A Single-center, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety After 14-week of Ginseng Polysaccharide Extract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean percentage change in natural killer cell activity from a baseline level
研究概览
简要总结
Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its function as an immunomodulatory molecule. The present study performed to evaluate the safety and beneficial effects of Y-75 on immune function in a group of healthy adults.
The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear phagocytes, and serum levels of monocyte-derived mediators.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
排除标准
- •human immunodeficiency virus-1 infection
- •malignancy
- •active cardiovascular, renal, pulmonary, hepatic, neurological, psychiatric disease
- •recent (within 4 weeks) acute respiratory tract symptoms
- •immunosuppressive therapy including cytotoxic agents and corticosteroids
- •medication (within 4 weeks) deemed likely to interfere with the evaluation
- •history of allergic or other adverse reactions to ginseng products
研究组 & 干预措施
Y-75
volunteers receive 3 packages twice a day up to 14 weeks
干预措施: Y-75 (Dietary Supplement)
Placebo
volunteers receive 3 packages twice a day up to 14 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Mean percentage change in natural killer cell activity from a baseline level
时间窗: baseline (prior to the initial dose) , week 8, and week 14
次要结局
- Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells(baseline, week 8, and week 14)
- Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12(baseline, week 8, and week 14)
- Number of patients with laboratory abnormalities(baseline, week 8, and week 14)
- Number of participants with serious and non-serious adverse events(Up to 14 weeks)
- Number of patients with abnormal findings in physical examination and vital signs(baseline, week 8, and week 14)
研究者
Kyung-Soo Kim
Professor
Seoul St. Mary's Hospital