A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Score (VAS)
研究概览
简要总结
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinical diagnosis of tennis elbow within the last 3 months
- •Subjects both male and female, aged 18-60 years (both inclusive)
- •Subjects who are willing to give informed consent and adhere to the study protocol
排除标准
- •Subjects aged less than 18 and more than 60 years
- •Subjects with autoimmune diseases
- •Subjects with immuno-compromised system
- •Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
- •Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
- •Subjects who have received treatment with corticosteroid injections within the last 6 months
研究组 & 干预措施
Study arm A
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
干预措施: Autologous Human Platelet Lysate (Biological)
Control Arm B
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Change in Visual Analog Score (VAS)
时间窗: Day 0, Month 1, Month 2, End of Study - Month 3
次要结局
- Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3(Day 0, End of study - Month 3)