The Effect Evaluation of Laser Acupuncture in Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- body composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male
排除标准
- •Pathmakers user
- •Epilepsy history
- •Pregnancy
- •Immuno-inhibiting agents user
- •Malignancy
- •Skin contacted disease
- •Weight controlled agents user during trial period
- •Eating disorder
研究组 & 干预措施
Group 1
arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks
干预措施: Handylaser Trion laser acupuncture (Device)
Group 2
arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks
干预措施: Handylaser Trion laser acupuncture (Device)
结局指标
主要结局
body composition
时间窗: 12 weeks
body weight
次要结局
- body mass index(12 weeks)
研究者
Cheng-Che Lin
Doctor of Chinese Medicine Department
Kaohsiung Medical University Chung-Ho Memorial Hospital