Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

Korea Ginseng

Status: Completed

Conditions: Hypertension; Healthy; Diabetes; Hyperlipidemia

Treatments: Dietary Supplement: Korean Red Ginseng; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428998

KGC-S-01

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups, including a placebo group

Korean Red Ginseng

Experimental group

Description:

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

Treatment:

Dietary Supplement: Korean Red Ginseng

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo