Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement (Carditone)

Principal Investigators: Ryan Bradley ND, MPH & Jenn Ryan ND, MS

Background & Significance: Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events. Carditone™ is a dietary supplement intended to support healthy blood pressure levels and cardiovascular health. Although Carditone™ has been on the market for over 20 years, no adverse events related to its use have been reported to Ayush Herbs Inc. or the Food and Drug Administration (FDA). However, prospective safety data and blood markers of end organ function have not previously been collected or reported. This is the first study evaluating the safety and tolerability of Carditone™.

Research Design & Methods: This single‐arm, open‐label study will assess the safety and tolerability of one daily tablet of Carditone™ by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Up to 30 men and women with screening blood pressure readings consistent with JNC‐7 criteria for pre‐hypertension or stage I hypertension will be recruited. Outcome measures will be collected at baseline, 3 months, and 6 months; these measures include questionnaires to monitor for potential side effects and adverse events, changes in mood and sleep quality, as well as blood markers that monitor cardiovascular, liver, and kidney function. In addition, safety will be assessed by monthly phone calls and at any time by spontaneous self‐report.