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IRCT20190626044030N1 IRCT 2019-12-25 Shahid Beheshti University of Medical Sciences N-acetylcysteine in Rheumatoid Arthritis Evaluation the Effect of N-acetylcysteine on Inflammatory Biomarkers and Disease Activity Score (DAS28-ESR) of Rheumatoid Arthritis 2019-07-23 anticipated 76 Complete https://irct.ir/trial/40656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use simple individual random method in this study, Blinding description: In our study, participants, researchist (clinical pharmacist) and physician are blind. 3 Rheumatoid arthritis. Intervention 1: Intervention group: The routine DMARDs in addition to 600 milligrams of effervescent of n-acetylcysteine(osve pharmaceutical company), twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too. Intervention 2: Control group: The routine DMARDs in addition to effervescent of placebo(osve pharmaceutical company ) ,twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too. 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 more information
public Jamshid Salamzadeh
Faculty of Pharmacy, Niayesh Intersection ,Valieasr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2243 9982 j.salamzadeh@yahoo.com Shahid Beheshti University of Medical Sciences scientific Jamshid Salamzadeh
Faculty of Pharmacy, Niayesh Intersection, Valieasr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2243 9982 j.salamzadeh@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Rheumatoid arthritis patients with a DAS28-ESR score>=2.6 No history of consuming antioxidant supplements within last 2 months No change of the type and dose of patient's drugs in the last 1 month No recent infectious disease Patients that are under treatment with DMARDs 18 years no limit Both Biologic agents therapy in the last 6 months Patients with concurrent autoimmune, rheumatoid disease and gout Using other complementary and alternative medicine Pregnancy and lactation Any addiction to psychotropic agents and opioids Uncontrolled hypertension Active gastrointestinal ulcer History of severe skin allergy Consuming nitroglycerin Treatment - Drugs Placebo Intervention group: The routine DMARDs in addition to 600 milligrams of effervescent of n-acetylcysteine(osve pharmaceutical company), twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too. Control group: The routine DMARDs in addition to effervescent of placebo(osve pharmaceutical company ) ,twice daily for two months. Before intervention, at the end of first month and second month of consumption, we will take blood sample for the measurement of serum level of IL-1, 17 and ESR. Physical examination for calculate DAS-28 ESR will be done, too. IL-1, IL-17, DAS28-ESR, patient global assessment. Timepoint: Base, the end of the fourth week, the end of the eighth week. Method of measurement: Serum level, clinical signs, DAS28-ESR questionnaire. ESR, Number of tender joints, number of swollen joints, reduced or increased need for oral or injectable corticosteroids. Timepoint: Baseline, at the end of the fourth week, at the end of the eighth week. Method of measurement: Serum level, clinical examination. Shahid Beheshti University of Medical Sciences Approved 2019-06-12 Iran National committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)