Herbal Compositions for Prostate Health and Prostate Cancer Prevention

Abstract

A composition for protecting prostate tissue and inhibiting the development of prostate cancer comprises pumpkin seed extract; nettle root extract; berberine; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium.

Description

[Technical field]

[0001] This application claims priority from U.S. Patent Application No. 63 / 313,018, filed February 23, 2022, the contents and components of which are incorporated herein by reference for all purposes.

[0002] FIELD OF THEINVENTION The present invention relates to a composition that can be used to protect prostate tissue, inhibit the development of prostate cancer, and alleviate urinary tract symptoms caused by prostate hyperplasia. More specifically, the present invention relates to a composition that contains multiple plant / herb extracts and mineral ingredients that protect prostate tissue and inhibit the development of prostate cancer. [Background technology]

[0003] 2. Background of the Invention The prostate is deeply involved in men's health. As men age, benign prostatic hyperplasia (BPH) becomes the most common problem affecting men's lives for decades. According to the American Urological Association, half of men aged 51-60 have BPH, and nearly 90% suffer from lower urinary tract symptoms (LUTS).

[0004] Prostate enlargement is a long-term condition caused by chronic inflammation at the cellular level. Several studies have demonstrated the link between chronic inflammation and carcinogenesis. A study from Johns Hopkins University of Medicine showed that chronic inflammation in the prostate gland more than doubles the risk of aggressive prostate cancer, even in the presence of low PSA levels. Prostate cancer affects a staggering 1 in 6 white men and 1 in 4 black men.

[0005] Fifty years ago, President Richard Nixon declared a "War on Cancer" and signed it into law in the hopes of finding a cure. Yet despite the enormous funding and research invested in finding a cure, 50 years later, and despite widespread nationwide screening, cancer remains a life-altering diagnosis, affecting one in six men and one in four and their families.

[0006] Current methods of screening and diagnosing prostate cancer involve invasive scans (transrectal ultrasound, transrectal prostate biopsy) with a high risk of infection, which can have a high number of false negatives and false positives, are expensive, and very uncomfortable for the patient.

[0007] Cancer treatments, including transurethral resection of the prostate, radiation therapy, and chemotherapy, carry a high risk of infection and serious side effects (including but not limited to impotence, urethral scarring, urinary incontinence, chronic urinary tract infections, urinary retention requiring catheterization, and sepsis), which place a significant burden on the healthcare system and take a toll on the mental health of patients and their families.

[0008] Currently, there are no safe and effective methods to prevent prostate cancer at the cellular level before tumors form.

[0009] There is an urgent need to reduce the high incidence of prostate malignancies, which affect one in six white men and one in four black men, while at the same time finding safe, affordable solutions to relieve the urinary symptoms of benign prostatic hyperplasia, which affects the vast majority of men over the age of 50. Summary of the Invention [Problem to be solved by the invention]

[0010] The present invention has been created in view of the above points. [Means for solving the problem]

[0011] Summary of the Invention A first aspect of the present invention provides a composition comprising pumpkin seed extract; nettle root extract; berberine; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium.

[0012] More specifically, in one embodiment, the composition is in the form of a tablet or capsule and includes 500-1000 mg per daily dose of pumpkin seed extract; 300-700 mg per daily dose of nettle root extract; 50-100 mg per daily dose of berberine hydrochloride 90%; 50-100 mg per daily dose of Embilica officinalis (amla berry); 50-100 mg per daily dose of Ganoderma Lucidum (lingzhi mushroom); 5-10 mg per daily dose of lycopene; and 30-40 mcg per daily dose of selenium in the form of L-selenomethionine, sodium selenite, or sodium selenate. The recommended daily dose can be reached in a single dosage form, such as a liquid or gel, or in multiple tablets or capsules.

[0013] In another embodiment of the invention, the composition comprises pumpkin seed extract equivalent to 1000-4000 mg pumpkin seed per daily dose; nettle root extract equivalent to 500-2000 mg nettle root per daily dose; berberine hydrochloride 90% 50-300 mg per daily dose; Embilica officinalis (amla berry) 50-300 mg per daily dose; Ganoderma Lucidum (lingzhi) 50-300 mg per daily dose; lycopene 5-20 mg per daily dose; and selenium 40-160 mcg per daily dose. In a further embodiment, the composition is in the form of a powder. In another embodiment, the composition is in the form of a liquid or gel.

[0014] In another aspect of the invention, the composition is in the form of a liquid, gel, or powder containing the following ingredients: 400 mg pumpkin seed extract 10:1, equivalent to 4000 mg pumpkin seed; 200 mg nettle root extract 10:1, equivalent to 2000 mg nettle root; 200-300 mg berberine hydrochloride; 200-300 mg Embilica Officinalis (amla berry); 200-300 mg Ganoderma lucidum (lingzhi); 20 mg lycopene; and 160 mcg selenium. In some embodiments, the liquid, gel, or powder is administered as a single daily dose.

[0015] In another embodiment of the invention, the composition is in the form of a tablet or capsule containing the following ingredients: pumpkin seed extract equivalent to 1000-2000 mg pumpkin seeds; nettle root extract equivalent to 500-1000 mg nettle root; 50-150 mg berberine hydrochloride 90%; 50-150 mg Embilica officinalis (amla berry); 50-150 mg Ganoderma Lucidum (Lingzhi); 5-10 mg lycopene; and 40-80 mcg selenium. In a further embodiment, the composition is in the form of a tablet or capsule containing the following ingredients: pumpkin seed extract equivalent to 1000 mg pumpkin seeds; nettle root extract equivalent to 500 mg nettle root; 50 mg berberine hydrochloride 90%; 50 mg Embilica Officinalis (amla berry); 50 mg / dose Ganoderma lucidum (Lingzhi); 5 mg lycopene; and 40 mcg selenium. In some embodiments, 2-4 tablets / capsules may be administered per day.

[0016] In yet another embodiment of the invention, the composition is in the form of a liquid or gel having pumpkin seed extract equivalent to about 4000 mg of pumpkin seed per daily dose; nettle root extract equivalent to about 2000 mg of nettle root per daily dose; berberine hydrochloride 90% approximately 200 mg per daily dose; Embilica Officinalis (amla berry) approximately 200 mg per daily dose; Ganoderma lucidum (lingzhi) approximately 20 mg per daily dose; Lycopene 15 approximately 20 mg per daily dose; and selenium approximately 160 mcg per daily dose.

[0017] In yet another embodiment of the invention, the composition is in the form of a tablet having 1000-4000 mg of pumpkin seed extract per daily dose; 500-2000 mg of nettle root extract per daily dose; 50-200 mg of berberine hydrochloride 90% per daily dose; 50-200 mg of Embilica officinalis (amla berry) per daily dose; 50-200 mg of Ganoderma lucidum (lingzhi) per daily dose; 5-20 mg of lycopene per daily dose; and 4-160 mcg of selenium per daily dose. In some embodiments, 2-4 tablets may be administered per day.

[0018] In some embodiments, the composition of the present invention comprises a pharma- ceutically acceptable excipient. Excipients for capsules, soft capsules, gels, powder sachets or liquids in different embodiments can include, by way of example, one or more of gelling agents, surfactants, emulsifiers, solubilizers, surfactants (non-ionic), plasticizers, matrix formers, sweeteners, bulking agents / diluents, preservatives, anti-caking agents / lubricants, and coating agents. Exemplary embodiments of such excipients include PEG-35 castor oil, polysorbate 80, poloxamer, polyethylene glycol-15-hydroxystearate, stevia (sweetener), microcrystalline cellulose (bulking agent / diluent), or silicon dioxide (anti-caking agent / lubricant). The above compounds are merely exemplary. In addition to or instead of them, other excipients known to those skilled in the art may be used. In further embodiments, the composition may include one or more of pharma- ceutically acceptable diluents, lubricants, polishing agents, and coating agents.

[0019] In another embodiment of the present invention, the composition is for preventing prostate cancer, protecting prostate cells from malignant changes, and significantly reducing the risk of prostate cancer.

[0020] In another embodiment, the composition is for use in relieving urinary symptoms of prostatic hyperplasia.In a further embodiment, the composition is for use in treating urinary symptoms caused by prostatic hyperplasia, and optionally, the urinary symptoms are selected from urinary frequency, nocturia, straining and urgency.In another embodiment, the composition is for use in treating erectile dysfunction or improving sexual function.

[0021] In another embodiment, a method for preventing prostate cancer and protecting prostate cells from malignant changes can comprise administering to an individual in need thereof any of the compositions described herein or contemplated herein (i.e., comprising pumpkin seed extract; nettle root extract; berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium; and optionally one or more of a pharma- ceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0022] In another embodiment, a method of lowering or reducing the risk of prostate cancer and protecting prostate cells from malignant changes can comprise administering to an individual in need thereof any of the compositions described herein or contemplated herein (i.e., pumpkin seed extract; nettle root extract; berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum; lycopene; and selenium; and optionally one or more pharma- ceutically acceptable excipients or diluents, lubricants, polishes, and coatings) (at any concentration or dosage).

[0023] In another embodiment, a method of alleviating urinary symptoms of prostatic hyperplasia can comprise administering to an individual in need thereof any of the compositions described herein or contemplated herein (i.e., comprising pumpkin seed extract; nettle root extract; berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium; and optionally one or more of a pharma- ceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0024] In another embodiment, a method for treating urinary symptoms caused by prostatic hyperplasia can comprise administering to an individual in need thereof any of the compositions described herein or contemplated herein (i.e., comprising pumpkin seed extract; nettle root extract; berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium; and optionally one or more of a pharma- ceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0025] In another embodiment, a method for treating urinary symptoms induced by prostatic hyperplasia optionally comprises administering to an individual in need thereof, where the urinary symptoms are selected from frequency, nocturia, straining, and urgency, any of the compositions described herein or contemplated herein (i.e., comprising pumpkin seed extract; nettle root extract; berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum (lingzhi); lycopene; and selenium; and optionally one or more of a pharma- ceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0026] The present invention includes combinations of the described embodiments and preferred features except where such combinations are expressly impermissible or explicitly avoided.

[0027] The present disclosure will be better understood by reading this specification in conjunction with the accompanying drawings, in which like reference numerals indicate like structure and like components, and in which: [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a graph illustrating the efficacy of the formulations used in accordance with the present invention. [Diagram 2]FIG. 2 shows images of the fields of PC-3 cells before (untreated) and 24 and 48 hours after application of the test composition. [Diagram 3] FIG. 3 graphically illustrates the efficacy of the composition used in accordance with the present invention, specifically the inhibitory effect on prostate cancer cell viability, and the synergistic effect of the composition compared to the individual components (pumpkin seed extract, nettle root, ganoderma lucidum, amla berry, berberine alone) and a control. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Aspects and embodiments of the present invention are now described. Further aspects and embodiments will be apparent to those skilled in the art.

[0030] Modern lifestyles expose us to a variety of carcinogenic factors, including smoking, chemicals, outdoor and indoor pollution, radiation and toxins, which generate particulates called free radicals that damage all major components of cells, including DNA, proteins and cell membranes, leading to oxidative stress, chronic inflammation and cellular dysfunction, thus initiating the carcinogenic process.

[0031] Cancer is a complex disease caused by chronic inflammation via metabolic pathways that have been demonstrated to contribute positively to the development, promotion and progression of cancer.As used herein, prostate cancer is a collective term for tumors of the prostate.Each tumor is composed of a variety of genetically different cancer cells, and if only one or two processes are targeted, mutations that evade targeted therapy will be rapidly added.

[0032] As a result, to date, there is no single solution or approach that provides sustainable results that provide both cell protection and improved bladder and urination comfort. The use of a single component can have side effects and does not comprehensively address all of the mechanisms by which cancer acquires cells, develops, and spreads. The above components work synergistically to provide greater benefits than each component acting alone. The synergistic effect of this composition compared to the individual components is demonstrated by Example 1 and Figure 3.

[0033] This is precisely why the composition of the present invention contains multiple components each addressing several aspects of cancer cell metabolism, such as antioxidant activity, anti-inflammatory activity, modulation of inflammatory enzymes, immune response, inhibition of rapid proliferation by induction of apoptosis, inhibition of angiogenesis, inhibition of enzymes allowing diffusion into the extracellular matrix, activation of detoxification mechanisms. By combining various phytochemicals and minerals at low doses, multiple ingredients can act synergistically with each other, avoiding toxicity and potential side effects. The herbal and mineral compositions of the present invention can provide cellular antioxidant protection, prophylactic and chemopreventive effects when administered daily.

[0034] Daily intake of the phytochemicals, antioxidants, and minerals described below that target cellular prostate health can effectively neutralize free radicals, mitigate chronic inflammatory pathways, and prevent and counteract cellular damage, providing a natural, non-toxic, and affordable long-term chemoprevention.The composition contains small amounts of each ingredient to achieve the desired chemoprevention counter effect while mitigating the chronic inflammation present in BPH and its effects on bladder function while avoiding possible side effects.

[0035] The proposed formulation contains the following ingredients:

[0036] 260,000 ORAC units EMBILICA OFFICINALIS (Amla berry) Amla berries have the highest antioxidant power (free radical scavenging capacity) of all fruits and vegetables, 27 times that of wild blueberries at 9,600 ORAC units. The high antioxidant potential of amla may be due to its high content of polyphenols such as vitamin C, flavonoids and hydrolyzable tannins, which exert strong anti-inflammatory activity and regulate various inflammatory enzymes such as NF-kB, one of the main factors in carcinogenesis leading to apoptosis of neoplastic cells. The amount of Embilica officinalis in the composition ranges from 50 to 300 mg per dose. In a further embodiment, the amount of Embilica officinalis in the composition ranges from 50 to 200 mg per dose. The daily dose of Embilica officinalis is 200 to 300 mg.

[0037] GANODERMA LUCIDUM (Ganoderma lucidum) Ganoderma lucidum contains β-glucan polysaccharides and triterpenoids. The chemopreventive activity of Ganoderma lucidum is exerted through multiple mechanisms, including downregulation of estrogen-α receptors and NF-kB pathway, antiangiogenic effects through downregulation of VEGF, downregulation of cell migration through inhibition of metalloproteinase (MMP-9), and induction of apoptosis in cancer cells. Prostate tissue is abundant with both ER-α and ER-β estrogen receptors, which promote carcinogenesis and upregulate tumor development. Ganoderma lucidum downregulates estrogen alpha receptors, which have been found to mediate high-grade prostatic intraepithelial neoplasia. Ganoderma lucidum has the shape of a mushroom fruiting body (stalk and cap) and comprises the reproductive structure of the organism. The amount of Ganoderma lucidum in the composition ranges from 50 to 300 mg per dose. In a further embodiment, the amount of Ganoderma lucidum in the composition ranges from 50 to 200 mg per dose. The daily dose of Ganoderma lucidum is 200 to 300 mg.

[0038] Berberine Berberine has the chemical formula C 20 H 18It is an isoquinoline plant alkaloid of the formula CINO4 and is widely present in various traditional medicines. 20 H 22 Berberine hydrochloride, an orally available synthetic form of berberine from CINO6, was used in the compositions of the present invention due to its direct effect on the prostatic stromal and glandular components known to be involved in the development of benign prostatic hyperplasia. Berberine acts on prostate cells through inhibition of the inflammatory microenvironment at the cellular level, disruption of metabolic changes leading to cancer development, inhibition of carcinogenesis, and induction of apoptosis of prostate cancer cells. Berberine taken in large doses may cause damage to immune cells as a result of altered liver function, gastric symptoms, hepatotoxicity, hemotoxicity, and hemorrhagic inflammation. Thus, the amount of berberine in the composition ranges from 50 to 300 mg per dose. In further embodiments, the amount of berberine in the composition ranges from 50 to 200 mg per dose. The daily dose of berberine is 200 to 300 mg. In some embodiments, berberine is in the form of a synthetic form, berberine hydrochloride (C 20 H 22 CINO6).

[0039] Pumpkin Seed Extract Pumpkin seed extract has antioxidant and anti-inflammatory properties as well as a dual beneficial effect on the bladder and prostate, which directly contributes to the improvement of urinary symptoms caused by BPH (frequency, urgency, nocturia, weak urinary stream, straining, etc.), significantly improving the quality of life for men with BPH. The pumpkin seed extract is used in an amount of 500-4000 mg per daily dose. The pumpkin seed extract can be water-soluble. The pumpkin seed extract used can be pumpkin seed extract 10:1. Pumpkin seed extract 10:1 (1 mg of extract corresponds to 10 mg of pumpkin seeds) means that a daily dose equivalent to 4000 mg is achieved by 400 mg of extract. In a further embodiment, the amount of pumpkin seed extract in the composition is an amount equivalent to 1000-4000 mg of pumpkin seeds per dose. A daily dose of pumpkin seed extract corresponds to 4000 mg of pumpkin seeds.

[0040] Nettle Root Extract Nettle root extract (Urtica doica) is used in the composition of the present invention because it contains several antioxidant and anti-inflammatory molecules (quercetin, rutin, campherol) that are effective in alleviating prostate enlargement, i.e. benign prostatic hyperplasia (BPH). Nettle not only inhibits fat oxidation, thereby protecting many tissues from oxidative stress, but also reduces the release of inflammatory cytokines and inflammatory biomarkers such as TF-kB and interleukins, thereby exerting an anti-proliferative effect on prostate cells. Nettle root extract enhances the effect of blood pressure medication as well as diabetes medication, so that when used in appropriate amounts, it not only has a chemopreventive effect on other medications, but also alleviates the effects of prostate enlargement and has a beneficial effect on the bladder, which is inevitably adversely affected by prostate enlargement.The nettle root extract used can be nettle root extract 10:1.For example, nettle root extract 10:1 (1 mg of extract is equivalent to 10 mg of nettle root) means that a daily dose equivalent to 2000 mg is achieved with 200 mg of extract. Nettle root extract is used in amounts of 500-2000 mg per dose. A daily dose of nettle root extract corresponds to 2000 mg of nettle root.

[0041] Lycopene Lycopene is the red pigment found in tomatoes and is the most powerful antioxidant of the carotenoids. Its oxidative properties protect prostate cells from oxidative stress, which can lead to chronic inflammation. It plays an important role in cardiovascular health, supporting healthy blood flow and improving capillary circulation. Lycopene has two effects: it protects prostate cells from oxidative damage and improves capillary blood flow, thereby improving the effectiveness of all ingredients contained in the composition through enhanced delivery at the cellular level. Lycopene may increase the risk of bleeding in people taking anticoagulants, so its use should be in moderation. In the composition of the present invention, lycopene is used in the range of 5-20 mg per dose. The daily dose of lycopene is 20 mg.

[0042] selenium Selenium is a micronutrient that cannot be produced by humans and is required in daily doses to maintain health. In the composition of the present invention, selenium has protective and cancer-preventive properties at the cellular level. Selenium exerts protective effects through multiple mechanisms, including antioxidant activity to protect prostate cells from oxidative damage, inhibition of DNA damage, induction of apoptosis, and inhibition of angiogenesis and invasion. A relationship between selenium supplementation and chemotherapy-induced anticancer activity has been found. This biological phenomenon may be due to selenium's ability to induce cellular apoptosis. However, selenium is toxic when taken in amounts of 400 mcg or more, causing peripheral neuropathy, stomach symptoms, liver, kidney, and heart disorders, alopecia, etc. Due to its toxicity, selenium cannot be used as a single component (a dose of 750 mg (equivalent to 750,000 mcg) is lethal), and can only be used in very small amounts. In order to benefit from its protective effect against carcinogenesis, the composition of the present invention uses very small amounts of selenium in the hope of a synergistic effect in combination with other components. Selenium is used in the range of 40-160 mcg per serving. The daily dose of selenium is 160 mg. In some embodiments, the selenium is in the form of either L-selenomethionine, sodium selenate (Na2SeO4) or sodium selenite (Na2SeO3). In further embodiments, the selenium is in the form of sodium selenate or sodium selenite.

[0043] Generally, the compositions of the present invention include pumpkin seed extract, nettle root extract, berberine, Embilica officinalis (amla berry), Ganoderma Lucidum (lingzhi), lycopene and selenium.

[0044] More specifically, in a first embodiment, each dose of the composition comprises the equivalent of 1000-4000 mg of pumpkin seed (extract); the equivalent of 500-2000 mg of nettle root (extract); 50-200 mg of berberine hydrochloride 90%; 50-200 mg of Embilica officinalis (amla berry); 50-200 mg of Ganoderma Lucidum (Lingzhi); 5-20 mg of lycopene; and 40-160 mcg of selenium in the form of one of L-selenomethionine or sodium selenate.

[0045] In another embodiment of the present invention, the composition is in the form of a powder. Each dose of the composition comprises 1000-4000 mg of pumpkin seed extract; 500-2000 mg of nettle root extract; 50-200 mg of berberine hydrochloride 90%; 50-200 mg of Embilica officinalis (amla berry); 50-200 mg of Ganoderma Lucidum (lingzhi); 5-20 mg of lycopene; and 40-160 mcg of selenium.

[0046] In yet another embodiment of the invention, the composition is in the form of a liquid or gel, each dose having the equivalent of 1000-4000 mg of pumpkin seed extract; the equivalent of 500-2000 mg of nettle root extract; 50-200 mg of berberine hydrochloride 90%; 50-200 mg of Embilica officinalis (amla berry); 50-200 mg of Ganoderma Lucidum (lingzhi); 5-20 mg of lycopene; and 40-160 mcg of selenium.

[0047] In yet another embodiment of the present invention, the composition is in the form of a tablet, each tablet of the composition comprising 1000-4000 mg of pumpkin seed extract, 500-2000 mg of nettle root extract, 50-200 mg of berberine hydrochloride 90%, 50-200 mg of Embilica officinalis (amla berry), 50-200 mg of Ganoderma Lucidum (lingzhi), 5-20 mg of lycopene, and 40-160 mcg of selenium.

[0048] In a preferred embodiment, the capsule or tablet form contains the following ingredients per tablet / capsule dose: Pumpkin seed extract equivalent to 1000mg, Nettle root extract equivalent to 50 mg, 50mg of berberine hydrochloride 90%, 50mg Embilica officinalis (Amla berry), 50mg Ganoderma Lucidum (Lingzhi), Lycopene: mg 40mg selenium. Two to four capsules / tablets may be administered daily to achieve the preferred daily dose.

[0049] Preferred daily dosages of the compositions of the present invention are as follows: Pumpkin seed extract equivalent to 4000mg of pumpkin seeds; Nettle root extract equivalent to 2000mg of nettle root; 200-300 mg of berberine hydrochloride; 200-300mg of Embilica officinalis (amla berry); 200-300mg of Ganoderma Lucidum (Lingzhi); 20mg lycopene; 160mcg Selenium.

[0050] The preferred daily dose can be provided as a single dose in gel, powder or liquid form, or if the preferred daily dose is provided in capsule or tablet form, it can be achieved in 2-4 capsules or tablets depending on their size.

[0051] The liquid or gel compositions may be in a suitable vehicle, such as polyethylene glycol ("PEG") or coconut oil, plus flavorings and sweeteners, such as stevia.

[0052] The compositions described herein may consist of the ingredients listed above, and may optionally also include pharma- ceutically acceptable excipients, fillers, etc., in the form of a vegetarian capsule, e.g., a hydroxypropylmethylcellulose capsule.

[0053] The compositions described herein may consist of the above ingredients in the form of a tablet and may optionally also include pharma- ceutically acceptable excipients, fillers, glazes, and coatings.

[0054] Further aspects of the invention are compositions for use in combating and relieving the symptoms of prostate hyperplasia, and for use as a prophylaxis against prostate cancer. The compositions of the invention can be used daily.

[0055] As a result of the synergistic interactions between the ingredients, the proposed composition taken daily acts on multiple cellular pathways through different mechanisms and has an inhibitory effect on the development and progression of prostate tumors, as demonstrated by the laboratory experiments described above (see Example 1).

[0056] Due to the synergistic action of the ingredients, the composition of the present invention has also been shown to improve urinary symptoms caused by prostatic hyperplasia, as demonstrated in the pilot study above (see Example 2).An unexpected benefit observed after six months of use was the improvement in sexual function, both in terms of erectile function and frequency of sexual activity, as reported by all subjects.

[0057] Administration Procedure The preferred method of administration is 2-4 capsules / tablets daily or 1 gel sachet daily with meals, depending on the tablet / capsule size.

[0058] dose The composition can be in the form of a powder in a capsule that is a vegetarian capsule of hydroxypropylmethylcellulose. The composition can also be administered in the form of a tablet, liquid, or gel in a sachet. Gel embodiments can include phosphatidylcholine, flavorings, natural sweeteners such as stevia, and preservatives. Capsule and tablet embodiments can also include pharma- ceutically acceptable flow agents, anti-caking agents, and coatings. EXAMPLES

[0059] Example 1 The purpose of the experiment was to investigate the effect of the composition of the present invention on the viability and apoptosis of prostate cancer cell PC-3 cell line.

[0060] material PC-3 prostate cancer cells (human prostate adenocarcinoma-derived cell line ATCC CRL-1435) were used. Growth medium for the PC-3 cell line was prepared by adding 10% v / v FBS, 1% v / v sodium pyruvate, and 1% v / v penicillin-streptomycin to Nutrient Mixture F-12 (Ham) supplemented with L-glutamine. The medium was stored at 4° C. until use. The compositions were dissolved in Dulbecco's Phosphate Buffered Saline ("DPBS").

[0061] procedure PC-3 cell line was cultured in complete growth medium in T75 flasks at 370° C. with 5% CO2 for three passages. 10,000 cells / well were seeded into two 96-well plates.

[0062] method The plates were incubated overnight at 37° C. in 5% CO 2 to allow adhesion. Fresh growth medium containing 10 mg / ml of the composition was plated onto the PC-3 cells, and one plate was incubated for 24 hours and the other plate was incubated at 37° C. in 5% CO2 for 48 hours. All treatments were performed in quadruplicate. Cells used as controls were treated with medium containing 5% DPBS as vehicle control. Results: See FIG. 1 which shows the effect of the composition of the invention on cell viability and cytotoxicity (apoptosis) 24 hours and 48 hours after application of the composition of the invention.

[0063] See also Figure 2, images of fields of PC-3 cells taken before (untreated) and 24 and 48 hours after application of a test composition of the present invention.

[0064] Referring to Figure 3, the effects of the individual ingredients: pumpkin seed extract, nettle root, ganoderma lucidum, amla berry, berberine, control, and the composition of the present invention on cell viability and cytotoxicity (apoptosis) 48 hours after application are shown. Figure 3 shows the synergistic anti-cancer effect of the composition of the present invention compared to the ingredients alone.

[0065] Example 2 The composition of the present invention has also been shown to improve urinary symptoms caused by prostatic hyperplasia, as demonstrated by the pilot study shown below. The pilot study was conducted using the International Prostate Symptom Score (IPSS), developed by the American Urological Association and adopted as a global standard. The IPSS is a global official assessment of benign prostatic hyperplasia (BPH) based on responses to seven questions about urinary symptoms and one question about quality of life.

[0066] Five male subjects aged 60-66 years completed a questionnaire at the start of the study and again after taking the proposed prostate health composition daily for three months. The initial scores are shown below: Subject 1: Moderate score 16 Subject 2: Moderate score 19 Subject 3: Moderate score 18 Subject 4 Severe Score 28 Subject 5 Severe Score 31

[0067] Subjects began taking the prostate health composition daily with meals. After three months, subjects were asked to complete the questionnaire again. All subjects reported significant improvements in their urinary symptoms and comfort: for example, Urinary frequency improved by an average of 40%. The initial mean score was 4. After 3 months, the mean score was 2.4. Nocturia (number of times going to the bathroom at night) improved by an average of 40%. The initial average score was 4.6. After three months, the average score was 2.4. Stressing improved by an average of 25%. Initial score was 4. After 3 months, the average score was 3. Urgency improved by an average of 30%. The initial mean score was 3.4. After 3 months, the mean score was 2.4. The quality of life score for urinary symptoms improved from a mean of 4 to a mean of 2, representing a 50% improvement.

[0068] Example 2 demonstrates that the compositions of the present invention improve urinary symptoms induced by prostatic hyperplasia and the quality of life of a subject.

[0069] Follow-up of the subjects six months later highlighted an unexpected benefit of the prostate composition: all subjects reported improved sexual activity, including both a significant improvement in erectile function that had previously required medication, and increased duration and frequency of sexual activity compared to pre-initiation.

Claims

1. Pumpkin seed extract; Nettle root extract; Berberine; Embilica officinalis (amla berry); Ganoderma Lucidum (Lingzhi); Lycopene; and selenium A composition comprising:

2. The composition, pumpkin seed extract in an amount equivalent to 1000-4000 mg of pumpkin seeds per dose; Nettle root extract in an amount equivalent to 500-2000 mg of nettle root per dose; Berberine hydrochloride 90% in an amount of 50-300 mg per dose; Embilica officinalis (amla berry) in an amount of 50-300 mg per dose; Ganoderma Lucidum (Lingzhi) in an amount of 50-300 mg per dose; Lycopene in an amount of 5 to 20 mg per dose; and Selenium in an amount of 40-160 mcg per dose The composition of claim 1 comprising:

3. The composition, Pumpkin seed extract equivalent to 4000 mg of pumpkin seeds per daily dose; Nettle root extract equivalent to 2000 mg of nettle root per daily dose; 200-300 mg of berberine hydrochloride per daily dose; Embilica Officinalis (Amla Berry) at 200-300 mg per daily dose; Ganoderma lucidum (Lingzhi) at 200-300 mg per daily dose; 20 mg of lycopene per daily dose; and 160mcg of selenium per daily dose The composition of claim 1 or 2, comprising:

4. The composition according to any one of claims 1 to 3, wherein the composition is in the form of a powder, liquid or gel.

5. The composition according to any one of claims 1 to 4, wherein the composition is in the form of a liquid, gel or powder comprising: 400 mg of 10:1 pumpkin seed extract equivalent to 4000 mg of pumpkin seeds; 200 mg of 10:1 nettle root extract equivalent to 2000 mg of nettle root; 200-300 mg of berberine hydrochloride; 200-300 mg of Embilica Officinalis (Amla Berry); 200-300 mg Ganoderma lucidum (Lingzhi); 20 mg lycopene; and 160mcg selenium.

6. 3. The composition of claim 1 or 2, wherein the composition is in the form of a tablet or capsule comprising: a pumpkin seed extract equivalent to 1000-2000 mg of pumpkin seeds; Nettle root extract equivalent to 500-1000 mg of nettle root; Berberine hydrochloride 90% in amounts of 50-150 mg; Embilica officinalis (amla berry) in an amount of 50-150 mg; Ganoderma Lucidum (Lingzhi) in an amount of 50-150 mg; Lycopene in an amount of 5 to 10 mg; and Selenium in amounts of 40-80 mcg.

7. A composition according to any one of claims 1 to 3 or 6, wherein the composition is in the form of a powder contained in a capsule, optionally the capsule being a vegetarian capsule of hydroxypropyl methylcellulose.

8. The composition of any of claims 1 to 7, further comprising one or more of a pharma-ceutically acceptable diluent, lubricant, polish and coating agent.

9. The composition according to any one of claims 1 to 8, wherein the selenium is in the form of L-selenomethionine, sodium selenate or sodium selenite.

10. A composition for preventing prostate cancer, protecting prostate cells from malignant changes, or alleviating urinary symptoms of benign prostatic hyperplasia, comprising: Pumpkin seed extract; Nettle root extract; Berberine hydrochloride; Embilica officinalis (amla berry); Ganoderma Lucidum (Lingzhi); Lycopene; Selenium; and Optionally, one or more of a pharma- ceutically acceptable diluent, lubricant, polish, and coating agent. A composition comprising:

11. The composition according to any one of claims 1 to 9 for use in significantly reducing the risk of prostate cancer and protecting prostate cells from malignant changes.

12. A composition according to any one of claims 1 to 9 for use in preventing prostate cancer and protecting prostate cells from malignant changes by daily administration, said composition comprising: pumpkin seed extract in an amount of 4000 mg of pumpkin seeds per daily dose; Nettle root extract in an amount of 2000 mg of nettle root per daily dose; Berberine hydrochloride 90% in an amount of 200-300 mg per daily dose; Embilica Officinalis (Amla Berry) in an amount of 200-300 mg per daily dose; Ganoderma lucidum (Lingzhi) in an amount of 200-300 mg per daily dose; Lycopene in an amount of 20 mg per daily dose; and Selenium in the form of either L-selenomethionine or sodium selenate in an amount of 160 mcg per daily dose A composition comprising:

13. The composition according to any one of claims 1 to 9, for relieving urinary symptoms due to prostatic hyperplasia.

14. 10. A composition according to any one of claims 1 to 9 for use in treating urinary symptoms induced by prostatic hyperplasia, optionally wherein said urinary symptoms are selected from frequency, nocturia, straining and urgency.

15. The composition according to any one of claims 1 to 9 for use in treating erectile dysfunction or improving sexual function.

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