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

February 18, 2016 updated by: Suodi ZHAI
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30400

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

  • China
      • Beijing, China, 100191
        • Peking University Third Hospital
    • Anhui
      • Hefei, Anhui, China, 230051
        • Anhui Provincial Children's Hospital
    • Beijing
      • Beijing, Beijing, China, 100072
        • The Fengtai district Hospital of Integrated TCM & WM
      • Beijing, Beijing, China, 100095
        • Beijing Geriatric Hospital
      • Beijing, Beijing, China, 101100
        • The 263rd Hospital of Chinese People's Liberation Army
      • Beijing, Beijing, China, 101149
        • Beijing Luhe Hospital, Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 404000
        • Chongqing Three Gorges Central Hospital
      • Chongqing, Chongqing, China, 400021
        • Chongqing Traditional Chinese Medicine Hospital
      • Chongqing, Chongqing, China, 400014
        • The Third People's Hospital of Chongqing
      • Chongqing, Chongqing, China, 400050
        • Chongqing Jiulongpo First People's Hospital
      • Chongqing, Chongqing, China, 405400
        • Chongqing Kaixian County People's Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Gansu Provincial Hospital of Traditional Chinese Medicine
      • Lanzhou, Gansu, China, 730060
        • Lanzhou Petrochemical General Hospital
    • Guangdong
      • Huizhou, Guangdong, China, 516002
        • The Third People's Hospital of Huizhou
      • Shenzhen, Guangdong, China, 518112
        • The Third People's Hospital of Shenzhen
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan Municipal People's Hospital
    • Guizhou
      • Bijie, Guizhou, China, 551700
        • Bijie First Municipal People's Hospital
      • Guiyang, Guizhou, China, 550003
        • Guiyang Children's Hospital
      • Guiyang, Guizhou, China, 550003
        • Guiyang Pulmonary Hospital
      • Guiyang, Guizhou, China, 550003
        • Guizhou Cancer Hospital
      • Guiyang, Guizhou, China, 550009
        • The 44th Hospital of chinese People's Liberation Army
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical College
    • Hainan
      • Haikou, Hainan, China, 570102
        • The Affiliated Hospital of Hainan Medical College
    • Hebei
      • Baoding, Hebei, China, 071700
        • People's Hospital of Rongcheng
      • Cangzhou, Hebei, China, 061000
        • People's hospital of Cangzhou
      • Handan, Hebei, China, 056002
        • First Hospital of Handan City
      • Hejian, Hebei, China, 062450
        • Hejian Municipal People's Hospital
      • Qinhuangdao, Hebei, China, 066000
        • The First Hospital of Qinhuangdao
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 050082
        • Bethune International Peace Hospital of the Chinese PLA
      • Shijiazhuang, Hebei, China, 051530
        • Hebei Zhaoxian People's Hospital
      • Xinle, Hebei, China, 050700
        • Xinle Municipal Hospital of Hebei
    • Henan
      • Pingdingshan, Henan, China, 467000
        • The 152nd Hospital of chinese People's Liberation Army
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450002
        • Henan Province Hospital of TCM
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430015
        • Hubei Xinhua Hospital
      • Wuhan, Hubei, China, 430033
        • Hubei Zhongshan Hospital Affiliated to Wuhan University
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410006
        • The Fourth Hospital of Changsha
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • The Third Affiliated Hospital of Inner Mongolia Medical College
      • Huhehaote, Inner Mongolia, China, 010030
        • The First Hospital Of Huhhot
      • Huhehaote, Inner Mongolia, China, 010080
        • The fourth Hospital of Inner Mongolia
      • Wulanchabu, Inner Mongolia, China, 012000
        • The Second Hospital of Wulanchabu City
    • Jiangsu
      • Nanjing, Jiangsu, China, 211100
        • Jiangning District Hospital of Traditional Chinese Medicine
      • Yangzhou, Jiangsu, China, 225002
        • The First People's Hospital of Yangzhou City
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
      • Nanchang, Jiangxi, China, 330003
        • The Second Hospital of Nanchang
      • Nanchang, Jiangxi, China, 330006
        • Traditional Chinese Medical Hospital of Jiangxi Province
      • Nanchang, Jiangxi, China, 330008
        • The First Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • Shenyang 242 Hospital
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
      • Yinchuan, Ningxia, China, 750001
        • The First People's Hospital of Yinchuan
      • Yinchuan, Ningxia, China, 750021
        • Chinese Traditional Medicine Hospital of Ningxia Autonomous Region
    • Qinghai
      • Xining, Qinghai, China, 810007
        • Qinghai Women and Childhood Hospital
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Jinan, Shandong, China, 250011
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
      • Xintai, Shandong, China, 271200
        • Xintai People's Hospital
      • Yantai, Shandong, China, 265200
        • Yantai Municipal Laiyang Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
      • Shanghai, Shanghai, China, 200081
        • Shanghai First People's Hospital Branch
      • Shanghai, Shanghai, China, 200940
        • Wu Song Central Hospital of Shanghai
      • Shanghai, Shanghai, China, 201199
        • Shanghai Minhang District Central Hospital
    • Shanxi
      • Datong, Shanxi, China, 037006
        • Fifth Hospital of Datong
      • Fenyang, Shanxi, China, 032200
        • Fenyang Hospital of Shanxi Province
      • Jinzhong, Shanxi, China, 030800
        • The Second People's Hospital of Jinzhong
      • Shuozhou, Shanxi, China, 036002
        • The Center Hospital of Shuozhou
      • Taiyuan, Shanxi, China, 030012
        • Maternal and Child Health Care Hospital of Taiyuan
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Maternity and Children Health Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, China, 610031
        • The Third People's Hospital of Chengdu
      • Chengdu, Sichuan, China, 610200
        • ShuangLiu Hospital of Traditional Chinese Medical
      • Dujiangyan, Sichuan, China, 611830
        • DuJiangyan Traditional Chinese Medicine Hospital
      • Nanchong, Sichuan, China, 637300
        • People's Hospital of Nanbu County
    • Tianjin
      • Tianjin, Tianjin, China, 300142
        • The 254th Hospital of chinese People's Liberation Army
      • Tianjin, Tianjin, China, 300381
        • The 464th Hospital of chinese People's Liberation Army
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830011
        • People's Hospital of Xinjiang Uigur Autonomous Region
    • Yunnan
      • Dali, Yunnan, China, 671099
        • Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
      • Kunming, Yunnan, China, 650101
        • Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Zhejiang Provincial Hospital of TCM
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Wenzhou Central Hospital
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital of Wenzhou Medical College
      • Wenzhou, Zhejiang, China, 325699
        • Wenzhou Yueqing People's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who use the Tanreqing Injection in selected 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 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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Tanreqing
Inpatient using the Tanreqing Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse drug reaction of Tanreqing Injection
Time Frame: 30 months
30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection
Time Frame: 30 months
Outcomes including cure, improved, null, or death.
30 months
Administration of Tanreqing Injection in real world
Time Frame: 30 months
30 months
Population characteristics of the adverse drug reaction of Tanreqing Injection
Time Frame: 30 months
30 months
Off-lable use of Tanreqing Injection
Time Frame: 30 months
30 months
Drug combination of Tanreqing Injection in real world
Time Frame: 30 months
30 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Related Risk Factors in severe allergic reaction of Tanreqing Injection
Time Frame: 30 months
30 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suodi ZHAI

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University
The Second Hospital of Hebei Medical University
West China Hospital
Hubei Cancer Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Gansu Provincial Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Central South University
The Second Affiliated Hospital of Chongqing Medical University
General Hospital of Ningxia Medical University
Shanghai Changzheng Hospital
Second Affiliated Hospital of Guangzhou Medical University
Wenzhou Central Hospital
Ningbo No. 1 Hospital
Sichuan Provincial People's Hospital
Second Hospital of Jilin University
Yangzhou No.1 People's Hospital
Yunnan Provinical Hospital of Traditional Chinese Medicine
Zhongshan People's Hospital, Guangdong, China
The First Hospital of Qinhuangdao
The 152nd Hospital of chinese People's Liberation Army
People's Hospital of Rongcheng
The Second Affiliated Hospital of Kunming Medical University
Zunyi Medical College
Shanxi Provincial Maternity and Children's Hospital
Jiangxi Provincial People's Hopital
Shenzhen Third People's Hospital
Zhejiang Provincial Hospital of TCM
Cancer Hospital of Guizhou Province
Chongqing Traditional Chinese Medicine Hospital
Shandong University of Traditional Chinese Medicine
Beijing Geriatric Hospital
Hubei Xinhua Hospital
The First Hospital of Nanchang
The Third People's Hospital of Chengdu
Chongqing Three Gorges Central Hospital
Anhui Provincial Children's Hospital
Handan First Hospital
Shanghai Kaibao Pharmaceutical CO.,LTD.
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 44th Hospital of chinese People's Liberation Army
First Affiliated Hospital of Kunming Medical University
ShuangLiu Hospital of Traditional Chinese Medical
People's Hospital of Nanbu County
DuJiangyan Traditional Chinese Medicine Hospital
The Third People's Hospital of Chongqing
The Fourth Hospital of Changsha
Affiliated Yueqing Hospital of Wenzhou Medical University
Shanghai Minhang District Central Hospital
Shanghai First People's Hospital Branch
The Affiliated Hospital of Hainan medical College
Guiyang Children's Hospital
Traditional Chinese Medical Hospital of Jiangxi Province
Jiangning District Hospital of Traditional Chinese Medicine
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
Chongqing Jiulongpo First People's Hospital
Shenyang 242 Hospital
Wu Song Central Hospital of Shanghai
Lanzhou Petrochemical General Hospital
Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
The First People's Hospital of Yinchuan
Yantai Municipal Laiyang Central Hospital
The Second Hospital of Nanchang
The Second Hospital of Wulanchabu City
Qinghai Women and Childhood Hospital
The Center Hospital of Shuozhou
Hubei Zhongshan Hospital Affiliated to Wuhan University
The Third Affiliated Hospital of Inner Mongolia Medical College
The fourth Hospital of Inner Mongolia
Fenyang Hospital of Shanxi Province
The First Hospital Of Huhhot
Taiyuan Xinghualing Maternity & Child Health Care Center
The Fifth People's Hospital of Datong
The Second People's Hospital of Jinzhong
Hebei Zhaoxian People's Hospital
Hejian Municipal People's Hospital
Xinle Municipal Hospital of Hebei
Beijing Luhe Hospital, Capital Medical University
Fengtai district Hospital of Chinese and Western medicine, Beijing
Xintai People's Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PekingUTH-Pharmacy-003

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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