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IRCT2015113025292N1 IRCT 2016-02-09 Vice chancellor for research, Babol University of Medical Sciences Efficacy of Ofloxacin in eradication of Helicobacter pylori Adding Ofloxacin to standard regimens versus standard triple-drug regimens consist of Clarithromycin, Amoxicillin, and Rabeprazole for Helicobacter Pylori Infection among patients with gastrointestinal problems based on Helicobacter pylori 2014-10-22 anticipated 160 Complete https://irct.ir/trial/21179 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The researcher does not know the type of drugs so this study is single blind study. Patients were selected randomly allocated . 2-3 Helicobacter Pylori Infection. Intervention 1: In intervention group, standard regimen including Amoxicillin (1000 mg, Farabi company, Iran), Clarithromycin (500 mg, Farabi company, Iran), and Rabeprazole (20 mg, Farabi company, Iran), with adding ofloxacin (200 mg, twice a day Exir company, Iran), was prescribed. Intervention 2: In control group, standard regimen including Amoxicillin (1000 mg, Farabi company, Iran), Clarithromycin (500 mg, Farabi company, Iran), and Rabeprazole (20 mg, Farabi company, Iran) were prescribed twice daily up to 10 days.
public Mahmoud Sadeghi Hadad zavareh
Rouhani Hospital, Ganjafrooz Street, Babol
Babol Iran (Islamic Republic of) +98 11 3223 8284 drm_sadeghihz@yahoo.com Babol University of Medical Science scientific Seyed Saeid Mohammadi Bonehi
Rouhani Hospital, Ganjafrooz Street, Babol
Babol Iran (Islamic Republic of) +98 11 3223 8284 Ssmmbb293@yahoo.com Babol University of Medical Science Iran (Islamic Republic of) Inclusion criteria: positive biopsies of H. pylori; positive rapid urease test of H. pylori, stomach ulcer; duodenal ulcer; dyspepsia with indications of Helicobacter pylori eradication. Exclusion criteria: previous treatment for H. pylori; renal failure; receiving antibiotics during the previous last month; cirrhosis; pregnancy; breast feeding; gastric cancer. 18 years 80 years Both B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs In intervention group, standard regimen including Amoxicillin (1000 mg, Farabi company, Iran), Clarithromycin (500 mg, Farabi company, Iran), and Rabeprazole (20 mg, Farabi company, Iran), with adding ofloxacin (200 mg, twice a day Exir company, Iran), was prescribed In control group, standard regimen including Amoxicillin (1000 mg, Farabi company, Iran), Clarithromycin (500 mg, Farabi company, Iran), and Rabeprazole (20 mg, Farabi company, Iran) were prescribed twice daily up to 10 days UBT (Urease Breath Test). Timepoint: 20 days after completing treatment. Method of measurement: Patients swallow urea labeled with an uncommon isotope, either radioactive carbon-14 or non-radioactive carbon-13. After10 to 30 minutes, the detection of isotope-labeled carbon dioxide in exhaled breath indicates that the urea was split. Vice chancellor for research, Babol University of Medical Sciences Approved 2014-10-12 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Street, Babol Babol Iran (Islamic Republic of)