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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- KSF-36 (Korean-Short Form Health Survey 36)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
KSF-36 (Korean-Short Form Health Survey 36)
时间窗: 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
VAS (Visual Analogue Scale)
时间窗: 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)
时间窗: 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
次要结局
- Subject's global impression of change scale(6 weeks, 12 weeks)
- Investigator's global impression of change scale(6 weeks, 12 weeks)
- CRP (C-reactive protein)(Change of the week 12 from baseline)
- ESR (Erythrocyte sedimentation rate)(Change of the week 12 from baseline)