Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
|ClinicalTrials.gov Identifier: NCT01872520|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 27, 2015
|Condition or disease|
|Adverse Drug Reaction|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||30180 participants|
|Target Follow-Up Duration:||2 Weeks|
|Official Title:||Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan
- The incidence of IDSDFSY induced adverse drug reaction [ Time Frame: 3 years ]
- The rare adverse drug reactions to the IDSDFSY [ Time Frame: 3 years ]
- The manifestation, treatment and outcomes of the ADRs [ Time Frame: 3 years ]To describe manifestation, treatment and outcomes of the ADRs.
- The risk factors of the ADRs [ Time Frame: 3 years ]To examine the risk factors of the ADRs.
- The patients' characteristics who are prescribed IDSDFSY [ Time Frame: 3 years ]To describe the patients' characteristics who are prescribed IDSDFSY.
- The prescribing pattern of IDSDFSY in real world clinical practice [ Time Frame: 3 years ]To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
- Off-label use of IDSDFSY [ Time Frame: 3 years ]To describe and evaluate the off-label use of IDSDFSY.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872520
Show 36 Study Locations
|Study Chair:||Suodi ZHAI, B.S.||Peking University Third Hospital|