Clinical trial NCT04658992: The Registration on the Use of Feilike Heji in Minors
Official title: A Study on the Registration of the Use of Feilike Heji in Minors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Asthma
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 3000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All minor patients (age \<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) and voluntarily participate in this study and meet ethical requirements.

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 minor patients (age \<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) .
* Voluntarily participate in this study and meet ethical requirements.

Exclusion Criteria:

* Not Applicable.

Primary outcomes:
measure: AE
timeFrame: The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Changping Hospital
state: Beijing
city: Peking
country: China
facility: Peking University Binhai Hospital
state: Beijing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second People's Hospital of Huadu District, Guangzhou
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Pingshan Women's and Children's Health Hospital
state: Guangdong
city: Bijie
country: China
facility: The First People's Hospital of Bijie City
state: Guizhou
city: Guiyang
country: China
facility: Guiyang Maternal and Child Health Hospital
state: Guizhou
city: Haerbin
country: China
facility: Harbin Children's Hospital
state: Helongjiang
city: Changsha
country: China
facility: Changsha First Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya San Hospital, Central South University
state: Hunan
city: Zhuzhou
country: China
facility: You County People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Second Affiliated Clinic, Nanjing Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Children's Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Lotus County Maternal and Child Health Hospital
state: Jiangxi
city: Anshan
country: China
facility: Haicheng Central Hospital
state: Liaoning
city: Fengcheng
country: China
facility: Fengcheng Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital affiliated with The Chinese Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
city: Xian
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shanxi
Study officials:
affiliation: Beijing Children's Hospital affiliated to Capital Medical University
name: Jing Liu, Prof
role: STUDY_DIRECTOR
References: