Healthy, Diabetes, Hypertension, Hyperlipidemia
Conditions
Brief summary
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.
Interventions
DIETARY_SUPPLEMENTKorean Red Ginseng
DIETARY_SUPPLEMENTPlacebo
Sponsors
Korea Ginseng Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 19 years or older 2. agree to participate in this test, voluntarily signed by the parties to a written agreement 3. In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
Exclusion criteria
1. Pregnant and lactating mothers 2. Patients with a history of hypersensitivity to contain ingredients that caused the test food 3. patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal 4. Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal) 5. autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with 6. patients with uncontrolled diabetes (for HbA1c 8.0% or more) 7. Sulphonylureas, diabetic patients being treated with Insulin 8. , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg) 9. uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher) 10. patients with uncontrolled thyroid dysfunction 11. patients with a dementia or psychiatric problems 12. treated with systemic steroid screening visit within 1 weeks ago 13. before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within 14. taking the medicine within 4 weeks before the screening visit 15. taking the other investigational drugs or human test food application within four weeks before the screening visit 16. taking health supplements other than vitamins and minerals within 2 weeks before randomization 17. which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events occurring up to 24 weeks time after taking the Investigational product | up to 24 weeks time after taking the Investigational product |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product | up to 24 weeks to collect all focus point after taking the Investigational product |
| Gastrointestinal adverse events that occurred after ingestion of Investigational product | up to 24 weeks time after taking the Investigational product |
| Cardiovascular adverse events that occurred after taking the Investigational product | up to 24 weeks time after taking the Investigational product |
| Grade 3 adverse events that occurred after ingestion of Investigational product | up to 24 weeks time after taking the Investigational product |
| Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product | up to 24 weeks time after taking the Investigational product |
| Neuropsychiatric adverse events that occurred after ingestion of Investigational product | up to 24 weeks time after taking the Investigational product |
Other
| Measure | Time frame |
|---|---|
| glucose, insulin, HbA1c levels, HOMA-IR index variation | up to 24 weeks time after taking the Investigational product |
| variation of biological age | up to 24 weeks time after taking the Investigational product |
| BMI, waist circumference variation | up to 24 weeks time after taking the Investigational product |
| adiponectin, leptin levels of variation | up to 24 weeks time after taking the Investigational product |
| URTI (Upper respiratory tract infection) rates | up to 24 weeks time after taking the Investigational product |
| hs-CRP, IL-6, homocysteine concentration of variation | up to 24 weeks time after taking the Investigational product |
| eGFR, change amount of urine protein | up to 24 weeks time after taking the Investigational product |
| Variation of CFS (Chalder fatigue scale) | up to 24 weeks time after taking the Investigational product |
Countries
South Korea
Outcome results
None listed