NCT02182934已完成2 期
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Recreational Sports People: 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
- 26
- 主要终点
- Baseline-adjusted half-time hemoglobin re-oxygenation
研究概览
简要总结
To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people 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 and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
- •Alcohol and drug abuse as stated in the clinical trial manual
- •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 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 before the date of inclusion or 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
Baseline-adjusted half-time hemoglobin re-oxygenation
时间窗: day 84
次要结局
- Change from baseline in thiobarbituric acid (TBARS)(Baseline, up to day 84)
- Change from baseline in glutathione superdismutase/glutathione superdismutase oxidised (GSG/GSSG) ratio(Baseline, up to day 84)
- Change from baseline in respiratory threshold(Baseline, up to day 84)
- Baseline-adjusted half-time hemoglobin re-oxygenation(day 21, 42 and 63)
- maximum endurance time(day 21, day 42, day 63 and day 84)
研究者
相似试验
已完成
2 期
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy PeopleHealthyNCT02182882Boehringer Ingelheim29
已完成
不适用
Effect of ginseng consumption on innate immunity in healthy adultsInnate immunityInflammatory and Immune System - Normal development and function of the immune systemAlternative and Complementary Medicine - Herbal remediesACTRN12617000701325Jocelyn Eason30
尚未招募
2 期
Effect of Vakrasana on Diabetes patients.CTRI/2024/05/067978Dr T Arularasi
进行中（未招募）
Unknown
Role of Red Ginseng in Improving Clinical Global Impression in Patients with Chronic Pancreatitis with Minimal SymptomsDiseases of the digestive systemKCT0009681Seoul National University Hospital40
已完成
不适用
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive FunctionCognitive FunctionNCT04184388Chonbuk National University Hospital100