WO2008094873A1

WO2008094873A1 - Therapeutic bph composition

Info

Publication number: WO2008094873A1
Application number: PCT/US2008/052244
Authority: WO
Inventors: John E. Ligums
Original assignee: Ligums John E
Priority date: 2007-01-29
Filing date: 2008-01-29
Publication date: 2008-08-07

Abstract

The invention relates to a therapeutic composition for the prevention and/or treatment of Benign Prostatic Hyperplasia (BPH) and other related prostate problems. The invention is a therapeutic composition that combines alfalfa and fennel to have a synergistic effect for the treatment of prostate problems. The composition may further include ginger, red reishi mushroom and oyster mushroom.

Description

THERAPEUTIC BPH COMPOSITION

CROSS-REFERENCE TO PRIORITY APPLICATION

[0001] This application hereby claims the benefit of and incorporates entirely by reference commonly assigned provisional patent application Ser. No. 60/887,036, for Therapeutic BPH Composition, filed January 29, 2007.

FIELD OF THE INVENTION

[0002] The invention relates to a therapeutic composition for the treatment (e.g., the prevention and/or cure) of prostate problems, such as Benign Prostatic Hyperplasia (BPH) .

BACKGROUND OF THE INVENTION

[0003] The prostate is a gland within the male reproductive system located just below the bladder. After puberty, the prostate gradually grows from roughly the size of a grape to the size of a golf ball. At around age 50, the prostate resumes growing. This increased growth can cause various problems, most commonly Benign Prostatic Hypertrophy (BPH), prostatitis, and even prostate cancer.

[0004] The specific cause of these problems is generally unknown, but is thought to be related to hormonal changes brought on by aging. As men age, an increased amount of hormones (e.g., androgen, estrogen and prolactin) decrease the rate at which testosterone and the dihydrotestosterone (DHT) are eliminated from the prostate. (Those having ordinary skill in the art will recognize that testosterone is converted into DHT by 5-alpha-reductase . ) This excessive accumulation of DHT is thought to be responsible for prostate problems . [0005] Benign prostatic hypertrophy (BPH) (i.e., enlarged prostate) occurs when, in response to hormones such as testosterone, the cells in the inner core of the prostate gland grow and form fibrous nodules. These nodules put pressure on the urethra causing pain and problems urinating. If left untreated, BPH can lead to prostatitis.

[0006] Common symptoms of BPH include a need to urinate frequently, pain, burning, blood in the urine, weak urine flow, nighttime wakening to empty the bladder, and generally a constant feeling that the bladder is full.

[0007] Drugs are often used to treat moderate cases of BPH. Such drugs include alpha-blockers, which make it easier to urinate by relaxing the muscles located where the bladder narrows toward the urethra. Other such drugs include finasteride or dutasteride, each of which shrinks the prostate gland. Finasteride and dutasteride, however, may achieve noticeable improvements only for men with significantly enlarged prostates. It is generally thought that a combination of these two kinds of drugs (i.e., alpha- blockers and finasteride or dutasteride) is more beneficial than either drug alone.

[0008] There are concerns about using conventional drugs. Some drugs are habit forming and even addictive; others have harmful side effects. Thus, alternative medicines are becoming increasingly popular. Alternative medicines are not only safe (e.g., do not have side effects) but also frequently work better then conventional medicines for the prevention and treatment of chronic disease. Moreover, alternative medicines may better satisfy the mental, emotional, and spiritual needs of an individual. [0009] It is well known that some herbs work better when used in combination rather than when used alone. Combining herbs with similar but different properties increases efficacy such that the total effect from the combination of herbs is greater than the sum of the individual effects provided by the respective herbs. In other words, the combination of herbs can provide a synergistic effect for the patient .

[0010] Several patents disclose herbal remedies for preventing and treating problems related to prostate.

[0011] U.S. Patent No. 7,022,350 discloses the use of palmetto as a dietary supplement for treating prostate disease .

[0012] U.S. Patent No. 6,261,607 discloses a herbal composition prepared from saw palmetto, green tea, pumpkin seed oil, ginger, dual urtica root extracts, selenium, watermelon, and rosemary to promote prostate health.

[0013] U.S. Patent No. 6,790,464 discloses compositions prepared from herbs (e.g., radix asparagi, radix angelicae, and pubescentis) for the prevention or treatment of prostate conditions .

[0014] U.S. Patent No. 6,482,447 discloses compositions comprising lycopene, serenoa repens, pygeum africanum, and Urtica dioica for the treatment of Benign Prostate Hypertrophy (BPH) and the prevention of prostate cancer.

[0015] It is recognized that different patients respond differently to different treatments. Therefore, there is a need for additional herbal compositions and methods for preventing and treating problems related to prostate gland. SUMMARY OF THE INVENTION

[0016] In one aspect, the invention is a composition for the relief and treatment of prostate problems (e.g., BPH) .

[0017] In another aspect, the invention is a composition for the prevention of prostate disorders (e.g., BPH).

[0018] In yet another aspect, the invention is a composition for the cure of prostate disorders (e.g., BPH).

[0019] In yet another aspect, the invention is a composition that includes a synergistic combination of phytoestrogenic compounds (e.g., isoflavones, coumestans, and lignans) .

[0020] In yet another aspect, the invention is a composition that includes a synergistic combination of alfalfa and fennel.

[0021] In yet another aspect, the invention is a composition that includes a combination of alfalfa, fennel, and ginger.

[0022] In yet another aspect, the invention is a composition that includes a synergistic combination of alfalfa and fennel, and optionally red reishi mushroom and/or oyster mushroom.

[0023] In yet another aspect, the invention is a composition that includes a combination of alfalfa, fennel, and ginger, and optionally red reishi mushroom and/or oyster mushroom.

[0024] In yet another aspect, the invention is a process for the preparation of various therapeutic compositions for the relief and treatment of prostate problems.

[0025] In yet another aspect, the invention is therapeutic method for the relief, treatment, prevention, and/or cure of prostate problems. [0026] The foregoing, as well as other objectives and advantages of the invention and the manner in which the same are accomplished, is further specified within the following detailed description.

DETAILED DESCRIPTION

[0027] The invention is a therapeutic composition for the prevention and/or treatment of prostate problems (e.g., BPH, and prostatitis) .

[0028] In one embodiment, the invention is a therapeutic composition formed from alfalfa, fennel, and ginger.

[0029] Alfalfa (scientifically known as Medicago Sativa) is a member of the legume family. A herbaceous perennial, it grows in various climates throughout the world. Alfalfa is rich in minerals and nutrients, including calcium, magnesium, potassium, carotene, and vitamins K and E. In addition, alfalfa leaves contain eight essential amino acids. Alfalfa is recognized as being useful, for example, for the treatment of urinary tract infections, heart diseases, and even cancer.

[0030] Alfalfa contains phytoestrogens (e.g., Biochanin-A, Coumestrol, Apigenin, Luteolin, Quercetin, Formononetin, Genistein, and Daidzein) . Phytoestrogens are compounds that possess oestrogenic properties. Most phytoestrogens belong to a large group of substituted phenolic compounds known as flavonoids .

[0031] Phytoestrogens (i.e., flavonoids) in alfalfa help to balance testosterone levels (e.g., decrease excessive amounts of testosterones) , thus inhibiting the enlargement of prostate. In this way, it is thought that these phytoestrogens in alfalfa help to prevent and/or treat BPH and related prostate problems.

[0032] Fennel (scientifically known as Foeniculum Vulgare) is a highly aromatic perennial herb that grows to six feet or so. Fennel, which has a flavor similar to that of anise and star anise, has been used as herbal medication in the past (e.g., to treat chills, stomach disorders and kidney stones) . It also has culinary uses in several parts of the world including India, Italy, and the Middle East.

[0033] Like alfalfa, fennel contains phytoestrogenic compounds (e.g., Anethole, Kaempherol, Beta-sitosterol, Eugenol, Ferulic Acid, Quercetin, and Rutin) that help balance testosterone levels. It is thus believed that the phytoestrogens in fennel help to treat BPH and other related prostate problems.

[0034] Those having ordinary skill in the art will appreciate that blending certain herbs can enhance the therapeutic benefits of a particular drug or medicinal supplement. Similarly, combining alfalfa and fennel together has a synergistic effect that helps broaden its therapeutic range (e.g., the isoflavone, Coumestrol in alfalfa and the isoflavone, Anethole in fennel have a synergistic effect in treating prostate problems) . [0035] Ginger, which may also be used as an additional ingredient in the present therapeutic composition, is a knotted, underground stem (i.e., a rhizome) of the plant Zingiber Officinale. Its stem extends roughly 12 inches above ground with long, narrow, ribbed, green leaves, and white or yellowish-green flowers.

[0036] Those skilled in the field of herbal medicine know that ginger has been used as a medicine in Asia and Arab since ancient times. In China, for example, ginger has been used for more than 2,000 years to aid digestion and treat stomach upset, diarrhea, and nausea. Ginger has also been used to help treat arthritis, colic, diarrhea, and heart conditions. In addition to medicinal uses, ginger is also used as an important cooking spice and is believed to help alleviate the symptoms of the flu and common cold.

[0037] The pungency of ginger is caused by a non-volatile resin containing the same kind of hydroxyaryl compound found in other spices of the ginger family (i.e., zingerone, gingeroles, and shogoales.) During storage, the pungent gingeroles degrade to the milder shogoales. Gingeroles and shogoales are the active constituents in ginger that reduce inflammation. Accordingly, it is thought that, with respect to the present invention, ginger provides relief from the inflammation associated with prostate problems.

[0038] In accordance with foregoing, the therapeutic composition of the present invention may include alfalfa plant extracts (e.g., dried or aqueous), alfalfa leaves, alfalfa seeds, and/or alfalfa flowers. It may further include fennel plant extracts, fennel leaves, and/or fennel seeds. Additionally, it may include ginger extracts and/or ginger rhizome. [0039] In another embodiment, the invention is a therapeutic composition formed from alfalfa, fennel, ginger, red reishi mushroom, and/or oyster mushroom.

[0040] Red reishi mushroom (scientifically known as Ganoderma Lucidum) has been used as a herbal medicine in Japan and China for over 2,000 years. It is mainly composed of complex carbohydrates (i.e., water-soluble polysaccharides), triterpenes, proteins, and amino acids. The water-soluble polysaccharides found in red reishi mushroom seem to be useful in lowering blood pressure and preventing and/or treating tumors. Another active ingredient in red reishi mushroom is triterpenes (e.g., ganoderic acids) . Preliminary studies have indicated that ganoderic acids help alleviate common allergies by inhibiting histamine release, improving oxygen utilization, and improving liver functions. Accordingly, it is thought that, with respect to the present invention, red reishi mushroom help in preventing and/or treating the tumor associated with prostate related problems .

[0041] Oyster mushroom (scientifically known as Pleurotus ostreatus) is an edible fungus that may reduce cholesterol levels and have anti-cancer properties, too. Traditionally, it has been used to strengthen veins and relax tendons. Dried oyster mushroom, which is high in iron, is helpful to maintain a healthy blood system (e.g., increase red blood cells) . In addition, oyster mushroom also contains carbohydrates, glucan, polysaccharo-peptides, triterpenes, fiber, vitamins Bl, B2, minerals, and antioxidants. It seems that the polysaccharides of fennel are ingested by macrophages (i.e., immune cells) and are transported to other immune cells. This leads to the increase in number of natural killer cells that are responsible for preventing and/or inhibiting tumors. Accordingly, with respect to the present invention, it is thought that oyster mushroom assist in preventing and/or treating tumors associated with prostate .

[0042] In yet another embodiment, the invention is a composition formed from phytoestrogenic compounds (e.g., Genestein and Gegnis) that may be found in alfalfa and fennel. These compounds have a synergistic therapeutic effect for preventing and/or treating BPH.

[0043] In yet another embodiment, the invention is a composition formed from the combination of phytoestrogens, such as those found in alfalfa and fennel. Further, the invention is a composition that may be formed from gingeroles and shogoales such as found in ginger. Furthermore, the composition may include ingredients such as those found in red reishi mushroom and/or oyster mushroom (e.g., polysaccharides, triterpenes, proteins, and amino acids)

[0044] The therapeutic composition of the present invention typically includes between about 20 and 60 weight percent of alfalfa. Typically, the composition includes between about 25 and 45 weight percent of alfalfa. More typically, the composition includes about 40 weight percent of alfalfa (e.g., between about 35 and 45 weight percent) .

[0045] The therapeutic composition of the present invention further includes between about 5 and 35 weight percent of fennel. Typically, the composition includes between about 10 and 25 weight percent of fennel. More typically, the composition includes about 15 weight percent of fennel (e.g., between about 10 and 20 weight percent) [0046] The therapeutic composition of the present invention may further include between about 1 and 15 weight percent of ginger. Typically, the composition may include between about 1 and 10 weight percent of ginger. More typically, the composition may include about 5 weight percent of ginger (e.g., between about 2 and 8 weight percent).

[0047] Further, the therapeutic composition may include between about 10 and 35 weight percent of red reishi mushroom. Typically, the composition includes between about 15 and 30 weight percent of red reishi mushroom. More typically, the composition includes about 20 weight percent of red reishi mushroom (e.g., between about 15 and 25 weight percent) .

[0048] Furthermore, the therapeutic composition may include between about 10 and 35 weight percent of oyster mushroom. Typically, the composition includes between about 15 and 30 weight percent of oyster mushroom. More typically, the composition includes about 20 weight percent of oyster mushroom (e.g., between about 15 and 25 weight percent).

[0049] In yet another aspect, the invention is a process for the preparation of a therapeutic composition for the relief and treatment of prostate problems.

[0050] In one aspect, the composition may be prepared by mixing the plant extracts of alfalfa and fennel.

[0051] In another aspect, the composition may be prepared by mixing the plant extracts of alfalfa, fennel, and ginger.

[0052] In yet another aspect, the composition may be prepared by mixing the plant extracts of alfalfa, fennel, ginger, and the extracts of red reishi mushroom and/or oyster mushroom.

[0053] In yet another aspect, the invention is a method for providing the therapeutic composition for prevention and/or treatment of prostate problems. In this regard, the composition may be administered orally to an adult male in the form of capsule, tablet, powder, or liquid solution in an amount of at least about one gram per day. More typically, the composition of the present invention is administered to an adult male in an amount of between about one to four grams per day.

[0054] In the specification, typical embodiments of the invention have been disclosed. Specific terms have been used only in a generic and descriptive sense, and not for purposes of limitation. The scope of the invention is set forth in the following claims.

Claims

Claim 1. A therapeutic composition, comprising: alfalfa; fennel; and ginger .

Claim 2. A therapeutic composition according to Claim 1, wherein said alfalfa comprises alfalfa extracts, alfalfa leaves, alfalfa seeds, and/or alfalfa flowers .

Claim 3. A therapeutic composition according to Claim 1, wherein said fennel comprises fennel extracts, fennel leaves, and/or fennel seeds.

Claim 4. A therapeutic composition according to Claim 1, wherein said ginger comprises ginger extracts and/or ginger rhizome.

Claim 5. A therapeutic composition according to Claim 1, consisting essentially of: alfalfa; fennel; and ginger .

Claim 6. A therapeutic composition according to Claim 1, wherein said alfalfa is present in said therapeutic composition in an amount between about 20 and 60 weight percent.

Claim 7. A therapeutic composition according to Claim 1, wherein said alfalfa is present in said therapeutic composition in an amount between about 30 and 50 weight percent.

Claim 8. A therapeutic composition according to Claim 1, wherein said fennel is present in said therapeutic composition in an amount between about 5 and 35 weight percent.

Claim 9. A therapeutic composition according to Claim 1, wherein said fennel is present in said therapeutic composition in an amount between about 10 and 25 weight percent.

Claim 10. A therapeutic composition according to Claim 1, wherein said ginger is present in said therapeutic composition in an amount between about 1 and 15 weight percent.

Claim 11. A therapeutic composition according to Claim 1, wherein said ginger is present in said therapeutic composition in an amount between about 1 and 10 weight percent.

Claim 12. A therapeutic composition according to Claim 1, wherein: said alfalfa is present in an amount between about 30 and 65 weight percent; said fennel is present in an amount between about 5 and 40 weight percent; and said ginger is present in an amount between about 1 and 20 weight percent.

Claim 13. A therapeutic composition according to Claim 1, further comprising red reishi mushroom.

Claim 14. A therapeutic composition according to Claim 13, consisting essentially of; alfalfa; fennel; ginger; and red reishi mushroom.

Claim 15. A therapeutic composition according to Claim 13, wherein said red reishi mushroom is present in said therapeutic composition in an amount between about 5 and 35 weight percent.

Claim 16. A therapeutic composition according to Claim 13, wherein said red reishi mushroom is present in said therapeutic composition in an amount between about 10 and 30 weight percent.

Claim 17. A therapeutic composition according to Claim 1, further comprising oyster mushroom.

Claim 18. A therapeutic composition according to Claim 17, consisting essentially of: alfalfa; fennel; ginger; and oyster mushroom.

Claim 19. A therapeutic composition according to

Claim 17, wherein said oyster mushroom is present in said therapeutic composition in an amount between about 5 to 35 weight percent.

Claim 20. A therapeutic composition according to

Claim 17, wherein said oyster mushroom is present in said therapeutic composition in an amount between about 10 to 30 weight percent.

Claim 21. A therapeutic composition according to Claim 1, further comprising; red reishi mushroom; and oyster mushroom.

Claim 22. A therapeutic composition according to Claim 21, consisting essentially of: alfalfa; fennel; ginger; red reishi mushroom; and oyster mushroom.

Claim 23. A therapeutic composition according to Claim 21, wherein said red reishi mushroom is present in said therapeutic composition in an amount between about 5 and 40 weight percent.

Claim 24. A therapeutic composition according to

Claim 21, wherein said oyster mushroom is present in said therapeutic composition in an amount between about 5 and 40 weight percent.

Claim 25. A therapeutic composition according to Claim 21, wherein: said alfalfa is present in an amount between about 30 and 60 weight percent; said fennel is present in an amount between about 5 and 35 weight percent; said ginger is present in an amount between about 1 and 15 weight percent; said red reishi mushroom is present in an amount between about 10 and 30 weight percent; and said oyster mushroom is present in an amount between about 10 and 30 weight percent.

Claim 26. A therapeutic composition according to Claim 21, wherein: said alfalfa is present in an amount between about 25 and 55 weight percent; said fennel is present in an amount between about 5 and 20 weight percent; said ginger is present in an amount between about 2 and 8 weight percent; said red reishi mushroom is present in an amount between about 10 and 25 weight percent; and said oyster mushroom is present in an amount between about 10 and 25 weight percent.

Claim 27. A method of providing the therapeutic composition of any of Claims 1-26, comprising administering said composition to an adult male. Claim 28. A method of providing the therapeutic composition of any of Claims 1-26, comprising administering said composition to an adult male with prostate problems.

Claim 29. A method of providing the therapeutic composition of any of Claims 1-26, comprising administering said composition to an adult male with BPH.

Claim 30. A method of providing the therapeutic composition of any of Claims 1-26, comprising orally administering said composition to an adult male.

Claim 31. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of capsule .

Claim 32. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of tablet.

Claim 33. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of powder . Claim 34. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of liquid solution.

Claim 35. A method of providing the therapeutic composition according to any of Claims 30, wherein said therapeutic composition is administered up to five times per day.

Claim 36. A method of providing the therapeutic composition according to any of Claims 30, wherein said therapeutic composition is administered in an amount between about 1 to 4 grams per day.

Claim 1. A therapeutic composition, comprising: alfalfa; fennel; and ginger .

12 Claim 6. A therapeutic composition according to Claim 1, wherein said alfalfa is present in said therapeutic composition in an amount between about 20 and 60 weight percent.

13 Claim 12. A therapeutic composition according to Claim 1, wherein: said alfalfa is present in an amount between about 30 and 65 weight percent; said fennel is present in an amount between about 5 and 40 weight percent; and said ginger is present in an amount between about 1 and 20 weight percent.

14 Claim 17. A therapeutic composition according to Claim 1, further comprising oyster mushroom.

Claim 19. A therapeutic composition according to

Claim 20. A therapeutic composition according to

15 Claim 22. A therapeutic composition according to Claim 21, consisting essentially of: alfalfa; fennel; ginger; red reishi mushroom; and oyster mushroom.

Claim 24. A therapeutic composition according to

16 Claim 25. A therapeutic composition according to Claim 21, wherein: said alfalfa is present in an amount between about 30 and 60 weight percent; said fennel is present in an amount between about 5 and 35 weight percent; said ginger is present in an amount between about 1 and 15 weight percent; said red reishi mushroom is present in an amount between about 10 and 30 weight percent; and said oyster mushroom is present in an amount between about 10 and 30 weight percent.

Claim 27. A method of providing the therapeutic composition of any of Claims 1-26, comprising administering said composition to an adult male.

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Claim 28. A method of providing the therapeutic composition of any of Claims 1-26, comprising administering said composition to an adult male with prostate problems.

Claim 33. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of powder .

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Claim 34. A method of providing the therapeutic composition according to Claim 30, wherein said therapeutic composition is administered in the form of liquid solution.

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