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The Effect of Korean Red Ginseng Supplementation on Glucose Control

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01911663
Enrollment
60
Registered
2013-07-30
Start date
2011-11-30
Completion date
2012-03-31
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Detailed description

Study participants, who were all aged between 20 and 70, were recruited from health checkup center at Ilsan hospital (Gyeonggi-do, Korea) and the advertisements in local newspaper. After the glucose screening test, 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. Exclusion criteria that all selected patients met were: 1) Taking glucose-lowering medications or having insulin injections. 2) Chronic alcoholism or having an evidence or alcoholism. 3) Pregnant or in breast feeding. 4) Having chronic gastrointestinal disorders. 5) Showing signs of nutrient deficiency of malnutrition. 6) Patients with serious kidney problems. 7) Patients with serious liver problems. 8) Patients whose job could be a threat when hypoglycemia occurs. 9) Patients who have experienced the complications such as headache, insomnia, heart palpitations and raised blood pressure after eating red ginseng. 10) Other patients who were considered unsuitable for this study by the researchers This study was designed for 12-week randomized, double-blinded, placebo-controlled trial. Sixty subjects were randomly assigned to receive placebo (corn starch) or 500 mg KRG. Both group consumed 10 capsules per day, three times daily after breakfast (3 capsules), lunch (3 capsules) and dinner (4 capsules), and it comes to total 5.0g daily. Red ginseng and placebo capsules were provided by the Korea Ginseng Cooperation (KGC, Daejeon, Korea). Subjects met with the investigational team at four different time points: Screening (Week -1), randomization and treatment baseline (Week 0), treatment midpoint (Week 6), and treatment endpoint (Week 12). Daily intake by 24-hour recall method and physical activity were measured at baseline (Week 0), midpoint (Week 6), and endpoint (Week 12) of the treatment period. Compliance with study restrictions and capsule consumption was monitored via daily documentation by subjects on individualized study calendars and end-study count of returned capsules.

Interventions

DIETARY_SUPPLEMENTKRG

500 mg Korea red ginseng (KRG)

DIETARY_SUPPLEMENTPlacebo

500 mg placebo

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
change from baseline in glucose12 week

Secondary

MeasureTime frame
change from baseline in insulin12 week
change from baseline in C-peptide12 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026