The Registration on the Use of Feilike Heji in Minors
- Conditions
- Bronchial Asthma
- Registration Number
- NCT04658992
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- 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.
- Not Applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AE 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. All adverse events occurred during the study were determined according to CTCAE V5.0 for severity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Peking University Binhai Hospital
π¨π³Peking, Beijing, China
Beijing Children's Hospital affiliated to Capital Medical University
π¨π³Beijing, Beijing, China
Second Affiliated Clinic, Nanjing Medical University
π¨π³Nanjing, Jiangsu, China
Harbin Children's Hospital
π¨π³Haerbin, Helongjiang, China
The Third Affiliated Hospital, Sun Yat-sen University
π¨π³Guangzhou, Guangdong, China
Qilu Hospital
π¨π³Jinan, Shandong, China
Beijing Changping Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Air Force Military Medical University
π¨π³Xian, Shanxi, China
Jiangxi Children's Hospital
π¨π³Nanchang, Jiangxi, China
The First People's Hospital of Bijie City
π¨π³Bijie, Guizhou, China
Guiyang Maternal and Child Health Hospital
π¨π³Guiyang, Guizhou, China
Haicheng Central Hospital
π¨π³Anshan, Liaoning, China
Fengcheng Central Hospital
π¨π³Fengcheng, Liaoning, China
Beijing Pinggu Hospital
π¨π³Beijing, Beijing, China
Shenzhen Pingshan Women's and Children's Health Hospital
π¨π³Shenzhen, Guangdong, China
You County People's Hospital
π¨π³Zhuzhou, Hunan, China
Lotus County Maternal and Child Health Hospital
π¨π³Pingxiang, Jiangxi, China
Changsha First Hospital
π¨π³Changsha, Hunan, China
Xiangya San Hospital, Central South University
π¨π³Changsha, Hunan, China
The First Hospital affiliated with The Chinese Medical University
π¨π³Shenyang, Liaoning, China
The Second People's Hospital of Huadu District, Guangzhou
π¨π³Guangzhou, Guangdong, China