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

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Shock; Coronary Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01612611

RSCMI-Ⅵ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

30,000 participants in 1 patient group

a cohort using Shenmai injection