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OpenTrials
Completed

NCT Number: NCT02663479

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hypertension Institute of Nashville, TN

Nashville, Tennessee, 37205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiopressin

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Blood Pressure

    Time frame: 4 months

    Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor)

Secondary outcomes

  1. Endothelial Function

    Time frame: 4 months

    Measured via Endopat

  2. Small arterial compliance

    Time frame: 4 months

    Measured via computerized arterial pulse wave analysis (CAPWA)

  3. Large arterial compliance

    Time frame: 4 months

    Measured via computerized arterial pulse wave analysis (CAPWA)

  4. Central arterial blood pressure

    Time frame: 4 months

    Measured via computerized arterial pulse wave analysis (CAPWA)

Sponsors and collaborators

Lead sponsor

Thorne HealthTech, Inc

Industry

Registry information

Official study title

Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2016
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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