<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/NCT03815253</url>
  </required_header>
  <id_info>
    <org_study_id>HKBU-HMRF</org_study_id>
    <nct_id>NCT03815253</nct_id>
  </id_info>
  <brief_title>Electro-acupuncture for Central Obesity</brief_title>
  <official_title>Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Margaret Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hong Kong Baptist University</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>
      In this study, a 8-week, single blinded, randomized controlled clinical trial will be&#xD;
      conducted to examine the efficacy and safety of body acupuncture in the treatment of central&#xD;
      obesity in Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients&#xD;
      will be randomly assigned to acupuncture group or control group. The duration of the&#xD;
      treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>single-blinded, randomized, sham-controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks</time_frame>
    <description>Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in hip circumference</measure>
    <time_frame>0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks</time_frame>
    <description>hip circumference measured at the level of maximum posterior extension of the buttocks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events after treatment and follow up</measure>
    <time_frame>0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks</time_frame>
    <description>Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist-to-hip circumference ratio</measure>
    <time_frame>0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks</time_frame>
    <description>waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Mass Index</measure>
    <time_frame>0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks</time_frame>
    <description>Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body fat percentage</measure>
    <time_frame>0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks</time_frame>
    <description>The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)</measure>
    <time_frame>0, 8 weeks</time_frame>
    <description>Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Central Obesity</condition>
  <arm_group>
    <arm_group_label>Acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.&#xD;
Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.&#xD;
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham-acupuncture group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2&quot; / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.&#xD;
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.</description>
    <arm_group_label>Acupuncture group</arm_group_label>
    <arm_group_label>sham-acupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who meet all of the following criteria are defined as eligible participants: men&#xD;
        and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC&#xD;
        of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving&#xD;
        any other weight control measures or any medical and/or drug history in last 3months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of the following criteria should be excluded from the study:&#xD;
        endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder,&#xD;
        etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients&#xD;
        with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating&#xD;
        women; impaired hepatic or renal function; stroke or unable to exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaoxiang Bian, MD., Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Hong Kong Chinese Medicine Clinical Study Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Linda Zhong</name>
      <address>
        <city>Kowloon Tong</city>
        <state>Kowloon</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
    <investigator_full_name>Zhong Lidan</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</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/NCT03815253
org study id: HKBU-HMRF
nct id: NCT03815253
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, a 8-week, single blinded, randomized controlled clinical trial will be
      conducted to examine the efficacy and safety of body acupuncture in the treatment of central
      obesity in Hong Kong.
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients
      will be randomly assigned to acupuncture group or control group. The duration of the
      treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single-blinded, randomized, sham-controlled clinical trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
measure: Changes in waist circumference
time frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks
description: Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).
measure: Changes in hip circumference
time frame: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks
description: hip circumference measured at the level of maximum posterior extension of the buttocks
measure: Adverse events after treatment and follow up
time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
description: Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.
measure: Changes in waist-to-hip circumference ratio
time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
description: waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).
measure: Changes in Body Mass Index
time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
description: Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
measure: Changes in body fat percentage
time frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks
description: The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.
measure: Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)
time frame: 0, 8 weeks
description: Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.
arm group label: Acupuncture group
arm group type: Experimental
description: Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.
Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
arm group label: sham-acupuncture group
arm group type: Placebo Comparator
description: As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.
intervention type: Other
intervention name: acupuncture
description: Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
arm group label: Acupuncture group
arm group label: sham-acupuncture group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zhaoxiang Bian, MD., Ph.D
role: Study Director
affiliation: Hong Kong Chinese Medicine Clinical Study Centre
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Baptist University
investigator full name: Zhong Lidan
investigator title: Research Assistant Professor
mesh term: Obesity
mesh term: Obesity, Abdominal
sharing ipd: Undecided