Antioxidative Stress, Healthy Ageing
Conditions
Keywords
Korean Red ginseng, Healthy Ageing, Antioxidant Effect
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.
Interventions
DRUGKorean 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.
DRUGKorean 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.
Sponsors
Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Beijing Obstetrics and Gynecology Hospital
Foshan Fuxing Changcheng Hospital
Nanchang Hongdu Hospital of TCM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in malondialdehyde (MDA) after 12 weeks of treatment | 12 weeks | To compare the change in serum MDA from baseline (week 1 to week 12) between KRGO and placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum lipofuscin after 12 weeks of treatment | 12 weeks | To compare the changes in serum lipofuscin from baseline (week 1 to week 12) between KRGO and placebo. |
| Change in serum protein carbonyl after 12 weeks of treatment | 12 weeks | To compare the changes in serum protein carbonyl from baseline (week 1 to week 12) between KRGO and placebo. |
| Change in serum 8-hydroxy-2'-deoxyguanosine(8-OHdG) after 12 weeks of treatment | 12 weeks | To compare the changes in serum 8-OHdG from baseline (week 1 to week 12) between KRGO and placebo. |
| Change in serum superoxide dismutase (SOD) after 12 weeks of treatment | 12 weeks | To compare the changes in serum SOD from baseline (week 1 to week 12) between KRGO and placebo. |
| Change in serum glutathione(GSH) after 12 weeks of treatment | 12 weeks | To compare the changes in serum GSH from baseline (week 1 to week 12) between KRGO and placebo. |
| Changes in the sub-health status evaluation questionnaire (shsq-25) after 12 weeks and 16 weeks treatment | 12 weeks # 16 weeks | 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 \[worst\]). |
Countries
China
Contacts
STUDY_DIRECTORYaomin Hu, Professor
RenJi Hospital
STUDY_DIRECTORChenghong Yin, Professor
Beijing Obstetrics and Gynecology Hospital
STUDY_DIRECTORSuzhen Wu, Professor
Foshan Fuxing Changcheng Hospital
Outcome results
None listed