Double Blind, Randomized, Multicentre, Placebo Controlled Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Reduction from baseline in total score of WOMAC osteoarthritis index at Week 24.
研究概览
简要总结
Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend contains individual ingredients which have been widely studied for its effectiveness in osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus reducing the pain and inflammation of the joint.
The two open-label studies have showed the effectiveness of the investigational product on OA. The 2 studies did not show any specific safety concern to be considered. The study demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in the formulation.
The supplement has been manufactured in GMP certified manufacturing units in Germany and India under strict quality control check. Hence, quality of the supplement and batch to batch consistency is well assured.
详细描述
The purpose of this study is to assess the effect of Reflex Plus on osteoarthritis(OA) patients. The duration of the study is 12 / 24 weeks excluding the screening period of approximate 1 week. The test product being studied is Reflex Plus is composed of Collagen hydrolysate and Rosehip extract, it is a health supplement. It is expected to help in the building of cartilage for efficient joint functioning and relieving pain associated with arthritis It helps in cartilage protection and joint pain management.The primary endpoint of the study is the change in knee pain as measured by the WOMAC osteoarthritis (OA) index sum score between baseline and last visit in the comparison between IP and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 24.
时间窗: 24 week for protocol B
To study the change in WOMAC index score from Baseline to Week 24 with respect to: Pain, Stiffness, Physical Function .Total WOMAC score 27 we expect a decrease from baseline WOMAC score in the subjects with knee joint pain.
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 12.
时间窗: 12 week for protocol A
To study the change in WOMAC index score from Baseline to Week 12 with respect to: Pain, Stiffness, Physical Function .Total WOMAC score 27 we expect a decrease from baseline WOMAC score in the subjects with knee joint pain.
次要结局
- Improvement in structure cartilage of knee joint measured as change in MRI analysis from baseline to Week 24.(24 weeks for protocol B)
- Reduction of anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 24.(24 week for protocol B)
- Increase in joint flexibility measured as change from baseline in axis and range of motion as assess by goniometry at Week 12.baseline in axis and range of motion as assess by goniometry at Week 24(24 week for protocol B)
- Reduction in anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 12.(12 week for protocol A)
- Increase in joint flexibility measured as change from baseline in axis and range of motion as assess by goniometry at Week 12.baseline in axis and range of motion as assess by goniometry at Week 12(12 week for protocol A)