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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.
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Anhui Provincial Children's Hospital
Hefei, Anhui, China
The Fengtai district Hospital of Integrated TCM & WM
Beijing, Beijing Municipality, China
Beijing Geriatric Hospital
Beijing, Beijing Municipality, China
The 263rd Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
Chongqing Jiulongpo First People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Start Date
January 1, 2014
Primary Completion Date
August 1, 2015
Last Updated
February 19, 2016
30,400
ESTIMATED participants
Lead Sponsor
Suodi ZHAI
Collaborators
NCT06406114
NCT04154553
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT00414115