A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China

• Conditions: Upper Respiratory Tract Infection; Acute Tracheobronchitis

• Registration Number: NCT01824719
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description

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 Reduning 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 Reduning injection in selected hospitals.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-30
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients using Reduning injection from January to March 2013

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction	to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning

Trial Locations

Locations (1)

Institute of Basic Research in Clinical Medicine; 🇨🇳 Beijing, Beijing, China