NCT02559960

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Zhong Wang · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Adverse Drug Event
• Adverse Drug Reaction
• Chinese Medicine
• Anaphylactic Reaction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2015-09-25
• Last updated: 2021-04-08

Locations

15 sites across 1 country: China