Influenza
Conditions
Interventions
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Aged 18 to 65 years old,no gender limitation; (2)Consistent with the clinical diagnosis of influenza; (3)Patients whose rapid influenza diagnostic tests result are positive; (4)Patients who accord with the dialectical standard of exogenous wind-heat syndrome in traditional Chinese medicine; (5)The axillary temperature 38 ? or higher; (6)Course within 48 hours(Definition of onset time of disease:fever with other typical flu symptoms,for instance headache,myalgia,chilly,shiver,joint pain,weak,pharyngalgia,cough,nasal congestion,runny nose,etc.at least one of the above); (7)Sign the informed consent before the test,and have a good understanding of the test contents, process and possible adverse reactions.
Exclusion criteria
Exclusion criteria: (1)Allergic constitution or allergic to known components of the test drug or control drug; (2)Patients who accord with the diagnostic criteria of Severe and critically ill cases in Influenza Diagnosis and Treatment Protocol (2020 Edition) published by National Health Commission; (3)The occurrence of other serious clinical conditions requiring monitoring treatment; (4)Patients with acute bacterial sinusitis,anaphylactic rhinitis,tracheitis - bronchitis,pneumonia,herpangina,etc.; (5)Patients with serious primary diseases of cardiovascular,cerebrovascular,lung,kidney and hematopoietic system; (6)Patients with acute or chronic gastroenteritis and unexplained diarrhea 1 week before administration; (7)Liver function test values (ALT, AST) were 1.5 times higher than the upper limit of normal values;Serum creatinine exceeds the upper limit of normal; (8)Blood leukocyte 10.0×10^9/L;and/or neutrophils above the upper limit of normal values,consider bacterial infection; (9)Patients who have taken other medications for the disease within 24 hours prior to administration(Including antiviral, hormone and other Chinese and western drugs and treatment methods); (10)Suspected or present history of alcohol or drug abuse; (11)Pregnancy,preparing for pregnancy or lactating women,patients who are in reproductive age unable or unwilling take adequate contraceptive measures or their spouse's reluctance to use contraception; (12)Patients with mental disorders who are unable to cooperate; (13)Participated in other interventional clinical trials within the last 3 months; (14)Patients deemed unsuitable by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to remission of clinical symptoms of influenza; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease recovery time/recovery rate;TCM syndrome efficacy;Complication,severe illness,critical illness incidence;Antifebrile effect time/Completely antifebrile time;The frequency and the dosage of emergency medicine;Negative rate of virus; | — |
Countries
China
Contacts
Public ContactBaigangZhang
Outcome results
None listed