Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Change in score of State&Trait version of STAI
研究概览
简要总结
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-65 years with chronic stress( S-STAI score 40~60)
排除标准
- •excessive physically chronic fatigue
- •Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study
- •Cardiovascular disease
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •Renal disease
- •Abnormal hepatic function
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •History of alcohol or substance abuse
- •Pregnancy or lacting women etc.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
Gynostemma Pentaphyllum(Dungkulcha) Extract
Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)
干预措施: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) (Dietary Supplement)
结局指标
主要结局
Change in score of State&Trait version of STAI
时间窗: Baseline and 8 weeks
Score of State\&Trait version of STAI was measured in study screening and visit 3(8 week).
次要结局
- Change of Blood Norepinephrine Level(Baseline and 8 week)
- Change of Blood Cortisol Level(Baseline and 8 week)
- Change in score of Beck Anxiety Inventory(Baseline and 8 week)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital