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IRCT20190823044589N1 IRCT 2019-12-28 Oroumia University of Medical Sciences Effect of Atorvastatin in Helicobacter pylori eradication AHBPE Evaluation of the effect of adding Atorvastatin to standard treatment in Helicobacter pylori eradication 2019-04-21 anticipated 120 Complete https://irct.ir/trial/41734 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly based on random number table, Blinding description: Patients don't know medications other patients receive for treatment. 3 Helicobacter pylori infection. Intervention 1: Intervention group: Atrostatin 40 mg at night for 14 days with standard treatment (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days). Intervention 2: Control group: Standard treatment for 14 days (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days). Yes - There is a plan to make this available What will be shared: All underlying information, grouping and the result of treatment of patients without mentioning the name of the patient in Excel and SPSS files are recorded and presented. When: 6 months after the article to be published To whom: All academic and non-academic person Conditions: In order to request the results and outputs of data analysis in the SPSS software, after submitting the application and approval of Urmia University of Medical Sciences, statistical outputs will be provided. Where to obtain: Vice chancellor for research and technology of Urmia University of Medical Sciences How to obtain: After submitting the application and approval of the Deputy of research and Technology of Urmia University of Medical Sciences, the results will be sent during the maximum one month period by researcher. Comments:
public Mohammad Reza Mohammad Hosseini Azar
Imam Khomeini Hospital, Ershad Street
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 mohammadazar@gmail.com Oroumia University of Medical Sciences scientific Mohammad Reza Mohammad Hosseini Azar
Imam Khomeini Hospital, Ershad Street
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 mohammadazar@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 18 years or older Indication for Helicobacter pylori eradication 18 years no limit Both liver disease at the same time Diabetes at the same time Statin use in 6 months History of gastric surgery History of treatment for eradication of H. pylori Antibiotics, PPIs, histamine receptor blockers, anti-inflammatory and non-steroidal drugs, bismuth salts in the past month Allergy to any of the antibiotics used in the study Gastrointestinal malignancy Active gastrointestinal bleeding Pregnant and lactating History of radiation therapy Treatment - Drugs Treatment - Drugs Intervention group: Atrostatin 40 mg at night for 14 days with standard treatment (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days) Control group: Standard treatment for 14 days (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days) Helicobacter pylori eradication. Timepoint: After 4 weeks of completion of treatment. Method of measurement: 38/5000Evaluation of Helicobacter pylori fecal antigen. Drug Side effects. Timepoint: During and after the course of treatment. Method of measurement: Ask the patient. Oroumia University of Medical Sciences Approved 2019-07-31 Ethics committee of Urmia University of Medical Sciences West Azarbaijan University of Medical Sciences and Health services, next to emergency department, Jahad St., Resalat Boulevard Urmia West Azarbaijan Iran (Islamic Republic of)