The Registration on the Use of Feilike Heji in Minors
A Study on the Registration of the Use of Feilike Heji in Minors
1 other identifier
observational
3,000
1 country
21
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 Dec 2020
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedAugust 4, 2021
August 1, 2021
12 months
December 2, 2020
August 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
All minor patients (age \<18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) and voluntarily participate in this study and meet ethical requirements.
You may qualify if:
- 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.
You may not qualify if:
- Not Applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Beijing Children's Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100045, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200, China
Beijing Changping Hospital
Beijing, Beijing Municipality, 102200, China
Peking University Binhai Hospital
Beijing, Beijing Municipality, 300450, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The Second People's Hospital of Huadu District, Guangzhou
Guangzhou, Guangdong, 510850, China
Shenzhen Pingshan Women's and Children's Health Hospital
Shenzhen, Guangdong, 518112, China
The First People's Hospital of Bijie City
Bijie, Guizhou, 551700, China
Guiyang Maternal and Child Health Hospital
Guiyang, Guizhou, 550003, China
Harbin Children's Hospital
Haerbin, Helongjiang, 150010, China
Changsha First Hospital
Changsha, Hunan, 410000, China
Xiangya San Hospital, Central South University
Changsha, Hunan, 410000, China
You County People's Hospital
Zhuzhou, Hunan, 412300, China
Second Affiliated Clinic, Nanjing Medical University
Nanjing, Jiangsu, 210003, China
Jiangxi Children's Hospital
Nanchang, Jiangxi, 330000, China
Lotus County Maternal and Child Health Hospital
Pingxiang, Jiangxi, 337100, China
Haicheng Central Hospital
Anshan, Liaoning, 114200, China
Fengcheng Central Hospital
Fengcheng, Liaoning, 118100, China
The First Hospital affiliated with The Chinese Medical University
Shenyang, Liaoning, 110000, China
Qilu Hospital
Jinan, Shandong, 250002, China
The First Affiliated Hospital of Air Force Military Medical University
Xian, Shanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jing Liu, Prof
Beijing Children's Hospital affiliated to Capital Medical University
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
- researcher
Study Record Dates
First Submitted
December 2, 2020
First Posted
December 9, 2020
Study Start
December 15, 2020
Primary Completion
December 1, 2021
Study Completion
March 1, 2022
Last Updated
August 4, 2021
Record last verified: 2021-08