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The Registration on the Use of Feilike Heji in Minors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658992
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

Study Description
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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.

Condition or disease
Bronchial Asthma

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: A Study on the Registration of the Use of Feilike Heji in Minors
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658992


Contacts
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Contact: Jing Liu, Prof 010-59616885 lljjred@126.com

Locations
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Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
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Study Director: Jing Liu, Prof Beijing Children's Hospital affiliated to Capital Medical University
More Information
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Responsible Party: Zhong Wang, researcher, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04658992    
Other Study ID Numbers: Feilike V2.0
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases