Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study

Zhong Wang

Status: Unknown

Conditions: Adverse Drug Event; Severe Adverse Reactions; Anaphylactic Reaction; Adverse Drug Reactions

Treatments: Drug: Xueshuantong-Injection

Study type: Observational

Funder types: Other

Identifiers

NCT03640884

Xueshuantong--V2.0

Details and patient eligibility

About

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

Full description

Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.

Enrollment: 30,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals

Exclusion criteria

• None

Trial design

30,000 participants in 1 patient group

Xueshuantong-Injection

Description:

Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-Injection and the combined medications, etc.

Treatment:

Drug: Xueshuantong-Injection