Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

NCT ID: NCT02428998

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Healthy; Diabetes; Hypertension; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Korean Red Ginseng

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

Group Type: EXPERIMENTAL

Korean Red Ginseng

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Korean Red Ginseng

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea Ginseng Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyungsoo Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Catholic Universtiy of Korea. Seoul St Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KGC-S-01

Identifier Type: -

Identifier Source: org_study_id