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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT01854164 |
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Date of registration:
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13/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
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Scientific title:
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An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01854164 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 20-70 years with fasting glucose 100~126 mg/dL
Exclusion Criteria:
- Abnormal lipid profile values
- Acute/chronic inflammation
- Treated with corticosteroid within past 4 weeks
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
- History of disease that could interfere with the test products or impede their
absorption
- Participation in any other clinical trials within past 2 months
- Renal disease
- Abnormal hepatic function
- Under hypolipidemic drugs therapy within past 3 months
- Under antipsychotic drugs therapy within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to
interfere with successful participation in the study
- History of alcohol or substance abuse
- Pregnancy or breast feeding
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperglycemia
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: HGE (hydrolyzed ginseng extract)
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Primary Outcome(s)
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Changes of blood glucose during OGTT(oral glucose tolerance test)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Changes of blood insulin during OGTT.
[Time Frame: 8 weeks]
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Changes of glycated albumin, fructosamine, and lipid profile
[Time Frame: 8 weeks]
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Secondary ID(s)
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Ilhwa-FG-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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