Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- QTc interval changes
研究概览
简要总结
To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.
详细描述
Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Healthy male or female adults 18-40 years old.
排除标准
- •Baseline corrected QT (QTc) interval greater than 440 milliseconds,
- •blood pressure at initial screening appointment greater than 140/90 mmHg,
- •concurrent use of prescriptions or OTC medications taken on a daily basis,
- •pregnant females,
- •patients with any baseline ECG abnormalities.
研究组 & 干预措施
Energy Drink
Two 16 ounce containers of an Energy Drink
干预措施: Energy Drink (Dietary Supplement)
Placebo
70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
干预措施: Placebo (Other)
Panax Ginseng
800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water
干预措施: Panax Ginseng (Dietary Supplement)
结局指标
主要结局
QTc interval changes
时间窗: 5.5 hours over 3 visits
Systolic blood pressure changes
时间窗: 5.5 hours over 3 visits
次要结局
- Heart rate changes(5.5 hours over 3 visits)
- QT interval changes(5.5 hours over 3 visits)
- PR interval changes(5.5 hours over 3 visits)
- QRS duration changes(5.5 hours over 3 visits)
- Diastolic blood pressure changes(5.5 hours over 3 visits)