The Effect Evaluation of Laser Acupuncture in Obesity

November 5, 2013 updated by: Cheng-Che Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

      • Kaohsiung, Taiwan
        • Recruiting
        • Chinese Medicine Department Clinic, Kaohsiung Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chen-Cheng Yang, MD

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male

Exclusion Criteria:

  • Pathmakers user
  • Epilepsy history
  • Pregnancy
  • Immuno-inhibiting agents user
  • Malignancy
  • Skin contacted disease
  • Weight controlled agents user during trial period
  • Eating disorder

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks
intervention interval is 3 times per week for 12 weeks
Other Names:
  • Handylaser Trion
Sham Comparator: Group 2
arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks
intervention interval is 3 times per week for 12 weeks
Other Names:
  • Handylaser Trion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: 12 weeks
body weight
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
body mass index
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
waist circumference
Time Frame: 12 weeks
12 weeks
blood pressure
Time Frame: 12 weeks
12 weeks
hip circumference
Time Frame: 12 weeks
12 weeks
body fat
Time Frame: 12 weeks
12 weeks
heart rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Cheng-Che Lin, MD, Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital
  • Study Director: Hung-Yi Chuang, ScD, MD, Department of Public Health, College of Health Sciences, Kaohsiung Medical University
  • Principal Investigator: Chen-Cheng Yang, MD, Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital

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.

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

September 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • KMUH-LAAC-OB-001

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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