Prospective Safety and Tolerability Assessment of a Cardi... | NCT02452749

Studies
Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

NCT02452749

Sponsor

National University of Natural Medicine

Status

Completed

Last Update Posted

Mar 15, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Cardiovascular health dietary supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2015Actual

Primary Completion Date

Jul 28, 2017Actual

Completion Date

Jul 28, 2017Actual

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2018

Last Update Posted Date

Mar 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiovascular Health Dietary Supplement	Experimental	The cardiovascular health dietary supplement will be administered at a dosage of 1 caplet po per day for a period of 6 months	Dietary Supplement: Cardiovascular health dietary supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiovascular health dietary supplement	Dietary Supplement	Herbal/mineral dietary supplement	Cardiovascular Health Dietary Supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases