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The Effect Evaluation of Laser Acupuncture in Obesity

NCT ID: NCT01975168

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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laser acupuncture obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Handylaser Trion laser acupuncture

Intervention Type DEVICE

intervention interval is 3 times per week for 12 weeks

Group 2

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

Group Type SHAM_COMPARATOR

Handylaser Trion laser acupuncture

Intervention Type DEVICE

intervention interval is 3 times per week for 12 weeks

Interventions

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Handylaser Trion laser acupuncture

intervention interval is 3 times per week for 12 weeks

Intervention Type DEVICE

Other Intervention Names

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Handylaser Trion

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheng-Che Lin

Doctor of Chinese Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheng-Che Lin, MD

Role: STUDY_CHAIR

Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital

Hung-Yi Chuang, ScD, MD

Role: STUDY_DIRECTOR

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

Chen-Cheng Yang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chinese Medicine Department Clinic, Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Che Lin, MD

Role: CONTACT

Phone: +8863121101

Email: [email protected]

Chen-Cheng Yang, MD

Role: CONTACT

Phone: +886929919132

Email: [email protected]

Facility Contacts

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Cheng-Che Lin

Role: primary

Chen-Cheng Yang

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 12580844 (View on PubMed)

Other Identifiers

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KMUH-LAAC-OB-001

Identifier Type: -

Identifier Source: org_study_id