Magnesium and Riboflavin Treatment for Post-Concussion Headache
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Headache Intensity and Duration
研究概览
简要总结
This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion;
- •Less than 3 days have elapsed since their injury;
- •Able to swallow capsules
排除标准
- •Concussion complicated by cranial bleed, skull fracture, additional severe injury;
- •Kidney disfunction or failure;
- •Significant gastro-intestinal dysfunction;
- •Varsity Athlete;
- •Two or more previous concussions;
- •Women who are pregnant or breast feeding;
- •Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine
研究组 & 干预措施
Active study product
400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation
干预措施: magnesium and riboflavin supplement (Drug)
Placebo study product
Inert placebo in capsule formation
干预措施: magnesium and riboflavin supplement (Drug)
结局指标
主要结局
Headache Intensity and Duration
时间窗: 14 days
t-test of mean differences between the groups
次要结局
未报告次要终点
研究者
Stephanie Hartman, MD
Associate Director of Primary Care UVA Student Health & Wellness
University of Virginia