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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KoreaGinseng F Max | Dietary Supplement | White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in ADP-induced platelet aggregation | from baseline to end of treatment | Baseline (Visit 2) and Week 8 (Visit 4) |
| Change and percent change in prothrombin time (PT) | from baseline to end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hai Phong University of Medicine and Pharmacy | Haiphong | Hải Phòng | 180000 | Vietnam |
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Two parallel groups randomized 1:1 to white ginseng extract or matching placebo.
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| Placebo | Dietary Supplement | Matching placebo control product; same dosing schedule and duration as the test product. |
|
| Baseline (Visit 2) and Week 8 (Visit 4) |
| Change and percent change in activated partial thromboplastin time (aPTT) | from baseline to end of treatment | Baseline (Visit 2) and Week 8 (Visit 4) |
| Change and percent change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides) | from baseline to end of treatment | Baseline (Visit 2) and Week 8 (Visit 4) |
| Change and percent change in serum serotonin | from baseline to end of treatment | Baseline (Visit 2) and Week 8 (Visit 4) |
| Change and percent change in blood pressure (systolic and diastolic) | from baseline to end of treatment | Baseline (Visit 2) and Week 8 (Visit 4) |