Clinical trial NCT02239237: Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
Official title: Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Surveillance
Adverse Drug Events
Adverse Drug Reactions
Severe Adverse Events
Severe Adverse Reactions
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shanxi Zhendong pharmaceutical Co. LTD.
First posted: 2014-09-12
Enrollment: 30283
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who use Compound Kushen Injection in the monitoring hospitals

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.


Eligibility criteria: Inclusion Criteria:

* Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
timeFrame: 2 years
Secondary outcomes:
measure: The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
timeFrame: 2 years
measure: The incidence of anaphylactic reaction to Compound Kuh-seng Injection
timeFrame: 2 years
measure: The incidence of new ADRs to Compound Kuh-seng Injection
timeFrame: 2 years
measure: The incidence of new SARs to Compound Kuh-seng Injection
timeFrame: 2 years
Other outcomes:
Locations:
city: HanDan
country: China
facility: HanDan Central Hospital
state: Hebei
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Bai Qiu'en International Peace Hospital
state: Hebei
city: Kaifeng
country: China
facility: Henan University Huaihe Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Luoyang
country: China
facility: Luoyang Central Hospital Affiliated to Zhengzhou University
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinyang
country: China
facility: Xinyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Hospital of Henan College of Traditional Chinese Medicine
state: Henan
city: Jinan
country: China
facility: Shandong Provincial Western Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Center Hospital
state: Shandong
city: Tai'an
country: China
facility: Tai'an Central Hospital
state: Shandong
city: Tai'an
country: China
facility: The 88th Hospital of People's Liberation Army
state: Shandong
city: Tai'an
country: China
facility: People's Hospital of Xintai City
state: Shandong
city: Weifang
country: China
facility: Weifang No.2 People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Zibo
country: China
facility: Central Hospital of Zibo
state: Shandong
city: Jincheng
country: China
facility: Jincheng General Hospital
state: Shanxi
city: Linfen
country: China
facility: The Fourth People's Hospital of Linfen
state: Shanxi
city: Taiyuan
country: China
facility: Traditional Chinese Hospital of Shanxi
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: AVIC 363 Hospital
state: Sichuan
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of T.C.M.
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
city: Tianjin
country: China
facility: Tianjin medical university cancer institute & hosptial
state: Tianjin
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, M.D.
role: STUDY_DIRECTOR
affiliation: Tianjin medical university cancer institute & hosptial
name: Zhan-Yu Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: