A Randomized, Double-blind, Placebo-controlled, Multicenter and Phase Ⅱa Clinical Trial for the Effectiveness and Safety of Baicalein Tablets in the Treatment of Improve Other Aspects of Healthy Adult With Influenza Fever

Study Overview
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Brief Summary
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This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza

Detailed Description
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This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza, The trial designed by randomized, double-blind, placebo-controlled, multicenter and optimal efficiency. Subjects will be randomly assigned to low-dose group, high-dose group or placebo group as 1:1:1 proportionally, planned to enroll 180 subjects, each group enroll 60 subjects. The primary indicator is the time of fever relieving, comparison after the second visit. The secondary indicator are symptom alleviating time of influenza, percentage of subjects with influenza complications, percentage of antipyretic drugs used, percentage of virus positive to negative, comparison at the end of the experiment.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter and Phase Ⅱa Clinical Trial for the Effectiveness and Safety of Baicalein Tablets in the Treatment of Improve Other Aspects of Healthy Adult With Influenza Fever

Conditions
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Influenza

Intervention / Treatment
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* Drug: Baicalein Tablets 400mg
* Drug: Baicalein Tablets 600mg
* Drug: blank control 0mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Meet the diagnostic criteria for influenza（non-severe）; 2.Fever to take medicine for the first time, The patient's maximum temperature (axillary temperature) is over 38℃; 3.The rapid virus antigen test of nasal swab was positive; 4.Course of disease ≤ 24 hours(The definition of course of disease is the time from fever to take investigational product for the first time); 5.Aged 18 to 65 years old(include 18 and 65), all genders; 6.Sign the informed consent form. Exclusion Criteria: 1.The patients with severe influenza or complication (e.g. secondary bacterial pneumonia, pneumonia caused by other pathogens or other viral pneumonia); 2.The patients with other acute upper respiratory tract infection (e.g. acute pharyngitis, tonsillitis, rhinitis and nasosinuitis); 3.Allergic to baicalin and its analogue, Paracetamol tablets, or allergic people; 4.Patients with any of the following risk factors: Residents living in long-term care facilities (e.g. welfare house, sanatorium); Combined with chronic respiratory diseases (e.g. bronchial asthma, chronic obstrctive palmonary diseases); Combined with chronic cardiovascular disease (e.g. congenital heart disease, congestive heart failure, or coronary artery disease, but doesnt include hypertension without any other cardio-related symptoms); Combined with hematological system diseases (e.g. chronic myelogenous leukemia, lymphocytic leukemia, myelodysplastic syndrome, aplastic anemia); Neurodevelopmental disorders, include cerebrum, spinal cord, Peripheral nerve and muscle disorders (e.g. cerebral palsy, epilepsy[epileptic seizure disorder], stroke, dysgnosia, Moderate to severe dysplasia, myodystrophy, or spinal cord injury); Poor control of chronic metabolic and endocrine diseases; Immunosuppression (long-term use of immunosuppressant, immunocom promise caused by infection by HIV or malignant tumour); Obese people[BMI>30, BMI=Weight(kg)/Height(m2)] 5.Long-term take aspirin under 19 years old; 6.White blood cell count>11.0×109/L, or the proportion of neutrophils >80%, or need systemic antibacterial therapy; 7.24 hours before the visit, the patients have received antiviral treatment for influenza; 8.The patients have received Influenza vaccine or research monoclonal antibody in a year; 9.ALT and AST is equal or greater than 1.5 times of upper limit of normal, Scr is greater than upper limit of normal; 10.Suspected or really have a history of alcohol or drug abuse; 11.Gestation (have a positive pregnancy test), lactating women, or have a family planning within the next 6 months; 12.The patients have participated in other clinical trials within 3 months; 13.The investigator considers it inappropriate to participate in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose group<br>Baicalein Tablets group | Drug: Baicalein Tablets 400mg<br>* 4 Baicalein Tablets and 2 placebo per time, three times a day<br>|
| Experimental: high-dose group<br>Baicalein Tablets group | Drug: Baicalein Tablets 600mg<br>* 6 Baicalein Tablets per time, three times a day<br>|
| Placebo Comparator: placebo group<br>control group | Drug: blank control 0mg<br>* 6 placebo per time, three times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of fever relieving | After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h. | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom alleviating time of influenza | The area under the curve (AUC) of the decline in the subjects' influenza symptom total score. | day 3 and day 5 | 
| Percentage of subjects with influenza complications Percentage of subjects with influenza complications | Percentage of subjects with influenza complications, e.g. be hospitalized, death, sinusitis, otitis media, bronchitis, pneumonia, and so on. | day 3 and day 5 | 
| Percentage of antipyretic drugs used | Percentage of the subjects used paracetamol. | day 3 and day 5 | 
| Percentage of virus positive to negative | Percentage of subjects' influenza virus positive change to negative | day 3 and day 5 |