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NCT02559960 Clinical Trial

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

Adverse Drug Event Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT02559960
Other study ID # Dengzhan-V1.0
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date September 2015
Est. completion date December 2021

Study information
Verified date April 2021
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Suspended
Enrollment 20000
Est. completion date December 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China The People's Hospital of Zuanjiang District, Chongqing City Chongqing Chongqing
China The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China People's Hospital of Jun County Hebi Henan
China First Affilicated Hospital of Kunming Medical University Kunming Yunnan
China The Red Cross Hosptal of Yunnan Kunming Yunnan
China Mudanjiang City Second People's Hospital Mudanjiang Heilongjiang
China Shanxi Provincial Hospital of Traditional Chinese Medicine Taiyuan Shanxi
China Changzheng Hospital of Tianjin City Tianjin Tianjin
China Tianjin Medical University General Hospital Tianjin Tianjin
China People's Hospital of Changge City Xuchang Henan
China Shandong Energy Zaozhuang Mining Group Center Hospital Zaozhuang Shandong
China Zaozhuang Hospital of T.C.M Zaozhuang Shandong
China The First Hospital of Henan College of Traditional Chinese Medicine Zhengzhou Henan
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China Zhengzhou Second Hospital Zhengzhou Henan

Sponsors (1)
Lead Sponsor Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of anaphylactic reaction to Breviscapine Powder-Injection 1 years
Secondary The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection 1 years
Secondary The incidence of new SAEs to Breviscapine Powder-Injection 1 years
Secondary The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection 1 years
Secondary The incidence of new ADEs to Breviscapine Powder-Injection 1 years
Secondary The effective rate of Breviscapine Powder-Injection The proportion of the patients whose drug effect is considered as "effective" by investigator. 1 years
Secondary The patient satisfaction rate for the therapy of Breviscapine Powder-Injection 1 years
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