The Effect of Auricular Point Stimulation on Obese Women

NCT ID: NCT00969267

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

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The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.

Detailed Description

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% change body weight, BMI, lipid profile, glucose and obese hormone.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Stimulation A

with needle A stimulation

Group Type EXPERIMENTAL

ear-acupuncture A

Intervention Type OTHER

with needle stimulation

Stimulation B

with stimulation

Group Type ACTIVE_COMPARATOR

stimulation B

Intervention Type OTHER

with bread stimulation on ear acupuncture point

Stimulation C

without needle

Group Type SHAM_COMPARATOR

stimulation C

Intervention Type OTHER

without needle stimulation

Interventions

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ear-acupuncture A

with needle stimulation

Intervention Type OTHER

stimulation B

with bread stimulation on ear acupuncture point

Intervention Type OTHER

stimulation C

without needle stimulation

Intervention Type OTHER

Other Intervention Names

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ear acupuncture needle ear acupuncture bread placebo needle

Eligibility Criteria

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Inclusion Criteria

* Age 16-65 years women
* BMI\>27 kg/mm
* Signed informed consent

Exclusion Criteria

* Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
* Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
* Allergy and Immunology disease.
* High aminotransferases ( Alanine, Aspartate \> 80 IU/L) or high serum creatinine (\> 2.5 mg/dL)
* Pregnant or lactating women.
* Childbirth within 6 months.
* Stroke or otherwise unable to exercise
* Management for weight control within 3 months.
* Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
* Endocrine disease
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chung-Hua Hsu

vice superintendent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chung-Hua Hsu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Insitute of Traditional Medicine, National Yang Ming University

Locations

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Branch of Chinese Medicine, Taipei City Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsu CH, Wang CJ, Hwang KC, Lee TY, Chou P, Chang HH. The effect of auricular acupuncture in obese women: a randomized controlled trial. J Womens Health (Larchmt). 2009 Jun;18(6):813-8. doi: 10.1089/jwh.2008.1005.

Reference Type BACKGROUND
PMID: 19445642 (View on PubMed)

Hsu CH, Hwang KC, Chao CL, Lin JG, Kao ST, Chou P. Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial. Int J Obes (Lond). 2005 Nov;29(11):1379-84. doi: 10.1038/sj.ijo.0802997.

Reference Type BACKGROUND
PMID: 15953937 (View on PubMed)

Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.

Reference Type BACKGROUND
PMID: 18468736 (View on PubMed)

Other Identifiers

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98001-62-020

Identifier Type: -

Identifier Source: org_study_id

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