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The Registration on the Use of Feilike Heji in Minors

Sponsor
China Academy of Chinese Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04658992
Collaborator
(none)
3,000
Enrollment
21
Locations
14.5
Anticipated Duration (Months)
142.9
Patients Per Site
9.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Study on the Registration of the Use of Feilike Heji in Minors
    Actual Study Start Date :
    Dec 15, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. AE [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

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Beijing Children's Hospital affiliated to Capital Medical University Beijing Beijing China 100045
    2 Beijing Pinggu Hospital Beijing Beijing China 101200
    3 Beijing Changping Hospital Beijing Beijing China 102200
    4 Peking University Binhai Hospital Peking Beijing China 300450
    5 The Third Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China 510630
    6 The Second People's Hospital of Huadu District, Guangzhou Guangzhou Guangdong China 510850
    7 Shenzhen Pingshan Women's and Children's Health Hospital Shenzhen Guangdong China 518112
    8 The First People's Hospital of Bijie City Bijie Guizhou China 551700
    9 Guiyang Maternal and Child Health Hospital Guiyang Guizhou China 550003
    10 Harbin Children's Hospital Haerbin Helongjiang China 150010
    11 Changsha First Hospital Changsha Hunan China 410000
    12 Xiangya San Hospital, Central South University Changsha Hunan China 410000
    13 You County People's Hospital Zhuzhou Hunan China 412300
    14 Second Affiliated Clinic, Nanjing Medical University Nanjing Jiangsu China 210003
    15 Jiangxi Children's Hospital Nanchang Jiangxi China 330000
    16 Lotus County Maternal and Child Health Hospital Pingxiang Jiangxi China 337100
    17 Haicheng Central Hospital Anshan Liaoning China 114200
    18 Fengcheng Central Hospital Fengcheng Liaoning China 118100
    19 The First Hospital affiliated with The Chinese Medical University Shenyang Liaoning China 110000
    20 Qilu Hospital Jinan Shandong China 250002
    21 The First Affiliated Hospital of Air Force Military Medical University Xian Shanxi China 710032

    Sponsors and Collaborators

    • China Academy of Chinese Medical Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong Wang, researcher, China Academy of Chinese Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT04658992
    Other Study ID Numbers:
    • Feilike V2.0
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Aug 4, 2021