Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 25
- 主要终点
- AE
研究概览
简要总结
Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (age ≥18 years old) who use Feilike HeJi at the specified monitoring time and in the monitoring center (department) ;
- •Must voluntarily participate in this study;
- •Must meet ethical requirements.
排除标准
- 未提供
结局指标
主要结局
AE
时间窗: From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.
All the data to be collected are included in Table A and Table B of the registration And Research Information collection of Adults using Feilike HeJi.Data in Table A are filled in by authorized researchers (such as clinicians) and patients, and data in Table B are filled in by authorized researchers (such as clinicians).
次要结局
未报告次要终点
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences