The Registration on the Use of Feilike Heji in Minors

Bronchial Asthma Clinical Trial

Official title:

A Study on the Registration of the Use of Feilike Heji in Minors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658992
• Other study ID #: Feilike V2.0
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2021
• Source: China Academy of Chinese Medical Sciences
• Contact: Jing Liu, Prof
• Phone: 010-59616885
• Email: lljjred[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Locations

Country	Name	City	State
China	Haicheng Central Hospital	Anshan	Liaoning
China	Beijing Changping Hospital	Beijing	Beijing
China	Beijing Children's Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Pinggu Hospital	Beijing	Beijing
China	The First People's Hospital of Bijie City	Bijie	Guizhou
China	Changsha First Hospital	Changsha	Hunan
China	Xiangya San Hospital, Central South University	Changsha	Hunan
China	Fengcheng Central Hospital	Fengcheng	Liaoning
China	The Second People's Hospital of Huadu District, Guangzhou	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Guiyang Maternal and Child Health Hospital	Guiyang	Guizhou
China	Harbin Children's Hospital	Haerbin	Helongjiang
China	Qilu Hospital	Jinan	Shandong
China	Jiangxi Children's Hospital	Nanchang	Jiangxi
China	Second Affiliated Clinic, Nanjing Medical University	Nanjing	Jiangsu
China	Peking University Binhai Hospital	Peking	Beijing
China	Lotus County Maternal and Child Health Hospital	Pingxiang	Jiangxi
China	The First Hospital affiliated with The Chinese Medical University	Shenyang	Liaoning
China	Shenzhen Pingshan Women's and Children's Health Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Air Force Military Medical University	Xian	Shanxi
China	You County People's Hospital	Zhuzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE	All adverse events occurred during the study were determined according to CTCAE V5.0 for severity.	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.