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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01612585
First received: June 3, 2012
Last updated: June 7, 2012
Last verified: June 2012
  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'.

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.


Condition
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

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 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 ] [ Designated as safety issue: Yes ]
    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

  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 30 hospitals

Criteria

Inclusion Criteria:

  • Patients using Dengzhanxixin injection from 2012 to 2014

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612585

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Guangdong Provincial Hospital of Traditional 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: NCT01612585     History of Changes
Other Study ID Numbers: RSCMI-Ⅴ, RSCMI-Ⅴ
Study First Received: June 3, 2012
Last Updated: June 7, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Stroke
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 20, 2014