US 2008.00899.46A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/008994.6 A1 Olalde Rangel (43) Pub. Date: Apr. 17, 2008

(54) SYNERGISTIC PHYTOCEUTICAL A6IR 36/21 (2006.01) COMPOSITIONS A6IR 36/232 (2006.01) A6IR 36/258 (2006.01) (76) Inventor: Jose Angel Olalde Rangel, Caracas A6IR 36/28 (2006.01) (VE) A6IR 36/286 (2006.01) A6IR 36/3 (2006.01) Correspondence Address: A6IR 36/4I (2006.01) BAKER & MCKENZE LLP A6IR 36/45 (2006.01) Pennzoil Place, South Tower A6IR 36/48 (2006.01) 711 Louisiana, Suite 3400 A6IR 36/7 (2006.01) HOUSTON, TX 77002-2716 (US) A6IP 7/00 (2006.01) A6IP 5/00 (2006.01) (21) Appl. No.: 11/924,122 A6IP 9/00 (2006.01) (52) U.S. Cl...... 424/548; 424/195.15; 424/725: (22) Filed: Oct. 25, 2007 424/726; 424/728; 424/732: 424/737; 424/752; 424/755; Related U.S. Application Data 424/757; 424/773; 424/775 (62) Division of application No. 1 1/271,940, filed on Nov. (57) ABSTRACT 10, 2005, now Pat. No. 7,303,772. Phytoceutical compositions for the prevention and treatment Publication Classification of circulatory disorders, feminine endocrine disorders, and dermal disorders. A specific combination of extracts of (51) Int. Cl. plants is taught, as well as principles for varying the for A6 IK 36/00 (2006.01) mulations based on categorizing plants into one of three A6 IK 35/32 (2006.01) groups, Energy, Bio-Intelligence, and Organization and A6 IK 36/074 (2006.01) selecting several plants from each group. Such combinations A6 IK 36/16 (2006.01) have synergistic effects, with minimal side effects. Patent Application Publication Apr. 17, 2008 Sheet 1 of 3 US 2008/008994.6 A1

Figars f: Fatigraphie sewidiaries of iaitetic Fest rismissics, irreiading isfigth of treatnessert sefree phasis.

?

Doppier titrestand fe Patent Application Publication Apr. 17, 2008 Sheet 2 of 3 US 2008/008994.6 A1

figure 2: Pts -before w after eitasaragrapefic carparison. Afterwal fetween echesonagranrass if trantis

SSSSSS

SS 87. Patent Application Publication Apr. 17, 2008 Sheet 3 of 3 US 2008/008994.6 A1

Figure 3: Photographic eviderace of severe Psoriasis remissions, including length of treatner between photos

US 2008/008994.6 A1 Apr. 17, 2008

SYNERGISTIC PHYTOCEUTICAL Polycystic Ovary Syndrome, ovarian cysts, fibrocystic COMPOSITIONS breast condition, uterine fibroids, dysfunctional uterine hem orrhage, female infertility, premenstrual syndrome, amenor PRIOR RELATED APPLICATIONS rhea, and the like. 0001. Not applicable. 0009. Another embodiment of the invention provides a composition for chronic skin disorders. It can be used alone FEDERALLY SPONSORED RESEARCH or combined with pharmaceuticals, and can be used to treat STATEMENT diseases such as psoriasis, dermatitis, skin infections, 0002) Not applicable. shingles (herpes Zoster), boils, eczema, rash, acne or burn, and the like. REFERENCE TO MICROFICHEAPPENDIX 0003) Not applicable. DETAILED DESCRIPTION OF THE FIGURES 0010 FIG. 1 shows representative examples of diabetic FIELD OF THE INVENTION foot lesions treated with the herbaria of Table 1. 0004 The invention relates to phytoceutical formulations 0011 FIG. 2 shows representative examples of PCOS used to treat a variety of diseases. The formulations are treated with the herbaria of Table 2. particular combinations of plants and have synergistic effect in combination. Principles for selecting beneficial formula 0012 FIG. 3 shows representative examples of psoriasis tions are provided. treated with the herbaria of Table 3.

BACKGROUND OF THE INVENTION DETAILED DESCRIPTION OF THE 0005 The academic study of medicinal plants for the INVENTION treatment of diverse diseases has been nearly as pervasive as 0013 “Pharmaceutically acceptable excipients’ is used the study of Western medicines—The active principles from herein according to art accepted meanings, and includes many traditional medicines have been extracted from plants, those ingredients needed to formulate a medicine for mam the curative agents identified and their mechanisms of action malian use, including the use of gelatin capsules. determined. Plant based medicines are typically well toler ated, with less severe side effects as well as a Smaller range 0014 “Synergistic' or “synergy” is used herein to mean of side effects. However, despite the excellent medicinal that the effect is more than its additive property. In preferred qualities of many plants, they are individually insufficient to embodiments, the synergy is at least 1.5, 2, 5, or 10 fold. take chronic degenerative diseases into remission. In con 0015. By use of “plants,” what is meant herein is that the trast, while synthetic drugs can be highly effective, their use plant (or that portion with medicinal activity) is used whole, is often hampered by severe side effects. What is needed in ground, or as an extract. Also included are purified active the art are better treatment regimes with improved patient ingredients and derivatives thereof. However, it is believed tolerance, while providing Sufficient efficacy. that the best efficacy of plants used herein is achieved with the use of the entire plant or its extracts, rather than with the SUMMARY OF THE INVENTION use of isolated active ingredients. 0006. A number of known beneficial plants were classi fied according to their capacity to enhance the three main 0016 Further, although plants are named here according elements that support overall health: Energy (E), Bio-intel to commonly used nomenclature, with improving taxonomy ligence (I) and Organization (O). A synergistic effect is plants are often reclassified. Whenever a plant is referenced, expected when all three categories of herbs (E. I. O) are it includes related species with similar active ingredients. included in a formulation, preferably at least two or three or 0017. The following examples are illustrative only and four plants from each category. Thus, one embodiment of the should not serve to unduly limit the invention. invention provides a method of selecting additional disease treating formulations according to these principles. Three EXAMPLE 1. examples of formulations prepared in this way are provided and additional formulations are being prepared and tested. Plant Characteristics Circulatory Disorders 0007 Another embodiment of the invention provides an 0018 Angelica sinensis (Dong Quai or Angelica, also effective, natural composition for treating circulatory dis Angelica Archangelia, Angelica Pubescens and Angelica eases. The composition can be used alone, or can be com Sylvestris) contains terpenes (terpenes, mainly B-phelland bined with simultaneous use of one or more pharmaceutical rene, with B-bisabolene, B-caryophyllene, B-phellandrene, compositions. It can be used for the treatment of diabetic C- and B-pinene, limonene, linalool, borneol, acetaldehyde, lesions, obliterative arteriosclerosis, Leriche Syndrome menthadienes, and nitromenthadienes), macrocyclic lac (aorto-iliac obliteration), Buerger's disease (thromboangiitis tones (including tridecanolide, 12-methyl tridecanolide, obliterans), thrombophlebitis, chronic venous insufficiency, pentadecanolide), phthalates (such as hexamethylphthalate), Varicose veins, varicose ulcers, hemorrhoids, and the like. (especially flirocoumarin glycosides Such as 0008 Another embodiment of the invention provides a and apterin), and byakangelicin deriva composition for the treatment of feminine endocrine dis tives (, , , , impera eases that can be used alone or combined with pharmaceu toren, , Xanthotoxin, oxypeucedanin and more), ticals. It provides an effective medicine for diseases such as as well as various Sugars, plant acids, flavonoids, and sterols. US 2008/008994.6 A1 Apr. 17, 2008

0.019 Acanthopanax senticosus (Russian Ginseng, Sibe of c(GMP and cAMP levels and prolongation of the time rian Ginseng, Eleuthero, Devil's Shrub, Touch-me-not, Wild interval between the conversion of fibrinogen to fibrin. Pepper, Shigoka, Acantopanacis senticosus) contains terpe Ginsenosides have also been shown to be relatively potent noids (oleanolic acid), glycosides (Eleutheroside A (daucos platelet activating factor antagonists. It has antioxidant, terin), B1, C-G, I, K, L, M), phytosterols (B-sitosterol), anti-inflammatory, and hypolipidemic effects. The incorpo coumarins (Eleutheroside B1 and B3, isofraxidine), polysac ration of this phytomedicine into a composition provides at charides (eleutherans), volatile oils, caffeic acid, coniferyl least 206 active principles in a single therapeutic. aldehyde, and sugars. Eleuthero has been shown to bind to estrogen, progestin, and mineralocorticoid receptors, and 0023 Pfaffia paniculata (Suma, Brazilian Ginseng, Pfaf stimulate T-lymphocyte and natural killer cell production. It fia, Para Toda, Corango-acu; also Hebanthe paniculata, has activity anti-platelet aggregation activity similar to aspi Gomphrena paniculata, G. eriantha, Iresine erianthos, I. rin, as well as antioxidant activity. Russian Ginseng contains paniculata, I. tenuis, P. eriantha, Xeraea paniculata) con at least 40 active ingredients. tains active glycosides (beta-ecdysone and three ecdys teroids), pfaffic acids, phytosterols (sitosterol and estimas 0020 Rhaponticum carthamoides (Leuzea, or Maral terol). It also contains Saponins. Its germanium content Root) contains a mixture of compounds called, “levseins.” probably accounts for its properties as an oxygenator at the Levseins represents a complex of more than 10 ecdysterones cellular level, and its high iron content may account for its including 20-beta-ecdysterone, makisterone C, 24-dehydro traditional use for anemia. This herb increases oxygenation makisterone A, carthamosterone, polypodyne B and ajugas at the cellular level, and it also has anabolic activity at the terone C. Researchers extracted and purified various ecdys muscular and cardiac levels by improving the contraction of teroids from Rhaponticum and found that the ecdysteroids the miocardia and diminishing arrhythmias and stabilizing increased the mass of the developing quails in a dose the membranes of cardiac cells. The incorporation of this dependent manner, with the rate of increase proportional to phytomedicine provides 44 active principles in a single the ecdysteroids content. The Soviets manufactured a syn therapeutic. thetic version of this powerful substance for their athletes with great success. Soon after, the U.S. version called 0024 Rhodiola rosea (Golden Root, Roseroot) consists Mesobolin circulated on the underground market for a long mainly of phenylpropanoids (rosavin, rosin, rosarin (specific time. Incorporation of this phytomedicine in a composition to R. rosea), phenylethanol derivatives (salidroside, rhodi provides at least 10 active principles in a single therapeutic. oloside, tyrosol), flavanoids (catechins, proanthocyanidins, rodiolin, rodionin, rodiosin, acetylrodalgin, tricin), monot 0021 Panax ginseng (Chinese ginseng, panax, ren shen, erpenes (rosiridol, rosaridin), triterpenes (daucosterol, beta jintsam, ninjin, Asiatic ginseng, Japanese ginseng, Oriental sitosterol), and phenolic acids (chlorogenic and hydroxycin ginseng, Korean red ginseng) main active components are namic, gallic acids). It also contains organic acids (gallic, ginsenosides (Ra1, Ra2, Rb1, Rg1, Rd, Re, Rh1, Rh2, Rh3. caffeic, and chlorogenic acids) and B-Tyrosol. There are F1, F2, F3) and panoxosides, which have been shown to many species of Rhodiola, but it appears that the rosavins have a variety of beneficial effects, including anti-inflam are unique to R. Rosea, and it is the preferred species. Its matory, antioxidant, and anticancer effects. Results of clini therapeutic properties include a strong estrogen binding cal research studies demonstrate that Panax ginseng may property. It also has properties of vasodilatation by activa improve psychological function, immune function, and con tion of mu-opiate receptors in heart muscle, and it is a ditions associated with diabetes. Studies indicate that Panax hypolipidemic, diminishing cholesterol and triglyceride lev ginseng enhances phagocytosis, natural killer cell activity, els. The incorporation of this phytomedicine provides at and the production of interferon; improves physical and least 20 active principles in a single therapeutic. mental performance in mice and rats; causes vasodilation; increases resistance to exogenous stress factors; and affects 0025. Echinacea angustifolia or purpurea (Black Samp hypoglycemic activity. It stimulates hepatic glutathione per son, Purple Coneflower, Rudbeckia, Missouri Snakeroot, oxidase, and the phytosterols inhibit prostaglandin synthe Red Sunflower) contains alkaloids (Isotussilagine, tussi sis. Also it displays vascular activity because the Saponins lagine), amides (echinacein, isobutylamides), carbohydrates act like calcium antagonists in the vasculature. The incor (echinacin, polysaccharides (heteroxylan and arabinogalac poration of this phytomedicine provides at least 86 active tan), inulin, fructose, glucose, pentose), glycosides (echina principles in a single therapeutic. coside), terpenoids (Germacrane), Cichoric acid, betaine, methyl-para-hydroxycinnamate, Vanillin, phytosterols, and 0022 Panax quinquefolius (American Ginseng, Anchi, volatile oils. Echinacea has been the subject of hundreds of Canadian Ginseng, Five Fingers, Ginseng, American, North clinical and Scientific studies which have primarily used an American Ginseng, Red Berry, Ren Shen, Tienchi) is related extract of the root and aerial portions of the botanical. The to Panax ginseng, but is a distinct species with higher levels rich content of polysaccharides and phytosterols in Echina of ginsenoside Rb1 and without ginsenoside Rf. Ginsenos cea are what make it a strong immune system stimulant. The ide Rb1 is believed to limit or prevent the growth of new sesquiterpene esters also have immuno-stimulatory effects. blood vessels, making it useful to treat tumors. Research Echinacin has also been found to possess anti-fungal and Suggests that several of ginseng's active ingredients also antibiotic properties. This component of Echinacea also has have a beneficial influence on platelet aggregation. It also cortisone-like actions which can help promote the healing of demonstrates an anti-atherosclerotic action, apparently wounds and helps to control the inflammatory reactions. The mediated by a correction in the imbalance between prosta incorporation of this phytomedicine into compositions pro cyclin and thromboxane. Other studies that have found vides at least 70 active principles in a single therapeutic. panaxynol or the lipophilic fraction to be the most potent anti-platelet agent in ginseng, chiefly due to an inhibition of 0026 Ganoderma lucidum (Reishi, also G. tsugae, G. thromboxane formation. This possibly occurs via regulation valesiacum, G. Oregonense, G. resinaceum, G. pfezfferi, G. US 2008/008994.6 A1 Apr. 17, 2008

Oerstedli, and G. ahmadii) is an edible fungus containing ipe, T. nicaraguensis, T. Schunkeuigoi, T. Serratifolia, T. bitter triterpenoids (ganoderic acid), B-D-glucan, coumarins, altissima, T. palmeri, T impetiginosa, T. heptaphylla, alkaloids and ergosterols. It has vasodilator effect and is Gelseminum avellanedae, Handroanthus avellanedae, H. useful in the treatment of angina. It is hypolipidemic and impetiginosus, Tecoma adenophylla, Tec. avellanedae, Tec. anti-artherotic. It contains at least 32 active principles. eximia, Tec. impetiginosa, Tec. integra, Tec. ipe) extracts contain diverse quinone derivatives and a Small quantity of 0027 Grifola frondosa (Maitake, Dancing Mushroom; benzenoids and flavonoids, including beta-lapachone, Xyloi also G. SOrdulenta, Polyporus umbellatus and Meripilus done, tabebuin, quercetin, tecomine, and steroidal Saponins. giganteus) contains the primary polysaccharide, B-D-glucan One important ingredient is lapachol, a derivative of which in the 1.3 and 1.6 forms. It also contains alpha glucan, lipids, was patented in 1975. It has anti-inflammatory and antibac phospholipids, and ergosterol. Animal studies suggest terial effects. The incorporation of this phytomedicine into a maitake may lower serum cholesterol and triglycerides. composition provides at least 32 active principles in a single Beta-D-glucan is also recognized as an effective immuno therapeutic. stimulator. This Substance increases the activity of macroph ages and other immunocompetent cells that destroy tumor 0032 Uncaria tomentosa (Cat's Claw, Peruvian Cats cells. The Substance also improves the immunological effi Claw, Samento, Saventaro, Una de Gato, also Uncaria ciency of these cells by increasing production of cytokines guianensis) has several alkaloids including pentacyclic IL-1, IL-2 and lymphokines. The final result is an increase oxindole alkaloids (POA) (isomitraphylline, isopteropodine, of the defenses against infectious diseases. The incorpora mitraphylline, pteropodine, speciophylline, uncarine F), tet tion of this phytomedicine provides at least 6 active ingre racyclic oxindole alkaloids (TOA) (isorynchophylline, ryn dients for therapeutic use. chophylline), glycosides (triterpenic quinovic acid glyco sides), hirsutine, tannins, catechins, phytosterols (beta 0028 Hydrastis canadensis (golden seal, yellow root, sitosterol, campesterol, Stigmasterol), triterpenes, turmeric root) contains mainly isoquinoline alkaloids (Xan polyphenols, flavanols and oligomeric proanthocyanidins thopuccine, berberine, hidrastine, hidrastanine, beta-hydras (OPC). It is an immune-stimulant, an anti-inflammatory, tine, canadine and canadaline). These confer anti-inflamma vasodilator, and antioxidant. In laboratory testing, ryncho tory, bacteriostatic, bacteriocidal, and vasodilator effects. In phylline displays an ability to inhibit platelet aggregation general, its antibacterial action is directed to metabolic and thrombosis, Suggesting that cat's claw may be useful in inhibition, inhibition of the formation of enterotoxins, and preventing strokes and reducing the risk of heart attack by inhibition of bacterial adhesion. It produces vasodilatation lowering blood pressure, increasing circulation, inhibiting by inhibiting Smooth muscle contraction, and inhibiting formation of plaque on arterial walls and formation of blood platelet aggregation. This plant provides at least 34 active clots in the brain, heart and arteries. This phytomedicine principles for therapeutic use. provides at least 10 active ingredients. 0029 Petiveria alliacea (Anamu, Apacin, Apacina, Apa 0033 Petiveria Alliacea (Anamu, Apacin, Apacina, Apa Zote De Zorro, Aposin, Ave, Aveterinaryte, Calauchin, Chas Zote De Zorro, Aposin, Ave, Aveterinaryte, Calauchin, Chas ser Vermine, Congo Root, Douvant-douvant, Emeruaiuma, ser Vermine, Congo Root, Douvant-douvant, Emeruaiuma, Garlic Guinea Henweed, Guine, Guine, Guinea, Guinea hen Garlic Guinea Henweed, Guine, Guine, Guinea, Guinea hen leaf, Gully Root, Herbe Aux Poules, Hierba De Las Gall leaf, Gully Root, Herbe Aux Poules, Hierba De Las Gall initas, Huevo De Gato, Kojo Root, Kuan, Kuduruk, Lemte initas, Huevo De Gato, Kojo Root, Kuan, Kuduruk, Lemte wei, Lemuru, Mal Pouri, Mapurit, Mapurite, Mucura-caa, wei, Lemuru, Mal Pouri, Mapurit, Mapurite. Mucura-caa, Mucura, Mucuracaa, Ocano, Payche, Pipi, Tipi, Verbena Mucura, Mucuracaa, Ocano, Payche, Pipi, Tipi, Verbena Hedionda, Verveine Puante, Zorrillo) contains Allantoin, Hedionda, Verveine Puante, Zorrillo) contains Allantoin, Arborinol, Arborinoliso Astilbin, Benzaldehyde, Benzoic Arborinol, Arborinoliso Astilbin, Benzaldehyde, Benzoic acid Benzyl-2-hydroxy-5-ethyl-trisulfide, , Diben acid Benzyl-2-hydroxy-5-ethyl-trisulfide, Coumarin, Diben Zyl Trisulfide, Engeletin, alpha Friedelinol, Isoarborinol, Zyl Trisulfide, Engeletin, alpha Friedelinol, Isoarborinol, Isoarborinol-acetate, Isoarborinol-cinnamate, Isothiocyan Isoarborinol-acetate, Isoarborinol-cinnamate, Isothiocyan ates, Kno3, Leridal, Leridol, Leridol-5-methyl Ether, Ligno ates, Kno3, Leridal, Leridol, Leridol-5-methyl Ether, Ligno ceric Acid, Lignoceryl Alcohol, Lignoceryl Lignocerate, ceric Acid, Lignoceryl Alcohol, Lignoceryl Lignocerate, Linoleic Acid Myricitrin, Nonadecanoic Acid, Oleic Acid, Linoleic Acid Myricitrin, Nonadecanoic Acid, Oleic Acid, Palmitic Acid, Pinitol, Polyphenols, Proline,trans-n-methyl Palmitic Acid, Pinitol, Polyphenols, Proline,trans-n-methyl 4-methoxy, Senfol, B-Sitosterol, Stearic Acid, Tannins, and 4-methoxy, Senfol, B-Sitosterol, Stearic Acid, Tannins, and Trithiolaniacine. Its therapeutic activities include anti-in Trithiolaniacine. Its therapeutic activities includes anti-in flammatory, immune-stimulant and antimicrobial effects. flammatory, immuno-stimulant and antimicrobial. This phy This phytomedicine provides about 25 active principles. tomedicine provides about 25 active principles. 0030 Sutherlandia frutescens (Cancer Bush, also Suth 0034 Angelica sinensis (Dong quai or Angelica, also erlandia Microphylla) contains L-canavanine, pinitol, Angelica archangelia, Angelica pubescens and Angelica GABA (gamma aminobuteric acid), and asparagine. In addi Sylvestris) contains terpenes (terpenes, mainly B-phelland tion, novel triterpenoid glucoside known as “SU1” has been rene, with B-bisabolene, B-caryophyllene, B-phellandrene, isolated and characterized. The therapeutic indications C- and B-pinene, limonene, linalool, borneol, acetaldehyde, include anti-inflammatory, antioxidant, immuno-modulador, menthadienes and nitromenthadienes), macrocyclic lactones and vasodilator effects. This phytomedicine provide at least (including tridecanolide, 12-methyl tridecanolide, pentade 5 active principles. canolide), phthalates (such as hexamethylphthalate), cou 0031 Tabebuia avellanedae (Pau d’arco, Ipe, Lapacho, marins (especially furocoumarin glycosides such as Tahuari, Taheebo, Trumpet Tree, Tabebuia Ipe, Tajy; also T. marmesin and apterin), angelicin and byakangelicin deriva US 2008/008994.6 A1 Apr. 17, 2008

tives (osthol, umbelliferone, psoralen, bergapten, impera It is used to treat chronic venous insufficiency, varicose toren, Xanthotoxol. Xanthotoxin, oxypeucedanin and more), veins, and venous hypertension. Incorporation of this phy as well as various Sugars, plant acids, flavonoids, and sterols. tomedicine in a composition provides at least 59 active These components have vasodilator activity, increase coro principles in a single therapeutic. nary flow and are antithrombotic. The incorporation of this phytomedicine into compositions provides at least 70 active 0039) Ruscus aculeatus (Butcher's Broom, Box Holly, principles in a single therapeutic. Jews Myrtle, Knee Holly, Kneeholm, Pettigree, Sweet Broom) contains as primary active ingredients the steroidal 0035 Crataegus oxyacantha (Hawthorn, see also C. saponins (ruscogenin and neoruscogenin), but other con monogyna) contains mainly flavonoids (such as flavonogly cosyls, hyperoside, rutin, flavonol, kaempferol, quercetin) stituents have been isolated, including flavonoids, tetra and oligomeric procyanadins (1-epicatechol), which relax cosanoic acid, chrysophanic acid, sitosterol, campesterol, arterial expansion to decrease peripheral vascular resistance. Stigmasterol, triterpenes, coumarins, Sparteine, tyramine, Also contains amines (phenyletylamine, tyramine, O-meth and glycolic acid. Its ingredients reduce vascular permeabil oxyphenethylamine), flavone (apigenin, luteolin) deriva ity, have anti-elastic properties and are vasoconstrictors. The tives, Vitexin glycosides, tannins, Saponins, and cyanoge incorporation of this phytomedicine in a composition pro netic glycosides. The incorporation of this phytomedicine vides at least 28 active agents. into a composition provides at least 52 active principles in a single therapeutic plant. 0040 Vaccinium myrtillus (European blueberry or bil berry, closely related to American blueberry, cranberry, and 0.036 Croton lechleri (Dragon's blood, Sangre de Grado, huckleberry) contains anthocyanosides Such as: cianadins, Sangre de Agua; also C. draconoides, C. palanostigma, C. malvidins, petunidins and peonidins. Other ingredients erythrochilus C. salutaris, and C. gossypifolius) produces a include arbutin, asperuloside, astragalin, beta-amyrin, caf distinctive red exudate from its trunk containing a consid feic-acid, catechin, chlorogenic-acid, cyanadin-3-O-arabi erable amount of secondary plant metabolites, the majority noside, dihydroxycinnamic-acid, epicatechin, epigallocat of which are hydrolyzing flavonoids, proanthocyanidins echin, epimyrtine, ferulic-acid, gallic-acid, gallocatechin, (mainly catechin, epicatechin, gallocatechin and/or galloepi hydroquinone, hyperoside, isoquercitrin, lutein, coumaric catechin), as well as taspine. Other components include the acids, m-hydroxybenzoic-acid, monotropein, myrtillin, myr dihydrobenzofuran lignan, six simple phenols and their tillol, myrtine, neomyrtillin, protocatechuic-acid, quercetins, derivatives, three steroids, non-saturated fatty acids, diter quinic-acid, resinic-acid, Syringic-acid, ursolic-acid, and penoids (hardwickiic acid, bincatriol, crollechinol, crole Vanillic-acid. Evidence Suggests that anthocyanosides may chinic acid, coberine A, coberine B), and diterpenoids. It benefit the retina, as well as strengthen the walls of blood heals wounds and ulcers of vascular origin. Incorporation of vessels, reduce inflammation, and Stabilize collagen con this phytomedicine into a composition provides at least 23 taining tissues. The anthocyanosides improve the activity of active principles in a single therapeutic. enzymes lactic dehydrogenase, glucose-6-phosphatase and phosphoglucomutase, each involved in processes of vascular 0037 Ginkgo biloba (Ginkgo) contains ginkgolides, bilo damage. They reduce the arterial deposits and stimulate the balides, bioflavones and flavone glycosides. Flavone glyco production of vasodilators, like prostaglandin (PG12), thus sides include quercetin, 3-methylguercetin and kaempferol. protecting the vascular wall. Anthocyanosides have strong Quercetin, myrcetin and the rest of the flavonoid fraction of antioxidant properties, as well. The incorporation of this the extract have antioxidant and free radical Scavenger phytomedicine into a composition provides at least 63 active effects. The flavonoids diminish infiltration by neutrophils principles in a single therapeutic. and increase blood flow. Their antioxidant properties and membrane Stabilizing activity increase the tolerance to hypoxia. They improve cellular metabolism and protect EXAMPLE 2 against the damage caused by ischemia. Ginkgolide B is a powerful inhibitor of platelet activating factor (PAF), bind Composition Circulatory Disorders ing to its membrane receptors, and antagonizing platelet 0041 A particularly preferred composition is shown in aggregation. Similarly, it has anti-inflammatory effect by Table 1. Ratios reflect the concentration of active ingredient decreasing vascular permeability, and has vasodilator activ over the natural state, and the amounts provided are mg of ity by inhibiting the liberation of thromboxane B2 and extract. Obviously, the amount should be increased where prostaglandins. Controlled double blind clinical studies con the strength is reduced, and Vice versa. clusively demonstrate the effectiveness of Gingko biloba in treating peripheral arterial insufficiency. The incorporation of this phytomedicine into a composition provides at least 59 TABLE 1. active principles in a single therapeutic. Herbaria 0038 Hydrocotyle asiatica (Gotu Kola, Bramhi, Penny Active Agent Ratio Amount (mg) wort, Marsh Penny, Pennywort; also Hydrocotile asiatica asiatica) contain terpenoids (triterpenes, asiaticoside, brah Energy enhancers moside and brahminosidea, (Saponin glycosides) aglycones, Eleutherococci is senticosits root extract 5:1 53.53 asiaticentoic acid, centellic acid, centoic acid and madecas Rhaponticum carthamoides root extract 12:1 3.85 Panax ginseng root extract 5:1 10.71 sic acid), sesquiterpenes (caryophyllene, trans-B-farnesene), Panax quinquefoil is root extract 5:1 32.12 volatile oils (Germacrene D), alkaloids (hydrocotylin), fla Pfafia paniculada (Suma) root extract 4:1 21.41 vones (Quercetin, kaempferol, sesquiterpenes, Stigmasterol, Rhodioia rosea root extract 5:1 9.64 and sitosterol), and Vallerine, fatty acids, resin, and tannins. US 2008/008994.6 A1 Apr. 17, 2008

immune-stimulants and anti-inflammatory by stimulating TABLE 1-continued the phagocytic activity of macrophages, of the cytotoxic response of T and NK lymphocytes and of the production Herbaria and activity of interferon; and astragalans which act as Active Agent Ratio Amount (mg) modulators of the hypothalamus-hypofisis-adrenal axis response. Bio-Intelligence modulators 0046 Echinacea See above. Echinacea anguistifolia root extract 6: 1.34 Echinacea purpurea root extract 6: 1.34 0047 Dioscorea villosa (Rheumatism root, huesos del Ganoderma iucidum extract 6: 32.12 dialo, Yuma, Yam, Wild Yam, Chinese Yam, Mexican Yam, Grifolia frondosa extract 10: 12.85 raiz, china, and colic root) contains steroid Sapogenins (dios Hydrastis canadensis root extract 5: 38.54 cine, dioScorin and diosgenine) as the main active principles. Peiiveria aiiacea 1: 64.24 Sutherlandia frutescens 1: 64.24 Diosgenine can change into ecdysone, pregnenolone, and Tabebuia a veilianedae bark extract 4: 40.15 progesterone, thus, diosgenine is a hormonal precursor, Uncaria tomentosa root extract 10: 16.06 which contributes to the neuroendocrine system's modula Organization improvers tion. On the other hand, diosgenine has demonstrated its Angelica Sinensis root extract 5: 64.24 important pro-apoptotic effects, in the therapy of benign and Crataegus Oxyacantha fruit extract 5: 42.83 malign tumors, including mamrinary and ovarian cysts, and Croton lechieri bark resin extract 10: 10.71 uterine fibroids. Ginkgo biloba leaf extract 50: 1949 Hydrocotyle asiatica plant extract 5: 64.24 0048 Ganoderma lucidum and Grifola frondosa The Riiscus actileathis root extract 5: 57.82 main active principles of these mushrooms are sterols and Vaccinium myrtilius fruit extract 5: 38.54 beta-proteoglucans which bestow anti-inflammatory and immune-modulating properties, because they increase the Total 700 mg phagocytotic capacity of macrophages and increase the production and lifespan of CD4 lymphocytes. 0049 Tabebuia avellanedae contains diverse substances EXAMPLE 3 derived from quinones, such as Alfa and Beta lapachone 2-hydroxi-3-(3-metil-2-butenil)-1,4-naftoquinona and Plant Characteristics—Female Endocrine Disorders cyclopentane dialdehydes. These confer important anti-in 0042 Panax quinquefolius The active principles respon flammatory, pro-apoptotic, antimitotic and cytostatic effects, sible for its therapeutic effects are triterpensaponides, of in treating benign and malign tumors including mammary which more than 25 different types have been identified. and ovarian cysts as well as uterine fibroids. These are denominated protopanaxadiols (ginsenosides Ric, 0050 Uncaria tomentosa See above. Rd., Rb1, Rb2) and protopanaxatriols (ginsenosides —Re, 0051 Vitex agnus castus (Chaste Tree or chaste berry) An —Rf. —Rg1, etc.). Panax also contains hydroSoluble essential oil is extracted from the fruit of this plant, two polysaccharides (panaxans A-U) and polyacetylenes (ginse iridoid glycosides (aucubine and agnuside); a flavone (cas nosides A-K, panaxynol and panaxatriol). These substances ticine, which seems to be the primary active principle) and confer energizing properties because they increase ATP 3 minor flavonoids derived from kaempferol and quercetin. synthesis. On the other hand they reduce the secretion of These active principles act on the anterior hypofisis dopam prolactin by increasing dopaminergic activity or by activat inergic-D2 receptors, modulating prolactin Secretion. This ing dopamine receptors at the anterior hipophysis level. hormone is implicated in the appearance of anovulatory Prolactin is a hormone involved in the appearance of ano cycles and dysfunctional uterine hemorrhages, menorrhea, Vulatory cycles and dysfunctional uterine hemorrhages, mammary fibrocystic condition, and cyclic mastalgy. Vitex menorrhea, mammary fibrocystic condition, and cyclic mas agnus castus modulates the Secretion of LH from the hypofi talgy. The reduction of this hormone explains the recovery sis, which act on the ovary, starting up the luteal phase and in the treatment of uterine dysfunctional hemorrhages, Poly progesterone secretion. Therefore, Vitex benefits dysfunc cystic Ovary Syndrome (PCOS). Ovary Cysts, fibromyoma tional uterine hemorrhages, premenstrual syndrome, PCOS, tous uteri, and infertility. infertility, ovary cysts, menopause, and fibromyomatous 0.043 Pfaffia paniculata. Its most important active prin uteri. ciples are: Beta-ecdysone and three glycoside ecdysteroids, 0052 Hydrocotile asiatica See above. Also, the active six different pfaffic acids, phytosterols and nortriterpenic principles include pentacyclic triterpene Saponins. The glycosides. These Substances are energizing through an major active principles are asiaticosides and madecassos increase in ATP synthesis and oxygenation at the cellular ides. Other minor saponins are the centelloside, brahmo level. Also, its phytosterols act as hormone originators, and sides, brahminosides and Hydrocotile asiatica Saponins B, C have demonstrated effectiveness in the management of and D. Mucopolysaccharides are the core components of the diverse conditions associated with hormone imbalance. Such cellular matrix. The biochemical action of these active as: premenstrual syndrome, dysmenorrhea, infertility, dys principles reduce the levels of lysosomal enzymes associ functional uterine hemorrhages, and menopause. ated with the degradation of mucopolysaccharides. On the other hand, the active agents act on the fibroblasts of the 0044 Rhodiola rosea See above. connective tissue, modulating collagen synthesis and inhib 0045 Astragalus membranaceus (Huang-Qi) This plant iting inflammatory processes. This diminishes the fibrosis contains three main types of active principles. Isoflavones, processes important to fibrocystic mammary and uterine which act as anti-oxidants; astragalans which act as conditions. US 2008/008994.6 A1 Apr. 17, 2008

EXAMPLE 4 not known, studies suggest that they stimulate the immune systems and activate macrophages. Composition Female Endocrine Disorders 0059 Angelica sinensis contains alkyl phthalides 0053 A particularly preferred composition is shown in (Ligustilide); terpenes, phenylpropanoids (ferulic acid) and Table 2. benzenoids. These Substances stimulate the immune sys tems actions, through diverse lymphokines and have an TABLE 2 anti-inflammatory effect by inhibiting 5-lipoxygenase and elastase, as well as selectively inhibiting 12-(S)-HHTrE Herbaria II production, a marker of cyclo-oxygenase activity. Amount 0060 Astragalus membranaceus See above. Also, Active Agent Ratio (mg) Astragalus membranaceus inhibits 5-lipoxygenase and Energy enhancers elastase, which indicates that it is valuable in the manage ment of skin pathologies involving chronic inflammation, Rhodioia rosea root extract 5: 8.16 Panax quinquefolius root extract 4: 67.97 Such as psoriasis. Pfaffia paniculada (Suma) 4: 5437 Bio-Intelligence modulators 0061 Echinacea See above. Astragalus membrenacetis root extract 5: 73.41 0062 Hydrastis canadensis The most important active Echinacea anguistifolia 6: 20.39 principles of Hydrastis are isoquinoline alcaloides (Berbe Echinacea anguistifolia radix 6: 340 rina, hydrastina, Hidrastanina, Canadina, Canadalina) which Echinacea purpurea 6: 20.39 award anti-inflammatory, and immuno-modulating proper Echinacea purpurea radix 6: 340 Dioscorea viliosa 4: 125.74 ties. Berberine inhibits activating protein 1 (AP-1), a key Ganoderma iticidum extract 6: 36.25 factor in transcription the inflammation. It also exerts a Grifolia fondosa mushroom extract 10: 21.75 significant inhibitory effect on lymphocyte transformation, Tabebuia a veianedae 4: 67.97 So its anti-inflammatory action seems to be due to the Uncaria tomentosa 10: 24.47 Vitex agnus Castus 5: 57.09 inhibition of DNA synthesis in the activated lymphocytes or Organization improvers to the inhibition of the liberation of arachidonic acid from the phospholipids of the cellular membrane. It also has Hydrocotile asiatica asiatica 5: 65.25 immuno-modulating properties by increasing the production of immunoglobulins G and M and stimulating the phago Total 6SO cytotic capacity of macrophages. 0063 Ganoderma lucidum The main active principles of EXAMPLE 5 this mushroom are sterols and beta-proteoglucans that bestow anti-inflammatory and immune-modulating proper Plant Characteristics—Dermal Disorders ties by increasing the phagocytotic capacity of macrophages and raising production and lifespan of CD4 lymphocytes. 0054 Lepidium meyenii (Maca) Its major active prin ciples are: alkaloids (Macaridina, Lepidiline A and B); 0064. Uncaria tomentosa see above. benzyl-isotiocyanate and glucosinolates; macamides; Beta 0065 Equisetum arvense (Horse tail) This plant contains ecdysone and phytosterols. These substances activate ATP abundant mineral salts particularly silicic acids and silicates. synthesis which confers energizing properties. It also contains phytosterols, phenolic acids, flavonoids 0.055 Rhaponticum carthamoides See above. (mainly quercetin glycosides and apigenine) and Saponins (equisetonin). These active principles block the liberation of 0056 Panax ginseng The active principles responsible arachidonic acid, which diminishes inflammation and for its therapeutic effects are triterpensaponides of which reduces the proliferation of keratinocytes, as well as induc more than 25 different types have been identified. These ing G2/M arrest in keratinocytes. The action mechanism is include protopanaxadiols (ginsenosides Rc, Rd, Rb1, Rb2) in part due to the inhibition of mitotic kinase activity of and protopanaxatriols (ginsenosides -Re, -Rf, -Rg1, etc.). p34cd2 and perturbation of cyclin B1 levels. Panax also contains hydroSoluble polysaccharides (panax ans A-U) and polyacetylenes (ginsenosides A-K, panaxynol 0066 Hydrocotile asiatica See above. and panaxatriol). These Substances confer energizing prop 0067 Tabebuia avellanedae contains diverse quinone erties because they increase ATP synthesis. derivatives such as alpha and beta-lapachone, cyclopentane 0057 Rhodiola rosea See above. Also, the active prin dialdehydes and a small quantity of benzenoids and fla ciples in this plant (phenylpropanoids, phenylethanol deriva vonoids, including, Xyloidone, tabebuin, quercetin, tecom tives, flavonoids, monoterpenes and phenolic acids) activate ine, and steroidal saponins. These compounds inhibit kera the synthesis of ATP in mitochondria and stimulate repara tinocyte growth and offer anti-inflammatory and tive energy processes. antibacterial effects, which are of great importance in the 0.058 Andrographis paniculata (King of Bitters, treatment of psoriasis. Chirettta, Kalmegh and Kiryat) Primary active principles 0068 Shilajit (Mumiyo) Mumiyo is a natural complex associated with Andrographis are: flavonoids, glucosides Substance, whose active principles are carboxylic acids: and diterpenic lactones (andrographolides). These Sub (hydroxylated derivatives of Benzoic, Phenylacetic and Hip stances offer immuno-modulator and anti-inflammatory puric acids), fulvic and humic acids, minerals and amino properties. Even though their precise mechanism of action is acids. Of Mumiyo's known properties, the most important US 2008/008994.6 A1 Apr. 17, 2008 ones are its ability to reduce excessive inflammatory reac beta-glucuronidase enzymes, thus improving glucoroniza tions and stimulate tissue regeneration. Oral intake of tion, which is an important step in hepatic detoxification. Mumiyo has been used to treat burns, trophic non-healing More corporal toxins are removed via glucoronization than wounds, eczema, and other skin diseases, such as psoriasis. through other detox pathways. It has been established that fulvic/humic acids stimulate 0072 Picrorhiza kurroa. The most important active con respiration and oxidative phosphorylation in liver mitochon stituents are iridoid glycoside picrosides I, II, III and kut dria, increase mechanical resistance of collagen fibers, acti koside, known collectively as kutkin. Though less well vate human leucocytes, reduce excessive inflammatory reac researched than Silybum, it appears to have similar applica tions, and stimulate tissue regeneration. tions and mechanisms of action. When compared with 0069. Shark cartilage This natural compound reduces Silybum, the curative efficacy of Picrorhiza was found to be psoriatic plaque vascularization. It inhibits the proliferation similar, or in many cases Superior, to the effect of Silybum. of endothelial cells, competitively blocking the Endothelial Picrorrhiza possesses significant antioxidant activity, by Growth Factor at the receptor level. It also inhibits tyrosine reducing lipid peroxidation and free radical damage. Like EGF and EGF-2 dependant phosphorylation as well as the sylimarin, it has also an effect on liver regeneration. Picr increase of FCE induced permeability. Shark cartilage also orrhiza also offers anti-inflammatory effects, inhibiting the induces endothelial cell apoptosis, by inducing caspase 3, 8 infiltration of pro-inflammatory cells. One of its minor and 9 activation, and the liberation of cytochrome c from the components, apocynin exhibits powerful anti-inflammatory mitochondria to the cytoplasm. Shark cartilage also induces effects, without affecting beneficial activities Such as phago fibrinolitic activity by increasing the secretion, activity and cytosis, chemotaxis or humoral immunity. affinity of Tissue Plasminogen Activator (tPA) for endothe 0073. Smilax spp. (sarsaparilla) Its main active principles lial cells. It also inhibits extracellular matrix degradation, by are: phytosterols, Steroid Saponins, Phenolic acids, Fla inhibiting matrix metalloproteinases MMP-2, MMP-7, vonoids and minerals. These substances adhere to toxins MMP-9, MMP-12 and MMP-13. It also stimulates produc inside the gastrointestinal tract, this way reducing their tion of angiostatin. absorption by the circulatory stream. On the other hand it 0070 Schizandra chinensis The major active principles improves the hepatic and renal excretory functions, facili of Schizandra (also known as Wuweizi and Wurenchum) are tating the removal of toxic Substances and waste found in lignans called Schizandrines. These Substances have known cells, blood vessels and lymphatic system. Also, phytoster hepato-protective and hepato-regenerative properties. It ols block prostaglandin synthetase action, explaining its maintains the integrity of hepatocyte cellular membranes; anti-inflammatory action and use to treat psoriasis. increases hepatic levels of ascorbic acid; inhibits NADPH 0074 Vaccinium myrtillus Angiogenesis appears to be a oxidation; inhibits lipid peroxidation at the hepatic microso fundamental inflammatory response early in the pathogen mal level as well as formation of hepatic malondialdehyde; esis of psoriasis and significant abnormalities of vascular diminishes production of carbon monoxide at the hepatic morphology and vascular endothelial growth factor (VEGF) level; has an inductor effect in the enzymatic anti-toxic play a crucial role in the vascularization of psoriatic plaques. microsomal hepatic cytochrome P-450; increases biliary During inflammatory skin diseases such as psoriasis, the flow and the excretion of toxic Substances; promotes recov skin initiates angiogenesis through VEGF and the active ery of hepatic functions; induces mRNA formation for the principles of this plant (anthocyanosides, flavonoids, quer Hepatocyte Growth Factor (HGF); encourages the prolifera cetin, tannins, iridoids and phenolic acids) significantly tion of the hepatocyte's endoplasmic Smooth reticula, and inhibit VEGF expression by the human keratinocytes, reduc accelerates the proliferation of hepatocytes; increases orni ing the psoriatic plaque’s angiogenesis. thine decarboxylase activity as well as the mitotic index, facilitates DNA synthesis and hepatic proteins; increases levels of glutathione, glutathione reductase and glucose-6- EXAMPLE 6 phosphate, improving the regeneration capacity of the liver. Composition-Dermal Disorders 0071 Silybum marianum (Milk Thistle) The active prin 0075) A particularly preferred composition is shown in ciples of this plant are flavonolignans, including silibine, Table 3. silicristine and silidianine and isosilibinin collectively known as Sylimarin. This compound has the highest grade of hepato-protective, hepato-generating, and anti-inflammatory TABLE 3 activity. The mechanisms which explain its hepato-protector Herbaria characteristics are diverse and include anti-oxidation, lipid anti-peroxidation, detoxification increase through a com Active Agent Ratio Amount (mg) petitive inhibition with toxic substances, as well as protec Energy enhancers tion against the depletion of glutathione. One of the mecha nisms that can explain its hepato-regenerative properties is Rhaponticum carthamoides root extract 6:1 0.72 Rhodioia rosea root extract 5:1 9.66 the increase in protein synthesis, obtained thanks to a Szchisandra chinensis 5:1 16.10 significant boost in the formation of ribosomes, DNA syn Bio-Intelligence modulators thesis and proteins at the hepatic level, because the active principles join a specific polymerase receptor, stimulating Angelica Sinensis 5:1 32.2O Astragalus membranacetis root extract 5:1 48.30 ribosome formation. Its anti-inflammatory effect is due to Echinacea anguistifolia 6:1 8.05 the stabilization of the mastocytes, the inhibition of neutro Echinacea anguistifolia radix 6:1 1.34 phils, a strong inhibition of leucotriene (LT) synthesis and Echinacea purpurea 6:1 8.05 formation of prostaglandins. Sylimarin inhibits intestinal US 2008/008994.6 A1 Apr. 17, 2008

TABLE 3-continued TABLE 4

Herbaria Diabetic Foot Lesion Study Active Agent Ratio Amount (mg) Number of Clinical QoL* Treatment Echinacea purpurea radix 5: 1.61 Patients Improvement Improvement tolerance Other Ganoderma iucidum mushroom extract 6: 35.78 Hydrastis Canadensis 5: 19.32 Lepidium meyenii 5: 48.30 110 80.9% 86.4% 97.3% Amputation Panax ginseng root extract 5: 16.10 (89 patients) (95 patients) (107 patients) avoided in 80% Silbum marianum 5: 28.98 of the cases Shark Cartilage extract 4: 93.92 Tabebuia a veilianedae 4: 67.08 diagnosed for Uncaria tomentosa 10: 14.49 Surgery Organization enhancers Equisetum arvense 5: 22.54 *QoL is Quality of Life Fulvic Acid -Shilajit 65% 1: 13.95 Hydrocotile asiatica 5: 42.94 Picrorhiza kurroa (Standardized 4% Kutkin) 5: 32.2O 0079. It is significant to note that the herbaria treatment Smilax officinialis 5: 72.45 prevented amputation in 40 patients (80% of the population) Vaccinium mirtylius 5: 16.10 who were already diagnosed for Surgical removal of portions Total 6SO of the foot. In contrast, in the usual course of standard medical treatment, almost 100% of these patients could have expected to have a partial or complete amputation. Thus, EXAMPLE 7 these Superior results are quite unexpected and clearly demonstrate the novel and non-obvious qualities of the formulation. Tolerance Studies 0.076 A multicentric, retrospective study was made on 0080. Likewise, 129 patients with chronic varicose ulcers 100 healthy volunteers with the intention of evaluating were evaluated. The treatment (six 700 mg capsules three patient tolerance and side effects of the herbaria combina times a day) improved ulcers in 79% of the population, and tion. A capsule containing 700 mg of the herbaria of Table remission was achieved in 21% of the population in only two 1 was administered to each participant three times per day months (Table 5). The systemic treatment also significantly for five days. During that period they were evaluated by a improved the most frequent symptoms (cramps 71.4%, pain physician, who registered any finding or symptom reported 78%, and edema 88.7%). In contrast, most patients with by each subject. The average age of the participants was 37.4 chronic varicose ulcers do not achieve remission under years with a SD of 8.2 years. Gender was 55% female, 45% existing pharmaceutical treatments and have high risk of male. The average weight of the subjects was 70 kilos with amputation. a SD of 12.3 kilos. No undesirable effects were observed in 96% of the subjects. Four (4%) subjects reported minor TABLE 5 undesirable effects. Chronic Varicose Ulcer Study 0077. The study showed that herbaria were well toler Number of Clinical QoL Treatment Remission ated-only minor symptoms were reported by 4 of the 100 Patients Improvement Improvement tolerance time subjects. These results showed the non-toxicity of the her 129 79% 81.2% 99.2% 2 months (102 patients) (105 patients) (128 patients) in 21% baria, demonstrating that the formulation is safe. Similar of all results have been obtained for the PCOS and Psoriasis patients formulations.

EXAMPLE 8 0081. In a study of 35 patients with Polycystic Ovary syndrome (PCOS), the treatment improved pelvic pain in all Clinical Studies 20 symptomatic patients, menstrual disorder (amenorrhea, 0078. To evaluate the efficacy of the combination, 110 dysmenorrhea, menometrorrhea, oligomenorrhea) in all 22 patients affected with diverse degrees of lesions of the symptomatic patients, asthenia and cephalea in all 17 Symp diabetic foot, were studied by means of retrospective, mul tomatic patients, as well as acne and hirsutism in 8 of 9 ticentric, and descriptive study for two year duration. Of symptomatic patients. Pelvic echo Sonograms revealed that these patients, 50 had grade III-V lesions, and were diag 29 patients (82.9%) experienced a total disappearance of nosed for Surgical amputation of the affected area. The cysts, while another 6 (17.2%) showed a decrease in cyst patients were treated as above, with ten 700 mg capsule of size. In contrast, most patients with PCOS do not achieve herbaria three times a day, but the treatment was continued symptomatic relief without Surgical intervention, and very on an as needed basis for times ranging from 1.5 months to few, if any, have a complete disappearance of cysts (Table 10 months. The data is summarized in Table 4. 6). The dosage was six 650 mg capsules three times a day. US 2008/008994.6 A1 Apr. 17, 2008

0083. In conclusion, these results indicate that synergistic TABLE 6 combinations of phytoceuticals, scientifically chosen from each category of herbal tonics described in the next section, Polycystic Ovary Syndrome Study is suprisingly effective

EXAMPLE 9 Number of Clinical Cyst QoL Treatment Patients Improvement Disappearance Improvement tolerance Principles for Selecting Synergistic Combinations 35 100% 82.9% 100% 100% 0084. In order to expand the range of formulations (29 patients) encompassed by the invention, we have categorized benefi cial plants into one of three groups, each of which should be present for Synergistic effect. The classifications are Energy, 0082 Similarly, in a study of 123 patients with severe Bio-Intelligence and Organization. Plants classified under psoriasis, clinical remission was observed in 77% of the Energy are associated with ATP synthesis (such as the Krebs patients, and almost two thirds of the patients achieved cycle, oxidative phosphorylation, beta-oxidation, etc.). clinical improvement in less than 45 days (Table 7). In Plants classified under Bio-Intelligence are those that regu contrast, most patients with severe psoriasis do not achieve late the neuroendocrine and immunological systems and remission, but only symptomatic relief with existing phar cellular processes, thus controlling the interactions between maceutical approaches. The dosage was seven 650 mg the various systems in the body. Finally, plants classified under Organization are those that relate to the structure and capsules three times a day. function of specific organs. Combinations of plants from these three classification groups have synergistic effect TABLE 7 because they address each necessary component of cellular and organic health in effect they provide the triangle on Severe Psoriasis Study which healing is fully supported. Number of Clinical QoL Treatment Remission time 0085. A large group of plants were classified (along with Patients Improvement Improvement tolerance s45 days Some vitamins, etc.) according to this system, based on what is known in the literature about their active ingredients and 123 77.29% 66.3% 100% 82.9% mode of action. The classification is presented in Table 8. (95 patients) (102 patients) Table 8 is representative only: based on the criterion described herein, additional plants can easily be categorized as their mode of action is elucidated.

TABLE 8 Plant Categories Energy Bio-Intelligence Organization Acantopanacis Senaticosits Agaricits blazei Angelica Sinensis Aiiiga turkestanica Aloe Vera Bupierum chinense Codonopsis piloStila Andrographis paniculata Clinicifiiga racemosa Cordyceps Sinensis Annona intificata Chitin fiber Cornu Cervi pantotrichum Araia mandschurica Chondroitin Sulphate Ilex paragliariensis Astragalus membranacetis Crataegus Oxyacantha L-arginine Beta 1.3 glucan Croton lechieri Lepidium meyenii Beta 1.6 glucan Curcubita pepo Ocintin Sanctum Camelia Sinensis Circiima longa Panax ginseng Corioius versicolor Dioscorea viliosa Panax quinquefolius Echinacea anguistifolia Equisetum arvense Pfafia paniculata Echinacea purpurea Eucommia bark Ptychopetalum oiacoides Ganoderma iticidum Fructus ligustri lucidum Rhaponticum carthamoides Grifolia fondosa Fructus lycii Rhodioia rosea Hydrastis Canadensis Fulvic acid Schizandra chinensis Lactoferrin Gentiana littea Ubiquinone (Coenzime Q10) Leniiniis edodes Ginkgo biloba Lobostomon trigonus Glucosamine Morinda citrifolia Glycyrrhiza glabra Peiiveria aiiacea Gynostemma Polygonum multiflorum radix Harpagophytum proclimbens Radix apeoniae alba Herba epimedii Radix polygalae Hydrocotile asiatica Shark cartilage Lintin itsitatissiniin Sutherlandia frutescens Minerals Tabebuia a veianedae Mumiyo US 2008/008994.6 A1 Apr. 17, 2008 10

TABLE 8-continued Plant Categories Energy Bio-Intelligence Organization Turnera aphrodisiaca Opiinitia fictis indica Uncaria tomentosa Picrorhiza kurroa Valeriana officinalis Plants enzymes Vitex agnus Castus Ptycopetailin oiacoides Pygeum africant in Rhamnus purshiana Riiscus actileatus Saix aiba Sargassum fitsiforme Sena alejandrina Serenoa repens Siibun marianum Similax china Soiant in nigrum Tributius terrestris Ulmus fulva Urtica dioica Uva ursi Vaccinium myrthillus Viburnum spp Vitamins

0.086 An illustrative example of synergy in medicinal synergy when the formulations of the invention are com plants is an in vitro study that demonstrates how the activity bined with existing pharmaceuticals, such as antibiotics. of herbal Berberine alkaloids is strongly potentiated by the action of herbal 5'-methoxyhydnocarpin (5-MHC). It shows What is claimed is: a strong increase of accumulation of berberine in the cells in 1. A synergistic phytoceutical composition comprising: the presence of 5'-MHC, indicating that this plant compound a) at least two plants selected from the group consisting of effectively disabled the bacterial resistance mechanism Acantopanacis, Ajuga, Codonopsis, Cordyceps, Cornu against the berberine antimicrobial, thus showing the Syn Cervi pantrotichum, Ilex, L-arginine, Lepidium, Oci ergy of both substances. Stermitz F R, et al., Synergy in a mum, Panax, Pfaffia, Ptychopetalum, Rhaponticum, medicinal plant: antimicrobial action of berberine potenti ated by 5'-methoxyhydnocarpin, a multidrug pump inhibitor. Rhodiola, and Schizandra, Proc Natl Acad Sci USA. 2000 Feb. 15: 97(4): 1433-7. b) plus at least two plants selected from the group 0087 We expect to further demonstrate synergistic effect consisting of Agaricus, Aloe, Andrographis, Annona, on a molecular scale by studying the gene expression profile Aralia, Astragalus, Camelia, Coriolus, Echinacea, changes in response to various plant ingredients and com Ganoderma, Grifola, Hydrastis, Lactoferrin, Lentinus, binations thereof. Experiments are already underway dem Lobostemon, Morinda, Petiveria, Polygonum multiflo onstrating the expression profile in response to the formu rum radix, Radix apeoniae alba, Radix polygalae, Suth lations. We will be aided in this work because researchers erlandia, Tabebuia, Tumera, Uncaria, Valeriana and have already begun studying the expression profiles of Vitex Uncaria, various medicinal plants, thus providing a database of c) plus at least two plants selected from the group con knowledge from which to build. E.g., Gohil, et al., mRNA sisting of Angelica, Bupleurum, Cimicifiuga, Chitin Expression Profile of a Human Cancer Cell Line in fiber, Chondroitin Sulfate, Crataegus, Croton, Curcu Response to Ginkgo Biloba Extract: Induction of Antioxi bita, Curcuma, Dioscorea, Equisetum, Eucommia bark, dant Response and the Golgi System, Free Radic Res. 2001 Fructus ligustri lucidum, Fructus lycii, Gentiana, December; 33(6):831-849. Ginkgo, Glucosamin, Glycyrrhiza, Gynostemma, 0088 We may also test combinations of plants for syn Harpagophytum, Herba epimedii, Hydrocotile, Linum, ergistic effects by using the mouse model for diabetic Minerals, Mumiyo, Opuntia ficus, Picrorhiza, Plant lesions, as described in Mastropaolo, et al., Synergy in enzymes, Ptycopetalum, Pygeum, Rhamnus, Ruscus, Polymicrobial Infections in a Mouse Model of Type 2 Salix, Sargassum, Sena, Serenoa, Silibum, Smilax, Diabetes Infection and Immunity, September 2005, p. 6055 Solanum, Tribulus, Ulmus, Urtica, Uva ursi, Vac 6063, Vol. 73, No. 9. Briefly, obese diabetic mouse strain cinium, and Viburnum, BKS.Cg-m +/- Leprodb/J are injected subcutaneously with d) together with pharmaceutically acceptable excipients mixed cultures containing Escherichia coli, Bacteroides or carriers. fragilis, and Clostridium perfingens. Progression of the 2. The synergistic phytoceutical composition of claim 1 infection (usually abscess formation) is monitored by exam ining mice for bacterial populations and numbers of white further comprising: blood cells at 1, 8, and 22 days post-infection. Various plant a) at least two plants or nutraceuticals selected from the ingredients and combinations thereof can be used to show a group consisting of Acantopanacis Senticosus, Ajuga synergistic effect. Further, the model can be used to show turkestanica, Codonopsis pilosula, Cordyceps sinensis, US 2008/008994.6 A1 Apr. 17, 2008 11

Comu Cervipantrotichum, Ilex paraguariensis, L-argi Pfaffia, Panax, Hydrocotile asiatica, together with pharma nine, Lepidium meyenii, Ocimum sanctum, Panax gin ceutically acceptable excipients. seng, Panax quinquefolius, Pfaffia paniculata, Ptycho 7. The phytoceutical composition of claim 6 further petalum Olacoides, Rhaponticum carthamoides, comprising Rhodiola rosea, Vitex agnus castus, Echinacea Rhodiola rosea, Schizandra chinensis, and Ubiquinone angustifolia, Echinacea angustifolia radix, Echinacea pur (Coenzyme Q10); purea, Echinacea purpurea radix, Astragilus membrana ceous, Uncaria tomentosa, Grifola frondosa, Dioscorea b) plus at least two plants or nutraceuticals selected from villosa, Tabebuia avellanedae, Pfaffia paniculata, Panax the group consisting of Agaricus blazei, Aloe vera, quinquefolius, Hydrocotile asiatica asiatica. Andrographis peniculata, Annona muricata, Aralia 8. The phytoceutical composition of claim 6, comprising Mandshurica, Astragalus membranaceus, Beta 1.3 glu the relative amounts of ingredients shown in Table 2. can, Beta 1.6 glucan, Camelia sinensis, Coriolus ver 9. The phytoceutical composition of claim 1, comprising sicolor, Echinacea angustifolia, Echinacea purpurea, plants or extracts or active ingredients derived from each of Ganoderma lucidum, Grifola frandosa, Hydrastis the following plants: Rhaponticum, Rhodiola, Szchisandra, Canadensis, Lactoferrin, Lentinus edodes, Lobostemon Angelica, Astragalus, Echinacea, Ganoderma, Hydrastism, trigonus, Morinda citrifolia, Petiveria alliacea, Lepidium, Panax, Silibum, Tabebuia, Uncaria, Equisetum, Polygonum multiflorum radix, Radix apeoniae alba, Hydrocotile, Picrorhiza, Smilax, and Vaccinium, plus shark Radix polygalae, Shark Cartilage, Sutherlandia frute cartilage and Fulvic Acid, together with pharmaceutically scens, Tabebuia avellanedae, Turnera aphrodisiaca, acceptable excipients. Uncaria tomentosa, Valeriana officinalis and Vitex 10. The phytoceutical composition of claim 9, comprising agnus Castus, Rhaponticum carthamoides, Rhodiola rosea, Szchisandra c) plus at least two plants or nutraceuticals selected from chinensis, Angelica sinensis, Astragalus membranaceus, the group consisting of Angelica sinensis, Bupleurum Echinacea angustifolia, Echinacea angustifolia radix, chinense, Cimicifiiga racemosa, Chitin fiber, Chon Echinacea purpurea, Echinacea purpurea radix, Gano droitin Sulfate, Crataegus Oxyacantha, Croton lechleri, derma lucidum, Hydrastis Canadensis, Lepidium meyenii, Curcubita pepo, Curcuna longa, Dioscorea villosa, Panax ginseng, Silibum marianum, Tabebuia avellanedae, Equisetum arvense, Eucommia bark, Fructus ligustri Uncaria tomentosa, Equisetum arvense, Hydrocotile asi lucidum, Fructus lycii, Fulvic acid, Gentiana lutea, atica, Picrorhiza kurroa, Smilax officinalis, and Vaccinium Ginkgo biloba, Glucosamin, Glycyrrhiza glabra, mirtylus. Gynostemma, Harpagophytum procumbens, Herba epi 11. The phytoceutical composition of claim 9, comprising medii, Hydrocotile asiatica, Linum usitatissimum, Min the relative amounts of ingredients in Table 3. erals, Mumiyo, Opuntia ficus indica, Picrorhiza kur 12. A phytoceutical composition, comprising a composi roa, Plant enzymes, Ptycopetalum Olacoides, Pygeum tion selected from the group consisting of the composition of africanum, Rhamnus purshiana, Ruscus aculeatus, Table 1, Table 2 and Table 3, together with pharmaceutically Salix alba, Sargassum fisiiforme, Sena alejandrina, acceptable excipients. Serenoa repens, Silibum marianum, Smilax china, 13. A method of treating disease comprising: Solanum nigrum, Tribulus terrestris, Ulmus filva, administering an effective amount of the composition of Urtica dioica, Uva ursi, Vaccinium myrtillus, Viburnum claim 1 to a patient Sufficient to alleviate said disease. spp and Vitamins. 14. The method of claim 13, wherein the disease is a 3. The phytoceutical composition of claim 1, comprising circulatory disease, a female endocrine disorder, or a skin plants or extracts or active ingredients derived from each of disorder. the following plants: Ginkgo, Vaccinium, Angelica, Cratae 15. (canceled) gus, Hydrocotyle, Ruscus, Croton, Echinacea, Eleuthero 16. The method of claim 13, comprising the composition coccus, Ganoderma, Grifola, Hydrastis, Panax, Pfaffia, of Table 2 used to treat PCOS. Rhaponticum, Rhodiola, Tabebuia, Panax, Uncaria, 17. The method of claim 13, comprising the composition Petiveria, and Sutherlandia, together with pharmaceutically of Table 3 used to treat psoriasis. acceptable excipients. 18. The phytoceutical composition of claim 12, compris 4. The phytoceutical composition of claim 3, further ing a composition selected from the group consisting of the comprising Ginkgo biloba, Vaccinium myrtilus, Angelica composition of Eleutherococcus senticosus, Rhaponticum Sinensis, Crataegus Oxyacantha, Hydrocotyle asiatica, Rus carthamoides, Panax ginseng, Panax quinquefolius, Pfaffia cus aculeatus, Croton lechleri, Echinacea purpurea, paniculada (Suma), Rhodiola rosea, Echinacea angustifo Echinacea angustifolia Eleutherococcus senticosus, Gano lia, Echinacea purpurea, Ganoderma lucidum, Grifola fron derma lucidum, Grifola frondosa, Hydrastis Canadensis, dosa, Hydrastis Canadensis, Petiveria alliacea, Sutherlan Panax ginseng, Pfaffia paniculada, Rhaponticum cartham dia frutescens, Tabebuia avellanedae, Uncaria tomentosa, Oides, Rhodiola rosea, Tabebuia avellanedae, Panax quin Angelica sinensis, Crataegus Oxyacantha, Croton lechleri, quefolius, Uncaria tomentosa, Petiveria alliacea, and Suth Ginkgo biloba, Hydrocotyle asiatica, Ruscus aculeatus, Vac erlandia frutescens. cinium myrtillus, together with pharmaceutically acceptable 5. The phytoceutical composition of claim 3, comprising excipients. the relative amounts of ingredients shown in Table 1, and 19. The phytoceutical composition of claim 12, compris optionally including water or gelatin. ing a composition selected from the group consisting of the 6. The phytoceutical composition of claim 1, comprising composition of Rhodiola rosea, Panax quinquefolius, Pfaffia plants or extracts or active ingredients derived from each of paniculada, Astragalus membrenaceus, Echinacea angusti the following plants: Rhodiola, Vitex, Echinacea, Astraga folia, Echinacea angustifolia radix, Echinacea purpurea, lus, Ganoderma, Uncaria, Grifola, Dioscorea, Tabebuia, Echinacea purpurea radix, Dioscorea villosa, Ganoderma US 2008/008994.6 A1 Apr. 17, 2008

lucidum, Grifola frondosa mushroom, Tabebuia avel radix, Echinacea purpurea, Echinacea purpurea radix, lanedae, Uncaria tomentosa, Vitex agnus castus and Hydro Ganoderma lucidum mushroom, Hydrastis Canadensis, cotile asiatica asiatica, together with pharmaceutically Lepidium meyenii, Panax ginseng, Silibum marianum, Shark acceptable excipients. Cartilage, Tabebuia avellanedae, Uncaria tomentosa, Equi 20. The phytoceutical composition of claim 12, compris setum arvense, Fulvic Acid-Shilajit, Hydrocotile asiatica, ing a composition selected from the group consisting of the Picrorhiza kurroa, Smilax officinialis and Vaccinium mirtyl composition of Rhaponticum carthamoides, Rhodiola rosea, lus, together with pharmaceutically acceptable excipients. Szchisandra chinensis, Angelica sinensis, Astragalus men branaceus, Echinacea angustifolia, Echinacea angustifolia k k k k k