Clinical trial NCT03640884: Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
Official title: Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Drug Event
Adverse Drug Reactions
Anaphylactic Reaction
Severe Adverse Reactions
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 30000
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 received the Xueshuantong-Injection for treatment will be consecutive included in this registry

Brief summary: This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.

Detailed description: Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.

Eligibility criteria: Inclusion Criteria:

* Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
timeFrame: 2 years
Secondary outcomes:
measure: The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection
timeFrame: 2 years
measure: The incidence of adverse events （AE）of Xueshuantong-Injection
timeFrame: 2 years
measure: The incidence of serious adverse events （SAE）of Xueshuantong-Injection
timeFrame: 2 years
measure: The incidence of anaphylactic reaction of Xueshuantong-Injection
timeFrame: 2 years
measure: The incidence of new ADRs of Xueshuantong-Injection
timeFrame: 2 years
measure: The effective rate of Xueshuantong-Injection
timeFrame: 2 years
Other outcomes:
Locations:
city: Hengshui
country: China
facility: Jizhou City Hospital
state: Hebei
city: Nanyang
country: China
facility: Tongbai County People's Hospital
state: Henan
city: Sanmenxia
country: China
facility: Lingbao 3th People's Hospital
state: Henan
city: Zhoukou
country: China
facility: People's Hospital of Dancheng County
state: Henan
city: Wuhan
country: China
facility: Dongxihu District People's Hospital
state: Hubei
city: Lianyungang
country: China
facility: Donghai Country People's Hospital
state: Jiangsu
city: Yichun
country: China
facility: People's Hospital of Yichun City
state: Jiangxi
city: Dalian
country: China
facility: Central Hospital of Wafangdian City
state: Liaoning
city: Lingyuan
country: China
facility: Lingyuan City Central Hospital
state: Liaoning
city: Binzhou
country: China
facility: Chinse Medical Hospital of Yangxin County
state: Shandong
city: Weihai
country: China
facility: Weihai Wendeng District People's Hospital
state: Shandong
city: Jincheng
country: China
facility: Yangcheng County People's Hospital
state: Shanxi
city: Jinzhong
country: China
facility: Lingshi Country People's Hospital
state: Shanxi
city: Yuanping
country: China
facility: Shanxi Yuanping First People's Hospital
state: Shanxi
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: Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
name: Jinmin Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: