Trials / Completed
CompletedNCT02452749
Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- National University of Natural Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Cardiovascular health dietary supplement | Herbal/mineral dietary supplement |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2017-07-28
- Completion
- 2017-07-28
- First posted
- 2015-05-25
- Last updated
- 2018-03-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02452749. Inclusion in this directory is not an endorsement.