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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

2026年6月8日 更新者：Haiphong University of Medicine and Pharmacy

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 越南
    • Hải Phòng
      • Haiphong、Hải Phòng、越南、180000
        • Hai Phong University of Medicine and Pharmacy
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：White Ginseng Extract (KoreaGinseng F Max)
Participants receive white ginseng extract (KoreaGinseng F Max), 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day) orally for 8 weeks.
膳食补充剂：KoreaGinseng F Max
White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.
安慰剂比较：placebo
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.
膳食补充剂：Placebo
Matching placebo control product; same dosing schedule and duration as the test product.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in ADP-induced platelet aggregation
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
Change in adenosine diphosphate (ADP)-induced platelet aggregation from baseline to end of treatment.
Baseline (Visit 2) and Week 8 (Visit 4)

次要结果测量

结果测量
措施说明
大体时间
Percent change in ADP-induced platelet aggregation
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)
Change and percent change in prothrombin time (PT)
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)
Change and percent change in activated partial thromboplastin time (aPTT)
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
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)
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)
Change and percent change in serum serotonin
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)
Change and percent change in blood pressure (systolic and diastolic)
大体时间：Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Haiphong University of Medicine and Pharmacy

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月10日

初级完成 (估计的)

2026年12月10日

研究完成 (估计的)

2028年6月10日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • NIHHS-24-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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