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NCT Number: NCT02094638

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

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.

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Key information

Conditions

Adverse Drug Reaction Chemically-Induced Disorders Drug Allergy Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions

Age range

24 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Provincial Children's Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of adverse drug reaction of Tanreqing Injection

    Time frame: 30 months

Secondary outcomes

  1. Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection

    Time frame: 30 months

    Outcomes including cure, improved, null, or death.

  2. Administration of Tanreqing Injection in real world

    Time frame: 30 months

  3. Population characteristics of the adverse drug reaction of Tanreqing Injection

    Time frame: 30 months

  4. Off-lable use of Tanreqing Injection

    Time frame: 30 months

  5. Drug combination of Tanreqing Injection in real world

    Time frame: 30 months

Other outcomes

  1. Related Risk Factors in severe allergic reaction of Tanreqing Injection

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Suodi ZHAI

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Mar 24, 2014
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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