NCT06236243

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Korea Ginseng Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Korean 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_SUPPLEMENT	Korean 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_SUPPLEMENT	Placebo	Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2024-02-01
• Last updated: 2024-11-27

Locations

1 site across 1 country: United States