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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hải Phòng
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Haiphong, Hải Phòng, 베트남, 180000
- Hai Phong University of Medicine and Pharmacy
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연락하다:
- Tran Van Anh, Master
- 전화번호: +84 343035492
- 이메일: tvanh@hpmu.edu.vn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ADP-induced platelet aggregation
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent change in ADP-induced platelet aggregation
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NIHHS-24-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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KoreaGinseng F Max에 대한 임상 시험
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Maxinovel Pty., Ltd.모병
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...아직 모집하지 않음교모세포종의 새로운 진단에 적합한 방사선학적, 임상적 및 기왕증 사진을 가진 환자