Influenza
Conditions
Interventions
Experimental group:Double clearing agent+oseltamivir phosphate capsule mimetic agent
Control group:Oseltamivir phosphate capsule + double clearing agent mimic
Sponsors
China-Japan Friendship Hospital;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for influenza; (2) Conform to the TCM standards of wind temperature, lung heat, health qi and syndrome differentiation; (3) Age 14~75 years old; (4) The course of the disease was within 48 hours before the insurance, and the axillary temperature = 37.3°C in the enrollment; (5) Agree and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe and critical influenza; (2) Confirmed or suspected cases of novel coronavirus pneumonia after nucleic acid testing and chest X-ray examination; (3) Routine blood test: white blood cell count = 12*10^9. And the percentage of neutrophils is greater than the upper limit of normal. (4) Complications, such as purulent tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia and myocarditis; (5) Patients with serious primary diseases such as heart, brain, liver, kidney, blood system and endocrine system, among which ALT and AST >Those with 3 times the upper limit of normal, and those with Cr > 2 times the upper limit of normal; (6) Presence of immunodeficiency or immunosuppression, such as AIDS, malignancy, organ transplantation, or taking immunosuppressants within the past 3 months He who; (7) Use of related drugs within 12 hours before enrollment, such as antiviral, hormonal, antipyretic and analgesic and similar to the efficacy of the drugs in this test of drug treatment for the disease; (8) Influenza vaccination within 12 months prior to the start of the trial; (9) Those who are allergic or allergic to the components of the test drug; (10) Women who are pregnant, preparing to become pregnant, or breastfeeding; (11) Those who have participated in other clinical trials in the past 1 month; (12) Those who suspect or have a history of alcohol or drug abuse; (13) Those who are considered by the investigator to be inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to remission of clinical symptoms was recorded daily at baseline and during the treatment period, and the evaluation at the end of treatment.;Time to complete defervescence, axillary temperature was measured every 6 hours after the first dose of the drug, and evaluation at the end of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset of antipyretic, axillary temperature measured every 0.5 hours within 3 hours of administration;;Acetaminophen dose used, end-of-treatment evaluation;;TCM syndrome scores, baseline and end-of-treatment evaluation;;Clinical single symptom AUC (area under the curve of daily symptom score versus time);;Other important clinical symptoms (cough, headache, sweating, thick or yellow sputum, red face, muscle or joint aches) are relieved Time;;Incidence of complications/severe/critical influenza, end-of-treatment evaluation.; | — |
Countries
China
Contacts
Public ContactLin Jiangtao; Feng Jihong
China-Japan Friendship Hospital;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed