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

NCT ID: NCT05592093

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-10

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, 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.

Conditions

Healthy Ageing; Antioxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KRGO group

Korean red ginseng capsule (KRGO)marketed product in Korea donated by The Korean Society of Ginseng.

Group Type: EXPERIMENTAL

Korean red ginseng capsule (marketed product in Korea)

Intervention Type: 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.

placebo group

Same smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules.

Group Type: PLACEBO_COMPARATOR

Korean red ginseng capsule(placebo)

Intervention Type: 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.

Interventions

Korean red ginseng capsule (marketed product in Korea)

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.

Intervention Type: DRUG

Korean red ginseng capsule(placebo)

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.

Intervention Type: DRUG

Other Intervention Names

red ginseng; placebo group

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 within 3 months before the study；

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role: collaborator

Foshan Fuxing Changcheng Hospital

UNKNOWN

Sponsor Role: collaborator

Nanchang Hongdu Hospital of TCM

UNKNOWN

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hongsheng Tan

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaomin Hu, Professor

Role: STUDY_DIRECTOR

RenJi Hospital

Chenghong Yin, Professor

Role: STUDY_DIRECTOR

Beijing Obstetrics and Gynecology Hospital

Suzhen Wu, Professor

Role: STUDY_DIRECTOR

Foshan Fuxing Changcheng Hospital

Locations

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 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 Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 21699953 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 33437155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34578969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22805313 (View on PubMed)

Other Identifiers

KRGO-2022

Identifier Type: -

Identifier Source: org_study_id