A Placebo-Controlled Trial of Korean Red Ginseng Extract to Prevent Acute Respiratory Illness in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Frequency of ILI(Influenza Like Illness)
研究概览
简要总结
Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of Korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. The investigators sought to examine the efficacy of an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red ginseng will be investigated in healthy subjects during the influenza season.
详细描述
The extract of Korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. The investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, South Korea. The subjects will be instructed to take 9 capsules per day of either the Korean red ginseng extract or a placebo for a period of 12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms will be scored by subjects.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 30-70 years old
- •have contracted at least 2 colds in the past year
排除标准
- •if they had been vaccinated against influenza in the previous 6 months.
- •Subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, HIV/AIDS, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities
- •Subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine
- •Abnormal liver or kidney function tests (ALT or AST>2 times the upper limit of normal; elevated creatinine, males>125uM/L, females>110uM/L)
- •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
Frequency of ILI(Influenza Like Illness)
时间窗: 12 weeks
Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.
次要结局
- Symptom Severity of All Colds(12 weeks)
- Total Number of Days of Symptoms and Duration of All Colds(up to 12 weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital