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Completed

NCT Number: NCT02239237

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

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.

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Key information

Conditions

Safety Surveillance Adverse Drug Events Adverse Drug Reactions Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Severe Adverse Events Severe Adverse Reactions

Sex eligibility

All sexes

Study type

Observational

Primary location

HanDan Central Hospital, Handan, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion criteria

  • None

Treatment and study plan

Compound Kuh-seng Injection

Drug

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.

Other names: Compound Kushen Injection, Fufang Kushen Zhusheye

Primary outcomes

  1. The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection

    Time frame: 2 years

Secondary outcomes

  1. The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection

    Time frame: 2 years

  2. The incidence of anaphylactic reaction to Compound Kuh-seng Injection

    Time frame: 2 years

  3. The incidence of new ADRs to Compound Kuh-seng Injection

    Time frame: 2 years

  4. The incidence of new SARs to Compound Kuh-seng Injection

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Zhong Wang

Other

Collaborators

  • Shanxi Zhendong pharmaceutical Co. LTD.

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2014
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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