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

NCT ID: NCT00219960

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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North American Ginseng (Panax Quinquefolius)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Ministry of Agriculture, Food and Rural Affairs

OTHER_GOV

Sponsor Role collaborator

Ontario Ginseng Growers Association

OTHER

Sponsor Role collaborator

Risk Factor Modification Centre

OTHER

Sponsor Role lead

Principal Investigators

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Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

Risk Factor Modification Centre, St. Michael's Hospital

Locations

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Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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SR-7093

Identifier Type: -

Identifier Source: secondary_id

RFMC-0001-77

Identifier Type: -

Identifier Source: org_study_id