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The Effect of Auricular Point Stimulation on Obese Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969267
First Posted: September 1, 2009
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial

Further study details as provided by Chung-Hua Hsu, Taipei City Hospital:

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

Enrollment: 90
Study Start Date: August 2009
Study Completion Date: July 2010
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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969267


Locations
Taiwan
Branch of Chinese Medicine, Taipei City Hospital
Taipei, Taiwan, 886
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