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A Clinical Trial of Ginseng in Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781534
First Posted: October 29, 2008
Last Update Posted: February 19, 2010
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.
Information provided by:
Washington University School of Medicine
October 27, 2008
October 29, 2008
February 19, 2010
September 2003
December 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00781534 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Clinical Trial of Ginseng in Diabetes
A Clinical Trial of Ginseng for Glucose Intolerance
a clinical study of Ginseng its potential affect on diabetes

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
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Diabetes
  • 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
  • Dietary Supplement: Ginseng
  • Dietary Supplement: ginsenoside RE
    active metabolite of ginseng
  • Dietary Supplement: Placebo (sugar pill)
  • Active Comparator: 1. Ginseng
    Ginseng group
    Intervention: Dietary Supplement: Ginseng, ginsenoside Re or placebo
  • Active Comparator: 2. Ginsenosdie RE
    Ginsenoside RE (a metabolite of ginseng) group
    Interventions:
    • Dietary Supplement: Ginseng
    • Dietary Supplement: ginsenoside RE
  • Placebo Comparator: 3. Placebo
    placebo ("sugar" pill) group
    Intervention: Dietary Supplement: Placebo (sugar pill)
Reeds DN, Patterson BW, Okunade A, Holloszy JO, Polonsky KS, Klein S. Ginseng and ginsenoside Re do not improve β-cell function or insulin sensitivity in overweight and obese subjects with impaired glucose tolerance or diabetes. Diabetes Care. 2011 May;34(5):1071-6. doi: 10.2337/dc10-2299. Epub 2011 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
September 2008
December 2004   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00781534
03-0824
No
Not Provided
Not Provided
Kenneth S. Polonsky, MD, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Kenneth S Polonsky, MD Washington University School of Medicine
Washington University School of Medicine
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP