Clinical trial NCT05592093: Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health Population
Official title: An RCT Study to Investigate the Effect of Korean Red Ginseng for Middle-aged and Elderly Sub-health Population on Anti-oxidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Ageing
Antioxidative Stress
Keywords: Korean Red ginseng
Healthy Ageing
Antioxidant Effect
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Beijing Obstetrics and Gynecology Hospital
name: Foshan Fuxing Changcheng Hospital
name: Nanchang Hongdu Hospital of TCM
First posted: 2022-10-24
Enrollment: 900
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase 2/3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Korean red ginseng capsule Administered by taking orally in Middle-aged and Elderly Sub-health population.
Primary purpose: TREATMENT

Brief 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.

Detailed 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 \[physical examinations, blood sampling, hearing sub-health status evaluation questionnaire (shsq-25), etc.\]. 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 Shanghai, Beijing and Foshan, in China.

Eligibility criteria: 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;
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.

Primary outcomes:
measure: Change in malondialdehyde (MDA) after 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in serum lipofuscin after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum protein carbonyl after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum 8-hydroxy-2'-deoxyguanosine(8-OHdG) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum superoxide dismutase (SOD) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum glutathione(GSH) after 12 weeks of treatment
timeFrame: 12 weeks
Other outcomes:
measure: Change in serum total cholesterol(TC) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum triglyceride(TG) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum low density lipoprotein (LDLC) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum high density lipoprotein (HDLC) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum C-reactive protein (CRP) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum interleukin 6 (IL6) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum tumor necrosis factor-α (TNF-α) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum immunoglobulin G (IgG) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum immunoglobulin A (IgA) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum immunoglobulin M (IgM) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum natural killer cell (NK) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum estradiol (E2) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum follicle stimulating hormone (FSH) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum luteinizing hormone (LH) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum testosterone after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum prolactin (PRL) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum progesterone (P) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in serum metabolomics after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in intestinal flora metabolomics after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in The Short-Form 36 physical component summary (SF-36 PCS) after 12 weeks and 16 weeks of treatment
timeFrame: 12 weeks#16 weeks
measure: Change in the TCM Physique Questionnaire score after 12 weeks and 16 weeks of treatment
timeFrame: 12 weeks#16 weeks
measure: Change in muscle strength with hydraulic-type handgrip dynamometer or spring-type handgrip dynamometer after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in skeletal muscle mass index (SMI) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in appendicular skeletal muscle mass (ASM) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in percentage body fat (PBF) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in body fat mass (BFM) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in visceral fat area (VFA) after 12 weeks of treatment
timeFrame: 12 weeks
measure: Change in Han Chinese medicine fire heat syndrome scale after 12 weeks and 16 weeks of treatment
timeFrame: 12 weeks#16 weeks
measure: Adverse Events
timeFrame: 16 weeks
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University
state: Beijing
city: Foshan
country: China
facility: Foshan Fuxing Changcheng Hospital
state: Guangdong
city: Nanchang
country: China
facility: Nanchang Hongdu Hospital of TCM
state: Jiangxi
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Yaomin Hu, Professor
role: STUDY_DIRECTOR
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Chenghong Yin, Professor
role: STUDY_DIRECTOR
affiliation: Foshan Fuxing Changcheng Hospital
name: Suzhen Wu, Professor
role: STUDY_DIRECTOR
References:
citation: Kim HG, Yoo SR, Park HJ, Lee NH, Shin JW, Sathyanath R, Cho JH, Son CG. Antioxidant effects of Panax ginseng C.A. Meyer in healthy subjects: a randomized, placebo-controlled clinical trial. Food Chem Toxicol. 2011 Sep;49(9):2229-35. doi: 10.1016/j.fct.2011.06.020. Epub 2011 Jun 15.
citation: Hou W. iTRAQ-based Proteomic Analysis Reveals Anti-Aging Effects of Red Ginseng Powder on Drosophila Melanogaster and its Mechanism Studies. Jilin University, 2021. DOI:10.27162/d.cnki.gjlin.2021.000482.
citation: Park SK, Hyun SH, In G, Park CK, Kwak YS, Jang YJ, Kim B, Kim JH, Han CK. The antioxidant activities of Korean Red Ginseng (Panax ginseng) and ginsenosides: A systemic review through in vivo and clinical trials. J Ginseng Res. 2021 Jan;45(1):41-47. doi: 10.1016/j.jgr.2020.09.006. Epub 2020 Oct 10.
citation: Chung TH, Kim JH, Seol SY, Kim YJ, Lee YJ. The Effects of Korean Red Ginseng on Biological Aging and Antioxidant Capacity in Postmenopausal Women: A Double-Blind Randomized Controlled Study. Nutrients. 2021 Sep 2;13(9):3090. doi: 10.3390/nu13093090.
citation: Kim JY, Park JY, Kang HJ, Kim OY, Lee JH. Beneficial effects of Korean red ginseng on lymphocyte DNA damage, antioxidant enzyme activity, and LDL oxidation in healthy participants: a randomized, double-blind, placebo-controlled trial. Nutr J. 2012 Jul 17;11:47. doi: 10.1186/1475-2891-11-47.