The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- change of symptom score
研究概览
简要总结
Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1 influenza virus first appeared in Mexico and the United States in March and April 2009 and has swept the globe with unprecedented speed.
The aim of this study is to evaluate effect of supplement vitamin on the clinical course of patients with acute respiratory illness suspected novel H1N1 infection.
详细描述
Patients with acute respiratory illness randomized to control or vitamin groups. The patients completed questionnaire about their initial symptom scores. After 5 days of vitamin trial, patients were asked about their symptom by telephone survey.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •Acute respiratory illness suspected H1N1 infection
- •Acute febrile respiratory illness(BT > 37.8) and throat pain or cough or nasal congestion
排除标准
- •Pregnancy
- •Hypersensitivity to vitamin A
- •History of liver disease or renal disease
- •Urinary stone disease
研究组 & 干预措施
Vitamin
Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
干预措施: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) (Drug)
Control
Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics
干预措施: Placebo (digestive tablet) (Drug)
结局指标
主要结局
change of symptom score
时间窗: 1 week after initial visit
次要结局
未报告次要终点