Influenza
Conditions
Interventions
Experimental Group:Shuangyu Granules, 3 packets per dose, twice daily, to be taken with warm water.
Placebo group:Double Fish Granule Simulator, 3 packets per dose, twice daily, taken with warm water.
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, gender; (2) Meet the diagnostic criteria for influenza in Western Medicine; (3) Meet the criteria for Wind-Heat attacking the Wei level in Traditional Chinese Medicine (TCM) pattern identification; (4) Patients with illness duration of within 48 hours at the time of enrollment; (5) Positive result from the influenza virus antigen test kit; (6) Confirmed influenza virus-infected patients must meet the following conditions: 1) Axillary temperature =38°C and <39°C; 2) At least one systemic symptom related to influenza (headache, fever or chills, muscle or joint pain, fatigue) with severity of moderate or above; 3) At least one respiratory symptom related to influenza (cough, sore throat, nasal congestion) with severity of moderate or above. (7) Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe or critical cases in accordance with the "Diagnosis and Treatment Plan for Influenza (2020 Edition)" issued by the National Health Commission; (2) Confirmed diseases such as bronchitis, pneumonia, pleural effusion, or interstitial lung disease via chest imaging (chest X-ray or CT); (3) Obesity, defined as a body mass index (BMI) > 30 kg/m²; (4) White blood cell (WBC) count > 11.0 × 10^9/L or neutrophil ratio > upper limit of normal range; (5) Severe liver or kidney impairment, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBiL) > 1.5 times the upper limit of normal range, or creatinine (Cr) > upper limit of normal range; (6) Immunodeficiency or use of immunosuppressants or glucocorticoids within the past 3 months; (7) Previous use of other or treatments for influenza during this illness episode (see 20.5 Prohibited Drug List); (8) Known allergy to any component of this drug, or to acetaminophen and/or alcohol; (9) 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 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) Concurrent infectious or mental diseases; (11) Positive COVID-19 antigen test; (12) Pregnancy, breastfeeding, or planning to become pregnant; (13) Participation in other drug clinical trials within the past 3 months; (14) Unwilling or unable to complete this clinical trial; (15) Investigators deem unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of fever reduction;antipyretic time;The changes in viral load in nasopharyngeal secretions;Effectiveness of single flu symptom;Change in Overall Influenza Symptoms Score;The change in Traditional Chinese Medicine (TCM) symptom scores from baseline.; | — |
Countries
China
Contacts
Public ContactWang Lan
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed