KR20150038906A

KR20150038906A - Pharmaceutical Composition Comprising Herbal Extracts for Preventing or Treating late Onset Hypogonadism and Functional Food Comprising This Extracts

Info

Publication number: KR20150038906A
Application number: KR20130117269A
Authority: KR
Inventors: 황성연; 박남철; 김세웅
Original assignee: 주식회사한국전통의학연구소; 황성연
Priority date: 2013-10-01
Filing date: 2013-10-01
Publication date: 2015-04-09

Abstract

The present invention relates to a composition for preventing or treating late onset male hypogonadism and andropause, and more specifically, to a composition which contains extracts of herbs medicines, such as ginseng, Chinese dioscorea, Chinese matrimony vine, and Oleoresin turmeric, and has an effect of the prevention or treatment of several symptoms of andropause. The composition of the present invention shows a significant improvement in the erectile function, a whole improvement in the IIFE test, and effects of the prevention and treatment of andropause symptoms thorough AMS, ADMA, and the penile doppler test. Moreover, these functional improvements are achieved even without large changes in male hormones, and thus the composition of the present invention is anticipated to be sufficiently usable as a hormone replacement therapy.

Description

Technical Field [0001] The present invention relates to a composition for preventing or treating late-onset male hypogonadism or male menopausal syndrome including herbal medicine extracts and health functional foods,

The present invention relates to a composition for the prevention or treatment of late-onset male hypogonadism or male menopausal syndrome, and more particularly to a composition for preventing or treating late menopausal male hypogonadism or male menopausal syndrome which comprises extracts of herbal medicines such as red ginseng, To a composition which is effective for preventing or treating symptoms.

In men, the amount of male hormone secretion decreases every year, resulting in a variety of physical and mental changes. Unlike women, this change, which is very slowly progressive, can lead to loss of libido, erectile dysfunction, abdominal obesity, decreased muscle mass and strength, Decrease, memory and concentration. According to the Korean Menopausal Society, men's menopause is a clinical and biochemical syndrome associated with typical symptoms experienced by increasing age in men and serum testosterone deficiency, which may lead to lower quality of life and negative effects on the function of various organs , And the name Hangul is technically a late manifestation of men with hypogonadism and generally uses the name of male menopausal syndrome. Recently, these symptoms may occur regardless of age. In the past, it was called male hormone deficiency in elderly men and diagnosed male menopause only with testosterone levels. However, the term "late onset hypogonadism (LOH)" emerged as well as testosterone levels as well as clinical symptoms, , And it is considered that considering clinical symptoms is a more important evaluation factor. LOH is also commonly referred to as the male menopausal syndrome. Clinical manifestations of menopausal symptoms include dyslipidemia, cardiovascular disease, abdominal obesity, decreased strength, decreased bone density, reduced motivation, decreased memory and concentration, and decreased erectile function.

The Aging Male Symptom Score (AMS), developed by Heinemann, Germany, is commonly used to determine the clinical manifestation of menopausal menstruation, which is based on the symptoms of normal aging in German men over age 40, It does not necessarily coincide with the degradation. However, the decrease in serum testosterone concentration due to aging is thought to be related to male menopause, with a decrease in total testosterone in men by 0.4% each year after the mid-thirties and less than 350 ng / dl. When male menopausal symptoms are present and testosterone levels fall below 12 nmol / L, male hormone replacement therapy is considered to be a testosterone replacement therapy (ART). However, patients with prostate cancer, severe polycythemia, untreated sleep apnea, severe heart failure, cimetidine, progestin, estrogen, and other antiandrogens are more likely to have cholesterol levels greater than 260 mg / dl, In cases such as severe psychiatric disorders requiring antidepressant medication, administration of male hormone replacement therapy is contraindicated. That is, there is a possibility of side effects of hormone replacement therapy.

AMS is a method to score according to each symptom level for 5 items of mental symptoms, 5 items of physical symptoms, 5 items of sexual symptoms. There are IIEF and ADAM which are used for clinical evaluation. The International Index of Erectile Function (IIEF) evaluates and quantifies foot function, orgasm, sexual desire, sexual satisfaction, and overall satisfaction. ADAM (Androgen Deficiency in Aging Male) was developed by Morley et al. In the case of men who answered "YES" to question 1 about the loss of sexual desire and question 7 to question 7 about the decrease in erectile function among 10 items, Possible.

Meanwhile, as of January 2013, the KFDA announced that there are no products that can help male menopause in the individual raw materials. However, in the case of menopausal women, three kinds of functionalities are recognized, namely, compound extracts such as Bacillus subtilis, fruit extracts, and extracts of pomegranate and concentrates.

Late-onset male hypogonadism is not simply a problem of erectile dysfunction, but is accompanied by a variety of symptoms such as dyslipidemia, cardiovascular disease, abdominal obesity, decreased strength, decreased bone density, decreased motivation, decreased memory and concentration, Quality can be threatened.

Accordingly, the present invention has been accomplished by confirming whether the composition of the present invention is effective in the prevention and treatment of late-onset male hypogonadism, whether it is effective in research on the natural substance which has an effect on the human body experiment.

The present invention aims to provide a composition which is effective in preventing or treating late-onset male hypogonadism, that is, male menopausal symptoms, while minimizing various side effects.

To this end, the present invention provides a composition for preventing or treating late-onset male hypogonadism comprising red ginseng extract, ginseng extract, gugija extract, corn oil extract and ginseng extract as effective ingredients.

The red ginseng extract, the ginseng extract extract, the gugija extract, the extract of corn oil, and the ginseng extract may be obtained by extracting red ginseng, ginseng, gugija, corn oil and ginseng with water or organic solvent and drying under reduced pressure. 50 to 130 parts by weight of an extract of Ganoderma lucidum extract, 50 to 130 parts by weight of Ganoderma lucidum extract, 30 to 100 parts by weight of an extract of corn oil, and 3 to 20 parts by weight of a ganoderma extract. More preferably, 70 to 90 parts by weight of the extract, 70 to 90 parts by weight of the ginger extract, 50 to 80 parts by weight of the extract of corn oil, and 5 to 8 parts by weight of the ginger extract.

The present invention also provides a functional food for improving late-onset male hypogonadism comprising red ginseng extract, ginseng extract, gugija extract, corn oil extract, and ginseng extract as an active ingredient, and a food-acceptable food-aid additive. Wherein the food comprises 50 to 130 parts by weight of a crude extract, 50 to 130 parts by weight of a crude extract, 30 to 100 parts by weight of an extract of corn oil, and 3 to 20 parts by weight of an ingame extract, based on 100 parts by weight of the red ginseng extract. Likewise, it is more preferable that 70 to 90 parts by weight of the crude extract, 70 to 90 parts by weight of the crude extract, 50 to 80 parts by weight of the crude oil extract, and 5 to 8 parts by weight of the uroguan extract are based on 100 parts by weight of the red ginseng extract.

Hereinafter, the present invention will be described in detail.

The inventors of the present invention have investigated herbal medicine extracts effective for erectile dysfunction from the viewpoint of vascular pathophysiology. However, the correlation between erectile dysfunction and late-onset male hypogonadism (male menopausal syndrome) is inconsistent as previously described in the background, and thus, through the results of recent clinical trials, It is necessary to examine whether it is effective for treatment. Strictly speaking, late-onset male hypogonadism should be regarded as a different disease from erectile dysfunction. The present invention has found a composition for the prevention and treatment of late-onset male hypogonadism by obtaining individual herbal extracts and combining them. Basically, the characteristics of individual herbal medicines were identified and studied based on the principles of Oriental medicine prescription. In conclusion, the herbal medicine which is the object of the present invention is a combination of red ginseng, liquorice liquorice (horse mackerel), gugija, corn oil,

Red ginseng is a processed ginseng root of Araliaceae, and it is known that it is used to treat the lungs' soil and follicles. About 750 kinds of saponins, which are the main active ingredients of ginseng, have been reported and are widely distributed in the vegetable field. Among them, saponin contained only in ginseng is called ginsonosides, There are 38 species of ginsenoside. Ginsenoside Rg1 is known to have an anti-fatigue effect. Rats were forced to exercise by vibration, and then anti-fatigue effect was observed through behavior observation. Anti-fatigue effect was observed in all experiments of G-Rg1 (Kaku T In addition, G-Rg1 of red ginseng has been shown to be effective in several experiments on animals with symptoms of sexual dysfunction such as erectile dysfunction (erectile dysfunction, erectile dysfunction, etc.) (Choi YD et al. J urol, 162: 1508-11 (1999)).

Diaphora is the root of the vineous perennial herbaceous perennials of monocotyledonous plant lilies. The main components are batasin Ⅰ, Ⅱ, Ⅲ and steroidal saponins such as diosin and diosgenin. Diosgenin is a kind of plant steroid saponin belonging to the triperpene. It is extracted from wild yam and fenugreek and contains cortisone, pregnenolone (prodrug of DHEA), progesterone (progesterone) And female hormones). Diosgenin is a sex hormone precursor that reacts with the body to form DHEA, which produces estrogen and testosterone in the DHEA. DHEA has various functions that reinforce the energy of life such as vitality enhancement, sexual desire enhancement, memory recovery, immune function recovery, anticancer ability enhancement, heart disease prevention, body fat reduction, and menopausal vitality enhancement.

Gugija is a deciduous shrub with a height of 2.5 m, the ends of the branches are hanging down, the branches are spiny and the leaves are 2 ~ 3 short-lived form at the bottom of long branches. And it is called the mongo, and it is non-toxic, and it regulates the dynasty and the inhalation of the internal injuries, strengthens the muscles, strengthens the yin, It is reported that the ruling of the 勞 and the Seven Wounds is to watch regularly, to change the complexion to whiten, to honor, to longe and to longe. In addition, there is no toxicity in the main gangbang, it can cool the heat, it accumulates in the body, inflammation of the chest, noise, diabetes, joints, rheumatism, neuralgia is good and long time to take the muscle healthy, refreshing body, It has been used for a long time by various methods such as tea and alcohol.

Sansui is tasted by drying the flesh of the fruit of the mountain fruit, which is a deciduous tree belonging to the Tertiary Tree, and has a warm temperament. According to the "Dongbibogam" and "肾气) reinforcement and convergence, such as headache, tinnitus (tinnitus), water bath, fever and menstrual overeating (汗) can be effective, As a known herbal medicine, there are Sichuan Daebotan (hot water) and Jukmi hot water (六味地黄汤), which is the most important medicinal ingredient in this prescription.

Ulgum has similar appearance to turmeric, but both sides of the leaf are smooth. Ulgum is called peat, turmeric is called rhizome, turmeric takes roots of plant, and turtles take roots. Ulchum is cold, while turmeric is warm. 금 은 行行行行行行行閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉閉(Chest and stomach pain), stabbing (stinging sickness), fever sickness (fever is confused with fever), epileptic crab (emotional psychosis), ichthyosis urine Red (jaundice), hemorrhage (hemorrhagic symptoms) and is used.

Each herbal medicine is washed, extracted with distilled water or organic solvent, and heated to increase the extraction efficiency. The extract is filtered with a filter paper and dried under reduced pressure to obtain the final extract. This type of extract can be made into a ring form by adding an excipient and the extract can be lyophilized into a powder form. Depending on the formulations desired, processing may be carried out, including appropriate pharmaceutically acceptable carriers. The term " pharmaceutically acceptable carrier " is intended to encompass pharmaceutically acceptable substances, such as liquid or solid fillers, diluents, excipients or solvents, which serve to transport the active ingredient from one or more parts of the body to other organs or parts of the body , Composition or vehicle. The carrier may be any suitable formulation known in the art (Remingtons ' s Pharmaceutical Science (recent edition), Mack Publishing Company, Easton PA).

The pharmaceutical composition of the present invention can be administered orally in clinical administration and can be used in the form of a general pharmaceutical preparation. In the case of pharmaceutical preparation, the filler, extender, binder, wetting agent, A surfactant, or the like. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like. Examples of liquid formulations for oral use include suspensions, solutions, emulsions and syrups. Common diluents such as water, In addition to liquids and paraffins, various excipients such as wetting agent sweetening agents, perfumes, preservatives and the like may be included. Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like can be used as the non-aqueous solvent and suspension agent. Examples of the suppository base include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like.

As used herein, the term "extract " means an active ingredient isolated from a natural product. The extract can be obtained by an extraction process using water, an organic solvent, or a mixed solvent thereof, and includes an extract, a dry powder thereof, or all the forms formulated with it. In the present invention, the extract may be extracted using water, an organic solvent, or a mixed solvent thereof. When extraction is carried out using an organic solvent, an organic solvent such as methanol, ethanol, isopropanol, butanol, ethylene, acetone, hexane, ether, chloroform, ethyl acetate, butyl acetate, dichloromethane, N, (DMSO), 1,3-butylene glycol, propylene glycol, or a mixed solvent thereof. The active ingredient of the herbal medicine may be extracted at room temperature or warmed under the condition that the active ingredient is not destroyed or minimized. Depending on the organic solvent to be extracted, the degree of extraction and the degree of loss of the active ingredient of the medicament may differ. Therefore, an appropriate organic solvent should be selected and used. Preferably, water or ethanol is used. The extraction method is not particularly limited, but hot water extraction is preferable. Filtration is a process of removing suspended solid particles from the extract. It is possible to filter particles by using cotton, nylon or the like, or to perform ultrafiltration, freezing filtration, But is not limited thereto.

Concentration of the extract can be carried out by reduced-pressure concentration, reverse osmosis concentration, or the like. The post-concentration drying step includes, but is not limited to, freeze drying, vacuum drying, hot air drying, spray drying, vacuum drying, foam drying, high frequency drying, infrared drying and the like. In some cases, a step of pulverizing the final dried extract may be added.

Red ginseng has been reported to have components such as ginsenoside Rg3, Rg1, Rb1, Rb2, Rg2, Rc, Re, and Rf, saponin as loganin, betaine as gugija, curcumin as curcumin as well as allantoin and diosgenin , ginsenoside Rg1, Rb1, Rb2, Rc, Re, Rf, loganin, curcumin, allantoin, diosgenin and the like contribute to the effect of the composition of the present invention.

In the composition for preventing or treating late-onset male hypogonadism according to the present invention, the composition comprises 50 to 130 parts by weight of a crude extract, 50 to 130 parts by weight of a crude extract, 30 to 100 parts by weight of a crude oil extract, It is preferable that the extract is 3 to 20 parts by weight. Preferably, the composition comprises 70 to 90 parts by weight of the crude extract, 70 to 90 parts by weight of the crude extract, 70 to 90 parts by weight of the crude extract, 50 to 90 parts by weight of the extract, To 80 parts by weight of the extract and 5 to 8 parts by weight of the extract. In the examples, the above ratio was prepared, named KBMSI-2, and the results of the clinical tests were very good.

The KBMSI-2 group and the placebo (placebo) group were administered twice a day for 8 weeks. The subjects were divided into two groups. Were evaluated for safety and efficacy. Safety was assessed by observing the presence or absence of adverse events in each group, assessing the severity of the symptoms and causality with the test product, and assessing the safety of the dose. Adverse events were not observed in the dose group, or were assessed to be safe if there was no causal relationship between the test product and Grade 1 in the WHO 5-step classification. Efficacy was assessed primarily by observing changes in the EEF domain scores of the IIEF for 8 weeks, and secondly, the changes in other IIEF domain scores, changes in the AMS scores, and changes in the percentage of respondents who answered yes to the ADAM questionnaire. Clinical results were improved for each symptom of menopausal period, and it was expected to be developed as a therapeutic agent to overcome the limitation of hormone replacement therapy by improving the symptoms without increasing the male hormone level in blood.

On the other hand, the composition of the present invention can be used to produce various types of functional foods. Beverage, candy, biscuit, ice cream, chocolate, and the like.

The compositions of the present invention show significant improvement in foot function, overall improvement of IIEF test, AMS, ADAM, and penile doppler test to be effective in the prevention and treatment of male menopausal symptoms. Moreover, this functional personality can be achieved without major changes in male hormone, and it is expected to be fully utilized as hormone replacement therapy.

Figure 1 shows the flow of the test product KBMSI-2 and placebo in human body.
FIG. 2 shows experimental results on the foot function as a primary efficacy evaluation.
FIGS. 3 to 7 show the results of the IIEF evaluation items as sexual satisfaction, sleepiness, libido, overall satisfaction, and total IIEF score change.
Figure 8 shows the AMS score.
Figure 9 shows ADAM results.
Figure 10 shows HDL-cholesterol changes.
Figure 11 shows changes in triglycerides.
Figures 12-13 show PSV and EDV, respectively, as a result of penile color Doppler.
Figure 14 shows the change in total testosterone.

Hereinafter, the present invention will be described in more detail with reference to Examples. It will be apparent to those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

< Example 1: Preparation of crude drug extract >

Red ginseng, red ginseng, gugija, corn oil, and Korean ginseng were thoroughly washed and then subjected to hot water extraction using 4 L of distilled water per 100 g each. The precipitate was filtered through a filter paper and dried under reduced pressure.

< Example 2 : KBMSI -2 >

A supplementary ingredient was added to the extract prepared in Example 1 to prepare a composition for the prevention or treatment of late-onset male hypogonadism. The main raw materials were mixed with fructooligosaccharide, carboxymethylcellulose calcium and carboxymethylcellulose sodium as a supplement to the main raw materials of red ginseng extract, gugija extract, corn oil extract,

< Example 3: Placebo Manufacturing>

Using a single dose of 4 g of placebo was made similar to that of KBMSI-2 using cornstarch, fructooligosaccharide, carboxymethylcellulose calcium, carboxymethylcellulose sodium, caramel coloring, caramel flavoring.

<Products for human body test>

The KBMSI-2 and placebo, which were labeled and packaged, were applied to the testing laboratory. The KBMSI-2 and placebo were packaged and labeled to ensure that there was no difference between the two groups. I was instructed about the caution and how to dispense.

<Human body test method>

Subjects who voluntarily agreed to the written consent were subjected to a screening test and had a 4-week run-in period. Based on the screening results, (KBMSI-2) and control (Placibo). Subjects randomized to receive a random assignment number were given the appropriate product code of the corresponding code and the control product, and took one capsule twice a day orally. Each subject was subjected to a screening visit, a 4-week run-in period, and an 8-week treatment period, for a total of 12 weeks. In the meantime, to exclude patients with erectile dysfunction due to excessive stress-induced menstrual erectile dysfunction and lowered sexual desire, the age limit was limited to 40 years, and the first sexual desire hypothesis was excluded, and representative indicators of erectile dysfunction IIEF test (International foot function measurement questionnaire) was set as the first validity. Fig. 1 briefly shows the flow of the human body test.

On the other hand, the human body application test was conducted after the examination approval committee of the clinical examination examination committee of Pusan National University Hospital received the notification of approval.

<Subjects>

The subjects were subjects with erectile dysfunction due to penile circulation disturbance, and those who had undergone erectile dysfunction for 6 months or more and who were under 40 years old and under 80 years of age. A male who has a fixed relationship with one or more partners, and a subject who satisfies the written consent of a man who has been fully informed of the purpose, content, and characteristics of the test product prior to taking the test.

On the other hand, the use of phosphodiesterase-5 (PDF-5) inhibitors, autologous injections of vasodilators for erectile dysfunction within 2 weeks prior to the start of the trial, had received radical prostatectomy or penis anatomical malformation, Myocardial infarction, unstable angina pectoris, or fatal arrhythmia within the past 6 months, or if there is a history of hypoactive sexual (hypoactive sexual desire), liver function abnormalities (ALT, AST greater than 2.5qo normal) or renal dysfunction (creatinine ≥ 2.5mg.dl).

In addition, in the case where an abnormal reaction of grade 3 or higher occurs according to the WHO toxicity standard, a subject who has found a systemic disease not found in the screening test, a subject who is judged to be unable to proceed due to an accidental disease, Even when the patient withdraws consent and refuses treatment, the medication is discontinued and excluded from the study.

<Statistical analysis method>

This test is intended to evaluate the safety and efficacy of KBMSI-2 granulosate in comparison with placebo, and therefore it should be used for intention to treat (ITT) and PP (per protocol) analyzes. And a statistical significance level of 0.05.

Subjects who were finally screened and enrolled were equally assigned to the test product (KBMSI-2) and placebo (placebo, control group) according to the randomization code. Of these, subjects who were enrolled in randomization and who took the test product or control product at least once, or those with validity variables, were included in the ITT analysis group.

The PP and ITT groups were statistically analyzed to determine the difference in demographic information (subject basic information, vital signs, drug hypersensitivity, diagnosis, duration of illness) There was no statistically significant difference between the groups.

There was no significant difference between the two groups in previous drug therapy and concomitant medication. No physical examination was performed on the screening visit.

<Hematologic examination>

Hematologic tests such as Hemoglobin, Hematocrit, WBC, RBC, Differential Count (Neutro, Eosino, Baso, Lympho, Mono), Platelet Count and Creatinine, LDH, ALT, AST, and Alkaline Phosphatase. In the PP analysis group, after 8 weeks of administration of KBMSI-2, changes in hematological and biochemical values were not statistically significant compared to baseline. (p = 0.0612-0.8599, LDH p <0.05). In the placebo group, LDH, total bilirubin, and SGPT were statistically significantly different from baseline (p <0.05) after 8 weeks (p <0.05). (p = 0.0592 to 0.8267). (p <0.05). There was no significant difference between the baseline and post-8-week differences in the Platelet Count (p = 0.1255 to 0.9790). In the ITT group, changes in hematologic and biochemical parameters after the 8-week administration of KBMSI-2 were not statistically significant compared to baseline (p <0.05). p = 0.1267-0.7568, LDH p <0.05). In the placebo group, LDH, SGPT, and SGOT were statistically significantly different from baseline (p <0.05) after 8 weeks (p <0.05), but there was no significant difference in other parameters (p = 0.0513 ~ 0.7854 ). (p <0.05), but there were no other significant differences (p = 0.0733 ~ 0.9399). The difference between the baseline and post - 8 - week differences was significant only in Alkaline phosphatase.

< Urinalysis >

In the urine test, the changes of protein (albumin), glucose (sugar), occult blood, pH, WBC and RBC (urine microscope examination) were compared by urine test after administering KBMSI-2 and placebo for 8 weeks . There was no significant difference between the baseline time of the KBMSI-2 group and the placebo group after 8 weeks of administration in both PP and ITT groups.

< By administration group Evaluation of efficacy before administration>

In order to evaluate the efficacy of the test, the International Index of Foot Function Index (IIEF), Sexual Encounter Profile (SEP), Aging Males' Symptom Score (AMS score), Total Testosterone, The differences between the two groups before and after the administration of the test product were tested for the values of total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglyceride, and PSV (Peak Systolic Velocity, EDV).

In the PP analysis group, there was no significant difference in the efficacy evaluation items before administration of KBMSI-2 and placebo (p = 0.0665 ~ 9572).

&Lt; Primary effectiveness evaluation >

In the present study, the EF domain (erectile function, questions 1 to 5, 15: 1) was used as the primary efficacy evaluation variable. The baseline and the baseline were compared with the baseline, and the baseline and the baseline were compared. The baseline and the baseline were compared with the baseline Differences between visits (4 weeks, 8 weeks) and differences between the two groups were tested.

In the PP group, the erectile function at 4 and 8 weeks after administration of KBMSI-2 group was statistically significant, from 14.86 ± 6.36 to 21.14 ± 5.55 at week 4 and from 20.29 ± 8.10 at week 8, (P <0.05), respectively. The placebo group increased slightly at 18.08 ± 8.06 and 18.25 ± 7.74 at 4th and 8th weeks, respectively, but not statistically significant (p = 0.3309, 0.0828). The difference in mean difference between baseline and baseline between the two groups was 6.29 ± 6.34 in KBMSI-2 group and 1.50 ± 5.11 in placebo group at 4 weeks (p <&Lt; 0.05). This is shown in FIG. The ITT group showed no statistically significant difference at 4 weeks (p = 0.1935) in comparison with baseline at 4 and 8 weeks after administration of KBMSI-2 group (p = 0.1935) (3.10 ± 6.45), respectively (p <0.05).

<Secondary Effectiveness Evaluation>

Secondary efficacy variables included the total score of each IIEF domain, the score of each IIEF domain, the total score of the AMS score, the percentage of ADAM who answered "yes", and the hematology and biochemical values total cholesterol, HDL-cholesterol, LDL- Neutral fat, and color Doppler (PSV, EDV) were compared between the two groups.

< IIEF >

PP analysis group showed significant increase (p <0.05) in all domains compared to baseline at 4 weeks after administration of KBMSI-2, but there was no significant difference in the placebo group and overall satisfaction (P <0.05). There was no statistically significant difference between the two groups. The changes in satisfaction were 2.00 ± 1.99, 0.67 ± 2.02, 2.14 ± 1.92, 0.08 ± 2.11, 1.43 ± 1.34, -0.08 ± 1.00, and 1.07 ± 1.64, respectively, in the KMBSI-2 and placebo groups, 0.17 ± 2.33, and the total IIEF score change was 13.43 ± 11.26 and 2.00 ± 10.92, respectively. After 8 weeks of KMBSI-2 administration, there was a statistically significant difference (p <0.05) between the two groups with placebo (p <0.05). The International Index of Functional Index was also increased by 10.79 ± 13.80 after 8 weeks of administration of KMBSI-2 compared to baseline (p <0.05). This is shown in FIGS. In the ITT analysis group, the IIEF domain score changes were decreased 0.29 ± 2.22 in the KBMSI-2 group and 0.05 ± 1.93 in the placebo group, and 0.52 ± 2.27 in the KBMSI-2 group, Group increased by 0.25 ± 2.02.

< AMS score Total score change>

After 8 weeks, the total score of AMS score was compared with baseline. In the PP analysis group, the average of the men's menopausal symptom score (AMS score) at 8 weeks after administration of KBMSI-2 decreased from 41.14 ± 12.15 to 35.43 ± 14.34, which was 5.71 ± 12.15, AMS socre was increased from 40.00 ± 16.81 to 42.42 ± 11.68, but there was no significant difference (p = 0.5998). This is shown in FIG. After the administration of KBMSI-2 in the ITT group, the mean of the men's menopausal symptom score (AMS score) at 8 weeks decreased from 38.00 ± 12.07 to 34.76 ± 12.56, which was 3.24 ± 11.73.

< ADAM Number of questions answered as example of>

After the 8-week treatment with KBMSI-2, male menopausal symptom (ADAM) questionnaire (10 items) was performed and the number of questions answered as yes was compared. The PP analysis group was administered KBMSI- The mean ADAM at 8 weeks decreased from 5.86 ± 1.66 to 4.86 ± 2.18, which was 1.00 ± 2.51, indicating a decrease in menopausal symptom, but the placebo group showed a decrease of 0.50 ± 1.24 from 5.17 ± 2.17 to 4.67 ± 2.90 = 0.1911), which is shown in Fig. In the ITT analysis group, the administration of KBMSI-2 tended to be slightly better than that of placebo (-0.30) to 0.76 ± 2.61.

<Hematology and Biochemical Numbers>

The changes in serum cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, PSV (Peak Systolic Velocity), and total testosterone after eight weeks The difference between the two groups was tested. Hematologic and biochemical PP values were analyzed. As a result, total cholesterol decreased by 9.50 ± 22.81 mg / dL and 9.33 ± 29.15 mg / dL, respectively, in KBMSI-2 and placebo (P = 0.2271). In the KBMSI-2 group, HDL-cholesterol increased 2.71 ± 10.15 mg / dL after 8 weeks compared with baseline and 2.64 ± 21.55 mg / dL in LDL-cholesterol It looked. After 8 weeks of treatment, triglyceride levels were reduced by 88.36 ± 176.90 mg / dL and 49.42 ± 157.49 mg / dL in the KBMSI-2 and placebo groups, respectively, but decreased in the KBMSI-2 group. After 8 weeks of administration of KBMSI-2, the change in baseline PSV was 3.41 ± 5.00, which was statistically significant (p <0.05). After 8 weeks of administration of KBMSI-2 , And the change in baseline EDV of the penile Doppler velocities was 1.51 ± 2.53, which was statistically significant (p <0.05). This is shown in Figures 10-13.

On the other hand, PP analysis showed that testosterone decreased 0.59 ± 1.50 ng / dL compared to baseline after 8 weeks of administration of KBMSI-2, but there was no statistically significant difference (p = 0.1624). This is shown in Fig.

In other words, it is expected to be developed as a therapeutic agent to overcome the limit of hormone replacement therapy by showing the effect of preventing or treating late-onset male hypogonadism without changing testosterone.

Claims

A composition for preventing or treating late-onset male hypogonadism or male menopausal syndrome which comprises red ginseng extract, ginseng extract, gugija extract, corn oil extract and ginseng extract as active ingredients

The method according to claim 1,
Wherein the red ginseng extract, the ginseng extract, the gugija extract, the mungbean oil extract and the ginseng extract are extracted with water or an organic solvent and dried under reduced pressure, respectively.

The method according to claim 1,
Wherein the composition comprises 50 to 130 parts by weight of the extract of Ganoderma lucidum, 50 to 130 parts by weight of Ganoderma extract, 30 to 100 parts by weight of the extract of Corn oil, and 3 to 20 parts by weight of the extract of Ganoderma lucidum, based on 100 parts by weight of the red ginseng extract.

The method of claim 3,
Wherein the composition is 70 to 90 parts by weight of a crude extract, 70 to 90 parts by weight of a crude extract, 50 to 80 parts by weight of a crude oil extract, and 5 to 8 parts by weight of an extract from a 100% by weight of red ginseng extract.

A functional food for late-onset male hypogonadism or male menopausal syndrome improvement comprising red ginseng extract, ginseng extract, gugija extract, corn oil extract and ginseng extract as effective ingredients and containing foodstuff acceptable food supplementary additives.

6. The method of claim 5,
Wherein the food comprises 50 to 130 parts by weight of a crude extract, 50 to 130 parts by weight of a crude extract, 30 to 100 parts by weight of an extract of corn oil, and 3 to 20 parts by weight of an ingame extract, based on 100 parts by weight of the red ginseng extract.