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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 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020928
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-01-15
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

influenza

Interventions

low-dose group:4 Baicalein Tablets and 2 placebo per time, three times a day
high-dose group:6 Baicalein Tablets per time, three times a day
placebo group:6 placebo per time, three times a day

Sponsors

Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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 male and female; 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>11.0×10^9/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.

Design outcomes

Primary

MeasureTime frame
The time of fever relieving;

Secondary

MeasureTime frame
symptom alleviating time of influenza;Percentage of subjects with influenza complications;Percentage of antipyretic drugs used;Percentage of virus positive to negative;

Countries

China

Contacts

Public ContactQingquan Liu

Beijing Chinese Medicine Hospital affiliated to Capital Medical University

liuqingquan@bjzhongyi.com+86 18910566722

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026