The Effect of Auricular Point Stimulation on Obese Women

May 28, 2014 updated by: Chung-Hua Hsu, Taipei City Hospital

The Effect of Auricular Point Stimulation on Obese Women: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation A
with needle A stimulation
Other: ear-acupuncture A
with needle stimulation
Other Names:
  • ear acupuncture needle
Active Comparator: Stimulation B
with stimulation
Other: stimulation B
with bread stimulation on ear acupuncture point
Other Names:
  • ear acupuncture bread
Sham Comparator: Stimulation C
without needle
Other: stimulation C
without needle stimulation
Other Names:
  • placebo needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% reducting of body mass index (BMI)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Collaborators

National Yang Ming University

Investigators

  • Principal Investigator: Chung-Hua Hsu, MD, PhD, Insitute of Traditional Medicine, National Yang Ming University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 98001-62-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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