Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Healthy; Diabetes; Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Korean Red Ginseng

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Catholic Universtiy of Korea. Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Korean Red Ginseng; 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
Placebo Comparator: Placebo; Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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
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

Other Outcome Measures

Outcome Measure	Time Frame
glucose, insulin, HbA1c levels, HOMA-IR index variation	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
variation of biological age	up to 24 weeks time after taking the Investigational product

Collaborators and Investigators

• Sponsor: Korea Ginseng Corporation
• Investigators: Principal Investigator: Kyungsoo Kim, M.D., Ph.D, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: KGC-S-01