Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
Sponsor: Affiliated Yueqing Hospital of Wenzhou Medical University
Listed as NCT02094638, this observational or N/A phase trial focuses on Adverse Drug Reaction and Drug Allergy and remains completed. Sponsored by Affiliated Yueqing Hospital of Wenzhou Medical University, it has been updated 21 times since 2014, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
21 versions recorded-
Sep 2025 — Present [monthly]
Completed
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Apr 2025 — Sep 2025 [monthly]
Completed
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Mar 2025 — Apr 2025 [monthly]
Completed
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Sep 2024 — Mar 2025 [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
▶ Show 16 earlier versions
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Feb 2023 — Jul 2024 [monthly]
Completed
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Dec 2022 — Feb 2023 [monthly]
Completed
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Dec 2021 — Dec 2022 [monthly]
Completed
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Oct 2021 — Dec 2021 [monthly]
Completed
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Jan 2021 — Oct 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
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Oct 2019 — Nov 2020 [monthly]
Completed
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Jan 2019 — Oct 2019 [monthly]
Completed
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Dec 2018 — Jan 2019 [monthly]
Completed
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Jun 2018 — Dec 2018 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
-
Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Completed NA
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Jul 2017 — Aug 2017 [monthly]
Completed NA
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May 2017 — Jul 2017 [monthly]
Completed NA
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Jan 2017 — May 2017 [monthly]
Completed NA
First recorded
Jan 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Affiliated Yueqing Hospital of Wenzhou Medical University
- Anhui Provincial Children's Hospital
- Beijing Geriatric Hospital
- Bethune International Peace Hospital of the Chinese PLA
- Bijie First Municipal People's Hospital
- Cancer Hospital of Guizhou Province
- Capital Medical University
- Central South University
- Changsha Fourth Hospital
- Chongqing Jiulongpo First People's Hospital
- Chongqing Kaixian County People's Hospital
- Chongqing Three Gorges Central Hospital
- Chongqing Traditional Chinese Medicine Hospital
- DuJiangyan Traditional Chinese Medicine Hospital
- Fengtai district Hospital of Chinese and Western medicine, Beijing
- Fenyang Hospital of Shanxi Province
- First Affiliated Hospital of Kunming Medical University
- Gansu Provincial Hospital
- General Hospital of Ningxia Medical University
- Guiyang Children's Hospital
- Guiyang Pulmonary Hospital
- Handan First Hospital
- Hebei Zhaoxian People's Hospital
- Hejian Municipal People's Hospital
- Henan Provincial People's Hospital
- Hubei Cancer Hospital
- Hubei Xinhua Hospital
- Hubei Zhongshan Hospital Affiliated to Wuhan University
- Jiangning District Hospital of Traditional Chinese Medicine
- Jiangxi Provincial People's Hopital
- Lanzhou Petrochemical General Hospital
- Ningbo No. 1 Hospital
- Peking University
- People's Hospital of Cangzhou
- People's Hospital of Nanbu County
- People's Hospital of Rongcheng
- People's Hospital of Xinjiang Uygur Autonomous Region
- Qinghai Women and Childhood Hospital
- Second Affiliated Hospital of Guangzhou Medical University
- Second Hospital of Jilin University
- Shandong Cancer Hospital and Institute
- Shandong University of Traditional Chinese Medicine
- Shanghai Changzheng Hospital
- Shanghai First People's Hospital Branch
- Shanghai Kaibao Pharmaceutical CO.,LTD.
- Shanghai Minhang District Central Hospital
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Shanxi Provincial Maternity and Children's Hospital
- Shenyang 242 Hospital
- Shenzhen Third People's Hospital
- ShuangLiu Hospital of Traditional Chinese Medical
- Sichuan Provincial People's Hospital
- Suodi ZHAI
- Taiyuan Xinghualing Maternity & Child Health Care Center
- The 152nd Hospital of chinese People's Liberation Army
- The 254th Hospital of chinese People's Liberation Army
- The 263rd Hospital of Chinese People's Liberation Army
- The 44th Hospital of chinese People's Liberation Army
- The 464th Hospital of chinese People's Liberation Army
- The Affiliated Hospital of Hainan medical College
- The Center Hospital of Shuozhou
- The Fifth People's Hospital of Datong
- The First Affiliated Hospital of Nanchang University
- The First Affiliated Hospital of Zhengzhou University
- The First Hospital Of Huhhot
- The First Hospital of Jilin University
- The First Hospital of Qinhuangdao
- The First People's Hospital of Yinchuan
- The Second Affiliated Hospital of Chongqing Medical University
- The Second Affiliated Hospital of Kunming Medical University
- The Second Hospital of Hebei Medical University
- The Second Hospital of Nanchang
- The Second Hospital of Wulanchabu City
- The Second People's Hospital of Jinzhong
- The Third Affiliated Hospital of Inner Mongolia Medical College
- The Third People's Hospital of Chengdu
- The Third People's Hospital of Chongqing
- The fourth Hospital of Inner Mongolia
- Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
- Traditional Chinese Medical Hospital of Jiangxi Province
- Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
- Wenzhou Central Hospital
- West China Hospital
- Wu Song Central Hospital of Shanghai
- Xinle Municipal Hospital of Hebei
- Xintai People's Hospital
- Yangzhou No.1 People's Hospital
- Yantai Municipal Laiyang Central Hospital
- Yunnan Provinical Hospital of Traditional Chinese Medicine
- Zhejiang Provincial Hospital of TCM
- Zhongshan People's Hospital, Guangdong, China
- Zunyi Medical College
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Baoding, China , Baotou, China , Beijing, China , Bijie, China , Cangzhou, China , Changchun, China , Changsha, China , Chengdu, China , Chongqing, China , Dali, China and 41 more locations