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IRCT2016020726407N1 IRCT 2016-09-15 Vice chancellor for research,Traditional Medicine College of Shahid Beheshti University of Medical S Effect of flaxseed oil on clinical sign of Knee Arthrosis Efficacy of "Linum usitatissimum" Seed topical oil, on Clinical Sign of Knee Osteoarthritis Compared with Placebo, A Double Blind Clinical Trial 2016-07-20 anticipated 80 Complete https://irct.ir/trial/21900 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 knee osteoarthritis. Intervention 1: Intervention group: Linum usitatissimum seed topical oil 20 drops every 8 hours without massage for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted. Intervention 2: Control group: placebo; paraffin oil with the same method and order of intervention groups and for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted.
public Nematollah Masoudi
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
Tehran Iran (Islamic Republic of) +98 21 8877 2521 nmasoudi@sbmu.ac.ir; salman.farsy@gmail.com College of Traditional Medicine, Shahid Beheshti University of Medical Sciences scientific Mahmood Khodadoost
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
Tehran Iran (Islamic Republic of) +98 21 8877 2521 mkhodadoost@LMO.ir; mkhodadoost2010@yahoo.com Traditional Medicine College of Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Patient between 40 to 70 yaers age with BMI less than 35 that fill clinical and radiologic criteria of ACR and have Kellgren-Lawrence Grading Scale III / II / I, with VAS over than 4 cm; Clinical and radiological criteria of ACR include: knee pain, osteophyte in radiography, plus at least 1 of 3 below criteria: age more than 50 years old; morning stiffness less than 30 minutes; crepitation of knee. Exclusion criteria: Acute arthritis, osteoarthritis due to rheumatologic disease such as RA and gout, infective arthritis, metabolic arthritis, traumatic, uncontrolled diabetes, known case of cardiac or hepatic disease, cancer; History of knee replacement surgery; Fibromyalgia, radiculopathy and neuropathy; Those who are unable to tolerate and complete the study or treatment and follow-up; As well as those who use more than 3 tablets Diclofenac 50mg daily or need other oral or injection form of pain control, are excluded; At the same time, patients with Glucosamine, Chondroitin sulfate, and muscle relaxants use; sensitivity to medicinal plants; History of receiving oral or topical steroids during the 14 days prior to the study; Corticosteroids injection in the period of 30 days before study; pregnancy, hepatorenal active disease, gastritis, addiction to alcohol and narcotic drugs, skin disease of knee, those receiving antidepressant for chronic pain, Also, people who have mild and intermittent pain that only require non-pharmacological recommendations; New forms of therapies such as hydrotherapy, physiotherapy, start to interfere with the study. 40 years 70 years Both M17 Gonarthrosis Treatment - Drugs Placebo Intervention group: Linum usitatissimum seed topical oil 20 drops every 8 hours without massage for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted Control group: placebo; paraffin oil with the same method and order of intervention groups and for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted Pain. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Pain and VAS. Knee discomfort. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring. Stiffness. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring. Activities and daily living. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring. Sport and recreation function. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring. Quality of life. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring and SF26 WHO. Vice chancellor for research,Traditional Medicine College of Shahid Beheshti University of Medical S Approved 2016-07-03 Ethics Committee in Biomedical Research, Shahid Beheshti University of Medical Sciences (IR.SBMU.REC Office of Research Management, Shahid Beheshti University of Medical Sciences, side of Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran Tehran Iran (Islamic Republic of)