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

NCT06205641 | Unknown

• 1 other identifier: XFBD-JL-001
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza A

Keywords

Influenza A; Xuanfei Baidu Granule

Outcome Measures

Primary Outcomes (1)

• The time to fever resolution.

  Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours. Definition of time to fever resolution: the time from the first dose to the resolution of fever.

  within 7 days of enrollment

Secondary Outcomes (11)

• The time to alleviation of influenza symptoms.

  within 7 days of enrollment

• The proportion of patients with fever resolution.

  within 7 days of enrollment

• The proportion of patients with alleviation of influenza symptoms.

  within 7 days of enrollment

• The proportion of patients with alleviation of clinical symptoms.

  within 7 days of enrollment

• The temporal variation of body temperature.

  within 7 days of enrollment

Study Arms (4)

Xuanfei Baidu Granule Placebo group

PLACEBO COMPARATOR

Drug: Xuanfei Baidu Granule Placebo

Xuanfei Baidu Granule group

EXPERIMENTAL

Drug: Xuanfei Baidu Granule

Baloxavir Marboxil Tablet group

ACTIVE COMPARATOR

Drug: Baloxavir Marboxil Tablet

Combination group

ACTIVE COMPARATOR

Drug: Xuanfei Baidu Granule; Drug: Baloxavir Marboxil Tablet

Interventions

Xuanfei Baidu Granule Placebo DRUG

Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.

Xuanfei Baidu Granule Placebo group

Xuanfei Baidu Granule DRUG

Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.

Combination group; Xuanfei Baidu Granule group

Baloxavir Marboxil Tablet DRUG

Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.

Baloxavir Marboxil Tablet group; Combination group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

baloxavir

Central Study Contacts

Zhaohui Tong, PhD

CONTACT

13910930309; tongzhaohuicy@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Derictor of Beijing Institute of Respiratory Diseases and Vice president of Beijing Chaoyang Hospital, Capital Medical University

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)