Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- WOMAC
研究概览
简要总结
This study was a randomized, double-blind, placebo-controlled study evaluating the efficacy of an oral liquid HA supplement (A+HA) in symptoms relief and improvement of quality of life in knee osteoarthritis patients with mild knee pain.
详细描述
Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into the treatment period and received the assigned treatment in a double-blind fashion for 8 weeks. During the 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8). Efficacy was measured by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Short Form-36 (SF-36).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age >= 40 years old
- •Diagnosed with knee OA which met the definition of Ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment
排除标准
- •Had administered glucosamine one month prior to enrollment
- •Had known allergy to oral HA
- •BMI ≧40 kg/m2
- •Knee OA was caused by occupational hazard or sports injury
- •Patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or Parkinsonism
- •Women in pregnancy
- •Wheel chair users
结局指标
主要结局
WOMAC
时间窗: 8 weeks
Mean change from baseline to 8 weeks. The higher the score, the greater the severity.
次要结局
- SF-36(8 weeks)