A Clinical Trial of Ginseng in Diabetes - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00781534

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

MedlinePlus related topics: Diabetes Dietary Supplements Diets

Drug Information available for: Ginseng

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Clinical Trial of Ginseng for Glucose Intolerance

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
1. Ginseng: Active Comparator 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
2. Ginsenosdie RE: Active Comparator Ginsenoside RE (a metabolite of ginseng) group	Dietary Supplement: Ginseng Dietary Supplement: ginsenoside RE active metabolite of ginseng
3. Placebo: Placebo Comparator 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:

ginseng
ginsenoside RE (a type of metabolized ginseng)
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
Investigator:	Samuel Klein, MD	Washington University School of Medicine
Investigator:	Dominic N Reeds, MD	Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Keneth S. Polonsky, MD )
Study ID Numbers:	03-0824
Study First Received:	October 27, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781534 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

Health Supplements
Ginseng
Diabetes

Study placed in the following topic categories:

Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009