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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 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.
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 (2)
Loading locations...
相似试验
招募中
2 期
The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated FatigueLong COVIDNCT05684952Hong Kong Baptist University152
尚未招募
2 期
A Chinese Herbal Medicine for IBS-CConstipation-predominant Irritable Bowel SyndromeNCT06319729Hong Kong Baptist University78
终止
2 期
Pilot Trial of XFBD, a TCM, in Persons With COVID-19Covid19NCT04810689Darcy Spicer10
Unknown
4 期
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina PectorisChinese Herbal MedicineUnstable AnginaCoronary Heart DiseaseNCT04661709Guang'anmen Hospital of China Academy of Chinese Medical Sciences502
进行中（未招募）
3 期
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)Axial SpondyloarthritisNCT06333210Biocad421