Flu(influenza)
Conditions
Interventions
Trial Group:Compound Xianlingdan Mixture, oral, 30ml each time, three times daily
Placebo Group:Placebo of Compound Xianlingdan Mixture, oral, 30ml each time, three times daily
Sponsors
Kunming Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and =37.3°C] or the appearance of >=1 systemic or respiratory symptom associated with influenza virus infection); 4. Positive test result for influenza virus; 5. All patients diagnosed with influenza virus infection must meet the following conditions: (1) Axillary temperature >=37.3°C and <39°C; (2) At least one influenza-related systemic symptom (headache, fever or chills, muscle or joint pain, fatigue) or respiratory symptom (cough, sore throat, nasal congestion, etc.) present with moderate or greater severity; 6. Willing to participate in the trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Meets the criteria for severe/critical cases and high-risk groups as defined in the "Influenza Diagnosis and Treatment Plan" issued by the National Health Commission of China; 2. Confirmed pneumonia, pleural effusion, or interstitial lesions via chest X-ray; 3. Obesity, defined as Body Mass Index (BMI) >30 kg/m²; 4. Received influenza vaccination within the past 6 months; 5. Positive for SARS-CoV-2; or received COVID-19 vaccination within 1 month prior to screening; 6. Neutrophil count >7×10?/L; 7. Severe liver impairment (any of ALT, AST, TBiL >1.5 times the upper limit of normal [ULN]) or renal dysfunction (serum creatinine >ULN); 8. Immunodeficiency, or use of immunosuppressants or glucocorticoids within the past 3 months; 9. Use of other anti-influenza medications (e.g., antivirals, traditional Chinese medicine) after the onset of the current illness; 10. Known allergy to any component of the study drug, acetaminophen, and/or alcohol; 11. Presence of any of the following risk factors: (1) Chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) or bronchial asthma; (2) Severe cardiovascular diseases such as congenital heart disease, congestive heart failure, or coronary artery disease (excluding hypertension); (3) Neurological and neuromuscular disorders, such as cerebral palsy, epilepsy, stroke, intellectual disability, muscular dystrophy, or spinal cord injury; (4) Severe hematological disorders such as sickle cell disease; (5) Malignant tumors; (6) Diabetes with poor glycemic control. 12. Concurrent other infectious diseases or psychiatric disorders; 13. Pregnant, lactating, or planning to become pregnant; 14. Participation in other drug clinical trials within the past 3 months; 15. Unwilling or unable to complete the clinical trial; 16. Investigator considers the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of flu relief time; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Relief time for individual flu symptoms;Proportion of subjects with fever relief;The incidence of influenza-related complications (sinusitis, bronchitis, otitis media, and pneumonia);Incidence of complications/severe/critical illness influenza;Analgesic-antipyretic drug usage and proportion;Virus negative conversion rate;Complete cooling time;Blood routine;Blood biochemistry;Urinalysis;12-lead ECGs; | — |
Countries
China
Contacts
Public ContactFu Yi
Kunming Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed