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Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences Identifier:
First received: June 3, 2012
Last updated: June 7, 2012
Last verified: June 2012

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Ischemic Stroke
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China

Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Number of participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction. [ Time Frame: The registry procedure will last 3 years only for patients using Dengzhanxixin ]
    All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin.

Estimated Enrollment: 30000
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.

Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals

Data will be collected in three aspects by three different forms as following:

Form A (green): demographic information ;Form B (pink): adverse drug events/reaction; Form C (white): extracted information from hospital information system and laboratory information system Form


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 30 hospitals

Inclusion Criteria:

  • Patients using Dengzhanxixin injection from 2012 to 2014

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01612585

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Guangdong Provincial Hospital of Traditional Chinese Medicine
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  More Information

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences Identifier: NCT01612585     History of Changes
Other Study ID Numbers: RSCMI-Ⅴ
Study First Received: June 3, 2012
Last Updated: June 7, 2012

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases processed this record on May 24, 2017