NCT01824732

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

March 30, 2013

Last Update Submit

April 2, 2013

Conditions

Pneumonia;Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction

    to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing

Study Arms (2)

Allergic group

All patients who used Tanreqing Injection have anaphylaxis.

Control group

All patients who used Tanreqing Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.

Eligibility Criteria

Age1 Month - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

An anticipated sample size was caculated in this study, about 3000 Patients using Tanreqing injection from January to March 2013 in hospitals.

You may qualify if:

  • Patients using Tanreqing injection from January to March 2013

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Basic Research in Clinical Medicine

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

PneumoniaBronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBronchial DiseasesLung Diseases, Obstructive

Study Officials

  • Xie Y Ming, BA

    China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 5, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

CN(1)