Clinical trial NCT04714489: Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults
Official title: Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Asthma
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The users of Feilike HeJi in adults.Patients in this study were sourced from outpatient or/and inpatient wards. Outpatient or inpatient patients are selected according to the Settings of the monitoring points of each research center. In other words, if the monitoring points of a research center are outpatient, the outpatient patients can be registered. If the monitoring site includes outpatient and ward, both outpatient and inpatient will need to be registered. The monitoring points of each research center can be one or more departments.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* NO

Primary outcomes:
measure: AE
timeFrame: From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital Yanqing Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Southern University of Science and Technology Hospital
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Guiyang
country: China
facility: The Second People's Hospital of Guiyang
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: First Affiliated Hospital, Hunan University of Traditional Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: People's Hospital of Ningxiang
state: Hunan
city: Changsha
country: China
facility: Xiangtan County People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Central Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Yifu Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Nankín
country: China
facility: Nanjing Jiangning Hospital of traditional Chinese Medicine
state: Jiangsu
city: Guixi
country: China
facility: Guixi People's Hospital, Jiangxi Province
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi University of Traditional Chinese Medicine Affiliated Hospital
state: Jiangxi
city: Yichun
country: China
facility: Wanzai County People's Hospital, Jiangxi Province
state: Jiangxi
city: Changchun
country: China
facility: Changchun Second Hospital
state: Jilin
city: Fuxin
country: China
facility: People's Hospital of Fuxin Mongolian Autonomous County
state: Liaoning
city: Jining
country: China
facility: First People's Hospital of Jining City
state: Shandong
city: Linyi
country: China
facility: People's Hospital of Mengyin County
state: Shandong
city: Ankang
country: China
facility: Hanyin County People's Hospital, Shaanxi Province
state: Shanxi
city: Xian
country: China
facility: First Affiliated Hospital of Xi'an Medical College
state: Shanxi
city: Tianjin
country: China
facility: Peking University Binhai Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
Study officials:
affiliation: China-Japan Friendship Hospital
name: Hongchun Zhang, M.D.
role: STUDY_DIRECTOR
References: