Clinical trial NCT02428998: Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Diabetes
Hypertension
Hyperlipidemia
Lead sponsor: Korea Ginseng Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: All adverse events occurring up to 24 weeks time after taking the Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
Secondary outcomes:
measure: Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product
timeFrame: up to 24 weeks to collect all focus point after taking the Investigational product
measure: Cardiovascular adverse events that occurred after taking the Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
measure: Gastrointestinal adverse events that occurred after ingestion of Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
measure: Neuropsychiatric adverse events that occurred after ingestion of Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
measure: Grade 3 adverse events that occurred after ingestion of Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
measure: Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product
timeFrame: up to 24 weeks time after taking the Investigational product
Other outcomes:
measure: glucose, insulin, HbA1c levels, HOMA-IR index variation
timeFrame: up to 24 weeks time after taking the Investigational product
measure: BMI, waist circumference variation
timeFrame: up to 24 weeks time after taking the Investigational product
measure: adiponectin, leptin levels of variation
timeFrame: up to 24 weeks time after taking the Investigational product
measure: URTI (Upper respiratory tract infection) rates
timeFrame: up to 24 weeks time after taking the Investigational product
measure: hs-CRP, IL-6, homocysteine concentration of variation
timeFrame: up to 24 weeks time after taking the Investigational product
measure: eGFR, change amount of urine protein
timeFrame: up to 24 weeks time after taking the Investigational product
measure: Variation of CFS (Chalder fatigue scale)
timeFrame: up to 24 weeks time after taking the Investigational product
measure: variation of biological age
timeFrame: up to 24 weeks time after taking the Investigational product
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Universtiy of Korea. Seoul St Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Kyungsoo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: