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Post-Marketing Surveillance o...

Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

NCT ID: NCT02094638

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adverse Drug Reaction Drug Allergy

Study Design

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Observational Model Type

COHORT

Study Groups

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Tanreqing

Inpatient using the Tanreqing Injection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who are less than 24 months.

Minimum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Suodi ZHAI

Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Anhui Provincial Children's Hospital

Hefei, Anhui, China

Site Status

The Fengtai district Hospital of Integrated TCM & WM

Beijing, Beijing Municipality, China

Site Status

Beijing Geriatric Hospital

Beijing, Beijing Municipality, China

Site Status

The 263rd Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Site Status