The Effect of Auricular Point Stimulation on Obese Women

This study has been completed.
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT00969267
First received: August 31, 2009
Last updated: May 28, 2014
Last verified: May 2014
  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:


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 ]

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information