Effect of Korean Red Ginseng on Oxidation in Middle-aged... | NCT05592093

Status Module

Name	Class
RenJi Hospital	OTHER
Beijing Obstetrics and Gynecology Hospital	OTHER
Foshan Fuxing Changcheng Hospital	UNKNOWN
Nanchang Hongdu Hospital of TCM

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KRGO group	Experimental	Korean red ginseng capsule (KRGO)marketed product in Korea donated by The Korean Society of Ginseng.	Drug: Korean red ginseng capsule (marketed product in Korea)
placebo group	Placebo Comparator	Same smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules.	Drug: Korean red ginseng capsule(placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Korean red ginseng capsule (marketed product in Korea)	Drug	Korean red ginseng capsule (marketed product in Korea) KRGO group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and KRGO group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the KRGO group and placebo group at a ratio of 1:1. The drug was administered for 12 weeks, 2 times a day, 3 capsules each time.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Change in serum protein carbonyl after 12 weeks of treatment

Other Outcomes

Measure	Description	Time Frame
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
Change in serum triglyceride(TG) after 12 weeks of treatment

Eligibility Module

Eligibility Criteria

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;
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.

Name	Affiliation	Role
Yaomin Hu, Professor	RenJi Hospital	Study Director
Chenghong Yin, Professor	Beijing Obstetrics and Gynecology Hospital	Study Director
Suzhen Wu, Professor	Foshan Fuxing Changcheng Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University		Beijing	Beijing Municipality	100026	China

References Module

Citations

PubMed Identifier	Type	Citation
21699953	Background	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.
	Background	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.
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