<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/NCT02250027</url>
  </required_header>
  <id_info>
    <org_study_id>HL_HL301_201</org_study_id>
    <nct_id>NCT02250027</nct_id>
  </id_info>
  <brief_title>A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)</brief_title>
  <acronym>HL301</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Hanlim Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanlim Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal dose of HL301 in patients with acute&#xD;
      bronchitis or acute exacerbations of chronic bronchitis.&#xD;
&#xD;
      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation&#xD;
      of symptoms of cough and sputum&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bronchitis Severity Score</measure>
    <time_frame>baseline(day 0) and day 7</time_frame>
    <description>Bronchitis Severity Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breathlessness, Cough, and Sputum Scale</measure>
    <time_frame>baseline(day 0) and day 7</time_frame>
    <description>Breathlessness, Cough, and Sputum Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of symptoms of cough and sputum</measure>
    <time_frame>baseline(day 0) and day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total usage of acetaminophen</measure>
    <time_frame>baseline(day 0) and day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Acute Bronchitis</condition>
  <condition>Acute Exacerbations of Chronic Bronchitis</condition>
  <arm_group>
    <arm_group_label>experimental A (0.6g/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experimental B (1.2g/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experimental C (1.8g/day)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo: 2 capsules at once, 3 times a day, for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HL301 300mg capsule</intervention_name>
    <description>2 capsules at once, 3 times a day, for 7 days</description>
    <arm_group_label>experimental A (0.6g/day)</arm_group_label>
    <arm_group_label>experimental B (1.2g/day)</arm_group_label>
    <arm_group_label>experimental C (1.8g/day)</arm_group_label>
    <other_name>experimental A (0.6g/day) : HL301 300mg 2 capsule</other_name>
    <other_name>experimental B (1.2g/day) : HL301 300mg 4 capsule</other_name>
    <other_name>experimental C (1.8g/day) : HL301 300mg 6 capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 capsules at once, 3 times a day, for 7 days</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>experimental A (0.6g/day)</arm_group_label>
    <arm_group_label>experimental B (1.2g/day)</arm_group_label>
    <other_name>Microcrystalline Cellulose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both gender, 19 years ≤ age ≤ 80 years&#xD;
&#xD;
          2. Acute bronchitis or acute exacerbations of chronic bronchitis patients with&#xD;
             BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2&#xD;
&#xD;
          3. Written consent voluntarily to participate in this clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who were increased the bleeding tendency&#xD;
&#xD;
          2. Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum&#xD;
             Blood Urea Nitrogen, Creatinine&gt; 2 times of the normal upper range&#xD;
&#xD;
          3. Patients who investigators determines to severe respiratory disease that would&#xD;
             interfere with study assessment&#xD;
&#xD;
          4. Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more&#xD;
&#xD;
          5. Patients who were treated with oral systemic adrenocortical hormone or&#xD;
             immunosuppressive drug within 4 weeks prior to study participation&#xD;
&#xD;
          6. Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine,&#xD;
             antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health&#xD;
             functional food for antitussive and mucolytic Effect within 1 weeks prior to study&#xD;
             participation&#xD;
&#xD;
          7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic&#xD;
             antimicrobial agent within 3 days prior to study medication dosing&#xD;
&#xD;
          8. Patients with drug or alcohol abuse&#xD;
&#xD;
          9. Patients with clinically significant active liver, renal, cardiovascular, respiratory,&#xD;
             endocrine, central nervous system disease or history of malignant tumor or mental&#xD;
             illness(except no relapse for 5 years after surgery)&#xD;
&#xD;
         10. The aged person with severe medical history which is mental disorder(dementia),&#xD;
             cancer, chronic renal failure, chronic liver failure&#xD;
&#xD;
         11. Pregnant or breast-feeding&#xD;
&#xD;
         12. Patients currently participating in or has participated in other clinical study within&#xD;
             30 days prior to study participation&#xD;
&#xD;
         13. Patients who investigators determines not appropriate to take part in this clinical&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>130-872</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute bronchitis</keyword>
  <keyword>acute exacerbations of chronic bronchitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 27, 2018</submitted>
    <returned>February 1, 2019</returned>
    <submitted>February 12, 2019</submitted>
    <returned>May 10, 2019</returned>
    <submitted>May 17, 2019</submitted>
    <returned>July 19, 2019</returned>
  </pending_results>
  <!-- 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/NCT02250027
org study id: HL_HL301_201
nct id: NCT02250027
lead sponsor: 
has dmc: No
The purpose of this study is to determine the optimal dose of HL301 in patients with acute
      bronchitis or acute exacerbations of chronic bronchitis.

      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation
      of symptoms of cough and sputum
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Bronchitis Severity Score
time frame: baseline(day 0) and day 7
description: Bronchitis Severity Score
measure: Breathlessness, Cough, and Sputum Scale
time frame: baseline(day 0) and day 7
description: Breathlessness, Cough, and Sputum Scale
measure: evaluation of symptoms of cough and sputum
time frame: baseline(day 0) and day 7
measure: Total usage of acetaminophen
time frame: baseline(day 0) and day 7
arm group label: experimental A (0.6g/day)
arm group type: Experimental
description: HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days
arm group label: experimental B (1.2g/day)
arm group type: Experimental
description: HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days
arm group label: experimental C (1.8g/day)
arm group type: Experimental
description: HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo: 2 capsules at once, 3 times a day, for 7 days
intervention type: Drug
intervention name: HL301 300mg capsule
description: 2 capsules at once, 3 times a day, for 7 days
arm group label: experimental A (0.6g/day)
arm group label: experimental B (1.2g/day)
arm group label: experimental C (1.8g/day)
other name: experimental A (0.6g/day) : HL301 300mg 2 capsule
other name: experimental B (1.2g/day) : HL301 300mg 4 capsule
other name: experimental C (1.8g/day) : HL301 300mg 6 capsule
intervention type: Drug
intervention name: Placebo
description: 2 capsules at once, 3 times a day, for 7 days
arm group label: Placebo
arm group label: experimental A (0.6g/day)
arm group label: experimental B (1.2g/day)
other name: Microcrystalline Cellulose
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Acute Disease
submitted: August 27, 2018
returned: February 1, 2019
submitted: February 12, 2019
returned: May 10, 2019
submitted: May 17, 2019
returned: July 19, 2019