NCT03640884

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: Zhong Wang · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Adverse Drug Event
• Adverse Drug Reactions
• Anaphylactic Reaction
• Severe Adverse Reactions

Interventions

Type	Name	Description
DRUG	Xueshuantong-Injection	Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.

Timeline

• Start date: 2019-02-18
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2018-08-21
• Last updated: 2021-07-07

Locations

14 sites across 1 country: China