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

NCT05592093 | Completed Phase 2 DMC

• 1 other identifier: KRGO-2022
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Ageing; Antioxidative Stress

Keywords

Korean Red ginseng; Healthy Ageing; Antioxidant Effect

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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 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

• Change in serum glutathione(GSH) after 12 weeks of treatment

  12 weeks

Other Outcomes (43)

• Change in serum total cholesterol(TC) after 12 weeks of treatment

  12 weeks

• Change in serum triglyceride(TG) after 12 weeks of treatment

  12 weeks

• Change in serum low density lipoprotein (LDLC) after 12 weeks of treatment

  12 weeks

Study Arms (2)

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

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.

Also known as: red ginseng

KRGO group

Korean red ginseng capsule(placebo) DRUG

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.

Also known as: placebo group

placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• RenJi Hospital: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Foshan Fuxing Changcheng Hospital: collaborator
• Nanchang Hongdu Hospital of TCM: collaborator

Study Sites (4)

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100026, China

Location

Foshan Fuxing Changcheng Hospital

Foshan, Guangdong, 528031, China

Location

Nanchang Hongdu Hospital of TCM

Nanchang, Jiangxi, 330006, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (5)

• 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.

  PMID: 21699953 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.

  BACKGROUND

• 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.

  PMID: 33437155 BACKGROUND

• 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.

  PMID: 34578969 BACKGROUND

• 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.

  PMID: 22805313 BACKGROUND

MeSH Terms

Interventions

Asian ginseng

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: March 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 10, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)