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NCT01872520 Clinical Trial

Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study

Adverse Drug Reaction Clinical Trial

Official title:
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01872520
Other study ID # PekingUTH-Pharmacy-001
Secondary ID
Status Completed
Phase N/A
First received April 13, 2013
Last updated October 26, 2015
Start date June 2012
Est. completion date September 2015

Study information
Verified date October 2015
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority China: State Administration of Traditional Chinese Medicine of the People's Republic of China
Study type Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 30180
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences Beijing Beijing
China Peking university third hospital Beijing Beijing
China The General Hospital of People's Liberation Army(301 hospital) Beijing Beijing
China The Military General Hospital of Beijing PLA Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China Affiliated Hospital of Chengdu University Chengdu Sichuan
China AVIC 363 Hospital Chengdu Sichuan
China Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.) Chengdu Sichuan
China Sichuan 2nd Hospital Of TCM Chengdu Sichuan
China China S.C.H.J. Hospital Of TCM Hejiang Sichuan
China First Hospital Of Qinhuangdao Qinhuangdao Hebei
China Central Hospital Of Qingpu District, Shanghai Shanghai Shanghai
China Huashan Hospital Fudan University Shanghai Shanghai
China Longhua Hospital Shanghai University of TCM Shanghai Shanghai
China Minhang District Central Hospital Shanghai Shanghai
China Shanghai Huangpu District Central Hospital Shanghai Shanghai
China Shuguang Hospital Shanghai University of Traditional Chinese Medicine Shanghai Shanghai
China The First Affiliated Hospital of the Medical College, Shihezi University Shihezi Xinjiang
China Hebei General Hospital Shijiazhuang Hebei
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China Chest Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang
China People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang
China The Fifth Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang
China Weinan Central Hospital Weinan Shaanxi
China Hubei Provincial Hospital of TCM Wuhan Hubei
China Wuhan Asia Heart Hospital Wuhan Hubei
China Wuhan Hospital of Traditional Chinese Medicine Wuhan Hubei
China Wuhan Integrated TCM and Western Medicine Hospital Wuhan Hubei
China Shaanxi Province Hospital of Traditional Chinese Medicine Xi'an Shaanxi
China Shaanxi Provincial People's Hospital Xi'an Shaanxi
China Tangdu Hospital Xi'an Shaanxi
China Xijing hospital Xi'an Shaanxi
China Yanan University Affiliated Hospital Yan'an Shaanxi
China Zhangjiagang Hospital Of Traditional Chinese Medicine Zhangjiagang Jiangsu

Sponsors (3)
Lead Sponsor Collaborator
Peking University Third Hospital Peking University, Shanghai Greenvalley Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of IDSDFSY induced adverse drug reaction 3 years Yes
Primary The rare adverse drug reactions to the IDSDFSY 3 years Yes
Secondary The manifestation, treatment and outcomes of the ADRs To describe manifestation, treatment and outcomes of the ADRs. 3 years Yes
Secondary The risk factors of the ADRs To examine the risk factors of the ADRs. 3 years Yes
Secondary The patients' characteristics who are prescribed IDSDFSY To describe the patients' characteristics who are prescribed IDSDFSY. 3 years Yes
Secondary The prescribing pattern of IDSDFSY in real world clinical practice To characterize the prescribing pattern of IDSDFSY in real world clinical practice. 3 years Yes
Secondary Off-label use of IDSDFSY To describe and evaluate the off-label use of IDSDFSY. 3 years Yes
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