Food Supplement for Restoring Male Sex Drive (Libido)

Abstract

A food supplement for restoring male sex drive (libido) comprises in a daily dose a set of L-arginine, rutin from pollen or beebread, decenic acids from drone brood, zinc from a zinc compound, and vitamin B.sub.6. It also comprises icariin from horny goat weed, saponins from true or false ginseng root, and ecdysteroids from Leuzea or crowned saw-wort, in various combinations thereof.

Claims

1. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, and 20 to 150 of icariin from horny goat weed (Epirnedium family).

2. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, and 5 to 20 mg of saponins from ginseng root.

3. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, and 0.1 to 30 mg of ecdysteroids from Leuzea or Serratula coronata.

4. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, 5 to 20 mg of saponins from ginseng root, and 0.1 to 30 mg of ecdysteroids from Leuzea or Serratula coronata.

5. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, 5 to 20 mg of saponins from ginseng root, and 20 to 150 of icariin from horny goat weed (Epimedium family).

6. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, 0.1 to 30 mg of ecdysteroids from Leuzea or Serratula coronata, and 20 to 150 of icariin from horny goat weed (Epimedium family).

7. A food supplement for restoring male sex drive, the composition comprising in a daily dose 300 to 1000 mg of L-arginine, 40 to mg of rutin from pollen, 0.4 to 1.0 mg of decenic acids from male bee brood, 6 to 60 mg of zinc from a zinc compound, 0.3 to 3.0 mg of vitamin B.sub.6, 0.1 to 30 mg of ecdysteroids from Leuzea or Serratula coronata, 5 to 20 mg of saponins from ginseng root, and 20 to 150 of icariin from horny goat weed (Epimedium family).

Description

EXAMPLE 1

[0028] For 1000 packages in capsules of 0.5 g with 100 capsules per package, provided is a 50 kg mixture of powdered pollen (5000 g), L-arginine (15000 g), male bee-brood homogenate (5000 g), zinc citrate (1000 g), icariin (Horny Goat Weed extract) (5000g), Vitamin B.sub.6 (30 g), true Ginseng root (4500 g), Leuzea root (2500 g), and fillers (lactose) (11970 g). The mixture is stirred in a mixer for 3 hours, and then it is encapsulated in a known manner.

EXAMPLE 2

[0029] For 2000 packages in tablets of 0.5 g with 100 tablets per package, provided is a 100 kg mixture of powdered pollen (10000 g), L-arginine (30000 g), male bee-brood homogenate (10000 g), zinc citrate (2000 g), icariin (Horny Goat Weed extract) (10000 g), Vitamin B.sub.6 (60 g), true Ginseng root (9000 g), Leuzea root (5000 g), and fillers (lactose) (23940 g). The mixture is stirred in a mixer for 3 hours; then it is tableted in a known manner.

[0030] The above-identified technical result is confirmed by researches conducted in the “Secrets of Longevity” medical center in Penza, which showed high efficiency of the claimed preparation with regard to the libido increase as compared to control groups.

[0031] Prepared for the first study were six-component food supplements based on Horny Goat Weed—Remedy 1 and on Leuzea—Remedy 2. The following compounds in a daily dosage were suggested for the study:

[0032] Contents of components in the “Remedy 1”:

TABLE-US-00002 Components mg L-Arginine 900 Icariin from Horny goat weed 60 Decenoic acids from male bee brood 1 Rutin from pollen or beebread 48 Zinc from zinc citrate 9 Vitamin B.sub.6 1.8

[0033] Contents of components in the “Remedy 2”:

TABLE-US-00003 Components mg L-Arginine 900 Ecdysteroids from Leuzea root 0.15 Decenoic acids from male bee brood 1 Rutin from pollen or beebread 48 Zinc from zinc citrate 9 Vitamin B.sub.6 1.8

[0034] The study investigated the clinical peculiarities of psychogenic erectile disorders and associated mental disorders, it estimated the efficacy of “Remedy 1” and “Remedy 2” as for the sexual function by dynamics of blood testosterone level, as for sexual activity parameters (libido and erection) and psycho-emotional status in patients with erectile dysfunction; therapeutic dynamics of the remedies was also compared.

[0035] The clinical study was conducted on 30 men with erectile dysfunction. Inclusion criteria were: 19-60 years old (the age limit was associated with frequent detection of the pronounced cerebral organic and somatic pathology and involutional processes in men beyond 60); matching of patient's condition at the time of the inclusion to diagnostic criteria of ICD-10 for F52.2—absence of genital response, accompanied by one of the following neurotic disorders: anxiety-phobic (F40); mixed anxiety-depressive disorder (F41.2) and adaptation disorder (F43.2); and absence of leading organic pathology in the sexual disorder pathogenesis.

[0036] The study did not include patients with alcoholism, drug addiction, anatomical deformity of the penis, proven endocrine causes of ED, decompensated somatic diseases, and those using other treatment agents for ED and drugs that can cause ED.

[0037] All patients gave an informed consent to participate in the study.

[0038] To achieve the objectives of the study, patients were divided into 3 treatment groups—two experimental ones and a control one—by simple randomization technique: Group 1—Experimental group—12 people with erectile dysfunction and associated psycho-emotional disorders—to receive “Remedy 1” and the traditional psycho-pharmacotherapy; Group 2—Experimental group—13 people with erectile dysfunction and combined psycho-emotional disorders—to receive “Remedy 2” and traditional psycho-pharmacotherapy; and Group 3—Control group—5 people with erectile dysfunction and combined psycho-emotional disorders—to receive traditional psycho-pharmacotherapy.

[0039] During clinical and sexual examination, the pronouncement and dynamics of sexopathological symptoms on the background of therapy were evaluated according to the clinical questionnaire “Sexual Formula for Men” (SFM) and the sexual function status questionnaire (Vakina T. N., Sexually-endocrinal function and lipid level in patients with cardiovascular pathology, Ph.D. Medicine thesis, Saratov, 2001).

[0040] Laboratory and instrumental examination included complete blood count, urinalysis, hormonal status examination—the level of total serum testosterone, as well as transrectal ultrasound examination (TRUSE) of the prostate. Used was data of a consultative urologist examination.

[0041] The mental state of the patients was determined by a clinical and psychopathological method. Examination of personality characteristics was performed by using a Mini-Mult questionnaire. The pronouncement and dynamics of anxiety-depressive disorder symptoms during therapy were evaluated by the Hospital Anxiety and Depression Scale (HADS).

[0042] Registration of side effects was conducted on the UKU scale with the date of their onset and end.

[0043] The regimen of examination is presented in Table 1. During 4 weeks, “Remedy 1” and “Remedy 2” were administrated within daily dose 2 times a day 30 minutes before meal. The evaluation of the therapy results was performed on the 28th day of the treatment. The main criterion of efficacy was the recovery of sexual activity.

TABLE-US-00004 TABLE 1 The patient examination regimen Stage 1, enrollment in the study Stage 2, therapy Screening and by the supplement Documents and randomization Days of treatment examination methods (0-7 days) 3 7 14 21 28 Informed consent to examination V — — — — — participation Case record form V V V V V V SFM V — — — — V Sexual function status V — — — — V questionnaire Total serum testosterone level V — — — — V HADS scale V — — — — V Mini-Mult questionnaire V — — — — — TRUSE of prostate V — — — — — Consultation of urologist V — — — — — Blood and urine tests V — — — — — Side effect evaluation — V V V V V

[0044] The examination results were processed using the statistical program “STATISTICA-6.0”. All 30 patients completed the study. Characteristics of patients with erectile dysfunction included in the study are presented in Table 2.

TABLE-US-00005 TABLE 2 Profile of the examined patients (n = 30) with erectile dysfunction Patients Patients Control treated by treated by group Remedy 1 Remedy 2 patients Criteria (n = 12) (n = 13) (n = 5) Age (average) 49.6 ± 6.9 47.3 ± 5.9 47.3 ± 5.1 Marital status Single — 4.8% — Married 83.4% 80.9% 80.0% Divorced 8.3% 4.8% — Civil marriage 8.3% 9.5% 20.0% Education Graduate degree 58.3% 57.2% 60.0% College degree 16.7% 19.0% 20.0% High school 25.0% 23.8% 20.0% Antropometric parameters Height to leg length  1.9 ± 0.03  1.9 ± 0.04  1.9 ± 0.02 ratio Body mass index 25.9 ± 1.9 24.9 ± 1.9 25.0 ± 1.2 Age at the onset of 45.0 ± 5.3 44.2 ± 5.1 43.6 ± 4.9 the disease (average) Duration of the 5.2 6.7 4.8 disease (average) Whether the yes - 1, no - 11 yes - 3, no - 10 no - 5 treatment was given (yes, no, number) Comorbid psycho- pathologic disorders Phobic anxiety 41.6% 46.1% 40.0% Anxiodepressive 33.3% 30.8% 40.0% Deadaptation 25.1% 23.1% 20.0% Somatic disease: CVD 33.3% 38.4% 20.0% Diabetes 8.3% 7.6% — Smoking 41.6% 46.5% 40.0% GIT 33.3% 30.7% 40.0% Prostate 41.6% 30.7% —

[0045] As far as patient clinical characteristics are concerned (at the treatment onset with “Remedy 1” and “Remedy 2”), no significant differences in the experimental and control groups were determined.

[0046] The average age of the patients was 48.1±6.0 years, the average duration of erectile disorder—5.6±2.7 years. Males with graduate degree (58.5%) dominated. By family status, patients were mostly married (81.4%). Most of the patients had weak (20%) and a weakened type of the average sexual constitution (55%).

[0047] When assessing risk factors, smoking was detected in 42.7%, increased body mass index—in 53.3%, cardiovascular diseases (with a history of hypertension, ischemic heart disease) were observed in 30.6% of patients.

[0048] According to the results of clinical and psychopathological examination, anxiety-phobic disorder was diagnosed in 42.6%, mixed anxiety-depressive disorder—34.7%, adaptation disorder—in 22.7% patients. The analysis of test results by Mini-Mult scale showed high levels of hypochondria in 86.7%, depression—54.3%, psychasthenia—52.7% patients. Average scores on the scales of hypochondria were 62 points, for psychasthenia—57 points, for depression—53 points, and schizoid type—51 points.

[0049] Sexual dysfunction in all patients included in the examination manifested as difficulty in the onset or maintaining erection sufficient for satisfactory sexual intercourse, in the absence of evident signs of organic pathology of sexual sphere, corresponding to ICD-10,“the lack of genital response” (F52.2).

[0050] Against the background of the therapy with “Remedy 1” and “Remedy 2” in the experimental groups, it was as early as on the 7th day of treatment that patients reported a subjective improvement in mood, increased self-esteem and confidence in their sexual opportunities, reducing tension and conflicts in family relationship, as well as increased frequency of spontaneous erections.

[0051] The analysis of the efficacy of “Remedy 1” and “Remedy 2” on sexual function of patients given clinical and dynamic changes in the testosterone level in blood revealed the following (Table 3):

TABLE-US-00006 TABLE 3 Dynamics of testosterone level at the background of the therapy Average cumulative factors Parameters 1.sup.st group (n = 12) 2.sup.nd group (n = 13) 3.sup.rd group (n = 5) studied before at 28.sup.th day before at 28.sup.th day before at 28.sup.th day Total 11.8 ± 4.4 14.6 ± 5.2 14.5 ± 4.7 17.3 ± 5.6 12.9 ± 4.7 13.1 ± 5.8 testosteron

[0052] In group 1, where “Remedy 1” was used, testosterone levels increased by 23.7%, in the 2.sup.nd group with “Remedy 2”—by 19.8%.

[0053] The growth of sexual activity indicators—libido and erection—with the use of “Remedy 1” and “Remedy 2” was detected by the Day 28 of therapy in 66.7 and 61.5% patients, respectively, the average increase of libido being 28.0 and 24.3% and erection—21.4 and 17.8%, respectively. The dynamic changes of sexual activity indicators (libido and erection) and psycho-emotional state of patients with erectile dysfunction and comorbid anxiety-depressive disorders are presented in Table 4.

TABLE-US-00007 TABLE 4 Results of therapy and performed tests as of 28.sup.th day Average cumulative factors (in points) Examined 1.sup.st group 2.sup.nd group 3.sup.rd group parameters before at 28.sup.th day before at 28.sup.th day before at 28.sup.th day SFM 18.8 ± 3.2 21.9 ± 3.5* 18.4 ± 3.1 21.4 ± 3.2* 18.9 ± 2.1 19.1 ± 2.5  questionn. Sexual function status questionn. Libido 2.8 3.6 2.7 3.4 2.9 3.0 Erection 3.0 3.6 2.9 3.4 3.0 3.0 HADS scale Anxiety 11.2 ± 0.8  6.9 ± 0.5** 10.9 ± 1.0  7.1 ± 0.5** 11.4 ± 0.3 8.5 ± 0.5 Depression  9.1 ± 0.4  6.2 ± 0.3*  9.5 ± 0.7  6.1 ± 0.3* 10.0 ± 0.4 7.9 ± 0.8 Clinical Abs. 8 8 1 effect % 66.7 61.5 20.0 Note: *p < 0.05, **p < 0.001

[0054] The therapeutic effect of the supplements was more pronounced in relatively young men in the absence of the above mentioned risk factors and pronounced anxiety-depressive psychopathologic disorders. It is shown by evidence of the effectiveness of the supplement in the treatment of erectile dysfunction in 75.2% of cases in men under 40.

[0055] The claimed preparation, a combined biologically active supplement based on L-arginine, icariin (Rhaponticum carthamoides extract), male bee brood, pollen (bee pollen), zinc citrate, and vitamin B.sub.6, has the ability to increase sexual desire and improve the quality of erections and, therefore, is a vegetational alternative for the treatment of sexual disorders in male.

[0056] The use of “Remedy 1” showed an increase in the level of testosterone in the blood serum by 23.7%, “Remedy 1”—by 19.8% by the day 28 of treatment.

[0057] The improvement of indicators of sexual activity—libido and erection—and of psycho-emotional state with the use of the “Remedy 1” and “Remedy 2” treatment by the day 28 of treatment were detected in 66.7 and 61.5% patients, respectively. In the group of patients with “Remedy 1”, average increase of libido and erection was by 28.0 and 21.4%, and in group 2—by 24.3 and 17.8%, respectively. There was a significant improvement of mental and emotional state, with the 50% reduction in the level of anxiety and depression in both the first and second groups of patients.

[0058] The second study was carried out with regard to all eight components of the supplement. The composition of “Remedy 3” in a daily dose was as follows:

TABLE-US-00008 Components Mg of active substance Saponins from true or false ginseng roots 9 Ecdysteroids from Leuzea root 0.15 L-arginine 900 Icariin from Horny goat weed 60 Decenoic acids from male bee brood 0.6 Rutin from pollen or beebread 48 Zinc from zinc citrate 9 Vitamin B.sub.6 1.8

[0059] Study objective: evaluation of the effectiveness of “Remedy 3” in the treatment of male sexual dysfunction.

[0060] The study explores clinical features of sexual dysfunctions in patients. The effectiveness of “Remedy 3” was evaluated by the dynamics of the level of testosterone, prolactin and dehydroepiandrosterone sulfate (DHEAS), and by the changes of the values of sexual functions (libido and erection) and psycho-emotional state of studied patients.

[0061] The study involved 10 men with sexual dysfunction (erectile dysfunction and decreased libido). The inclusion criteria were: [0062] the age of 19-60 (the age disaggregation is in connection with frequent detection of the pronounced cerebral organic and somatic pathology, as well as involution processes in men over 65); [0063] matching patient's condition at the time of inclusion to diagnostic criteria of ICD 10 for F52—sexual dysfunction (absence or loss of the sexual desire (F 52.0), absence of the genital response (F52.2)), accompanied by one of the following neurotic disorders: anxiety-phobic (F40); mixed anxiety-depressive disorder (F41.2) and adaptation disorder (F 43.2); [0064] absence of leading organic pathology in pathogenesis of the sexual disorder.

[0065] The study did not include patients with alcoholism, drug addiction, anatomical deformity of the penis, decompensated somatic diseases, with the use of other treatment agents for ED and drugs that can cause ED.

[0066] It was an unblinded study, without a placebo control.

[0067] During clinical and sexologic examination, the pronouncement and dynamics of sexopathological symptoms during therapy were evaluated by a clinical questionnaire “Sexual Formula for Men” (SFM), an IIEF-5 questionnaire (International Index of Erectile Function), scale of assessment of sexual function (Vakina T. N. 2001, ibid.)

[0068] A laboratory and instrumental examinations included a complete blood count, a urinalysis, a quantitative determination of hormone content in blood serum as to total testosterone, prolactin and DHEAS by enzyme-linked immunosorbent assay, as well as a transrectal prostate ultrasound examination. Also used was urologist consultative examination data.

[0069] The mental state of the patients was determined by clinical and psychopathological method. Examination of personality characteristics was performed using Mini-Mult questionnaire. Pronouncement and dynamics of anxiety-depressive disorder symptoms during therapy were evaluated with the use of the Hospital Anxiety and Depression Scale (HADS).

[0070] The research was conducted as follows (Table 5): a preliminary study—1 week (checking the inclusion and exclusion criteria, obtaining consent to participate in the study, collecting medical history, assessing the general condition of organs and systems, conducting laboratory tests, clinical sexological and psychological testing). A phase of treatment—using “Remedy 3” at a dose of 2 tablets 3 times a day 30 minutes before meals for 4 weeks with the registration of changes in the general condition of the patient and side effects. A final evaluation of the treatment was carried on the 28-30 day with the assessment by the SFM questionnaire, scale of assessment of sexual function, hormonal tests, HADS scale, identification of the preparation acceptability.

TABLE-US-00009 TABLE 5 Patient examination regimen Stage I (enrollment) Stage II (therapy Screening and using ‘Remedy 3” Documents and research randomization Days of treatment methods (0-7 days) 3 7 14 21 28 Informed consent to the V — — — — — participation CRF V V V V V V CFM questionnaire V — — — — V IIEF-5 questionnaire V — — — — — Sexual function state scale V — — — — V Total testosterone, prolactin, V — — — — V DHEAS level in blood serum HADS scale V — — — — V Mini-Mult questionnaire V — — — — — TRUS of prostate V — — — — — Consultation of urologist V — — — — — Blood and urine tests V — — — — V Evaluation of side effects — V V V V V

[0071] Effectiveness evaluation was based on the dynamics of indicators of the scale of assessment of sexual function, the “Sexual Formula for Men” (SFM) questionnaire, HADS scale, the results of hormone tests, and evaluation of the clinical effectiveness of the therapy by a physician.

[0072] When assessing the clinical efficacy by the patient, the end result was defined as excellent (no complaints, resumption of sexual activity in full extent), good (considerable improvement, but still with some complaints), satisfactory (the patient noted improvement, but full recovery of sexual activity did not occur), with no effect.

[0073] The results were processed using the “STATISCTICA-6.0” statistical program.

[0074] According to the results of the study, all 10 patients completed the study. General characteristics of the patients included in the study are presented in the Table 6.

TABLE-US-00010 TABLE 6 Personalities of examined patients with sexual dysfunctions (n = 10) Patients treated with Indices EROMAX 3 (n = 10) Age (average) 46.9 ± 5.1 Marital status Single 10% Married 60% Divorced 30% Civil union — Level of education Graduate 80% Undergraduate 20% High school — Anthropometric parameters Trochanteric index  1.89 ± 0.04 Body-weight index 26.9 ± 2.9 Age at the onset of disease (average) 41.6 ± 6.0 Duration of disease (average)  4.9 ± 2.3 Whether treatment was provided (yes, no) Yes - 4, no - 6 Comorbid psychopathological disorders: Anxiophobic 10% Mixed Anxiodepressive 30% Deadaptation 60% Somatic diseases: CVD 70% Diabetes 10% Smoking 30% GI diseases 30% Prostate diseases 40%

[0075] Average age of patients was 46.9±5.1, average duration of sexual disorders—4.9±2.3 years. Dominant (80% 0 were men with the graduate level of education. By family status, patients were mostly married men (60%). The majority of the patients had weak (50%) and a weakened type of the average sexual constitution (30%).

[0076] The assessment of risk factors, smoking was detected in 30%, increased body-weight index—in 50%; cardiovascular diseases (hypertension, ischemic heart disease in history) were observed in 70% of patients.

[0077] Most of the patients had a history of significant mental and physical stress, and the clinical and psychopathological study revealed adaptation disorders in 60% patients. Analysis of test results on Mini-Mult scale showed high levels of hypochondria in 60%, depression—in 50%, psychasthenia—in 50% of patients. Average scores on a psychasthenia scale were 62.8 points, hypochondria—59.8 points, depression—52 points and hysteria—51 points.

[0078] Sexual dysfunction in all patients included in the study showed themselves as decreased libido with a decrease of sexual fantasies, search of sexual incentives, thoughts about the sexual side of life and difficulties in the onset of, or sustaining, erection sufficient for satisfactory sexual intercourse, with the absence of evident signs of organic pathology of the sexual sphere, accompanied by anxiety and depressive symptoms.

[0079] The main complaints of patients reflecting the clinic of androgen deficiency according to age groups are presented in Table 7.

TABLE-US-00011 TABLE 7 Patient main complaints characteristic for androgen deficiency clinical findings Age groups Before 45 Over 45 Symptoms (n = 2) (n = 8) Genitourinary disorders libido lowering 50% 100%  erectile dysfunction 100%  75% decrease in orgasm freshness 50% 75% Vascular and autonomic dysfunction sudden hyperemia of the face, neck — 37.5%.sup.  blood pressure fluctuations — 75% cardialgia — 50% dizziness — 25% short-of-breath feeling — 37.5%.sup.  hyperhidrosis — 50% Psycho-emotional disorders hyperirritability 100%  75% lowered ability to concentrate — 75% cognitive and memory deterioration 50% 50% depression 50% 50% insomnia — 25% “vital power” decreasing 75% Somatic disorders decrease in muscle mass and strength — 37.5%.sup.  adipose tissue build-up — 75% osteoporosis — 12.5%.sup.  decreased skin tone and thickness (skin laxity) — 25%

[0080] It is noteworthy that in the age group over 45 the decreased libido was observed in all patients (100%), the erectile dysfunction being present in 75% of the cases (Table 7).

[0081] The analysis of erectile dysfunction according to the IIEF-5 scale showed that 1 patient (10%, 22 points) had a value within the normal range; mild erectile dysfunction was detected in 5 cases (50%, 18 points average), moderate ED—in 4 (40%, 14 points average).

[0082] Against the background of therapy by “Remedy 3,” the majority of patients (60%) by the 5-7.sup.th day noted subjective improvement of mood, increased self-esteem and confidence in their sexual abilities, reducing tension and conflict situation in the family relationship, as well as increased frequency of nocturnal erections.

[0083] Studying the “Remedy 3” effectiveness on sexual function of patients taking into account clinical and dynamic changes in the level of testosterone, prolactin and dehydroepiandrosterone sulfate (DHEAS) in serum showed the following (Table 8):

TABLE-US-00012 TABLE 8 Dynamics of testosterone, prolactin and DHEAS level in serum in view of the therapy performed As of 28.sup.th Before day of Parameters treatment treatment Normal values p Total 11.8 ± 4.4  17.1 ± 5.7 12.1-38.3 nmol/L <0.02 testosterone Prolactin 548 ± 136 285 ± 60 24.5-467 mU/L <0.02 DHEAS 1.2 ± 0.3  1.4 ± 0.7 1.0-4.2 mcg/mL >0.054

[0084] Against the background of the use of “Remedy 3”, there were reliably elevated levels of total testosterone (p<0.02) and DHEAS against the lowered prolactin level (p<0.02) (the latter could also be regarded as anti-stress improving trends in the studied group of patients).

[0085] The testosterone level growth rate when using “Remedy 3” was 44.9%. These changes of hormonal status made it possible to reduce the number of patients' complaints on vegeto-vascular dysfunction—sudden hyperemia of face and/or neck, hyperhidrosis, short-of-breath feeling, fluctuations of blood pressure, as well as on psycho-emotional sphere. Patients reported mood stabilization, addition of “vital energy force”, improvement of alertness, memory, normalization of sleep. The amount of adipose tissue decreased which revealed itself in a decrease of waist circumference by an average of 3.9 cm for 1 month.

[0086] At the time of the control evaluation—after 4 weeks of treatment—patients had significant change of factors on the scale of sexual function assessment: libido—4.0 points versus baseline of 2.8 (p<0.02), average increase of the libido was 42.8%, erection—3.8 points versus baseline of 2.9 (p<0.032), average increase of the erection factor was 31%.

[0087] When assessing the sexual function in accordance with the SFM questionnaire, revealed before treatment was a general decline of male copulation cycle values. Against the background of the therapy with “Remedy 3”, the total score of male sexual function increased from 17.7±2.5 to 23.8±2.9 (p<0.02). Among the structural indicators of SFM, a mental component of the male copulation cycle improved more significantly that resulted in the increase of libido and overall satisfaction with sexual relations in the studied patients.

[0088] Consideration of dynamic changes of parameters of comorbid psycho-emotional disorders—anxiety and depression—in patients with sexual dysfunction showed that if before the treatment the average level of anxiety was regarded as a clinical one and was 11.5±0.6 points on HADS, it decreased after treatment to a normal level of 6.9±0.3 points (p<0.02). The average level of depression on the HADS scale at the beginning of treatment was approaching to clinical one—10.8±0.5 points; but by the checking 28.sup.th day the depression values were reduced to normal levels—6.7±0.3 (p<0.02).

[0089] During therapy with “Remedy 3” (from Day 2 to Day 4 of the treatment) three patients had transient diarrhea. It resolved aidlessly. Indicators of blood count, urinalysis, and biochemical blood tests were within the normal range before the start of treatment and at its end. Overall tolerability of “Remedy 3” was good.

[0090] When evaluating the clinical efficacy of the treatment, two (20%) patients evaluated results as “excellent”—no complaints, the resumption of sexual life in its entirety; six (60%) patients—as “good”—a considerable improvement, though some complaints remain; and two (20%)—as “satisfactory”—the patients noticed an improvement, but there occurred no full recovery of sexual activity. However, the latter ones had an improvement in the parameters of hormonal status with the higher levels of total testosterone and the decrease of prolactin.

[0091] Summing up, sexual dysfunction is common in patients with anxiety and depression and requires an adequate specific therapy. “Remedy 3” is a combined biologically active supplement that is based on L-arginine, ginseng root, Leuzea root, horny goat weed extract, pollen (beebread), zinc citrate, vitamin B.sub.6, and it is able to increase sexual desire and improve the quality of erection, and hence is a natural and safe alternative effective treatment for sexual dysfunction in males. The use of “Remedy 3” showed by day 28 of treatment a reliable increase of testosterone level (average increase of 44.9%) against the background of the prolactin level decrease, as well as a tendency to DHEAS increase. When using “Remedy 3”, parameters of sexual activity—libido and erection—significantly changed: the average increase of libido was 42.8%, erection—31%. The therapy with “Remedy 3” led to stabilization of vegetative vascular system, as well as to significant improvement of mental and emotional state of patients with reducing anxiety and depressive disorders.