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IRCT20191216045760N1 IRCT 2020-02-15 Esfahan University of Medical Sciences Comparison of Curcuma and Russian olive in the Treatment of Knee Osteoarthritis The effectiveness of Turmeric extract (Curcuma) versus Russian olive extract on the pain, function and quality of life in the patients with knee osteoarthritis 2020-02-29 anticipated 50 Complete https://irct.ir/trial/44316 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a computer-based randomization method, 50 people will be randomly assigned in to two groups (Group A, N=25 and Group B, N=25). The list will be given to the senior researcher. Patients will be assigned in to treatment A or treatment B by a designated peer after recruitment (by sequential sampling) according to the determined numbers, Blinding description: In this study, the primary investigator and supervisor are considered as physicians who are fully aware of the purpose of the study and the type of treatment. Patients will not be informed about the statistical purposes of the study and how the treatments are supposed to be compared. Patients will be informed of the name of their medication (as the treatment will be performed on an outpatient basis with the drug capsules available on the market). The researcher who evaluates the outcomes, as well as the statistical consultant and data analyst, does not know about the treatment A or B (Elartrit or curcumin, respectively) and the patients' names. Therefore, this study is a single-blind study. N/A Osteoarthritis of knee. Intervention 1: The itervention group will be orally treated with 250 mg Elartrit capsules (containing Russian olive extract) of Reyhaneh Isfahan Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time. Intervention 2: The control group will be orally treated with 370 mg curcumin capsules of Razak Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Sadegh Baradaran Mahdavi
Close to Negin building, Ahmadieh alley, Taleghani St
Isfahan Iran (Islamic Republic of) 8136833691 +98 31 3236 0339 sadegh.b.mahdavi@gmail.com Esfahan University of Medical Sciences scientific Sadegh Baradaran Mahdavi
Close to Negin building, Ahmadieh alley, Taleghani St
Isfahan Iran (Islamic Republic of) 8136833691 +98 31 3236 0339 sadegh.b.mahdavi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients older than 45 years Patients diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria with symptoms for at least 3 months Knee X-ray as grade 2 or 3 of Kellgren-Lawrence (K-L) classification Patients' willingness to participate in the study after providing complete information about the project's goals 45 years no limit Both Clinical findings in other joints of the body such as hip, wrist or spine. Evidence of neuropathy such as radiculopathy or peripheral neuropathy Systemic inflammatory disease such as RA, AS Fibromyalgia or endocrine and metabolic diseases Corticosteroid use in the past 48 hours or intra-articular injection of Corticosteroid in the past 4 months Taking NSAIDs in the past week Psychiatric disease Severe blood dyscrasia, coagulopathy, current warfarin use Liver failure or liver tests more than 1.5 times of normal values Biliary Disease PUD or reflux history (GERD) Renal Failure - Uncontrolled hypertension Lack of medication compliance in the patient M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs The itervention group will be orally treated with 250 mg Elartrit capsules (containing Russian olive extract) of Reyhaneh Isfahan Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time. The control group will be orally treated with 370 mg curcumin capsules of Razak Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time. Knee pain intensity. Timepoint: Before treatment, 2 and 4 weeks after treatment. Method of measurement: VAS (Visual Analogue Scale). Symptoms of disease and quality of life. Timepoint: Before treatment, 2 and 4 weeks after treatment. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Function. Timepoint: Before treatment, 2 and 4 weeks after treatment. Method of measurement: Roles and Maudsley score. Esfahan University of Medical Sciences Approved 2019-12-04 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)