None listed
Conditions
Interventions
Drug : Test group: A weight-normalized dose of test drug + 0.9%
normal saline is dosed once intravenously, and at the same time, placebo for the control drug is orally administered once
Control group: 0.9%
normal saline is dosed once intravenously, and at the same time, the control drug is orally administered once
Sponsors
Yungjin Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection Criteria Patients who meet the following criteria should be selected. 1) Children 6 months to 14 years old 2) fever due to cold (acute upper respiratory infection) (=38 ?) 3) The applicant or who has a written consent of his / her parent (legal representative)
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients who meet the conditions described below are excluded from the study. 1) Those taking antipyretic drugs within 4 hours 2) Those who had a febrile crisis within the last 6 months 3) Patients with severe blood disorders 4) Those with a medical history of kidney, liver, lung, endocrine, hematology, and heart, but who are within 6 months of termination of treatment 5) Those with neurologic or CNS disorders 6) Diabetic patients, currently unregulated status 7) Those suspected of having respiratory diseases caused by lower respiratory tract infection 8) Patients who participated in other clinical trial drug studies within the previous 4 weeks 9) Severe hemolytic anemia patients 10) Patients undergoing maintenance therapy for bronchial asthma 11) Those with asthma, urticaria or allergic reactions to aspirin or NSAIDs 12) A person who is not suitable for participation in the clinical trial, for either physically and mentally, judged by the examiner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of body temperature | — |
Secondary
| Measure | Time frame |
|---|---|
| Area-Under-Curve (AUC) of axillary temperature-time cuve from the administration time to 6 hours after administration;Maximal reduction of the body temperature until 6 hours after administration;the ratio of the body temperature reduction to normal for each test group and the control group from 6 hours after administration;the time taken for the body temperature to first decline to normal | — |
Countries
Korea, Republic of
Contacts
Public ContactDaeChul Jeong
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed