The Effect of Auricular Point Stimulation on Obese Women
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of the study is to examine whether the ear acupoint stimulation is effective on obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 obesity
Started Aug 2009
Shorter than P25 for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMay 29, 2014
May 1, 2014
9 months
August 31, 2009
May 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% reducting of body mass index (BMI)
4 weeks
Study Arms (3)
Stimulation A
EXPERIMENTALwith needle A stimulation
Stimulation B
ACTIVE COMPARATORwith stimulation
Stimulation C
SHAM COMPARATORwithout needle
Interventions
with bread stimulation on ear acupuncture point
Eligibility Criteria
You may qualify if:
- Age 16-65 years women
- BMI\>27 kg/mm
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei City Hospitallead
- National Yang Ming Chiao Tung Universitycollaborator
Study Sites (1)
Branch of Chinese Medicine, Taipei City Hospital
Taipei, 886, Taiwan
Related Publications (3)
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.
PMID: 19445642BACKGROUNDHsu 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.
PMID: 15953937BACKGROUNDHsu 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.
PMID: 18468736BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Hua Hsu, MD, PhD
Insitute of Traditional Medicine, National Yang Ming University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice superintendent
Study Record Dates
First Submitted
August 31, 2009
First Posted
September 1, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
May 29, 2014
Record last verified: 2014-05