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Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428998
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Korea Ginseng Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Diabetes Hypertension Hyperlipidemia Dietary Supplement: Korean Red Ginseng Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : September 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Cardiovascular adverse events that occurred after taking the Investigational product [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  3. Gastrointestinal adverse events that occurred after ingestion of Investigational product [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  4. Neuropsychiatric adverse events that occurred after ingestion of Investigational product [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  5. Grade 3 adverse events that occurred after ingestion of Investigational product [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  6. 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 ]

Other Outcome Measures:
  1. glucose, insulin, HbA1c levels, HOMA-IR index variation [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  2. BMI, waist circumference variation [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  3. adiponectin, leptin levels of variation [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  4. URTI (Upper respiratory tract infection) rates [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  5. hs-CRP, IL-6, homocysteine concentration of variation [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  6. eGFR, change amount of urine protein [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  7. Variation of CFS (Chalder fatigue scale) [ Time Frame: up to 24 weeks time after taking the Investigational product ]
  8. variation of biological age [ Time Frame: up to 24 weeks time after taking the Investigational product ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428998


Locations
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Korea, Republic of
Catholic Universtiy of Korea. Seoul St Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Korea Ginseng Corporation
Investigators
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Principal Investigator: Kyungsoo Kim, M.D., Ph.D The Catholic University of Korea

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Responsible Party: Korea Ginseng Corporation
ClinicalTrials.gov Identifier: NCT02428998    
Other Study ID Numbers: KGC-S-01
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases