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

NCT03830684 | Unknown Phase 2

• 1 other identifier: HQS201801/PRO
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with influenza

Conditions

Influenza

Outcome Measures

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.

  day 3

Secondary Outcomes (4)

• symptom alleviating time of influenza

  day 3 and day 5

• Percentage of subjects with influenza complications Percentage of subjects with influenza complications

  day 3 and day 5

• Percentage of antipyretic drugs used

  day 3 and day 5

• Percentage of virus positive to negative

  day 3 and day 5

Study Arms (3)

low-dose group

EXPERIMENTAL

Baicalein Tablets group

Drug: Baicalein Tablets 400mg

high-dose group

EXPERIMENTAL

Baicalein Tablets group

Drug: Baicalein Tablets 600mg

placebo group

PLACEBO COMPARATOR

control group

Drug: blank control 0mg

Interventions

Baicalein Tablets 400mg DRUG

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

low-dose group

Baicalein Tablets 600mg DRUG

6 Baicalein Tablets per time, three times a day

high-dose group

blank control 0mg DRUG

6 placebo per time, three times a day

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

baicalein

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Qingquan Liu, Professor

  Beijing Chinese Medicine Hospital affiliated to Capital Medical University

  STUDY CHAIR

Central Study Contacts

Kun Lou

CONTACT

0311-67808817; loukun@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 5, 2019
• Study Start: February 1, 2019
• Primary Completion: May 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share