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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Cardiopressin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Hypertension Institute of Nashville, TN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thorne Research Inc.
• Investigators: Principal Investigator: Mark Houston, MD, MS, MSc, Hypertension Institute; Principal Investigator: Bodi Zhang, MD, MPH, PhD, Thorne Research

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TruCardia-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No