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NCT02239237 Clinical Trial

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

Adverse Drug Events Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02239237
Other study ID # Kuh-seng1.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date October 2018

Study information
Verified date October 2018
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30283
Est. completion date October 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Compound 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.

Locations
Country Name City State
China AVIC 363 Hospital Chengdu Sichuan
China Chengdu Second People's Hospital Chengdu Sichuan
China Teaching Hospital of Chengdu University of T.C.M. Chengdu Sichuan
China HanDan Central Hospital HanDan Hebei
China Handan First Hospital Handan Hebei
China Shandong Provincial Western Hospital Jinan Shandong
China Jincheng General Hospital Jincheng Shanxi
China Henan University Huaihe Hospital Kaifeng Henan
China The Fourth People's Hospital of Linfen Linfen Shanxi
China Luoyang Central Hospital Affiliated to Zhengzhou University Luoyang Henan
China The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
China Qingdao Center Hospital Qingdao Shandong
China Bai Qiu'en International Peace Hospital Shijiazhuang Hebei
China People's Hospital of Xintai City Tai'an Shandong
China Tai'an Central Hospital Tai'an Shandong
China The 88th Hospital of People's Liberation Army Tai'an Shandong
China Traditional Chinese Hospital of Shanxi Taiyuan Shanxi
China Tianjin medical university cancer institute & hosptial Tianjin Tianjin
China Weifang No.2 People's Hospital Weifang Shandong
China Weihai Municipal Hospital Weihai Shandong
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China Xinxiang Central Hospital Xinxiang Henan
China Xinyang Central Hospital Xinyang Henan
China The Second People's Hospital of Yibin Yibin Sichuan
China Yuncheng Central Hospital Yuncheng Shanxi
China Henan Cancer Hospital Zhengzhou Henan
China People's Hospital of Zhengzhou Zhengzhou Henan
China The First Hospital of Henan College of Traditional Chinese Medicine Zhengzhou Henan
China Central Hospital of Zibo Zibo Shandong

Sponsors (2)
Lead Sponsor Collaborator
Zhong Wang Shanxi Zhendong pharmaceutical Co. LTD.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection 2 years
Secondary The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection 2 years
Secondary The incidence of anaphylactic reaction to Compound Kuh-seng Injection 2 years
Secondary The incidence of new ADRs to Compound Kuh-seng Injection 2 years
Secondary The incidence of new SARs to Compound Kuh-seng Injection 2 years
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