Antioxidative Stress Clinical Trial
Official title:
An RCT Study to Investigate the Effect of Korean Red Ginseng for Middle-aged and Elderly Sub-health Population on Anti-oxidation
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.
| Status | Recruiting |
| Enrollment | 900 |
| Est. completion date | December 1, 2024 |
| Est. primary completion date | September 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University | Beijing | Beijing |
| China | Foshan Fuxing Changcheng Hospital | Foshan | Guangdong |
| China | Nanchang Hongdu Hospital of TCM | Nanchang | Jiangxi |
| China | Renji Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Jiao Tong University School of Medicine | Beijing Obstetrics and Gynecology Hospital, Foshan Fuxing Changcheng Hospital, Nanchang Hongdu Hospital of TCM, RenJi Hospital |
China,
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. — View 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.
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in serum total cholesterol(TC) after 12 weeks of treatment | To compare the changes in serum TC from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum triglyceride(TG) after 12 weeks of treatment | To compare the changes in serum TG from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum low density lipoprotein (LDLC) after 12 weeks of treatment | To compare the changes in serum LDLC from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum high density lipoprotein (HDLC) after 12 weeks of treatment | To compare the changes in serum HDLC from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum C-reactive protein (CRP) after 12 weeks of treatment | To compare the changes in serum CRP from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum interleukin 6 (IL6) after 12 weeks of treatment | To compare the changes in serum IL6 from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in serum tumor necrosis factor-a (TNF-a) after 12 weeks of treatment | To compare the changes in serum TNF-a from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in serum immunoglobulin G (IgG) after 12 weeks of treatment | To compare the changes in serum IgG from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum immunoglobulin A (IgA) after 12 weeks of treatment | To compare the changes in serum IgA from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum immunoglobulin M (IgM) after 12 weeks of treatment | To compare the changes in serum IgM from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum natural killer cell (NK) after 12 weeks of treatment | To compare the changes in serum NK from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in serum estradiol (E2) after 12 weeks of treatment | To compare the changes in serum E2 from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum follicle stimulating hormone (FSH) after 12 weeks of treatment | To compare the changes in serum FSH from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum luteinizing hormone (LH) after 12 weeks of treatment | To compare the changes in serum LH from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum testosterone after 12 weeks of treatment | To compare the changes in serum testosterone from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum prolactin (PRL) after 12 weeks of treatment | To compare the changes in serum PRL from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum progesterone (P) after 12 weeks of treatment | To compare the changes in serum P from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in serum metabolomics after 12 weeks of treatment | To compare the change in serum metabolomics from baseline(week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in intestinal flora metabolomics after 12 weeks of treatment | To compare the change in intestinal flora metabolomics from baseline(week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Other | Change in The Short-Form 36 physical component summary (SF-36 PCS) after 12 weeks and 16 weeks of treatment | To compare the change in SF-36 PCS using Face to face Interview for the scores from baseline (week 1 to week 12#week 16) between KRGO and placebo. (range, 0 [best] to 100 [worst]) | 12 weeks#16 weeks | |
| Other | Change in the TCM Physique Questionnaire score after 12 weeks and 16 weeks of treatment | To compare the change in the TCM Physique Questionnaire using Face to face Interview for the scores from baseline (week 1 to week 12#week 16) between KRGO and placebo (range, 0 [best] to 100 [worst]). | 12 weeks#16 weeks | |
| Other | Change in muscle strength with hydraulic-type handgrip dynamometer or spring-type handgrip dynamometer after 12 weeks of treatment | To compare the change in muscle strength with hydraulic-type handgrip dynamometer or spring-type handgrip dynamometer from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in skeletal muscle mass index (SMI) after 12 weeks of treatment | To compare the change in SMI with spring grip from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in appendicular skeletal muscle mass (ASM) after 12 weeks of treatment | To compare the change in ASM from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in percentage body fat (PBF) after 12 weeks of treatment | To compare the change in PBF from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in body fat mass (BFM) after 12 weeks of treatment | To compare the change in BFM from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in visceral fat area (VFA) after 12 weeks of treatment | To compare the change in VFA from baseline (week 1 to week 12) between KRGO and placebo. Patients from lead trial center were selected for this study. | 12 weeks | |
| Other | Change in Han Chinese medicine fire heat syndrome scale after 12 weeks and 16 weeks of treatment | To compare the change in Han Chinese medicine fire heat syndrome scale using Face to face Interview for the scores from baseline (week 1 to week 12#week 16) between KRGO and placebo. (range, 0 [best] to 100 [worst]) | 12 weeks#16 weeks | |
| Other | Adverse Events | Incidence of adverse events. | 16 weeks | |
| Primary | Change in malondialdehyde (MDA) after 12 weeks of treatment | To compare the change in serum MDA from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Secondary | Change in serum lipofuscin after 12 weeks of treatment | To compare the changes in serum lipofuscin from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Secondary | Change in serum protein carbonyl after 12 weeks of treatment | To compare the changes in serum protein carbonyl from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Secondary | Change in serum 8-hydroxy-2'-deoxyguanosine(8-OHdG) after 12 weeks of treatment | To compare the changes in serum 8-OHdG from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Secondary | Change in serum superoxide dismutase (SOD) after 12 weeks of treatment | To compare the changes in serum SOD from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | |
| Secondary | Change in serum glutathione(GSH) after 12 weeks of treatment | To compare the changes in serum GSH from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks |