FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Observational [Patient Registry]
Eligible Ages N/A - 14 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Trial Details

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.

Trial ID:
NCT03461692

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.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
China Academy of Chinese Medical Sciences

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
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.

Agency Class
OtherOtherOtherOtherOther
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Upper Respiratory Tract Infection, Acute Tracheobronchitis
Additional Details

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.

Contact Information

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

86-13911112416

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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