Efficacy of a Lipolytic Cream in the Body Composition of an Overweight and Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- Change in body composition with a scientific impedanciometer
研究概览
简要总结
The coadyouvant efficacy of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients.
详细描述
The coadyouvant efficacy and safety of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients of both gender and different age groups. DESIGN: In a monocenter, open-label, randomized, parallel-group study of 102 patients that consulted for overweight and obesity treatment were analyzed in perimeters and body composition for 12 consecutive weeks that were medically prescribed a weekly hypocaloric diet and physical activity for one group of 51 patients, and hypocaloric diet, physical activity and the lypolitic cream at least twice per day for the other group of 51 patients. Efficacy was evaluated by comparing intial and final of all values in both groups. Safety was monitored by the incidence of adverse events. Patients also assessed the acceptability of the cream presentation.
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
- None
盲法说明
Researchers assessed the efficacy of a lipolytic cream with hypocaloric diet and physical activity in the treatment of overweight and obesity. The control treatment was lypolitic cream with hypocaloric diet and physicial activity and hypocaloric diet and physicial activity alone. In total, 102 patients were recruited and allocated to treatment (51: lypolitic cream with hypocaloric diet and physicial activity and, 51: hypocaloric diet and physicial activity alone.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight and obesity treatment voluntary assistance
排除标准
- •Hearth disease
研究组 & 干预措施
LC
Lypolitic cream with hypocaloric diet and physicial activity in 51 patients
干预措施: Dr.K. Treatment (Combination Product)
NLC
Hypocaloric diet and physicial activity alone in 51 patients
干预措施: Dr.K. Treatment (Combination Product)
结局指标
主要结局
Change in body composition with a scientific impedanciometer
时间窗: Baseline and weeks: 1, 4, 8, 12,16
Body fat in kilograms and percentage variation measured with an impendaciometer (Tanita MC780)
次要结局
- Change in perimeters measured with measuring tape(Baseline and weeks: 1, 4, 8, 12,16)