Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Several dietary studies have shown that not only the progress of coronary artery disease can be slowed down, but it may also increase significantly the survival of these patients.
Up until now there is little known about therapeutic effects by complementary medicine. In particular, Traditional Tibetan medicine dietary programs have shown in few case reports that weight could be reduced in patients with obesity.
Therefore, the investigators developed a specific dietary program for patients with coronary artery disease, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years old
- •male and female
- •coronary artery disease
- •criteria of International Diabetes Federation (IDF)
排除标准
- •<18 years old
- •incapability for informed consent
- •history of malignity, psychiatric disorder, tissue, thyroid gland and renal diseases, anorexia or bulimia
- •administration of steroids or hormones
- •pregnancy
- •body mass index < 25
结局指标
主要结局
Body mass index
时间窗: 6 months
次要结局
- Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers(6 months)
研究者
Boris Bigalke
Prof. Dr.
University Hospital Tuebingen