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A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

Sponsor
China Academy of Chinese Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT01612572
Collaborator
(none)
20,000
Enrollment
47
Duration (Months)

Study Details

Study Description

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

    In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

    Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China
    Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction [The registry procedure will last 3 years only for patients using Xiyanping.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Xiyanping injection from 2012 to 2014

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • China Academy of Chinese Medical Sciences

    Investigators

    • Principal Investigator: Yan M Xie, BA, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01612572
    Other Study ID Numbers:
    • RSCMI-Ⅲ
    • RSCMI- Ⅲ
    First Posted:
    Jun 6, 2012
    Last Update Posted:
    Jun 6, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Bronchitis
    Pneumonia, Viral
    Dysentery, Bacillary
    Dysentery
    Diarrhea
    Diarrhea, Infantile

    Study Results

    No Results Posted as of Jun 6, 2012