A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China

• Conditions: Acute Tracheobronchitis; Upper Respiratory Tract Infection

• Registration Number: NCT03461692
• 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 February 2018.

The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed Description

In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study Start: 2018-03-10
• Primary Completion: 2018-03-10
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

Patients aged 14 and below using Reduning injection from February 2018 to December 2018.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reaction	3 days	Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction

Secondary Outcome Measures

Name	Time	Method
The Ratio of Body Temperature to Normal	3 days	The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)
The Ratio of WBC to Normal	3 days	The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L)
The Ratio of The Antibiotic Used	3 days	Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.