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IRCT20101014004934N2 IRCT 2020-11-25 Kashan University of Medical Sciences Investigation of the effect of N-acetylcysteine in rheumatoid arthritis Study effect of N-acetylcysteine on clinical status and paraclinical outcomes in patients with rheumatoid arthritis 2020-11-30 anticipated 74 Complete https://irct.ir/trial/50641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to a treatment group or placebo based on randomly generated numbers (1 to 74) from the website at (https://stattrek.com/statistics/random-number-generator.aspx). Also, to achieve two equal groups in terms of number of participants, the block randomization method with a ratio of 1 to 1 will be used. Drugs and placebos will be packaged in the same packages by a third party who has no role in the study and only a special code will be written on them. The patients and the investigators will be unaware of the type of intervention and after the end of the study, the codes will be decoded, Blinding description: Participants, investigators, and outcome assessors will be unaware of the type of intervention until the end of the study. This will be done by encrypting the drug and placebo packages by a third party who has no role in the study, and the codes will be decrypted at the end of the study. 3 Rheumatoid arthritis. Intervention 1: Intervention group: one tablet (600 mg) of N-acetylcysteine (Osvah, Iran) daily. Intervention 2: Control group: Patients receiving one placebo tablet daily (Barij Essence, Iran). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Kamal Esalatmanesh
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 87159/81151 +98 31 5554 0026 kamalesalatmanesh@kaums.ac.ir Kashan University of Medical Sciences scientific Kamal Esalatmanesh
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 87159/81151 +98 31 5554 0026 kamalesalatmanesh@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patient with rheumatoid arthritis 20 to 70 Years old 20 years 70 years Both Unwillingness to cooperate Hypo or hyperthyroidism Use of any supplements (vitamins, minerals and etc) within 3 months prior to enrollment in the study Incidence of intolerable complications Current smokers M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo Intervention group: one tablet (600 mg) of N-acetylcysteine (Osvah, Iran) daily Control group: Patients receiving one placebo tablet daily (Barij Essence, Iran) Disease activity. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: DAS28-ESR (using a questionnaire for VAS and a checklist to note physical examination results). Hs-CRP. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Elisa kit. ESR. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: mm/h. Malondialdehyde. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Spectrophotometry. Morning stiffness duration. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Minutes. Vice chancellor for research, Kashan University of Medical Sciences Approved 2020-07-13 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Pezeshk Boulevard, Ghotbe Ravandi Boulevard, Kashan, Iran Kashan Isfehan Iran (Islamic Republic of)