NCT04031651Unknown不适用
Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 主要终点
- Incidence of Adverse Drug Reaction
研究概览
简要总结
To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
- •(2)Aged between 18 and 80.
排除标准
- •Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.
结局指标
主要结局
Incidence of Adverse Drug Reaction
时间窗: 7 days
Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction
次要结局
- The Ratio of Body Temperature to Normal(7 days)
- Change of liver function(7 days)
- Change of renal function(7 days)
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences
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