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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014