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CompletedNCT00219960Updated Sep 22, 2005

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

A Phase 3 interventional study of North American Ginseng (Panax Quinquefolius) in Hypertension, sponsored by Risk Factor Modification Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2005-09-22.

Sponsored by Risk Factor Modification Centre · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Blood Pressure
  • Ambulatory Blood Pressure Monitoring
  • Complementary and Alternative Medicine
  • Herbal
  • North American Ginseng
  • Panax Quinquefolius
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 52 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Risk Factor Modification Centre is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
52 participants

Interventions

  • DrugNorth American Ginseng (Panax Quinquefolius)
06

What researchers measure

Primary outcomes

  1. Mean 24 Hour Ambulatory Blood Pressure

Secondary outcomes

  1. Mean Daytime Ambulatory Blood Pressure

  2. Mean Nighttime Ambulatory Blood Pressure

  3. Cystatin C

07

Study locations

1 site
  • Risk Factor Modification Centre, St. Michael's Hospital
    Toronto, Ontario M5C 2T2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00219960
Lead sponsor
Risk Factor Modification Centre
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs, Ontario Ginseng Growers Association
First posted
Sep 22, 2005
Start date
Apr 2001
Completion
Oct 2003
Last update
Sep 22, 2005

Study contacts

Vladimir Vuksan, PhD
principal investigator · Risk Factor Modification Centre, St. Michael's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2004. You cannot join it, but the record below documents what was studied.

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