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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks |
|
| Group 2 | Sham Comparator | arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handylaser Trion laser acupuncture | Device | intervention interval is 3 times per week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| body composition | body weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body mass index | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| waist circumference | 12 weeks | |
| hip circumference | 12 weeks | |
| body fat |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Che Lin, MD | Contact | +8863121101 | 6422 | abcmacoto@gmail.com |
| Chen-Cheng Yang, MD | Contact | +886929919132 | cheng10042001@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Cheng-Che Lin, MD | Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital | Study Chair |
| Hung-Yi Chuang, ScD, MD | Department of Public Health, College of Health Sciences, Kaohsiung Medical University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Medicine Department Clinic, Kaohsiung Medical University | Recruiting | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12580844 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 12 weeks |
| blood pressure | 12 weeks |
| heart rate | 12 weeks |
| Chen-Cheng Yang, MD | Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital | Principal Investigator |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |