An observational study in Adverse Drug Event, Adverse Drug Reactions and Anaphylactic Reaction, sponsored by Zhong Wang. Status unknown at 14 sites in China. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Zhong Wang · Observational
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
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.
88 studies on the registry are indexed under Anaphylaxis; 16 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 147 across 45 observational studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Zhong Wang is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry
Exclusion Criteria:
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.
Drug: Xueshuantong-Injection
Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.
Also known as: Chenzhong
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
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.
Time frame: 2 years
The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection
Time frame: 2 years
The incidence of adverse events （AE）of Xueshuantong-Injection
Time frame: 2 years
The incidence of serious adverse events （SAE）of Xueshuantong-Injection
Time frame: 2 years
The incidence of anaphylactic reaction of Xueshuantong-Injection
Time frame: 2 years
The incidence of new ADRs of Xueshuantong-Injection
Time frame: 2 years
The effective rate of Xueshuantong-Injection
The proportion of the patients whose drug effect is considered as "effective" by investigator
Time frame: 2 years
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Zhong Wang