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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01872520
Collaborator
Shanghai Greenvalley Pharmaceutical Co., Ltd. (Industry), Peking University (Other)
30,180
Enrollment
36
Locations
39
Duration (Months)
838.3
Patients Per Site
21.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    30180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    the Injection of DanShenDuoFenSuanYan

    Patient who use the Injection of DanShenDuoFenSuanYan

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of IDSDFSY induced adverse drug reaction [3 years]

    2. The rare adverse drug reactions to the IDSDFSY [3 years]

    Secondary Outcome Measures

    1. The manifestation, treatment and outcomes of the ADRs [3 years]

      To describe manifestation, treatment and outcomes of the ADRs.

    2. The risk factors of the ADRs [3 years]

      To examine the risk factors of the ADRs.

    3. The patients' characteristics who are prescribed IDSDFSY [3 years]

      To describe the patients' characteristics who are prescribed IDSDFSY.

    4. The prescribing pattern of IDSDFSY in real world clinical practice [3 years]

      To characterize the prescribing pattern of IDSDFSY in real world clinical practice.

    5. Off-label use of IDSDFSY [3 years]

      To describe and evaluate the off-label use of IDSDFSY.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004
    2 Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences Beijing Beijing China 100053
    3 Peking university third hospital Beijing Beijing China 100191
    4 The Military General Hospital of Beijing PLA Beijing Beijing China 100700
    5 The General Hospital of People's Liberation Army(301 hospital) Beijing Beijing China 100853
    6 First Hospital Of Qinhuangdao Qinhuangdao Hebei China 66000
    7 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
    8 Hebei General Hospital Shijiazhuang Hebei China 50051
    9 Wuhan Hospital of Traditional Chinese Medicine Wuhan Hubei China 430014
    10 Wuhan Asia Heart Hospital Wuhan Hubei China 430022
    11 Wuhan Integrated TCM and Western Medicine Hospital Wuhan Hubei China 430022
    12 Hubei Provincial Hospital of TCM Wuhan Hubei China 430061
    13 Zhangjiagang Hospital Of Traditional Chinese Medicine Zhangjiagang Jiangsu China 215600
    14 Weinan Central Hospital Weinan Shaanxi China
    15 Tangdu Hospital Xi'an Shaanxi China 710000
    16 Xijing hospital Xi'an Shaanxi China 710000
    17 Shaanxi Province Hospital of Traditional Chinese Medicine Xi'an Shaanxi China 710003
    18 Shaanxi Provincial People's Hospital Xi'an Shaanxi China 710068
    19 Yanan University Affiliated Hospital Yan'an Shaanxi China 716000
    20 Shanghai Huangpu District Central Hospital Shanghai Shanghai China 200002
    21 Shuguang Hospital Shanghai University of Traditional Chinese Medicine Shanghai Shanghai China 200021
    22 Huashan Hospital Fudan University Shanghai Shanghai China 200031
    23 Longhua Hospital Shanghai University of TCM Shanghai Shanghai China 200032
    24 Minhang District Central Hospital Shanghai Shanghai China 201100
    25 Central Hospital Of Qingpu District, Shanghai Shanghai Shanghai China 201700
    26 Sichuan 2nd Hospital Of TCM Chengdu Sichuan China 610031
    27 Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.) Chengdu Sichuan China 610041
    28 Affiliated Hospital of Chengdu University Chengdu Sichuan China 610081
    29 AVIC 363 Hospital Chengdu Sichuan China
    30 China S.C.H.J. Hospital Of TCM Hejiang Sichuan China 646200
    31 The First Affiliated Hospital of the Medical College, Shihezi University Shihezi Xinjiang China 832008
    32 The Fifth Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang China 830000
    33 Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang China 830000
    34 People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang China 830001
    35 Chest Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang China 830049
    36 The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang China 830054

    Sponsors and Collaborators

    • Peking University Third Hospital
    • Shanghai Greenvalley Pharmaceutical Co., Ltd.
    • Peking University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suodi ZHAI, Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital, Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT01872520
    Other Study ID Numbers:
    • PekingUTH-Pharmacy-001
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Oct 27, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Suodi ZHAI, Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital, Peking University Third Hospital
    the Injection of DanShenDuoFenSuanYan
    Magnesium Lithospermate B
    Safety
    Real World Study
    Additional relevant MeSH terms:
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Oct 27, 2015