NCT00781534

Brief Summary

a clinical study of Ginseng its potential affect on diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for early_phase_1 diabetes

Timeline
Completed

Started Sep 2003

Longer than P75 for early_phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

October 27, 2008

Last Update Submit

September 5, 2019

Conditions

Diabetes

Keywords

Health SupplementsGinsengDiabetes

Study Arms (3)

1. Ginseng

ACTIVE COMPARATOR

Ginseng group

Drug: Ginseng

2. Ginsenosdie RE

ACTIVE COMPARATOR

Ginsenoside RE (a metabolite of ginseng) group

Drug: GinsengDrug: ginsenoside RE

3. Placebo

PLACEBO COMPARATOR

placebo ("sugar" pill) group

Dietary Supplement: Placebo (sugar pill)

Interventions

GinsengDRUG

Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups

1. Ginseng
ginsenoside REDRUG

active metabolite of ginseng

2. Ginsenosdie RE
Placebo (sugar pill)DIETARY_SUPPLEMENT

placebo group

3. Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Reeds DN, Patterson BW, Okunade A, Holloszy JO, Polonsky KS, Klein S. Ginseng and ginsenoside Re do not improve beta-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.

    PMID: 21411505DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Asian ginsengginsenoside ReSugars

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Kenneth S Polonsky, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 29, 2008

Study Start

September 1, 2003

Primary Completion

December 1, 2004

Study Completion

September 1, 2008

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations

US(1)