NCT02182882已完成2 期
Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology
研究概览
简要总结
Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in healthy, recreational sportspeople and to assess the safety of the product
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
- Double
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
- •Male and female volunteers between 18 and 40 years old
- •Females must test negative for pregnancy
- •Recreational athletes according to the american college of sports medicine (ACSM) definition
- •Familiar with the cycle ergometer exercise methodology
- •Written inform consent according to good clinical practice (GCP) and local regulations
排除标准
- •Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
- •Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
- •Known hypertension
- •Known hypercholesterolemia (moderate/severe)
- •Female volunteers taking oral or injectable contraceptives
- •Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
- •Pregnancy and/or lactation
- •Liver and/or renal disease and/or vascular disease
- •Relevant allergy or known hypersensitivity to the investigational drug or its excipients
- •Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
研究组 & 干预措施
GINSANA
Experimental
干预措施: GINSANA (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology
时间窗: Baseline, day 84 post first drug dispense
次要结局
- Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology(Baseline, day 21, 42 and 63 post first drug dispense)
- Maximum endurance time(up to day 84 post first drug dispense)
- Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG)(Baseline, up to day 84 post first drug dispense)
- Change from baseline in respiratory threshold(Baseline, up to day 84 post first drug dispense)
- Change from baseline in thiobarbituric acid (TBARS)(Baseline, up to day 84 post first drug dispense)
研究者
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