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
- 97
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This is a double-blinded, placebo-controlled, randomized trial to assess the efficacy of oral solution of hyaluronic acid mixture (A+ HA(tm)). During 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8).
详细描述
Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into treatment period, and received the assigned treatment in a double-blind fashion for 8 weeks. Efficacy was measured by the several questionnaire including Knee injury and Osteoarthritis (KOOS), the Short Form-36 (SF-36) and Pittsburgh Sleep Quality Index (CPSQI) for each visit. Incidences of adverse events (AEs) were monitored for each subject once the subject had received 1 dose of study medication; the incidence of serious AEs (SAEs) were monitored for each subject once the subject had signed the informed consent through to the End-of-Study or ET Visit. Vital signs were measured at baseline and End-of-Study or ET Visit.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age >= 40 years old
- •Male or Female
- •With osteoarthritis of the knee based on the definition of Ahlback 1968 and with significant symptoms within 30 days before enrollment.
- •No limitation for use of concomitant medication
排除标准
- •Use of Glucosamine within 1 month before enrollment
- •Osteoarthritis of the knee due to exercise or occupational injury
- •Allergy with Oral Hyaluronic Acid
- •Bilateral Total Knee Replacement
- •Need use wheelchairs
- •With at least one condition: Known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain. Knee instability defined as report of knee bucking or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent, and parkinsonism.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 8 weeks
A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(8 weeks)
- SF-36(8 weeks)
- Chinese version Pittsburgh Sleep Quality Index (CPSQI)(8 weeks)