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IRCT20170521034070N2 IRCT 2019-10-28 Mazandaran University of Medical Sciences Concomitant therapies for first-line Helicobacter pylori eradication Comparison of the efficacy of 10-day vs. 12-day concomitant therapies for first-line Helicobacter pylori eradication in Iran. 2018-12-22 anticipated 200 Complete https://irct.ir/trial/41660 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was used. So that patients were classified in 5-patients blocks according to their age and gender and the first five patients will enter the 10-day regimen group and the next five patients will enter the 12-day regimen group and this classification will be continued respectively until the total number of cases would be completed, Blinding description: The statistician is blind to the study groups. 3 Condition 1: Gastric ulcer. Condition 2: Duodenal ulcer. Intervention 1: Patients in the intervention group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for ten days. Intervention 2: Patients in the control group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for twelve days. Yes - There is a plan to make this available What will be shared: The results of this study about Helicobacter pylori eradication rate will be published after deidentification of the participants. When: immediately after being published To whom: There is no limitation. Conditions: There is no limitation. Where to obtain: There is no limitation. How to obtain: It will be according to guidelines of the journal that will publish the article derived from the results of this study. Comments:
public Zohreh Bari
Amir Mazandarani street
Sari Iran (Islamic Republic of) 4816613135 +98 11 3377 1760 zohreb252@yahoo.com Mazandaran University of Medical Sciences scientific Zohreh Bari
Amir Mazandarani
Sari Iran (Islamic Republic of) 4816613134 +98 11 3377 1760 zohreb252@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with peptic ulcer disease according to endoscopic findings Presence of Helicobacter pylori is proven in gastric tissue according to pathologic assessment of gastric biopsy No history of previous treatment for Helicobacter pylori 18 years 80 years Both Breast feeding History of gastrointestinal surgery History of gastrointestinal malignancy using anticoagulant drugs using anti convulsion drugs pregnancy K25 K26 Gastric ulcer Duodenal ulcer Treatment - Drugs Treatment - Drugs Patients in the intervention group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for ten days. Patients in the control group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for twelve days. Helicobacter pylori eradication. Timepoint: Eight weeks after receiving the drugs, Helicobacter pylori eradication will be evaluated by Urea Breath test. Method of measurement: Urea Breath test. Mazandaran University of Medical Sciences Approved 2018-06-11 Ethics committee of Mazandaran University of Medical Sciences Amir Mazandarani street Sari Mazandaran Iran (Islamic Republic of)