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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Upper Respiratory Tract Infection
- Sponsor
- China Academy of Chinese Medical Sciences
- Enrollment
- 100000
- Primary Endpoint
- Incidence of Adverse Drug Reaction
- Last Updated
- 8 years ago
Overview
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.
Investigators
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Adverse Drug Reaction
Time Frame: 3 days
Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction
Secondary Outcomes
- The Ratio of Body Temperature to Normal(3 days)
- The Ratio of WBC to Normal(3 days)
- The Ratio of The Antibiotic Used(3 days)