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

Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01872520

Enrollment

30180

Registered

2013-06-07

Start date

2012-06-30

Completion date

2015-09-30

Last updated

2015-10-27

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

Conditions

Adverse Drug Reaction

Keywords

the Injection of DanShenDuoFenSuanYan, Magnesium Lithospermate B, Safety, Real World Study

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
The incidence of IDSDFSY induced adverse drug reaction	3 years
The rare adverse drug reactions to the IDSDFSY	3 years

Secondary

Measure	Time frame	Description
The patients' characteristics who are prescribed IDSDFSY	3 years	To describe the patients' characteristics who are prescribed IDSDFSY.
The manifestation, treatment and outcomes of the ADRs	3 years	To describe manifestation, treatment and outcomes of the ADRs.
Off-label use of IDSDFSY	3 years	To describe and evaluate the off-label use of IDSDFSY.
The prescribing pattern of IDSDFSY in real world clinical practice	3 years	To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
The risk factors of the ADRs	3 years	To examine the risk factors of the ADRs.

Countries

China

Outcome results