- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07643532
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hải Phòng
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Haiphong, Hải Phòng, Vietnam, 180000
- Hai Phong University of Medicine and Pharmacy
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Contacto:
- Tran Van Anh, Master
- Número de teléfono: +84 343035492
- Correo electrónico: tvanh@hpmu.edu.vn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in ADP-induced platelet aggregation
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent change in ADP-induced platelet aggregation
Periodo de tiempo: Baseline (Visit 2) and Week 8 (Visit 4)
|
from baseline to end of treatment
|
Baseline (Visit 2) and Week 8 (Visit 4)
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|
Change and percent change in prothrombin time (PT)
Periodo de tiempo: Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
|
Baseline (Visit 2) and Week 8 (Visit 4)
|
|
Change and percent change in activated partial thromboplastin time (aPTT)
Periodo de tiempo: 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)
|
|
Change and percent change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides)
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Visit 2) and Week 8 (Visit 4)
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from baseline to end of treatment
|
Baseline (Visit 2) and Week 8 (Visit 4)
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|
Change and percent change in blood pressure (systolic and diastolic)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NIHHS-24-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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