Traditional Tibetan Medicine for Patients With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Nutritional and behavioral program A; Behavioral: Nutritional and behavioral program B

• Registration Number: NCT00810992
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2011-04
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Program A	Nutritional and behavioral program A	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
2 Program B	Nutritional and behavioral program B	Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine

Primary Outcome Measures

Name	Time	Method
Body mass index	6 months

Secondary Outcome Measures

Name	Time	Method
Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers	6 months

Trial Locations

Locations (1)

University Hospital Tübingen; 🇩🇪 Tübingen, Germany