A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Xuanfei Baidu Granule for people with Influenza A, which is a type of flu virus. The goal is to find out if this herbal treatment is effective and safe for patients. The study will include 584 participants who will be randomly assigned to one of four groups: one group will receive Xuanfei Baidu Granule, another group will receive a placebo (a treatment that does not contain the active ingredient), and a third group will receive Xuanfei Baidu Granule along with a medication called Baloxavir Marboxil. Participants will take the treatment for five days and will have daily check-ins for a week to monitor their health.

To be eligible for this trial, individuals must be between 18 and 65 years old, have flu symptoms that started within the last 72 hours, and have a confirmed positive test for Influenza A. However, certain people cannot participate, including those with severe health conditions, pregnant or breastfeeding women, and those who have recently used other treatments for flu. If someone qualifies and chooses to participate, they can help researchers learn more about how effective this new treatment might be for others with Influenza A in the future.

Gender

ALL

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.