A Clinical Trial of Ginseng in Diabetes

NCT ID: NCT00781534

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-09-30

Brief Summary

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a clinical study of Ginseng its potential affect on diabetes

Detailed Description

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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

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Ginseng

Ginseng group

Group Type ACTIVE_COMPARATOR

Ginseng

Intervention Type DRUG

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

Ginsenoside RE (a metabolite of ginseng) group

Group Type ACTIVE_COMPARATOR

Ginseng

Intervention Type DRUG

ginsenoside RE

Intervention Type DRUG

active metabolite of ginseng

3. Placebo

placebo ("sugar" pill) group

Group Type PLACEBO_COMPARATOR

Placebo (sugar pill)

Intervention Type DIETARY_SUPPLEMENT

placebo group

Interventions

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Ginseng

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

Intervention Type DRUG

Ginseng

Intervention Type DRUG

ginsenoside RE

active metabolite of ginseng

Intervention Type DRUG

Placebo (sugar pill)

placebo group

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Washington University School of Medicine

Principal Investigators

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Kenneth S Polonsky, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21411505 (View on PubMed)

Other Identifiers

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03-0824

Identifier Type: -

Identifier Source: org_study_id

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