NCT01681069已完成3 期
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Body Weight at End of Study Compared to Baseline
研究概览
简要总结
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 60 years
- •25 kg/m2 ≤ BMI ≤ 35 kg/m2
- •Written informed consent
排除标准
- •Known sensitivity to sources of the active ingredients and excipients
- •Pregnancy or nursing
- •Inability to comply with study requirements, e.g. due to language difficulties
- •Participation in another study during the last 30 days of the screening visit
研究组 & 干预措施
Placebo
Placebo Comparator
2 tablets twice a day
干预措施: Placebo (Other)
结局指标
主要结局
Change in Body Weight at End of Study Compared to Baseline
时间窗: 12 weeks
Change in body weight at the end of study compared to baseline
次要结局
- Change in Waist Circumference (in cm) at End of Study From Baseline(12 weeks)
- Change in Mean Body Fat at End of Study From Baseline(12 weeks)
研究者
研究点 (2)
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