Clinical trial NCT02559960: Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Official title: Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Adverse Drug Event
Adverse Drug Reaction
Chinese Medicine
Anaphylactic Reaction
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of anaphylactic reaction to Breviscapine Powder-Injection
timeFrame: 1 years
Secondary outcomes:
measure: The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection
timeFrame: 1 years
measure: The incidence of new SAEs to Breviscapine Powder-Injection
timeFrame: 1 years
measure: The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection
timeFrame: 1 years
measure: The incidence of new ADEs to Breviscapine Powder-Injection
timeFrame: 1 years
measure: The effective rate of Breviscapine Powder-Injection
timeFrame: 1 years
measure: The patient satisfaction rate for the therapy of Breviscapine Powder-Injection
timeFrame: 1 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The People's Hospital of Zuanjiang District, Chongqing City
state: Chongqing
city: Mudanjiang
country: China
facility: Mudanjiang City Second People's Hospital
state: Heilongjiang
city: Hebi
country: China
facility: People's Hospital of Jun County
state: Henan
city: Xuchang
country: China
facility: People's Hospital of Changge City
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Second Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Hospital of Henan College of Traditional Chinese Medicine
state: Henan
city: Zaozhuang
country: China
facility: Zaozhuang Hospital of T.C.M
state: Shandong
city: Zaozhuang
country: China
facility: Shandong Energy Zaozhuang Mining Group Center Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Hospital of Traditional Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: Changzheng Hospital of Tianjin City
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: The Red Cross Hosptal of Yunnan
state: Yunnan
city: Kunming
country: China
facility: First Affilicated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Zhong Wang, M.D.
role: STUDY_DIRECTOR
affiliation: The First Hospital of Henan College of Traditional Chinese Medicine
name: Xin-zhi Wang
role: PRINCIPAL_INVESTIGATOR
References: