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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02239237

Enrollment

30283

Registered

2014-09-12

Start date

2014-09-30

Completion date

2018-10-31

Last updated

2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Events, Adverse Drug Reactions, Safety Surveillance, Severe Adverse Events, Severe Adverse Reactions

Brief summary

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.

Interventions

DRUGCompound Kuh-seng Injection

Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection	2 years

Secondary

Measure	Time frame
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection	2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection	2 years
The incidence of new ADRs to Compound Kuh-seng Injection	2 years
The incidence of new SARs to Compound Kuh-seng Injection	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026