NCT03461692

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

A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Day – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Respiratory Tract Infection
• Acute Tracheobronchitis

Interventions

Type	Name	Description
DRUG	patients under 14 years of age using Reduning injeciton	To assess in patients using Reduning injection's clinical features and drug adverse reaction during patients' hospital stay. The registry procedure will only for patients under 14 years of age using Reduning injection,observed from February 2018 to December 2018.

Timeline

• Start date: 2018-03-10
• Primary completion: 2018-03-10
• Completion: 2018-12-31
• First posted: 2018-03-12
• Last updated: 2018-03-12