A 8-week, 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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Changes in Cytotoxicity
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-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP, antibody titer, and upper respiratory tract infection(URI)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 20-80 years old
- •Who had suffered more than twice Upper respiratory infection* disorder or common cold causing URI
- •Able to give informed consent
排除标准
- •WBC concentration below 3000 ㎕
- •Subjects vaccinated against influenza within the last 6 months prior to the study
- •Subjects with Upper respiratory infection at screening visit
- •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
干预措施: Placebo (Dietary Supplement)
Cordyceps sinensis mycelium culture extract 0.76 g
Cordyceps sinensis mycelium culture extract 0.76 g
干预措施: Cordyceps sinensis mycelium culture extract 0.76 g (Dietary Supplement)
Cordyceps sinensis mycelium culture extract 1.15 g
Cordyceps sinensis mycelium culture extract 1.15 g
干预措施: Cordyceps sinensis mycelium culture extract 1.15 g (Dietary Supplement)
结局指标
主要结局
Changes in Cytotoxicity
时间窗: 4, 8 weeks
Cytotoxicity was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). cytotoxicity was measured by NK cell activity. Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100
次要结局
- Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)(4, 8 weeks)
- Changes in hs-CRP(4, 8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital