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

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Acute Tracheobronchitis; Upper Respiratory Tract Infection

Treatments: Drug: patients under 14 years of age using Reduning injeciton

Study type: Observational

Funder types: Other

Identifiers

NCT03461692

RDN2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 1 day to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None