Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
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.
Adverse Drug Reaction
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- The adverse reaction rate to the Injection of DanShenDuoFenSuanYan [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- The rare adverse drug reactions to the Injection of DanShenDuoFenSuanYan [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872520
|Contact: Suodi ZHAIfirstname.lastname@example.org|
|Peking university third hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Suodi ZHAI, B.S. +8615611908515 email@example.com|
|Principal Investigator: Suodi ZHAI, B.S.|