Nutraceutical Supplement in the Management of Hypertension

NCT02663479 | Completed Phase 1

• 1 other identifier: TruCardia-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Endothelial Function

  4 months

• Small arterial compliance

  4 months

• Large arterial compliance

  4 months

• Central arterial blood pressure

  4 months

Study Arms (2)

Cardiopressin

EXPERIMENTAL

A 5 capsule proprietary blend of herbal extracts and nutrients

Dietary Supplement: Cardiopressin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Cardiopressin DIETARY_SUPPLEMENT

Cardiopressin

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thorne HealthTech, Inc: lead

Study Sites (1)

Hypertension Institute of Nashville, TN

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Houston, MD, MS, MSc

  Hypertension Institute

  PRINCIPAL INVESTIGATOR

• Bodi Zhang, MD, MPH, PhD

  Thorne Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 26, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)