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

This study has been completed.
Sponsor:
Collaborators:
Ontario Ministry of Agriculture, Food and Rural Affairs
Ontario Ginseng Growers Association
Information provided by:
Risk Factor Modification Centre
ClinicalTrials.gov Identifier:
NCT00219960
First received: September 14, 2005
Last updated: NA
Last verified: June 2004
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00219960     History of Changes
Other Study ID Numbers: RFMC-0001-77, SR-7093
Study First Received: September 14, 2005
Last Updated: September 14, 2005
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013