<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/NCT02254603</url>
  </required_header>
  <id_info>
    <org_study_id>1011003</org_study_id>
    <nct_id>NCT02254603</nct_id>
  </id_info>
  <brief_title>The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss</brief_title>
  <official_title>To Evaluate the Effects of Weight-loss by the Combined Therapy of Acupuncture and Yoga Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the effects of combination of acupuncture and ayuveda&#xD;
      yoga exercise on weight loss for the overweight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a common health problem in developed countries. At present,the medical staff have&#xD;
      already been alerted that the obesity is a kind of disease actually and one of the epidemic&#xD;
      diseases which erode the human health in the world. It is not only about the person's health&#xD;
      but also a main public health problem. It has been caught to our attention that some&#xD;
      diseases, such as cardiovascular diseases,diabetes, and high blood pressure are coming along&#xD;
      with overweight and obesity. Recent studies had demonstrated a positive correlation between&#xD;
      chronic diseases and obesity. There are many treatments for the obesity, in general,&#xD;
      acupuncture may be an effective one. Acupuncture may suppress the people's appetite, slow&#xD;
      down the stomach's creeping motion, and increase the stomach's evacuation time.&#xD;
      Simultaneously, acupuncture controls the body through the absorption and storage of the&#xD;
      calorie via the adjustment of the endocrine system. But we still need a more efficiency way&#xD;
      to accelerate the body fat metabolism and decrease the storage of the fat in vivo. Therefore,&#xD;
      the purpose of this study is to examine the effects of combination of acupuncture and ayuveda&#xD;
      yoga exercise on weight loss among the overweight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduce body mass index.</measure>
    <time_frame>Change from baseline in body mass index at 3 months</time_frame>
    <description>Outcome measure compares the change in body mass index during 3 months treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduce waistline</measure>
    <time_frame>Change from baseline in waistline at 3 months</time_frame>
    <description>Outcome measure compares the change in waistline during 3 months treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change biochemical profile of blood</measure>
    <time_frame>Change from baseline in biochemical profile of blood at 3 months</time_frame>
    <description>Outcome measure compares the changes in biochemical profile of blood including cholesterol/high-density lipoprotein/low-density lipoprotein/blood sugar during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune modulation</measure>
    <time_frame>Change from baseline in lymphocyte profile and polarization at 3 months</time_frame>
    <description>Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF-β/ IL-10) during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Acupuncture controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Acupuncture group will receive 30-minutes treatment three times a week for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acupuncture and yoga exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.</description>
    <arm_group_label>Acupuncture controls</arm_group_label>
    <arm_group_label>acupuncture and yoga exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga exercise</intervention_name>
    <description>Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.</description>
    <arm_group_label>acupuncture and yoga exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 24&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuender D. Yang, PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shu-Hui Yeh, PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital &amp; Central Taiwan University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yu-Kwan Lu, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kuender D. Yang, PhD</last_name>
    <phone>886-975617006</phone>
    <email>yehshuhui@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shu-Hui Yeh</investigator_full_name>
    <investigator_title>RN, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity, ayuveda yoga exercise, acupuncture.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT02254603
org study id: 1011003
nct id: NCT02254603
lead sponsor: 
has dmc: No
The aim of this study is to examine the effects of combination of acupuncture and ayuveda
      yoga exercise on weight loss for the overweight.
Obesity is a common health problem in developed countries. At present,the medical staff have
      already been alerted that the obesity is a kind of disease actually and one of the epidemic
      diseases which erode the human health in the world. It is not only about the person's health
      but also a main public health problem. It has been caught to our attention that some
      diseases, such as cardiovascular diseases,diabetes, and high blood pressure are coming along
      with overweight and obesity. Recent studies had demonstrated a positive correlation between
      chronic diseases and obesity. There are many treatments for the obesity, in general,
      acupuncture may be an effective one. Acupuncture may suppress the people's appetite, slow
      down the stomach's creeping motion, and increase the stomach's evacuation time.
      Simultaneously, acupuncture controls the body through the absorption and storage of the
      calorie via the adjustment of the endocrine system. But we still need a more efficiency way
      to accelerate the body fat metabolism and decrease the storage of the fat in vivo. Therefore,
      the purpose of this study is to examine the effects of combination of acupuncture and ayuveda
      yoga exercise on weight loss among the overweight.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Reduce body mass index.
time frame: Change from baseline in body mass index at 3 months
description: Outcome measure compares the change in body mass index during 3 months treatment.
measure: Reduce waistline
time frame: Change from baseline in waistline at 3 months
description: Outcome measure compares the change in waistline during 3 months treatment.
measure: Change biochemical profile of blood
time frame: Change from baseline in biochemical profile of blood at 3 months
description: Outcome measure compares the changes in biochemical profile of blood including cholesterol/high-density lipoprotein/low-density lipoprotein/blood sugar during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.
measure: Immune modulation
time frame: Change from baseline in lymphocyte profile and polarization at 3 months
description: Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF-β/ IL-10) during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.
arm group label: Acupuncture controls
arm group type: Other
description: Acupuncture group will receive 30-minutes treatment three times a week for 3 months.
arm group label: acupuncture and yoga exercise
arm group type: Experimental
description: Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.
intervention type: Device
intervention name: Acupuncture
description: Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.
arm group label: Acupuncture controls
arm group label: acupuncture and yoga exercise
intervention type: Behavioral
intervention name: Yoga exercise
description: Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.
arm group label: acupuncture and yoga exercise
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Kuender D. Yang, PhD.
role: Study Chair
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shu-Hui Yeh, PhD.
role: Study Director
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
last name: Yu-Kwan Lu, MD.
role: Principal Investigator
affiliation: Show Chwan Memorial Hospital
last name: Kuender D. Yang, PhD
phone: 886-975617006
email: yehshuhui@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Shu-Hui Yeh
investigator title: RN, PhD, Professor
mesh term: Weight Loss