Influenza ANCT06205641
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
A study testing Xuanfei Baidu Granule and Baloxavir Marboxil Tablet in people with Influenza A, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza A
- What is being tested?
- Xuanfei Baidu Granule and Baloxavir Marboxil Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing
Zhaohui Tong, PhD, 13910930309, tongzhaohuicy@sina.com
About this study
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
- Being tested
- Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Baloxavir Marboxil Tablet
- Keywords
- Influenza A, Xuanfei Baidu Granule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanfei Baidu Granule PlaceboDrug
Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.
Xuanfei Baidu GranuleDrug
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Baloxavir Marboxil TabletDrug
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
| Study group | Role | What they receive |
|---|---|---|
| Xuanfei Baidu Granule Placebo group | Placebo comparator | Not described Receives: Drug: Xuanfei Baidu Granule Placebo |
| Xuanfei Baidu Granule group | Experimental | Not described Receives: Drug: Xuanfei Baidu Granule |
| Baloxavir Marboxil Tablet group | Active comparator | Not described Receives: Drug: Baloxavir Marboxil Tablet |
| Combination group | Active comparator | Not described Receives: Drug: Xuanfei Baidu Granule; Drug: Baloxavir Marboxil Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 7 days of enrollment
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 7 days of enrollment
All-cause hospitalization rate.
All-cause hospitalization rate.
Measured: 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.
Measured: within 7 days of enrollment
The incidence of clinical abnormalities was examined by electrocardiogram.
The incidence of clinical abnormalities was examined by electrocardiogram.
Measured: 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.
Measured: 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.
Measured: within 7 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Tong, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205641
- Sponsor's protocol ID
- XFBD-JL-001
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A
- ClinicalTrials.gov ID
- NCT06205641
- Acronym / sponsor ID
- XFBD-JL-001
- Conditions
- Influenza A
- Keywords
- Influenza A, Xuanfei Baidu Granule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanfei Baidu Granule PlaceboTake Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days. | Drug | Xuanfei Baidu Granule Placebo group |
| Xuanfei Baidu GranuleTake Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days. | Drug | Combination group, Xuanfei Baidu Granule group |
| Baloxavir Marboxil TabletTake Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day. | Drug | Baloxavir Marboxil Tablet group, Combination group |
Primary outcome
The time to fever resolution.
Time frame: within 7 days of enrollment
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.
11 secondary outcomes
The time to alleviation of influenza symptoms.
Time frame: within 7 days of enrollment
The proportion of patients with fever resolution.
Time frame: within 7 days of enrollment
The proportion of patients with alleviation of influenza symptoms.
Time frame: within 7 days of enrollment
The proportion of patients with alleviation of clinical symptoms.
Time frame: within 7 days of enrollment
The temporal variation of body temperature.
Time frame: within 7 days of enrollment
The temporal variation of Influenza Symptom Rating Scale.
Time frame: within 7 days of enrollment
All-cause hospitalization rate.
Time frame: within 7 days of enrollment
The incidence of clinical abnormalities was examined in the laboratory.
Time frame: within 7 days of enrollment
The incidence of clinical abnormalities was examined by electrocardiogram.
Time frame: within 7 days of enrollment
The incidence of all-cause adverse events during the study period.
Time frame: within 7 days of enrollment
The incidence of serious adverse events during the study period.
Time frame: within 7 days of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xuanfei Baidu Granule and Baloxavir Marboxil Tablet in people with Influenza A, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Tong, PhD (13910930309, tongzhaohuicy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to fever resolution. (time frame: within 7 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.