Clinical trial NCT01872520: Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
Official title: Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reaction
Keywords: the Injection of DanShenDuoFenSuanYan
Magnesium Lithospermate B
Safety
Real World Study
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Greenvalley Pharmaceutical Co., Ltd.
name: Peking University
First posted: 2013-06-07
Enrollment: 30180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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))

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of IDSDFSY induced adverse drug reaction
timeFrame: 3 years
measure: The rare adverse drug reactions to the IDSDFSY
timeFrame: 3 years
Secondary outcomes:
measure: The manifestation, treatment and outcomes of the ADRs
timeFrame: 3 years
measure: The risk factors of the ADRs
timeFrame: 3 years
measure: The patients' characteristics who are prescribed IDSDFSY
timeFrame: 3 years
measure: The prescribing pattern of IDSDFSY in real world clinical practice
timeFrame: 3 years
measure: Off-label use of IDSDFSY
timeFrame: 3 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
city: Beijing
country: China
facility: The Military General Hospital of Beijing PLA
state: Beijing
city: Beijing
country: China
facility: The General Hospital of People's Liberation Army(301 hospital)
state: Beijing
city: Qinhuangdao
country: China
facility: First Hospital Of Qinhuangdao
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Wuhan
country: China
facility: Wuhan Hospital of Traditional Chinese Medicine
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Integrated TCM and Western Medicine Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Hospital of TCM
state: Hubei
city: Zhangjiagang
country: China
facility: Zhangjiagang Hospital Of Traditional Chinese Medicine
state: Jiangsu
city: Weinan
country: China
facility: Weinan Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Province Hospital of Traditional Chinese Medicine
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Yan'an
country: China
facility: Yanan University Affiliated Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Huangpu District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Minhang District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital Of Qingpu District, Shanghai
state: Shanghai
city: Chengdu
country: China
facility: Sichuan 2nd Hospital Of TCM
state: Sichuan
city: Chengdu
country: China
facility: Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
state: Sichuan
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University
state: Sichuan
city: Chengdu
country: China
facility: AVIC 363 Hospital
state: Sichuan
city: Hejiang
country: China
facility: China S.C.H.J. Hospital Of TCM
state: Sichuan
city: Shihezi
country: China
facility: The First Affiliated Hospital of the Medical College, Shihezi University
state: Xinjiang
city: Urumqi
country: China
facility: The Fifth Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Urumqi
country: China
facility: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Urumqi
country: China
facility: Chest Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Peking University Third Hospital
name: Suodi ZHAI, B.S.
role: STUDY_CHAIR
References:
citation: Yan YY, Yang YH, Wang WW, Pan YT, Zhan SY, Sun MY, Zhang H, Zhai SD. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study. PLoS One. 2017 Jan 26;12(1):e0170182. doi: 10.1371/journal.pone.0170182. eCollection 2017.