Korean red ginseng extracts for improvement of blood glucose with prediabetes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004639
- Lead Sponsor
- Korea Ginseng Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1) Male or female adults aged 19 to 64
2) Participant who satisfies one of the followings;
a. fasting blood glucose level between 100 and 125 mg/dL
b. blood glucose level between 140 and 199 mg/dL with oral glucose tolerance test
c. HbA1C level between 5.7 and 6.4%
3) Participants who voluntarily assent to participate in the study and sign the informed consents
1) Participants taking hypoglycemic agents within 3 months
2) Patients diagnosed with thyroid diseases and under their treatments
3) Patients diagnosed with chronic gastrointestinal disorders
4) Uncontrolled hypertensive patients
5) Patients taking continuous treatments due to significantly glycometabolism-related disorders
6) Participants with 30kg/m2 or more of body mass index
7) Participants with renal dysfunction (1.5 times or more of upper limit of normal creatinine level), hepatic dysfunction (2.5 times or more of upper limits of normal alanine and aspartate aminotransferase levels), malignant tumors, or mental diseases
8) Participants who took any medications, herb medicines, or functional supplements for 3 days or more within 4 weeks
9) Pregnant or lactating females
10) Participants who took any surgeries due to significantly glycometabolism-related disorders within recent 6 months
11) Participants who have ever addicted to any drugs or alcohol
12) Participants who participated in other clinical studies within 1 month
13) Participants who are allergic or overreactive to the investigator’s product
14) Participants who are illiterate or cannot read written letters
15) Participants who have any other inappropriate reasons to participant in the study, judged by the investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oral Glucose Tolerance Test;Fasting glucose
- Secondary Outcome Measures
Name Time Method blood insulin;C-peptide;Lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, free fatty acid);Abdominal obesity index (waist circumference, waist hip ratio);HOMA-IR;Vital sign (systolic blood pressure, diastolic blood pressure, pulse rate);Labarotary test;Adverse events