InfluenzaPhase 2NCT03830684
A Randomized, Double-blind, Placebo-controlled, Multicenter and Phase Ⅱa Clinical Trial for the Effectiveness and Safety of Baicalein Tablets in the Treatment of Improve Other Aspects of Healthy Adult With Influenza Fever
A Phase 2 study testing Baicalein Tablets 400mg and Baicalein Tablets 600mg in people with Influenza, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Baicalein Tablets 400mg and Baicalein Tablets 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 31 Oct 2019
- Phase
- Phase 2
- 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
- 1.Meet the diagnostic criteria for influenza（non-severe）; 2.Fever to take medicine for the first time, The patient's maximum temperature (axillary temperature) is over 38℃; 3.The rapid virus antigen test of nasal swab was positive; 4.Course of disease ≤ 24 hours(The definition of course of disease is the time from fever to take investigational product for the first time); 5.Aged 18 to 65 years old(include 18 and 65), all genders; 6.Sign the informed consent form.
Who cannot join
- 1.The patients with severe influenza or complication (e.g. secondary bacterial pneumonia, pneumonia caused by other pathogens or other viral pneumonia); 2.The patients with other acute upper respiratory tract infection (e.g. acute pharyngitis, tonsillitis, rhinitis and nasosinuitis); 3.Allergic to baicalin and its analogue, Paracetamol tablets, or allergic people; 4.Patients with any of the following risk factors:
- Residents living in long-term care facilities (e.g. welfare house, sanatorium);
- Combined with chronic respiratory diseases (e.g. bronchial asthma, chronic obstrctive palmonary diseases);
- Combined with chronic cardiovascular disease (e.g. congenital heart disease, congestive heart failure, or coronary artery disease, but doesnt include hypertension without any other cardio-related symptoms);
- Combined with hematological system diseases (e.g. chronic myelogenous leukemia, lymphocytic leukemia, myelodysplastic syndrome, aplastic anemia);
- Neurodevelopmental disorders, include cerebrum, spinal cord, Peripheral nerve and muscle disorders (e.g. cerebral palsy, epilepsy[epileptic seizure disorder], stroke, dysgnosia, Moderate to severe dysplasia, myodystrophy, or spinal cord injury);
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- Poor control of chronic metabolic and endocrine diseases;
- Immunosuppression (long-term use of immunosuppressant, immunocom promise caused by infection by HIV or malignant tumour);
- Obese people[BMI>30, BMI=Weight(kg)/Height(m2)] 5.Long-term take aspirin under 19 years old; 6.White blood cell count>11.0×109/L, or the proportion of neutrophils >80%, or need systemic antibacterial therapy; 7.24 hours before the visit, the patients have received antiviral treatment for influenza; 8.The patients have received Influenza vaccine or research monoclonal antibody in a year; 9.ALT and AST is equal or greater than 1.5 times of upper limit of normal, Scr is greater than upper limit of normal; 10.Suspected or really have a history of alcohol or drug abuse; 11.Gestation (have a positive pregnancy test), lactating women, or have a family planning within the next 6 months; 12.The patients have participated in other clinical trials within 3 months; 13.The investigator considers it inappropriate to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza
Read the detailed description
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza, The trial designed by randomized, double-blind, placebo-controlled, multicenter and optimal efficiency. Subjects will be randomly assigned to low-dose group, high-dose group or placebo group as 1:1:1 proportionally, planned to enroll 180 subjects, each group enroll 60 subjects. The primary indicator is the time of fever relieving, comparison after the second visit. The secondary indicator are symptom alleviating time of influenza, percentage of subjects with influenza complications, percentage of antipyretic drugs used, percentage of virus positive to negative, comparison at the end of the experiment.
- Conditions
- Influenza
- Being tested
- Baicalein Tablets 400mg, Baicalein Tablets 600mg, blank control 0mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baicalein Tablets 400mgDrug
4 Baicalein Tablets and 2 placebo per time, three times a day
Baicalein Tablets 600mgDrug
6 Baicalein Tablets per time, three times a day
blank control 0mgDrug
6 placebo per time, three times a day
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | Experimental | Baicalein Tablets group Receives: Drug: Baicalein Tablets 400mg |
| high-dose group | Experimental | Baicalein Tablets group Receives: Drug: Baicalein Tablets 600mg |
| placebo group | Placebo comparator | control group Receives: Drug: blank control 0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of fever relieving
After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h.
Measured: day 3
Secondary outcomes (4)
symptom alleviating time of influenza
The area under the curve (AUC) of the decline in the subjects' influenza symptom total score.
Measured: day 3 and day 5
Percentage of subjects with influenza complications Percentage of subjects with influenza complications
Percentage of subjects with influenza complications, e.g. be hospitalized, death, sinusitis, otitis media, bronchitis, pneumonia, and so on.
Measured: day 3 and day 5
Percentage of antipyretic drugs used
Percentage of the subjects used paracetamol.
Measured: day 3 and day 5
Percentage of virus positive to negative
Percentage of subjects' influenza virus positive change to negative
Measured: day 3 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Feb 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingquan Liu, Professor, Study chair, Beijing Chinese Medicine Hospital affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830684
- Sponsor's protocol ID
- HQS201801/PRO
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JW, Li YR, Tao LY, Tang SY, Shu XY, Feng S, Yuan RS, Tay GP, Zhang RY, Yang CD, Wang XQ. 12/15-lipoxygenase deficiency attenuates disturbed flow-induced LDL oxidation in endothelial cells. Biochem Biophys Res Commun. 2026 Jan 1;794:153010. doi: 10.1016/j.bbrc.2025.153010. Epub 2025 Nov 19.
PubMed 41313942
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter and Phase Ⅱa Clinical Trial for the Effectiveness and Safety of Baicalein Tablets in the Treatment of Improve Other Aspects of Healthy Adult With Influenza Fever
- ClinicalTrials.gov ID
- NCT03830684
- Acronym / sponsor ID
- HQS201801/PRO
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 5 Feb 2019 (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 in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza
Detailed description
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza, The trial designed by randomized, double-blind, placebo-controlled, multicenter and optimal efficiency. Subjects will be randomly assigned to low-dose group, high-dose group or placebo group as 1:1:1 proportionally, planned to enroll 180 subjects, each group enroll 60 subjects. The primary indicator is the time of fever relieving, comparison after the second visit. The secondary indicator are symptom alleviating time of influenza, percentage of subjects with influenza complications, percentage of antipyretic drugs used, percentage of virus positive to negative, comparison at the end of the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose group | Experimental | Drug: Baicalein Tablets 400mgBaicalein Tablets group |
| high-dose group | Experimental | Drug: Baicalein Tablets 600mgBaicalein Tablets group |
| placebo group | Placebo comparator | Drug: blank control 0mgcontrol group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Meet the diagnostic criteria for influenza（non-severe）; 2.Fever to take medicine for the first time, The patient's maximum temperature (axillary temperature) is over 38℃; 3.The rapid virus antigen test of nasal swab was positive; 4.Course of disease ≤ 24 hours(The definition of course of disease is the time from fever to take investigational product for the first time); 5.Aged 18 to 65 years old(include 18 and 65), all genders; 6.Sign the informed consent form.
Key exclusion criteria (9 listed)
- 1.The patients with severe influenza or complication (e.g. secondary bacterial pneumonia, pneumonia caused by other pathogens or other viral pneumonia); 2.The patients with other acute upper respiratory tract infection (e.g. acute pharyngitis, tonsillitis, rhinitis and nasosinuitis); 3.Allergic to baicalin and its analogue, Paracetamol tablets, or allergic people; 4.Patients with any of the following risk factors:
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 |
|---|---|---|
| Baicalein Tablets 400mg4 Baicalein Tablets and 2 placebo per time, three times a day | Drug | low-dose group |
| Baicalein Tablets 600mg6 Baicalein Tablets per time, three times a day | Drug | high-dose group |
| blank control 0mg6 placebo per time, three times a day | Drug | placebo group |
Primary outcome
The time of fever relieving
Time frame: day 3
After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h.
4 secondary outcomes
symptom alleviating time of influenza
Time frame: day 3 and day 5
Percentage of subjects with influenza complications Percentage of subjects with influenza complications
Time frame: day 3 and day 5
Percentage of antipyretic drugs used
Time frame: day 3 and day 5
Percentage of virus positive to negative
Time frame: day 3 and day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 41313942Chen JW, Li YR, Tao LY, Tang SY, Shu XY, Feng S, Yuan RS, Tay GP, Zhang RY, Yang CD, Wang XQ. 12/15-lipoxygenase deficiency attenuates disturbed flow-induced LDL oxidation in endothelial cells. Biochem Biophys Res Commun. 2026 Jan 1;794:153010. doi: 10.1016/j.bbrc.2025.153010. Epub 2025 Nov 19.
- 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.
Qingquan Liu, Professor study chair
Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baicalein Tablets 400mg and Baicalein Tablets 600mg in people with Influenza, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 1 inclusion and 9 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kun Lou (0311-67808817, loukun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of fever relieving (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830684, which also lists 1 linked publication.
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 5 Feb 2019.