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The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Yoga exercise
Sponsored by
Chang Bing Show Chwan Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, ayuveda yoga exercise, acupuncture.

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 24

Exclusion Criteria:

  • Diagnosis of cancer.

Sites / Locations

  • Division of Core Laboratory; Chang Bing Show Chwan Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Acupuncture controls

acupuncture and yoga exercise

Arm Description

Acupuncture group will receive 30-minutes treatment three times a week for 3 months.

Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.

Outcomes

Primary Outcome Measures

Reduce body mass index.
Outcome measure compares the change in body mass index during 3 months treatment.

Secondary Outcome Measures

Reduce waistline
Outcome measure compares the change in waistline during 3 months treatment.
Change biochemical profile of blood
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.
Immune modulation
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.

Full Information

First Posted
September 25, 2014
Last Updated
September 29, 2014
Sponsor
Chang Bing Show Chwan Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02254603
Brief Title
The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss
Official Title
To Evaluate the Effects of Weight-loss by the Combined Therapy of Acupuncture and Yoga Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Bing Show Chwan Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss for the overweight.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, ayuveda yoga exercise, acupuncture.

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture controls
Arm Type
Other
Arm Description
Acupuncture group will receive 30-minutes treatment three times a week for 3 months.
Arm Title
acupuncture and yoga exercise
Arm Type
Experimental
Arm Description
Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Yoga exercise
Intervention Description
Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.
Primary Outcome Measure Information:
Title
Reduce body mass index.
Description
Outcome measure compares the change in body mass index during 3 months treatment.
Time Frame
Change from baseline in body mass index at 3 months
Secondary Outcome Measure Information:
Title
Reduce waistline
Description
Outcome measure compares the change in waistline during 3 months treatment.
Time Frame
Change from baseline in waistline at 3 months
Title
Change biochemical profile of blood
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.
Time Frame
Change from baseline in biochemical profile of blood at 3 months
Title
Immune modulation
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.
Time Frame
Change from baseline in lymphocyte profile and polarization at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 24 Exclusion Criteria: Diagnosis of cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuender D. Yang, PhD
Phone
886-975617006
Email
yehshuhui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD.
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shu-Hui Yeh, PhD.
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu-Kwan Lu, MD.
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
City
Changhua County
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD
Phone
886-975617006
Email
yangkd.yeh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss

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