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

NCT ID: NCT03640884

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Adverse Drug Event Adverse Drug Reactions Anaphylactic Reaction Severe Adverse Reactions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Xueshuantong-Injection

Intervention Type DRUG

Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.

Interventions

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Xueshuantong-Injection

Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.

Intervention Type DRUG

Other Intervention Names

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Chenzhong

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhong Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhong Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhong Wang, M.D.

Role: STUDY_DIRECTOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Jinmin Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine

Locations

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Jizhou City Hospital

Hengshui, Hebei, China

Site Status RECRUITING

Tongbai County People's Hospital

Nanyang, Henan, China

Site Status RECRUITING

Lingbao 3th People's Hospital

Sanmenxia, Henan, China

Site Status RECRUITING

People's Hospital of Dancheng County

Zhoukou, Henan, China

Site Status RECRUITING

Dongxihu District People's Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Donghai Country People's Hospital

Lianyungang, Jiangsu, China

Site Status RECRUITING

People's Hospital of Yichun City

Yichun, Jiangxi, China

Site Status RECRUITING

Central Hospital of Wafangdian City

Dalian, Liaoning, China

Site Status RECRUITING

Lingyuan City Central Hospital

Lingyuan, Liaoning, China

Site Status RECRUITING

Chinse Medical Hospital of Yangxin County

Binzhou, Shandong, China

Site Status RECRUITING

Weihai Wendeng District People's Hospital

Weihai, Shandong, China

Site Status RECRUITING

Yangcheng County People's Hospital

Jincheng, Shanxi, China

Site Status RECRUITING

Lingshi Country People's Hospital

Jinzhong, Shanxi, China

Site Status RECRUITING

Shanxi Yuanping First People's Hospital

Yuanping, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhong Wang, M.D.

Role: CONTACT

8610-64093140

Yanan Yu, M.D.

Role: CONTACT

8610-64093140

Facility Contacts

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Zhuci Li

Role: primary

86-13785829166

Yuqian Liu

Role: primary

86-13849716243

Wenhui Li

Role: primary

86-13569601991

Yuwang Yang

Role: primary

86-13333943936

Hanqiao Wang

Role: primary

86-13707141018

Liangliang Xia

Role: primary

86-15961321388

Huilin Leng

Role: primary

‭86-13870538072‬

Qiang Zhao

Role: primary

86-15542661833

Shuying Bai

Role: primary

86-13842101618

Bingyi Qin

Role: primary

86-15206898878

Jinguo Zhao

Role: primary

86-13561852177

Wangtai Cheng

Role: primary

86-13934060268

Xiaoqin Wu

Role: primary

86-13834185284

Yutian Zhang

Role: primary

86-13994126666

Other Identifiers

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Xueshuantong--V2.0

Identifier Type: -

Identifier Source: org_study_id

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