Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05928676
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2023-06-26
Brief Title:
Open Label Clinical Trial of Vascanox HP on Nitric Oxide and Blood Pressure
Sponsor:
Calroy Health Sciences
Organization:
Calroy Health Sciences
Study Overview
Official Title:
Effects of S-allylcysteine-rich Garlic Extract and Dietary Inorganic Nitrate Formula Vascanox HP on Blood Pressure and Nitric Oxide Levels an Open-label Clinical Trial Among Hypertensive Adults
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Conversion of dietary nitrates to nitric oxide NO is a non-canonical pathway that plays an important role in NO biology particulalry under pathological conditions Nitrate supplementation has been shown to help control mild hypertension Recent studies have suggested that another gaseous transmitter hydrogen sulfide also influences NO biosynthesis and metabolism This open-label clinical trial will evalute the effect of Vascanox HP a proprietary formulation that combines dietary sources of nitric oxide and hydrogen sulfide on nitric oxide bioavailability and on blood pressure in subjects experiencing elevated blood pressure Participants will supplement with Vascanox HP for four weeks Blood pressure will be measured at baseline two weeks and fours weeks Salivary nitric oxide will be assessed prior to and two six and 24 hours after dosing on the first day of the study and prior to and two hours after dosing at subsequent study visits Participants will also self-monitor their saliva nitric oxide levels and blood pressure daily for 4 weeks Changes in study outcomes over time will be evaluated via analysis of variance ANOVA and paired t-tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None