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Status unknownNCT03830684Updated Feb 5, 2019

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 interventional study of Baicalein Tablets 400mg and Baicalein Tablets 600mg in Influenza, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 180 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Residents living in long-term care facilities (e.g. welfare house, sanatorium);
    2. Combined with chronic respiratory diseases (e.g. bronchial asthma, chronic obstrctive palmonary diseases);
    3. 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);
    4. Combined with hematological system diseases (e.g. chronic myelogenous leukemia, lymphocytic leukemia, myelodysplastic syndrome, aplastic anemia);
    5. 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);
    6. Poor control of chronic metabolic and endocrine diseases;
    7. Immunosuppression (long-term use of immunosuppressant, immunocom promise caused by infection by HIV or malignant tumour);
    8. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    low-dose group

    Baicalein Tablets group

    Drug: Baicalein Tablets 400mg

  • Experimental
    high-dose group

    Baicalein Tablets group

    Drug: Baicalein Tablets 600mg

  • Placebo comparator
    placebo group

    control group

    Drug: blank control 0mg

Interventions

  • DrugBaicalein Tablets 400mg

    4 Baicalein Tablets and 2 placebo per time, three times a day

  • DrugBaicalein Tablets 600mg

    6 Baicalein Tablets per time, three times a day

  • Drugblank control 0mg

    6 placebo per time, three times a day

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 3

Secondary outcomes

  1. symptom alleviating time of influenza

    The area under the curve (AUC) of the decline in the subjects' influenza symptom total score.

    Time frame: day 3 and day 5

  2. 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.

    Time frame: day 3 and day 5

  3. Percentage of antipyretic drugs used

    Percentage of the subjects used paracetamol.

    Time frame: day 3 and day 5

  4. Percentage of virus positive to negative

    Percentage of subjects' influenza virus positive change to negative

    Time frame: day 3 and day 5

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03830684
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2019
Start date
Feb 1, 2019 (estimated)
Primary completion
May 31, 2019 (estimated)
Completion
Oct 31, 2019 (estimated)
Last update
Feb 5, 2019

Study contacts

Kun Lou
Contact
loukun@mail.ecspc.com
0311-67808817
Qingquan Liu, Professor
study chair · Beijing Chinese Medicine Hospital affiliated to Capital Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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