Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

Zhong Wang

Status: Completed

Conditions: Adverse Drug Events; Severe Adverse Reactions; Safety Surveillance; Severe Adverse Events; Adverse Drug Reactions

Treatments: Drug: Compound Kuh-seng Injection

Study type: Observational

Funder types: Other

Identifiers

NCT02239237

Kuh-seng1.0

Details and patient eligibility

About

This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.

Enrollment: 30,283 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion criteria

• None

Trial design

30,283 participants in 1 patient group

Compound Kuh-seng Injection

Description:

Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.

Treatment:

Drug: Compound Kuh-seng Injection