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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01612611
Other study ID # RSCMI-?
Secondary ID
Status Unknown status
Phase N/A
First received June 3, 2012
Last updated June 5, 2012
Start date January 2012
Est. completion date December 2015

Study information

Verified date June 2012
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 30000
Est. completion date December 2015
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Locations

Country Name City State
China Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
China Academy of Chinese Medical Sciences First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

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