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

A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01612611

Enrollment

30000

Registered

2012-06-06

Start date

2012-01-31

Completion date

2015-12-31

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Shock

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Countries

China

Outcome results