A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 584
- Locations
- 1
- Primary Endpoint
- The time to fever resolution.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals aged ≥18 and <65, regardless of gender.
- •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
- •Individuals with known allergies to the test drugs, placebo components, or having allergic constitution.
- •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.
Arms & Interventions
Xuanfei Baidu Granule Placebo group
Intervention: Xuanfei Baidu Granule Placebo (Drug)
Xuanfei Baidu Granule group
Intervention: Xuanfei Baidu Granule (Drug)
Baloxavir Marboxil Tablet group
Intervention: Baloxavir Marboxil Tablet (Drug)
Combination group
Intervention: Xuanfei Baidu Granule (Drug)
Combination group
Intervention: Baloxavir Marboxil Tablet (Drug)
Outcomes
Primary Outcomes
The time to fever resolution.
Time Frame: within 7 days of enrollment
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.
Secondary Outcomes
- The time to alleviation of influenza symptoms.(within 7 days of enrollment)
- The proportion of patients with fever resolution.(within 7 days of enrollment)
- The temporal variation of Influenza Symptom Rating Scale.(within 7 days of enrollment)
- All-cause hospitalization rate.(within 7 days of enrollment)
- The proportion of patients with alleviation of influenza symptoms.(within 7 days of enrollment)
- The incidence of serious adverse events during the study period.(within 7 days of enrollment)
- The proportion of patients with alleviation of clinical symptoms.(within 7 days of enrollment)
- The temporal variation of body temperature.(within 7 days of enrollment)
- The incidence of clinical abnormalities was examined in the laboratory.(within 7 days of enrollment)
- 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.(within 7 days of enrollment)
Investigators
Zhaohui Tong
Derictor of Beijing Institute of Respiratory Diseases and Vice president of Beijing Chaoyang Hospital, Capital Medical University
Beijing Chao Yang Hospital