To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
Viral Upper Respiratory Tract Infection
About this trial
This is an interventional treatment trial for Viral Upper Respiratory Tract Infection focused on measuring Viral Upper Respiratory Tract Infection, recombinant human interferon ω, Safety, Efficacy, 3-12 years
Eligibility Criteria
Inclusion Criteria: 3 years old ≤ age ≤ 12 years old, gender unlimited; Routine blood test of white cells < Upper limit of normal value, C reactive protein < Upper limit of normal value. Meeting the description of the diagnostic criteria for viral upper respiratory tract infection in Zhufutang Practical Pediatrics; Body temperature ≥ 38 ℃(axillary temperature); The guardian should give informed consent and sign the informed consent form (if the child is ≥ 10 years old, the child should also give informed consent and sign the informed consent form). Exclusion Criteria: Diagnosed as bacterial upper respiratory tract infection. Patients with onset time more than 72 hours. With severe cardiac, hepatic and renal insufficiency(ALT and AST are 1.5 times above the upper limit of normal value), abnormal renal function(Scr abnormality) . Treated with antiviral drugs orally within two weeks or for external use within one week before inclusion. Participated in other clinical trials and took the study medication within one month before inclusion. People with low immune function, systemic failure or long-term use of glucocorticoids and immunosuppressants. Those who suffer from nervous and mental diseases and cannot cooperate well. Allergy constitution(allergic to more than two kinds of drugs or food)or known allergy to interferon and its matrix. Because of other diseases that affect the efficacy observer of this study. Other conditions considered by the investigator as not appropriate to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Low dose group
High dose group
Placebo group
1 bottle of recombinant human interferon ω spray and 1 bottle of placebo(recombinant human interferon ω spray mimics)+base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.
2 bottle of recombinant human interferon ω spray +base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.
2 bottle of placebo(recombinant human interferon ω spray mimics)+base drugs(Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.