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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Vietnam
    • Hải Phòng
      • Haiphong, Hải Phòng, Vietnam, 180000
        • Hai Phong University of Medicine and Pharmacy
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: KoreaGinseng F Max
White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.
Placebo komparator: 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.
Kosttilskudd: Placebo
Matching placebo control product; same dosing schedule and duration as the test product.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in ADP-induced platelet aggregation
Tidsramme: 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)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Haiphong University of Medicine and Pharmacy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. juni 2026

Primær fullføring (Antatt)

10. desember 2026

Studiet fullført (Antatt)

10. juni 2028

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • NIHHS-24-01

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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