Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
1 other identifier
observational
30,000
1 country
14
Brief Summary
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 7, 2021
July 1, 2021
2.8 years
August 17, 2018
July 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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 incidence of anaphylactic reaction of Xueshuantong-Injection
2 years
The incidence of new ADRs of Xueshuantong-Injection
2 years
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.
Eligibility Criteria
Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry
You may qualify if:
- Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhong Wanglead
Study Sites (14)
Jizhou City Hospital
Hengshui, Hebei, 053200, China
Tongbai County People's Hospital
Nanyang, Henan, 474750, China
Lingbao 3th People's Hospital
Sanmenxia, Henan, 472500, China
People's Hospital of Dancheng County
Zhoukou, Henan, 477150, China
Dongxihu District People's Hospital
Wuhan, Hubei, 430040, China
Donghai Country People's Hospital
Lianyungang, Jiangsu, 222300, China
People's Hospital of Yichun City
Yichun, Jiangxi, 362201, China
Central Hospital of Wafangdian City
Dalian, Liaoning, 116300, China
Lingyuan City Central Hospital
Lingyuan, Liaoning, 222500, China
Chinse Medical Hospital of Yangxin County
Binzhou, Shandong, 251800, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, 264422, China
Yangcheng County People's Hospital
Jincheng, Shanxi, 048100, China
Lingshi Country People's Hospital
Jinzhong, Shanxi, 031300, China
Shanxi Yuanping First People's Hospital
Yuanping, Shanxi, 034100, China
Biospecimen
Whole blood sample of the patient with severe adverse event
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhong Wang, M.D.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
- PRINCIPAL INVESTIGATOR
Jinmin Liu, M.D.
Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
February 18, 2019
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
July 7, 2021
Record last verified: 2021-07