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IRCT20190405043169N1 IRCT 2019-05-18 Babol University of Medical Sciences Comparison of two quadruple regimens to eradication of helicobacter pylori infection Comparison of 5-day and 10-day levofloxacin-based concomitant regimen to eradication of Helicobacter pylori : A randomized clinical trial 2019-04-21 anticipated 120 Complete https://irct.ir/trial/38762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician. 3 Helicobacter pylori. Intervention 1: Intervention group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 5 day. Intervention 2: Control group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 10 day. Yes - There is a plan to make this available What will be shared: اطلاعات مربوط به پیامد اصلی When: 10 months after publication To whom: For people working in academic institutions Conditions: No criteria Where to obtain: aminvahedi@hotmail.com amin vahedi How to obtain: At least 2 months after receiving their Email Comments:
public javad shokri shirvani
Ayatollah Rohani hospital, Ganjafrouz ave, Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 javadshokri@gmail.com Babol University of Medical Sciences scientific javad shokri shirvani
Ayatollah Rohani hospital, Ganjafrouz ave, Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 javadshokri@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) All patients with the age of 18 to 80 years old with proven Helicobacter pylori infection with histological sample 18 years 80 years Both age lesser than 18 years old or more than 80 years old taking antibiotics, NSAIDs or proton pump inhibitors over the last month history of stomach surgery severe impaired renal (Cr> 2 mg/dl) or hepatic function gastric cancer allergy to levofloxacin, amoxicillin, Metronidazole or pantoprazole pregnant patients chronic or severe disease B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 5 day Control group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 10 day Rate of H pylori eradication. Timepoint: six weeks after the end of treatment. Method of measurement: H. pylori stool antigen test. Side effects. Timepoint: six weeks after treatment. Method of measurement: Questionnaire. Babol University of Medical Sciences Approved 2018-09-16 Ethics committee of Babol University of Medical Sciences Babol university of medical sciences, Ganjafrouz ave, Babol, Iran Babol Mazandaran Iran (Islamic Republic of)