The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension - Full Text View

Purpose

To determine the effect of North American ginseng on blood pressure in individuals with hypertension.

Condition	Intervention	Phase
Hypertension	Drug: North American Ginseng (Panax Quinquefolius)	Phase III

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Ginseng

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension

Further study details as provided by Risk Factor Modification Centre:

Primary Outcome Measures:

Mean 24 Hour Ambulatory Blood Pressure

Secondary Outcome Measures:

Mean Daytime Ambulatory Blood Pressure
Mean Nighttime Ambulatory Blood Pressure
Cystatin C

Estimated Enrollment:	52
Study Start Date:	April 2001
Estimated Study Completion Date:	October 2003

Detailed Description:

Ginseng lacks proper clinical scrutiny for its effect on blood pressure (BP), in spite of observational evidence linking its intake to hypertension. This should be addressed considering the potential overlap between the prevalence of ginseng use and hypertension.

We undertook a single centre, randomized, controlled, double-blinded, crossover trial to determine the effect of North American ginseng (NAG) on 24-hour BP and renal function. After a 4-week placebo run-in, we randomly assigned participants to NAG or placebo treatment for 12-weeks at a dose of 3g/day. This was followed by an 8-week washout, and a subsequent 12-week period in which the opposite treatment was consumed. At run-in, and at weeks 0 and 12 of each treatment period, participants were fitted with an ambulatory BP monitor to assess 24-hour BP and serum cystatin C was measured.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

aged 18 to 85 years
hypertension as defined by the use of antihypertensive drugs or a seated systolic blood pressure greater than or equal to 140 mm Hg or a diastolic BP greater than or equal to 90 mm Hg at each of 3 pre-study visits.

Exclusion Criteria:

secondary hypertension
diabetes
kidney
liver disease
unstable angina
ginseng use for two months prior to or during the study
any changes in the type or dose of antihypertensive drugs one month prior to or during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219960

Locations


Canada, Ontario
	Risk Factor Modification Centre, St. Michael's Hospital
	Toronto, Ontario, Canada, M5C 2T2

Sponsors and Collaborators

Risk Factor Modification Centre

Ontario Ministry of Agriculture, Food and Rural Affairs

Ontario Ginseng Growers Association

Investigators


Principal Investigator:	Vladimir Vuksan, PhD	Risk Factor Modification Centre, St. Michael's Hospital

More Information

Study ID Numbers:	RFMC-0001-77, SR-7093
First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00219960
Health Authority:	Canada: Health Canada

Keywords provided by Risk Factor Modification Centre:

Hypertension

Blood Pressure

Ambulatory Blood Pressure Monitoring

Complementary and Alternative Medicine

Herbal

North American Ginseng

Panax Quinquefolius

Study placed in the following topic categories:

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Risk Factor Modification Centre Ontario Ministry of Agriculture, Food and Rural Affairs Ontario Ginseng Growers Association
Information provided by:	Risk Factor Modification Centre
ClinicalTrials.gov Identifier:	NCT00219960