Status:
RECRUITING
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
Lead Sponsor:
Capital Medical University
Conditions:
Influenza A
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT06205641
Start Date
January 1 2024
End Date
January 1 2025
Last Update
January 16 2024
Active Locations (1)
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1
Beijing Chaoyang Hospital
Beijing, China