Suspended

a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Bronchial Diseases+5

+ Infections

+ Lung Diseases

From 1 Months to 80 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: January 2013
See protocol details

Summary

Principal SponsorChina Academy of Chinese Medical Sciences
Study ContactChang Y Peng, DoctorMore contacts
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood. Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.

Principal SponsorChina Academy of Chinese Medical Sciences
Study ContactChang Y Peng, DoctorMore contacts
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesInfectionsLung DiseasesLung Diseases, ObstructiveRespiratory Tract DiseasesRespiratory Tract InfectionsBronchitisPneumonia

Criteria

Inclusion Criteria: Patients using Tanreqing injection from January to March 2013 Exclusion Criteria: -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institute of Basic Research in Clinical Medicine

Beijing, ChinaOpen Institute of Basic Research in Clinical Medicine in Google Maps
SuspendedOne Study Center