Nutraceutical Supplement in the Management of Hypertension

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

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-10-31

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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cardiopressin

A 5 capsule proprietary blend of herbal extracts and nutrients

Group Type EXPERIMENTAL

Cardiopressin

Intervention Type DIETARY_SUPPLEMENT

Placebo

A 5 capsule placebo matched in color and size to the Experimental supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Cardiopressin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No