Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Bronchial Asthma Clinical Trial

Official title:

Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714489
• Other study ID #: Felike V1.0
• Status: Recruiting
• Start date: January 16, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: June 2021
• Source: China Academy of Chinese Medical Sciences
• Contact: Hongchun Zhang, M.D.
• Phone: +86 13701226664
• Email: 13701226664[@]139.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: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Other:
• NO.
NO.

Locations

Country	Name	City	State
China	Hanyin County People's Hospital, Shaanxi Province	Ankang	Shanxi
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University Third Hospital Yanqing Hospital	Beijing	Beijing
China	Changchun Second Hospital	Changchun	Jilin
China	First Affiliated Hospital, Hunan University of Traditional Chinese Medicine	Changsha	Hunan
China	People's Hospital of Ningxiang	Changsha	Hunan
China	Xiangtan County People's Hospital	Changsha	Hunan
China	People's Hospital of Fuxin Mongolian Autonomous County	Fuxin	Liaoning
China	The First Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong
China	Guixi People's Hospital, Jiangxi Province	Guixi	Jiangxi
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	The Second People's Hospital of Guiyang	Guiyang	Guizhou
China	First People's Hospital of Jining City	Jining	Shandong
China	People's Hospital of Mengyin County	Linyi	Shandong
China	Jiangxi University of Traditional Chinese Medicine Affiliated Hospital	Nanchang	Jiangxi
China	Nanjing Central Hospital	Nanjing	Jiangsu
China	Yifu Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital of traditional Chinese Medicine	Nankín	Jiangsu
China	Southern University of Science and Technology Hospital	Shenzhen	Guangdong
China	The Eighth Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong
China	Peking University Binhai Hospital	Tianjin	Tianjin
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xi'an Medical College	Xian	Shanxi
China	Wanzai County People's Hospital, Jiangxi Province	Yichun	Jiangxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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 the data to be collected are included in Table A and Table B of the registration And Research Information collection of Adults using Feilike HeJi.Data in Table A are filled in by authorized researchers (such as clinicians) and patients, and data in Table B are filled in by authorized researchers (such as clinicians).	From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.