The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lequesne Functional Index
研究概览
简要总结
The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis confirmed by radiography or tomography
- •Lequesne Functional Index score of 10-14
- •WOMAC-A pain subscale score greater than or equal to 25
排除标准
- •History of knee trauma
- •History of joint infection
- •History of joint surgery
- •History of intra-articular injection (viscotherapy)
- •History of gastrointestinal diseases
- •Use of corticosteroids
- •Use of COX-II inhibitors
- •Use of glucosamine/chondroitin
- •Known sensitivity to paracetamol
- •Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)
- •Known sensitivity to oral enzymes
研究组 & 干预措施
Wobenzym
Subjects assigned to receive 2 tablets of Wobenzym(R) and 1 tablet of an indistinguishable placebo three times daily for a duration of 12 weeks.
干预措施: Wobenzym (Dietary Supplement)
Diclofenac
Subjects assigned to receive 1 tablet of Diclofenac Sodium (50 mg) and two tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
干预措施: Diclofenac (Drug)
Placebo
Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Lequesne Functional Index
时间窗: Change from baseline to 12 weeks
Self-assessment of the affected knee joint by physician interview using the Lequesne Functional Index (providing an estimate of the degree of pain associated with the affected joint, the maximum distance talked, and activities of daily living).
次要结局
- Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)(Change from baseline to 12 weeks)
- Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)(Change from baseline to 12 weeks)
- Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)(Change from baseline to 12 weeks)
- Paracetamol Consumption(Change from baseline to 12 weeks)
- Indices of systemic inflammation(Change from baseline to 12 weeks)
- Adverse Events(Through baseline to 12 weeks)