A Single-center, Randomized, Double-blind, Placebo-controlled, Intervention Clinical Trial to Evaluate the Efficacy and Safety of "KoreaGinseng F Max" on Blood Circulation Improvement in Adults With Poor Peripheral Blood Flow

Study design: Single-center, randomized, double-blind, placebo-controlled, parallel-group interventional trial.

Population: Men or women aged ≥20 and <65 years requiring improvement of blood circulation, with ADP- and collagen-induced platelet aggregation above 55%, who provide written informed consent.

Intervention: Participants are randomized 1:1 to the test product (white ginseng extract, KoreaGinseng F Max) or a matching placebo control. Dosing is 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day) for 8 weeks, taken orally.

Visit schedule: Screening (Visit 1, Week -2 to 0); randomization/baseline (Visit 2, Week 0); interim visit (Visit 3, Week 4 ±5 days); end-of-treatment (Visit 4, Week 8 ±5 days); plus a supplementary visit if needed.

Primary endpoint: Change in ADP-induced platelet aggregation from baseline (Visit 2) to Visit 4.

Secondary endpoints: Percent change in ADP-induced platelet aggregation; change and percent change in prothrombin time and activated partial thromboplastin time; change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides); change in serotonin; change in systolic and diastolic blood pressure; and - all from baseline to Visit 4.

Sample size: 100 participants (2 groups); approximately 50 evaluable per group, accounting for an ~8% dropout rate.

Inclusion criteria

• Men or women aged 20 to under 65 years
• Platelet aggregation response above 55% (satisfied for both collagen and ADP)
• Provides voluntary written informed consent to participate

Exclusion criteria

• History of hypersensitivity or allergy to ginseng-containing products that may affect the results
• Surgery under general anesthesia within 12 weeks before participation
• Use of contraindicated products such as red ginseng or omega-3 fatty acids within 2 weeks before screening
• Use of antiplatelet drugs such as aspirin within 2 weeks before screening (subjects on prophylactic aspirin <100 mg with unchanged dose/method may participate)
• Uncontrolled hypertension not managed by medication (systolic BP >160 mmHg or diastolic BP >97 mmHg)
• Currently using study-indicated medications such as those for dyslipidemia or diabetes
• On drug treatment with a history of peripheral atherosclerosis and coronary artery disease (peripheral vascular disease, abdominal aortic aneurysm, carotid artery disease)
• Coronary artery bypass surgery, vascular anastomosis, pacemaker use, myocardial infarction, heart failure, arrhythmia, or other cardiac disease within 6 months
• Infectious inflammatory disease, systemic infection, immune-resistance-related disease, or leukemia (blood cancer)
• Irritable bowel syndrome, gastrointestinal resection surgery, or GI-related disease such as Crohn's disease
• History of cerebral ischemia or cerebral hemorrhage such as cerebral infarction or stroke due to atherosclerosis
• Concurrent symptoms of myocardial infarction, atherosclerosis, or congestive heart failure
• Clinically significant liver dysfunction (ALT or AST ≥2.5x the upper limit of normal)
• Clinically significant renal dysfunction (serum creatinine >2.0 mg/dL)
• TSH outside 0.27-5.07 microIU/mL or thyroid disease
• History of, or current treatment for, psychiatric/neurological disorders including schizophrenia, depression, or drug addiction
• History of malignant tumor within 5 years before screening
• Pregnant or breastfeeding women, women of childbearing potential not using medically reliable contraception, or women within 6 months postpartum
• Alcohol consumption within the last 3 days (men 30 g/day, women 20 g/day)
• Participation in another clinical trial within 4 weeks before participation
• Subjects judged unsuitable by the investigator or other physicians