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A Clinical Trial of Ginseng in Diabetes

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ClinicalTrials.gov Identifier: NCT00781534
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:
Washington University School of Medicine

Brief Summary:
a clinical study of Ginseng its potential affect on diabetes

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Ginseng, ginsenoside Re or placebo Dietary Supplement: Ginseng Dietary Supplement: ginsenoside RE Dietary Supplement: Placebo (sugar pill) Early Phase 1

Detailed Description:

Comparing three groups (those with & without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking:

  1. ginseng
  2. ginsenoside RE (a type of metabolized ginseng)
  3. placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Clinical Trial of Ginseng for Glucose Intolerance
Study Start Date : September 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1. Ginseng
Ginseng group
Dietary Supplement: Ginseng, ginsenoside Re or placebo
Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups
Active Comparator: 2. Ginsenosdie RE
Ginsenoside RE (a metabolite of ginseng) group
Dietary Supplement: Ginseng Dietary Supplement: ginsenoside RE
active metabolite of ginseng
Placebo Comparator: 3. Placebo
placebo ("sugar" pill) group
Dietary Supplement: Placebo (sugar pill)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 18-65
  • healthy, non-diabetic
  • healthy, impaired glucose tolerance/mild diabetes (no medications required)

Exclusion Criteria:

  • impaired glucose tolerance (borderline diabetes that requires medications)
  • diabetes (requiring medications)
  • caffeine sensitivity
  • known cardiac, peripheral vascular diseases
  • arrhythmias (irregular heart rhythms)

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): NCT00781534


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kenneth S Polonsky, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth S. Polonsky, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00781534     History of Changes
Other Study ID Numbers: 03-0824
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010

Keywords provided by Washington University School of Medicine:
Health Supplements
Ginseng
Diabetes