- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872520
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Anhui
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Bengbu, Anhui, China, 233004
- The First Affiliated Hospital of Bengbu Medical College
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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Beijing, Beijing, China, 100053
- Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
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Beijing, Beijing, China, 100700
- The Military General Hospital of Beijing PLA
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Beijing, Beijing, China, 100853
- The General Hospital of People's Liberation Army(301 hospital)
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Hebei
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Qinhuangdao, Hebei, China, 66000
- First Hospital of Qinhuangdao
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Shijiazhuang, Hebei, China, 050000
- The Second Hospital of Hebei Medical University
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Shijiazhuang, Hebei, China, 50051
- Hebei General Hospital
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Asia Heart Hospital
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Wuhan, Hubei, China, 430014
- Wuhan Hospital of Traditional Chinese Medicine
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Wuhan, Hubei, China, 430022
- Wuhan integrated TCM and western medicine hospital
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Wuhan, Hubei, China, 430061
- Hubei Provincial Hospital of TCM
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Jiangsu
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Zhangjiagang, Jiangsu, China, 215600
- Zhangjiagang Hospital Of Traditional Chinese Medicine
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Shaanxi
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Weinan, Shaanxi, China
- weinan Central Hospital
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Xi'an, Shaanxi, China, 710068
- Shaanxi Provincial People's Hospital
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Xi'an, Shaanxi, China, 710000
- Tangdu Hospital
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Xi'an, Shaanxi, China, 710000
- Xijing Hospital
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Xi'an, Shaanxi, China, 710003
- Shaanxi Province Hospital of Traditional Chinese Medicine
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Yan'an, Shaanxi, China, 716000
- Yanan University Affiliated Hospital
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Shanghai
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Shanghai, Shanghai, China, 200002
- Shanghai Huangpu District Central Hospital
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Shanghai, Shanghai, China, 200021
- Shuguang Hospital Shanghai University of Traditional Chinese Medicine
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Shanghai, Shanghai, China, 200031
- Huashan Hospital Fudan University
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Shanghai, Shanghai, China, 200032
- LONGHUA Hospital Shanghai University of TCM
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Shanghai, Shanghai, China, 201100
- Minhang District Central Hospital
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Shanghai, Shanghai, China, 201700
- Central Hospital Of Qingpu District, Shanghai
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Sichuan
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Chengdu, Sichuan, China, 610031
- Sichuan 2nd Hospital Of TCM
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Chengdu, Sichuan, China, 610041
- Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
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Chengdu, Sichuan, China, 610081
- Affiliated Hospital of Chengdu University
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Chengdu, Sichuan, China
- Avic 363 Hospital
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Hejiang, Sichuan, China, 646200
- China S.C.H.J. Hospital Of TCM
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Xinjiang
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Shihezi, Xinjiang, China, 832008
- The First Affiliated Hospital of the Medical College, Shihezi University
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Urumqi, Xinjiang, China, 830054
- The First Affiliated Hospital of Xinjiang Medical University
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Urumqi, Xinjiang, China, 830000
- The Fifth Affiliated Hospital of Xinjiang Medical University
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Urumqi, Xinjiang, China, 830000
- Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region
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Urumqi, Xinjiang, China, 830001
- People's Hospital of Xinjiang Uygur Autonomous Region
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Urumqi, Xinjiang, China, 830049
- Chest Hospital of Xinjiang Uygur Autonomous Region
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of IDSDFSY induced adverse drug reaction
Time Frame: 3 years
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3 years
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The rare adverse drug reactions to the IDSDFSY
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The manifestation, treatment and outcomes of the ADRs
Time Frame: 3 years
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To describe manifestation, treatment and outcomes of the ADRs.
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3 years
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The risk factors of the ADRs
Time Frame: 3 years
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To examine the risk factors of the ADRs.
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3 years
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The patients' characteristics who are prescribed IDSDFSY
Time Frame: 3 years
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To describe the patients' characteristics who are prescribed IDSDFSY.
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3 years
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The prescribing pattern of IDSDFSY in real world clinical practice
Time Frame: 3 years
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To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
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3 years
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Off-label use of IDSDFSY
Time Frame: 3 years
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To describe and evaluate the off-label use of IDSDFSY.
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Suodi ZHAI, B.S., Peking University Third Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUTH-Pharmacy-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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