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

• Conditions: Bronchial Asthma

• Registration Number: NCT04714489
• 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: 2021-01-15
• Study Start: 2021-01-16
• Study First Posted: 2021-01-19
• Status Verified: 2021-06
• Primary Completion: 2021-06-01
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28
• Study Completion: 2021-08-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AE	From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.	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).

Trial Locations

Locations (25)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital Yanqing Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital Of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Eighth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Shenzhen, Guangdong, China

Southern University of Science and Technology Hospital; 🇨🇳 Shenzhen, Guangdong, China

Guizhou Provincial People's Hospital; 🇨🇳 Guiyang, Guizhou, China

The Second People's Hospital of Guiyang; 🇨🇳 Guiyang, Guizhou, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

First Affiliated Hospital, Hunan University of Traditional Chinese Medicine; 🇨🇳 Changsha, Hunan, China

People's Hospital of Ningxiang; 🇨🇳 Changsha, Hunan, China

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