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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: CE
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cortex Eucommiae(CE)<br>CE capsule administered orally twice daily for 12 weeks. | Dietary Supplement: CE<br>* 550mg capsule (Eucommia ulmoides Oliver extract)<br>|
| Placebo Comparator: Placebo<br>Placebo capsule administered orally twice daily for 12 weeks. | Dietary Supplement: Placebo<br>* 550mg capsule (Placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analogue Scale) | VAS to measure changes in joint pain on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline | 
| K-WOMAC (Korean-Western Ontario and McMaster Universities) | K-WOMAC to measure changes in joint pain and function on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline | 
| KSF-36 (Korean-Short Form Health Survey 36) | KSF-36 to measure changes in physical and mental function on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's global impression of change scale | 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 | 6 weeks, 12 weeks | 
| Investigator's global impression of change scale | 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 | 6 weeks, 12 weeks | 
| ESR (Erythrocyte sedimentation rate) | ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline | 
| CRP (C-reactive protein) | CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cortex Eucommiae, mild OA