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Healthy AgeingPhase 2/3NCT05592093

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

A Phase 2/3 study testing Korean red ginseng capsule (marketed product in Korea) in people with Healthy Ageing and Antioxidative Stress, run by Shanghai Jiao Tong University School of Medicine at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Healthy Ageing, Antioxidative Stress
What is being tested?
Korean red ginseng capsule (marketed product in Korea)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
4 sitesChina
Study dates
1 Mar 2023to 10 Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100026

  • Foshan Fuxing Changcheng Hospital

    Foshan, Guangdong, 528031

  • Nanchang Hongdu Hospital of TCM

    Nanchang, Jiangxi, 330006

  • Renji Hospital Affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

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.

Read the 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.

Being tested
Korean red ginseng capsule (marketed product in Korea), Korean red ginseng capsule(placebo)
Keywords
Korean Red ginseng, Healthy Ageing, Antioxidant Effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Korean red ginseng capsule (marketed product in Korea)Drug

    Also called red ginseng

    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.

  • Korean red ginseng capsule(placebo)Drug

    Also called placebo group

    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.

Study groups in NCT05592093
Study groupRoleWhat they receive
KRGO groupExperimentalKorean red ginseng capsule (KRGO)marketed product in Korea donated by The Korean Society of Ginseng.
Receives: Drug: Korean red ginseng capsule (marketed product in Korea)
placebo groupPlacebo comparatorSame smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules.
Receives: Drug: Korean red ginseng capsule(placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. Changes in the sub-health status evaluation questionnaire (shsq-25) after 12 weeks and 16 weeks treatment

    To compare the change in the sub-health status evaluation questionnaire (shsq-25) using face to face Interview for the scores from baseline (week 1 to week 12, week 12 to week 16) between KRGO and placebo (range, 0 [best] to 100 [worst]).

    Measured: 12 weeks # 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start1 Mar 2023
  3. Primary completion30 Oct 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592093
Sponsor's protocol ID
KRGO-2022
Status last verified
Jan 2026
First submitted
20 Oct 2022
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21699953

  • 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.

  • 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.

    PubMed 33437155

  • 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.

    PubMed 34578969

  • 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.

    PubMed 22805313

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Korean red ginseng capsule (marketed product in Korea) in people with Healthy Ageing and Antioxidative Stress, run by Shanghai Jiao Tong University School of Medicine at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in malondialdehyde (MDA) after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592093, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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