Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT02452749

Run by

National University of Natural Medicine

People needed

30

Starts

2015-05-01

Expected to finish

2017-07-28

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Helfgott Research Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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