The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation
1 other identifier
interventional
18
1 country
1
Brief Summary
While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive individuals. However, it is unknown which dose is the most effective in producing a desired effect. To address this issue, we will test escalating doses of a single Korean red ginseng batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most efficacious dose. The most promising dose will be extracted and will advance to next level to be tested again on BP control. The findings of the study may result in better ginseng standardization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hypertension
Started Jun 2007
Shorter than P25 for phase_2 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
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 6, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedJuly 31, 2015
July 1, 2015
7 months
August 6, 2008
July 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor
every 5 min for first 30 min, then every 10 minutes for 180 minutes
Secondary Outcomes (1)
Blood samples will be drawn and tested for Nitric Oxide levels.
every 30 minutes
Study Arms (5)
1
EXPERIMENTAL0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules)
2
EXPERIMENTAL1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules)
3
EXPERIMENTAL3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules)
4
EXPERIMENTAL6g Korean Red Ginseng (12 capsules)
5
EXPERIMENTAL6g Corn Starch Control (12 capsules)
Interventions
Eligibility Criteria
You may qualify if:
- Essential Hypertension
You may not qualify if:
- Secondary Hypertension
- Diabetes
- Chronic Kidney Disease
- Liver Disease
- Unstable Angina
- Coronary / Cerebrovascular event in the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (1)
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Vuksan, PhD
Clinical Nutritian and Risk Factor Modification Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2008
First Posted
August 8, 2008
Study Start
June 1, 2007
Primary Completion
January 1, 2008
Study Completion
March 1, 2008
Last Updated
July 31, 2015
Record last verified: 2015-07