<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/NCT03258229</url>
  </required_header>
  <id_info>
    <org_study_id>WBP-HG-AG2</org_study_id>
    <nct_id>NCT03258229</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia</brief_title>
  <official_title>A 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 was conducted to investigate the effects of daily supplementation of Angelica&#xD;
      gigas N. extract on improvement of Hyperglycemia .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design&#xD;
      human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a&#xD;
      placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test&#xD;
      (OGTT) were assessed before and after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">December 7, 2017</completion_date>
  <primary_completion_date type="Actual">December 7, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>2×2 cross-over Assignment</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of blood glucose during OGTT (oral glucose tolerance test)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of blood insulin during OGTT</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of blood insulin during OGTT were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Homeostatic model assessment-insulin resistance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Homeostatic model assessment-beta-cell</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of HbA1c</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of HbA1c(%) were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Adiponectin, Leptin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lipid profile</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes of lipid profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Angelica gigas N. extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>capsules(2cap/d, 1,000mg/d) for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Angelica gigas N. extract</intervention_name>
    <description>capsules(2cap/d, 1,000mg/d) for 8 weeks.</description>
    <arm_group_label>Angelica gigas N. extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose&#xD;
             140-199 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight less than 48 kg or weight decreased by more than 10% within past 3 months&#xD;
&#xD;
          -  Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or&#xD;
             Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks&#xD;
&#xD;
          -  Treated with corticosteroid within past 4 weeks&#xD;
&#xD;
          -  Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)&#xD;
&#xD;
          -  Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic&#xD;
             syndrome, etc)&#xD;
&#xD;
          -  Rheumatoid arthritis, Autoimmune disease&#xD;
&#xD;
          -  Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
&#xD;
          -  History of disease that could interfere with the test products or impede their&#xD;
             absorption&#xD;
&#xD;
          -  Under antipsychotic drugs therapy within past 2 months&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Laboratory test by show the following results&#xD;
&#xD;
               -  aspartate aminotransferase, alanine aminotransferase &gt; Reference range upper&#xD;
                  limit treble&#xD;
&#xD;
               -  Serum Creatinine &gt; 2.0 mg/dl&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Not Contraception(except: Surgery for female infertility)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods; Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>560-822</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>March 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-Wan Chae</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <keyword>Angelica gigas N. extract</keyword>
  <keyword>Glucose</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03258229
org study id: WBP-HG-AG2
nct id: NCT03258229
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to investigate the effects of daily supplementation of Angelica
      gigas N. extract on improvement of Hyperglycemia .
This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design
      human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a
      placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test
      (OGTT) were assessed before and after the intervention.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 2×2 cross-over Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of blood glucose during OGTT (oral glucose tolerance test)
time frame: 8 weeks
description: Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
measure: Changes of blood insulin during OGTT
time frame: 8 weeks
description: Changes of blood insulin during OGTT were assessed before and after the intervention.
measure: Changes of Homeostatic model assessment-insulin resistance
time frame: 8 weeks
description: Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention
measure: Changes of Homeostatic model assessment-beta-cell
time frame: 8 weeks
description: Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
measure: Changes of HbA1c
time frame: 8 weeks
description: Changes of HbA1c(%) were assessed before and after the intervention
measure: Changes of Adiponectin, Leptin
time frame: 8 weeks
description: Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention
measure: Changes of lipid profile
time frame: 8 weeks
description: Changes of lipid profile were assessed before and after the intervention
arm group label: Angelica gigas N. extract
arm group type: Experimental
description: capsules(2cap/d, 1,000mg/d) for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 8 weeks
intervention type: Dietary Supplement
intervention name: Angelica gigas N. extract
description: capsules(2cap/d, 1,000mg/d) for 8 weeks.
arm group label: Angelica gigas N. extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 8 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal Investigator, Clinical Trial Center for Functional Foods
mesh term: Hyperglycemia
sharing ipd: Undecided