Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study

Adverse Drug Event Clinical Trial

Official title:

Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640884
• Other study ID #: Xueshuantong--V2.0
• Status: Recruiting
• Start date: February 18, 2019
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: China Academy of Chinese Medical Sciences
• Contact: Zhong Wang, M.D.
• Phone: 8610-64093140
• Email: zhonw[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Adverse Drug Event
• Adverse Drug Reactions
• Anaphylactic Reaction
• Anaphylaxis
• Drug-Related Side Effects and Adverse Reactions
• Severe Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
China	Chinse Medical Hospital of Yangxin County	Binzhou	Shandong
China	Central Hospital of Wafangdian City	Dalian	Liaoning
China	Jizhou City Hospital	Hengshui	Hebei
China	Yangcheng County People's Hospital	Jincheng	Shanxi
China	Lingshi Country People's Hospital	Jinzhong	Shanxi
China	Donghai Country People's Hospital	Lianyungang	Jiangsu
China	Lingyuan City Central Hospital	Lingyuan	Liaoning
China	Tongbai County People's Hospital	Nanyang	Henan
China	Lingbao 3th People's Hospital	Sanmenxia	Henan
China	Weihai Wendeng District People's Hospital	Weihai	Shandong
China	Dongxihu District People's Hospital	Wuhan	Hubei
China	People's Hospital of Yichun City	Yichun	Jiangxi
China	Shanxi Yuanping First People's Hospital	Yuanping	Shanxi
China	People's Hospital of Dancheng County	Zhoukou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhong Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection		2 years
Secondary	The incidence of adverse events (AE)of Xueshuantong-Injection		2 years
Secondary	The incidence of serious adverse events (SAE)of Xueshuantong-Injection		2 years
Secondary	The incidence of anaphylactic reaction of Xueshuantong-Injection		2 years
Secondary	The incidence of new ADRs of Xueshuantong-Injection		2 years
Secondary	The effective rate of Xueshuantong-Injection	The proportion of the patients whose drug effect is considered as "effective" by investigator	2 years