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Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China (RSCMI-Ⅱ)

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
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences Identifier:
First received: June 3, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

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'.

Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris 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.

Coronary Heart Disease
Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study on Safety Surveillance of Kudiezi (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 Kudiezi'ADRs and identify factors that contributed to the occurrence of the adverse reaction [ Time Frame: to assess Kudiezi's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Kudiezi will be registered every day. The registry procedure will last 3 years only for patients using Kudiezi. ]
    All patients will be measured and assessed at the time Kudiezi is administered to them until they discharge. Patients using Kudiezi will be registered on a registration form including disease background, Kudiezi'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 Kudiezi.

Estimated Enrollment: 30000
Study Start Date: January 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 Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Kudiezi injection in selected hospitals

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

Form A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information


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 20 hospitals.

Inclusion Criteria:

  • Patients using Kudiezi injection from 2012 to 2014

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01612559

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Dongfang Hospital Affiliated to Beijing University of 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: NCT01612559     History of Changes
Other Study ID Numbers: RSCMI-Ⅱ
RSCMI-Ⅱ ( Registry Identifier: Registry study on Chinese Medicine Injection )
Study First Received: June 3, 2012
Last Updated: June 3, 2012

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 28, 2017