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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Hải Phòng
-
Haiphong, Hải Phòng, Viêt Nam, 180000
- Hai Phong University of Medicine and Pharmacy
-
Contact:
- Tran Van Anh, Master
- Numéro de téléphone: +84 343035492
- E-mail: tvanh@hpmu.edu.vn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.
|
|
Comparateur placebo: 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.
|
Matching placebo control product; same dosing schedule and duration as the test product.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in ADP-induced platelet aggregation
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percent change in ADP-induced platelet aggregation
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: Baseline (Visit 2) and Week 8 (Visit 4)
|
from baseline to end of treatment
|
Baseline (Visit 2) and Week 8 (Visit 4)
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- NIHHS-24-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .