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 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.

Study Overview

• Status: Recruiting
• Conditions: Influenza A
• Intervention / Treatment: Drug: Xuanfei Baidu Granule Placebo; Drug: Xuanfei Baidu Granule; Drug: Baloxavir Marboxil Tablet

• Study Type: Interventional
• Enrollment (Estimated): 584
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaohui Tong, PhD; Phone Number: 13910930309; Email: tongzhaohuicy@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing ChaoYang Hospital
    • Contact: Zhaohui Tong, PhD; Phone Number: 13910930309; Email: tongzhaohuicy@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Xuanfei Baidu Granule Placebo group	Drug: Xuanfei Baidu Granule Placebo; Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.
Experimental: Xuanfei Baidu Granule group	Drug: Xuanfei Baidu Granule; Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Active Comparator: Baloxavir Marboxil Tablet group	Drug: Baloxavir Marboxil Tablet; Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
Active Comparator: Combination group	Drug: Xuanfei Baidu Granule; Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.; Drug: Baloxavir Marboxil Tablet; Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to alleviation of influenza symptoms.	Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of alleviation of influenza symptoms: symptom score ≤1. Definition of time to alleviation of influenza symptoms: the time from the first dose to symptom improvement.	within 7 days of enrollment
The proportion of patients with fever resolution.	Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours.	within 7 days of enrollment
The proportion of patients with alleviation of influenza symptoms.	Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of alleviation of influenza symptoms: symptom score ≤1.	within 7 days of enrollment
The proportion of patients with alleviation of clinical symptoms.	Clinical symptoms include fever resolution and alleviation of influenza symptoms. Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome. Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours. Definition of alleviation of influenza symptoms: symptom score ≤1.	within 7 days of enrollment
The temporal variation of body temperature.	The temperature was measured at 8 o 'clock, 12 o 'clock, 16 o 'clock and 20 o 'clock every day, and the measurement time and measurement results were recorded.	within 7 days of enrollment
The temporal variation of Influenza Symptom Rating Scale.	Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue. Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome.	within 7 days of enrollment
All-cause hospitalization rate.	All-cause hospitalization rate.	within 7 days of enrollment
The incidence of clinical abnormalities was examined in the laboratory.	The incidence of clinical abnormalities was examined in the laboratory.	within 7 days of enrollment
The incidence of clinical abnormalities was examined by electrocardiogram.	The incidence of clinical abnormalities was examined by electrocardiogram.	within 7 days of enrollment
The incidence of all-cause adverse events during the study period.	The incidence of all-cause adverse events during the study period.	within 7 days of enrollment
The incidence of serious adverse events during the study period.	The incidence of serious adverse events during the study period.	within 7 days of enrollment

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Influenza A; Xuanfei Baidu Granule
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Baloxavir
• Other Study ID Numbers: XFBD-JL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No