Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities (WOMAC)
研究概览
简要总结
Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.
详细描述
This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.
Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.
Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years old
- •Written informed consent obtained
- •Been diagnosed with knee or hip osteoarthritis
- •The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed
- •In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week
- •The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain
排除标准
- •Pregnant or breast-feeding women.
- •Chemotherapy or radiation therapy in cancer patients
研究组 & 干预措施
TCM OA2
TCM OA2 3G BID FOR 8 WEEKS
干预措施: TCM OA2 (Drug)
PLACEBO
PLACEBO
干预措施: PLACEBO (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities (WOMAC)
时间窗: week 0, week 4, week 8
The investigators use WOMAC to compared the difference between the week 8 and week 0
次要结局
- Quality of life by SF-36(week0, week 2 and week 4)
- Erythrocyte sedimentation rate (ESR)(week0, week 8)
- High sensitivity C-reactive protein (Hs-CRP)(week0, week 8)
- Visual Analog Scale for pain (VAS)(week0, week 4 and 8)
- Physicians Global Assessment to measure quality of life (PGA)(week0, week 4 and week 8)
研究者
Cheng-Chung Wei
Professor
Chung Shan Medical University