Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
- Conditions
- Adverse Drug ReactionsAnaphylactic ReactionSevere Adverse ReactionsAdverse Drug Event
- Interventions
- Drug: Xueshuantong-Injection
- Registration Number
- NCT03640884
- Lead Sponsor
- Zhong Wang
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30000
- Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Xueshuantong-Injection Xueshuantong-Injection Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-Injection and the combined medications, etc.
- Primary Outcome Measures
Name Time Method The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection 2 years A serious adverse reactions (SAR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.
- Secondary Outcome Measures
Name Time Method The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection 2 years The incidence of adverse events （AE）of Xueshuantong-Injection 2 years The incidence of serious adverse events （SAE）of Xueshuantong-Injection 2 years The effective rate of Xueshuantong-Injection 2 years The proportion of the patients whose drug effect is considered as "effective" by investigator
The incidence of anaphylactic reaction of Xueshuantong-Injection 2 years The incidence of new ADRs of Xueshuantong-Injection 2 years
Trial Locations
- Locations (14)
Jizhou City Hospital
🇨🇳Hengshui, Hebei, China
Tongbai County People's Hospital
🇨🇳Nanyang, Henan, China
Lingbao 3th People's Hospital
🇨🇳Sanmenxia, Henan, China
Dongxihu District People's Hospital
🇨🇳Wuhan, Hubei, China
People's Hospital of Dancheng County
🇨🇳Zhoukou, Henan, China
Donghai Country People's Hospital
🇨🇳Lianyungang, Jiangsu, China
People's Hospital of Yichun City
🇨🇳Yichun, Jiangxi, China
Central Hospital of Wafangdian City
🇨🇳Dalian, Liaoning, China
Lingyuan City Central Hospital
🇨🇳Lingyuan, Liaoning, China
Chinse Medical Hospital of Yangxin County
🇨🇳Binzhou, Shandong, China
Weihai Wendeng District People's Hospital
🇨🇳Weihai, Shandong, China
Lingshi Country People's Hospital
🇨🇳Jinzhong, Shanxi, China
Shanxi Yuanping First People's Hospital
🇨🇳Yuanping, Shanxi, China
Yangcheng County People's Hospital
🇨🇳Jincheng, Shanxi, China