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

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Coronary Heart Disease

Treatments: Other: a cohort using Dazhuhongjingtian injection

Study type: Observational

Funder types: Other

Identifiers

NCT03189199

RSCMI-12

Details and patient eligibility

About

The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian 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 few be found now.A registry study for Dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from June.2017 to Dec.2019.Eligibility criteria Patients who will use Dazhuhongjingtian injection in 4 selected hospitals from2017-2019.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 1+ hour old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals

Exclusion criteria

none