Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428998
• Other study ID #: KGC-S-01
• 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
• 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 · 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

Related Conditions & MeSH terms

• Diabetes
• Healthy
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

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