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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Hải Phòng
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Haiphong、Hải Phòng、ベトナム、180000
- Hai Phong University of Medicine and Pharmacy
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コンタクト：
- Tran Van Anh, Master
- 電話番号：+84 343035492
- メール：tvanh@hpmu.edu.vn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.
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プラセボコンパレーター：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.
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Matching placebo control product; same dosing schedule and duration as the test product.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in ADP-induced platelet aggregation
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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Change in adenosine diphosphate (ADP)-induced platelet aggregation from baseline to end of treatment.
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Baseline (Visit 2) and Week 8 (Visit 4)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent change in ADP-induced platelet aggregation
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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Change and percent change in prothrombin time (PT)
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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Change and percent change in activated partial thromboplastin time (aPTT)
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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Change and percent change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides)
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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Change and percent change in serum serotonin
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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Change and percent change in blood pressure (systolic and diastolic)
時間枠：Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
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Baseline (Visit 2) and Week 8 (Visit 4)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NIHHS-24-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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KoreaGinseng F Maxの臨床試験
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...まだ募集していません膠芽腫の新しい診断と一致する放射線学的、臨床的および既往歴のある患者
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JointResearch完了