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 elements of which are incorporated herein by reference for all purposes.

[0002] FIELD OF THE INVENTION 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] Background of the Invention The prostate gland plays a vital role in men's health. As men age, benign prostatic hyperplasia (BPH) becomes one of the most common problems 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] Benign prostatic hyperplasia is a long-term condition caused by chronic inflammation at the cellular level. Multiple studies have demonstrated a link between chronic inflammation and carcinogenesis. A study from Johns Hopkins University School of Medicine showed that chronic inflammation in the prostate, despite low PSA levels, more than doubles the risk of developing aggressive prostate cancer. Prostate cancer affects a staggering 1 in 6 Caucasian men and 1 in 4 African-American 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. But despite the enormous amount of money 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 for screening and diagnosing prostate cancer involve invasive scans (transrectal ultrasound, transrectal prostate biopsy) that carry a high risk of infection, can have a high number of false negatives and false positives, are expensive, and are 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 rate of prostate malignancies, which affect one in six white men and one in four black men, while at the same time, safe and affordable solutions are needed to alleviate 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 made 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 (reishi mushroom); lycopene; and selenium.

[0012] More specifically, in one embodiment, the composition is in tablet or capsule form and contains 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 (Reishi 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 achieved in a single dosage form, such as a liquid or gel, or in multiple tablets or capsules.

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

[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 seeds; 200 mg nettle root extract 10:1 equivalent to 2000 mg nettle root; 200-300 mg berberine hydrochloride; 200-300 mg Emblica Officinalis (amla berry); 200-300 mg Ganoderma lucidum (reishi mushroom); 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 present 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 Emblica officinalis (amla berry); 50-150 mg Ganoderma lucidum (reishi mushroom); 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 Emblica Officinalis (amla berry); 50 mg / dose Ganoderma lucidum (reishi mushroom); 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 present invention, the composition is in the form of a liquid or gel having pumpkin seed extract equivalent to about 4000 mg of pumpkin seeds per daily dose; nettle root extract equivalent to about 2000 mg of nettle root per daily dose; about 200 mg of berberine hydrochloride 90% per daily dose; about 200 mg of Embilica Officinalis (amla berry) per daily dose; about 200 mg of Ganoderma lucidum (reishi mushroom) per daily dose; about 20 mg of lycopene 15 per daily dose; and about 160 mcg of selenium per daily dose.

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

[0018] In some embodiments, the compositions of the present invention include pharmaceutically acceptable excipients. Excipients for different capsule, soft capsule, gel, powder sachet, or liquid embodiments can include, by way of example, one or more of gelling agents, surfactants, emulsifiers, solubilizers, surfactants (non-ionic), plasticizers, matrix-forming agents, 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. Other excipients known to those skilled in the art may also be used in addition to or instead of these. In further embodiments, the compositions may include one or more of pharmaceutically 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 alleviating urinary symptoms of benign prostatic hyperplasia. In a further embodiment, the composition is for use in treating urinary symptoms caused by benign prostatic hyperplasia, optionally wherein 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 (Reishi mushroom); lycopene; and selenium; and optionally one or more of a pharmaceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0022] In another embodiment, a method for reducing or decreasing 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); Reishi (Ganoderma Lucidum); lycopene; and selenium; and optionally one or more pharmaceutically acceptable excipients or diluents, lubricants, polishes, and coatings) (at any concentration or dosage).

[0023] In another embodiment, a method for alleviating urinary symptoms of benign 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 (Reishi mushroom); lycopene; and selenium; and optionally one or more of a pharmaceutically 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 (Reishi mushroom); lycopene; and selenium; and optionally one or more of a pharmaceutically acceptable excipient or diluent, lubricant, polish, and coating agent) (at any concentration or dosage).

[0025] In another embodiment, a method for treating urinary symptoms caused by prostatic hyperplasia optionally comprises administering to an individual in need thereof, wherein 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 (Reishi mushroom); lycopene; and selenium; and optionally one or more of a pharmaceutically 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 clearly 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 structures and like components, and in which: [Brief explanation of the drawings]

[0028] [Figure 1] FIG. 1 is a graph illustrating the effectiveness of formulations used in accordance with the present invention. [Figure 2]FIG. 2 shows images of the fields of PC-3 cells before application of the test composition (untreated), and 24 and 48 hours after application. [Figure 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, reishi mushroom, amla berry, berberine alone) and a control. DETAILED DESCRIPTION OF THE INVENTION

[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 fine particles called free radicals. Free radicals damage all major components of cells, including DNA, proteins and cell membranes, leading to oxidative stress, chronic inflammation and cellular dysfunction, which in turn trigger the carcinogenic process.

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

[0032] As a result, to date, no single solution or approach has provided sustainable results that provide both cellular 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 takes hold, develops, and spreads. The components listed above work synergistically, providing benefits beyond those achieved by each component acting alone. The synergistic effect of this composition compared to the individual components is demonstrated in Example 1 and Figure 3.

[0033] This is precisely why the compositions of the present invention contain multiple components that each address several aspects of cancer cell metabolism: 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 that allow diffusion into the extracellular matrix, and activation of detoxification mechanisms. By combining various phytochemicals and minerals at low doses, the components can synergize with each other, avoiding toxicity and potential side effects. Daily administration of the herbal and mineral compositions of the present invention can provide cellular antioxidant protection, preventative and chemopreventive effects.

[0034] Daily intake of the phytochemicals, antioxidants, and minerals described below that target cellular prostate health effectively neutralize free radicals, mitigate chronic inflammatory pathways, and prevent and counteract cellular damage, providing a natural, non-toxic, and affordable long-term chemoprevention. This composition contains small amounts of each ingredient to achieve the desired chemoprevention counter-effect while alleviating the chronic inflammation present in BPH and its impact on bladder function, while avoiding potential 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 capacity (free radical scavenging ability) of all fruits and vegetables, 27 times that of wild blueberries at 9,600 ORAC units. Amla's high antioxidant potential is thought to be due to its high content of polyphenols such as vitamin C, flavonoids and hydrolyzable tannins, which exert potent anti-inflammatory activity and regulate various inflammatory enzymes such as NF-kB, one of the main factors in carcinogenesis that leads 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 (Reishi) 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 the 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 rich in both ER-α and ER-β estrogen receptors, which promote carcinogenesis and upregulate tumor development. Reishi mushrooms down-regulate estrogen alpha receptors, which have been found to mediate high-grade prostatic intraepithelial neoplasia. Reishi mushrooms have the shape of a mushroom fruiting body (stem and cap) and comprise the organism's reproductive structures. The amount of reishi mushrooms in the composition ranges from 50 to 300 mg per dose. In a further embodiment, the amount of reishi mushrooms in the composition ranges from 50 to 200 mg per dose. The daily dose of reishi mushrooms 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, which is widely found in various traditional medicines. 20 H 22 An orally available synthetic form of berberine, CINO6 berberine hydrochloride, was used in the compositions of the present invention due to its direct effects on the stromal and glandular components of the prostate, which are known to be involved in the development of benign prostatic hyperplasia. Berberine acts on prostate cells at the cellular level by inhibiting the inflammatory microenvironment, disrupting metabolic changes that lead to cancer development, suppressing carcinogenesis, and inducing apoptosis in prostate cancer cells. High doses of berberine can cause damage to immune cells, resulting in 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, the berberine is in the form of a synthetic berberine hydrochloride (C 20 H 22 CINO6).

[0039] Pumpkin Seed Extract Pumpkin seed extract has dual beneficial effects on the bladder and prostate, along with antioxidant and anti-inflammatory properties, which directly contribute 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 a 10:1 pumpkin seed extract. A 10:1 pumpkin seed extract (1 mg of extract is equivalent to 10 mg of pumpkin seeds) means that a daily dose equivalent to 4000 mg is achieved with 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 is equivalent to 4000 mg of pumpkin seeds.

[0040] Nettle Root Extract Nettle root extract (Urtica doica) is used in the present compositions because it contains several antioxidant and anti-inflammatory molecules (quercetin, rutin, and campherol) that are effective in alleviating prostate enlargement, or benign prostatic hyperplasia (BPH). Nettle inhibits fat oxidation, thereby protecting many tissues from oxidative stress, and also reduces the release of inflammatory cytokines and inflammatory biomarkers, such as TF-kB and interleukins, thereby exerting an antiproliferative effect on prostate cells. Nettle root extract enhances the effects of not only blood pressure medications but also diabetes medications, so when used in appropriate amounts, it not only provides chemopreventive effects against other medications, but also alleviates the effects of prostate enlargement and has beneficial effects 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 can be 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 is equivalent to 2000 mg of nettle root.

[0041] Lycopene Lycopene, the red pigment found in tomatoes, 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 enhancing 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 moderate. In the composition of the present invention, lycopene is used in the range of 5 to 20 mg per dose. The daily dose of lycopene is 20 mg.

[0042] selenium Selenium is a micronutrient that humans cannot synthesize and is required in daily doses for maintaining health. In the compositions of the present invention, selenium has protective and cancer-preventing properties at the cellular level. Selenium exerts its 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 identified. This biological phenomenon may be due to selenium's ability to induce cellular apoptosis. However, selenium is toxic at intakes of 400 mcg or more, causing peripheral neuropathy, stomach symptoms, liver, kidney, and heart damage, and alopecia. Due to its toxicity, selenium cannot be used as a single ingredient (a lethal dose of 750 mg (equivalent to 750,000 mcg) is required), and it can only be used in very small amounts. To benefit from its protective effect against carcinogenesis, selenium is used in very small amounts in the compositions of the present invention, with the expectation of a synergistic effect in combination with other ingredients. Selenium is used in the range of 40-160 mcg per dose. The daily dose of selenium is 160 mg. In some embodiments, the selenium is in the form of L-selenomethionine, sodium selenate (NaSeO), or sodium selenite (NaSeO). 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 (reishi mushroom), 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 Emblica officinalis (amla berry); 50-200 mg of Ganoderma Lucidum (Reishi mushroom); 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, wherein each dose of the composition contains 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 (reishi mushroom), 5-20 mg of lycopene, and 40-160 mcg of selenium.

[0046] In yet another embodiment of the invention, the composition is in liquid or gel form, with 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 Emblica officinalis (amla berry); 50-200 mg of Ganoderma Lucidum (Reishi mushroom); 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 tablets, 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 (reishi mushroom), 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 50mg, 50mg berberine hydrochloride 90%, 50mg Embilica officinalis (amla berry), 50mg Ganoderma Lucidum (Reishi mushroom), 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; 200-300 mg of Embilica officinalis (amla berry); 200-300 mg of Ganoderma Lucidum (Reishi mushroom); 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 to 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 pharmaceutically acceptable excipients, fillers, for example in the form of a vegetarian capsule, such as 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 pharmaceutically acceptable excipients, fillers, glazes, and coatings.

[0054] Further aspects of the present invention are compositions for use in combating and relieving the symptoms of benign prostatic hyperplasia, and for use as a prophylactic against prostate cancer. The compositions of the present 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 compositions of the present invention have also been shown to improve urinary symptoms caused by prostatic hyperplasia, as demonstrated in the above-mentioned pilot study (see Example 2). An unexpected benefit observed after six months of use was improved 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, such as a vegetarian capsule of hydroxypropyl methylcellulose. The composition can also be administered in the form of a tablet, liquid, or gel in a sachet. Gel embodiments can include phosphatidylcholine, flavoring, a natural sweetener such as stevia, and a preservative. Capsule and tablet embodiments can also include pharmaceutically acceptable glidants, anti-caking agents, and coating agents. [Example]

[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 composition was 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 and 5% CO for three passages. 10,000 cells / well were seeded into two 96-well plates.

[0062] method These plates were incubated overnight at 37°C in 5% CO2 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 a vehicle control. Results: See Figure 1, which shows the effect of the composition of the present invention on cell viability and cytotoxicity (apoptosis) 24 and 48 hours after application of the composition of the present invention.

[0063] See also Figure 2, field images 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, reishi mushroom, amla berry, berberine, a control, and the composition of the present invention on cell viability and cytotoxicity (apoptosis) 48 hours after application are shown, demonstrating the synergistic anti-cancer effect of the composition of the present invention compared to the ingredients alone.

[0065] Example 2 The compositions of the present invention have also been shown to improve urinary symptoms caused by benign prostatic hyperplasia, as demonstrated by the following pilot study. This 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 an official global assessment of benign prostatic hyperplasia (BPH) based on responses to seven questions regarding urinary symptoms and one question regarding quality of life.

[0066] Five male subjects, ages 60-66, completed a questionnaire at the start of the study and again after three months of daily intake of the proposed prostate health composition. 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 showed significant improvement 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 toilet 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%. The 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 caused by prostatic hyperplasia and the quality of life of subjects.

[0069] A follow-up survey 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, which previously required medication, and increased duration and frequency of sexual activity compared to pre-treatment.

Claims

1. Pumpkin seed extract in an amount equivalent to 1000 to 4000 mg of pumpkin seeds per dose; Nettle root extract (Urtica doica) in an amount equivalent to 500-2000 mg of nettle root per dose; Berberine in the form of berberine hydrochloride 90% in an amount of 50-300 mg per dose; Emblica officinalis (amla berry) in an amount of 50 to 300 mg per dose; Ganoderma Lucidum (Reishi mushroom) 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 A composition consisting of:

2. The composition comprises: Pumpkin seed extract equivalent to 4000 mg of pumpkin seeds per daily dose; Nettle root extract (Urtica doica) equivalent to 2000 mg of nettle root per daily dose; berberine in the form of berberine hydrochloride, 200-300 mg per daily dose; Emblica Officinalis (Amla Berry) at 200-300 mg per daily dose; Ganoderma lucidum (reishi mushroom) 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 consisting of:

3. The composition according to claim 1 or 2, wherein the composition is used in the form of a powder, liquid or gel.

4. 3. The composition according to claim 1 or 2, wherein the composition is used in the form of a liquid, gel or powder, comprising the following components: 400 mg of 10:1 pumpkin seed extract, equivalent to 4000 mg of pumpkin seeds; 200 mg of 10:1 nettle root extract (Urtica doica), equivalent to 2000 mg of nettle root; 200-300 mg of berberine hydrochloride; 200-300 mg of Emblica Officinalis (Amla berry); 200-300 mg Ganoderma lucidum (Reishi mushroom); 20 mg lycopene; and 160mcg of selenium.

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

6. The composition according to claim 5, wherein the composition is used in the form of a powder contained in a capsule.

7. 7. The composition of claim 6, wherein the capsule is a hydroxypropyl methylcellulose vegetarian capsule.

8. A pumpkin seed extract in an amount equivalent to 1000-4000 mg of pumpkin seeds per dose; Nettle root extract (Urtica doica) in an amount equivalent to 500-2000 mg of nettle root per dose; Berberine in the form of berberine hydrochloride 90% in an amount of 50-300 mg per dose; Emblica officinalis (amla berry) in an amount of 50 to 300 mg per dose; Ganoderma Lucidum (Reishi mushroom) in an amount of 50-300 mg per dose; lycopene in an amount of 5-20 mg per dose; Selenium in an amount of 40-160 mcg per dose; and one or more of a pharmaceutically acceptable diluent, lubricant, polishing agent, and coating agent A composition consisting of:

9. 3. The composition of claim 1, wherein the selenium is in the form of L-selenomethionine, sodium selenate, or sodium selenite.

10. 1. A composition for use in preventing prostate cancer, protecting prostate cells from malignant changes, or alleviating urinary symptoms of benign prostatic hyperplasia, comprising: pumpkin seed extract in an amount equivalent to 1000-4000 mg of pumpkin seeds per dose; Nettle root extract (Urtica doica) in an amount equivalent to 500-2000 mg of nettle root per dose; berberine hydrochloride in an amount of 50 to 300 mg per dose; Emblica officinalis (amla berry) in an amount of 50 to 300 mg per dose; Ganoderma Lucidum (Reishi mushroom) 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 A composition consisting of:

11. 1. A composition for use in preventing prostate cancer, protecting prostate cells from malignant changes, or alleviating urinary symptoms of benign prostatic hyperplasia, comprising: pumpkin seed extract in an amount equivalent to 1000-4000 mg of pumpkin seeds per dose; Nettle root extract (Urtica doica) in an amount equivalent to 500-2000 mg of nettle root per dose; berberine hydrochloride in an amount of 50 to 300 mg per dose; Emblica officinalis (amla berry) in an amount of 50 to 300 mg per dose; Ganoderma Lucidum (Reishi mushroom) in an amount of 50-300 mg per dose; lycopene in an amount of 5-20 mg per dose; Selenium in an amount of 40-160 mcg per dose; and one or more of a pharmaceutically acceptable diluent, lubricant, polish, and coating agent A composition consisting of:

12. 3. The composition of claim 1 or 2 for use in significantly reducing the risk of prostate cancer and protecting prostate cells from malignant changes.

13. 3. The composition of claim 1 or 2 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 (Urtica doica) 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; Emblica Officinalis (Amla Berry) in an amount of 200-300 mg per daily dose; Ganoderma lucidum (Reishi mushroom) 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 consisting of:

14. 3. The composition of claim 1 or 2 for use in alleviating urinary symptoms associated with benign prostatic hyperplasia.

15. 3. The composition of claim 1 or 2 for use in treating urinary symptoms induced by prostatic hyperplasia, wherein the urinary symptoms are selected from frequency, nocturia, straining, and urgency.

16. 3. The composition of claim 1 or 2 for use in treating erectile dysfunction or improving sexual function.

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