The Registration on the Use of Feilike Heji in Minors

August 2, 2021 updated by: Zhong Wang, China Academy of Chinese Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Recruiting
        • Beijing Children's Hospital Affiliated to Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 101200
        • Recruiting
        • Beijing Pinggu Hospital
        • Contact:
      • Beijing, Beijing, China, 102200
        • Recruiting
        • Beijing Changping Hospital
        • Contact:
      • Peking, Beijing, China, 300450
        • Not yet recruiting
        • Peking University BinHai Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510850
        • Not yet recruiting
        • The Second People's Hospital of Huadu District, Guangzhou
        • Contact:
      • Shenzhen, Guangdong, China, 518112
        • Not yet recruiting
        • Shenzhen Pingshan Women's and Children's Health Hospital
        • Contact:
          • Hanhua Yang, Doctor
          • Phone Number: 13537784919
          • Email: drsam@126.com
    • Guizhou
      • Bijie, Guizhou, China, 551700
        • Not yet recruiting
        • The First People's Hospital of Bijie City
        • Contact:
      • Guiyang, Guizhou, China, 550003
        • Not yet recruiting
        • Guiyang Maternal and Child Health Hospital
        • Contact:
    • Helongjiang
      • Haerbin, Helongjiang, China, 150010
        • Not yet recruiting
        • Harbin Children's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Changsha First Hospital
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya San Hospital, Central South University
        • Contact:
      • Zhuzhou, Hunan, China, 412300
        • Recruiting
        • You County People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Recruiting
        • Second Affiliated Clinic, Nanjing Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • Jiangxi Children's Hospital
        • Contact:
      • Pingxiang, Jiangxi, China, 337100
        • Recruiting
        • Lotus County Maternal and Child Health Hospital
        • Contact:
    • Liaoning
      • Anshan, Liaoning, China, 114200
        • Recruiting
        • Haicheng Central Hospital
      • Fengcheng, Liaoning, China, 118100
        • Recruiting
        • Fengcheng Central Hospital
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital affiliated with The Chinese Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250002
        • Not yet recruiting
        • Qilu hospital
    • Shanxi
      • Xian, Shanxi, China, 710032
        • Not yet recruiting
        • The First Affiliated Hospital of Air Force Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Investigators

  • Study Director: Jing Liu, Prof, Beijing Children's Hospital Affiliated to Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Feilike V2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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