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IRCT20231209060313N1 IRCT 2024-01-10 Shahre-kord University of Medical Sciences Therapeutic effect of the regiment of helicobacter pylori treatment on the improvement of pain and symptoms of arthritis in patients with rheumatoid arthritis Therapeutic effect of the regiment of helicobacter pylori treatment on the improvement of pain and symptoms of arthritis in patients with rheumatoid arthritis 2024-01-27 anticipated 60 Complete https://irct.ir/trial/74887 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Rheumatoid arthritis. Intervention 1: Intervention group: patients with rheumatoid arthritis whose presence of Helicobacter pylori has been proven by endoscopy or stool test or positive Helicobacter pylori serology test. Intervention 2: Control group: patient with rheumatoid arthritis in whose Helicobacter pylori has been proven negative by endoscopy or fecal test or negative 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 ardalanmemar@yahoo.com or the contact number 00989139291792 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 Ardalan Memar
parastar street
shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 ardalanmemar@yahoo.com Shahre-kord University of Medical Sciences scientific Shahin Asgari
Parastar street
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 st_asgari.sh@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Patients with mild to moderate rheumatoid arthritis diagnosed by EULAR criteria (under traditional treatment with DMARD) Willingness to participate in the clinical trial Presence of positive H pylori infection based on endoscopy, fecal antigen or serum antibody test No recent use of antibiotics Absence of immunodeficiency diseases and active cancer Having an indication for the treatment of Helicobacter pylori infection 18 years no limit Both The patient's unwillingness to participate in the clinical trial death of the patient Severe rheumatoid arthritis and the use of biological drugs in the treatment of RA Patients with other systemic diseases, who have gastrointestinal surgery, have an active gastric ulcer, or synovectomy in any major joint. pregnancy M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Other Intervention group: patients with rheumatoid arthritis whose presence of Helicobacter pylori has been proven by endoscopy or stool test or positive Helicobacter pylori serology test. Control group: patient with rheumatoid arthritis in whose Helicobacter pylori has been proven negative by endoscopy or fecal test or negative serology test. Severity of pain. Timepoint: Measurement of pain severity before the intervention and 4 and 8 weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS) Questionnaire. Disease activity. Timepoint: Measurement of Disease activity before the intervention and 4 and 8 weeks after the intervention. Method of measurement: DAS-28 Questionnaire. Tender joints. Timepoint: Measurement of Tender joints before the intervention and 4 and 8 weeks after the intervention. Method of measurement: DAS-28 Questionnaire. Swollen joints. Timepoint: Measurement of swollen joints before the intervention and 4 and 8 weeks after the intervention. Method of measurement: DAS-28 Questionnaire. Morning stiffness. Timepoint: Measurement of morning stifness before the intervention and 4 and 8 weeks after the intervention. Method of measurement: DAS-28 Questionnaire. Serum level of C-reactive protein. Timepoint: Measurement of Serum level of C-reactive protein before the intervention and 4 and 8 weeks after the intervention. Method of measurement: Measurement Serum level of C-reactive protein with a Flame Photometer. Serum level of ESR. Timepoint: Measurement of Serum level of ESR before the intervention and 4 and 8 weeks after the intervention. Method of measurement: Measurement of serum ESR level with a Flame Photometer. Quality of life. Timepoint: Measuring different aspects of quality of life before the intervention and 4 and 8 weeks after the intervention. Method of measurement: HAQ , EQ-5D 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 Sciences,Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)