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This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose group | Experimental | Baicalein Tablets group |
|
| high-dose group | Experimental | Baicalein Tablets group |
|
| placebo group | Placebo Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baicalein Tablets 400mg | Drug | 4 Baicalein Tablets and 2 placebo per time, three times a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Lou | Contact | 0311-67808817 | loukun@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingquan Liu, Professor | Beijing Chinese Medicine Hospital affiliated to Capital Medical University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41313942 | Derived | Chen JW, Li YR, Tao LY, Tang SY, Shu XY, Feng S, Yuan RS, Tay GP, Zhang RY, Yang CD, Wang XQ. 12/15-lipoxygenase deficiency attenuates disturbed flow-induced LDL oxidation in endothelial cells. Biochem Biophys Res Commun. 2026 Jan 1;794:153010. doi: 10.1016/j.bbrc.2025.153010. Epub 2025 Nov 19. |
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| Baicalein Tablets 600mg | Drug | 6 Baicalein Tablets per time, three times a day |
|
| blank control 0mg | Drug | 6 placebo per time, three times a day |
|
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 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C006680 | baicalein |
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