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Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): 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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Peking university third hospital
Beijing, Beijing Municipality, China
The Military General Hospital of Beijing PLA
Beijing, Beijing Municipality, China
The General Hospital of People's Liberation Army(301 hospital)
Beijing, Beijing Municipality, China
First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
Wuhan Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Start Date
June 1, 2012
Primary Completion Date
September 1, 2015
Completion Date
September 1, 2015
Last Updated
October 27, 2015
30,180
ACTUAL participants
Lead Sponsor
Peking University Third Hospital
Collaborators
NCT04154553
NCT00414115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06766071