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IRCT20181211041923N1 IRCT 2019-07-14 Zahedan University of Medical Sciences The effect of Nigella sativa oil and Dichlophenac Gel on the reduction of knee Osteoarthritis pain Comparison the effect of Nigella sativa oil and Dichlophenac Gel on the reduction of knee pain in patient with Osteoarthritis 2019-01-30 anticipated 70 Complete https://irct.ir/trial/35853 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients will not be aware of the type of medication they receive and the second executor of the research project will complete the questionnaire at the end of the treatment without knowledge of the two groups. Also the data will be analyzed without any information about group selection. 3 Patients with knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology (ACR = 2_3). Intervention 1: Intervention group: rub one gram of nigella sativa oil on a knee every six hours for three weeks. Intervention 2: Control group: rub one gram diclofenac gel on a knee every six hours for three 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 The need for evaluation data and the decision to publish it after data analysis
public Mahnaz Sandooghi
Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5796 Mahnazsandooghi@yahoo.com Zahedan University of Medical Sciences scientific Mahnaz Sandooghi
, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3329 5796 Mahnazsandooghi@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Patiant with knee osteoarthritis based on ACR=2_3 and clinical standard Satisfaction to enter the study no limit no limit Female Joint effusion Arthritis Liver and kidney failure Consumption of neurological drugs 80-M94 Osteopathies and chondropathies Treatment - Drugs Treatment - Drugs Intervention group: rub one gram of nigella sativa oil on a knee every six hours for three weeks Control group: rub one gram diclofenac gel on a knee every six hours for three weeks Pain based on the Visual Analogue Scale (VAS). Timepoint: At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration. Method of measurement: Visual Analogue Scale. The intensity of osteoarthritis based on the KellgreneLawrence scale. Timepoint: At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration. Method of measurement: KellgreneLawrence scale. Patients knee conditions based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Timepoint: At the beginning of the study (before the intervention) and 3 weeks after starting the drug administration. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Zahedan University of Medical Sciences Approved 2018-07-27 Ethics committee of Zahedan University of Medical Sciences Research Deputy, Zahedan University of Medical Sciences, Balochestan Blvd, Persian Gulf Expressway Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)