Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study

Peking University

Status: Completed

Conditions: Adverse Drug Reaction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01872520

PekingUTH-Pharmacy-001

Details and patient eligibility

About

Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.

Full description

As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions.

In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection.

This real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.

Enrollment: 30,180 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)).

Exclusion criteria

• none

Trial design

30,180 participants in 1 patient group

the Injection of DanShenDuoFenSuanYan

Description:

Patient who use the Injection of DanShenDuoFenSuanYan