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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730951
First Posted: August 8, 2008
Last Update Posted: July 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention Phase
Hypertension Dietary Supplement: Korean Red Ginseng Dietary Supplement: Corn Starch Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure Regulation

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Blood samples will be drawn and tested for Nitric Oxide levels. [ Time Frame: every 30 minutes ]

Enrollment: 18
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Essential Hypertension

Exclusion Criteria:

  • Secondary Hypertension
  • Diabetes
  • Chronic Kidney Disease
  • Liver Disease
  • Unstable Angina
  • Coronary / Cerebrovascular event in the previous 6 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730951


Locations
Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutritian and Risk Factor Modification Centre
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00730951     History of Changes
Other Study ID Numbers: 107460
First Submitted: August 6, 2008
First Posted: August 8, 2008
Last Update Posted: July 31, 2015
Last Verified: July 2015


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