ObesityNCT02254603
The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss
A study testing Acupuncture and Yoga exercise in people with Obesity, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Acupuncture and Yoga exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 24
Who cannot join
- Diagnosis of cancer.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County
Kuender D. Yang, PhD, 886-975617006, yangkd.yeh@hotmail.com
About this study
Official title: To Evaluate the Effects of Weight-loss by the Combined Therapy of Acupuncture and Yoga Exercise
The aim of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss for the overweight.
Read the 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.
- Conditions
- Obesity
- Being tested
- Acupuncture, Yoga exercise
- Keywords
- Obesity, ayuveda yoga exercise, acupuncture.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.
Yoga exerciseBehavioural
Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture controls | Other | Acupuncture group will receive 30-minutes treatment three times a week for 3 months. Receives: Device: Acupuncture |
| acupuncture and yoga exercise | Experimental | Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months. Receives: Device: Acupuncture; Behavioral: Yoga exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce body mass index.
Outcome measure compares the change in body mass index during 3 months treatment.
Measured: Change from baseline in body mass index at 3 months
Secondary outcomes (3)
Reduce waistline
Outcome measure compares the change in waistline during 3 months treatment.
Measured: Change from baseline in waistline at 3 months
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.
Measured: Change from baseline in biochemical profile of blood at 3 months
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.
Measured: Change from baseline in lymphocyte profile and polarization at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Bing Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
- Investigators
- Kuender D. Yang, PhD., Study chair, Chang Bing Show Chwan Memorial HospitalShu-Hui Yeh, PhD., Study director, Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and TechnologyYu-Kwan Lu, MD., Principal investigator, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254603
- Sponsor's protocol ID
- 1011003
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effects of Weight-loss by the Combined Therapy of Acupuncture and Yoga Exercise
- ClinicalTrials.gov ID
- NCT02254603
- Acronym / sponsor ID
- 1011003
- Conditions
- Obesity
- Keywords
- Obesity, ayuveda yoga exercise, acupuncture.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture controls | Other | Device: AcupunctureAcupuncture group will receive 30-minutes treatment three times a week for 3 months. |
| acupuncture and yoga exercise | Experimental | Device: Acupuncture, Behavioral: Yoga exerciseSubject will receive a combination of acupuncture and yoga exercise three times a week for 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI > 24
Key exclusion criteria (1 listed)
- Diagnosis of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months. | Device | Acupuncture controls, acupuncture and yoga exercise |
| Yoga exerciseSubject will receive regular 60-minutes yoga exercise three times a week for 3 months. | Behavioural | acupuncture and yoga exercise |
Primary outcome
Reduce body mass index.
Time frame: Change from baseline in body mass index at 3 months
Outcome measure compares the change in body mass index during 3 months treatment.
3 secondary outcomes
Reduce waistline
Time frame: Change from baseline in waistline at 3 months
Change biochemical profile of blood
Time frame: Change from baseline in biochemical profile of blood at 3 months
Immune modulation
Time frame: Change from baseline in lymphocyte profile and polarization at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuender D. Yang, PhD. study chair
Chang Bing Show Chwan Memorial Hospital
Shu-Hui Yeh, PhD. study director
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Yu-Kwan Lu, MD. principal investigator
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Yoga exercise in people with Obesity, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuender D. Yang, PhD (886-975617006, yehshuhui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce body mass index. (time frame: Change from baseline in body mass index at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.