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

July 4, 2021 updated by: Zhong Wang
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Hengshui, Hebei, China, 053200
        • Recruiting
        • Jizhou City Hospital
        • Contact:
          • Zhuci Li
          • Phone Number: 86-13785829166
        • Principal Investigator:
          • Zhuci Li
    • Henan
      • Nanyang, Henan, China, 474750
        • Recruiting
        • Tongbai County People's Hospital
        • Contact:
          • Yuqian Liu
          • Phone Number: 86-13849716243
        • Principal Investigator:
          • Yuqian Liu
      • Sanmenxia, Henan, China, 472500
        • Recruiting
        • Lingbao 3th People's Hospital
        • Contact:
          • Wenhui Li
          • Phone Number: 86-13569601991
        • Principal Investigator:
          • Wenhui Li
      • Zhoukou, Henan, China, 477150
        • Recruiting
        • People's Hospital of Dancheng County
        • Contact:
          • Yuwang Yang
          • Phone Number: 86-13333943936
        • Principal Investigator:
          • Yuwang Yang
    • Hubei
      • Wuhan, Hubei, China, 430040
        • Recruiting
        • Dongxihu District People's Hospital
        • Contact:
          • Hanqiao Wang
          • Phone Number: 86-13707141018
        • Principal Investigator:
          • Hanqiao Wang
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222300
        • Recruiting
        • Donghai Country People's Hospital
        • Contact:
          • Liangliang Xia
          • Phone Number: 86-15961321388
        • Principal Investigator:
          • Liangliang Xia
    • Jiangxi
      • Yichun, Jiangxi, China, 362201
        • Recruiting
        • People's Hospital of Yichun City
        • Contact:
          • Huilin Leng
          • Phone Number: ‭86-13870538072‬
        • Principal Investigator:
          • Huilin Leng
    • Liaoning
      • Dalian, Liaoning, China, 116300
        • Recruiting
        • Central Hospital of Wafangdian City
        • Principal Investigator:
          • Qiang Zhao
        • Contact:
      • Lingyuan, Liaoning, China, 222500
        • Recruiting
        • Lingyuan City Central Hospital
        • Contact:
          • Shuying Bai
          • Phone Number: 86-13842101618
        • Principal Investigator:
          • Shuying Bai
    • Shandong
      • Binzhou, Shandong, China, 251800
        • Recruiting
        • Chinse Medical Hospital of Yangxin County
        • Contact:
          • Bingyi Qin
          • Phone Number: 86-15206898878
        • Principal Investigator:
          • Bingyi Qin
      • Weihai, Shandong, China, 264422
        • Recruiting
        • Weihai Wendeng District People's Hospital
        • Contact:
          • Jinguo Zhao
          • Phone Number: 86-13561852177
        • Principal Investigator:
          • Jinguo Zhao
    • Shanxi
      • Jincheng, Shanxi, China, 048100
        • Recruiting
        • Yangcheng County People's Hospital
        • Contact:
          • Wangtai Cheng
          • Phone Number: 86-13934060268
        • Principal Investigator:
          • Wangtai Cheng
      • Jinzhong, Shanxi, China, 031300
        • Recruiting
        • Lingshi Country People's Hospital
        • Contact:
          • Xiaoqin Wu
          • Phone Number: 86-13834185284
        • Principal Investigator:
          • Xiaoqin Wu
      • Yuanping, Shanxi, China, 034100
        • Recruiting
        • Shanxi Yuanping First People's Hospital
        • Contact:
          • Yutian Zhang
          • Phone Number: 86-13994126666
        • Principal Investigator:
          • Yutian Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Chenzhong

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection
Time Frame: 2 years
2 years
The incidence of adverse events （AE）of Xueshuantong-Injection
Time Frame: 2 years
2 years
The incidence of serious adverse events （SAE）of Xueshuantong-Injection
Time Frame: 2 years
2 years
The incidence of anaphylactic reaction of Xueshuantong-Injection
Time Frame: 2 years
2 years
The incidence of new ADRs of Xueshuantong-Injection
Time Frame: 2 years
2 years
The effective rate of Xueshuantong-Injection
Time Frame: 2 years
The proportion of the patients whose drug effect is considered as "effective" by investigator
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhong Wang

Investigators

  • Principal Investigator: Jinmin Liu, M.D., Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 19, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xueshuantong--V2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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