Cardiovascular DiseasesNCT06236243
Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults
A study testing Korean Red Ginseng Extract Powder 120 mg/tablet and Korean Red Ginseng Extract Powder 500 mg/tablet in people with Cardiovascular Diseases and Blood Pressure Disorders, run by Korea Ginseng Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Blood Pressure Disorders, Vasodilation
- What is being tested?
- Korean Red Ginseng Extract Powder 120 mg/tablet and Korean Red Ginseng Extract Powder 500 mg/tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Valiance Clinical Research
Tarzana, California, 91356
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Effect of G1899 (Korean Red Ginseng Extract Powder) on Blood Flow in Healthy Adults
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).
- Being tested
- Korean Red Ginseng Extract Powder 120 mg/tablet, Korean Red Ginseng Extract Powder 500 mg/tablet, Placebo
- Keywords
- Blood Circulation
- Medical subject headings
- Cardiovascular Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red Ginseng Extract Powder 120 mg/tabletDietary supplement
Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.
Korean Red Ginseng Extract Powder 500 mg/tabletDietary supplement
Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.
PlaceboDietary supplement
Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| G1899 Korean Red Ginseng Extract Powder 120 mg/tablet | Active comparator | 480 mg of Korean Red Ginseng Extract powder per day for a total of 12 weeks. Receives: Dietary Supplement: Korean Red Ginseng Extract Powder 120 mg/tablet |
| G1899 Korean Red Ginseng Extract Powder 500 mg/tablet | Active comparator | 2000 mg of Korean Red Ginseng Extract Powder per day for a total of 12 weeks. Receives: Dietary Supplement: Korean Red Ginseng Extract Powder 500 mg/tablet |
| Placebo | Placebo comparator | Inactive Ingredients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow
Between placebo and test products, change from baseline to 6 weeks in flow-mediated dilation of the brachial artery.
Measured: 6 weeks
Blood Flow
Between placebo and test products, change from baseline to 12 weeks in flow-mediated dilation of the brachial artery.
Measured: 12 weeks
Platelet Aggregation
Between placebo and test products, change from baseline to 12 weeks in platelet aggregation.
Measured: 12 weeks
Secondary outcomes (59)
Augmentation Index
Between placebo and test products, change from baseline to 6 weeks in augmentation index
Measured: 6 weeks
Augmentation Index
Between placebo and test products, change from baseline to 12 weeks in augmentation index
Measured: 12 weeks
Blood Levels of Nitric Oxide
Between placebo and test products, change from baseline to 6 weeks in blood levels of nitric oxide.
Measured: 6 weeks
Blood Levels of Nitric Oxide
Between placebo and test products, change from baseline to 12 weeks in blood levels of nitric oxide.
Measured: 12 weeks
Blood Levels Cyclic Guanosine Monophosphate (cGMP)
Between placebo and test products, change from baseline to 6 weeks in blood levels of cGMP.
Measured: 6 weeks
Blood Levels of cGMP
Between placebo and test products, change from baseline to 12 weeks in blood levels of cGMP.
Measured: 12 weeks
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).
Measured: 6 weeks
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).
Measured: 12 weeks
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).
Measured: 6 weeks
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).
Measured: 12 weeks
Serum Levels of Triglycerides (TGs)
Between placebo and test products, change from baseline to 6 weeks in serum levels of TGs.
Measured: 6 weeks
Serum Levels of TGs
Between placebo and test products, change from baseline to 12 weeks in serum levels of TGs.
Measured: 12 weeks
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.
Measured: 6 weeks
Serum Levels of LDL cholesterol
Between placebo and test products, change from baseline to 12 weeks in serum levels of LDL cholesterol.
Measured: 12 weeks
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.
Measured: 6 weeks
Serum Levels of HDL cholesterol
Between placebo and test products, change from baseline to 12 weeks in serum levels of HDL cholesterol.
Measured: 12 weeks
Serum Levels of Total Cholesterol
Between placebo and test products, change from baseline to 6 weeks in serum levels of cholesterol.
Measured: 6 weeks
Serum Levels of Total Cholesterol
Between placebo and test products, change from baseline to 12 weeks in serum levels of cholesterol.
Measured: 12 weeks
Endothelial Function
Between placebo and test products, change from baseline to 6 weeks in log-transformed reactive hyperemia index via EndoPAT.
Measured: 6 weeks
Endothelial Function
Between placebo and test products, change from baseline to 12 weeks in log-transformed reactive hyperemia index via EndoPAT.
Measured: 12 weeks
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.
Measured: 6 weeks
Blood levels of hs-CRP
Between placebo and test products, change from baseline to 12 weeks in blood levels of hs-CRP.
Measured: 12 weeks
Blood Coagulation assessed by Prothrombin Time (PT)
Between placebo and test products, change from baseline to 12 weeks in PT.
Measured: 12 weeks
Blood Coagulation assessed by Activated Partial Thromboplastin Time (aPTT)
Between placebo and test products, change from baseline to 12 weeks in aPTT.
Measured: 12 weeks
Blood Coagulation assessed by Thromboxane B2
Between placebo and test products, change from baseline to 12 weeks in Thromboxane B2.
Measured: 12 weeks
Heart Rate
Change from baseline in heart rate (beats per minute).
Measured: 12 weeks
Blood Pressure
Change from baseline in blood pressure (mmHg) (seated only).
Measured: 12 weeks
Body Weight
Change from baseline in weight (kg).
Measured: 12 weeks
Body Mass Index (BMI)
Change from baseline in BMI (kg/m^2).
Measured: 12 weeks
Whole Blood Hemoglobin
Change from baseline in fasting whole blood hemoglobin (g/dL) between test products and placebo.
Measured: 12 weeks
Whole Blood Hematocrit
Change from baseline in fasting whole blood hematocrit (%) test products and placebo.
Measured: 12 weeks
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.
Measured: 12 weeks
Whole Blood Red Blood Cell Distribution Width
Change from baseline in fasting whole blood red blood cell distribution width (%) between test products and placebo.
Measured: 12 weeks
Whole Blood Mean Corpuscular Volume
Change from baseline in fasting whole blood mean corpuscular volume (fL) between test products and placebo.
Measured: 12 weeks
Whole Blood Mean Corpuscular Hemoglobin
Change from baseline in fasting whole blood mean corpuscular hemoglobin (pg) between test products and placebo.
Measured: 12 weeks
Whole Blood Mean Corpuscular Hemoglobin Concentration
Change from baseline in fasting whole blood mean corpuscular hemoglobin concentration (g/dL) between test products and placebo.
Measured: 12 weeks
Whole Blood White Blood Cells
Change from baseline in fasting whole blood white blood cells (x10^3/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Neutrophils
Change from baseline in fasting whole blood neutrophils (cells/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Basophils
Change from baseline in fasting whole blood basophils (cells/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Eosinophils
Change from baseline in fasting whole blood eosinophils (cells/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Lymphocytes
Change from baseline in fasting whole blood lymphocytes (cells/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Monocytes
Change from baseline in fasting whole blood monocytes (cells/uL) between test products and placebo.
Measured: 12 weeks
Whole Blood Mean Platelet Volume (MPV)
Change from baseline in fasting whole blood MPV (fL) between test products and placebo.
Measured: 12 weeks
Whole Blood Platelet Count
Change from baseline in fasting whole blood platelet count (x10^9/L) between test products and placebo.
Measured: 12 weeks
Serum Creatinine
Change from baseline in fasting serum creatinine (umol/L) between test products and placebo.
Measured: 12 weeks
Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in fasting eGFR (mL/min/1.73m^2) between test products and placebo.
Measured: 12 weeks
Serum Total Bilirubin
Change from baseline in fasting serum total bilirubin (mg/dL) between test products and placebo.
Measured: 12 weeks
Serum Alkaline Phosphatase (ALP)
Change from baseline in fasting serum ALP (U/L) between test products and placebo.
Measured: 12 weeks
Serum Aspartate Transaminase (AST)
Change from baseline in fasting serum AST (U/L) between test products and placebo.
Measured: 12 weeks
Serum Alanine Transaminase (ALT)
Change from baseline in fasting serum ALT (U/L) between test products and placebo.
Measured: 12 weeks
Serum Albumin
Change from baseline in fasting serum albumin (g/dL) between test products and placebo.
Measured: 12 weeks
Serum Globulin
Change from baseline in fasting serum globulin (g/dL) between test products and placebo.
Measured: 12 weeks
Serum Total Protein
Change from baseline in fasting serum total protein (g/dL) between test products and placebo.
Measured: 12 weeks
Serum Chloride
Change from baseline in fasting serum chloride (mmol/L) between test products and placebo.
Measured: 12 weeks
Serum Sodium
Change from baseline in fasting serum sodium (mmol/L) between test products and placebo.
Measured: 12 weeks
Serum Potassium
Change from baseline in fasting serum potassium (mmol/L) between test products and placebo.
Measured: 12 weeks
Serum Fasting Glucose
Change from baseline in fasting serum glucose (mg/dL) between test products and placebo.
Measured: 12 weeks
Serum Urea
Change from baseline in fasting serum urea (mg/dL) between test products and placebo.
Measured: 12 weeks
Adverse Events
Number of adverse events and number of participants with adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start31 Jan 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Parallel, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Ginseng Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Amir H.S. Rafie, MD, Principal investigator, Valiance Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236243
- Sponsor's protocol ID
- K04-23-01-T0049
- Status last verified
- Nov 2024
- First submitted
- 24 Jan 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 22123100Hyun 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 35058725Irfan 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 32617033Liu 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 36532771Jovanovski 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 24758417Kang 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 23596810Rhee 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Effect of G1899 (Korean Red Ginseng Extract Powder) on Blood Flow in Healthy Adults
- ClinicalTrials.gov ID
- NCT06236243
- Acronym / sponsor ID
- K04-23-01-T0049
- Keywords
- Blood Circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Korea Ginseng CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Parallel, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| G1899 Korean Red Ginseng Extract Powder 120 mg/tablet | Active comparator | Dietary Supplement: Korean Red Ginseng Extract Powder 120 mg/tablet480 mg of Korean Red Ginseng Extract powder per day for a total of 12 weeks. |
| G1899 Korean Red Ginseng Extract Powder 500 mg/tablet | Active comparator | Dietary Supplement: Korean Red Ginseng Extract Powder 500 mg/tablet2000 mg of Korean Red Ginseng Extract Powder per day for a total of 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInactive Ingredients |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red Ginseng Extract Powder 120 mg/tabletParticipants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks. | Dietary supplement | G1899 Korean Red Ginseng Extract Powder 120 mg/tablet |
| Korean Red Ginseng Extract Powder 500 mg/tabletParticipants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks. | Dietary supplement | G1899 Korean Red Ginseng Extract Powder 500 mg/tablet |
| PlaceboParticipants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Blood Flow
Time frame: 6 weeks
Between placebo and test products, change from baseline to 6 weeks in flow-mediated dilation of the brachial artery.
Blood Flow
Time frame: 12 weeks
Between placebo and test products, change from baseline to 12 weeks in flow-mediated dilation of the brachial artery.
Platelet Aggregation
Time frame: 12 weeks
Between placebo and test products, change from baseline to 12 weeks in platelet aggregation.
59 secondary outcomes
Augmentation Index
Time frame: 6 weeks
Augmentation Index
Time frame: 12 weeks
Blood Levels of Nitric Oxide
Time frame: 6 weeks
Blood Levels of Nitric Oxide
Time frame: 12 weeks
Blood Levels Cyclic Guanosine Monophosphate (cGMP)
Time frame: 6 weeks
Blood Levels of cGMP
Time frame: 12 weeks
Systolic Blood Pressure (SBP) at rest (seated and supine)
Time frame: 6 weeks
SBP at rest (seated and supine)
Time frame: 12 weeks
Diastolic Blood Pressure (DBP) at rest (seated and supine)
Time frame: 6 weeks
DBP at rest (seated and supine)
Time frame: 12 weeks
Serum Levels of Triglycerides (TGs)
Time frame: 6 weeks
Serum Levels of TGs
Time frame: 12 weeks
Serum Levels of Low-density lipoprotein (LDL) cholesterol
Time frame: 6 weeks
Serum Levels of LDL cholesterol
Time frame: 12 weeks
Serum Levels of High-density lipoprotein (HDL) cholesterol
Time frame: 6 weeks
Serum Levels of HDL cholesterol
Time frame: 12 weeks
Serum Levels of Total Cholesterol
Time frame: 6 weeks
Serum Levels of Total Cholesterol
Time frame: 12 weeks
Endothelial Function
Time frame: 6 weeks
Endothelial Function
Time frame: 12 weeks
Blood levels of high-sensitivity C-reactive protein (hs-CRP)
Time frame: 6 weeks
Blood levels of hs-CRP
Time frame: 12 weeks
Blood Coagulation assessed by Prothrombin Time (PT)
Time frame: 12 weeks
Blood Coagulation assessed by Activated Partial Thromboplastin Time (aPTT)
Time frame: 12 weeks
Blood Coagulation assessed by Thromboxane B2
Time frame: 12 weeks
Heart Rate
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Body Weight
Time frame: 12 weeks
Body Mass Index (BMI)
Time frame: 12 weeks
Whole Blood Hemoglobin
Time frame: 12 weeks
Whole Blood Hematocrit
Time frame: 12 weeks
Whole Blood Red Blood Cell Count
Time frame: 12 weeks
Whole Blood Red Blood Cell Distribution Width
Time frame: 12 weeks
Whole Blood Mean Corpuscular Volume
Time frame: 12 weeks
Whole Blood Mean Corpuscular Hemoglobin
Time frame: 12 weeks
Whole Blood Mean Corpuscular Hemoglobin Concentration
Time frame: 12 weeks
Whole Blood White Blood Cells
Time frame: 12 weeks
Whole Blood Neutrophils
Time frame: 12 weeks
Whole Blood Basophils
Time frame: 12 weeks
Whole Blood Eosinophils
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 22123100Chen 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.
- Background: PubMed 35058725Hyun 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.
- Background: PubMed 32617033Irfan 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.
- Background: PubMed 36532771Liu 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.
- Background: PubMed 24758417Jovanovski 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.
- Background: PubMed 23596810Kang 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.
- Background: PubMed 24871654Rhee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir H.S. Rafie, MD principal investigator
Valiance Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean Red Ginseng Extract Powder 120 mg/tablet and Korean Red Ginseng Extract Powder 500 mg/tablet in people with Cardiovascular Diseases and Blood Pressure Disorders, run by Korea Ginseng Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236243, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.