Hypertension
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCardiopressin
DIETARY_SUPPLEMENTPlacebo
Sponsors
Thorne HealthTech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 4 months | Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function | 4 months | Measured via Endopat |
| Small arterial compliance | 4 months | Measured via computerized arterial pulse wave analysis (CAPWA) |
| Large arterial compliance | 4 months | Measured via computerized arterial pulse wave analysis (CAPWA) |
| Central arterial blood pressure | 4 months | Measured via computerized arterial pulse wave analysis (CAPWA) |
Countries
United States
Outcome results
None listed