Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults
Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults
1 other identifier
observational
3,000
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2020
CompletedStudy Start
First participant enrolled
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJune 28, 2021
June 1, 2021
5 months
December 2, 2020
June 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
experimental group
Interventions
Eligibility Criteria
The users of Feilike HeJi in adults.Patients in this study were sourced from outpatient or/and inpatient wards. Outpatient or inpatient patients are selected according to the Settings of the monitoring points of each research center. In other words, if the monitoring points of a research center are outpatient, the outpatient patients can be registered. If the monitoring site includes outpatient and ward, both outpatient and inpatient will need to be registered. The monitoring points of each research center can be one or more departments.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University Third Hospital Yanqing Hospital
Beijing, Beijing Municipality, 102100, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518033, China
Southern University of Science and Technology Hospital
Shenzhen, Guangdong, 518051, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550001, China
The Second People's Hospital of Guiyang
Guiyang, Guizhou, 550023, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
First Affiliated Hospital, Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410000, China
People's Hospital of Ningxiang
Changsha, Hunan, 410000, China
Xiangtan County People's Hospital
Changsha, Hunan, 410000, China
Nanjing Central Hospital
Nanjing, Jiangsu, 210018, China
Yifu Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 211112, China
Nanjing Jiangning Hospital of traditional Chinese Medicine
Nanjing, Jiangsu, 211199, China
Guixi People's Hospital, Jiangxi Province
Guixi, Jiangxi, 335400, China
Jiangxi University of Traditional Chinese Medicine Affiliated Hospital
Nanchang, Jiangxi, 330000, China
Wanzai County People's Hospital, Jiangxi Province
Yichun, Jiangxi, 336100, China
Changchun Second Hospital
Changchun, Jilin, 132000, China
People's Hospital of Fuxin Mongolian Autonomous County
Fuxin, Liaoning, 123000, China
First People's Hospital of Jining City
Jining, Shandong, 272011, China
People's Hospital of Mengyin County
Linyi, Shandong, 276200, China
Hanyin County People's Hospital, Shaanxi Province
Ankang, Shanxi, 725100, China
First Affiliated Hospital of Xi'an Medical College
Xian, Shanxi, 710000, China
Peking University Binhai Hospital
Tianjin, Tianjin Municipality, 010100, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 010100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hongchun Zhang, M.D.
China-Japan Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 2, 2020
First Posted
January 19, 2021
Study Start
January 16, 2021
Primary Completion
June 1, 2021
Study Completion
August 1, 2021
Last Updated
June 28, 2021
Record last verified: 2021-06