Nutraceutical Supplement in the Management of Hypertension

Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension

The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.

Inclusion Criteria

• Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
• Subjects are not taking any prescription anti-hypertensive drugs.
• Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.

Exclusion Criteria

• Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
• History of cerebrovascular accident (CVA).
• Creatinine over 2.5 mg/dL.
• Known allergy or sensitivity to any components of the study blood pressure supplement.
• Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
• Known cancer within 2 years.
• Clinical congestive heart failure ( systolic or diastolic CHF)
• Pregnant and nursing women and women.
• Women of child bearing age not on approved contraception control.
• Type 1 and Type 2 diabetes mellitus on medications.
• If the study subjects develop BP over 180 mm Hg systolic or 110 mm Hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for BP control.