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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01612559
First received: June 3, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition
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

Resource links provided by NLM:


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. ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Patients using Kudiezi injection from 2012 to 2014

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612559

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Investigators
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01612559     History of Changes
Other Study ID Numbers: RSCMI-Ⅱ, RSCMI-Ⅱ
Study First Received: June 3, 2012
Last Updated: June 3, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014