Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started May 2015
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2017
CompletedMarch 15, 2018
March 1, 2018
2.2 years
May 19, 2015
March 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
Baseline, 3 months, 6 months
Study Arms (1)
Cardiovascular Health Dietary Supplement
EXPERIMENTALThe cardiovascular health dietary supplement will be administered at a dosage of 1 caplet po per day for a period of 6 months
Interventions
Herbal/mineral dietary supplement
Eligibility Criteria
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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helfgott Research Institute
Portland, Oregon, 97201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer J Ryan, ND, MS
National University of Natural Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Fellow
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 25, 2015
Study Start
May 1, 2015
Primary Completion
July 28, 2017
Study Completion
July 28, 2017
Last Updated
March 15, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share