<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830684</url>
  </required_header>
  <id_info>
    <org_study_id>HQS201801/PRO</org_study_id>
    <nct_id>NCT03830684</nct_id>
  </id_info>
  <brief_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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with&#xD;
      influenza&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with&#xD;
      influenza, The trial designed by randomized, double-blind, placebo-controlled, multicenter&#xD;
      and optimal efficiency. Subjects will be randomly assigned to low-dose group, high-dose group&#xD;
      or placebo group as 1:1:1 proportionally, planned to enroll 180 subjects, each group enroll&#xD;
      60 subjects. The primary indicator is the time of fever relieving, comparison after the&#xD;
      second visit. The secondary indicator are symptom alleviating time of influenza, percentage&#xD;
      of subjects with influenza complications, percentage of antipyretic drugs used, percentage of&#xD;
      virus positive to negative, comparison at the end of the experiment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The time of fever relieving</measure>
    <time_frame>day 3</time_frame>
    <description>After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptom alleviating time of influenza</measure>
    <time_frame>day 3 and day 5</time_frame>
    <description>The area under the curve (AUC) of the decline in the subjects' influenza symptom total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with influenza complications Percentage of subjects with influenza complications</measure>
    <time_frame>day 3 and day 5</time_frame>
    <description>Percentage of subjects with influenza complications, e.g. be hospitalized, death, sinusitis, otitis media, bronchitis, pneumonia, and so on.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of antipyretic drugs used</measure>
    <time_frame>day 3 and day 5</time_frame>
    <description>Percentage of the subjects used paracetamol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of virus positive to negative</measure>
    <time_frame>day 3 and day 5</time_frame>
    <description>Percentage of subjects' influenza virus positive change to negative</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>low-dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baicalein Tablets group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high-dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baicalein Tablets group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baicalein Tablets 400mg</intervention_name>
    <description>4 Baicalein Tablets and 2 placebo per time, three times a day</description>
    <arm_group_label>low-dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baicalein Tablets 600mg</intervention_name>
    <description>6 Baicalein Tablets per time, three times a day</description>
    <arm_group_label>high-dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>blank control 0mg</intervention_name>
    <description>6 placebo per time, three times a day</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Meet the diagnostic criteria for influenza（non-severe）; 2.Fever to take medicine for&#xD;
             the first time, The patient's maximum temperature (axillary temperature) is over 38℃;&#xD;
             3.The rapid virus antigen test of nasal swab was positive; 4.Course of disease ≤ 24&#xD;
             hours(The definition of course of disease is the time from fever to take&#xD;
             investigational product for the first time); 5.Aged 18 to 65 years old(include 18 and&#xD;
             65), all genders; 6.Sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.The patients with severe influenza or complication (e.g. secondary bacterial&#xD;
             pneumonia, pneumonia caused by other pathogens or other viral pneumonia); 2.The&#xD;
             patients with other acute upper respiratory tract infection (e.g. acute pharyngitis,&#xD;
             tonsillitis, rhinitis and nasosinuitis); 3.Allergic to baicalin and its analogue,&#xD;
             Paracetamol tablets, or allergic people; 4.Patients with any of the following risk&#xD;
             factors:&#xD;
&#xD;
               1. Residents living in long-term care facilities (e.g. welfare house, sanatorium);&#xD;
&#xD;
               2. Combined with chronic respiratory diseases (e.g. bronchial asthma, chronic&#xD;
                  obstrctive palmonary diseases);&#xD;
&#xD;
               3. Combined with chronic cardiovascular disease (e.g. congenital heart disease,&#xD;
                  congestive heart failure, or coronary artery disease, but doesnt include&#xD;
                  hypertension without any other cardio-related symptoms);&#xD;
&#xD;
               4. Combined with hematological system diseases (e.g. chronic myelogenous leukemia,&#xD;
                  lymphocytic leukemia, myelodysplastic syndrome, aplastic anemia);&#xD;
&#xD;
               5. Neurodevelopmental disorders, include cerebrum, spinal cord, Peripheral nerve and&#xD;
                  muscle disorders (e.g. cerebral palsy, epilepsy[epileptic seizure disorder],&#xD;
                  stroke, dysgnosia, Moderate to severe dysplasia, myodystrophy, or spinal cord&#xD;
                  injury);&#xD;
&#xD;
               6. Poor control of chronic metabolic and endocrine diseases;&#xD;
&#xD;
               7. Immunosuppression (long-term use of immunosuppressant, immunocom promise caused&#xD;
                  by infection by HIV or malignant tumour);&#xD;
&#xD;
               8. Obese people[BMI&gt;30, BMI=Weight(kg)/Height(m2)] 5.Long-term take aspirin under 19&#xD;
                  years old; 6.White blood cell count&gt;11.0×109/L, or the proportion of neutrophils&#xD;
                  &gt;80%, or need systemic antibacterial therapy; 7.24 hours before the visit, the&#xD;
                  patients have received antiviral treatment for influenza; 8.The patients have&#xD;
                  received Influenza vaccine or research monoclonal antibody in a year; 9.ALT and&#xD;
                  AST is equal or greater than 1.5 times of upper limit of normal, Scr is greater&#xD;
                  than upper limit of normal; 10.Suspected or really have a history of alcohol or&#xD;
                  drug abuse; 11.Gestation (have a positive pregnancy test), lactating women, or&#xD;
                  have a family planning within the next 6 months; 12.The patients have&#xD;
                  participated in other clinical trials within 3 months; 13.The investigator&#xD;
                  considers it inappropriate to participate in this clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qingquan Liu, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Chinese Medicine Hospital affiliated to Capital Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kun Lou</last_name>
    <phone>0311-67808817</phone>
    <email>loukun@mail.ecspc.com</email>
  </overall_contact>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Baicalein</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830684
org study id: HQS201801/PRO
nct id: NCT03830684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study in order to evaluate the Baicalein Tablets' safety and efficiency for audit with
      influenza
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The time of fever relieving
time frame: day 3
description: After the first dose, the time of subjects' armpit temperature reduced to 37.3℃, and no longer increases in 24h.
measure: symptom alleviating time of influenza
time frame: day 3 and day 5
description: The area under the curve (AUC) of the decline in the subjects' influenza symptom total score.
measure: Percentage of subjects with influenza complications Percentage of subjects with influenza complications
time frame: day 3 and day 5
description: Percentage of subjects with influenza complications, e.g. be hospitalized, death, sinusitis, otitis media, bronchitis, pneumonia, and so on.
measure: Percentage of antipyretic drugs used
time frame: day 3 and day 5
description: Percentage of the subjects used paracetamol.
measure: Percentage of virus positive to negative
time frame: day 3 and day 5
description: Percentage of subjects' influenza virus positive change to negative
arm group label: low-dose group
arm group type: Experimental
description: Baicalein Tablets group
arm group label: high-dose group
arm group type: Experimental
description: Baicalein Tablets group
arm group label: placebo group
arm group type: Placebo Comparator
description: control group
intervention type: Drug
intervention name: Baicalein Tablets 400mg
description: 4 Baicalein Tablets and 2 placebo per time, three times a day
arm group label: low-dose group
intervention type: Drug
intervention name: Baicalein Tablets 600mg
description: 6 Baicalein Tablets per time, three times a day
arm group label: high-dose group
intervention type: Drug
intervention name: blank control 0mg
description: 6 placebo per time, three times a day
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Qingquan Liu, Professor
role: Study Chair
affiliation: Beijing Chinese Medicine Hospital affiliated to Capital Medical University
last name: Kun Lou
phone: 0311-67808817
email: loukun@mail.ecspc.com
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Baicalein
sharing ipd: No