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This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A.
This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, once a day for 1 day.
The subjects were visited every day for 7 days after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuanfei Baidu Granule Placebo group | Placebo Comparator |
| |
| Xuanfei Baidu Granule group | Experimental |
| |
| Baloxavir Marboxil Tablet group | Active Comparator |
| |
| Combination group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuanfei Baidu Granule Placebo | Drug | Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to fever resolution. | Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours. Definition of time to fever resolution: the time from the first dose to the resolution of fever. | within 7 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| The time to alleviation of influenza symptoms. | Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of alleviation of influenza symptoms: symptom score ≤1. Definition of time to alleviation of influenza symptoms: the time from the first dose to symptom improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Tong, PhD | Contact | 13910930309 | tongzhaohuicy@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Recruiting | Beijing | China |
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| Xuanfei Baidu Granule | Drug | Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days. |
|
| Baloxavir Marboxil Tablet | Drug | Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day. |
|
| within 7 days of enrollment |
| The proportion of patients with fever resolution. | Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours. | within 7 days of enrollment |
| The proportion of patients with alleviation of influenza symptoms. | Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of alleviation of influenza symptoms: symptom score ≤1. | within 7 days of enrollment |
| The proportion of patients with alleviation of clinical symptoms. | Clinical symptoms include fever resolution and alleviation of influenza symptoms. Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours. Definition of alleviation of influenza symptoms: symptom score ≤1. | within 7 days of enrollment |
| The temporal variation of body temperature. | The temperature was measured at 8 o 'clock, 12 o 'clock, 16 o 'clock and 20 o 'clock every day, and the measurement time and measurement results were recorded. | within 7 days of enrollment |
| The temporal variation of Influenza Symptom Rating Scale. | Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. | within 7 days of enrollment |
| All-cause hospitalization rate. | All-cause hospitalization rate. | within 7 days of enrollment |
| The incidence of clinical abnormalities was examined in the laboratory. | The incidence of clinical abnormalities was examined in the laboratory. | within 7 days of enrollment |
| The incidence of clinical abnormalities was examined by electrocardiogram. | The incidence of clinical abnormalities was examined by electrocardiogram. | within 7 days of enrollment |
| The incidence of all-cause adverse events during the study period. | The incidence of all-cause adverse events during the study period. | within 7 days of enrollment |
| The incidence of serious adverse events during the study period. | The incidence of serious adverse events during the study period. | within 7 days of enrollment |
| ID | Term |
|---|---|
| C000628402 | baloxavir |
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