Phase
Condition
Low Blood Pressure (Hypotension)
Vascular Diseases
Blood Clots
Treatment
Placebo
Korean Red Ginseng Extract Powder 120 mg/tablet
Korean Red Ginseng Extract Powder 500 mg/tablet
Clinical Study ID
Ages 20-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 bythe investigator.
Have acceptable heart rate as assessed by the investigator at screening andbaseline.
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 diastolicblood 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 studyprotocol.
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) andlifestyle for the last 3 months before screening.
Willing and able to agree to the requirements of this study, be willing to givevoluntary consent, and carry out all study-related procedures.
Exclusion
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 ortheir excipients (including lactose).
Have positive medical history of heart disease/cardiovascular disease, kidneydisease (dialysis or renal failure), blood or bleeding disorder, hepatic impairmentor disease, thyroid disease, or Type I or Type II diabetes.
Has an abnormality or obstruction of the gastrointestinal tract precludingswallowing (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 (exceptlocalized skin cancer without metastases or in situ cervical cancer) within 5 yearsprior to screening visit.
Have a positive medical history of psychiatric disorder that requiredhospitalization in the prior year.
Report a clinically significant illness during the 28 days before the first dose ofstudy product.
Have undergone major surgery in 3 months prior to screening or planned major surgeryduring the study.
Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), chronic use defined asbeing 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-patientintervention program).
Current enrolment or past participation in another study with any product(s) with atleast one active ingredient within 28 days before first dose of study product orlonger, if the previous test product is deemed by the investigator to have lastingeffects that might influence the eligibility criteria or outcomes of current study.
Living in the same household as another currently/previously enrolled participant inthe present study.
Any other medical condition/situation or use of medications/supplements/therapiesthat, in the opinion of the investigator, may adversely affect the participant'sability to participate in the study or its measures or pose a significant risk tothe participant.
Study Design
Study Description
Connect with a study center
Valiance Clinical Research
Tarzana, California 91356
United StatesSite Not Available
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