Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01612533
First received: June 3, 2012
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  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'.

Shenfu is kind of Chinese Medicine injection used for treating shock 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 20,000 patients.


Condition
Shock
Coronary Heart Disease

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of participants with adverse events; incidence of Shenfu'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 Shenfu. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20000
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:

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Shenfu injection in selected hospitals.

  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 20000. Patients using Shenmai injection from 2012 to 2014 in 15 hospitals.

Criteria

Inclusion Criteria:

  • Patients using Shenfu injection from 2012 to 2014
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612533

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
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: NCT01612533     History of Changes
Other Study ID Numbers: RSCMI-IV
Study First Received: June 3, 2012
Last Updated: June 5, 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
Shock
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013