Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study
试验速览
- 阶段
- 3 期
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- the incidence rates of influenza infection
研究概览
简要总结
Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.
详细描述
Influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. It spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important.
Experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. In clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.
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
- None
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged from 15 to 20 years
- •obtained written informed consent from both the student and parent before participation
- •possible to gargle during 90 days
- •possible to fill in questionnaire
排除标准
- •Possessing allergy to green tea
- •Possessing history of influenza infection within 6 months before entering the study
- •Possessing severe immune disease or whole body infection
- •severe cardiac, respiratory, renal, or hepatic dysfunction
- •diagnosed as inadequate to participate in the study by student doctor
结局指标
主要结局
the incidence rates of influenza infection
时间窗: Until 3 months gargling
次要结局
- severity of influenza symptoms(until 3 months gargling)
- influenza-free time during the study period(until 3 months gargling)
- incidence of complications(until 3 months gargling)
- incidence of days of absence from school(until 3 months gargling)
- occurrence of the adverse events(until 3 months gargling)
- incidence rates of upper respiratory tract infections(until 3 months gargling)