Nutraceutical Supplement in the Management of Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Cardiopressin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiopressin<br>A 5 capsule proprietary blend of herbal extracts and nutrients | Dietary Supplement: Cardiopressin<br> <br> |
| Placebo Comparator: Placebo<br>A 5 capsule placebo matched in color and size to the Experimental supplement | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function | Measured via Endopat | 4 months | 
| Small arterial compliance | Measured via computerized arterial pulse wave analysis (CAPWA) | 4 months | 
| Large arterial compliance | Measured via computerized arterial pulse wave analysis (CAPWA) | 4 months | 
| Central arterial blood pressure | Measured via computerized arterial pulse wave analysis (CAPWA) | 4 months |