<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/NCT02242461</url>
  </required_header>
  <id_info>
    <org_study_id>CS11144</org_study_id>
    <nct_id>NCT02242461</nct_id>
  </id_info>
  <brief_title>Rhodiola Crenulata as an Adjunctive Therapy in COPD</brief_title>
  <acronym>COPD</acronym>
  <official_title>Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung Shan Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chung Shan Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with&#xD;
      moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation&#xD;
      and anti-oxidation for these patients, and these effects (2) may reflect in the improvement&#xD;
      of patients' physiological measurements, quality of life and exercise tolerance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, randomized, double-blind, placebo controlled clinical trial.&#xD;
&#xD;
      Eligibility criteria:&#xD;
&#xD;
        1. moderate-to-severe COPD patients&#xD;
&#xD;
        2. aged 40-80 years,&#xD;
&#xD;
        3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,&#xD;
&#xD;
        4. no acute exacerbation of COPD,&#xD;
&#xD;
        5. clinically being stable for one month and longer,&#xD;
&#xD;
        6. not undergoing exercise training program.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      six-minute walk distance in meters at week 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>six-minute walk distance in meters at week 12.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Rhodiola placebo capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhodiola Crenulata</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rhodiola Crenulata</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rhodiola placebo capsules</intervention_name>
    <description>Corn starch</description>
    <arm_group_label>Rhodiola placebo capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rhodiola Crenulata</intervention_name>
    <description>Rhodiola Crenulata</description>
    <arm_group_label>Rhodiola Crenulata</arm_group_label>
    <other_name>Rhodiola</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. moderate-to-severe COPD patients&#xD;
&#xD;
          2. aged 40-80 years,&#xD;
&#xD;
          3. abstaining from cigarette smoking or maintaining a stable dose of cigarette&#xD;
             consumption,&#xD;
&#xD;
          4. no acute exacerbation of COPD,&#xD;
&#xD;
          5. clinically being stable for one month and longer,&#xD;
&#xD;
          6. not undergoing exercise training program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. uncontrolled diabetes mellitus by plasma fasting sugar &gt;200 mg/dl,&#xD;
&#xD;
          2. uremia or CKD stage 5,&#xD;
&#xD;
          3. chronic heart failureby NYFC III,&#xD;
&#xD;
          4. cerebrovascular disease,&#xD;
&#xD;
          5. uncontrolled anemia by Hb &lt; 10 mg/dl,&#xD;
&#xD;
          6. active malignant diseases,&#xD;
&#xD;
          7. other hospitalized acute illness,&#xD;
&#xD;
          8. systemic prednisolone &gt; 10 mg per day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Lung Chuang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Critical Care Medicine and Division of Pulmonary Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Critical Care Medicine and Division of Pulmonary Medicine</name>
      <address>
        <city>Taiwan</city>
        <state>Ming-Lung Chuang</state>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
    <investigator_full_name>GCRC</investigator_full_name>
    <investigator_title>Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine</investigator_title>
  </responsible_party>
  <keyword>COPD, Rhodiola L., clinical trial, biomarkers, spirometry</keyword>
  <!-- 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/NCT02242461
org study id: CS11144
nct id: NCT02242461
lead sponsor: 
has dmc: No
We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with
      moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation
      and anti-oxidation for these patients, and these effects (2) may reflect in the improvement
      of patients' physiological measurements, quality of life and exercise tolerance.
This is a single center, randomized, double-blind, placebo controlled clinical trial.

      Eligibility criteria:

        1. moderate-to-severe COPD patients

        2. aged 40-80 years,

        3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,

        4. no acute exacerbation of COPD,

        5. clinically being stable for one month and longer,

        6. not undergoing exercise training program.

      Primary endpoint:

      six-minute walk distance in meters at week 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: six-minute walk distance in meters at week 12.
time frame: 12 weeks
measure: mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test
time frame: 12 weeks
arm group label: Rhodiola placebo capsules
arm group type: Placebo Comparator
description: starch
arm group label: Rhodiola Crenulata
arm group type: Experimental
description: Rhodiola Crenulata
intervention type: Drug
intervention name: Rhodiola placebo capsules
description: Corn starch
arm group label: Rhodiola placebo capsules
intervention type: Drug
intervention name: Rhodiola Crenulata
description: Rhodiola Crenulata
arm group label: Rhodiola Crenulata
other name: Rhodiola
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ming Lung Chuang
role: Principal Investigator
affiliation: Department of Critical Care Medicine and Division of Pulmonary Medicine
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chung Shan Medical University
investigator full name: GCRC
investigator title: Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine