Osteoarthritis
Conditions
Keywords
Cortex Eucommiae, mild OA
Brief summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild osteoarthritis (OA).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCE
550mg capsule (Eucommia ulmoides Oliver extract)
DIETARY_SUPPLEMENTPlacebo
550mg capsule (Placebo)
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Scale) | Change of the week 6, 12 from baseline | VAS to measure changes in joint pain on 6, 12 weeks after administration in comparison with baseline |
| K-WOMAC (Korean-Western Ontario and McMaster Universities) | Change of the week 6, 12 from baseline | K-WOMAC to measure changes in joint pain and function on 6, 12 weeks after administration in comparison with baseline |
| KSF-36 (Korean-Short Form Health Survey 36) | Change of the week 6, 12 from baseline | KSF-36 to measure changes in physical and mental function on 6, 12 weeks after administration in comparison with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's global impression of change scale | 6 weeks, 12 weeks | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject Level of Quality * Excellent: substantial overall improvement of symptoms * Good: overall improvement of symptoms * Neutral: no change compared with before * Worse: overall deterioration of symptoms * Very much worse: substantial overall deterioration of symptoms |
| CRP (C-reactive protein) | Change of the week 12 from baseline | CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline |
| Investigator's global impression of change scale | 6 weeks, 12 weeks | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator Level of Quality * Excellent: substantial overall improvement of symptoms * Good: overall improvement of symptoms * Neutral: no change compared with before * Worse: overall deterioration of symptoms * Very much worse: substantial overall deterioration of symptoms |
| ESR (Erythrocyte sedimentation rate) | Change of the week 12 from baseline | ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline |
Countries
South Korea
Outcome results
None listed