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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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