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

Study Overview
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Brief Summary
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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
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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, hearing 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 Shanghai, Beijing and Foshan, in China.

Official Title
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An RCT Study to Investigate the Effect of Korean Red Ginseng for Middle-aged and Elderly Sub-health Population on Anti-oxidation

Conditions
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Healthy Ageing, Antioxidative Stress

Intervention / Treatment
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* Drug: Korean red ginseng capsule (marketed product in Korea)
* Drug: Korean red ginseng capsule(placebo)


Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRGO group<br>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)<br>* 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.<br>* Other names: red ginseng;|
| Placebo Comparator: placebo group<br>Same smell, color and shape as Korean red ginseng capsule (KRGO)without herbs in capsules. | Drug: Korean red ginseng capsule(placebo)<br>* 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.<br>* Other names: placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | To compare the changes in serum protein carbonyl from baseline (week 1 to week 12) between KRGO and placebo. | 12 weeks | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean Red ginseng, Healthy Ageing, Antioxidant Effect