Traditional Tibetan Medicine for Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— TTM in CAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810992
• Other study ID #: 337/2008BO1 UKT
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: January 11, 2013
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: April 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Bigalke B, Geisler T, Stellos K, Langer H, Daub K, Kremmer E, Seizer P, May AE, Lindemann S, Gawaz M. Platelet collagen receptor glycoprotein VI as a possible novel indicator for the acute coronary syndrome. Am Heart J. 2008 Jul;156(1):193-200. doi: 10.1016/j.ahj.2008.02.010. Epub 2008 Apr 23. — View Citation

Bigalke B, Lindemann S, Ehlers R, Seizer P, Daub K, Langer H, Schonberger T, Kremmer E, Siegel-Axel D, May AE, Gawaz M. Expression of platelet collagen receptor glycoprotein VI is associated with acute coronary syndrome. Eur Heart J. 2006 Sep;27(18):2165-9. Epub 2006 Aug 21. — View Citation

Liu L, Liu L, Ding Y, Huang Z, He B, Sun S, Zhao G, Zhang H, Miki T, Mizushima S, Ikeda K, Nara Y, Yamori Y. Ethnic and environmental differences in various markers of dietary intake and blood pressure among Chinese Han and three other minority peoples of — View Citation

Michels KB, Wolk A. A prospective study of variety of healthy foods and mortality in women. Int J Epidemiol. 2002 Aug;31(4):847-54. — View Citation

Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. — View Citation

Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. — View Citation

Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003 Jun 26;348(26):2599-608. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		6 months	No
Secondary	Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers		6 months	No

External Links

•   German Society of Nutritional Medicine
•   International Task Force for Prevention of Coronary Heart Disease