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Completed

NCT Number: NCT00219960

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

North American Ginseng (Panax Quinquefolius)

Drug

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

Sponsors and collaborators

Lead sponsor

Risk Factor Modification Centre

Other

Collaborators

  • Ontario Ginseng Growers Association
  • Ontario Ministry of Agriculture, Food and Rural Affairs

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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