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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219960
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Ministry of Agriculture, Food and Rural Affairs
Ontario Ginseng Growers Association
Information provided by:
Risk Factor Modification Centre
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00219960     History of Changes
Other Study ID Numbers: RFMC-0001-77
SR-7093
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2004

Keywords provided by Risk Factor Modification Centre:
Hypertension
Blood Pressure
Ambulatory Blood Pressure Monitoring
Complementary and Alternative Medicine
Herbal
North American Ginseng
Panax Quinquefolius

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases