The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Incidence rate of ARI (by questionnaire)
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of GS-3K8 or GINst15 on acute respiratory illness (ARI) in healthy subjects.
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15 (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measure was the development and duration of ARI symptoms.
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
- 39 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 39-65 years with healthy adults
排除标准
- •Subjects had been vaccinated against influenza in the previous 6 months
- •Subjects with symptoms of upper respiratory tract infection
- •Subjects with acute/chronic disease
- •History of alcohol or substance abuse
- •History of disease that could interfere with the test products or impede their absorption
- •Subjects taking medications such as immune or upper respiratory tract infection related drug or functional foods
- •Abnormal liver or kidney function tests
- •Pregnant or lactating women and heavy smokers
- •Being judged by the responsible physician of the local study center as unfit to participate in the study
结局指标
主要结局
Incidence rate of ARI (by questionnaire)
时间窗: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.
次要结局
- Development of ARI symptoms (by questionnaire)(18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination))
- Duration of ARI symptoms (by questionnaire)(18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination))
研究者
Soo-Wan Chae
Principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital