Influenza (wind-heat pattern)
Conditions
Interventions
Experimental group:Compound Shuanghua Oral Liquid + simulated preparation of Shuanghuanglian
Control group:Double Yellow Lotus Compound + Compound Honeysuckle Oral Solution Placebo
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medical diagnostic criteria for "clinically diagnosed case" and/or "confirmed case" of influenza; (2) Meets the Traditional Chinese Medicine diagnostic criteria for wind-heat syndrome; (3) Body temperature (axillary temperature) between 37.5°C and 39.5°C at enrollment; (4) Disease duration =48 hours; (5) Age between 18 and 65 years (inclusive), regardless of gender; (6) Voluntarily participating in the clinical study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Clinically diagnosed with severe or critical influenza or influenza complications; (2) Patients with bronchitis, pneumonia, pleural effusion, interstitial lung disease, etc.; (3) Obese individuals, defined as body mass index (BMI) > 30 kg/m²; (4) Complete blood count showing white blood cell count > 11.0 × 10^ 9/L, or neutrophil percentage > 80%, or presence of purulent sputum suggesting bacterial infection; (5) Patients with other types of respiratory tract infections including acute rhinitis, sinusitis, etc.; (6) Patients with chronic respiratory diseases (e.g., COPD), cardiovascular diseases (e.g., coronary heart disease, myocarditis, excluding well-controlled hypertension and asymptomatic old lacunar cerebral infarction), renal disease, liver disease, hematological disorders, neurological and neuromuscular diseases, metabolic and endocrine disorders (e.g., diabetes), or immunosuppression (including those receiving immunosuppressive agents or with HIV infection leading to impaired immune function); (7) Having received prior treatment for this condition within 48 hours before enrollment (including antipyretics, cold remedies, antiviral drugs, antibiotics, traditional Chinese medicine, etc.); (8) Patients with liver function impairment (ALT or AST = 1.5 times the upper limit of normal), renal insufficiency (Cr > upper limit of normal); patients with serious primary diseases involving cardiovascular, cerebrovascular, endocrine, or hematopoietic systems, or patients with psychiatric disorders; (9) Individuals suspected of or with a history of alcohol or drug abuse; (10) Pregnant or lactating women, or women planning pregnancy during the study period; (11) Individuals with known hypersensitivity or allergic constitution to the investigational drug; (12) Participation in other clinical trials within the past 3 months; (13) Deemed unsuitable for participation in this clinical trial by the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to take effect for fever reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from onset of main symptoms (sore throat, headache, nasal congestion, runny nose) to sustained clinical recovery;Time to complete defervescence;Change in sore throat score from baseline on Day 4 and Day 6 after administration;Time to onset of sore throat relief;Total TCM syndrome scores and individual symptom scores on day 4 and day 6 after administration, changes from baseline, and TCM efficacy;Usage rate of antipyretic analgesics; | — |
Countries
China
Contacts
Public ContactWang Shuo
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed