Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health Population

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Antioxidative Stress; Healthy Ageing

Treatments: Drug: Korean red ginseng capsule (marketed product in Korea); Drug: Korean red ginseng capsule(placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT05592093

KRGO-2022

Details and patient eligibility

About

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.

Full description

Processed red ginseng are non-toxic and healthy "tonics". It was recorded in medical books and Materia Medica that taking it for a long time can prolong life. The main purpose of this study is to evaluate the effect of ginseng on antioxidation and healthy aging indicators of sub-health subjects in Han Chinese population. Subjects will undergo a safety follow-up after the treatment period. Safety and efficacy will be determined by looking at a number of assessments [physical examinations, blood sampling, sub-health status evaluation questionnaire (shsq-25), etc.]. It is expected that around 900 people (at least 450 in each arm) with sub-healthy state may take part in the study. The study participants will be recruited at around 3 sites from Northern(Beijing),Central(Shanghai), Southern(Foshan and Nanchang) in China.

Enrollment: 900 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 40-75 years old, male or female, Han nationality;
2. 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;
3. According to the sub-health status evaluation questionnaire (shsq-25), ≥ 35 points can be judged as sub-health;
4. 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);
5. 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

1. 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;
2. Obesity population (BMI index) (kg / m2) BMI ≥ 28KG / m2; Low body weight population (BMI index) (kg / m2) BMI < 18.5kg/m2;
3. Vegetarians within 3 months before the study;
4. 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.);
5. Those who took (or used) microecological regulators within 3 months before the study;
6. Those who drank more than 200ml of coffee per day (converted as pure coffee) within 3 months before the study;
7. 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;
8. 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；
9. Those who smoked more than 10 cigarettes per day in the 3 months before the study;
10. Those who have participated in or are participating in other clinical trials within 3 months before the study;
11. The investigator considered that there were other patients who were not suitable to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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900 participants in 2 patient groups, including a placebo group

KRGO group

Experimental group

Description:

Korean red ginseng capsule (KRGO)marketed product in Korea donated by The Korean Society of Ginseng.

Treatment:

Drug: Korean red ginseng capsule (marketed product in Korea)

placebo group

Placebo Comparator group

Description:

Same smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules.

Treatment:

Drug: Korean red ginseng capsule(placebo)