Efficacy Study of SD Device for Overweight and Obesity Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.
详细描述
Obesity and Overweight had become the number 1 health concern of the modern world. Over 1 Billion people worldwide are overweight or obese. Those who suffer from overweight or obesity are exposed to other severe illnesses such as: diabetes, cardiovascular disease and cancer.
Only few drugs and surgeries are currently available as approved treatments for those who wish to reduce weight.
The purpose of this study is to determine whether the SD unique medical device, is effective in treatment of overweight and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-41.99
- •AGE 18-65 years
排除标准
- •Pregnant Women,
- •Type I and II diabetes,
- •People with disfunctioning of thyroid gland
- •Hypertension
结局指标
主要结局
Change from Baseline in Body Weight
时间窗: once in every two weeks up to 13 weeks for each participant
Each participant's body weight will be measured at his/her beginning of the trial. This measure will become the participant's body weight base-line. Once in every 2 weeks the body weight will be taken again and will be compared to base-line and to previous body weight measures of the participant taken during the study.
次要结局
- Change from Baseline in Waist Circumference(once in every two weeks up to 13 weeks for each participant)