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IRCT20231216060428N1 IRCT 2024-01-24 Shahre-kord University of Medical Sciences Investigating the effect of Helicobacter pylori treatment regimen on osteoarthritis Investigating the effect of Helicobacter pylori treatment regimen on improving pain and arthritis symptoms in patients with osteoarthritis 2024-01-27 anticipated 60 Complete https://irct.ir/trial/74888 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Osteoarthritis. Intervention 1: IIntervention group: people suffering from osteoarthritis, whose presence of posituve Helicobacter pylori has been proven by endoscopy, fecal test or serology test. For this group, in addition to the common treatment of osteoarthritis, Helicobacter pylori treatment regimen includes: levofloxacin 500 mg per day from Abidi Pharmaceutical Company, amoxicillin 1 gram twice a day from Farabi Pharmaceutical Company and PPI (standard dose) twice a day from Abidi Pharmaceutical Company and tinidazole 500 mg twice a day Tehran Daru Pharmaceutical Company for 5 days is also give. Intervention 2: Control group: People with osteoarthritis in whom Helicobacter pylori has been proven negative by endoscopy, fecal test or serology test. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address ghazaleh.heidari.1992@gmail.com or the contact number 00989131889039 How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Ghazaleh Heidari Soodejani
Parastar street
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3222 0016 ghazaleh.heidari.1992@gmail.com Shahre-kord University of Medical Sciences scientific Shahin Askari Savadjani
Kashani street
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3222 0016 st_asgari.sh@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age over 50 years Osteoarthritis diagnosis according to the findings of the graphy, examination and Clinical diagnosis of a specialist doctor Presence of positiveHelicobacter pylori infection based on endoscopy, fecal antigen test or serum antibody Patient consent to enter the study 50 years no limit Both The presence of immunodeficiency disease, active cancer and other rheumatological diseases in the patient lack of consent to participate and the patient's request to withdraw from the research plan recent use of antibiotics M17 Osteoarthritis of knee Treatment - Drugs Treatment - Other IIntervention group: people suffering from osteoarthritis, whose presence of posituve Helicobacter pylori has been proven by endoscopy, fecal test or serology test. For this group, in addition to the common treatment of osteoarthritis, Helicobacter pylori treatment regimen includes: levofloxacin 500 mg per day from Abidi Pharmaceutical Company, amoxicillin 1 gram twice a day from Farabi Pharmaceutical Company and PPI (standard dose) twice a day from Abidi Pharmaceutical Company and tinidazole 500 mg twice a day Tehran Daru Pharmaceutical Company for 5 days is also give Control group: People with osteoarthritis in whom Helicobacter pylori has been proven negative by endoscopy, fecal test or serology test Severity of Pain. Timepoint: Measurement of pain severity before the intervention and 4 and 8 weeks after the intervention. Method of measurement: WOMAC questionnaire, ten-point visual assessment of pain intensity (VAS), 5-question European quality of life (EQ-5D-3L). Joint stiffness. Timepoint: before the intervention and four and eight weeks after starting Helicobacter pylori treatment regimen. Method of measurement: WOMAC questionnaire. Disease activity. Timepoint: before the intervention and four and eight weeks after starting Helicobacter pylori treatment regimen. Method of measurement: WOMAC questionnaire. Quality of Life. Timepoint: before the intervention and Four and eight weeks after starting Helicobacter pylori treatment regimen. Method of measurement: Ten-point visual assessment of pain intensity (VAS), 5-question European quality of life (EQ-5D-3L). Physical performance. Timepoint: Measurement of Physical performance before the intervention and 4 and 8 weeks after the intervention. Method of measurement: WOMAC questionnaire. Shahre-kord University of Medical Sciences Approved 2024-01-03 Ethics Committee of the School of Medicine,Shahrekord University of Medical Sciences Headquarters of Shahrekord University of Medical Science,Kashani street.Shahrekord,Charmahal va Bakhtiari ,Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)