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IRCT20190419043318N1 IRCT 2019-07-02 Bojnourd University of Medical Sciences Evaluation of therapeutic effects of Crocina in knee osteoarthritis Evaluation of therapeutic and immunologic effects of Crocina in knee osteoarthritis patients: A randomized double-blind placebo-controlled trial 2019-07-23 anticipated 60 Complete https://irct.ir/trial/39893 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible patients who meet the criteria will assigned into one of the intervention groups, by using a permuted block randomization method. Blocks of four will be used. Each prescribed medication will be given a six-digit number by the principal investigator. Patients, treatment team, and the investigator of clinical responses will not be aware of the types of interventions. At the end of the study, the principal investigator will decode the numbered consumed medications and assigne each to the appropriate group correctly, Blinding description: Each prescribed medication will be given a six-digit number by the principal investigator. At the end of the study, the principal investigator will decode the numbered consumed medications and assigne each to the appropriate group correctly. The orthopedic physician, participated patients, and the medical student who is responsible for collecting data and filling out the questionnaire will be blinded to the intervention groups. 3 osteoarthritis. Intervention 1: Intervention group: Acetaminophen tablet 4 times a day plus NSAIDs with one glass of water (one of the following NSAIDs will be considered: 1200mg Ibuprofen, 75mg Indomethacin, 500mg Naproxen, 10mg Piroxicam, 75mg Diclofenac) for 16 weeks. Intervention 2: Control group: Acetaminophen tablet 4 times a day plus placebo tablet daily with one glass of water (identical appearance to Crocina tablets, prepared from Pooyesh Sina company) for 16 weeks. Intervention 3: Intervention group: Acetaminophen tablet 4 times a day plus Crocina tablet daily with one glass of water (identical appearance to placebo tablets, prepared from Pooyesh Sina company) for 16 weeks. 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 No more information
public Adeleh Sahebnasagh
Shahriar Street
Bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3226 3604 adelehsn67@yahoo.com Bojnourd University of Medical Sciences scientific Adeleh Sahebnasagh
Shahriar Street
Bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3226 3604 adelehsn67@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) 1) aged over 40 years 2) Primary osteoarthritis 3) Pain in more than half the days of the previous month during one of the following activities: walking, climbing and stairs, standing up or sleeping on the bed or mattress during the night 4) Radiographic evidence of tibiafemoral or patellofemoral osteoarthritis 5) A score of 40 from the WOMAC scale as a base 6) No intra-articular injection of hyaluronic acid / glucocorticoid over the last six months 7) The lack of a positive pregnancy test or pregnancy program during the study 40 years no limit Both 1) intolerance to the drug 2) Do not take medicine properly 3) Serious medical conditions that the patient can not regularly attend periodic visits include severe cardiovascular disease such as angina or heart attack, severe hypertension, recent stroke, insulin dependent diabetes, psychiatric disorders, kidney disease, liver disease, active concen , And anemia 4) history of liver disease 5) Inability to walk without a cane 6) A history of autoimmune diseases such as rheumatoid arthritis 7) Secondary osteoarthritis, for example, following a trauma M19.0 Primary osteoarthritis of other joints Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Acetaminophen tablet 4 times a day plus NSAIDs with one glass of water (one of the following NSAIDs will be considered: 1200mg Ibuprofen, 75mg Indomethacin, 500mg Naproxen, 10mg Piroxicam, 75mg Diclofenac) for 16 weeks Control group: Acetaminophen tablet 4 times a day plus placebo tablet daily with one glass of water (identical appearance to Crocina tablets, prepared from Pooyesh Sina company) for 16 weeks Intervention group: Acetaminophen tablet 4 times a day plus Crocina tablet daily with one glass of water (identical appearance to placebo tablets, prepared from Pooyesh Sina company) for 16 weeks Joint range of movement. Timepoint: Weeks 1,2,3,7,16. Method of measurement: Clinical examination. Pain. Timepoint: Weeks 1,2,3,7,16. Method of measurement: VAS, KOOS and WOMAC questionnaire. Change in serum levels of inflammatory mediators (IL-1، INF-γ). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits. Change in serum levels of inflammatory and anti-inflammatory mediators(IL-10). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits. Bojnourd University of Medical Sciences Approved 2019-02-24 Ethics committee of North Khorasan University of Medical Sciences Street Shahriar Bojnurd North Khorasan Iran (Islamic Republic of)