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Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

Study Purpose

This registry aims to monitor the safety of Breviscapine Powder-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
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients who use Breviscapine Powder-Injection in the monitoring departments of centain 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.

NCT02559960
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.Xin-zhi Wang
Principal Investigator Affiliation China Academy of Chinese Medical SciencesThe First Hospital of Henan College 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 Reaction, Chinese Medicine, Anaphylactic Reaction
Additional Details

Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

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

Kunming, Yunnan, China

Status

Recruiting

Address

First Affilicated Hospital of Kunming Medical University

Kunming, Yunnan, 650032

Site Contact

Ying-lei Miu, M.D.

zhonw@vip.sina.com

The Red Cross Hosptal of Yunnan, Kunming, Yunnan, China

Status

Recruiting

Address

The Red Cross Hosptal of Yunnan

Kunming, Yunnan, 650021

Site Contact

Cheng-guo Dai

zhonw@vip.sina.com

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, Tianjin, 300052

Site Contact

Zheng-xiang Li

zhonw@vip.sina.com

Changzheng Hospital of Tianjin City, Tianjin, Tianjin, China

Status

Recruiting

Address

Changzheng Hospital of Tianjin City

Tianjin, Tianjin, 300021

Site Contact

Xin-jian Yang

zhonw@vip.sina.com

Taiyuan, Shanxi, China

Status

Recruiting

Address

Shanxi Provincial Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, 030012

Site Contact

Yao-fei Song

zhonw@vip.sina.com

Zaozhuang, Shandong, China

Status

Recruiting

Address

Shandong Energy Zaozhuang Mining Group Center Hospital

Zaozhuang, Shandong, 277800

Site Contact

Si-jian Wang

zhonw@vip.sina.com

Zaozhuang Hospital of T.C.M, Zaozhuang, Shandong, China

Status

Recruiting

Address

Zaozhuang Hospital of T.C.M

Zaozhuang, Shandong, 277000

Site Contact

Wen-jie Zhou

zhonw@vip.sina.com

Zhengzhou, Henan, China

Status

Recruiting

Address

The First Hospital of Henan College of Traditional Chinese Medicine

Zhengzhou, Henan, 451199

Site Contact

Xin-zhi Wang

zhonw@vip.sina.com

Zhengzhou Second Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Zhengzhou Second Hospital

Zhengzhou, Henan, 450015

Site Contact

Jian-ping Wang

zhonw@vip.sina.com

Zhengzhou, Henan, China

Status

Recruiting

Address

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014

Site Contact

Xian-ying Yin

zhonw@vip.sina.com

People's Hospital of Changge City, Xuchang, Henan, China

Status

Recruiting

Address

People's Hospital of Changge City

Xuchang, Henan, 461599

Site Contact

Wan-ping Zhang

zhonw@vip.sina.com

People's Hospital of Jun County, Hebi, Henan, China

Status

Recruiting

Address

People's Hospital of Jun County

Hebi, Henan, 456250

Site Contact

Bei-hai Jiang

zhonw@vip.sina.com

Mudanjiang City Second People's Hospital, Mudanjiang, Heilongjiang, China

Status

Recruiting

Address

Mudanjiang City Second People's Hospital

Mudanjiang, Heilongjiang, 157013

Site Contact

Xiu-hua Fu

zhonw@vip.sina.com

Chongqing, Chongqing, China

Status

Recruiting

Address

The People's Hospital of Zuanjiang District, Chongqing City

Chongqing, Chongqing, 401420

Site Contact

Yi Dai

zhonw@vip.sina.com

Chongqing, Chongqing, China

Status

Recruiting

Address

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing, 400010

Site Contact

Yan Qian

zhonw@vip.sina.com

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.