Traditional Tibetan Medicine for Patients With Coronary Artery Disease (TTM in CAD)

University Hospital Tuebingen

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: Nutritional and behavioral program B; Behavioral: Nutritional and behavioral program A

Study type: Interventional

Funder types: Other

Identifiers

NCT00810992

337/2008BO1 UKT

Details and patient eligibility

About

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).

Enrollment: 524 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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524 participants in 2 patient groups

1 Program A

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutritional and behavioral program A

2 Program B

Experimental group

Description:

Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine

Treatment:

Behavioral: Nutritional and behavioral program B