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Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Sponsor
Suodi ZHAI (Other)
Overall Status
Completed
CT.gov ID
NCT02094638
Collaborator
Shanghai Kaibao Pharmaceutical CO.,LTD. (Other), Peking University (Other), First Hospital of Handan City (Other), Bethune International Peace Hospital of the Chinese PLA (Other), The 254th Hospital of chinese People's Liberation Army (Other), The 464th Hospital of chinese People's Liberation Army (Other), People's Hospital of Cangzhou (Other), The First Hospital of Qinhuangdao (Other), The 44th Hospital of chinese People's Liberation Army (Other), The First Affiliated Hospital of Kunming Medical College (Other), The Second Affiliated Hospital of Kunming Medical University (Other), Chongqing Three Gorges Central Hospital (Other), Sichuan Provincial People's Hospital (Other), ShuangLiu Hospital of Traditional Chinese Medical (Other), People's Hospital of Nanbu County (Other), DuJiangyan Traditional Chinese Medicine Hospital (Other), West China Hospital (Other), Chongqing Traditional Chinese Medicine Hospital (Other), The Third People's Hospital of Chongqing (Other), The Fourth Hospital of Changsha (Other), Hubei Xinhua Hospital (Other), Wenzhou Central Hospital (Other), Affiliated Yueqing Hospital of Wenzhou Medical University (Other), The First Hospital of Nanchang (Other), Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other), Shanghai Minhang District Central Hospital (Other), Shanghai First People's Hospital Branch (Other), Zhejiang Provincial Hospital of TCM (Other), The Affiliated Hospital of Hainan medical College (Other), Guiyang Children's Hospital (Other), Traditional Chinese Medical Hospital of Jiangxi Province (Other), Jiangxi Provincial People's Hopital (Other), Hubei Cancer Hospital (Other), Jiangning District Hospital of Traditional Chinese Medicine (Other), Shenzhen Third People's Hospital (Other), Ningbo No. 1 Hospital (Other), Second Hospital of Jilin University (Other), The First Hospital of Jilin University (Other), Yangzhou No.1 People's Hospital (Other), Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali (Other), Bijie First Municipal People's Hospital (Other), Guiyang Pulmonary Hospital (Other), The 263rd Hospital of Chinese People's Liberation Army (Other), Chongqing Kaixian County People's Hospital (Other), The Second Affiliated Hospital of Chongqing Medical University (Other), Chongqing Jiulongpo First People's Hospital (Other), People's Hospital of Xinjiang Uygur Autonomous Region (Other), Shenyang 242 Hospital (Other), Second Affiliated Hospital of Guangzhou Medical University (Other), Cancer Hospital of Guizhou Province (Other), Wu Song Central Hospital of Shanghai (Other), Gansu Provincial Hospital (Other), Lanzhou Petrochemical General Hospital (Other), Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region (Other), General Hospital of Ningxia Medical University (Other), The First People's Hospital of Yinchuan (Other), Yantai Municipal Laiyang Central Hospital (Other), Shandong Cancer Hospital (Other), Shandong University of Traditional Chinese Medicine (Other), Zunyi Medical College (Other), The 152nd Hospital of chinese People's Liberation Army (Other), Henan Province Hospital of TCM (Other), The First Affiliated Hospital of Zhengzhou University (Other), Central South University (Other), The Second Hospital of Nanchang (Other), The Second Hospital of Wulanchabu City (Other), Qinghai Women and Childhood Hospital (Other), The Third People's Hospital of Chengdu (Other), The Center Hospital of Shuozhou (Other), Yunnan Provinical Hospital of Traditional Chinese Medicine (Other), Beijing Geriatric Hospital (Other), Hubei Zhongshan Hospital Affiliated to Wuhan University (Other), Anhui Provincial Children's Hospital (Other), The Third Affiliated Hospital of Inner Mongolia Medical College (Other), The fourth Hospital of Inner Mongolia (Other), Zhongshan People's Hospital, Guangdong, China (Other), Fenyang Hospital of Shanxi Province (Other), The First Hospital Of Huhhot (Other), Taiyuan Xinghualing Maternity & Child Health Care Center (Other), The Fifth People's Hospital of Datong (Other), Shanxi Provincial Maternity and Children's Hospital (Other), The Second People's Hospital of Jinzhong (Other), The Second Hospital of Hebei Medical University (Other), People's Hospital of Rongcheng (Other), Hebei Zhaoxian People's Hospital (Other), Hejian Municipal People's Hospital (Other), Xinle Municipal Hospital of Hebei (Other), Luhe Hospital, Capital Medical University (Other), Fengtai district Hospital of Chinese and Western medicine, Beijing (Other), Shanghai Changzheng Hospital (Other), Xintai People's Hospital (Other)
30,400
Enrollment
90
Locations
337.8
Patients Per Site

Study Details

Study Description

Brief Summary

Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30400 participants
    Observational Model:
    Cohort
    Official Title:
    Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Tanreqing

    Inpatient using the Tanreqing Injection

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse drug reaction of Tanreqing Injection [30 months]

    Secondary Outcome Measures

    1. Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection [30 months]

      Outcomes including cure, improved, null, or death.

    2. Administration of Tanreqing Injection in real world [30 months]

    3. Population characteristics of the adverse drug reaction of Tanreqing Injection [30 months]

    4. Off-lable use of Tanreqing Injection [30 months]

    5. Drug combination of Tanreqing Injection in real world [30 months]

    Other Outcome Measures

    1. Related Risk Factors in severe allergic reaction of Tanreqing Injection [30 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.

    • Outpatients will be only in some hospitals which can get the patients' complete information.

    Exclusion Criteria:
    • Patients who are less than 24 months.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Children's Hospital Hefei Anhui China 230051
    2 The Fengtai district Hospital of Integrated TCM & WM Beijing Beijing China 100072
    3 Beijing Geriatric Hospital Beijing Beijing China 100095
    4 The 263rd Hospital of Chinese People's Liberation Army Beijing Beijing China 101100
    5 Beijing Luhe Hospital, Capital Medical University Beijing Beijing China 101149
    6 The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
    7 The Third People's Hospital of Chongqing Chongqing Chongqing China 400014
    8 Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing China 400021
    9 Chongqing Jiulongpo First People's Hospital Chongqing Chongqing China 400050
    10 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404000
    11 Chongqing Kaixian County People's Hospital Chongqing Chongqing China 405400
    12 Gansu Provincial Hospital of Traditional Chinese Medicine Lanzhou Gansu China 730050
    13 Lanzhou Petrochemical General Hospital Lanzhou Gansu China 730060
    14 The Third People's Hospital of Huizhou Huizhou Guangdong China 516002
    15 The Third People's Hospital of Shenzhen Shenzhen Guangdong China 518112
    16 Zhongshan Municipal People's Hospital Zhongshan Guangdong China 528403
    17 Bijie First Municipal People's Hospital Bijie Guizhou China 551700
    18 Guiyang Children's Hospital Guiyang Guizhou China 550003
    19 Guiyang Pulmonary Hospital Guiyang Guizhou China 550003
    20 Guizhou Cancer Hospital Guiyang Guizhou China 550003
    21 The 44th Hospital of chinese People's Liberation Army Guiyang Guizhou China 550009
    22 Affiliated Hospital of Zunyi Medical College Zunyi Guizhou China 563000
    23 The Affiliated Hospital of Hainan medical College Haikou Hainan China 570102
    24 People's Hospital of Rongcheng Baoding Hebei China 071700
    25 People's Hospital of Cangzhou Cangzhou Hebei China 061000
    26 First Hospital of Handan City Handan Hebei China 056002
    27 Hejian Municipal People's Hospital Hejian Hebei China 062450
    28 The First Hospital of Qinhuangdao Qinhuangdao Hebei China 066000
    29 the Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
    30 Bethune International Peace Hospital of the Chinese PLA Shijiazhuang Hebei China 050082
    31 Hebei Zhaoxian People's Hospital Shijiazhuang Hebei China 051530
    32 Xinle Municipal Hospital of Hebei Xinle Hebei China 050700
    33 The 152nd Hospital of chinese People's Liberation Army Pingdingshan Henan China 467000
    34 Henan Province Hospital of TCM Zhengzhou Henan China 450002
    35 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
    36 Hubei Xinhua Hospital Wuhan Hubei China 430015
    37 Hubei Zhongshan Hospital Affiliated to Wuhan University Wuhan Hubei China 430033
    38 Hubei Cancer Hospital Wuhan Hubei China 430079
    39 The Fourth Hospital of Changsha Changsha Hunan China 410006
    40 the Second Xiangya Hospital of Central South University Changsha Hunan China 410011
    41 The Third Affiliated Hospital of Inner Mongolia Medical College Baotou Inner Mongolia China 014010
    42 The First Hospital Of Huhhot Huhehaote Inner Mongolia China 010030
    43 The fourth Hospital of Inner Mongolia Huhehaote Inner Mongolia China 010080
    44 The Second Hospital of Wulanchabu City Wulanchabu Inner Mongolia China 012000
    45 Jiangning District Hospital of Traditional Chinese Medicine Nanjing Jiangsu China 211100
    46 The First People's Hospital of Yangzhou City Yangzhou Jiangsu China 225002
    47 The Second Hospital of Nanchang Nanchang Jiangxi China 330003
    48 Jiangxi Provincial People's Hospital Nanchang Jiangxi China 330006
    49 Traditional Chinese Medical Hospital of Jiangxi Province Nanchang Jiangxi China 330006
    50 The First Hospital of Nanchang Nanchang Jiangxi China 330008
    51 The First Hospital of Jilin University Changchun Jilin China 130021
    52 The Second Hospital of Jilin University Changchun Jilin China 130041
    53 Shenyang 242 Hospital Shenyang Liaoning China 110034
    54 The First People's Hospital of Yinchuan Yinchuan Ningxia China 750001
    55 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004
    56 Chinese Traditional Medicine Hospital of Ningxia Autonomous Region Yinchuan Ningxia China 750021
    57 Qinghai Women and Childhood Hospital Xining Qinghai China 810007
    58 Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong China 250011
    59 Shandong Cancer Hospital Jinan Shandong China 250117
    60 Xintai People's Hospital Xintai Shandong China 271200
    61 Yantai Municipal Laiyang Central Hospital Yantai Shandong China 265200
    62 Shanghai Changzheng Hospital Shanghai Shanghai China 200003
    63 Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Shanghai Shanghai China 200011
    64 Shanghai First People's Hospital Branch Shanghai Shanghai China 200081
    65 Wu Song Central Hospital of Shanghai Shanghai Shanghai China 200940
    66 Shanghai Minhang District Central Hospital Shanghai Shanghai China 201199
    67 Fifth Hospital of Datong Datong Shanxi China 037006
    68 Fenyang Hospital of Shanxi Province Fenyang Shanxi China 032200
    69 The Second People's Hospital of Jinzhong Jinzhong Shanxi China 030800
    70 The Center Hospital of Shuozhou Shuozhou Shanxi China 036002
    71 Maternal and Child Health Care Hospital of Taiyuan Taiyuan Shanxi China 030012
    72 Shanxi Maternity and Children Health Hospital Taiyuan Shanxi China 030013
    73 The Third People's Hospital of Chengdu Chengdu Sichuan China 610031
    74 West China Hospital, Sichuan University Chengdu Sichuan China 610041
    75 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072
    76 ShuangLiu Hospital of Traditional Chinese Medical Chengdu Sichuan China 610200
    77 DuJiangyan Traditional Chinese Medicine Hospital Dujiangyan Sichuan China 611830
    78 People's Hospital of Nanbu County Nanchong Sichuan China 637300
    79 The 254th Hospital of chinese People's Liberation Army Tianjin Tianjin China 300142
    80 The 464th Hospital of chinese People's Liberation Army Tianjin Tianjin China 300381
    81 People's Hospital of Xinjiang Uigur Autonomous Region Wulumuqi Xinjiang China 830011
    82 Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali Dali Yunnan China 671099
    83 First Affiliated Hospital of Kunming Medical University Kunming Yunnan China 650032
    84 Second Affiliated Hospital of Kunming Medical University Kunming Yunnan China 650101
    85 Zhejiang Provincial Hospital of TCM Hangzhou Zhejiang China 310006
    86 Ningbo First Hospital Ningbo Zhejiang China 315010
    87 Wenzhou Central Hospital Wenzhou Zhejiang China 325000
    88 The Second Affiliated Hospital of Wenzhou Medical College Wenzhou Zhejiang China 325027
    89 Wenzhou Yueqing People's Hospital Wenzhou Zhejiang China 325699
    90 Peking university third hospital Beijing China 100191

    Sponsors and Collaborators

    • Suodi ZHAI
    • Shanghai Kaibao Pharmaceutical CO.,LTD.
    • Peking University
    • First Hospital of Handan City
    • Bethune International Peace Hospital of the Chinese PLA
    • The 254th Hospital of chinese People's Liberation Army
    • The 464th Hospital of chinese People's Liberation Army
    • People's Hospital of Cangzhou
    • The First Hospital of Qinhuangdao
    • The 44th Hospital of chinese People's Liberation Army
    • The First Affiliated Hospital of Kunming Medical College
    • The Second Affiliated Hospital of Kunming Medical University
    • Chongqing Three Gorges Central Hospital
    • Sichuan Provincial People's Hospital
    • ShuangLiu Hospital of Traditional Chinese Medical
    • People's Hospital of Nanbu County
    • DuJiangyan Traditional Chinese Medicine Hospital
    • West China Hospital
    • Chongqing Traditional Chinese Medicine Hospital
    • The Third People's Hospital of Chongqing
    • The Fourth Hospital of Changsha
    • Hubei Xinhua Hospital
    • Wenzhou Central Hospital
    • Affiliated Yueqing Hospital of Wenzhou Medical University
    • The First Hospital of Nanchang
    • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    • Shanghai Minhang District Central Hospital
    • Shanghai First People's Hospital Branch
    • Zhejiang Provincial Hospital of TCM
    • The Affiliated Hospital of Hainan medical College
    • Guiyang Children's Hospital
    • Traditional Chinese Medical Hospital of Jiangxi Province
    • Jiangxi Provincial People's Hopital
    • Hubei Cancer Hospital
    • Jiangning District Hospital of Traditional Chinese Medicine
    • Shenzhen Third People's Hospital
    • Ningbo No. 1 Hospital
    • Second Hospital of Jilin University
    • The First Hospital of Jilin University
    • Yangzhou No.1 People's Hospital
    • Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
    • Bijie First Municipal People's Hospital
    • Guiyang Pulmonary Hospital
    • The 263rd Hospital of Chinese People's Liberation Army
    • Chongqing Kaixian County People's Hospital
    • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing Jiulongpo First People's Hospital
    • People's Hospital of Xinjiang Uygur Autonomous Region
    • Shenyang 242 Hospital
    • Second Affiliated Hospital of Guangzhou Medical University
    • Cancer Hospital of Guizhou Province
    • Wu Song Central Hospital of Shanghai
    • Gansu Provincial Hospital
    • Lanzhou Petrochemical General Hospital
    • Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
    • General Hospital of Ningxia Medical University
    • The First People's Hospital of Yinchuan
    • Yantai Municipal Laiyang Central Hospital
    • Shandong Cancer Hospital
    • Shandong University of Traditional Chinese Medicine
    • Zunyi Medical College
    • The 152nd Hospital of chinese People's Liberation Army
    • Henan Province Hospital of TCM
    • The First Affiliated Hospital of Zhengzhou University
    • Central South University
    • The Second Hospital of Nanchang
    • The Second Hospital of Wulanchabu City
    • Qinghai Women and Childhood Hospital
    • The Third People's Hospital of Chengdu
    • The Center Hospital of Shuozhou
    • Yunnan Provinical Hospital of Traditional Chinese Medicine
    • Beijing Geriatric Hospital
    • Hubei Zhongshan Hospital Affiliated to Wuhan University
    • Anhui Provincial Children's Hospital
    • The Third Affiliated Hospital of Inner Mongolia Medical College
    • The fourth Hospital of Inner Mongolia
    • Zhongshan People's Hospital, Guangdong, China
    • Fenyang Hospital of Shanxi Province
    • The First Hospital Of Huhhot
    • Taiyuan Xinghualing Maternity & Child Health Care Center
    • The Fifth People's Hospital of Datong
    • Shanxi Provincial Maternity and Children's Hospital
    • The Second People's Hospital of Jinzhong
    • The Second Hospital of Hebei Medical University
    • People's Hospital of Rongcheng
    • Hebei Zhaoxian People's Hospital
    • Hejian Municipal People's Hospital
    • Xinle Municipal Hospital of Hebei
    • Luhe Hospital, Capital Medical University
    • Fengtai district Hospital of Chinese and Western medicine, Beijing
    • Shanghai Changzheng Hospital
    • Xintai People's Hospital

    Investigators

    None specified.

    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:
    NCT02094638
    Other Study ID Numbers:
    • PekingUTH-Pharmacy-003
    First Posted:
    Mar 24, 2014
    Last Update Posted:
    Feb 19, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Suodi ZHAI, Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital, Peking University Third Hospital
    Traditional Chinese Medicine Injection
    Additional relevant MeSH terms:
    Drug Hypersensitivity
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Feb 19, 2016