The Effect Evaluation of Laser Acupuncture in Obesity

Obesity Clinical Trial

Official title:

The Effect Evaluation of Laser Acupuncture in Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01975168
• Other study ID #: KMUH-LAAC-OB-001
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2013
• Last updated: November 5, 2013
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: November 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Cheng-Che Lin, MD
• Phone: +8863121101
• Email: abcmacoto[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Handylaser Trion laser acupuncture
intervention interval is 3 times per week for 12 weeks

Locations

Country	Name	City	State
Taiwan	Chinese Medicine Department Clinic, Kaohsiung Medical University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Wozniak P, Stachowiak G, Piêta-Doliñska 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	waist circumference		12 weeks	No
Other	hip circumference		12 weeks	No
Other	body fat		12 weeks	No
Other	blood pressure		12 weeks	No
Other	heart rate		12 weeks	No
Primary	body composition	body weight	12 weeks	No
Secondary	body mass index		12 weeks	No