Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

Study Overview
=================
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.

Official Title
-----------------
Safety Evaluation for 24 Weeks Intake of Korean Red Ginseng in Adults: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Exploratory Trial

Conditions
-----------------
Healthy, Diabetes, Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Korean Red Ginseng
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years or older agree to participate in this test, voluntarily signed by the parties to a written agreement 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: Pregnant and lactating mothers Patients with a history of hypersensitivity to contain ingredients that caused the test food patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal) autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with patients with uncontrolled diabetes (for HbA1c 8.0% or more) Sulphonylureas, diabetic patients being treated with Insulin , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg) uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher) patients with uncontrolled thyroid dysfunction patients with a dementia or psychiatric problems treated with systemic steroid screening visit within 1 weeks ago before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within taking the medicine within 4 weeks before the screening visit taking the other investigational drugs or human test food application within four weeks before the screening visit taking health supplements other than vitamins and minerals within 2 weeks before randomization 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Red Ginseng<br>Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses | Dietary Supplement: Korean Red Ginseng<br> <br> |
| Placebo Comparator: Placebo<br>Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Cardiovascular adverse events that occurred after taking the Investigational product |  | up to 24 weeks time 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 | 
| Neuropsychiatric adverse events that occurred after ingestion of 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 |