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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02428998
Other study ID # KGC-S-01
Secondary ID
Status Completed
Phase N/A
First received April 20, 2015
Last updated August 9, 2017
Start date September 2014
Est. completion date April 2017

Study information

Verified date August 2017
Source Korea Ginseng Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 ยท 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 Design


Intervention

Dietary Supplement:
Korean Red Ginseng

Placebo


Locations

Country Name City State
Korea, Republic of Catholic Universtiy of Korea. Seoul St Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korea Ginseng Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other glucose, insulin, HbA1c levels, HOMA-IR index variation up to 24 weeks time after taking the Investigational product
Other BMI, waist circumference variation up to 24 weeks time after taking the Investigational product
Other adiponectin, leptin levels of variation up to 24 weeks time after taking the Investigational product
Other URTI (Upper respiratory tract infection) rates up to 24 weeks time after taking the Investigational product
Other hs-CRP, IL-6, homocysteine concentration of variation up to 24 weeks time after taking the Investigational product
Other eGFR, change amount of urine protein up to 24 weeks time after taking the Investigational product
Other Variation of CFS (Chalder fatigue scale) up to 24 weeks time after taking the Investigational product
Other variation of biological age up to 24 weeks time after taking the Investigational product
Primary 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 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
Secondary Cardiovascular adverse events that occurred after taking the Investigational product up to 24 weeks time after taking the Investigational product
Secondary Gastrointestinal adverse events that occurred after ingestion of Investigational product up to 24 weeks time after taking the Investigational product
Secondary Neuropsychiatric adverse events that occurred after ingestion of Investigational product up to 24 weeks time after taking the Investigational product
Secondary Grade 3 adverse events that occurred after ingestion of Investigational product up to 24 weeks time after taking the Investigational product
Secondary 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
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