Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
1 other identifier
observational
30,400
1 country
90
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFebruary 19, 2016
February 1, 2016
1.6 years
March 20, 2014
February 18, 2016
Conditions
Keywords
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
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
- Suodi ZHAIlead
- Shanghai Kaibao Pharmaceutical CO.,LTD.collaborator
- Peking Universitycollaborator
- Handan First Hospitalcollaborator
- Bethune International Peace Hospital of the Chinese PLAcollaborator
- The 254th Hospital of chinese People's Liberation Armycollaborator
- The 464th Hospital of chinese People's Liberation Armycollaborator
- People's Hospital of Cangzhoucollaborator
- The First Hospital of Qinhuangdaocollaborator
- The 44th Hospital of chinese People's Liberation Armycollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- The Second Affiliated Hospital of Kunming Medical Universitycollaborator
- Chongqing Three Gorges Central Hospitalcollaborator
- Sichuan Provincial People's Hospitalcollaborator
- ShuangLiu Hospital of Traditional Chinese Medicalcollaborator
- People's Hospital of Nanbu Countycollaborator
- DuJiangyan Traditional Chinese Medicine Hospitalcollaborator
- West China Hospitalcollaborator
- Chongqing Traditional Chinese Medicine Hospitalcollaborator
- The Third People's Hospital of Chongqingcollaborator
- Changsha Fourth Hospitalcollaborator
- Hubei Xinhua Hospitalcollaborator
- Wenzhou Central Hospitalcollaborator
- Affiliated Yueqing Hospital of Wenzhou Medical Universitycollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong Universitycollaborator
- Shanghai Minhang District Central Hospitalcollaborator
- Shanghai First People's Hospital Branchcollaborator
- Zhejiang Provincial Hospital of TCMcollaborator
- The Affiliated Hospital of Hainan medical Collegecollaborator
- Guiyang Children's Hospitalcollaborator
- Traditional Chinese Medical Hospital of Jiangxi Provincecollaborator
- Jiangxi Provincial People's Hopitalcollaborator
- Hubei Cancer Hospitalcollaborator
- Jiangning District Hospital of Traditional Chinese Medicinecollaborator
- Shenzhen Third People's Hospitalcollaborator
- Ningbo No. 1 Hospitalcollaborator
- Second Hospital of Jilin Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- Yangzhou No.1 People's Hospitalcollaborator
- Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dalicollaborator
- Bijie First Municipal People's Hospitalcollaborator
- Guiyang Pulmonary Hospitalcollaborator
- The 263rd Hospital of Chinese People's Liberation Armycollaborator
- Chongqing Kaixian County People's Hospitalcollaborator
- The Second Affiliated Hospital of Chongqing Medical Universitycollaborator
- Chongqing Jiulongpo First People's Hospitalcollaborator
- People's Hospital of Xinjiang Uygur Autonomous Regioncollaborator
- Shenyang 242 Hospitalcollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Cancer Hospital of Guizhou Provincecollaborator
- Wu Song Central Hospital of Shanghaicollaborator
- Gansu Provincial Hospitalcollaborator
- Lanzhou Petrochemical General Hospitalcollaborator
- Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Regioncollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- The First People's Hospital of Yinchuancollaborator
- Yantai Municipal Laiyang Central Hospitalcollaborator
- Shandong Cancer Hospital and Institutecollaborator
- Shandong University of Traditional Chinese Medicinecollaborator
- Zunyi Medical Collegecollaborator
- The 152nd Hospital of chinese People's Liberation Armycollaborator
- Henan Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Central South Universitycollaborator
- The Second Hospital of Nanchangcollaborator
- The Second Hospital of Wulanchabu Citycollaborator
- Qinghai Women and Childhood Hospitalcollaborator
- The Third People's Hospital of Chengducollaborator
- The Center Hospital of Shuozhoucollaborator
- Yunnan Provinical Hospital of Traditional Chinese Medicinecollaborator
- Beijing Geriatric Hospitalcollaborator
- Hubei Zhongshan Hospital Affiliated to Wuhan Universitycollaborator
- Anhui Provincial Children's Hospitalcollaborator
- The Third Affiliated Hospital of Inner Mongolia Medical Collegecollaborator
- The fourth Hospital of Inner Mongoliacollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
- Fenyang Hospital of Shanxi Provincecollaborator
- The First Hospital Of Huhhotcollaborator
- Taiyuan Xinghualing Maternity & Child Health Care Centercollaborator
- The Fifth People's Hospital of Datongcollaborator
- Shanxi Provincial Maternity and Children's Hospitalcollaborator
- The Second People's Hospital of Jinzhongcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- People's Hospital of Rongchengcollaborator
- Hebei Zhaoxian People's Hospitalcollaborator
- Hejian Municipal People's Hospitalcollaborator
- Xinle Municipal Hospital of Hebeicollaborator
- Capital Medical Universitycollaborator
- Fengtai district Hospital of Chinese and Western medicine, Beijingcollaborator
- Shanghai Changzheng Hospitalcollaborator
- Xintai People's Hospitalcollaborator
Study Sites (90)
Anhui Provincial Children's Hospital
Hefei, Anhui, 230051, China
The Fengtai district Hospital of Integrated TCM & WM
Beijing, Beijing Municipality, 100072, China
Beijing Geriatric Hospital
Beijing, Beijing Municipality, 100095, China
The 263rd Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 101100, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 400014, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021, China
Chongqing Jiulongpo First People's Hospital
Chongqing, Chongqing Municipality, 400050, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Chongqing Kaixian County People's Hospital
Chongqing, Chongqing Municipality, 405400, China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, 730050, China
Lanzhou Petrochemical General Hospital
Lanzhou, Gansu, 730060, China
The Third People's Hospital of Huizhou
Huizhou, Guangdong, 516002, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518112, China
Zhongshan Municipal People's Hospital
Zhongshan, Guangdong, 528403, China
Bijie First Municipal People's Hospital
Bijie, Guizhou, 551700, China
Guiyang Children's Hospital
Guiyang, Guizhou, 550003, China
Guiyang Pulmonary Hospital
Guiyang, Guizhou, 550003, China
Guizhou Cancer Hospital
Guiyang, Guizhou, 550003, China
The 44th Hospital of chinese People's Liberation Army
Guiyang, Guizhou, 550009, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 563000, China
The Affiliated Hospital of Hainan medical College
Haikou, Hainan, 570102, China
People's Hospital of Rongcheng
Baoding, Hebei, 071700, China
People's Hospital of Cangzhou
Cangzhou, Hebei, 061000, China
First Hospital of Handan City
Handan, Hebei, 056002, China
Hejian Municipal People's Hospital
Hejian, Hebei, 062450, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
the Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Bethune International Peace Hospital of the Chinese PLA
Shijiazhuang, Hebei, 050082, China
Hebei Zhaoxian People's Hospital
Shijiazhuang, Hebei, 051530, China
Xinle Municipal Hospital of Hebei
Xinle, Hebei, 050700, China
The 152nd Hospital of chinese People's Liberation Army
Pingdingshan, Henan, 467000, China
Henan Province Hospital of TCM
Zhengzhou, Henan, 450002, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Xinhua Hospital
Wuhan, Hubei, 430015, China
Hubei Zhongshan Hospital Affiliated to Wuhan University
Wuhan, Hubei, 430033, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Fourth Hospital of Changsha
Changsha, Hunan, 410006, China
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Affiliated Hospital of Inner Mongolia Medical College
Baotou, Inner Mongolia, 014010, China
The First Hospital Of Huhhot
Hohhot, Inner Mongolia, 010030, China
The fourth Hospital of Inner Mongolia
Hohhot, Inner Mongolia, 010080, China
The Second Hospital of Wulanchabu City
Wulanchabu, Inner Mongolia, 012000, China
Jiangning District Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 211100, China
The First People's Hospital of Yangzhou City
Yangzhou, Jiangsu, 225002, China
The Second Hospital of Nanchang
Nanchang, Jiangxi, 330003, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Traditional Chinese Medical Hospital of Jiangxi Province
Nanchang, Jiangxi, 330006, China
The First Hospital of Nanchang
Nanchang, Jiangxi, 330008, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Shenyang 242 Hospital
Shenyang, Liaoning, 110034, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750001, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Chinese Traditional Medicine Hospital of Ningxia Autonomous Region
Yinchuan, Ningxia, 750021, China
Qinghai Women and Childhood Hospital
Xining, Qinghai, 810007, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Xintai People's Hospital
Xintai, Shandong, 271200, China
Yantai Municipal Laiyang Central Hospital
Yantai, Shandong, 265200, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
Shanghai First People's Hospital Branch
Shanghai, Shanghai Municipality, 200081, China
Wu Song Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 200940, China
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, 201199, China
Fifth Hospital of Datong
Datong, Shanxi, 037006, China
Fenyang Hospital of Shanxi Province
Fenyang, Shanxi, 032200, China
The Second People's Hospital of Jinzhong
Jinzhong, Shanxi, 030800, China
The Center Hospital of Shuozhou
Shuozhou, Shanxi, 036002, China
Maternal and Child Health Care Hospital of Taiyuan
Taiyuan, Shanxi, 030012, China
Shanxi Maternity and Children Health Hospital
Taiyuan, Shanxi, 030013, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610031, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
ShuangLiu Hospital of Traditional Chinese Medical
Chengdu, Sichuan, 610200, China
DuJiangyan Traditional Chinese Medicine Hospital
Dujiangyan, Sichuan, 611830, China
People's Hospital of Nanbu County
Nanchong, Sichuan, 637300, China
The 254th Hospital of chinese People's Liberation Army
Tianjin, Tianjin Municipality, 300142, China
The 464th Hospital of chinese People's Liberation Army
Tianjin, Tianjin Municipality, 300381, China
People's Hospital of Xinjiang Uigur Autonomous Region
Ürümqi, Xinjiang, 830011, China
Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
Dali, Yunnan, 671099, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, 310006, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
Wenzhou Yueqing People's Hospital
Wenzhou, Zhejiang, 325699, China
Peking university third hospital
Beijing, 100191, China
Biospecimen
biospecimen including serum, plasma, blood cells with DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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