Nutraceutical Supplement in the Management of Hypertension

Thorne HealthTech

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertension

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cardiopressin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02663479

TruCardia-002

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Cardiopressin

Experimental group

Description:

A 5 capsule proprietary blend of herbal extracts and nutrients

Treatment:

Dietary Supplement: Cardiopressin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo