Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain (VNRS)
研究概览
简要总结
Randomized controlled trial
Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:
Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen
Group 2: Control patients will take placebo
Primary outcome : Pain level
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 50-80 years old
- •Medial compartment knee osteoarthritis
- •Kellgren and Lawrence classification stage 2 -3
- •Able to walk without walking aid
排除标准
- •History of knee surgery on the study side
- •History of intra-articular steroid injection within 6 months prior to study entry
- •Systemic arthritis conditions
- •Degenerative neurological and muscular conditions in the lower extremities
- •Chronic kidney disease with CrCl < 30 ml/min (glomerular filtration rate <60 mL/min/1.73 m2)
研究组 & 干预措施
Control group
Control patients will take placebo 2 tabs a day
干预措施: Placebo (Other)
Collagen supplement group
Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day
干预措施: Collagen (Dietary Supplement)
结局指标
主要结局
Pain (VNRS)
时间窗: 12 weeks
Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain
次要结局
- Rescue medication(12 weeks)
- Knee and Osteoarthritis Outcome Score (KOOS)(12 weeks)
- Patient satisfaction(12 weeks)
研究者
Varah Yuenyongviwat
Professor
Prince of Songkla University