This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The proposed study will evaluate the efficacy of Maharishi Ayurvedic herbal therapy [Cholesterol Protection (CP) herbal product] on lipids and other cardiovascular risk factors. Specifically, the following will be investigated: 1. The efficacy of Ayur-Vedic CP therapy on lowering total and low-density lipoprotein (LDL) cholesterol in persons with moderate elevations of LDL-cholestrol indicated for dietary management. 2. The efficacy of Ayur-Vedic CP therapy on reducing systemic inflammation (as measured by C-reactive protein) and thrombotic potential (as measured by fibrinogen). Maharishi Ayur-Ved is a comprehensive healthcare system that dates back more than 5000 years to the ancient Vedic civilization of India. Maharishi Mahesh Yogi, founder of the transcendental meditation technique, recently established the complete system which has been made available worldwide, covering all facets of life - including mind, physiology, behavior, and the environment. It is prevention-oriented and focuses on treatment of chronic ailments. There are a number of herbal formulas that are central to the Ayur-Ved system - ingredients of these formulas function syndergistically to maximize health-promoting benefits. MAK-4 and MAK-5 have been among the most widely studied such agents, and have been shown to inhibit human LDL oxidation in vitro and in patients with hyperlipidemia. In addition, these are reports that these products prevent platelet aggregation and reduce blood pressure and frequency of angina. Others, including investigators at the University of California, Irvine, have examined rat brain both in vitro and in vivo antioxidant properties of these preparations. MA-631 has been shown to inhibit (in vitro and in vivo) rat microsomal lipid peroxidation and may be useful in the prevention on free radical-linked diseases. In a comparison study with M-4, M-5, vitamin C, vitamin E, and probucol (an antioxidant cholesterol-lowering drug), MA-631 was seen to have the strongest antioxidant potency in preventing LDL oxidation. While thrombotic potential and inflammation have been well-documented to be associated with increased cardiovascular risk, the effects of Ayurvedic and other herbal therapies on these factors have not been shown. The limited efficacy of the standard National Cholesterol Education Program diet in lowering total (about 10%) and LDL-cholesterol (about 15%) limits it applicability, and pharmacologic therapy is frequently prescribed in lieu of adequate effots to comply to dietary regimens. Non-pharmacologic herbal and other dietary approaches may enhance the efficacy achieved from a standard low-fat, low-cholesterol diet; however, published evidence on the efficacy of these products are limited. The National Cholesterol Education Program recommends dietary treatment of hypercholesterolemia when the LDL-C exceeds 160 mg/dl (4.1 mmol/l) in persons with fewer than two risk factors, 130 mg/dl (3.3 mmol/l) or greater in those with two or more risk factors, and 100 mg/dl (2.6 mmol/l) or greater in those with pre-existing CAD. Dietary treatment should be given for a period of 8-12 weeks prior to beginning pharmacologic treatment, if LDL-C levels are not reduced sufficiently by diet alone. MA-631 and Cholesterol Protection (CP) (Maharishi Ayur-Ved Products International, Inc.) are Ayurvedic herbal preparations. MA-631 is a powerful antioxidant with the following herbal ingredients: mineral pitch, gallas, Indian bedelium, Himalayan silver fir, dry ginger, catkins, Picrorrhiza kurrora, black pepper, Indian kudju, bamboo, Chinese cinnamon, cinnamon, saffron, and cardamom. CP is an herbal mixture consisting of Indian Bedellium (Guggul), Tumeric, Triphala (Emblic, Beleric, and Chebulic Myrobalans), Night Hasmine (Parijat), Phyllanthus niruri (Bitter Gooseberry), Heart-leaved Moonseed leaf (Guduchi), Indian Sarsaparilla, Indian Madder (Manfistha), Mineral Pitch (Shilajit), Heart-leaved Moonseed starch (Guduchi Sattwa), Licorice, Trikatu (Dry Ginger, Long Pepper, Black Petter), and Zinc Bhasma (Yasad Bhasma). These herbs are combined in exact proportions and prepared in the traditional Ayurvedic way, improving bioavailability and assimiliation of vital nutrients and creating synergy, where the collective benefit of all the herbs is greater than that of isolated individual herbs. Liver function is enhanced, generating more bile and decreasing cholesterol levels. Parijat, Phyllanthus niruri, Guduchi, Indian Sarsaparilla, and Manjistha are related to bile secretion and help detoxify the blood. Tumeric also slightly increases bile flow. Trikatu and Licorice aids bioavailability, and Triphala enhances elimination of cholesterol through the colon. Yasad Bhasma increases fat metabolism.

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University of California San Diego
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