Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
1 other identifier
observational
30,180
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 27, 2015
October 1, 2015
3.3 years
April 13, 2013
October 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The incidence of IDSDFSY induced adverse drug reaction
3 years
The rare adverse drug reactions to the IDSDFSY
3 years
Secondary Outcomes (5)
The manifestation, treatment and outcomes of the ADRs
3 years
The risk factors of the ADRs
3 years
The patients' characteristics who are prescribed IDSDFSY
3 years
The prescribing pattern of IDSDFSY in real world clinical practice
3 years
Off-label use of IDSDFSY
3 years
Study Arms (1)
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan
Eligibility 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))
You may qualify if:
- 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)).
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Third Hospitallead
- Shanghai Greenvalley Pharmaceutical Co., Ltd.collaborator
- Peking Universitycollaborator
Study Sites (36)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Peking university third hospital
Beijing, Beijing Municipality, 100191, China
The Military General Hospital of Beijing PLA
Beijing, Beijing Municipality, 100700, China
The General Hospital of People's Liberation Army(301 hospital)
Beijing, Beijing Municipality, 100853, China
First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, 66000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Hebei General Hospital
Shijiazhuang, Hebei, 50051, China
Wuhan Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430014, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Wuhan Integrated TCM and Western Medicine Hospital
Wuhan, Hubei, 430022, China
Hubei Provincial Hospital of TCM
Wuhan, Hubei, 430061, China
Zhangjiagang Hospital Of Traditional Chinese Medicine
Zhangjiagang, Jiangsu, 215600, China
Weinan Central Hospital
Weinan, Shaanxi, China
Tangdu Hospital
Xi'an, Shaanxi, 710000, China
Xijing hospital
Xi'an, Shaanxi, 710000, China
Shaanxi Province Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710003, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Yanan University Affiliated Hospital
Yan’an, Shaanxi, 716000, China
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, 200002, China
Shuguang Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200021, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200031, China
Longhua Hospital Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032, China
Minhang District Central Hospital
Shanghai, Shanghai Municipality, 201100, China
Central Hospital Of Qingpu District, Shanghai
Shanghai, Shanghai Municipality, 201700, China
Sichuan 2nd Hospital Of TCM
Chengdu, Sichuan, 610031, China
Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
Chengdu, Sichuan, 610041, China
Affiliated Hospital of Chengdu University
Chengdu, Sichuan, 610081, China
AVIC 363 Hospital
Chengdu, Sichuan, China
China S.C.H.J. Hospital Of TCM
Hejiang, Sichuan, 646200, China
The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, 832008, China
The Fifth Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
Chest Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830049, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Related Publications (1)
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.
PMID: 28125608DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Suodi ZHAI, B.S.
Peking University Third Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital
Study Record Dates
First Submitted
April 13, 2013
First Posted
June 7, 2013
Study Start
June 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 27, 2015
Record last verified: 2015-10