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Adverse Drug ReactionNCT02094638

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

An observational study of Adverse Drug Reaction and Drug Allergy, run by Suodi ZHAI at 90 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 24 months and older
Conditions the study is for
Adverse Drug Reaction, Drug Allergy
Type of treatment
Injection or infusion
How many people
30,400 participants
Where
90 sitesChina
Study dates
Jan 2014to Aug 2015
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)).

Who may be able to join

  • 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.

Who cannot join

  • Patients who are less than 24 months.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

China90 sites

  • People's Hospital of Rongcheng

    Baoding, Hebei, 071700

  • The Third Affiliated Hospital of Inner Mongolia Medical College

    Baotou, Inner Mongolia, 014010

  • The Fengtai district Hospital of Integrated TCM & WM

    Beijing, Beijing Municipality, 100072

  • Beijing Geriatric Hospital

    Beijing, Beijing Municipality, 100095

  • The 263rd Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 101100

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Peking university third hospital

    Beijing, 100191

  • Bijie First Municipal People's Hospital

    Bijie, Guizhou, 551700

  • People's Hospital of Cangzhou

    Cangzhou, Hebei, 061000

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The Fourth Hospital of Changsha

    Changsha, Hunan, 410006

  • the Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Third People's Hospital of Chengdu

    Chengdu, Sichuan, 610031

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • ShuangLiu Hospital of Traditional Chinese Medical

    Chengdu, Sichuan, 610200

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • The Third People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400014

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing Municipality, 400021

  • Chongqing Jiulongpo First People's Hospital

    Chongqing, Chongqing Municipality, 400050

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • Chongqing Kaixian County People's Hospital

    Chongqing, Chongqing Municipality, 405400

  • Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali

    Dali, Yunnan, 671099

  • Fifth Hospital of Datong

    Datong, Shanxi, 037006

  • DuJiangyan Traditional Chinese Medicine Hospital

    Dujiangyan, Sichuan, 611830

  • Fenyang Hospital of Shanxi Province

    Fenyang, Shanxi, 032200

  • Guiyang Children's Hospital

    Guiyang, Guizhou, 550003

  • Guiyang Pulmonary Hospital

    Guiyang, Guizhou, 550003

  • Guizhou Cancer Hospital

    Guiyang, Guizhou, 550003

  • The 44th Hospital of chinese People's Liberation Army

    Guiyang, Guizhou, 550009

  • The Affiliated Hospital of Hainan medical College

    Haikou, Hainan, 570102

  • First Hospital of Handan City

    Handan, Hebei, 056002

  • Zhejiang Provincial Hospital of TCM

    Hangzhou, Zhejiang, 310006

  • Anhui Provincial Children's Hospital

    Hefei, Anhui, 230051

  • Hejian Municipal People's Hospital

    Hejian, Hebei, 062450

  • The First Hospital Of Huhhot

    Hohhot, Inner Mongolia, 010030

  • The fourth Hospital of Inner Mongolia

    Hohhot, Inner Mongolia, 010080

  • The Third People's Hospital of Huizhou

    Huizhou, Guangdong, 516002

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250011

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The Second People's Hospital of Jinzhong

    Jinzhong, Shanxi, 030800

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    Lanzhou, Gansu, 730050

  • Lanzhou Petrochemical General Hospital

    Lanzhou, Gansu, 730060

  • The Second Hospital of Nanchang

    Nanchang, Jiangxi, 330003

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Traditional Chinese Medical Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330006

  • The First Hospital of Nanchang

    Nanchang, Jiangxi, 330008

  • People's Hospital of Nanbu County

    Nanchong, Sichuan, 637300

  • Jiangning District Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, 211100

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The 152nd Hospital of chinese People's Liberation Army

    Pingdingshan, Henan, 467000

  • The First Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 066000

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Shanghai First People's Hospital Branch

    Shanghai, Shanghai Municipality, 200081

  • Wu Song Central Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200940

  • Shanghai Minhang District Central Hospital

    Shanghai, Shanghai Municipality, 201199

  • Shenyang 242 Hospital

    Shenyang, Liaoning, 110034

  • The Third People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518112

  • the Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Bethune International Peace Hospital of the Chinese PLA

    Shijiazhuang, Hebei, 050082

  • Hebei Zhaoxian People's Hospital

    Shijiazhuang, Hebei, 051530

  • The Center Hospital of Shuozhou

    Shuozhou, Shanxi, 036002

  • Maternal and Child Health Care Hospital of Taiyuan

    Taiyuan, Shanxi, 030012

  • Shanxi Maternity and Children Health Hospital

    Taiyuan, Shanxi, 030013

  • The 254th Hospital of chinese People's Liberation Army

    Tianjin, Tianjin Municipality, 300142

  • The 464th Hospital of chinese People's Liberation Army

    Tianjin, Tianjin Municipality, 300381

  • People's Hospital of Xinjiang Uigur Autonomous Region

    Ürümqi, Xinjiang, 830011

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang, 325000

  • The Second Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325027

  • Wenzhou Yueqing People's Hospital

    Wenzhou, Zhejiang, 325699

  • Hubei Xinhua Hospital

    Wuhan, Hubei, 430015

  • Hubei Zhongshan Hospital Affiliated to Wuhan University

    Wuhan, Hubei, 430033

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The Second Hospital of Wulanchabu City

    Wulanchabu, Inner Mongolia, 012000

  • Qinghai Women and Childhood Hospital

    Xining, Qinghai, 810007

  • Xinle Municipal Hospital of Hebei

    Xinle, Hebei, 050700

  • Xintai People's Hospital

    Xintai, Shandong, 271200

  • The First People's Hospital of Yangzhou City

    Yangzhou, Jiangsu, 225002

  • Yantai Municipal Laiyang Central Hospital

    Yantai, Shandong, 265200

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750001

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Chinese Traditional Medicine Hospital of Ningxia Autonomous Region

    Yinchuan, Ningxia, 750021

  • Henan Province Hospital of TCM

    Zhengzhou, Henan, 450002

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Zhongshan Municipal People's Hospital

    Zhongshan, Guangdong, 528403

  • Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

About this 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.

Read the 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.

Keywords
Traditional Chinese Medicine Injection
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Drug Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02094638
Study groupRoleWhat they receive
TanreqingInpatient using the Tanreqing Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse drug reaction of Tanreqing Injection

    Measured: 30 months

Secondary outcomes (5)

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

    Outcomes including cure, improved, null, or death.

    Measured: 30 months

  2. Administration of Tanreqing Injection in real world

    Measured: 30 months

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

    Measured: 30 months

  4. Off-lable use of Tanreqing Injection

    Measured: 30 months

  5. Drug combination of Tanreqing Injection in real world

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
30,400 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094638
Sponsor's protocol ID
PekingUTH-Pharmacy-003
Status last verified
Feb 2016
First submitted
20 Mar 2014
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Adverse Drug Reaction and Drug Allergy, run by Suodi ZHAI at 90 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse drug reaction of Tanreqing Injection (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02094638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.

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