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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
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.
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.
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
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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 \[worst\]).
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Time frame: 12 weeks # 16 weeks