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

NCT ID: NCT02559960

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Adverse Drug Event Adverse Drug Reaction Chinese Medicine Anaphylactic Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Breviscapine Powder-Injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Zhusheyong Deng-zhan-hua-su

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhong Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhong Wang

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhong Wang, M.D.

Role: STUDY_DIRECTOR

China Academy of Chinese Medical Sciences

Xin-zhi Wang

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Henan College of Traditional Chinese Medicine

Locations

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The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

The People's Hospital of Zuanjiang District, Chongqing City

Chongqing, Chongqing Municipality, China

Site Status

Mudanjiang City Second People's Hospital

Mudanjiang, Heilongjiang, China

Site Status

People's Hospital of Jun County

Hebi, Henan, China

Site Status

People's Hospital of Changge City

Xuchang, Henan, China

Site Status

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Zhengzhou Second Hospital

Zhengzhou, Henan, China

Site Status

The First Hospital of Henan College of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status

Zaozhuang Hospital of T.C.M

Zaozhuang, Shandong, China

Site Status

Shandong Energy Zaozhuang Mining Group Center Hospital

Zaozhuang, Shandong, China

Site Status

Shanxi Provincial Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, China

Site Status

Changzheng Hospital of Tianjin City

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status

The Red Cross Hosptal of Yunnan

Kunming, Yunnan, China

Site Status

First Affilicated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

Other Identifiers

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Dengzhan-V1.0

Identifier Type: -

Identifier Source: org_study_id

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