<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/NCT02989012</url>
  </required_header>
  <id_info>
    <org_study_id>DalianZhen-Ao</org_study_id>
    <nct_id>NCT02989012</nct_id>
  </id_info>
  <brief_title>Phase IIaTrials of GanMaoKangNing Granules</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalian Zhen-Ao Bio-Tech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalian Zhen-Ao Bio-Tech Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled,&#xD;
      multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the&#xD;
      symptoms of influenza.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <primary_completion_date type="Anticipated">July 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flu recovery time</measure>
    <time_frame>six days</time_frame>
    <description>All the time needed for symptoms eased that from medication to fever and headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single symptom remission rate</measure>
    <time_frame>six days</time_frame>
    <description>After the medication and three days later, The proportion of each individual symptoms of subjects which include of headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.&#xD;
Symptoms defined as symptom scores dropped to 0 or 1 minute, and maintain for 24 h or more.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The antifebrile effect</measure>
    <time_frame>six days</time_frame>
    <description>Antifebrile rate: After the medication and three days later, the percentage of Body temperature returned to normal subjects (the axillary temperature &lt; 37.1 ℃, and maintain of 24 h or more time).&#xD;
Medicine antifebrile time (h) : Medication for the first time to the axillary temperature &lt; 37.1 ℃, and maintain of 24 h or more time.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The conditions of drug utilization of the antipyretic and some cough medicine</measure>
    <time_frame>six days</time_frame>
    <description>Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Epidemic Influenza</condition>
  <arm_group>
    <arm_group_label>Drugs for experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drugs for control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GanMaoKangNing Granules</intervention_name>
    <description>3 times a day, 2 bags each time.</description>
    <arm_group_label>Drugs for experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Analogous Oseltamivir Phosphate Capsules</intervention_name>
    <description>2 times a day,1 capsule each time.</description>
    <arm_group_label>Drugs for experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oseltamivir Phosphate Capsules</intervention_name>
    <description>2 times a day,1 capsule each time.</description>
    <arm_group_label>Drugs for control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Analogous GanMaoKangNing Granules</intervention_name>
    <description>3 times a day, 2 bags each time.</description>
    <arm_group_label>Drugs for control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign the informed consent;&#xD;
&#xD;
          -  Male and female patients aged between 18 and 65 years old , there is no limit on the&#xD;
             gender;&#xD;
&#xD;
          -  In line with the diagnostic criteria for pandemic influenza;&#xD;
&#xD;
          -  Duration less than 48 (Duration is defined as the time from onset to test drugs for&#xD;
             the first time before, the onset time pointed out that now the axillary temperature&#xD;
             38.0 ℃, headache, muscle or joint pain, chills, fatigue, cough, sore throat and a&#xD;
             stuffy nose eight any flu symptoms and signs in time);&#xD;
&#xD;
          -  The axillary temperature is 38.0 ℃ or higher;&#xD;
&#xD;
          -  Nose and throat swabs rapid virus antigen test result is positive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe influenza and of patients with complications of influenza.&#xD;
&#xD;
          -  With the following any severe risk factors:&#xD;
&#xD;
        A. With chronic respiratory diseases such as bronchial asthma, chronic obstructive&#xD;
        pulmonary disease (copd), etc.&#xD;
&#xD;
        B. with chronic diseases of the cardiovascular system, such as congestive heart failure,&#xD;
        high blood pressure.&#xD;
&#xD;
        C. with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes&#xD;
        (HbA1c 7.0% or higher).&#xD;
&#xD;
        D. with chronic kidney disease, chronic liver disease, blood system diseases, neurological&#xD;
        and neuromuscular diseases (such as epilepsy, cognitive impairment, etc.).&#xD;
&#xD;
        E. A weakened immune system, such as long-term use of immunosuppressive agents, HIV&#xD;
        infection or tumor.&#xD;
&#xD;
        F. Under the age of 19, long-term aspirin use. G. The obese (BMI BMI &gt; 30).&#xD;
&#xD;
          -  With influenza complications, such as secondary bacterial pneumonia and other&#xD;
             pathogenic bacteria and other viral pneumonia caused by pneumonia.&#xD;
&#xD;
          -  A history of peptic ulcer disease or gastrointestinal bleeding.&#xD;
&#xD;
          -  Into the group received within 48 h before flu antiviral treatment.&#xD;
&#xD;
          -  Into the group of 12 months before been vaccinated against the flu.&#xD;
&#xD;
          -  Into the group used within 2 weeks before the monoamine oxidase inhibitors.&#xD;
&#xD;
          -  Blood leukocyte count &gt; 10.0 x 109 / L, neutrophils ratio &gt; 80%, or the need for&#xD;
             systemic antibiotic therapy.&#xD;
&#xD;
          -  For GanMaoKangNing Granules, Oseltamivir Phosphate Capsules, Acetaminophen Tablets,&#xD;
             Dextromethorphan Hydrobromide Capsule, GanMaoKangNing Granules simulation agent or&#xD;
             Oseltamivir Phosphate Capsules simulation agent composition of allergy, or allergic&#xD;
             constitution.&#xD;
&#xD;
          -  Aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 1.5 x Upper Limit&#xD;
             Normal (ULN)， Scr &gt; Upper Limit Normal (ULN).&#xD;
&#xD;
          -  Doubt or does have a history of alcohol or drug abuse.&#xD;
&#xD;
          -  Pregnancy (defined as the pregnancy test positive), nursing mothers, or past in family&#xD;
             planning.&#xD;
&#xD;
          -  For nearly three months participated in other clinical trials of patients.&#xD;
&#xD;
          -  Researchers think not appropriate to participate in this clinical subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University</name>
      <address>
        <city>Beijing Shi</city>
        <state>Beijing</state>
        <zip>100010</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jing Wang Jing Wang, Dr.</last_name>
      <phone>010-64011516</phone>
      <email>lunlihui@163.com</email>
    </contact>
    <investigator>
      <last_name>QingQuan Liu Liu QingQuan, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.who.int/mediacentre/factsheets/fs211/en/.</url>
    <description>WHO. Influenza（Seasonal）[EB/OL].[2015-12-31]</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02989012
org study id: DalianZhen-Ao
nct id: NCT02989012
lead sponsor: 
has dmc: No
Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled,
      multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the
      symptoms of influenza.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Flu recovery time
time frame: six days
description: All the time needed for symptoms eased that from medication to fever and headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
measure: Single symptom remission rate
time frame: six days
description: After the medication and three days later, The proportion of each individual symptoms of subjects which include of headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
Symptoms defined as symptom scores dropped to 0 or 1 minute, and maintain for 24 h or more.
measure: The antifebrile effect
time frame: six days
description: Antifebrile rate: After the medication and three days later, the percentage of Body temperature returned to normal subjects (the axillary temperature < 37.1 ℃, and maintain of 24 h or more time).
Medicine antifebrile time (h) : Medication for the first time to the axillary temperature < 37.1 ℃, and maintain of 24 h or more time.
measure: The conditions of drug utilization of the antipyretic and some cough medicine
time frame: six days
description: Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.
arm group label: Drugs for experimental group
arm group type: Experimental
description: GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
arm group label: Drugs for control group
arm group type: Sham Comparator
description: Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
intervention type: Drug
intervention name: GanMaoKangNing Granules
description: 3 times a day, 2 bags each time.
arm group label: Drugs for experimental group
intervention type: Drug
intervention name: Analogous Oseltamivir Phosphate Capsules
description: 2 times a day,1 capsule each time.
arm group label: Drugs for experimental group
intervention type: Drug
intervention name: Oseltamivir Phosphate Capsules
description: 2 times a day,1 capsule each time.
arm group label: Drugs for control group
intervention type: Drug
intervention name: Analogous GanMaoKangNing Granules
description: 3 times a day, 2 bags each time.
arm group label: Drugs for control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
contact: 
investigator: 
country: China
url: http://www.who.int/mediacentre/factsheets/fs211/en/.
description: WHO. Influenza（Seasonal）[EB/OL].[2015-12-31]
responsible party type: Sponsor
mesh term: Oseltamivir