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

Upper Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03461692
• Other study ID #: RDN2018
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2018
• Last updated: March 5, 2018
• Start date: March 10, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: datamining5288[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Tracheobronchitis
• Bronchitis
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Children's Hospital Affiliaten of Zhengzhou University, Qilu Children's Hospital of Shandong University, The Affiliated Children's Hospital of Nanjing Medical University, The First Hospital of Hunan University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Drug Reaction	Incidence of Reduning Injection'Adverse Drug Reaction(ADRs)and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction	3 days
Secondary	The Ratio of Body Temperature to Normal	The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)	3 days
Secondary	The Ratio of WBC to Normal	The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L)	3 days
Secondary	The Ratio of The Antibiotic Used	Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.	3 days