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The Effect of Auricular Point Stimulation on Obese Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Taipei City Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Yang Ming University
Information provided by:
Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT00969267
First received: August 31, 2009
Last updated: September 2, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Obesity
 Other: ear-acupuncture A
Other: stimulation B
Other: stimulation C
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • % reducting of body mass index (BMI) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: August 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulation A
with needle A stimulation
 Other: ear-acupuncture A
with needle stimulation
Other Name: ear acupuncture needle
Active Comparator: Stimulation B
with stimulation
 Other: stimulation B
with bread stimulation on ear acupuncture point
Other Name: ear acupuncture bread
Sham Comparator: Stimulation C
without needle
 Other: stimulation C
without needle stimulation
Other Name: placebo needle

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969267

Contacts
Contact: Chung-Hua Hsu, MD, PhD 886-02-2389-9147 ext 3828 owlherbs@yahoo.com.tw

Locations
Taiwan
Branch of Chinese Medicine, Taipei City Hospital Recruiting
Taipei, Taiwan, 886
Contact: Chung-Hua Hsu, MD, PhD            
Principal Investigator: Chung-Hua Hsu, MD, PhD            
Sponsors and Collaborators
Taipei City Hospital
National Yang Ming University
Investigators
Principal Investigator: Chung-Hua Hsu, MD, PhD Insitute of Traditional Medicine, National Yang Ming University
  More Information

Additional Information:
Institute of Traditional Medicine, School of Medicine,  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Branch of Chinese Medicine, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT00969267     History of Changes
Other Study ID Numbers: 98001-62-020
Study First Received: August 31, 2009
Last Updated: September 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei City Hospital:
ear acupuncture
obese
obese women
women

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013