]>
IRCT20201213049694N1 IRCT 2020-12-15 Oroumia University of Medical Sciences Effect of dual drug therapy with coamoxiclav-based on Helicobacter pylori eradication Assessment of dual drug therapy effect with coamoxiclav-based on Helicobacter pylori eradication 2020-09-22 anticipated 188 Complete https://irct.ir/trial/52957 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients randomly using computer software Random allocation into two groups of 94 patients treated with amoxicillin-based two-drug regimen coamoxiclav-based and quadruple regimen will be standard. 3 Helicobacter pylori infection. Intervention 1: Intervention group: The two-drug regimen consists of amoxicillin 500 mg twice daily with coamoxiclav 625 mg twice daily and rabizol four times daily for two weeks, after that, antibiotics are discontinued and rabizol alone is administered for two weeks later. Intervention 2: Control group: Control group: Standard regimen includes amoxicillin 1000 mg twice daily, bismuth twice daily, metronidazole 500 mg twice daily and pantoprazole twice daily for two weeks. The drugs are then discontinued and pantoprazole is continued for two weeks. 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 Pashaei
Imam Khomeini Hospital, Ershad Street
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 dr.pashaei@yahoo.com Oroumia University of Medical Sciences scientific Mohammad Reza Pashaei
Imam Khomeini Hospital, Ershad Street
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3346 9931 dr.pashaei@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Helicobacter pylori serology test is positive Severe disorders affecting the gastrointestinal tract 18 years no limit Both Gastrointestinal malignancy Pregnant and lactating History of radiotherapy Allergy to any of the antibiotics used in the study Active gastrointestinal bleeding B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: The two-drug regimen consists of amoxicillin 500 mg twice daily with coamoxiclav 625 mg twice daily and rabizol four times daily for two weeks, after that, antibiotics are discontinued and rabizol alone is administered for two weeks later Control group: Control group: Standard regimen includes amoxicillin 1000 mg twice daily, bismuth twice daily, metronidazole 500 mg twice daily and pantoprazole twice daily for two weeks. The drugs are then discontinued and pantoprazole is continued for two weeks. Helicobacter pylori eradication. Timepoint: After 2weeks of completion of treatment. Method of measurement: Urea breath test. Drug Side effects. Timepoint: During and after the course of treatment. Method of measurement: Ask the patient. Oroumia University of Medical Sciences Approved 2020-09-30 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)