<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/NCT02232945</url>
  </required_header>
  <id_info>
    <org_study_id>HWBY-001</org_study_id>
    <nct_id>NCT02232945</nct_id>
  </id_info>
  <brief_title>Banlangen Granules Anti-seasonal Influenza Study</brief_title>
  <acronym>BLG</acronym>
  <official_title>Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled，Clinical Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen&#xD;
      granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria:&#xD;
&#xD;
        1. Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real&#xD;
           time PCR&#xD;
&#xD;
        2. age between 18-65 years old&#xD;
&#xD;
        3. axillary temperature ≥38ºC and with at least two constitutional symptoms (headache,&#xD;
           chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) .&#xD;
&#xD;
        4. Illness onset had to be within 36 hours, and informed consent was obtained.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. age younger than 18 or older than 65 years old.&#xD;
&#xD;
        2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung&#xD;
           disease by Chest imaging (chest X-ray or CT) .&#xD;
&#xD;
        3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil&#xD;
           percentage ≥80%.&#xD;
&#xD;
        4. Those have got suppurative tonsillitis or cough purulent sputum.&#xD;
&#xD;
        5. Those with underling primary disorders, such as hematological disease, chronic&#xD;
           obstructive pulmonary disease（FEV1/FVC&lt;70％，FEV1/ predicated value&lt;50％； or respiratory&#xD;
           failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal&#xD;
           disease（Serum Creatinine&gt;2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV)&#xD;
&#xD;
      7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly&#xD;
      become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass&#xD;
      index (BMI) of 25 kg/m2 or more).&#xD;
&#xD;
      9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow&#xD;
      transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.&#xD;
&#xD;
      10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other&#xD;
      clinical trial within three month before study randomization.&#xD;
&#xD;
      12. Two weeks before the test , those with acute respiratory Infection，otitis,or&#xD;
      nasosinusitis .&#xD;
&#xD;
      13. Those already vaccinated or who will receive influenza vaccine. 14. other reasons not&#xD;
      suitable for enrollment based on the investigator's discretion.&#xD;
&#xD;
      The primary efficacy endpoint:&#xD;
&#xD;
        1. The primary end point was the duration of illness which was defined as the time from&#xD;
           onset of symptoms to the alleviation of the ten influenza-like symptoms including ,&#xD;
           nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills&#xD;
           and sweating.&#xD;
&#xD;
        2. The time to defervescence, defined as the time from the first dose of study medication&#xD;
           to the time when the body temperature declined to lower than 37.4ºC and was sustained&#xD;
           for at least 24 hours.&#xD;
&#xD;
      Secondary efficacy endpoint:&#xD;
&#xD;
      The secondary end points included: 1) viral shedding duration, defined as the time from the&#xD;
      illness onset to the first time the viral nucleic acid test was negative; 2) the severity of&#xD;
      the disease,assessed by an area under the curve (AUC) analysis of a total of nine&#xD;
      influenza-like symptom scores, the AUC was calculated as the product of the daily symptom&#xD;
      scores times the duration of illness;3)frequency of Usage of Acetaminophen;4)and incidence of&#xD;
      secondary complications of influenza, such as otitis, bronchitis, pneumonia，Nasosinusitis&#xD;
      ,suppurative tonsillitis,acute parotitis，Reye'ssyndrome，central nervous system disease,&#xD;
      Myocarditis and pericarditis, acute myositis, and toxic shock syndrome.5) economic&#xD;
      evaluation.&#xD;
&#xD;
      Specimen:&#xD;
&#xD;
      the pharyngeal or the throat swab，blood. Pharyngea /throat secretions will be obtained from&#xD;
      the upper respiratory tract of each patient.&#xD;
&#xD;
      All specimens will be stored at -80℃ in virus laboratory of the first affiliated hospital of&#xD;
      guangzhou medical university for 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 4</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improving the flu-like symptoms, such as fever etc</measure>
    <time_frame>21+7days</time_frame>
    <description>The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improving the flu-like symptoms, such as fever etc</measure>
    <time_frame>21+7days</time_frame>
    <description>The time to defervescence, defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.4ºC and was sustained for at least 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>others</measure>
    <time_frame>21+7days</time_frame>
    <description>viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others</measure>
    <time_frame>21+7days</time_frame>
    <description>the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others</measure>
    <time_frame>21+7days</time_frame>
    <description>frequency of Usage of Acetaminophen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others</measure>
    <time_frame>21+7days</time_frame>
    <description>incidence of secondary complications of influenza</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others</measure>
    <time_frame>21+7days</time_frame>
    <description>economic evaluation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">177</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Banlangen granules &amp; placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oseltamivir phosphate &amp; placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo of oseltamivir phosphate</intervention_name>
    <arm_group_label>Banlangen granules &amp; placebo</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oseltamivir phosphate</intervention_name>
    <arm_group_label>oseltamivir phosphate &amp; placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Banlangen (Radix Isatidis) granules</intervention_name>
    <arm_group_label>Banlangen granules &amp; placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo of Banlangen(Radix Isatidis) granules</intervention_name>
    <arm_group_label>oseltamivir phosphate &amp; placebo</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR&#xD;
        (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two&#xD;
        constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom&#xD;
        (cough ，sore throat,or coryza) . Illness onset had to be within 36 hours, and informed&#xD;
        consent was obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age younger than 18 or older than 65 years old.&#xD;
&#xD;
          2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung&#xD;
             disease by Chest imaging (chest X-ray or CT) .&#xD;
&#xD;
          3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil&#xD;
             percentage ≥80%.&#xD;
&#xD;
          4. Those have got suppurative tonsillitis or cough purulent sputum.&#xD;
&#xD;
          5. Those with underling primary disorders, such as hematological disease, chronic&#xD;
             obstructive pulmonary disease（FEV1/FVC&lt;70％，FEV1/ predicated value&lt;50％； or respiratory&#xD;
             failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal&#xD;
             disease（Serum Creatinine&gt;2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV)&#xD;
&#xD;
        7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may&#xD;
        possibly become pregnant or are lactating with a positive urine pregnant test, obesity&#xD;
        (abody mass index (BMI) of 25 kg/m2 or more).&#xD;
&#xD;
        9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow&#xD;
        transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.&#xD;
&#xD;
        10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other&#xD;
        clinical trial within three month before study randomization.&#xD;
&#xD;
        12. Two weeks before the test , those with acute respiratory Infection，otitis,or&#xD;
        nasosinusitis .&#xD;
&#xD;
        13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not&#xD;
        suitable for enrollment based on the investigator's discretion.&#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>Nanshan Zhong, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Guangzhou Institute of Respiratory Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuedong Cai, Master</last_name>
    <phone>86-20-66282326</phone>
    <email>caiyuedong@813zy.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangzhou Institute of Respiratory Disease</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510230</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nan S Zhong, PHD</last_name>
      <phone>020-83062718</phone>
      <email>nanshan@vip.163.com</email>
    </contact>
    <investigator>
      <last_name>N S Zhong, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza A (H1N1,H3N2)</keyword>
  <keyword>influenza B virus</keyword>
  <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>Oseltamivir</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02232945
org study id: HWBY-001
nct id: NCT02232945
lead sponsor: 
collaborator: 
has dmc: Yes
This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen
      granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.
Inclusion criteria:

        1. Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real
           time PCR

        2. age between 18-65 years old

        3. axillary temperature ≥38ºC and with at least two constitutional symptoms (headache,
           chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) .

        4. Illness onset had to be within 36 hours, and informed consent was obtained.

      Exclusion criteria:

        1. age younger than 18 or older than 65 years old.

        2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung
           disease by Chest imaging (chest X-ray or CT) .

        3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil
           percentage ≥80%.

        4. Those have got suppurative tonsillitis or cough purulent sputum.

        5. Those with underling primary disorders, such as hematological disease, chronic
           obstructive pulmonary disease（FEV1/FVC<70％，FEV1/ predicated value<50％； or respiratory
           failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal
           disease（Serum Creatinine>2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV)

      7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly
      become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass
      index (BMI) of 25 kg/m2 or more).

      9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow
      transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.

      10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other
      clinical trial within three month before study randomization.

      12. Two weeks before the test , those with acute respiratory Infection，otitis,or
      nasosinusitis .

      13. Those already vaccinated or who will receive influenza vaccine. 14. other reasons not
      suitable for enrollment based on the investigator's discretion.

      The primary efficacy endpoint:

        1. The primary end point was the duration of illness which was defined as the time from
           onset of symptoms to the alleviation of the ten influenza-like symptoms including ,
           nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills
           and sweating.

        2. The time to defervescence, defined as the time from the first dose of study medication
           to the time when the body temperature declined to lower than 37.4ºC and was sustained
           for at least 24 hours.

      Secondary efficacy endpoint:

      The secondary end points included: 1) viral shedding duration, defined as the time from the
      illness onset to the first time the viral nucleic acid test was negative; 2) the severity of
      the disease,assessed by an area under the curve (AUC) analysis of a total of nine
      influenza-like symptom scores, the AUC was calculated as the product of the daily symptom
      scores times the duration of illness;3)frequency of Usage of Acetaminophen;4)and incidence of
      secondary complications of influenza, such as otitis, bronchitis, pneumonia，Nasosinusitis
      ,suppurative tonsillitis,acute parotitis，Reye'ssyndrome，central nervous system disease,
      Myocarditis and pericarditis, acute myositis, and toxic shock syndrome.5) economic
      evaluation.

      Specimen:

      the pharyngeal or the throat swab，blood. Pharyngea /throat secretions will be obtained from
      the upper respiratory tract of each patient.

      All specimens will be stored at -80℃ in virus laboratory of the first affiliated hospital of
      guangzhou medical university for 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Improving the flu-like symptoms, such as fever etc
time frame: 21+7days
description: The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.
measure: Improving the flu-like symptoms, such as fever etc
time frame: 21+7days
description: The time to defervescence, defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.4ºC and was sustained for at least 24 hours.
measure: others
time frame: 21+7days
description: viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative
measure: Others
time frame: 21+7days
description: the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness
measure: Others
time frame: 21+7days
description: frequency of Usage of Acetaminophen
measure: Others
time frame: 21+7days
description: incidence of secondary complications of influenza
measure: Others
time frame: 21+7days
description: economic evaluation
arm group label: placebo
arm group type: Placebo Comparator
description: placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.
arm group label: Banlangen granules & placebo
arm group type: Experimental
description: Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate
arm group label: oseltamivir phosphate & placebo
arm group type: Active Comparator
description: oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules
intervention type: Drug
intervention name: placebo of oseltamivir phosphate
arm group label: Banlangen granules & placebo
arm group label: placebo
intervention type: Drug
intervention name: oseltamivir phosphate
arm group label: oseltamivir phosphate & placebo
intervention type: Drug
intervention name: Banlangen (Radix Isatidis) granules
arm group label: Banlangen granules & placebo
intervention type: Drug
intervention name: placebo of Banlangen(Radix Isatidis) granules
arm group label: oseltamivir phosphate & placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nanshan Zhong, PhD
role: Study Chair
affiliation: Guangzhou Institute of Respiratory Disease
last name: Yuedong Cai, Master
phone: 86-20-66282326
email: caiyuedong@813zy.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Oseltamivir