Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health Population (NCT05592093) | Clinical Trial Compass
CompletedPhase 2/3
Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health Population
China900 participantsStarted 2023-03-01
Plain-language summary
The objective of this study is to examine the effects and safety of Korean red ginseng capsule and placebo with middle-aged and elderly sub-health population.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
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
. 40-75 years old, male or female, Han nationality;
. There was no history of major chronic disease or clinically active disease within 3 months before the study, including any cardiovascular, cerebrovascular, lung, kidney, liver, endocrine, digestive tract, nervous system or metabolic disease; Inflammation, psychosis, AIDS, tumor or traumatic injury, etc., and the disease history that the researcher judges to have an impact on the study;
. According to the sub-health status evaluation questionnaire (shsq-25), ≥ 35 points can be judged as sub-health;
. Agree to have no family planning or sperm donation plan during the trial and within 6 months after the end of the trial and voluntarily take effective contraceptive measures (avoid using contraceptives);
. Cohabitants included only one subject; Those who sign the informed consent shall fully understand the test content, process and possible adverse reactions, and be able to communicate well with the investigator.
Exclusion criteria
. Those who need to take medicine (traditional Han Chinese medicine, western medicine, biological medicine) due to any major chronic disease or clinically active disease within 3 months before the study;
. Obesity population (BMI index) (kg / m2) BMI ≥ 28KG / m2; Low body weight population (BMI index) (kg / m2) BMI \< 18.5kg/m2;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in malondialdehyde (MDA) after 12 weeks of treatment
Timeframe: 12 weeks
Trial details
NCT IDNCT05592093
SponsorShanghai Jiao Tong University School of Medicine
. Those who took other antioxidant health products within 3 months before the study (vitamin health products or supplements; zinc and selenium health products or supplements; superoxide dismutase (SOD) health products; health products containing grape seeds, lycopene, flavonoids, astaxanthin, propolis, squalene, nicotinamide nucleoside, omega-3 or omega-6, etc.);
. Those who took (or used) microecological regulators within 3 months before the study;
. Those who drank more than 200ml of coffee per day (converted as pure coffee) within 3 months before the study;
. Those who are known to be allergic to red ginseng ingredients, or who have a specific history of allergy (asthma, measles, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, food such as milk and pollen), or who have a history of food, drug hypersensitivity or allergic reaction judged by other researchers to have clinical significance;
. Alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol, such as 360ml beer or 45ml spirit with 40% alcohol or 150ml wine), or those with positive breath test within 3 months before the study；