A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
NCT ID: NCT06205641
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
584 participants
INTERVENTIONAL
2024-01-31
2025-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Xuanfei Baidu Granule Placebo group
Xuanfei Baidu Granule Placebo
Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.
Xuanfei Baidu Granule group
Xuanfei Baidu Granule
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Baloxavir Marboxil Tablet group
Baloxavir Marboxil Tablet
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
Combination group
Xuanfei Baidu Granule
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Baloxavir Marboxil Tablet
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
Interventions
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Xuanfei Baidu Granule Placebo
Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.
Xuanfei Baidu Granule
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Baloxavir Marboxil Tablet
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
Eligibility Criteria
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Inclusion Criteria
* Meet the western medicine diagnostic criteria for influenza in the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
* Onset of illness within ≤72 hour.
* Body temperature ≥37.5℃ within 24 hours before treatment.
* Tested positive for influenza A virus by antigen.
* The subject understands and voluntarily signs the informed consent, and is able to follow the visit and related procedures prescribed by the program.
Exclusion Criteria
* Meet the criteria for severe or critical cases as per the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
* Patients with acute bacterial sinusitis, allergic rhinitis, tracheitis-bronchitis, pneumonia, herpetic pharyngitis, or similar diseases.
* Individuals with severe primary diseases in cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems.
* Patients with mental illness or those unable or unwilling to cooperate.
* History of epilepsy or febrile convulsions.
* Obesity (BMI \>30).
* Patients with acute and chronic gastroenteritis and unexplained diarrhea within 1 week before administration.
* Liver function test values (ALT, AST) exceed 60U/L;Serum creatinine over 106μmol/L.
* Use of other drugs for the treatment of the disease within 24 hours before administration (including antiviral, hormone and other Chinese and Western drugs and treatment methods).
* Suspected or confirmed history of alcohol or drug abuse, heavy smoker.
* Women who are pregnant or trying to become pregnant, breastfeeding women, those of childbearing age who are unable or unwilling to use adequate contraception during the trial or whose spouse is unwilling to use contraception.
* Immunodeficient, immunosuppressed patients or those who have received steroid therapy or other immunosuppressive therapy in the last 3 months.
* Received influenza vaccine within the last 12 months.
* Participants who have participated in other interventional clinical trials within the last 3 months.
* Participants considered unsuitable for this clinical trial by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Zhaohui Tong
Derictor of Beijing Institute of Respiratory Diseases and Vice president of Beijing Chaoyang Hospital, Capital Medical University
Locations
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Beijing Chaoyang Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XFBD-JL-001
Identifier Type: -
Identifier Source: org_study_id
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