<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/NCT01724099</url>
  </required_header>
  <id_info>
    <org_study_id>HP001</org_study_id>
    <nct_id>NCT01724099</nct_id>
  </id_info>
  <brief_title>Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity</brief_title>
  <official_title>A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gachon University Gil Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a&#xD;
      superior reduction compared to those taking the placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm.&#xD;
      They will be screened at first visit. At the baseline, that is the second visit, they will be&#xD;
      evaluated each outcomes including weight, waist circumference, lipid profile (total&#xD;
      cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat&#xD;
      area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and&#xD;
      eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it&#xD;
      contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be&#xD;
      repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be&#xD;
      given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be&#xD;
      repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated&#xD;
      including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous&#xD;
      fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes,&#xD;
      etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight reduction</measure>
    <time_frame>between baseline and 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist/hip ratio</measure>
    <time_frame>4 weeks, 8 weeks, and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean Obesity-related Quality of Life scale</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean version of Eating Attitudes Test-26</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral fat area</measure>
    <time_frame>baseline and 12 weeks</time_frame>
    <description>Using abdominal computed tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subcutaneous fat area</measure>
    <time_frame>baseline and 12 weeks</time_frame>
    <description>Using abdominal computed tomography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Euiiyin-tang</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>powder type, 3 times per day before the meal, 12 weeks total</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>powder type, 3 times per day before the meal, 12 weeks total</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Euiiyin-tang</intervention_name>
    <description>Korean medicinal herbal drug</description>
    <arm_group_label>Euiiyin-tang</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo drug, same odor and formula as Euiiyin-tang</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged 18-65 years old&#xD;
&#xD;
          2. Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI&#xD;
             27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled&#xD;
             (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent&#xD;
             diabetes mellitus and fasting blood glucose &lt; 7.8mmol/L(140mg/dL) 2.4. BMI&#xD;
             27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total&#xD;
             cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening&#xD;
&#xD;
          3. Agreed to low-calorie diet during the trial&#xD;
&#xD;
          4. Written informed consent of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.&#xD;
&#xD;
          2. Heart disease (heart failure, angina pectoris, myocardial infarction)&#xD;
&#xD;
          3. Uncontrolled hypertension (SBP &gt; 145 mmHg or DBP &gt; 95 mmHg)&#xD;
&#xD;
          4. Malignant tumour or lung disease&#xD;
&#xD;
          5. Cholelithiasis&#xD;
&#xD;
          6. Severe renal disability (SCr &gt; 2.0 mg/dL)&#xD;
&#xD;
          7. Severe liver disability (2.5 fold of normal high range value on Alanine&#xD;
             Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)&#xD;
&#xD;
          8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL)&#xD;
             or over&#xD;
&#xD;
          9. Narrow angle glaucoma&#xD;
&#xD;
         10. History or existence of neurological or psychological disease (schizophrenia,&#xD;
             epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)&#xD;
&#xD;
         11. History of stroke or temporary ischemic cardioplegia&#xD;
&#xD;
         12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa,&#xD;
             etc.&#xD;
&#xD;
         13. Use of medication that could have effect on weight within last 3 months (appetite&#xD;
             suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine,&#xD;
             phenothiazine or medication having effect on absorption, metabolism, excretion)&#xD;
&#xD;
         14. Use of β--blocker or diuretic as hypertension medication within last 3 months&#xD;
&#xD;
         15. Use of medication for central nervous system or central active weight reduction&#xD;
             medication&#xD;
&#xD;
         16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent,&#xD;
             barbiturate, antipsychotic, medication concerns of abuse)&#xD;
&#xD;
         17. Difficult to measure anthropometric dimensions because of anatomical change such as&#xD;
             resection&#xD;
&#xD;
         18. Surgical history for weight reduction; bariatric surgery, etc.&#xD;
&#xD;
         19. Unable to follow instructions of the trial as judged by investigator&#xD;
&#xD;
         20. Women who were pregnant, lactating, planning a pregnancy or women of childbearing age&#xD;
             who do not agree to proper contraception (birth-control pill, hormone implant, IUD,&#xD;
             spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2&#xD;
             years of menopause who did not receive hysterectomy, bilateral tubal ligation,&#xD;
             bilateral oophorectomy, etc.)&#xD;
&#xD;
         21. Use of other investigational product within last 1 month&#xD;
&#xD;
         22. Reduction over 10% of the previous weight within 6 months&#xD;
&#xD;
         23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoon-kyung SONG, KMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Seong-Gyu Ko</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Herbal product</keyword>
  <keyword>Korean Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_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/NCT01724099
org study id: HP001
nct id: NCT01724099
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a
      superior reduction compared to those taking the placebo.
This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm.
      They will be screened at first visit. At the baseline, that is the second visit, they will be
      evaluated each outcomes including weight, waist circumference, lipid profile (total
      cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat
      area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and
      eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it
      contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be
      repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be
      given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be
      repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated
      including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous
      fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes,
      etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Weight reduction
time frame: between baseline and 12 weeks
measure: C-reactive protein (CRP)
time frame: baseline and 12 weeks
measure: Blood pressure
time frame: baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Blood glucose
time frame: baseline and 12 weeks
measure: Waist/hip ratio
time frame: 4 weeks, 8 weeks, and 12 weeks
measure: Waist circumference
time frame: baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Korean Obesity-related Quality of Life scale
time frame: baseline and 12 weeks
measure: Korean version of Eating Attitudes Test-26
time frame: baseline and 12 weeks
measure: Total cholesterol
time frame: baseline and 12 weeks
measure: Triglyceride
time frame: baseline and 12 weeks
measure: Visceral fat area
time frame: baseline and 12 weeks
description: Using abdominal computed tomography
measure: Subcutaneous fat area
time frame: baseline and 12 weeks
description: Using abdominal computed tomography
arm group label: Euiiyin-tang
arm group type: Experimental
description: powder type, 3 times per day before the meal, 12 weeks total
arm group label: Placebo
arm group type: Placebo Comparator
description: powder type, 3 times per day before the meal, 12 weeks total
intervention type: Drug
intervention name: Euiiyin-tang
description: Korean medicinal herbal drug
arm group label: Euiiyin-tang
intervention type: Drug
intervention name: Placebo
description: Placebo drug, same odor and formula as Euiiyin-tang
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yoon-kyung SONG, KMD
role: Principal Investigator
affiliation: Gachon University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Seong-Gyu Ko
investigator title: Professor
mesh term: Obesity