A human study to evaluate the efficacy and safety of extracts of Ficus erecta var. sieboldii King Leaves on arthritis : a randomized, double-blind, placebo-controlled study

Jeju Technopark0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年1月28日

适应症

试验速览

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•1) Subject who voluntarily agree to participate and signs informed consent form
•2) Age = 50 years
•3) Subject who suffers from osteoarthritis

•1) Subjects with Kellgren-Lawrence grade 3 or 4
•2) Subjects who intakes medication of nonsteroidal anti-inflammatory drug (NSAID) within 1 week prior to the first visit
•3) Inflammatory osteoarthritis (increase of ESR(erythrocyte sedimentation rate) or CRP(C-reactive protein))
•4) High obesity (BMI = 30)
•5) Other nervous system or lower limb abnormality such as hip joint or foot joint that can disturb gait
•6) More than moderate degree of back pain or radiating pain in lower limbs
•7) Severe neurological and vascular disorders in lower limbs
•8) Continuous consumption of health functional food (glucosamine, MSM) that affect osteoarthritis within 4 weeks before the first visit
•9) Hypersensitivity to test materials
•10) Pregnant or lactating women
•11) Participation in another clinical trial within 4 weeks prior to the study
•12) Any other disease affecting the results of the study

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