Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild OA. One hundred subjects with mild OA will be recruited and randomly divided into 2 groups, each group will receive Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) or placebo and will take CE or placebo for 12 weeks. Outcomes will be evaluated by self-administered questionnaires and lab test results. The hypothesis is that Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) which as a dietary supplementation may slow down or reverse OA.

Inclusion criteria

• Male or female 40 ~ 75 years of age
• VAS (Visual Analogue Scale) over 30mm
• Kellgren & Lawrence Grade I~II by X-ray
• Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)

Exclusion criteria

• Joint space under 2mm by X-ray
• Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
• Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthtritis, gout), or articulation fracture with abnormal values at ESR and CRP
• Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
• Subjects having gastrointestinal diseases
• Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
• Uncontrolled diabetes melitusl patients (fasting glucose level ≥ 180mg/dl)
• Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
• Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
• Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
• Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
• History of osteoarthritis treatment therapy within 2 weeks prior to screening
• Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
• Have participated in another clinical trial within the 3 months prior to screening
• Subjects who have hypersensitivity history about investigational product
• Have difficulty to be participated in this clinical trial by investigator's decision