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OpenTrials
Completed

NCT Number: NCT02428998

Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic Universtiy of Korea. Seoul St Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea Ginseng Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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