Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Metabolic syndrome
研究概览
简要总结
This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.
详细描述
Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •18 to 65 years old
- •CUPW worker
- •prescreening indicates higher than normal TC/HDL ratio
排除标准
- •Experienced an MI or stroke within past 6 months
结局指标
主要结局
Metabolic syndrome
时间窗: 1 year
General Cardiovascular Risk Profile: Framingham Heart Study
时间窗: 1 year
次要结局
- Adverse events(1 year)
- HbA1C(1 year)
- Compliance with naturopathic interventions(1 year)
- Quality of Life (Short-form 36)(1 year)