A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China
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|ClinicalTrials.gov Identifier: NCT03461692|
Recruitment Status : Unknown
Verified February 2018 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
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.
|Condition or disease||Intervention/treatment|
|Upper Respiratory Tract Infection Acute Tracheobronchitis||Drug: patients under 14 years of age using Reduning injeciton|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100000 participants|
|Target Follow-Up Duration:||15 Days|
|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|
|Estimated Study Start Date :||March 10, 2018|
|Estimated Primary Completion Date :||March 10, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- 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.
- 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
- The Ratio of Body Temperature to Normal [ Time Frame: 3 days ]The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)
- The Ratio of WBC to Normal [ Time Frame: 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 [ Time Frame: 3 days ]Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461692
|Contact: Yanming Xie, BAfirstname.lastname@example.org|
|Contact: Lianxin Wang, email@example.com|
|Principal Investigator:||Yanming Xie, BA||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|