Influenza (Wind-Heat invading the Exterior)
Conditions
Interventions
Test Group 1:Shuangyu Granules: Take 3 packets per dose, dissolve in warm water, twice daily.
Content Group 2:Shuangyu Granules 2 packets + Shuangyu Granules placebo 1 packet, dissolve in warm water and take orally, twice daily.
Content Test Group 3:Shuangyu Granules 1 packet + Shuangyu Simulated Drug 2 packets, take with warm water, twice daily.
Control Group:Simulated Drug, 3 packets per dose, to be taken with warm water, twice daily.
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 and < 65 years old, regardless of gender; (2) Meeting the diagnostic criteria for wind-heat invading the defensive qi syndrome in traditional Chinese medicine and influenza in Western medicine; (3) Having the illness for no more than 48 hours at the time of enrollment; (4) Positive result from the influenza virus antigen detection kit; (5) Patients diagnosed with influenza virus infection must meet the following conditions: 1) Axillary temperature = 38? and < 39?; 2) At least one systemic symptom related to influenza (headache, fever or chills, muscle or joint pain, fatigue) with a severity of moderate or above; 3) At least one respiratory symptom related to influenza (cough, sore throat, nasal congestion) with a severity of moderate or above. (6) Agree to participate in this trial and voluntarily sign the informed consent form. Wind-heat invading the exterior syndrome: Chief symptoms: 1) Fever 2) Sore throat. Secondary symptoms: 1) Cough 2) Nasal congestion and runny nose 3) Thirst 4) Headache 5) Muscle aches 6) Fatigue 7) Sensitivity to wind. Tongue and pulse: Red tongue, thin yellow or thin white coating; floating and rapid pulse. If two chief symptoms and two or more secondary symptoms are present, along with the tongue and pulse, the diagnosis of wind-heat invading the exterior syndrome can be made.
Exclusion criteria
Exclusion criteria: (1) Cases of severe or critical illness in accordance with the "Diagnosis and Treatment Plan for Influenza (2019 Edition)" issued by the National Health Commission; (2) Patients with confirmed diseases such as bronchitis, pneumonia, pleural effusion, or interstitial lung disease, as evidenced by chest imaging (chest X-ray or CT); (3) Obese individuals, defined as having a body mass index (BMI) > 30 kg/m²; (4) Patients with a white blood cell (WBC) count > 11.0 × 10 9/L or neutrophil percentage > 75%; (5) Patients with severe liver or kidney impairment (alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBiL) > 1.5 times the upper limit of normal, or creatinine (Cr) > upper limit of normal); (6) Patients with immunodeficiency or who have taken immunosuppressants or glucocorticoids in the past 3 months; (7) Patients who have received other treatments for influenza, such as antiviral drugs, antibiotics, or traditional Chinese medicine, since the onset of the current illness; (8) Patients with a history of allergy to any component of this drug, or to acetaminophen and/or alcohol; (9) Patients with one or more of the following risk factors: 1) Chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) or asthma; 2) Severe cardiovascular diseases such as congenital heart disease, congestive heart failure, or coronary artery disease (excluding hypertension); 3) Neurological or neuromuscular diseases such as cerebral palsy, epilepsy, stroke, intellectual disability, muscular dystrophy, or spinal cord injury; 4) Severe hematological diseases such as sickle cell disease; 5) Malignant tumors. (10) Patients with infectious diseases or mental disorders; (11) Pregnant, breastfeeding, or intending to become pregnant; (12) Patients who have participated in other drug clinical trials in the past 3 months; (13) Patients unwilling or unable to complete the clinical trial; (14) Patients 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 |
|---|---|
| antipyretic time;The changes in viral load in nasopharyngeal secretions;Single symptom resolution rate;The daily changes in the total flu symptoms score.;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Onset time of fever reduction; | — |
Countries
China
Contacts
Public ContactWang Lan
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed