An RCT Study to Investigate the Effect of Korean Red Ginseng for Middle-aged and Elderly Sub-health Population on Anti-oxidation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Change in malondialdehyde (MDA) after 12 weeks of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Vegetarians within 3 months before the study;
- •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；
- •Those who smoked more than 10 cigarettes per day in the 3 months before the study;
- •Those who have participated in or are participating in other clinical trials within 3 months before the study;
- •The investigator considered that there were other patients who were not suitable to participate in this study.
研究组 & 干预措施
KRGO group
Korean red ginseng capsule (KRGO)marketed product in Korea donated by The Korean Society of Ginseng.
干预措施: Korean red ginseng capsule (marketed product in Korea) (Drug)
placebo group
Same smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules.
干预措施: Korean red ginseng capsule(placebo) (Drug)
结局指标
主要结局
Change in malondialdehyde (MDA) after 12 weeks of treatment
时间窗: 12 weeks
To compare the change in serum MDA from baseline (week 1 to week 12) between KRGO and placebo.
次要结局
- Change in serum lipofuscin after 12 weeks of treatment(12 weeks)
- Change in serum protein carbonyl after 12 weeks of treatment(12 weeks)
- Change in serum glutathione(GSH) after 12 weeks of treatment(12 weeks)
- Change in serum 8-hydroxy-2'-deoxyguanosine(8-OHdG) after 12 weeks of treatment(12 weeks)
- Change in serum superoxide dismutase (SOD) after 12 weeks of treatment(12 weeks)
研究者
Hongsheng Tan
professor
Shanghai Jiao Tong University School of Medicine