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

Completed · Not applicable · Has a placebo group

Conditions studied: Cardiovascular Diseases, Blood Pressure Disorders, Vasodilation, Platelet Aggregation

In brief

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.

Key facts

Study ID

NCT06236243

Run by

Korea Ginseng Corporation

People needed

108

Starts

2024-01-31

Expected to finish

2024-09-25

Last updated by the study team

2024-11-27

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Valiance Clinical Research — Tarzana, California, United States

Full record on ClinicalTrials.gov

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