NCT02094638

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

90 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

March 20, 2014

Last Update Submit

February 18, 2016

Conditions

Keywords

Traditional Chinese Medicine Injection

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reaction of Tanreqing Injection

    30 months

Secondary Outcomes (5)

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

    30 months

  • Administration of Tanreqing Injection in real world

    30 months

  • Population characteristics of the adverse drug reaction of Tanreqing Injection

    30 months

  • Off-lable use of Tanreqing Injection

    30 months

  • Drug combination of Tanreqing Injection in real world

    30 months

Other Outcomes (1)

  • Related Risk Factors in severe allergic reaction of Tanreqing Injection

    30 months

Study Arms (1)

Tanreqing

Inpatient using the Tanreqing Injection

Eligibility Criteria

Age24 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)).

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are less than 24 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (90)

Anhui Provincial Children's Hospital

Hefei, Anhui, 230051, China

Location

The Fengtai district Hospital of Integrated TCM & WM

Beijing, Beijing Municipality, 100072, China

Location

Beijing Geriatric Hospital

Beijing, Beijing Municipality, 100095, China

Location

The 263rd Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 101100, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

The Third People's Hospital of Chongqing

Chongqing, Chongqing Municipality, 400014, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, 400021, China

Location

Chongqing Jiulongpo First People's Hospital

Chongqing, Chongqing Municipality, 400050, China

Location

Chongqing Three Gorges Central Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Chongqing Kaixian County People's Hospital

Chongqing, Chongqing Municipality, 405400, China

Location

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, 730050, China

Location

Lanzhou Petrochemical General Hospital

Lanzhou, Gansu, 730060, China

Location

The Third People's Hospital of Huizhou

Huizhou, Guangdong, 516002, China

Location

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 518112, China

Location

Zhongshan Municipal People's Hospital

Zhongshan, Guangdong, 528403, China

Location

Bijie First Municipal People's Hospital

Bijie, Guizhou, 551700, China

Location

Guiyang Children's Hospital

Guiyang, Guizhou, 550003, China

Location

Guiyang Pulmonary Hospital

Guiyang, Guizhou, 550003, China

Location

Guizhou Cancer Hospital

Guiyang, Guizhou, 550003, China

Location

The 44th Hospital of chinese People's Liberation Army

Guiyang, Guizhou, 550009, China

Location

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, 563000, China

Location

The Affiliated Hospital of Hainan medical College

Haikou, Hainan, 570102, China

Location

People's Hospital of Rongcheng

Baoding, Hebei, 071700, China

Location

People's Hospital of Cangzhou

Cangzhou, Hebei, 061000, China

Location

First Hospital of Handan City

Handan, Hebei, 056002, China

Location

Hejian Municipal People's Hospital

Hejian, Hebei, 062450, China

Location

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Bethune International Peace Hospital of the Chinese PLA

Shijiazhuang, Hebei, 050082, China

Location

Hebei Zhaoxian People's Hospital

Shijiazhuang, Hebei, 051530, China

Location

Xinle Municipal Hospital of Hebei

Xinle, Hebei, 050700, China

Location

The 152nd Hospital of chinese People's Liberation Army

Pingdingshan, Henan, 467000, China

Location

Henan Province Hospital of TCM

Zhengzhou, Henan, 450002, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Hubei Xinhua Hospital

Wuhan, Hubei, 430015, China

Location

Hubei Zhongshan Hospital Affiliated to Wuhan University

Wuhan, Hubei, 430033, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

The Fourth Hospital of Changsha

Changsha, Hunan, 410006, China

Location

the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The Third Affiliated Hospital of Inner Mongolia Medical College

Baotou, Inner Mongolia, 014010, China

Location

The First Hospital Of Huhhot

Hohhot, Inner Mongolia, 010030, China

Location

The fourth Hospital of Inner Mongolia

Hohhot, Inner Mongolia, 010080, China

Location

The Second Hospital of Wulanchabu City

Wulanchabu, Inner Mongolia, 012000, China

Location

Jiangning District Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, 211100, China

Location

The First People's Hospital of Yangzhou City

Yangzhou, Jiangsu, 225002, China

Location

The Second Hospital of Nanchang

Nanchang, Jiangxi, 330003, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

Traditional Chinese Medical Hospital of Jiangxi Province

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Nanchang

Nanchang, Jiangxi, 330008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

Shenyang 242 Hospital

Shenyang, Liaoning, 110034, China

Location

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, 750001, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Chinese Traditional Medicine Hospital of Ningxia Autonomous Region

Yinchuan, Ningxia, 750021, China

Location

Qinghai Women and Childhood Hospital

Xining, Qinghai, 810007, China

Location

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250011, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Xintai People's Hospital

Xintai, Shandong, 271200, China

Location

Yantai Municipal Laiyang Central Hospital

Yantai, Shandong, 265200, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

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

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai First People's Hospital Branch

Shanghai, Shanghai Municipality, 200081, China

Location

Wu Song Central Hospital of Shanghai

Shanghai, Shanghai Municipality, 200940, China

Location

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, 201199, China

Location

Fifth Hospital of Datong

Datong, Shanxi, 037006, China

Location

Fenyang Hospital of Shanxi Province

Fenyang, Shanxi, 032200, China

Location

The Second People's Hospital of Jinzhong

Jinzhong, Shanxi, 030800, China

Location

The Center Hospital of Shuozhou

Shuozhou, Shanxi, 036002, China

Location

Maternal and Child Health Care Hospital of Taiyuan

Taiyuan, Shanxi, 030012, China

Location

Shanxi Maternity and Children Health Hospital

Taiyuan, Shanxi, 030013, China

Location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610031, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

ShuangLiu Hospital of Traditional Chinese Medical

Chengdu, Sichuan, 610200, China

Location

DuJiangyan Traditional Chinese Medicine Hospital

Dujiangyan, Sichuan, 611830, China

Location

People's Hospital of Nanbu County

Nanchong, Sichuan, 637300, China

Location

The 254th Hospital of chinese People's Liberation Army

Tianjin, Tianjin Municipality, 300142, China

Location

The 464th Hospital of chinese People's Liberation Army

Tianjin, Tianjin Municipality, 300381, China

Location

People's Hospital of Xinjiang Uigur Autonomous Region

Ürümqi, Xinjiang, 830011, China

Location

Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali

Dali, Yunnan, 671099, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

Zhejiang Provincial Hospital of TCM

Hangzhou, Zhejiang, 310006, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

Wenzhou Central Hospital

Wenzhou, Zhejiang, 325000, China

Location

The Second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Wenzhou Yueqing People's Hospital

Wenzhou, Zhejiang, 325699, China

Location

Peking university third hospital

Beijing, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

biospecimen including serum, plasma, blood cells with DNA.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsDrug Hypersensitivity

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 24, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations