influenza
Conditions
Interventions
Xuanfeibaidu granules placebo group:Take Xuanfeibaidu Granules placebo
Xuanfeibaidu granules group:Take Xuanfeibaidu Granules
Mabaloxavir tablet group:Take Mabaloxavir tablet
Combination drug group (Xuanfeibaidu Granules combined with Mabaloxavir Tablets):Take Xuanfeibaidu Granules combined with Mabaloxavir Tablets
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those aged = 18 = 37.5°C within 24 hours before consultation; 5. Positive for influenza virus by antigen test; 6. Subjects understand and voluntarily sign the informed consent form and are able to follow the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Those with allergies or allergies to the known components of the experimental drug or placebo; 2. Those who meet the diagnostic criteria for severe and critical cases of influenza diagnosis and treatment protocol (2020 edition); 3. Patients with acute bacterial sinusitis, allergic rhinitis, tracheitis-bronchitis, pneumonia, herpangina and other diseases; 4. Patients with serious primary diseases such as cardiovascular and cerebrovascular, lung, liver and kidney, and hematopoietic system; 5. Persons with mental illness or others who are unable or unwilling to cooperate; 6. Have a history of epilepsy or febrile convulsions; 7. Obesity (body mass index > 30); 8. Those with acute and chronic gastroenteritis and unexplained diarrhea within 1 week before administration; 9. Liver function test value (ALT, AST) exceeds 60U/L; Serum creatinine exceeding 106 µmol/L; 10. Those who use other drugs for the treatment of the disease within 24 hours before administration (including antiviral, hormonal and other Chinese and Western drugs and treatments); 11. Suspected or confirmed history of alcohol or drug abuse, heavy smoker; 12. Women who are pregnant or preparing to become pregnant, lactating women, those of childbearing age who are unable or unwilling to take adequate contraception during the test or whose spouses are unwilling to take contraceptive measures; 13. Patients with immunodeficiency or immunosuppression or treatment with steroids or other immunosuppressants in the past 3 months; 14. Influenza vaccine received within 12 months before the start of the trial; 15. Those who have participated in other interventional clinical trials in the past 3 months; 16. Those who are considered inappropriate by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to fever resolution; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to alleviation of symptoms;The proportion of patients with fever resolution;The proportion of patients with symptoms of influenza alleviation;The proportion of patients with clinical symptoms alleviation;The temporal variation of body temperature;The temporal variation of Influenza Symptom Rating Scale;All-cause hospitalization rate;The incidence of clinical abnormalities was examined in the laboratory;The incidence of clinical abnormalities was examined by electrocardiogram;The incidence of all-cause adverse events during the study period;The incidence of serious adverse events during the study period; | — |
Countries
China
Contacts
Public ContactZhaohui Tong
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed