Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- NRS
研究概览
简要总结
The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.
详细描述
Previous studies have indicated that ginseng root may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine FSS(fatigue severity scale), CIS, lactate, Ammonia, Exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.
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
- 30 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CIS > 76 points
排除标准
- •A person who feels tired due to surgical operation within 6 months.
- •drug/alcoholic hepatitis, cirrhosis, and fatty liver
- •anorexia or bulimia
- •a person on night duty, shift work, or heavy redundancy
- •A person who is unable to perform an exercise load test
- •A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
- •A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
- •A person who continues to exercise regularly within three months of visiting
- •Immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines
结局指标
主要结局
NRS
时间窗: 8 weeks
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
FSS
时间窗: 8 weeks
Fatigue severity Index (9-item questionnaire, 1-7 Likert scale, the minimum and maximum values is 9\~63. Higher scores mean a worse outcome.)
CIS
时间窗: 8 weeks
Checklist Individual Strength (20-item questionnaire, 1-7 Likert score, the minimum and maximum values is 20\~140. Higher scores mean a worse outcome.)
Blood Indicators Related to Mental Fatigue
时间窗: 8 weeks
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Blood Indicators Related to Physical Fatigue
时间窗: 8 weeks
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
exercise test
时间窗: 8 weeks
VO2max (ml/kg/min, maximal oxygen consumption)
次要结局
未报告次要终点