Clincosm LogoSign in Get a demo

Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

Sponsor
Zhong Wang (Other)
Overall Status
Suspended
CT.gov ID
NCT02559960
Collaborator
(none)
20,000
Enrollment
15
Locations
75
Anticipated Duration (Months)
1333.3
Patients Per Site
17.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Condition or Disease Intervention/Treatment Phase
  • Drug: Breviscapine Powder-Injection

Detailed Description

Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Actual Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Breviscapine Powder-Injection

Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc.

Drug: Breviscapine Powder-Injection
Patients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.
Other Names:
  • Zhusheyong Deng-zhan-hua-su

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of anaphylactic reaction to Breviscapine Powder-Injection [1 years]

    Secondary Outcome Measures

    1. The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection [1 years]

    2. The incidence of new SAEs to Breviscapine Powder-Injection [1 years]

    3. The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection [1 years]

    4. The incidence of new ADEs to Breviscapine Powder-Injection [1 years]

    5. The effective rate of Breviscapine Powder-Injection [1 years]

      The proportion of the patients whose drug effect is considered as "effective" by investigator.

    6. The patient satisfaction rate for the therapy of Breviscapine Powder-Injection [1 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
    2 The People's Hospital of Zuanjiang District, Chongqing City Chongqing Chongqing China 401420
    3 Mudanjiang City Second People's Hospital Mudanjiang Heilongjiang China 157013
    4 People's Hospital of Jun County Hebi Henan China 456250
    5 People's Hospital of Changge City Xuchang Henan China 461599
    6 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    7 Zhengzhou Second Hospital Zhengzhou Henan China 450015
    8 The First Hospital of Henan College of Traditional Chinese Medicine Zhengzhou Henan China 451199
    9 Zaozhuang Hospital of T.C.M Zaozhuang Shandong China 277000
    10 Shandong Energy Zaozhuang Mining Group Center Hospital Zaozhuang Shandong China 277800
    11 Shanxi Provincial Hospital of Traditional Chinese Medicine Taiyuan Shanxi China 030012
    12 Changzheng Hospital of Tianjin City Tianjin Tianjin China 300021
    13 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    14 The Red Cross Hosptal of Yunnan Kunming Yunnan China 650021
    15 First Affilicated Hospital of Kunming Medical University Kunming Yunnan China 650032

    Sponsors and Collaborators

    • Zhong Wang

    Investigators

    • Study Director: Zhong Wang, M.D., China Academy of Chinese Medical Sciences
    • Principal Investigator: Xin-zhi Wang, The First Hospital of Henan College of Traditional Chinese Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong Wang, Dr, China Academy of Chinese Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02559960
    Other Study ID Numbers:
    • Dengzhan-V1.0
    First Posted:
    Sep 25, 2015
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Anaphylaxis
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Apr 8, 2021