Clinical trial NCT06205641: A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Influenza A
Keywords: Influenza A
Xuanfei Baidu Granule
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The time to fever resolution.
timeFrame: within 7 days of enrollment
Secondary outcomes:
measure: The time to alleviation of influenza symptoms.
timeFrame: within 7 days of enrollment
measure: The proportion of patients with fever resolution.
timeFrame: within 7 days of enrollment
measure: The proportion of patients with alleviation of influenza symptoms.
timeFrame: within 7 days of enrollment
measure: The proportion of patients with alleviation of clinical symptoms.
timeFrame: within 7 days of enrollment
measure: The temporal variation of body temperature.
timeFrame: within 7 days of enrollment
measure: The temporal variation of Influenza Symptom Rating Scale.
timeFrame: within 7 days of enrollment
measure: All-cause hospitalization rate.
timeFrame: within 7 days of enrollment
measure: The incidence of clinical abnormalities was examined in the laboratory.
timeFrame: within 7 days of enrollment
measure: The incidence of clinical abnormalities was examined by electrocardiogram.
timeFrame: within 7 days of enrollment
measure: The incidence of all-cause adverse events during the study period.
timeFrame: within 7 days of enrollment
measure: The incidence of serious adverse events during the study period.
timeFrame: within 7 days of enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
Study officials:
References: