Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
- Conditions
- Drug AllergyAdverse Drug Reaction
- Registration Number
- NCT02094638
- Lead Sponsor
- Suodi ZHAI
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30400
- 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.
- Patients who are less than 24 months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reaction of Tanreqing Injection 30 months
- Secondary Outcome Measures
Name Time Method Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection 30 months Outcomes including cure, improved, null, or death.
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
Trial Locations
- Locations (90)
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing Jiulongpo First People's Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
Anhui Provincial Children's Hospital
🇨🇳Hefei, Anhui, China
The Fengtai district Hospital of Integrated TCM & WM
🇨🇳Beijing, Beijing, China
Beijing Geriatric Hospital
🇨🇳Beijing, Beijing, China
The 263rd Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Third People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Kaixian County People's Hospital
🇨🇳Chongqing, Chongqing, China
Gansu Provincial Hospital of Traditional Chinese Medicine
🇨🇳Lanzhou, Gansu, China
Lanzhou Petrochemical General Hospital
🇨🇳Lanzhou, Gansu, China
The Third People's Hospital of Huizhou
🇨🇳Huizhou, Guangdong, China
The Third People's Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Zhongshan Municipal People's Hospital
🇨🇳Zhongshan, Guangdong, China
Bijie First Municipal People's Hospital
🇨🇳Bijie, Guizhou, China
Guiyang Children's Hospital
🇨🇳Guiyang, Guizhou, China
People's Hospital of Cangzhou
🇨🇳Cangzhou, Hebei, China
Guiyang Pulmonary Hospital
🇨🇳Guiyang, Guizhou, China
People's Hospital of Rongcheng
🇨🇳Baoding, Hebei, China
Guizhou Cancer Hospital
🇨🇳Guiyang, Guizhou, China
The 44th Hospital of chinese People's Liberation Army
🇨🇳Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical College
🇨🇳Zunyi, Guizhou, China
The Affiliated Hospital of Hainan medical College
🇨🇳Haikou, Hainan, China
First Hospital of Handan City
🇨🇳Handan, Hebei, China
Hejian Municipal People's Hospital
🇨🇳Hejian, Hebei, China
The First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
the Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Bethune International Peace Hospital of the Chinese PLA
🇨🇳Shijiazhuang, Hebei, China
Hebei Zhaoxian People's Hospital
🇨🇳Shijiazhuang, Hebei, China
Xinle Municipal Hospital of Hebei
🇨🇳Xinle, Hebei, China
The 152nd Hospital of chinese People's Liberation Army
🇨🇳Pingdingshan, Henan, China
The Third Affiliated Hospital of Inner Mongolia Medical College
🇨🇳Baotou, Inner Mongolia, China
The fourth Hospital of Inner Mongolia
🇨🇳Huhehaote, Inner Mongolia, China
The First People's Hospital of Yangzhou City
🇨🇳Yangzhou, Jiangsu, China
Henan Province Hospital of TCM
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hubei Xinhua Hospital
🇨🇳Wuhan, Hubei, China
the Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Hospital Of Huhhot
🇨🇳Huhehaote, Inner Mongolia, China
The Second Hospital of Wulanchabu City
🇨🇳Wulanchabu, Inner Mongolia, China
Hubei Zhongshan Hospital Affiliated to Wuhan University
🇨🇳Wuhan, Hubei, China
Traditional Chinese Medical Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
🇨🇳Jinan, Shandong, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Jiangning District Hospital of Traditional Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The Fourth Hospital of Changsha
🇨🇳Changsha, Hunan, China
Qinghai Women and Childhood Hospital
🇨🇳Xining, Qinghai, China
The Second Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
Shenyang 242 Hospital
🇨🇳Shenyang, Liaoning, China
Chinese Traditional Medicine Hospital of Ningxia Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Xintai People's Hospital
🇨🇳Xintai, Shandong, China
Yantai Municipal Laiyang Central Hospital
🇨🇳Yantai, Shandong, China
Fifth Hospital of Datong
🇨🇳Datong, Shanxi, China
The Second People's Hospital of Jinzhong
🇨🇳Jinzhong, Shanxi, China
ShuangLiu Hospital of Traditional Chinese Medical
🇨🇳Chengdu, Sichuan, China
DuJiangyan Traditional Chinese Medicine Hospital
🇨🇳Dujiangyan, Sichuan, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Minhang District Central Hospital
🇨🇳Shanghai, Shanghai, China
Wu Song Central Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Fenyang Hospital of Shanxi Province
🇨🇳Fenyang, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
People's Hospital of Nanbu County
🇨🇳Nanchong, Sichuan, China
Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Center Hospital of Shuozhou
🇨🇳Shuozhou, Shanxi, China
Maternal and Child Health Care Hospital of Taiyuan
🇨🇳Taiyuan, Shanxi, China
Shanxi Maternity and Children Health Hospital
🇨🇳Taiyuan, Shanxi, China
The Third People's Hospital of Chengdu
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The 254th Hospital of chinese People's Liberation Army
🇨🇳Tianjin, Tianjin, China
The 464th Hospital of chinese People's Liberation Army
🇨🇳Tianjin, Tianjin, China
People's Hospital of Xinjiang Uigur Autonomous Region
🇨🇳Wulumuqi, Xinjiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China
Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
🇨🇳Dali, Yunnan, China
Zhejiang Provincial Hospital of TCM
🇨🇳Hangzhou, Zhejiang, China
Peking university third hospital
🇨🇳Beijing, China
Wenzhou Yueqing People's Hospital
🇨🇳Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai First People's Hospital Branch
🇨🇳Shanghai, Shanghai, China