NCT02814617已完成2 期
The Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in serum natural killer cell activity
研究概览
简要总结
The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 20-75 years old
- •Able to give informed consent
排除标准
- •WBC concentration below 3000 ㎕, over 8000㎕
- •Subjects with BMI < 18.5 kg/m2 at screening visit
- •Allergic or hypersensitive to any of the ingredients in the test products
- •Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
Cordyceps sinensis mycelium culture extract
Experimental
Cordyceps sinensis mycelium culture extract 1.68 g
干预措施: Cordyceps sinensis mycelium culture extract 1.68 g (Dietary Supplement)
结局指标
主要结局
Changes in serum natural killer cell activity
时间窗: Baseline, 8 weeks
次要结局
- Changes in Cytokine(IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α)(Baseline, 8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (1)
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