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

Completed

• Conditions: Safety Surveillance; Adverse Drug Reactions; Adverse Drug Events; Severe Adverse Reactions; Severe Adverse Events
• Interventions: Drug: Compound Kuh-seng Injection

• Registration Number: NCT02239237
• Lead Sponsor: Zhong Wang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2018-06
• Status Verified: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30283

Inclusion Criteria

• Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compound Kuh-seng Injection	Compound Kuh-seng Injection	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection	2 years

Trial Locations

Locations (29)

HanDan Central Hospital; 🇨🇳 HanDan, Hebei, China

Handan First Hospital; 🇨🇳 Handan, Hebei, China

Bai Qiu'en International Peace Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Henan University Huaihe Hospital; 🇨🇳 Kaifeng, Henan, China

The First Affiliated Hospital of Henan University of Science & Technology; 🇨🇳 Luoyang, Henan, China

Luoyang Central Hospital Affiliated to Zhengzhou University; 🇨🇳 Luoyang, Henan, China

Xinxiang Central Hospital; 🇨🇳 Xinxiang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University; 🇨🇳 Xinxiang, Henan, China

Xinyang Central Hospital; 🇨🇳 Xinyang, Henan, China

People's Hospital of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

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