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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01612611
First received: June 3, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.


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 Shenmai (a Chinese Medicine Injection) Used in China

Resource links provided by NLM:


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

Estimated Enrollment: 30000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Groups/Cohorts
a cohort using Shenmai injection

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 shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all inpatients used Shenmai injection in 30 selected hospitals in mainland China

Criteria

Inclusion Criteria:

  • all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

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: NCT01612611

Locations
China, Beijing
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100700
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Investigators
Principal Investigator: Yan M Xie 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: NCT01612611     History of Changes
Other Study ID Numbers: RSCMI-Ⅵ
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
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014