Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
- Conditions
- Adverse Drug Reaction
- Registration Number
- NCT01872520
- Lead Sponsor
- Peking University Third Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30180
- 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)).
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rare adverse drug reactions to the IDSDFSY 3 years The incidence of IDSDFSY induced adverse drug reaction 3 years
- Secondary Outcome Measures
Name Time Method The patients' characteristics who are prescribed IDSDFSY 3 years To describe the patients' characteristics who are prescribed IDSDFSY.
Off-label use of IDSDFSY 3 years To describe and evaluate the off-label use of IDSDFSY.
The manifestation, treatment and outcomes of the ADRs 3 years To describe manifestation, treatment and outcomes of the ADRs.
The risk factors of the ADRs 3 years To examine the risk factors of the ADRs.
The prescribing pattern of IDSDFSY in real world clinical practice 3 years To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
Trial Locations
- Locations (36)
First Hospital Of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
The Military General Hospital of Beijing PLA
🇨🇳Beijing, Beijing, China
China S.C.H.J. Hospital Of TCM
🇨🇳Hejiang, Sichuan, China
Minhang District Central Hospital
🇨🇳Shanghai, Shanghai, China
Longhua Hospital Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China
Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Peking university third hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The General Hospital of People's Liberation Army(301 hospital)
🇨🇳Beijing, Beijing, 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
Hubei Provincial Hospital of TCM
🇨🇳Wuhan, Hubei, China
Wuhan Integrated TCM and Western Medicine Hospital
🇨🇳Wuhan, Hubei, China
Weinan Central Hospital
🇨🇳Weinan, Shaanxi, China
Shaanxi Province Hospital of Traditional Chinese Medicine
🇨🇳Xi'an, Shaanxi, China
Zhangjiagang Hospital Of Traditional Chinese Medicine
🇨🇳Zhangjiagang, Jiangsu, China
Xijing hospital
🇨🇳Xi'an, Shaanxi, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Shanghai Huangpu District Central Hospital
🇨🇳Shanghai, Shanghai, China
Yanan University Affiliated Hospital
🇨🇳Yan'an, Shaanxi, China
Shuguang Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Central Hospital Of Qingpu District, Shanghai
🇨🇳Shanghai, Shanghai, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Sichuan 2nd Hospital Of TCM
🇨🇳Chengdu, Sichuan, China
Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
🇨🇳Chengdu, Sichuan, China
Affiliated Hospital of Chengdu University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of the Medical College, Shihezi University
🇨🇳Shihezi, Xinjiang, China
AVIC 363 Hospital
🇨🇳Chengdu, Sichuan, China
The Fifth Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Chest Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China