NCT02772237Unknown2 期
The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Time to return to participation in sports after a sports-related concussion
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of riboflavin to decrease the duration of time for a student-athlete to return to participation in sports after a sports related concussion.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion
排除标准
- •Less than 18 years old
- •Greater than 24 hours have elapsed since the concussion occurred.
- •The student-athlete has already participated in the study during which he/she took Riboflavin
- •Non-sports related concussion not incurred while participating in the sport or training for the sport. As an example, a student-athlete who sustains a concussion as a result of a motor vehicle accident will be excluded from the study for that concussion.
- •A previous concussion within the last 12 months.
- •Any concussion that is complicated by a cranial bleed, skull fracture, additional severe injury (e.g. torn knee ligament) that might affect the return to normal activities above and beyond the sport-related concussion.
- •If the student athlete is cognitively impaired to a level that prevents verbal communication, the consent will be deemed 'opted out' and the student-athlete will not be enrolled in the study.
研究组 & 干预措施
Placebo group
Placebo Comparator
Placebo
干预措施: Placebo (Biological)
Treatment group
Active Comparator
Riboflavin 400mg daily
干预措施: Riboflavin (Biological)
结局指标
主要结局
Time to return to participation in sports after a sports-related concussion
时间窗: 14 days
次要结局
未报告次要终点
研究者
Jeremy Kent, MD
Assistant Professor
University of Virginia
研究点 (2)
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