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

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Study Start: 2020-12-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

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.

Trial Locations

Locations (21)

Beijing Children's Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Pinggu Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Changping Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Binhai Hospital; 🇨🇳 Peking, Beijing, China

The Third Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The Second People's Hospital of Huadu District, Guangzhou; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen Pingshan Women's and Children's Health Hospital; 🇨🇳 Shenzhen, Guangdong, China

The First People's Hospital of Bijie City; 🇨🇳 Bijie, Guizhou, China

Guiyang Maternal and Child Health Hospital; 🇨🇳 Guiyang, Guizhou, China

Harbin Children's Hospital; 🇨🇳 Haerbin, Helongjiang, China

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