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A Clinical Trial of Ginseng in Diabetes

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00781534
First received: October 27, 2008
Last updated: February 18, 2010
Last verified: February 2010
History of Changes
  Purpose

a clinical study of Ginseng its potential affect on diabetes


Condition Intervention Phase
Diabetes
 Dietary Supplement: Ginseng, ginsenoside Re or placebo
Dietary Supplement: Ginseng
Dietary Supplement: ginsenoside RE
Dietary Supplement: Placebo (sugar pill)
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Clinical Trial of Ginseng for Glucose Intolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Enrollment: 19
Study Start Date: September 2003
Study Completion Date: September 2008
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Washington University School of Medicine

Additional 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
Study First Received: October 27, 2008
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 16, 2013