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

NCT07643532 | Not Yet Recruiting DMC

• 1 other identifier: NIHHS-24-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of a white ginseng extract (KoreaGinseng F Max) for improving blood circulation in adults with poor peripheral blood flow. A total of 100 adults aged 20 to under 65 years with platelet aggregation above 55% will be enrolled and randomly assigned in a 1:1 ratio to receive either the white ginseng extract or a matching placebo for 8 weeks. Each participant takes 3 tablets after breakfast and 3 tablets after dinner (6 tablets per day). The main goal is to measure the change in ADP-induced platelet aggregation from baseline (Visit 2) to the end of treatment (Visit 4, Week 8). The study also assesses effects on coagulation measures, blood lipids, serotonin, blood pressure, white blood cell count, and overall safety.

Conditions

Blood Circulation; Peripheral Blood Flow; Platelet Aggregation

Keywords

White ginseng extract; KoreaGinseng F Max; Platelet aggregation; Blood circulation; Antiplatelet; Dietary supplement; Functional food

Outcome Measures

Primary Outcomes (1)

• Change in ADP-induced platelet aggregation

  Change in adenosine diphosphate (ADP)-induced platelet aggregation from baseline to end of treatment.

  Baseline (Visit 2) and Week 8 (Visit 4)

Secondary Outcomes (6)

• Percent change in ADP-induced platelet aggregation

  Baseline (Visit 2) and Week 8 (Visit 4)

• Change and percent change in prothrombin time (PT)

  Baseline (Visit 2) and Week 8 (Visit 4)

• Change and percent change in activated partial thromboplastin time (aPTT)

  Baseline (Visit 2) and Week 8 (Visit 4)

• Change and percent change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides)

  Baseline (Visit 2) and Week 8 (Visit 4)

• Change and percent change in serum serotonin

  Baseline (Visit 2) and Week 8 (Visit 4)

Study Arms (2)

White Ginseng Extract (KoreaGinseng F Max)

EXPERIMENTAL

Participants receive white ginseng extract (KoreaGinseng F Max), 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day) orally for 8 weeks.

Dietary Supplement: KoreaGinseng F Max

placebo

PLACEBO COMPARATOR

Participants receive a matching placebo control product on the same dosing schedule (3 tablets after breakfast and 3 tablets after dinner, 6 tablets/day) orally for 8 weeks.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Matching placebo control product; same dosing schedule and duration as the test product.

placebo

KoreaGinseng F Max DIETARY_SUPPLEMENT

White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.

White Ginseng Extract (KoreaGinseng F Max)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Hai Phong University of Medicine and Pharmacy

Haiphong, Hải Phòng, 180000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups randomized 1:1 to white ginseng extract or matching placebo.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): June 10, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

VN (1)