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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

8 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Vietnam
    • Hải Phòng
      • Haiphong, Hải Phòng, Vietnam, 180000
        • Hai Phong University of Medicine and Pharmacy
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: KoreaGinseng F Max
White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.
Placebo-jämförare: 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.
Kosttillskott: Placebo
Matching placebo control product; same dosing schedule and duration as the test product.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in ADP-induced platelet aggregation
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent change in ADP-induced platelet aggregation
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline (Visit 2) and Week 8 (Visit 4)
from baseline to end of treatment
Baseline (Visit 2) and Week 8 (Visit 4)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Haiphong University of Medicine and Pharmacy

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juni 2026

Primärt slutförande (Beräknad)

10 december 2026

Avslutad studie (Beräknad)

10 juni 2028

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

8 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • NIHHS-24-01

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