Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

Not Applicable

Completed

• Conditions: Hypertension; Hyperlipidemia; Healthy; Diabetes
• Interventions: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Placebo

• Registration Number: NCT02428998
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Primary Completion: 2016-08
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Korean Red Ginseng	Korean Red Ginseng	Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses
Placebo	Placebo	Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Cardiovascular adverse events that occurred after taking the Investigational product	up to 24 weeks time after taking the Investigational product
Gastrointestinal adverse events that occurred after ingestion of Investigational product	up to 24 weeks time after taking the Investigational product
Neuropsychiatric adverse events that occurred after ingestion of Investigational product	up to 24 weeks time after taking the Investigational product
Grade 3 adverse events that occurred after ingestion of Investigational product	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	up to 24 weeks time after taking the Investigational product

Trial Locations

Locations (1)

Catholic Universtiy of Korea. Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of