential diet, including PPI and amoxicillin for 5 days, followed by PPI and clarithromycin and tinidazole for 5 days. The drugs are made by Sobhan Company from Iran. The incidence of complications. Timepoint: Days 15 and 30 after starting treatment. Method of measurement: Question from the patient. Duration of treatment. Timepoint: After treatment. Method of measurement: Counting the days of receiving treatment. Helicobacter pylori eradication rate. Timepoint: After treatment. Method of measurement: Stool test. Patient symptoms. Timepoint: Before and after treatment. Method of measurement: SF-LDQ questionnaire. Esfahan University of Medical Sciences Approved 2020-06-28 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave., Isfahan University of Medical Sciences. Isfahan Isfehan Iran (Islamic Republic of)