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CompletedNCT06236243Updated Nov 27, 2024

Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults

An interventional study of Korean Red Ginseng Extract Powder 120 mg/tablet and Korean Red Ginseng Extract Powder 500 mg/tablet in Cardiovascular Diseases, Blood Pressure Disorders and Vasodilation, sponsored by Korea Ginseng Corporation. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Korea Ginseng Corporation · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

The objectives of this clinical trial are to 1) determine the effect of the TP compared to placebo on blood flow and platelet aggregation, 2) to determine the effect of the TP on cardiovascular health compared to a placebo and 3) to assess the safety and tolerability of the TP in healthy adults.

Read the detailed description

Platelet aggregation and optimal blood flow are crucial for maintaining overall health. Platelet aggregation is necessary in order to form blood clots, essential for preventing excessive bleeding after injury. However, excessive aggregation can lead to the formation of blood clots within blood vessels, which can progress to cardiovascular complications. Further, efficient blood flow ensures the delivery of oxygen, nutrients and immune cells to various tissues and organs throughout the body to maintain cellular functions and organ health. Disruption in platelet aggregation and blood flow are associated with cardiovascular diseases (CVD) such as coronary artery disease, heart failure, vascular disease, dyslipidemia and high blood pressure which are the leading cause of death in adults. Risk factors for CVD include oxidative stress, diabetes, smoking, obesity, and lack of physical activity.

Intervention strategies such as lifestyle modifications and medications are often implemented for managing of CVD risk. However, there is an increasing interest in preventative measures such as dietary supplements, that may have protective properties against CVD through improving factors such as platelet aggregation and blood flow.

Panax ginseng, the dry root and rhizome of the Araliaeae ginseng plant, is considered an adaptogen known to help the body adapt to various stressors and promote overall wellbeing. The benefits of ginseng are thought to be in part from ginsenosides, a class of bioactive ingredients found in the plant. Ginsenosides have been suggested to improve blood flow through enhancing production of nitric oxide (NO) and vasodilation, thereby protecting against cardiovascular dysfunction. Only few randomized controlled trials have investigated the efficacy of ginseng on risk factors of CVD. Both Korean red ginseng root and Korean red ginseng ginsenoside extract have been shown to significantly improve flow-mediated dilation, a measure of endothelial function, when compared to a control at 180-minute post-dose. However, further research is needed to confirm the vasodilating capabilities of panax ginseng.

The present study is a randomized, double-blind, placebo-controlled clinical trial to investigate the effects of a panax ginseng supplement on cardiovascular health in healthy adults. The primary objective of this study is to explore the ability of panax ginseng to improve markers of blood flow and platelet aggregation compared to a placebo.

Efficacy outcomes include flow-mediated dilation (FMD), augmentation index (AI), platelet aggregation, and blood coagulation markers, lipids, blood pressure and endothelial function as assessed by log-transformed reactive hyperemia index (lnRHI) and blood levels of high sensitivity C-reactive protein (hs-CRP), NO and cyclic guanosine monophosphate (cGMP). These parameters will be assessed at baseline, interim, and end of study (EOS) visits. The study will last up to 16 weeks for each participant. The study will include a screening visit followed by a screening period lasting up to 28 days in duration, a baseline visit on Day 1, and 84 ± 3 days of study product use, followed by an EOS visit on the day after (Day 85 ± 3). The study will include a total of 4 in-person visit days: screening (Visit 1), baseline (Visit 2), interim (Visit 3), and EOS (Visit 4).

02

Conditions studied

  • Cardiovascular Diseases
  • Blood Pressure Disorders
  • Vasodilation
  • Platelet Aggregation

Keywords

  • Blood Circulation
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 108 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Korea Ginseng Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults (male and female) who are 20 to 75 years of age (inclusive).
  • Are able to swallow tablets whole.
  • In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator.
  • Have acceptable heart rate as assessed by the investigator at screening and baseline.

  • Have acceptable levels of blood lipid biomarkers at screening:

    • Triglycerides \<200 mg/dL
    • Total cholesterol \<240 mg/dL
    • LDL cholesterol \<160 mg/dL
    • HDL cholesterol >39 mg/dL (for males) or >49 mg/dL (females)
  • Have resting (seated) systolic blood pressure between 90 to 129 mmHg and diastolic blood pressure between 60 to 79 mmHg (inclusive) at screening and baseline.
  • Have a body mass index (BMI) between 18.0 to 34.9 kg/m\^2 (inclusive) at screening.
  • Agrees to follow restriction on concomitant treatments as described in the study protocol.
  • Agrees to use acceptable contraceptive methods for the study.
  • Agrees to follow the restrictions on lifestyle as described in the study protocol.
  • Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months before screening.
  • Willing and able to agree to the requirements of this study, be willing to give voluntary consent, and carry out all study-related procedures.

Exclusion criteria

Exclusion Criteria:

  • Are lactating, pregnant or planning to become pregnant during the study (e.g., positive pregnancy test at Visit 2).
  • Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients (including lactose).
  • Have positive medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), blood or bleeding disorder, hepatic impairment or disease, thyroid disease, or Type I or Type II diabetes.
  • Has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, steatorrhea).
  • Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
  • Have a positive medical history of immune disorder or is immunocompromised (i.e., HIV/AIDS, Systemic Lupus Erythematosus, etc.), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
  • Have a positive medical history of psychiatric disorder that required hospitalization in the prior year.
  • Report a clinically significant illness during the 28 days before the first dose of study product.
  • Have undergone major surgery in 3 months prior to screening or planned major surgery during the study.
  • Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), chronic use defined as being taken more than 3 times a week for more than 3 months.
  • Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
  • Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
  • Living in the same household as another currently/previously enrolled participant in the present study.
  • Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    G1899 Korean Red Ginseng Extract Powder 120 mg/tablet

    480 mg of Korean Red Ginseng Extract powder per day for a total of 12 weeks.

    Dietary Supplement: Korean Red Ginseng Extract Powder 120 mg/tablet

  • Active comparator
    G1899 Korean Red Ginseng Extract Powder 500 mg/tablet

    2000 mg of Korean Red Ginseng Extract Powder per day for a total of 12 weeks.

    Dietary Supplement: Korean Red Ginseng Extract Powder 500 mg/tablet

  • Placebo comparator
    Placebo

    Inactive Ingredients

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementKorean Red Ginseng Extract Powder 120 mg/tablet

    Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

  • Dietary supplementKorean Red Ginseng Extract Powder 500 mg/tablet

    Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

  • Dietary supplementPlacebo

    Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Blood Flow

    Between placebo and test products, change from baseline to 6 weeks in flow-mediated dilation of the brachial artery.

    Time frame: 6 weeks

  2. Blood Flow

    Between placebo and test products, change from baseline to 12 weeks in flow-mediated dilation of the brachial artery.

    Time frame: 12 weeks

  3. Platelet Aggregation

    Between placebo and test products, change from baseline to 12 weeks in platelet aggregation.

    Time frame: 12 weeks

Secondary outcomes

  1. Augmentation Index

    Between placebo and test products, change from baseline to 6 weeks in augmentation index

    Time frame: 6 weeks

  2. Augmentation Index

    Between placebo and test products, change from baseline to 12 weeks in augmentation index

    Time frame: 12 weeks

  3. Blood Levels of Nitric Oxide

    Between placebo and test products, change from baseline to 6 weeks in blood levels of nitric oxide.

    Time frame: 6 weeks

  4. Blood Levels of Nitric Oxide

    Between placebo and test products, change from baseline to 12 weeks in blood levels of nitric oxide.

    Time frame: 12 weeks

  5. Blood Levels Cyclic Guanosine Monophosphate (cGMP)

    Between placebo and test products, change from baseline to 6 weeks in blood levels of cGMP.

    Time frame: 6 weeks

  6. Blood Levels of cGMP

    Between placebo and test products, change from baseline to 12 weeks in blood levels of cGMP.

    Time frame: 12 weeks

  7. Systolic Blood Pressure (SBP) at rest (seated and supine)

    Between placebo and test products, change from baseline to 6 weeks in blood levels of SBP at rest (seated and supine).

    Time frame: 6 weeks

  8. SBP at rest (seated and supine)

    Between placebo and test products, change from baseline to 12 weeks in blood levels of SBP at rest (seated and supine).

    Time frame: 12 weeks

  9. Diastolic Blood Pressure (DBP) at rest (seated and supine)

    Between placebo and test products, change from baseline to 6 weeks in blood levels of DBP at rest (seated and supine).

    Time frame: 6 weeks

  10. DBP at rest (seated and supine)

    Between placebo and test products, change from baseline to 12 weeks in blood levels of DBP at rest (seated and supine).

    Time frame: 12 weeks

  11. Serum Levels of Triglycerides (TGs)

    Between placebo and test products, change from baseline to 6 weeks in serum levels of TGs.

    Time frame: 6 weeks

  12. Serum Levels of TGs

    Between placebo and test products, change from baseline to 12 weeks in serum levels of TGs.

    Time frame: 12 weeks

  13. Serum Levels of Low-density lipoprotein (LDL) cholesterol

    Between placebo and test products, change from baseline to 6 weeks in serum levels of LDL cholesterol.

    Time frame: 6 weeks

  14. Serum Levels of LDL cholesterol

    Between placebo and test products, change from baseline to 12 weeks in serum levels of LDL cholesterol.

    Time frame: 12 weeks

  15. Serum Levels of High-density lipoprotein (HDL) cholesterol

    Between placebo and test products, change from baseline to 6 weeks in serum levels of HDL cholesterol.

    Time frame: 6 weeks

  16. Serum Levels of HDL cholesterol

    Between placebo and test products, change from baseline to 12 weeks in serum levels of HDL cholesterol.

    Time frame: 12 weeks

  17. Serum Levels of Total Cholesterol

    Between placebo and test products, change from baseline to 6 weeks in serum levels of cholesterol.

    Time frame: 6 weeks

  18. Serum Levels of Total Cholesterol

    Between placebo and test products, change from baseline to 12 weeks in serum levels of cholesterol.

    Time frame: 12 weeks

  19. Endothelial Function

    Between placebo and test products, change from baseline to 6 weeks in log-transformed reactive hyperemia index via EndoPAT.

    Time frame: 6 weeks

  20. Endothelial Function

    Between placebo and test products, change from baseline to 12 weeks in log-transformed reactive hyperemia index via EndoPAT.

    Time frame: 12 weeks

  21. Blood levels of high-sensitivity C-reactive protein (hs-CRP)

    Between placebo and test products, change from baseline to 6 weeks in blood levels of hs-CRP.

    Time frame: 6 weeks

  22. Blood levels of hs-CRP

    Between placebo and test products, change from baseline to 12 weeks in blood levels of hs-CRP.

    Time frame: 12 weeks

  23. Blood Coagulation assessed by Prothrombin Time (PT)

    Between placebo and test products, change from baseline to 12 weeks in PT.

    Time frame: 12 weeks

  24. Blood Coagulation assessed by Activated Partial Thromboplastin Time (aPTT)

    Between placebo and test products, change from baseline to 12 weeks in aPTT.

    Time frame: 12 weeks

  25. Blood Coagulation assessed by Thromboxane B2

    Between placebo and test products, change from baseline to 12 weeks in Thromboxane B2.

    Time frame: 12 weeks

  26. Heart Rate

    Change from baseline in heart rate (beats per minute).

    Time frame: 12 weeks

  27. Blood Pressure

    Change from baseline in blood pressure (mmHg) (seated only).

    Time frame: 12 weeks

  28. Body Weight

    Change from baseline in weight (kg).

    Time frame: 12 weeks

  29. Body Mass Index (BMI)

    Change from baseline in BMI (kg/m\^2).

    Time frame: 12 weeks

  30. Whole Blood Hemoglobin

    Change from baseline in fasting whole blood hemoglobin (g/dL) between test products and placebo.

    Time frame: 12 weeks

  31. Whole Blood Hematocrit

    Change from baseline in fasting whole blood hematocrit (%) test products and placebo.

    Time frame: 12 weeks

  32. Whole Blood Red Blood Cell Count

    Change from baseline in fasting whole blood red blood cell count (x10\^6/uL) between test products and placebo.

    Time frame: 12 weeks

  33. Whole Blood Red Blood Cell Distribution Width

    Change from baseline in fasting whole blood red blood cell distribution width (%) between test products and placebo.

    Time frame: 12 weeks

  34. Whole Blood Mean Corpuscular Volume

    Change from baseline in fasting whole blood mean corpuscular volume (fL) between test products and placebo.

    Time frame: 12 weeks

  35. Whole Blood Mean Corpuscular Hemoglobin

    Change from baseline in fasting whole blood mean corpuscular hemoglobin (pg) between test products and placebo.

    Time frame: 12 weeks

  36. Whole Blood Mean Corpuscular Hemoglobin Concentration

    Change from baseline in fasting whole blood mean corpuscular hemoglobin concentration (g/dL) between test products and placebo.

    Time frame: 12 weeks

  37. Whole Blood White Blood Cells

    Change from baseline in fasting whole blood white blood cells (x10\^3/uL) between test products and placebo.

    Time frame: 12 weeks

  38. Whole Blood Neutrophils

    Change from baseline in fasting whole blood neutrophils (cells/uL) between test products and placebo.

    Time frame: 12 weeks

  39. Whole Blood Basophils

    Change from baseline in fasting whole blood basophils (cells/uL) between test products and placebo.

    Time frame: 12 weeks

  40. Whole Blood Eosinophils

    Change from baseline in fasting whole blood eosinophils (cells/uL) between test products and placebo.

    Time frame: 12 weeks

  41. Whole Blood Lymphocytes

    Change from baseline in fasting whole blood lymphocytes (cells/uL) between test products and placebo.

    Time frame: 12 weeks

  42. Whole Blood Monocytes

    Change from baseline in fasting whole blood monocytes (cells/uL) between test products and placebo.

    Time frame: 12 weeks

  43. Whole Blood Mean Platelet Volume (MPV)

    Change from baseline in fasting whole blood MPV (fL) between test products and placebo.

    Time frame: 12 weeks

  44. Whole Blood Platelet Count

    Change from baseline in fasting whole blood platelet count (x10\^9/L) between test products and placebo.

    Time frame: 12 weeks

  45. Serum Creatinine

    Change from baseline in fasting serum creatinine (umol/L) between test products and placebo.

    Time frame: 12 weeks

  46. Estimated Glomerular Filtration Rate (eGFR)

    Change from baseline in fasting eGFR (mL/min/1.73m\^2) between test products and placebo.

    Time frame: 12 weeks

  47. Serum Total Bilirubin

    Change from baseline in fasting serum total bilirubin (mg/dL) between test products and placebo.

    Time frame: 12 weeks

  48. Serum Alkaline Phosphatase (ALP)

    Change from baseline in fasting serum ALP (U/L) between test products and placebo.

    Time frame: 12 weeks

  49. Serum Aspartate Transaminase (AST)

    Change from baseline in fasting serum AST (U/L) between test products and placebo.

    Time frame: 12 weeks

  50. Serum Alanine Transaminase (ALT)

    Change from baseline in fasting serum ALT (U/L) between test products and placebo.

    Time frame: 12 weeks

  51. Serum Albumin

    Change from baseline in fasting serum albumin (g/dL) between test products and placebo.

    Time frame: 12 weeks

  52. Serum Globulin

    Change from baseline in fasting serum globulin (g/dL) between test products and placebo.

    Time frame: 12 weeks

  53. Serum Total Protein

    Change from baseline in fasting serum total protein (g/dL) between test products and placebo.

    Time frame: 12 weeks

  54. Serum Chloride

    Change from baseline in fasting serum chloride (mmol/L) between test products and placebo.

    Time frame: 12 weeks

  55. Serum Sodium

    Change from baseline in fasting serum sodium (mmol/L) between test products and placebo.

    Time frame: 12 weeks

  56. Serum Potassium

    Change from baseline in fasting serum potassium (mmol/L) between test products and placebo.

    Time frame: 12 weeks

  57. Serum Fasting Glucose

    Change from baseline in fasting serum glucose (mg/dL) between test products and placebo.

    Time frame: 12 weeks

  58. Serum Urea

    Change from baseline in fasting serum urea (mg/dL) between test products and placebo.

    Time frame: 12 weeks

  59. Adverse Events

    Number of adverse events and number of participants with adverse events.

    Time frame: 12 weeks

07

Study locations

1 site
  • Valiance Clinical Research
    Tarzana, California 91356, United States
08

References and documents

Publications

  • Chen J, Rizzo JA. The economics of cardiovascular disease in the United States. Crit Care Clin. 2012 Jan;28(1):77-88, vi. doi: 10.1016/j.ccc.2011.10.007. PubMed 22123100 ↗
  • Hyun SH, Bhilare KD, In G, Park CK, Kim JH. Effects of Panax ginseng and ginsenosides on oxidative stress and cardiovascular diseases: pharmacological and therapeutic roles. J Ginseng Res. 2022 Jan;46(1):33-38. doi: 10.1016/j.jgr.2021.07.007. Epub 2021 Jul 26. PubMed 35058725 ↗
  • Irfan M, Kwak YS, Han CK, Hyun SH, Rhee MH. Adaptogenic effects of Panax ginseng on modulation of cardiovascular functions. J Ginseng Res. 2020 Jul;44(4):538-543. doi: 10.1016/j.jgr.2020.03.001. Epub 2020 Mar 28. PubMed 32617033 ↗
  • Liu L, Hu J, Mao Q, Liu C, He H, Hui X, Yang G, Qu P, Lian W, Duan L, Dong Y, Pan J, Liu Y, He Q, Li J, Wang J. Functional compounds of ginseng and ginseng-containing medicine for treating cardiovascular diseases. Front Pharmacol. 2022 Dec 2;13:1034870. doi: 10.3389/fphar.2022.1034870. eCollection 2022. PubMed 36532771 ↗
  • Jovanovski E, Peeva V, Sievenpiper JL, Jenkins AL, Desouza L, Rahelic D, Sung MK, Vuksan V. Modulation of endothelial function by Korean red ginseng (Panax ginseng C.A. Meyer) and its components in healthy individuals: a randomized controlled trial. Cardiovasc Ther. 2014 Aug;32(4):163-9. doi: 10.1111/1755-5922.12077. PubMed 24758417 ↗
  • Kang J, Lee N, Ahn Y, Lee H. Study on improving blood flow with Korean red ginseng substances using digital infrared thermal imaging and Doppler sonography: randomized, double blind, placebo-controlled clinical trial with parallel design. J Tradit Chin Med. 2013 Feb;33(1):39-45. doi: 10.1016/s0254-6272(13)60098-9. PubMed 23596810 ↗
  • Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396. PubMed 24871654 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06236243
Lead sponsor
Korea Ginseng Corporation
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Feb 1, 2024
Start date
Jan 31, 2024
Primary completion
Sep 25, 2024
Completion
Sep 25, 2024
Last update
Nov 27, 2024

Study contacts

Amir H.S. Rafie, MD
principal investigator · Valiance Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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