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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03640884
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zhong Wang
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhong Wang, M.D.Jinmin Liu, M.D.
Principal Investigator Affiliation Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical SciencesDongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adverse Drug Event, Adverse Drug Reactions, Anaphylactic Reaction, Severe Adverse Reactions
Additional Details

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.

Arms & Interventions

Arms

: 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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Jizhou City Hospital, Hengshui, Hebei, China

Status

Recruiting

Address

Jizhou City Hospital

Hengshui, Hebei, 053200

Site Contact

Zhuci Li

zhonw@vip.sina.com

86-13785829166

Tongbai County People's Hospital, Nanyang, Henan, China

Status

Recruiting

Address

Tongbai County People's Hospital

Nanyang, Henan, 474750

Site Contact

Yuqian Liu

zhonw@vip.sina.com

86-13849716243

Lingbao 3th People's Hospital, Sanmenxia, Henan, China

Status

Recruiting

Address

Lingbao 3th People's Hospital

Sanmenxia, Henan, 472500

Site Contact

Wenhui Li

zhonw@vip.sina.com

86-13569601991

People's Hospital of Dancheng County, Zhoukou, Henan, China

Status

Recruiting

Address

People's Hospital of Dancheng County

Zhoukou, Henan, 477150

Site Contact

Yuwang Yang

zhonw@vip.sina.com

86-13333943936

Dongxihu District People's Hospital, Wuhan, Hubei, China

Status

Recruiting

Address

Dongxihu District People's Hospital

Wuhan, Hubei, 430040

Site Contact

Hanqiao Wang

zhonw@vip.sina.com

86-13707141018

Donghai Country People's Hospital, Lianyungang, Jiangsu, China

Status

Recruiting

Address

Donghai Country People's Hospital

Lianyungang, Jiangsu, 222300

Site Contact

Liangliang Xia

zhonw@vip.sina.com

86-15961321388

People's Hospital of Yichun City, Yichun, Jiangxi, China

Status

Recruiting

Address

People's Hospital of Yichun City

Yichun, Jiangxi, 362201

Site Contact

Huilin Leng

zhonw@vip.sina.com

‭86-13870538072‬

Central Hospital of Wafangdian City, Dalian, Liaoning, China

Status

Recruiting

Address

Central Hospital of Wafangdian City

Dalian, Liaoning, 116300

Site Contact

Qiang Zhao

ywk85603813@163.com

86-15542661833

Lingyuan City Central Hospital, Lingyuan, Liaoning, China

Status

Recruiting

Address

Lingyuan City Central Hospital

Lingyuan, Liaoning, 222500

Site Contact

Shuying Bai

zhonw@vip.sina.com

86-13842101618

Binzhou, Shandong, China

Status

Recruiting

Address

Chinse Medical Hospital of Yangxin County

Binzhou, Shandong, 251800

Site Contact

Bingyi Qin

zhonw@vip.sina.com

86-15206898878

Weihai, Shandong, China

Status

Recruiting

Address

Weihai Wendeng District People's Hospital

Weihai, Shandong, 264422

Site Contact

Jinguo Zhao

zhonw@vip.sina.com

86-13561852177

Yangcheng County People's Hospital, Jincheng, Shanxi, China

Status

Recruiting

Address

Yangcheng County People's Hospital

Jincheng, Shanxi, 048100

Site Contact

Wangtai Cheng

zhonw@vip.sina.com

86-13934060268

Lingshi Country People's Hospital, Jinzhong, Shanxi, China

Status

Recruiting

Address

Lingshi Country People's Hospital

Jinzhong, Shanxi, 031300

Site Contact

Xiaoqin Wu

zhonw@vip.sina.com

86-13834185284

Shanxi Yuanping First People's Hospital, Yuanping, Shanxi, China

Status

Recruiting

Address

Shanxi Yuanping First People's Hospital

Yuanping, Shanxi, 034100

Site Contact

Yutian Zhang

zhonw@vip.sina.com

86-13994126666

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