NCT01714284已完成不适用
Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 11
- 主要终点
- Any change from baseline of PASI index
研究概览
简要总结
This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic plaque psoriasis
- •BMI > 25 Kg/m²
- •Patients under systemic treatments for psoriasis or candidates for such treatments
排除标准
- •Diagnosis of other type of psoriasis or psoriatic arthritis
- •Patients under local treatments or candidates for such treatments
- •Patients expected to have poor compliance at follow-up evaluation
研究组 & 干预措施
Diet and Exercise
Experimental
干预措施: Diet and Exercise (Behavioral)
Informative
Sham Comparator
干预措施: Informative (Behavioral)
结局指标
主要结局
Any change from baseline of PASI index
时间窗: 20 weeks
次要结局
- Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)(8 weeks, 16 weeks, 20 weeks)
- Percent change from baseline of PASI index equal to 100% (PASI100)(8 weeks, 16 weeks, 20 weeks)
- Any change from baseline of PASI index(8 weeks, 16 weeks, 20 weeks)
- Any reduction from baseline of Body Mass Index (BMI)(8 weeks, 16 weeks, 20 weeks)
- Any reduction from baseline of waist circumference(8 weeks, 16 weeks, 20 weeks)
- Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)(8 weeks, 16 weeks, 20 weeks)
研究者
研究点 (11)
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