NCT00219960

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Apr 2001

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

June 1, 2004

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Hypertension

Keywords

HypertensionBlood PressureAmbulatory Blood Pressure MonitoringComplementary and Alternative MedicineHerbalNorth American GinsengPanax Quinquefolius

Outcome Measures

Primary Outcomes (1)

  • Mean 24 Hour Ambulatory Blood Pressure

Secondary Outcomes (3)

  • Mean Daytime Ambulatory Blood Pressure

  • Mean Nighttime Ambulatory Blood Pressure

  • Cystatin C

Interventions

North American Ginseng (Panax Quinquefolius)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Vladimir Vuksan, PhD

    Risk Factor Modification Centre, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

April 1, 2001

Study Completion

October 1, 2003

Last Updated

September 22, 2005

Record last verified: 2004-06

Locations

CA(1)