Traditional Tibetan Medicine for Patients With Coronary Artery Disease

NCT ID: NCT00810992

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

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).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 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

Group Type ACTIVE_COMPARATOR

Nutritional and behavioral program A

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Nutritional and behavioral program B

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Boris Bigalke

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1016/0140-6736(90)91656-u.

Reference Type BACKGROUND
PMID: 1973470 (View on PubMed)

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. doi: 10.1016/S0140-6736(02)11472-3.

Reference Type BACKGROUND
PMID: 12433513 (View on PubMed)

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. doi: 10.1093/ije/31.4.847.

Reference Type BACKGROUND
PMID: 12177033 (View on PubMed)

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. doi: 10.1056/NEJMoa025039.

Reference Type BACKGROUND
PMID: 12826634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18585516 (View on PubMed)

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. doi: 10.1093/eurheartj/ehl192. Epub 2006 Aug 21.

Reference Type BACKGROUND
PMID: 16923742 (View on PubMed)

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 China: results from the WHO Cardiovascular Diseases and Alimentary Comparison (CARDIAC) Study. Hypertens Res. 2001 May;24(3):315-22. doi: 10.1291/hypres.24.315.

Reference Type RESULT
PMID: 11409657 (View on PubMed)

von Haehling S, Stellos K, Qusar N, Gawaz M, Bigalke B. Weight reduction in patients with coronary artery disease: comparison of Traditional Tibetan Medicine and Western diet. Int J Cardiol. 2013 Sep 30;168(2):1509-15. doi: 10.1016/j.ijcard.2013.07.034. Epub 2013 Jul 26.

Reference Type DERIVED
PMID: 23890855 (View on PubMed)

Related Links

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http://www.dgem.de

German Society of Nutritional Medicine

Other Identifiers

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337/2008BO1 UKT

Identifier Type: -

Identifier Source: org_study_id

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