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IRCT20081004001292N5 IRCT 2019-01-22 Tabriz University of Medical Sciences The effect of of black seed oil on knee osteoarthritis The effect of oral administration and topical application of black seed oil (Nigella Sativa) on pain, function and serum indices of inflammation and oxidative stress in patients with knee osteoarthritis 2019-10-23 anticipated 45 Complete https://irct.ir/trial/33351 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated randomly using random blocking method using blocks 8 and 12 and RASS software and 1: 1: 1 allocation ratio to three groups: (1) oral nigella sativa oil, (2) topical nigella sativa oil, 3) placebo, Blinding description: To randomize a random number table and block randomization method will be use. In this method, eligible patients are divided into blocks of 15 patients.The members of the first group are given supplemental edible therapy with black seed oil and topical placebo oil. The second group uses the black seed oil as topical and edible placebo oil, and the third group or the control group receive placebo edible oil as well as topical placebo oil. 2 Knee osteoarthritis. Intervention 1: First intervention group: Edible Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days. Intervention 2: Second intervention group: Topical Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, twice a day in addition edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day for 45 days. Intervention 3: Control group: Edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company,which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days. 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 Neda Dolatkhah
Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Neda Dolatkhah
Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Moderate knee osteoarthritis no limit no limit Both Rheumatologic disorder such as rheumatoid arthritis History of knee joint surgery History of lower limb bone fracture which encounter knee joint surface Severe knee osteoarthritis Neuropathic or sensory disorders Cutaneous disorder at knee area M19.8 Other specified arthrosis Treatment - Drugs Treatment - Drugs Placebo First intervention group: Edible Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days. Second intervention group: Topical Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, twice a day in addition edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day for 45 days. Control group: Edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company,which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days. Pain severity. Timepoint: Evaluating the pain scale at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: Visual Analogue Scale. Osteoarthritis index. Timepoint: Evaluating activity at the beginning of the study (before intervention) and six weeks after the intervention began. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Mobility. Timepoint: Evaluating mobility at the beginning of the study and six weeks after the intervention began. Method of measurement: Time up and go test. Serum inflammatory high-sensitivity C-reactive protein index. Timepoint: Measuring serum level of C-reactive protein inflammatory factor at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay. Serum stress oxidative index. Timepoint: Measuring serum level of total antioxidant capacity and 3,4-Methylene​dioxy​amphetamine at the beginning of the study and six weeks after the intervention began. Method of measurement: Biochemical assay. Tabriz University of Medical Sciences Approved 2017-03-01 Regional Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for research, Tabriz University of Medical Sciences, Golgasht Str. Tabriz East Azarbaijan Iran (Islamic Republic of)