Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

This single-arm, open-label study will assess the safety and tolerability of one daily tablet of a commercially available cardiovascular health dietary supplement by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Although the cardiovascular health dietary supplement being investigated has been on the market for over 20 years, prospective safety data and blood markers of end organ function have not previously been reported.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helfgott Research Institute

Portland, Oregon, 97201, United States

About this study

Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events, including myocardial infarction and stroke, and cardiovascular-related mortality with advancing age. Based on population based studies and clinical trials, both systolic blood pressure (SBP) and diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors for cardiovascular disease.

The product being studies is a cardiovascular health dietary supplement that has been commercially available since 1993. It is currently sold to healthcare practitioners as well as directly to consumers. Some healthcare providers use the product as part of a plan to treat high blood pressure in their patients. This is the first study collecting prospective safety data on this product.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age 18-65
Systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg upon screening

Exclusion criteria

Bradycardia
Initiation of or changes to blood pressure lowering medications within the last month
Initiation of or changes to thyroid medications within the last month
Currently taking any of the following orally (or they were taken within the last month):

Rauwolfia serpentina, Terminalia arjuna, Tribulus terrestris, Convolvulus pluricaulis, Boerhavia diffusa, Rosa vinca, rose powder, or coral powder
Beta blockers
Alpha blockers
Propranolol
Digoxin
Levodopa
Anti-depressant medications
Anti-psychotic medications
Sedatives or tranquilizers
Present or past history of any of the following:

Cardiovascular disease
Heart surgery
Cardiac arrhythmia
Abnormal EKG
Abnormal echocardiogram
Diabetes
Chronic liver, kidney or bowel disease
Ulcers
Gallbladder disease
Depression
Alcoholism
Obstructive sleep apnea and/or use of a continuous positive airway pressure device
Parkinson's disease
Pheochromocytoma
Cancer within the last 5 years
Consuming more than fourteen alcoholic beverages per week
Current smoking/tobacco use
Current illicit and/or recreational drug use
Women who are lactating, pregnant or planning pregnancy within the next six months
Known intolerance or allergy to study agents

Treatment and study plan

Cardiovascular health dietary supplement

Dietary Supplement

Herbal/mineral dietary supplement

Primary outcomes

Safety and tolerability of a cardiovascular health dietary supplement assessed by composite changes in multi-system symptoms, a validated mood/depression questionnaire, electrolytes, and surrogate markers of heart, liver and kidney function

Time frame: Baseline, 3 months, 6 months

Standardized adverse event monitoring form, Patient Health Questionnaire (PHQ-9), electrolytes (sodium, potassium, calcium, magnesium), b-type natriuretic peptide, aspartate aminotransferase, alanine aminotransferase, and estimated glomerular filtration rate

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 25, 2015
Registry last updated: Mar 15, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed