Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults (NCT06236243) | Clinical Trial Compass
CompletedNot Applicable
Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults
United States108 participantsStarted 2024-01-31
Plain-language 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.
Who can participate
Age range20 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Are lactating, pregnant or planning to become pregnant during the study (e.g., positive pregnancy test at Visit 2).
* Have a known sensitivity, intolerability…