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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorHaiphong University of Medicine and Pharmacy

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • KoreaGinseng F Max

    Dietary supplement

    White ginseng extract; 3 tablets after breakfast and 3 tablets after dinner (6 tablets/day), oral, for 8 weeks.

  • Placebo

    Dietary supplement

    Matching placebo control product; same dosing schedule and duration as the test product.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: White Ginseng Extract (KoreaGinseng F Max)Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in ADP-induced platelet aggregation

Change in adenosine diphosphate (ADP)-induced platelet aggregation from baseline to end of treatment.

Time frame
Baseline (Visit 2) and Week 8 (Visit 4)

Secondary outcomes

1

Percent change in ADP-induced platelet aggregation

from baseline to end of treatment

Time frame
Baseline (Visit 2) and Week 8 (Visit 4)
2

Change and percent change in prothrombin time (PT)

from baseline to end of treatment

Time frame
Baseline (Visit 2) and Week 8 (Visit 4)
3

Change and percent change in activated partial thromboplastin time (aPTT)

from baseline to end of treatment

Time frame
Baseline (Visit 2) and Week 8 (Visit 4)
4

Change and percent change in serum lipids (total cholesterol, HDL-C, LDL-C, triglycerides)

from baseline to end of treatment

Time frame
Baseline (Visit 2) and Week 8 (Visit 4)

Other outcomes

Sponsors and contacts

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