Overview

This trial is active, not recruiting.

Conditions healthy, diabetes, hypertension, hyperlipidemia
Treatments korean red ginseng, placebo
Sponsor Korea Ginseng Corporation
Start date September 2014
End date September 2016
Trial size 1000 participants
Trial identifier NCT02428998, KGC-S-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses
korean red ginseng
(Placebo Comparator)
Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses
placebo

Primary Outcomes

Measure
All adverse events occurring up to 24 weeks time after taking the Investigational product
time frame: 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
time frame: up to 24 weeks to collect all focus point after taking the Investigational product
Cardiovascular adverse events that occurred after taking the Investigational product
time frame: up to 24 weeks time after taking the Investigational product
Gastrointestinal adverse events that occurred after ingestion of Investigational product
time frame: up to 24 weeks time after taking the Investigational product
Neuropsychiatric adverse events that occurred after ingestion of Investigational product
time frame: up to 24 weeks time after taking the Investigational product
Grade 3 adverse events that occurred after ingestion of Investigational product
time frame: 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
time frame: up to 24 weeks time after taking the Investigational product

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

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
Principal investigator Kyungsoo Kim, M.D., Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Korea Ginseng Corporation.