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

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

Study Overview

• Status: Suspended
• Conditions: Adverse Drug Event; Adverse Drug Reaction; Chinese Medicine; Anaphylactic Reaction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 401420
      • The People's Hospital of Zuanjiang District, Chongqing City
  • Heilongjiang
    • Mudanjiang, Heilongjiang, China, 157013
      • Mudanjiang City Second People's Hospital
  • Henan
    • Hebi, Henan, China, 456250
      • People's Hospital of Jun County
    • Xuchang, Henan, China, 461599
      • People's Hospital of Changge City
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 451199
      • The First Hospital of Henan College of Traditional Chinese Medicine
    • Zhengzhou, Henan, China, 450015
      • Zhengzhou Second Hospital
  • Shandong
    • Zaozhuang, Shandong, China, 277000
      • Zaozhuang Hospital of T.C.M
    • Zaozhuang, Shandong, China, 277800
      • Shandong Energy Zaozhuang Mining Group Center Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Shanxi Provincial Hospital of Traditional Chinese Medicine
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300021
      • Changzheng Hospital of Tianjin City
  • Yunnan
    • Kunming, Yunnan, China, 650021
      • The Red Cross Hosptal of Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affilicated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of anaphylactic reaction to Breviscapine Powder-Injection	1 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Anaphylaxis
• Other Study ID Numbers: Dengzhan-V1.0