FARE Clinical Trial Finder
A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Observational [Patient Registry]|
|Eligible Ages||N/A - 14 Years|
Inclusion Criteria:Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|China Academy of Chinese Medical Sciences|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yanming Xie, BA|
|Principal Investigator Affiliation||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Upper Respiratory Tract Infection, Acute Tracheobronchitis|
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.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Yanming Xie, BA
For additional contact information, you can also visit the trial on clinicaltrials.gov.