NCT01911663

Brief Summary

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes Mellitus and to establish a clinical evidence on glucose control effect of KRG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

July 26, 2013

Last Update Submit

July 26, 2013

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • change from baseline in glucose

    12 week

Secondary Outcomes (2)

  • change from baseline in insulin

    12 week

  • change from baseline in C-peptide

    12 week

Study Arms (2)

KRG

EXPERIMENTAL

500 mg Korea red ginseng (KRG)

Dietary Supplement: KRG

Placebo

PLACEBO COMPARATOR

500 mg placebo (corn starch)

Dietary Supplement: Placebo

Interventions

KRGDIETARY_SUPPLEMENT

500 mg Korea red ginseng (KRG)

KRG
PlaceboDIETARY_SUPPLEMENT

500 mg placebo

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with IFG (100 mg/dL ≤ fasting blood glucose ≤ 125mg/dL), IGT (140mg/dL ≤ 2-h OGTT), or newly-diagnosed T2DM (fasting glucose ≥ 126 mg/dL) were enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of clinical Nutrigenetics/Nutrigenomic

Seoul, 120-749, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 30, 2013

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

KR(1)