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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Chaoyang Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhaohui Tong, PhD
tongzhaohuicy@sina.com
13910930309
Time Frame
Start Date: 2024-01
Estimated Completion Date: 2025-01
Participants
Target number of participants: 584
Treatments
Placebo_comparator: Xuanfei Baidu Granule Placebo group
Experimental: Xuanfei Baidu Granule group
Active_comparator: Baloxavir Marboxil Tablet group
Active_comparator: Combination group
Related Therapeutic Areas
Sponsors
Leads: Capital Medical University

This content was sourced from clinicaltrials.gov