The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation

July 30, 2015 updated by: Unity Health Toronto
While the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. This surge in demand prompts a call for its evaluation. Preliminary data demonstrates that KRG can affect vascular function and our research group has previously shown that Korean Red Ginseng (KRG) can lower blood pressure (BP) in hypertensive individuals. However, it is unknown which dose is the most effective in producing a desired effect. To address this issue, we will test escalating doses of a single Korean red ginseng batch of 0.5g, 1g 3g and 6g on BP in patients with hypertension to determine the most efficacious dose. The most promising dose will be extracted and will advance to next level to be tested again on BP control. The findings of the study may result in better ginseng standardization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals will arrive at the Risk Factor Modification Centre, St. Michael's Hospital between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings. They will not have consumed any antihypertensive medications on the study mornings. Each visit will be separated by a minimum of a week. Since the half-life of ginsenosides in humans is less than 24-hours, to allow for a washout of approximately seven half-lives.

In each of the four studies, when individuals arrive at our clinic on a test day they will first have their weight measured and subsequently rest in the seated position. They will then have a catheter inserted into a forearm vein, which will be kept patent by saline. From this device, a registered intravenous nurse will obtain a series of 7ml blood samples. Blood will be taken at 30-min intervals. Subsequently, individuals will fill out forms detailing their pharmacological regimen for the previous 24-hours and their diet (dinner) and activity (sleep, urination, morning routine) regimen for the previous 12-hours. As well, they will detail any adverse events that they experienced since their previous visit. Individuals will then have their office BP measured with a mercury sphygmomanometer until three consecutive measurements of both SBP and DBP <5 mmHg different are obtained. At this point, BP should be steady and subjects will be fitted with an ABPM. Measurements will be taken every 5-min for 30-min, for a total of seven measurements. After the seventh measurement (time 0-min), measurements will be taken automatically every 10-min for 180-min. At time 0-min, treatment or placebo capsules will be consumed. At time 60-min a 360-calorie Ensure® breakfast will be consumed within 5-min. Blood samples will be drawn at 30-min intervals, starting at time 0-min. For 24-hours after the ingestion of treatment, a record of any side effects will be detailed by the participants and then provided to us.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Clinical Nutrition and Risk Factor Modification Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Essential Hypertension

Exclusion Criteria:

  • Secondary Hypertension
  • Diabetes
  • Chronic Kidney Disease
  • Liver Disease
  • Unstable Angina
  • Coronary / Cerebrovascular event in the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules)
Dietary supplement: Korean Red Ginseng
500mg Capsulated Ground Dried Korean Red Ginseng Root
Dietary supplement: Corn Starch
500mg Capsulated Corn Starch
Experimental: 2
1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules)
Dietary supplement: Korean Red Ginseng
500mg Capsulated Ground Dried Korean Red Ginseng Root
Dietary supplement: Corn Starch
500mg Capsulated Corn Starch
Experimental: 3
3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules)
Dietary supplement: Korean Red Ginseng
500mg Capsulated Ground Dried Korean Red Ginseng Root
Dietary supplement: Corn Starch
500mg Capsulated Corn Starch
Experimental: 4
6g Korean Red Ginseng (12 capsules)
Dietary supplement: Korean Red Ginseng
500mg Capsulated Ground Dried Korean Red Ginseng Root
Experimental: 5
6g Corn Starch Control (12 capsules)
Dietary supplement: Corn Starch
500mg Capsulated Corn Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor
Time Frame: every 5 min for first 30 min, then every 10 minutes for 180 minutes
every 5 min for first 30 min, then every 10 minutes for 180 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood samples will be drawn and tested for Nitric Oxide levels.
Time Frame: every 30 minutes
every 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Vladimir Vuksan, PhD, Clinical Nutritian and Risk Factor Modification Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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