KR101304707B1 - Improvemnet composition including ginseng for cognitive function - Google Patents

Abstract

The present invention relates to a cognitive function improving composition. The cognitive function improving composition of the present invention is characterized by containing ginseng as an active ingredient.
The cognitive function improving composition containing ginseng of the present invention as an active ingredient has an effect of improving visual language learning ability and visual memory recall ability due to containing ginseng and contributing to the improvement of cognitive function as a whole.

Description

Cognitive function improving composition containing ginseng as an active ingredient {Improvemnet composition including ginseng for cognitive function}

The present invention relates to a cognitive function improving composition containing ginseng as an active ingredient.

Mild cognitive impairment is a state of cognitive function, especially memory compared to the same age, and the ability to perform everyday life is not yet dementia represents a state. In other words, it is an intermediate step between normal aging and dementia. Epidemiologic studies suggest that mild cognitive impairment is a high risk group for the transition to Alzheimer's disease. These mild cognitive impairments are classified into amnesia-type mild cognitive impairment and non-memory-deleted mild cognitive impairment according to what cognitive area shows the disorder. Most patients with amnesiac mild cognitive impairment progress to Alzheimer's disease, while patients with non-memory mild cognitive impairment often have different neuropathies than Alzheimer's disease, which is likely to progress to other dementia diseases such as forehead dementia and vascular dementia. It is known. Most mild cognitive impairment is known to be caused by the cause of the disease.

Symptoms of mild cognitive impairment often complain of indifference (no change in mood or slow mood), or mild memory disorder that does not cause major problems in daily life.

This mild cognitive impairment is a precursor to Alzheimer's disease and dementia, and it is also the earliest stage of early detection of Alzheimer's disease and dementia. Therefore, improvement of mild cognitive impairment is clinically important in that the treatment effect can be maximized. However, if appropriate measures are taken to prevent mild cognitive impairment that maximizes the therapeutic effect, there is a problem that there is a lack of measures and treatments to treat it early after onset.

On the other hand, ginseng has been used as an important active ingredient in herbal prescriptions that improve memory. In addition, red ginseng (saponin) has been found to have a prophylactic effect of neuronal cell damage and learning behavioral disorder associated with cerebral ischemia.

Dr. Petkov and Ph.D. Oh Jin-seop, professor of physiology at the Bulgarian Academy of Sciences, said that Korean ginseng promotes brain activity and maintains psychological stability by selectively regulating bilateral effects of excitement and calm.

However, the effect of the treatment of clinical mild cognitive impairment in humans using ginseng has not been confirmed.

Accordingly, the present invention is to provide a cognitive function improving composition containing ginseng, which is effective in improving the cognitive function, such as mild cognitive impairment in humans.

The cognitive function improving composition according to one feature of the present invention for solving the above problems is made by containing ginseng as an active ingredient.

In the cognitive function improving composition containing the ginseng as an active ingredient, the ginseng is characterized in that the ginseng (Panax ginseng).

In addition, the cognitive function is characterized in that the visual cognitive function.

In addition, the visual cognitive function is characterized by visual language learning ability or visual memory recall ability.

The cognitive function improving composition containing the ginseng of the present invention as an active ingredient improves visual language learning ability and visual memory recall ability of patients with mild cognitive impairment, thereby improving the overall cognitive function.

The present inventors have found that the results of applying ginseng components to testers showing mild cognitive impairment have improved the cognitive ability to a significant extent, and found that ginseng is effective in treating mild cognitive impairment, thereby completing the present invention.

Accordingly, the cognitive function improving composition of the present invention contains ginseng as an active ingredient.

In the cognitive function improving composition containing the ginseng of the present invention as an active ingredient, ginseng that can be used is preferably used ginseng (Panax ginseng).

In the present invention, white ginseng or red ginseng may be used as Korean ginseng.

White ginseng in the present invention refers to the ginseng of the round fat ginseng processed to remove the epidermis, dried and moisture content less than 14% by using the fresh ginseng more than 4 years, red ginseng dried red ginseng without steaming the ginseng without peeling use.

Both white ginseng and red ginseng are included in the present invention, and the form of ginseng may be contained in the cognitive function improving composition of the present invention in any form without distinguishing powder or liquid.

Hereinafter, the present invention will be described in detail with reference to the preferred embodiments, which will be readily apparent to those skilled in the art to which the present invention pertains. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

Example

After preparing fresh ginseng for more than 4 years, the epidermis was removed, and then pulverized through a grinder or mixer to prepare a powder. From the prepared white ginseng powder, a capsule was prepared such that the total weight of one capsule was 300 mg.

Comparative example

As a control agent to show the efficacy of the ginseng capsule of Example, a capsule was prepared using starch powder. Specifically, from the starch powder, a capsule was prepared such that the total weight of one capsule was 300 mg.

Test Example

The capsules prepared in Examples and Comparative Examples were administered to subjects with mild cognitive impairment, respectively, to test the effect of improving cognitive function.

Selection of subject

The selection criteria of the subjects are as follows: First, they must be at least 50 and 75 years old. Second, males and females with mild cognitive impairment symptom should be over 26 K-MMSE (Korean version Mini-Mental Statement Exam). Third, the subjects who agreed in writing to the human application test agreement were enrolled.

In addition, as an exclusion criterion, first, subjects who experienced allergic reactions such as allergies when taking ginseng products were excluded.

Second, subjects who were diagnosed with dementia, depression, brain tumors, and hydrocephalus, or who underwent hormonal replacement therapy within three months, were excluded.

Third, subjects with stroke, heart disease (heart failure, angina pectoris, myocardial infarction), malignant tumor, narrow angle glaucoma, uncontrolled hypertension subjects (> SBP 145mmHg or DBP 90mmHg) or lung disease are also excluded. It became.

Fourth, subjects with severe renal or hepatic dysfunction (serum creatinine> 2.0 mg / dl, ALT, AST, alkaline phosphatase> normal upper limit × 2.5) were also excluded.

Fifth, if blood glucose control is difficult due to hypoglycemic agents (HbA1C 8% or more), and platelets are 150,000 / mm ³ or less, and leukocytes are 3000 / mm ³ or less, the hemoglobin level is 9.5g / dL for men and 9.0g / dL for women. Human subjects were also excluded from the subject.

Sixth, subjects with gastrointestinal disorders or psychologically significant medical history or current diseases (schizophrenia, epilepsy, alcoholism, anorexia, anorexia nervosa, etc.) were also excluded.

Seventh, they have taken oral steroids, thyroid hormones, etc. within the last three months, have had a history of taking medications that affect the absorption, metabolism, or excretion of test foods or drugs that may affect cognitive function or other human testing. Subjects with experience of participating were also excluded.

Eighth, subjects who were surgically operated within six months or who were forbidden within one month (treatment for the purpose of acupuncture or brain function or health food or drug abuse) were excluded.

Ninth, subjects deemed to have decreased brain function and cognitive function due to other diseases were also excluded.

Tenth, subjects with abnormal test results from thyrotropin tests were excluded.

Eleventh, pregnant women, lactating women and women of childbearing potential were also excluded.

Twelfth, subjects who were judged to be unable to follow the test requirements or other physicians who were judged by the human subjects were excluded.

A screening period of two weeks is required to determine whether the subject is subject to the above requirements.

The number of subjects for reliably confirming the effect of improving the cognitive function of the subject with mild cognitive impairment is calculated by the following formula.

N = [2 （Ｚ _{a / 2} + Ｚ _β ) ² σ ² ] / δ ²

In addition, the following assumptions are made to estimate the number of subjects valid for this study.

(1) level of significance, α = 0.05

Z _{α / 2} = 1.96 (two-sided test)

(2) Power of the test, 1-β = 0.8

Z _β = 0.845

(3). The Verbal Recall score of 50 patients with mild cognitive impairment, which was extracted by SNSB test, was 4.32 ± 3.23. The Verbal Recall scores of the normal and middle school students (including drop out of middle school) were 5.71 ± 2.21. From these previous studies, (conservatively) estimate the variance of the mild cognitive impairment group as (3 points) ² and calculate the number of subjects needed to show that the ginseng administration group differed by 2 points compared to the placebo group.

N = [2 (1.96 + 0.845) ² (3) ² ] / 2 ² = 35.3

 to be.

Therefore, considering the marginal dropout rate, the number of subjects is preferably 45 people per group.

Through this process, 45 subject groups to administer ginseng capsules and 45 subject groups to administer starch capsules were selected, respectively. At this time, the subjects were randomized by 1: 1 according to age and gender.

Subject Basic Information Ginseng capsule group
(n = 45) Starch capsule
(n = 45) P -value * Sex guys
female 14 (31.8) 16 (34.8) 0.7655 30 (68.2) 30 (65.2) age 62.0 ± 6.8 62.4 ± 6.4 0.8160 EKG top
abnormal 40 (90.9) 40 (87.0) 0.5509 4 (9.1) 6 (13.0) X-ray normal
abnormal 34 (77.3) 36 (78.3) 0.9103 10 (22.7) 10 (21.7) Drug Availability Yes
no 23 (52.3) 20 (43.5) 0.4038 21 (47.7) 26 (56.5) Diseases and accompanying diseases
no 22 (50.0) 21 (45.7) 0.6798 22 (50.0) 25 (54.3) Smoking example
no
past 3 (6.8) 1 (2.2) 0.2803 36 (81.8) 35 (76.1) 5 (11.4) 10 (21.7) Drinking alcohol
no 16 (36.4) 14 (30.4) 0.5509 28 (63.6) 32 (69.6) Diet compliance
Non-compliance 31 (70.5) 42 (91.3) 0.0152 13 (29.5) 4 (8.7) Exercise rules
irregular 29 (65.9) 34 (73.9) 0.4075 15 (34.1) 12 (26.1)

Data are mean ± standard deviation or n (%); * two-sample t-test or Chi-square test or Fisher's Exact test

Capsule Dosing

In order to prevent the subjects from distinguishing each capsule prepared according to the Examples and Comparative Examples, each group was orally administered 10 capsules (3 g per day) twice a day for 5 weeks each for morning, evening, and meal for 24 weeks. The purpose of this study was to evaluate the efficacy and safety of cognitive function, such as decreased cognitive function, when three grams of ginseng (white ginseng powder) were administered daily after a meal.

At this time, the assignment of the selected subject is a random assignment in which the computer is assigned to the group according to a random code that allows the number of subjects in the two groups to be the same.In the course of the test, neither the researcher nor the subject knows which group the subject is assigned to. It proceeded in the form of a blind test.

The test capsule is prescribed once every 8 weeks (approximately 2 months) for 6 months, and is given at 0 weeks (visit 2), 8 weeks (visit 3), 16 weeks (visit 4), and 24 weeks (visit 5). Performance test and cognitive function test (KMMSE, KIADL, SNSB) were conducted. Details of such a cognitive function test will be omitted in the specification of the present invention.

Finally, 82 of the 90 subjects completed the test to the end.

Per protocol (PP) analysis was performed on the above test, and the results are as follows. In this case, the PP analysis is an analysis method of a clinical trial in which only the subjects who completed the trial (excluding the dropouts) are analyzed. In addition, P- value is a statistic that shows that there is a difference between two groups because the validity of the item is confirmed when the value is less than 0.05 under the hypothesis that there is no difference between the two groups.

Test result of cognitive function before test Ginseng capsule group
(n = 41) Starch capsules
(n = 41) P -value * KMMSE 27.85 ± 1.12 27.74 ± 1.06 0.6437 KIADL 1.33 ± 1.19 1.21 ± 1.34 0.6929 VERL 17.03 ± 6.85 17.33 ± 4.99 0.8172 VISL 13.21 ± 6.30 12.33 ± 6.34 0.5308 VERR 7.78 ± 4.32 7.21 ± 4.75 0.5695 VISR 12.95 ± 6.11 12.73 ± 5.69 0.8640

Data are mean ± standard deviation; two-sample t-test

KMMSE = Mini-Mental Statement Exam (Korean version); KIADL = Instrumental Activities of Daily Living (Korean version); VERL = Verbal Learning; VISL = Visual Learning; VERR = Verbal Recall; VISR = Visual Recall

Test result of cognitive function after test (after 24 weeks) Ginseng capsule group
(n = 41) Starch capsule
(n = 41) P -value * KMMSE 0.60 ± 1.39 0.55 ± 1.66 0.8775 KIADL -0.45 ± 1.09 -0.24 ± 1.36 0.4387 VERL 2.53 ± 5.65 2.00 ± 4.68 0.6475 VISL 4.90 ± 5.91 2.51 ± 4.97 0.0507 VERR -0.99 ± 5.65 -1.00 ± 4.29 0.9910 VISR 3.93 ± 5.15 1.50 ± 5.18 0.0368

Data are mean ± standard deviation; two-sample t-test

KMMSE = Mini-Mental Statement Exam (Korean version); KIADL = Instrumental Activities of Daily Living (Korean version); VERL = Verbal Learning; VISL = Visual Learning; VERR = Verbal Recall; VISR = Visual Recall

VISL (Visual Learning), which corresponds to visual language learning ability among the cognitive functions compared with ginseng capsule and starch capsule, showed only slight difference from baseline as 13.3 ± 6.30 in ginseng capsule group and 12.33 ± 6.34 in starch capsule group. However, after 24 weeks of administration, the changes per group were 4.90 ± 5.91 in the ginseng capsule group and 2.51 ± 4.97 in the starch capsule group. The visual language learning ability of the ginseng capsule group taking the ginseng capsules was significantly improved. (p = 0.0507)

In addition, the change in visual recall recall (VISR), which is a visual memory recall score, was 12.95 ± 6.11 in the ginseng capsule group and 12.73 ± 5.69 in the starch capsule group before administration. However, after 24 weeks, the starch capsule group showed an increase of 1.50 ± 5.18, but the increase in the ginseng capsule group was 3.93 ± 5.15, indicating that the visual memory recall ability of the ginseng capsule group was significantly improved. Can be. (p = 0.0368).

In addition, the ITT (Intention to Treat) analysis was performed for the above test. The results are as follows. In this case, the ITT analysis is an analysis method of a clinical trial in which all subjects who participated in the study are analyzed (including dropouts). In addition, P- value is a statistic that shows that there is a difference between two groups because the validity of the item is confirmed when the value is less than 0.05 under the hypothesis that there is no difference between the two groups.

Test result of cognitive function before test Ginseng capsule group
(n = 45) Starch capsule
(n = 45) P -value * KMMSE 27.82 ± 1.11 27.78 ± 1.05 0.8761 KIADL 1.30 ± 1.15 1.20 ± 1.31 0.7027 VERL 17.21 ± 6.67 17.46 ± 4.79 0.8380 VISL 13.25 ± 6.05 11.90 ± 6.23 0.3010 VERR 7.53 ± 4.30 7.20 ± 4.54 0.7175 VISR 12.83 ± 5.96 12.62 ± 5.47 0.8621

Data are mean ± standard deviation; two-sample t-test

KMMSE = Mini-Mental Statement Exam (Korean version); KIADL = Instrumental Activities of Daily Living (Korean version); VERL = Verbal Learning; VISL = Visual Learning; VERR = Verbal Recall; VISR = Visual Recall

Test result of cognitive function after test (after 24 weeks) Ginseng capsule group
(n = 45) Starch capsule
(n = 45) P -value * KMMSE 0.60 ± 1.39 0.56 ± 1.64 0.9008 KIADL -0.45 ± 1.09 -0.23 ± 1.34 0.4215 VERL 2.53 ± 5.65 2.02 ± 4.63 0.6583 VISL 4.90 ± 5.91 2.45 ± 4.93 0.0432 VERR -0.99 ± 5.65 -0.95 ± 4.25 0.9752 VISR 3.93 ± 5.15 1.48 ± 5.13 0.0330

Data are mean ± standard deviation; * two-sample t-test result

KMMSE = Mini-Mental Statement Exam (Korean version); KIADL = Instrumental Activities of Daily Living (Korean version); VERL = Verbal Learning; VISL = Visual Learning; VERR = Verbal Recall; VISR = Visual Recall

Visual language (VISL), a visual language learning ability, was only 13.25 ± 6.05 in the ginseng capsule group and 11.90 ± 6.23 in the starch capsule group. After 24 weeks of administration, the changes per group were 4.90 ± 5.91 in the ginseng capsule group and 2.45 ± 4.93 in the starch capsule group. The visual language learning ability of the ginseng capsule group taking the ginseng capsules was significantly improved. (p = 0.0432)

In addition, the change in visual recall recall (VISR), which is a visual memory recall score, was 12.83 ± 5.96 in the ginseng capsule group and 12.62 ± 5.47 in the starch capsule group before administration. However, after 24 weeks, the starch capsule group showed an increase of 1.48 ± 5.13, but the increase in the ginseng capsule group was 3.93 ± 5.15, indicating that the visual memory recall ability of the ginseng capsule group was significantly improved. Can be. (p = 0.0330).

In conclusion, in the cognitive function test performed by ITT or PP method, the administration of ginseng capsules did not show significant difference in KMMSE and KIADL compared to the administration of starch capsules, but the visual learning ability of SNSB test (visual learning, VISL) and visual recall (VISR).

These differences were statistically confirmed that the items were validated, which contributes to the overall improvement of cognitive function by improving visual cognitive function.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention is not limited to the disclosed exemplary embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. It is natural.

Claims (4)

As a cognitive function improving composition for visual language learning ability (Visual Learning, VISL) containing ginseng as an active ingredient,
The visual language learning ability (VISL) is a cognitive function improving composition, characterized in that when the SNSB test for mild cognitive impairment subjects, the rate of decline of the value of VISL (Visual Learning) is improved by 10.5 ~ 20.4%.
As a cognitive function improving composition for visual recall (VISR) containing ginseng as an active ingredient,
The visual memory recall ability (VISR) is a cognitive function improving composition, characterized in that when the SNSB test for mild cognitive impairment subjects, the rate of decline of the value of VISR (Visual Recall) is improved by 13.4 ~ 23.7%.
3. The method according to claim 1 or 2,
The ginseng is Goryeo ginseng (Panax ginseng) characterized in that the cognitive function improving composition.
Comprising the cognitive function improving composition of claim 1,
A cognitive decline medicine, characterized in that the daily dose is 2500 ~ 3500mg.