Influenza
Conditions
Interventions
Experimental drug group:Qiang Qin Granules, dissolve in boiling water, 1 packet once, 2 times per day.
Placebo group:Qiang Qin Granule Simulant, dissolve in boiling water, 1 sachet per dose, twice daily.
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for influenza; (2) Meets the diagnostic criteria for wind-heat pattern in traditional Chinese medicine; (3) At the time of consultation, axillary temperature is =37.8°C and <39.5°C (if antipyretic medication has been taken, axillary temperature must be =37.8°C four hours or more after administration); (4) The time interval between the onset of influenza symptoms and the first administration of medication is =48 hours; (5) At the time of consultation, at least one systemic symptom (muscle or joint pain, headache, sweating, fever or chills, fatigue or weakness) and at least one respiratory symptom (cough, sore throat, nasal congestion, or rhinorrhea) related to influenza are of moderate severity or higher; (6) Positive results for influenza virus antigen detection and/or influenza virus nucleic acid detection (influenza virus nucleic acid detection is preferred and can be performed randomly if the antigen detection result is positive); (7) Age is between 18 and 64 years (inclusive), with no restriction on gender; (8) Informed consent is obtained and the informed consent form is signed.
Exclusion criteria
Exclusion criteria: 1. Severe influenza, critical influenza, and high-risk populations for severe illness; 2. Individuals who developed acute respiratory infections, otitis media, acute or chronic sinusitis, acute tracheobronchitis, or pneumonia within the past 14 days prior to screening; 3. Individuals suspected of or confirmed by chest imaging (chest X-ray or CT) to have bronchitis, pneumonia, pleural effusion, or interstitial lung disease; 4. Individuals with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; 5. Individuals with purulent sputum or concurrent purulent tonsillitis; 6. Individuals weighing less than 40 kg; 7. Individuals who have taken immunosuppressants or glucocorticoids within the past 3 months prior to screening; 8. Individuals who have used other medications for influenza, such as antiviral drugs, antibiotics, or traditional Chinese medicine, since the onset of the current illness; 9. Individuals with a total white blood cell count exceeding the upper reference limit by 10%, or a neutrophil percentage exceeding the upper reference limit by 10%; 10. Individuals with a positive antigen test for COVID-19; 11. Individuals suspected of or confirmed to have alcohol dependence, drug abuse history, or concurrent cognitive impairment, severe mental illness that would prevent cooperation in completing the clinical trial; 12. Pregnant women, women planning pregnancy within the next 6 months, or breastfeeding women; 13. Individuals with a history of allergy to two or more drugs or foods, or known allergy to the components of the investigational drug or acetaminophen tablets; 14. Individuals who have participated in any clinical trial within the past 3 months prior to screening; 15. Individuals deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of fever reduction;Time to return to normal body temperature;Systemic symptoms related to influenza (muscle or joint pain, headache, sweating, fever or chills, fatigue or weakness) relief time.;The time to relief of respiratory symptoms related to influenza (cough, sore throat, nasal congestion, or rhinorrhea).;Time and rate of disappearance of single symptoms;The change in Traditional Chinese Medicine (TCM) syndrome scores from baseline;The incidence rate of complications (such as otitis media, acute sinusitis, tracheobronchitis, pneumonia, neurological injury, cardiac injury, hemophagocytic lymphohistiocytosis, myositis and rhabdomyolysis, shock, etc.);The usage of emergency medications.; | — |
Countries
China
Contacts
Public ContactQi Wensheng
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Outcome results
None listed