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

October 26, 2015 updated by: Suodi ZHAI, Peking University Third Hospital

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

30180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100053
        • Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
      • Beijing, Beijing, China, 100700
        • The Military General Hospital of Beijing PLA
      • Beijing, Beijing, China, 100853
        • The General Hospital of People's Liberation Army(301 hospital)
    • Hebei
      • Qinhuangdao, Hebei, China, 66000
        • First Hospital of Qinhuangdao
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 50051
        • Hebei General Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Asia Heart Hospital
      • Wuhan, Hubei, China, 430014
        • Wuhan Hospital of Traditional Chinese Medicine
      • Wuhan, Hubei, China, 430022
        • Wuhan integrated TCM and western medicine hospital
      • Wuhan, Hubei, China, 430061
        • Hubei Provincial Hospital of TCM
    • Jiangsu
      • Zhangjiagang, Jiangsu, China, 215600
        • Zhangjiagang Hospital Of Traditional Chinese Medicine
    • Shaanxi
      • Weinan, Shaanxi, China
        • weinan Central Hospital
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710000
        • Tangdu Hospital
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital
      • Xi'an, Shaanxi, China, 710003
        • Shaanxi Province Hospital of Traditional Chinese Medicine
      • Yan'an, Shaanxi, China, 716000
        • Yanan University Affiliated Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200002
        • Shanghai Huangpu District Central Hospital
      • Shanghai, Shanghai, China, 200021
        • Shuguang Hospital Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200031
        • Huashan Hospital Fudan University
      • Shanghai, Shanghai, China, 200032
        • LONGHUA Hospital Shanghai University of TCM
      • Shanghai, Shanghai, China, 201100
        • Minhang District Central Hospital
      • Shanghai, Shanghai, China, 201700
        • Central Hospital Of Qingpu District, Shanghai
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Sichuan 2nd Hospital Of TCM
      • Chengdu, Sichuan, China, 610041
        • Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)
      • Chengdu, Sichuan, China, 610081
        • Affiliated Hospital of Chengdu University
      • Chengdu, Sichuan, China
        • Avic 363 Hospital
      • Hejiang, Sichuan, China, 646200
        • China S.C.H.J. Hospital Of TCM
    • Xinjiang
      • Shihezi, Xinjiang, China, 832008
        • The First Affiliated Hospital of the Medical College, Shihezi University
      • Urumqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
      • Urumqi, Xinjiang, China, 830000
        • The Fifth Affiliated Hospital of Xinjiang Medical University
      • Urumqi, Xinjiang, China, 830000
        • Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region
      • Urumqi, Xinjiang, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Urumqi, Xinjiang, China, 830049
        • Chest Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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))

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
the Injection of DanShenDuoFenSuanYan
Patient who use the Injection of DanShenDuoFenSuanYan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of IDSDFSY induced adverse drug reaction
Time Frame: 3 years
3 years
The rare adverse drug reactions to the IDSDFSY
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The manifestation, treatment and outcomes of the ADRs
Time Frame: 3 years
To describe manifestation, treatment and outcomes of the ADRs.
3 years
The risk factors of the ADRs
Time Frame: 3 years
To examine the risk factors of the ADRs.
3 years
The patients' characteristics who are prescribed IDSDFSY
Time Frame: 3 years
To describe the patients' characteristics who are prescribed IDSDFSY.
3 years
The prescribing pattern of IDSDFSY in real world clinical practice
Time Frame: 3 years
To characterize the prescribing pattern of IDSDFSY in real world clinical practice.
3 years
Off-label use of IDSDFSY
Time Frame: 3 years
To describe and evaluate the off-label use of IDSDFSY.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Suodi ZHAI, B.S., Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 13, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

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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