Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Western Ontario and McMaster Universities (WOMAC)
研究概览
简要总结
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
详细描述
This trial was a 12 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. Sixty 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 or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.
Primary outcome measures were WOMAC at week 12.
Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and 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 OA1
JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day
干预措施: JING CEIH SHERN YUAN EXTRACT PILL (Drug)
Placebo
Placebo 3 TABLET For 2 Times per day
干预措施: JING CEIH SHERN YUAN EXTRACT PILL (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities (WOMAC)
时间窗: week 0, week 12
The investigators use WOMAC to compared the difference between the week 12 and week 0
次要结局
- serum C-terminal telopeptide (CTX) level(week 0, week 12)
- Western Ontario and McMaster Universities (WOMAC)(week 0, week 4, week 8)
- Physicians Global Assessment to measure quality of life (PGA)(week 0, week 4, week 8, week 12)
- Quality of life by SF-36(week 0, week 4, week 8, week 12)
- High sensitivity C-reactive protein (Hs-CRP)(week 0, week 12)
- serum osteocalcin level(week 0, week 12)
- Visual Analog Scale for pain (VAS)(week 0, week 4, week 8, week 12)
- Erythrocyte sedimentation rate (ESR)(week 0, week 12)
研究者
Cheng-Chung Wei
Professor
Chung Shan Medical University