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The Effect Evaluation of Laser Acupuncture in Obesity

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Handylaser Trion laser acupuncture

About this trial

This is an interventional treatment trial for Obesity focused on measuring laser acupuncture, obesity

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chinese Medicine Department Clinic, Kaohsiung Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group 1

Group 2

Arm Description

arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks

arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks

Outcomes

Primary Outcome Measures

body composition

body weight

Secondary Outcome Measures

body mass index

Full Information

NCT ID

NCT01975168

First Posted

October 23, 2013

Last Updated

November 5, 2013

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01975168

Brief Title

The Effect Evaluation of Laser Acupuncture in Obesity

Official Title

The Effect Evaluation of Laser Acupuncture in Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

laser acupuncture, obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks

Arm Title

Group 2

Arm Type

Sham Comparator

Arm Description

arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks

Intervention Type

Device

Intervention Name(s)

Handylaser Trion laser acupuncture

Other Intervention Name(s)

Handylaser Trion

Intervention Description

intervention interval is 3 times per week for 12 weeks

Primary Outcome Measure Information:

Title

body composition

Description

body weight

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

body mass index

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

waist circumference

Time Frame

12 weeks

Title

hip circumference

Time Frame

12 weeks

Title

body fat

Time Frame

12 weeks

Title

blood pressure

Time Frame

12 weeks

Title

heart rate

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheng-Che Lin, MD

Phone

+8863121101

Ext

6422

abcmacoto@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chen-Cheng Yang, MD

Phone

+886929919132

cheng10042001@yahoo.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheng-Che Lin, MD

Organizational Affiliation

Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hung-Yi Chuang, ScD, MD

Organizational Affiliation

Department of Public Health, College of Health Sciences, Kaohsiung Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chen-Cheng Yang, MD

Organizational Affiliation

Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese Medicine Department Clinic, Kaohsiung Medical University

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cheng-Che Lin

Phone

+8863121101

Ext

6422

abcmacoto@gmail.com

First Name & Middle Initial & Last Name & Degree

Chen-Cheng Yang

Phone

+886929919132

cheng10042001@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Chen-Cheng Yang, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12580844

Citation

Wozniak P, Stachowiak G, Pieta-Dolinska A, Oszukowski P. Laser acupuncture and low-calorie diet during visceral obesity therapy after menopause. Acta Obstet Gynecol Scand. 2003 Jan;82(1):69-73. doi: 10.1034/j.1600-0412.2003.820113.x.

Results Reference

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The Effect Evaluation of Laser Acupuncture in Obesity

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