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

Suspended

• Conditions: Chinese Medicine; Adverse Drug Event; Adverse Drug Reaction; Anaphylactic Reaction
• Interventions: Drug: Breviscapine Powder-Injection

• Registration Number: NCT02559960
• Lead Sponsor: Zhong Wang

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breviscapine Powder-Injection	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.

Primary Outcome Measures

Name	Time	Method
The incidence of anaphylactic reaction to Breviscapine Powder-Injection	1 years

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection	1 years
The effective rate of Breviscapine Powder-Injection	1 years	The proportion of the patients whose drug effect is considered as "effective" by investigator.
The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection	1 years
The incidence of new SAEs to Breviscapine Powder-Injection	1 years
The incidence of new ADEs to Breviscapine Powder-Injection	1 years
The patient satisfaction rate for the therapy of Breviscapine Powder-Injection	1 years

Trial Locations

Locations (15)

Zhengzhou Second Hospital; 🇨🇳 Zhengzhou, Henan, China

The Red Cross Hosptal of Yunnan; 🇨🇳 Kunming, Yunnan, China

Shanxi Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Taiyuan, Shanxi, China

The People's Hospital of Zuanjiang District, Chongqing City; 🇨🇳 Chongqing, Chongqing, China

First Affilicated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Zaozhuang Hospital of T.C.M; 🇨🇳 Zaozhuang, Shandong, China

Shandong Energy Zaozhuang Mining Group Center Hospital; 🇨🇳 Zaozhuang, Shandong, China

Mudanjiang City Second People's Hospital; 🇨🇳 Mudanjiang, Heilongjiang, China

People's Hospital of Changge City; 🇨🇳 Xuchang, Henan, China

People's Hospital of Jun County; 🇨🇳 Hebi, Henan, China

Changzheng Hospital of Tianjin City; 🇨🇳 Tianjin, Tianjin, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Hospital of Henan College of Traditional Chinese Medicine; 🇨🇳 Zhengzhou, Henan, China