Evaluating Xuanfei Baidu Granule for treating Influenza A
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
This study is testing if a new treatment called Xuanfei Baidu Granule can help people with Influenza A feel better compared to a placebo and a combination treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 584 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06205641 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multicenter, randomized controlled study designed to assess the efficacy and safety of Xuanfei Baidu Granule in treating Influenza A. A total of 584 participants will be randomly assigned to one of four groups: receiving Xuanfei Baidu Granule, a placebo, or a combination of Xuanfei Baidu Granule with Baloxavir Marboxil. Participants will take the granule or placebo twice daily for five days, while the Baloxavir Marboxil will be administered once daily for one day. Daily visits will be conducted for seven days post-enrollment to monitor health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have tested positive for Influenza A and have shown symptoms within the last 72 hours.
Not a fit: Patients with severe cases of influenza or those with known allergies to the study medications may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from Influenza A.
How similar studies have performed: While the specific use of Xuanfei Baidu Granule is novel, other studies have explored similar herbal treatments for influenza with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Beijing Chaoyang Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhaohui Tong, PhD
- Email: tongzhaohuicy@sina.com
- Phone: 13910930309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.