Traditional Tibetan Medicine for Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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).

Official Title
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Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Nutritional and behavioral program A
* Behavioral: Nutritional and behavioral program B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years old male and female coronary artery disease criteria of International Diabetes Federation (IDF) Exclusion Criteria: <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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Program A<br>Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease | Behavioral: Nutritional and behavioral program A<br>* Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease<br>|
| Experimental: 2 Program B<br>Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine | Behavioral: Nutritional and behavioral program B<br>* Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary, behavior, IDF criteria, coronary artery disease, Traditional Tibetan Medicine, coronary artery disease in patients, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF)