Seasonal Influenza
Conditions
Interventions
1:Lingdancao granules, 4 packs per time (3g/pack), three times per day
analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day
2:Oseltamivir phosphate capsule (tamiflu), 1 capsule per time (75mg), twice per day
analogous Lingdancao granules, 4 packs per time, three times per day
3:Analogous Lingdancao granules, 4 packs per time, three times per day, analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day
Sponsors
The 1st Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.1. Confirmed infection by the influenza A or B virus or the new influenza A (H1N1) virus according to virological examination; 1.2. Aged 14-65 from the outpatient; 1.3. Acute onset within 72 hours; 1.4. Axillary temperature >=38 degree C, with at least two of the following symptoms, headache, body discomfort, muscle pain, aversion to cold or cold chills, fatigue; along with either one of the respiratory symptoms from cough, sore throat and nasal symptoms; 1.5. Voluntarily signed informed consents.
Exclusion criteria
Exclusion criteria: With one of the following are excluded from the study: 2.1. Chest imaging (X-ray or CT) confirmed bronchitis, pneumonia, pleural effusion, interstitial lesions, etc. 2.2. Routine blood test when screening displayed WBC>10.0x10^9/L, or NEUT. >=75%; 2.3. Patients coughing purulent sputum or with suppurative tonsillitis; 2.4. Patients with diabetes or serious underlying disease, such as blood disease, severe COPD (FEV1 / EVC 2 mg/dL); chronic congestive heart failure (NYHA heart function level III-IV), psychiatric diseases; 2.5. Have already taken antiviral drugs (amantadine, rimantadine, zanamivir and oseltamivir phosphate, etc.) or related Chinese medicine or Chinese patent medicine after the onset before the screening. Or patients have taken Choulingdan or Chinese patent medicine with Choulingdan as part of the ingredients within 1 week before the onset; 2.6. Allergic to Choulingdan or its preparations composition, to oseltamivir or its ingredients, and to drug simulation ingredients, or allergic constitution; 2.7. Women in pregnancy or lactation period, women of childbearing age with plan of a pregnancy; 2.8. Patients with immune deficiency, such as malignant tumor, organ or bone marrow transplantation and AIDS, or taking immunosuppressant in 3 months; 2.9. With dubious or confirmed alcohol and drug abuse history; 2.10. Patients that have been in a similar drug clinical study in 3 months; 2.11. Suffered from acute respiratory infection, otitis media or sinusitis 2 weeks before; 2.12. Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 mouths before; 2.13. Other reasons that researchers think not fitting to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time needed for alleviation of all influenza symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time needed for defervescence from the first dose of study medication to the time when body temperature drop to normal;Total AUC scores of influenza-like symptoms other than fever;ime to return to normal states of health and activity;Duration of viral shedding;The frequency of symptomatic treatment such as usage of acetaminophen;The incidence of influenza complications; | — |
Countries
China
Contacts
Public ContactXinhua Wang
Outcome results
None listed