US 20090 155377A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0155377 A1 Olalde Rangel (43) Pub. Date: Jun. 18, 2009

(54) SYNERGISTIC PHYTOCEUTICAL Publication Classification COMPOSITIONS (51) Int. Cl. (76) Inventor: Jose Angel Olalde Rangel, Caracus A6II 35/56 (2006.01) (VE) Correspondence Address: BAKER & MCKENZE LLP (52) U.S. Cl...... 424/548 Pennzoil Place, South Tower, 711 Louisiana, Suite 34OO HOUSTON, TX 77002-2716 (US) (57) ABSTRACT (21) Appl. No.: 12/372,673 Phytoceutical compositions for the prevention and treatment (22) Filed: Feb. 17, 2009 of circulatory disorders, feminine endocrine disorders, and Related U.S. Application Data dermal disorders. A specific combination of extracts of plants is taught, as well as principles for varying the formulations (62) Division of application No. 1 1/924,122, filed on Oct. based on categorizing plants into one of three groups, Energy, 25, 2007, which is a division of application No. Bio-Intelligence, and Organization and selecting several 1 1/271,940, filed on Nov. 10, 2005, now Pat. No. plants from each group. Such combinations have synergistic 7,303,772. effects, with minimal side effects. Patent Application Publication Jun. 18, 2009 Sheet 1 of 3 US 2009/O155377 A1

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Boppler tirestaurid fee Patent Application Publication Jun. 18, 2009 Sheet 2 of 3 US 2009/O155377 A1

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Patent Application Publication Jun. 18, 2009 Sheet 3 of 3 US 2009/O155377 A1

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

US 2009/0155377 A1 Jun. 18, 2009

SYNERGISTC PHYTOCEUTICAL uterine fibroids, dysfunctional uterine hemorrhage, female COMPOSITIONS infertility, premenstrual syndrome, amenorrhea, and the like. 0009. Another embodiment of the invention provides a PRIOR RELATED APPLICATIONS composition for chronic skin disorders. It can be used alone or 0001. Not applicable. combined with pharmaceuticals, and can be used to treat diseases such as psoriasis, dermatitis, skin infections, FEDERALLY SPONSORED RESEARCH shingles (herpes Zoster), boils, eczema, rash, acne or burn, STATEMENT and the like. 0002. Not applicable. DETAILED DESCRIPTION OF THE FIGURES REFERENCE TO MICROFICHEAPPENDIX 0010 FIG. 1 shows representative examples of diabetic foot lesions treated with the herbaria of Table 1. 0003) Not applicable. (0011 FIG. 2 shows representative examples of PCOS treated with the herbaria of Table 2. FIELD OF THE INVENTION 0012 FIG. 3 shows representative examples of psoriasis 0004. The invention relates to phytoceutical formulations treated with the herbaria of Table 3. used to treat a variety of diseases. The formulations are par ticular combinations of plants and have synergistic effect in DETAILED DESCRIPTION OF THE INVENTION combination. Principles for selecting beneficial formulations 0013 “Pharmaceutically acceptable excipients' is used are provided. hereinaccording to art accepted meanings, and includes those ingredients needed to formulate a medicine for mammalian BACKGROUND OF THE INVENTION use, including the use of gelatin capsules. 0005. The academic study of medicinal plants for the 0014 “Synergistic' or “synergy” is used herein to mean treatment of diverse diseases has been nearly as pervasive as that the effect is more than its additive property. In preferred the study of Western medicines The active principles from embodiments, the synergy is at least 1.5, 2, 5, or 10 fold. many traditional medicines have been extracted from plants, 0015. By use of “plants.” what is meant herein is that the the curative agents identified and their mechanisms of action plant (or that portion with medicinal activity) is used whole, determined. Plant based medicines are typically well toler ground, or as an extract. Also included are purified active ated, with less severe side effects as well as a smaller range of ingredients and derivatives thereof. However, it is believed side effects. However, despite the excellent medicinal quali that the best efficacy of plants used herein is achieved with the ties of many plants, they are individually insufficient to take use of the entire plant or its extracts, rather than with the use chronic degenerative diseases into remission. In contrast, of isolated active ingredients. while synthetic drugs can be highly effective, their use is 0016 Further, although plants are named here according often hampered by severe side effects. What is needed in the to commonly used nomenclature, with improving taxonomy art are better treatment regimes with improved patient toler plants are often reclassified. Whenever a plant is referenced, ance, while providing sufficient efficacy. it includes related species with similar active ingredients. 0017. The following examples are illustrative only and SUMMARY OF THE INVENTION should not serve to unduly limit the invention. 0006. A number of known beneficial plants were classified according to their capacity to enhance the three main ele EXAMPLE 1. ments that support overall health: Energy (E), Bio-intelli Plant Characteristics Circulatory Disorders gence (I) and Organization (O). A synergistic effect is expected when all three categories of herbs (E. I. O) are 0018 Angelica sinensis (Dong Quai or Angelica, also included in a formulation, preferably at least two or three or Angelica Archangelia, Angelica Pubescens and Angelica four plants from each category. Thus, one embodiment of the Sylvestris) contains terpenes (terpenes, mainly B-phelland invention provides a method of selecting additional disease rene, with B-bisabolene, B-caryophyllene, B-phellandrene, C.- treating formulations according to these principles. Three and B-pinene, limonene, linalool, borneol, acetaldehyde, examples of formulations prepared in this way are provided menthadienes, and nitromenthadienes), macrocyclic lactones and additional formulations are being prepared and tested. (including tridecanolide, 12-methyl tridecanolide, pentade 0007 Another embodiment of the invention provides an canolide), phthalates (such as hexamethylphthalate), cou effective, natural composition for treating circulatory dis marins (especially flirocoumarin glycosides such as eases. The composition can be used alone, or can be com marmesin and apterin), angelicin and byakangelicin deriva bined with simultaneous use of one or more pharmaceutical tives (osthol, umbelliferone, psoralen, bergapten, impera compositions. It can be used for the treatment of diabetic toren, XanthotoXol, Xanthotoxin, oxypeucedanin and more), lesions, obliterative arteriosclerosis, Leriche Syndrome as well as various Sugars, plant acids, flavonoids, and sterols. (aorto-iliac obliteration), Buerger's disease (thromboangiitis 0019 Acanthopanax senticosus (Russian Ginseng, Sibe obliterans), thrombophlebitis, chronic venous insufficiency, rian Ginseng, Eleuthero, Devil's Shrub, Touch-me-not, Wild Varicose veins, varicose ulcers, hemorrhoids, and the like. Pepper, Shigoka, Acantopanacis senticosus) contains terpe 0008 Another embodiment of the invention provides a noids (oleanolic acid), glycosides (Eleutheroside A (daucos composition for the treatment offeminine endocrine diseases terin), B1, C-G, I, K, L, M), phytosterols (B-sitosterol), cou that can be used alone or combined with pharmaceuticals. It marins (Eleutheroside B1 and B3, isofraxidine), provides an effective medicine for diseases such as Polycystic polysaccharides (eleutherans), Volatile oils, caffeic acid, Ovary Syndrome, ovarian cysts, fibrocystic breast condition, coniferyl aldehyde, and Sugars. Eleuthero has been shown to US 2009/0155377 A1 Jun. 18, 2009 bind to estrogen, progestin, and mineralocorticoid receptors, paniculata, I. tenuis, Periantha, Xeraea paniculata) contains and stimulate T-lymphocyte and natural killer cell produc active glycosides (beta-ecdysone and three ecdysteroids), tion. It has activity anti-plateletaggregation activity similar to pfaffic acids, phytosterols (sitosterol and estimasterol). It also aspirin, as well as antioxidant activity. Russian Ginsengcon contains Saponins. Its germanium content probably accounts tains at least 40 active ingredients. for its properties as an oxygenator at the cellular level, and its 0020 Rhaponticum carthamoides (Leuzea, or Maral high iron content may account for its traditional use for ane Root) contains a mixture of compounds called, “levseins.” mia. This herb increases oxygenation at the cellular level, and LeVSeins represents a complex of more than 10 ecdysterones it also has anabolic activity at the muscular and cardiac levels including 20-beta-ecdysterone, makisterone C, 24-dehydro by improving the contraction of the miocardia and diminish makisterone A, carthamosterone, polypodyne B and ajugas ing arrhythmias and stabilizing the membranes of cardiac terone C. Researchers extracted and purified various ecdys cells. The incorporation of this phytomedicine provides 44 teroids from Rhaponticum and found that the ecdysteroids active principles in a single therapeutic. increased the mass of the developing quails in a dose-depen 0024 Rhodiola rosea (Golden Root, Roseroot) consists dent manner, with the rate of increase proportional to the mainly of phenylpropanoids (rosavin, rosin, rosarin (specific ecdysteroids content. The Soviets manufactured a synthetic to R. rosea), phenylethanol derivatives (salidroside, rhodiolo version of this powerful substance for their athletes with great side, tyrosol), flavanoids (catechins, proanthocyanidins, success. Soon after, the U.S. version called Mesobolin circu rodiolin, rodionin, rodiosin, acetylrodalgin, tricin), monoter lated on the underground market for a long time. Incorpora penes (rosiridol, rosaridin), triterpenes (daucosterol, beta tion of this phytomedicine in a composition provides at least sitosterol), and phenolic acids (chlorogenic and hydroxycin 10 active principles in a single therapeutic. namic, gallic acids). It also contains organic acids (gallic, 0021 Panax ginseng (Chinese ginseng, panax, ren shen, caffeic, and chlorogenic acids) and B-Tyrosol. There are jintsam, ninjin, Asiatic ginseng, Japanese ginseng, Oriental many species of Rhodiola, but it appears that the rosavins are ginseng, Korean red ginseng) main active components are unique to R. Rosea, and it is the preferred species. Its thera ginsenosides (Ra1, Ra2, Rb1, Rg1, Rd, Re, Rh1, Rh2, Rh3. peutic properties include a strong estrogen binding property. F1, F2, F3) and panoxosides, which have been shown to have It also has properties of vasodilatation by activation of mu a variety of beneficial effects, including anti-inflammatory, opiate receptors in heart muscle, and it is a hypolipidemic, antioxidant, and anticancer effects. Results of clinical diminishing cholesterol and triglyceride levels. The incorpo research studies demonstrate that Panax ginseng may ration of this phytomedicine provides at least 20 active prin improve psychological function, immune function, and con ciples in a single therapeutic. ditions associated with diabetes. Studies indicate that Panax 0025. Echinacea angustifolia or purpurea (Black Samp ginseng enhances phagocytosis, natural killer cell activity, son, Purple Coneflower, Rudbeckia, Missouri Snakeroot, Red and the production of interferon; improves physical and men Sunflower) contains alkaloids (Isotussilagine, tussilagine), tal performance in mice and rats; causes vasodilation; amides (echinacein, isobutylamides), carbohydrates (echina increases resistance to exogenous stress factors; and affects cin, polysaccharides (heteroxylan and arabinogalactan), inu hypoglycemic activity. It stimulates hepatic glutathione per lin, fructose, glucose, pentose), glycosides (echinacoside), oxidase, and the phytosterols inhibit prostaglandin synthesis. terpenoids (Germacrane), Cichoric acid, betaine, methyl Also it displays vascular activity because the Saponins act like para-hydroxycinnamate, Vanillin, phytosterols, and volatile calcium antagonists in the vasculature. The incorporation of oils. Echinacea has been the subject of hundreds of clinical this phytomedicine provides at least 86 active principles in a and Scientific studies which have primarily used an extract of single therapeutic. the root and aerial portions of the botanical. The rich content 0022 Panax quinquefolius (American Ginseng, Anchi, of polysaccharides and phytosterols in Echinacea are what Canadian Ginseng, Five Fingers, Ginseng, American, North make it a strong immune system stimulant. The sesquiterpene American Ginseng, Red Berry, Ren Shen, Tienchi) is related esters also have immuno-stimulatory effects. Echinacin has to Panax ginseng, but is a distinct species with higher levels of also been found to possess anti-fungal and antibiotic proper ginsenoside Rb1 and without ginsenoside Rf. Ginsenoside ties. This component of Echinacea also has cortisone-like Rb1 is believed to limit or prevent the growth of new blood actions which can help promote the healing of wounds and vessels, making it useful to treat tumors. Research Suggests helps to control the inflammatory reactions. The incorpora that several of ginseng's active ingredients also have a ben tion of this phytomedicine into compositions provides at least eficial influence on platelet aggregation. It also demonstrates 70 active principles in a single therapeutic. an anti-atherosclerotic action, apparently mediated by a cor 0026. Ganoderma lucidum (Reishi, also G. tsugae, G. rection in the imbalance between prostacyclin and thrombox valesiacum, G. Oregonense, G. resinaceum, G. pfezferi, G. ane. Other studies that have found panaxynol or the lipophilic Oerstedli, and G. ahmadii) is an edible fungus containing fraction to be the most potent anti-platelet agent in ginseng, bitter triterpenoids (ganoderic acid), B-D-glucan, coumarins, chiefly due to an inhibition of thromboxane formation. This alkaloids and ergosterols. It has vasodilator effect and is use possibly occurs via regulation of c(GMP and cAMP levels and ful in the treatment of angina. It is hypolipidemic and anti prolongation of the time interval between the conversion of artherotic. It contains at least 32 active principles. fibrinogen to fibrin. Ginsenosides have also been shown to be 0027 Grifola frondosa (Maitake, Dancing Mushroom; relatively potent platelet activating factor antagonists. It has also G. SOrdulenta, Polyporus umbellatus and Meripilus antioxidant, anti-inflammatory, and hypolipidemic effects. giganteus) contains the primary polysaccharide, B-D-glucan The incorporation of this phytomedicine into a composition in the 1.3 and 1.6 forms. It also contains alpha glucan, lipids, provides at least 206 active principles in a single therapeutic. phospholipids, and ergosterol. Animal studies Suggest 0023 Pfafia paniculata (Suma, Brazilian Ginseng, Pfaf maitake may lower serum cholesterol and triglycerides. Beta fia, Para Toda, Corango-acu; also Hebanthe paniculata, D-glucan is also recognized as an effective immuno-stimula Gomphrena paniculata, G. eriantha, Iresine erianthos, I. tor. This substance increases the activity of macrophages and US 2009/0155377 A1 Jun. 18, 2009 other immunocompetent cells that destroy tumor cells. The ensis) has several alkaloids including pentacyclic oxindole Substance also improves the immunological efficiency of alkaloids (POA) (isomitraphylline, isopteropodine, mitra these cells by increasing production of cytokines IL-1, IL-2 phylline, pteropodine, speciophylline, uncarine F), tetracy and lymphokines. The final result is an increase of the clic oxindole alkaloids (TOA) (isorynchophylline, ryncho defenses against infectious diseases. The incorporation of this phylline), glycosides (triterpenic quinovic acid glycosides), phytomedicine provides at least 6 active ingredients forthera hirsutine, tannins, catechins, phytosterols (beta-sitosterol, peutic use. campesterol, Stigmasterol), triterpenes, polyphenols, fla 0028 Hydrastis Canadensis (golden seal, yellow root, tur Vanols and oligomeric proanthocyanidins (OPC). It is an meric root) contains mainly isoquinoline alkaloids (Xantho immune-stimulant, an anti-inflammatory, vasodilator, and puccine, berberine, hidrastine, hidrastanine, beta-hydrastine, antioxidant. In laboratory testing, rynchophylline displays an canadine and canadaline). These confer anti-inflammatory, ability to inhibit platelet aggregation and thrombosis, Sug bacteriostatic, bacteriocidal, and vasodilator effects. In gen eral, its antibacterial action is directed to metabolic inhibi gesting that cat's claw may be useful in preventing strokes and tion, inhibition of the formation of enterotoxins, and inhibi reducing the risk of heart attack by lowering blood pressure, tion of bacterial adhesion. It produces vasodilatation by increasing circulation, inhibiting formation of plaque on arte inhibiting Smooth muscle contraction, and inhibiting platelet rial walls and formation of blood clots in the brain, heart and aggregation. This plant provides at least 34 active principles arteries. This phytomedicine provides at least 10 active ingre for therapeutic use. dients. 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 Gallini leaf, Gully Root, Herbe Aux Poules, Hierba De Las Gallini tas, Huevo De Gato, Kojo Root, Kuan, Kuduruk, Lemtewei, tas, Huevo De Gato, Kojo Root, Kuan, Kuduruk, Lemtewei, Lemuru, Mal Pouri, Mapurit, Mapurite, Mucura-caa, 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, Coumarin, 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 Suther 0034 Angelica sinensis (Dong quai or Angelica, also landia Microphylla) contains L-canavanine, pinitol, GABA Angelica archangelia, Angelica pubescens and Angelica (gamma aminobuteric acid), and asparagine. In addition, Sylvestris) contains terpenes (terpenes, mainly B-phelland novel triterpenoid glucoside known as “SU1” has been iso rene, with B-bisabolene, B-caryophyllene, B-phellandrene, C.- lated and characterized. The therapeutic indications include and B-pinene, limonene, linalool, borneol, acetaldehyde, anti-inflammatory, antioxidant, immuno-modulador, and menthadienes and nitromenthadienes), macrocyclic lactones vasodilator effects. This phytomedicine provide at least 5 (including tridecanolide, 12-methyl tridecanolide, pentade 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 ipe, T. nicaraguensis, T. Schunkeuigoi, T. Serratifolia, T. tives (osthol, umbelliferone, psoralen, bergapten, impera altissima, T. palmeri, T impetiginosa, T. heptaphylla, toren, XanthotoXol, Xanthotoxin, oxypeucedanin and more), Gelseminum avellanedae, Handroanthus avellanedae, H. as well as various Sugars, plant acids, flavonoids, and sterols. impetiginosus, Tecoma adenophylla, Tec. avellanedae, Tec. These components have vasodilator activity, increase coro eximia, Tec. impetiginosa, Tec. integra, Tec. ipe) extracts con nary flow and are antithrombotic. The incorporation of this tain diverse quinone derivatives and a small quantity of ben phytomedicine into compositions provides at least 70 active Zenoids and flavonoids, including beta-lapachone, Xyloidone, principles in a single therapeutic. tabebuin, quercetin, tecomine, and steroidal saponins. One 0035 Crataegus Oxyacantha (Hawthorn, see also C. important ingredient is lapachol, a derivative of which was monogyna) contains mainly flavonoids (such as flavonogly patented in 1975. It has anti-inflammatory and antibacterial cosyls, hyperoside, rutin, flavonol, kaempferol, quercetin) effects. The incorporation of this phytomedicine into a com and oligomeric procyanadins (1-epicatechol), which relax position provides at least 32 active principles in a single arterial expansion to decrease peripheral vascular resistance. therapeutic. Also contains amines (phenyletylamine, tyramine, O-meth 0032 Uncaria tomentosa (Cat's Claw, Peruvian Cat's oxyphenethylamine), flavone (apigenin, luteolin) derivatives, Claw, Samento, Saventaro, Una de Gato, also Uncaria guian Vitexin glycosides, tannins, saponins, and cyanogenetic gly US 2009/0155377 A1 Jun. 18, 2009 cosides. The incorporation of this phytomedicine into a com huckleberry) contains anthocyanosides such as: cianadins, position provides at least 52 active principles in a single malvidins, petunidins and peonidins. Other ingredients therapeutic plant. include arbutin, asperuloside, astragalin, beta-amyrin, caf 0036 Croton lechleri (Dragon's blood, Sangre de Grado, feic-acid, catechin, chlorogenic-acid, cyanadin-3-O-arabino Sangre de Agua; also C. draconoides, C. palanostigma, C. side, dihydroxycinnamic-acid, epicatechin, epigallocatechin, erythrochilus C. salutaris, and C. gossypifolius) produces a epimyrtine, ferulic-acid, gallic-acid, gallocatechin, hydro distinctive red exudate from its trunk containing a consider quinone, hyperoside, isoquercitrin, lutein, coumaric-acids, able amount of secondary plant metabolites, the majority of m-hydroxybenzoic-acid, monotropein, myrtillin, myrtillol, which are hydrolyzing flavonoids, proanthocyanidins myrtine, neomyrtillin, protocatechuic-acid, quercetins, qui (mainly catechin, epicatechin, gallocatechin and/or galloepi nic-acid, resinic-acid, Syringic-acid, ursolic-acid, and Vanil catechin), as well as taspine. Other components include the lic-acid. Evidence Suggests that anthocyanosides may benefit dihydrobenzofuran lignan, six simple phenols and their the retina, as well as strengthen the walls of blood vessels, derivatives, three steroids, non-Saturated fatty acids, diterpe reduce inflammation, and stabilize collagen containing tis noids (hardwickiic acid, bincatriol, crollechinol, crollechinic Sues. The anthocyanosides improve the activity of enzymes acid, coberine A, coberine B), and diterpenoids. It heals lactic dehydrogenase, glucose-6-phosphatase and phospho wounds and ulcers of vascular origin. Incorporation of this glucomutase, each involved in processes of vascular damage. phytomedicine into a composition provides at least 23 active They reduce the arterial deposits and stimulate the production principles in a single therapeutic. of vasodilators, like prostaglandin (PG12), thus protecting 0037 Ginkgo biloba (Ginkgo) contains ginkgolides, bilo the vascular wall. Anthocyanosides have strong antioxidant balides, bioflavones and flavone glycosides. Flavone glyco properties, as well. The incorporation of this phytomedicine sides include quercetin, 3-methylguercetin and kaempferol. into a composition provides at least 63 active principles in a Quercetin, myrcetin and the rest of the flavonoid fraction of single therapeutic. the extract have antioxidant and free radical scavenger effects. The flavonoids diminish infiltration by neutrophils EXAMPLE 2 and increase blood flow. Their antioxidant properties and membrane Stabilizing activity increase the tolerance to Composition Circulatory Disorders hypoxia. They improve cellular metabolism and protect against the damage caused by ischemia. Ginkgolide B is a 0041 A particularly preferred composition is shown in powerful inhibitor of platelet activating factor (PAF), binding Table 1. Ratios reflect the concentration of active ingredient to its membrane receptors, and antagonizing platelet aggre over the natural state, and the amounts provided are mg of gation. Similarly, it has anti-inflammatory effect by decreas extract. Obviously, the amount should be increased where the ing vascular permeability, and has vasodilator activity by strength is reduced, and vice versa. inhibiting the liberation of thromboxane B2 and prostaglan dins. Controlled double blind clinical studies conclusively TABLE 1 demonstrate the effectiveness of Gingko biloba in treating peripheral arterial insufficiency. The incorporation of this Herbaria phytomedicine into a composition provides at least 59 active Amount principles in a single therapeutic. Active Agent Ratio (mg) 0038 Hydrocotyle asiatica (Gotu Kola, Bramhi, Penny Energy enhancers wort, Marsh Penny, Pennywort; also Hydrocotile asiatica asiatica) contain terpenoids (triterpenes, asiaticoside, brah Eleutherococci is senticosus root extract 5: 53.53 Rhaponticum carthamoides root extract 12: 3.85 moside and brahminosidea, (Saponin glycosides) aglycones, Panaxginseng root extract 5: 10.71 asiaticentoic acid, centellic acid, centoic acid and madecassic Panax quinquefolius root extract 5: 32.12 acid), sesquiterpenes (caryophyllene, trans-B-farnesene), Pfafia paniculada (Suma) root extract 4: 21.41 volatile oils (Germacrene D), alkaloids (hydrocotylin), fla Rhodioia rosea root extract 5: 9.64 Vones (Quercetin, kaempferol, sesquiterpenes, Stigmasterol, Bio-Intelligence modulators and Sitosterol), and Vallerine, fatty acids, resin, and tannins. It Echinacea angustifolia root extract 6: 1.34 is used to treat chronic venous insufficiency, varicose veins, Echinacea purpurea root extract 6: 1.34 and venous hypertension. Incorporation of this phytomedi Ganoderma lucidum extract 6: 32.12 Grifolia fondosa extract 10: 12.85 cine in a composition provides at least 59 active principles in Hydrastis canadensis root extract 5: 38.54 a single therapeutic. Peiiveria aiiacea 1: 64.24 0039 Ruscus aculeatus (Butcher's Broom, Box Holly, Sutherlandia frutescens 1: 64.24 Tabebuia a veianedae bark extract 4: 40.15 Jew’s Myrtle, Knee Holly, Kneeholm, Pettigree, Sweet Uncaria tonemiosa root extract 10: 16.06 Broom) contains as primary active ingredients the steroidal Organization improvers saponins (ruscogenin and neoruscogenin), but other constitu ents have been isolated, including flavonoids, tetracosanoic Angelica Sinensis root extract 5: 64.24 acid, chrysophanic acid, Sitosterol, campesterol, Stigmas Crataegus Oxyacantha fruit extract 5: 42.83 Croton iechieri bark resin extract 10: 10.71 terol, triterpenes, coumarins, Sparteine, tyramine, and gly Ginkgo biloba leaf extract 50: 1949 colic acid. Its ingredients reduce vascular permeability, have Hydrocotyle asiatica plant extract 5: 64.24 anti-elastic properties and are vasoconstrictors. The incorpo Riiscus actitieattis root extract 5: 57.82 ration of this phytomedicine in a composition provides at Vaccinium myrtillus fruit extract 5: 38.54 least 28 active agents. Total 700 mg 0040 Vaccinium myrtillus (European blueberry or bil berry, closely related to American blueberry, cranberry, and US 2009/0155377 A1 Jun. 18, 2009

EXAMPLE 3 in treating benign and malign tumors including mammary and ovarian cysts as well as uterine fibroids. Plant Characteristics—Female Endocrine Disorders 0050. Uncaria tomentosa See above. 0.042 Panax quinquefolius The active principles respon 0051 Vitex agnus castus (Chaste Tree orchaste berry) An sible for its therapeutic effects are triterpensaponides, of essential oil is extracted from the fruit of this plant, two which more than 25 different types have been identified. iridoid glycosides (aucubine and agnuside); a flavone (casti These are denominated protopanaxadiols (ginsenosides Ric, cine, which seems to be the primary active principle) and 3 Rd., Rb1, Rb2) and protopanaxatriols (ginsenosides —Re, minor flavonoids derived from kaempferol and quercetin. These active principles act on the anterior hypofisis dopam —Rf. —Rg1, etc.). Panax also contains hydroSoluble inergic-D2 receptors, modulating prolactin Secretion. This polysaccharides (panaxans A-U) and polyacetylenes (ginse hormone is implicated in the appearance of anovulatory nosides A-K, panaxynol and panaxatriol). These substances cycles and dysfunctional uterine hemorrhages, menorrhea, confer energizing properties because they increase ATP syn mammary fibrocystic condition, and cyclic mastalgy. Vitex thesis. On the other hand they reduce the secretion of prolac agnus castus modulates the Secretion of LH from the hypofi tin by increasing dopaminergic activity or by activating sis, which act on the ovary, starting up the luteal phase and dopamine receptors at the anterior hipophysis level. Prolactin progesterone secretion. Therefore, Vitex benefits dysfunc is a hormone involved in the appearance of anovulatory tional uterine hemorrhages, premenstrual syndrome, PCOS, cycles and dysfunctional uterine hemorrhages, menorrhea, infertility, ovary cysts, menopause, and fibromyomatous mammary fibrocystic condition, and cyclic mastalgy. The uteri. reduction of this hormone explains the recovery in the treat 0.052 Hydrocotile asiatica See above. Also, the active ment of uterine dysfunctional hemorrhages, Polycystic Ovary principles include pentacyclic triterpene Saponins. The major Syndrome (PCOS), Ovary Cysts, fibromyomatous uteri, and active principles areasiaticosides and madecassosides. Other infertility. minor Saponins are the centelloside, brahmosides, brahmino 0043 Pfafia paniculata. Its most important active prin sides and Hydrocotile asiatica Saponins B, C and D. Muco ciples are: Beta-ecdysone and three glycoside ecdysteroids, polysaccharides are the core components of the cellular six different pfaffic acids, phytosterols and nortriterpenic gly matrix. The biochemical action of these active principles cosides. These Substances are energizing through an increase reduce the levels of lysosomal enzymes associated with the in ATP synthesis and oxygenation at the cellular level. Also, degradation of mucopolysaccharides. On the other hand, the its phytosterols act as hormone originators, and have demon active agents act on the fibroblasts of the connective tissue, strated effectiveness in the management of diverse conditions modulating collagen synthesis and inhibiting inflammatory associated with hormone imbalance, such as: premenstrual processes. This diminishes the fibrosis processes important to syndrome, dysmenorrhea, infertility, dysfunctional uterine fibrocystic mammary and uterine conditions. hemorrhages, and menopause. 0044 Rhodiola rosea See above. EXAMPLE 4 0045 Astragalus membranaceus (Huang-Qi) This plant contains three main types of active principles. Isoflavones, Composition Female Endocrine Disorders which act as anti-oxidants; astragalans which act as immune 0053 A particularly preferred composition is shown in stimulants and anti-inflammatory by stimulating the phago Table 2. cytic activity of macrophages, of the cytotoxic response of T and NK lymphocytes and of the production and activity of TABLE 2 interferon; and astragalans which act as modulators of the hypothalamus-hypofisis-adrenal axis response. Herbaria II

0046 Echinacea See above. Amount 0047 Dioscorea villosa (Rheumatism root, huesos del Active Agent Ratio (mg) dialo, Yuma, Yam, Wild Yam, Chinese Yam, Mexican Yam, raiz, china, and colic root) contains steroid Sapogenins (dios Energy enhancers cine, dioScorin and diosgenine) as the main active principles. Rhodioia rosea root extract 5: 8.16 Diosgenine can change into ecdysone, pregnenolone, and Panax quinquefolius root extract 4: 67.97 progesterone, thus, diosgenine is a hormonal precursor, Pfafia paniculada (Suma) 4: 54.37 which contributes to the neuroendocrine system's modula Bio-Intelligence modulators tion. On the other hand, diosgenine has demonstrated its Astragalus membrenacetis root extract 5: 73.41 important pro-apoptotic effects, in the therapy of benign and Echinacea angustifolia 6: 20.39 malign tumors, including mamrinary and ovarian cysts, and Echinacea angustifolia radix 6: 3.40 uterine fibroids. Echinacea purpurea 6: 20.39 Echinacea purpurea radix 6: 3.40 0048 Ganoderma lucidum and Grifola frondosa. The Dioscorea viliosa 4: 125.74 main active principles of these mushrooms are sterols and Ganoderma lucidum extract 6: 36.25 beta-proteoglucans which bestow anti-inflammatory and Grifolia fondosa mushroom extract 10: 21.75 Tabebuia a veianedae 4: 67.97 immune-modulating properties, because they increase the Uncaria tonemiosa 10: 24.47 phagocytotic capacity of macrophages and increase the pro Vitex agnus Castus 5: 57.09 duction and lifespan of CD4 lymphocytes. Organization improvers 0049 Tabebuia avellanedae contains diverse substances derived from quinones, such as Alfa and Beta lapachone Hydrocotile asiatica asiatica 5: 65.25 2-hydroxi-3-(3-metil-2-butenil)-1,4-naftoquinona and Total 6SO cyclopentane dialdehydes. These confer important anti-in flammatory, pro-apoptotic, antimitotic and cytostatic effects, US 2009/0155377 A1 Jun. 18, 2009

EXAMPLE 5 (mainly quercetin glycosides and apigenine) and Saponins Plant Characteristics—Dermal Disorders (equisetonin). These active principles block the liberation of arachidonic acid, which diminishes inflammation and 0054 Lepidium meyenii (Maca) Its major active principles reduces the proliferation of keratinocytes, as well as inducing are: alkaloids (Macaridina, Lepidiline A and B); benzyl-iso G2/Marrest in keratinocytes. The action mechanism is in part tiocyanate and glucosinolates; macamides; Beta-ecdysone due to the inhibition of mitotic kinase activity of p34cd2 and and phytosterols. These substances activate ATP synthesis perturbation of cyclin B1 levels. which confers energizing properties. 0055 Rhaponticum carthamoides See above. 0.066 Hydrocotile asiatica See above. 0056 Panax ginseng The active principles responsible for 0067 Tabebuia avellanedae contains diverse quinone its therapeutic effects are triterpensaponides of which more derivatives such as alpha and beta-lapachone, cyclopentane than 25 different types have been identified. These include dialdehydes and a small quantity of benzenoids and fla protopanaxadiols (ginsenosides Ric, Rd, Rb1, Rb2) and pro vonoids, including, Xyloidone, tabebuin, quercetin, tecomine, topanaxatriols (ginsenosides-Re, -Rf-Rg1, etc.). Panax also contains hydroSoluble polysaccharides (panaxans A-U) and and steroidal saponins. These compounds inhibit kerati polyacetylenes (ginsenosides A-K, panaxynol and panaxa nocyte growth and offer anti-inflammatory and antibacterial triol). These Substances confer energizing properties because effects, which are of great importance in the treatment of they increase ATP synthesis. psoriasis. 0057 Rhodiola rosea See above. Also, the active prin 0068. Shilajit (Mumiyo) Mumiyo is a natural complex ciples in this plant (phenylpropanoids, phenylethanol deriva Substance, whose active principles are carboxylic acids: (hy tives, flavonoids, monoterpenes and phenolic acids) activate droxylated derivatives of Benzoic, Phenylacetic and Hippuric the synthesis of ATP in mitochondria and stimulate reparative acids), fulvic and humic acids, minerals and amino acids. Of energy processes. Mumiyo's known properties, the most important ones are its 0058 Andrographis paniculata (King of Bitters, ability to reduce excessive inflammatory reactions and stimu Chirettta, Kalmegh and Kiryat) Primary active principles late tissue regeneration. Oral intake of Mumiyo has been used associated with Andrographis are: flavonoids, glucosides and to treat burns, trophic non-healing wounds, eczema, and other diterpenic lactones (andrographolides). These substances skin diseases, such as psoriasis. It has been established that offer immuno-modulator and anti-inflammatory properties. fulvic/humic acids stimulate respiration and oxidative phos Even though their precise mechanism of action is not known, phorylation in liver mitochondria, increase mechanical resis studies Suggest that they stimulate the immune systems and tance of collagen fibers, activate human leucocytes, reduce activate macrophages. excessive inflammatory reactions, and stimulate tissue regen 0059 Angelica sinensis contains alkyl phthalides (Li eration. gustilide); terpenes, phenylpropanoids (ferulic acid) and ben Zenoids. These Substances stimulate the immune system's 0069. Shark cartilage This natural compound reduces pso actions, through diverse lymphokines and have an anti-in riatic plaque vascularization. It inhibits the proliferation of flammatory effect by inhibiting 5-lipoxygenase and elastase, endothelial cells, competitively blocking the Endothelial as well as selectively inhibiting 12-(S)-HHTrE production, a Growth Factor at the receptor level. It also inhibits tyrosine marker of cyclo-oxygenase activity. EGF and EGF-2 dependant phosphorylation as well as the 0060 Astragalus membranaceus See above. Also, increase of FCE induced permeability. Shark cartilage also Astragalus membranaceus inhibits 5-lipoxygenase and induces endothelial cell apoptosis, by inducing caspase 3, 8 elastase, which indicates that it is valuable in the management and 9 activation, and the liberation of cytochrome c from the of skin pathologies involving chronic inflammation, such as mitochondria to the cytoplasm. Shark cartilage also induces psoriasis. fibrinolitic activity by increasing the secretion, activity and 0061 Echinacea See above. affinity of Tissue Plasminogen Activator (tPA) for endothelial 0062 Hydrastis canadensis The most important active cells. It also inhibits extracellular matrix degradation, by principles of Hydrastis are isoquinoline alcaloides (Berbe inhibiting matrix metalloproteinases MMP-2, MMP-7, rina, hydrastina, Hidrastanina, Canadina, Canadalina) which MMP-9, MMP-12 and MMP-13. It also stimulates produc award anti-inflammatory, and immuno-modulating proper tion of angiostatin. ties. Berberine inhibits activating protein 1 (AP-1), a key factor in transcription the inflammation. It also exerts a sig 0070 Schizandra chinensis The major active principles of nificant inhibitory effect on lymphocyte transformation, So its Schizandra (also known as Wuweizi and Wurenchum) are anti-inflammatory action seems to be due to the inhibition of lignans called schizandrines. These Substances have known DNA synthesis in the activated lymphocytes or to the inhibi hepato-protective and hepato-regenerative properties. It tion of the liberation of arachidonic acid from the phospho maintains the integrity of hepatocyte cellular membranes; lipids of the cellular membrane. It also has immuno-modu increases hepatic levels of ascorbic acid; inhibits NADPH lating properties by increasing the production of oxidation; inhibits lipid peroxidation at the hepatic microso immunoglobulins G and M and stimulating the phagocytotic mal level as well as formation of hepatic malondialdehyde; capacity of macrophages. diminishes production of carbon monoxide at the hepatic 0063 Ganoderma lucidum The main active principles of level; has an inductor effect in the enzymatic anti-toxic this mushroom are sterols and beta-proteoglucans that bestow microsomal hepatic cytochrome P-450; increases biliary flow anti-inflammatory and immune-modulating properties by and the excretion of toxic Substances; promotes recovery of increasing the phagocytotic capacity of macrophages and hepatic functions; induces mRNA formation for the Hepato raising production and lifespan of CD4 lymphocytes. cyte Growth Factor (HGF); encourages the proliferation of 0064. Uncaria tomentosa see above. the hepatocyte's endoplasmic smooth reticula, and acceler 0065 Equisetum arvense (Horse tail) This plant contains ates the proliferation of hepatocytes; increases ornithine abundant mineral salts particularly silicic acids and silicates. decarboxylase activity as well as the mitotic index, facilitates It also contains phytosterols, phenolic acids, flavonoids DNA synthesis and hepatic proteins; increases levels of glu US 2009/0155377 A1 Jun. 18, 2009 tathione, glutathione reductase and glucose-6-phosphate, improving the regeneration capacity of the liver. TABLE 3 0071 Silybum marianum (Milk Thistle) The active prin ciples of this plant are flavonolignans, including silibine, Herbaria silicristine and silidianine and isosilibinin collectively known as Sylimarin. This compound has the highest grade of hepato Active Agent Ratio Amount (mg) protective, hepato-generating, and anti-inflammatory activ Energy enhancers ity. The mechanisms which explain its hepato-protector char Rhaponticum carthamoides root extract 6: 0.72 acteristics are diverse and include anti-oxidation, lipid anti Rhodioia rosea root extract 5: 9.66 peroxidation, detoxification increase through a competitive Szchisandra chinensis 5: 16.10 inhibition with toxic Substances, as well as protection against Bio-Intelligence modulators the depletion of glutathione. One of the mechanisms that can explain its hepato-regenerative properties is the increase in Angelica Sinensis 5: 32.2O protein synthesis, obtained thanks to a significant boost in the Astragalus membranaceus root extract 5: 48.30 Echinacea angustifolia 6: 8. OS formation of ribosomes, DNA synthesis and proteins at the Echinacea angustifolia radix 6: 1.34 hepatic level, because the active principles join a specific Echinacea purpurea 6: 8. OS polymerase receptor, stimulating ribosome formation. Its Echinacea purpurea radix 5: 1.61 anti-inflammatory effect is due to the stabilization of the Ganoderma iticidum mushroom extract 6: 35.78 mastocytes, the inhibition of neutrophils, a strong inhibition Hydrastis Canadensis 5: 19.32 Lepidium meyenii 5: 48.30 of leucotriene (LT) synthesis and formation of prostaglan Panaxginseng root extract 5: 16.10 dins. Sylimarin inhibits intestinal beta-glucuronidase Siibun marianum 5: 28.98 enzymes, thus improving glucoronization, which is an impor Shark Cartilage extract 4: 93.92 tant step in hepatic detoxification. More corporal toxins are Tabebuia a veianedae 4: 67.08 removed via glucoronization than through other detox path Uncaria tomentosa 10: 14.49 ways. Organization enhancers 0072 Picrorhiza kurroa The most important active con Equisetum arvense 5: 22.54 stituents are iridoid glycoside picrosides I, II, III and kutko Fulvic Acid-Shilajit 65% 1: 13.95 side, known collectively as kutkin. Though less well Hydrocotile asiatica 5: 42.94 researched than Silybum, it appears to have similar applica Picrorhiza kurroa (Standardized 4% Kutkin) 5: 32.2O tions and mechanisms of action. When compared with Sily Smilax officinialis 5: 72.45 bum, the curative efficacy of Picrorhiza was found to be Vaccinium mirtyllus 5: 16.10 similar, or in many cases Superior, to the effect of Silybum. Total 6SO Picrorrhiza possesses significant antioxidant activity, by reducing lipid peroxidation and free radical damage. Like sylimarin, it has also an effect on liver regeneration. Picror rhiza also offers anti-inflammatory effects, inhibiting the EXAMPLE 7 infiltration of pro-inflammatory cells. One of its minor com ponents, apocynin exhibits powerful anti-inflammatory Tolerance Studies effects, without affecting beneficial activities Such as phago 0076. A multicentric, retrospective study was made on cytosis, chemotaxis or humoral immunity. 100 healthy volunteers with the intention of evaluating 0073. Smilax spp. (sarsaparilla) Its main active principles patient tolerance and side effects of the herbaria combination. are: phytosterols, Steroid Saponins, Phenolic acids, Fla A capsule containing 700 mg of the herbaria of Table 1 was vonoids and minerals. These Substances adhere to toxins administered to each participant three times per day for five inside the gastrointestinal tract, this way reducing their days. During that period they were evaluated by a physician, absorption by the circulatory stream. On the other hand it who registered any finding or symptom reported by each improves the hepatic and renal excretory functions, facilitat Subject. The average age of the participants was 37.4 years ing the removal of toxic Substances and waste found in cells, blood vessels and lymphatic system. Also, phytosterols block with a SD of 8.2 years. Gender was 55% female, 45% male. prostaglandin synthetase action, explaining its anti-inflam The average weight of the subjects was 70 kilos with a SD of matory action and use to treat psoriasis. 12.3 kilos. No undesirable effects were observed in 96% of 0074 Vaccinium myrtillus Angiogenesis appears to be a the subjects. Four (4%) subjects reported minor undesirable fundamental inflammatory response early in the pathogenesis effects. of psoriasis and significant abnormalities of vascular mor (0077. The study showed that herbaria were well tolerated phology and vascular endothelial growth factor (VEGF) play only minor symptoms were reported by 4 of the 100 subjects. a crucial role in the vascularization of psoriatic plaques. Dur These results showed the non-toxicity of the herbaria, dem ing inflammatory skin diseases such as psoriasis, the skin onstrating that the formulation is safe. Similar results have initiates angiogenesis through VEGF and the active prin been obtained for the PCOS and Psoriasis formulations. ciples of this plant (anthocyanosides, flavonoids, quercetin, tannins, iridoids and phenolic acids) significantly inhibit EXAMPLE 8 VEGF expression by the human keratinocytes, reducing the psoriatic plaque’s angiogenesis. Clinical Studies EXAMPLE 6 (0078. To evaluate the efficacy of the combination, 110 Composition-Dermal Disorders patients affected with diverse degrees of lesions of the dia 0075) A particularly preferred composition is shown in betic foot, were studied by means of retrospective, multicen Table 3. tric, and descriptive study for two year duration. Of these US 2009/0155377 A1 Jun. 18, 2009 patients, 50 had grade III-V lesions, and were diagnosed for Surgical amputation of the affected area. The patients were TABLE 6 treated as above, with ten 700 mg capsule of herbaria three Polycystic Ovary Syndrome Study times a day, but the treatment was continued on an as needed basis for times ranging from 1.5 months to 10 months. The Number of Clinical Cyst QoL Treatment data is Summarized in Table 4. Patients Improvement Disappearance Improvement tolerance 35 100% 82.9% 100% 100% TABLE 4 (29 patients) Diabetic Foot Lesion Study I0082 Similarly, in a study of 123 patients with severe Number of Clinical QoL* Treatment psoriasis, clinical remission was observed in 77% of the Patients Improvement Improvement tolerance Other patients, and almost two thirds of the patients achieved clini 110 80.9% 86.4% 97.3% Amputation avoided cal improvement in less than 45 days (Table 7). In contrast, (89 patients) (95 patients) (107 in 80% of the cases most patients with severe psoriasis do not achieve remission, patients) diagnosed for but only symptomatic relief with existing pharmaceutical Surgery approaches. The dosage was seven 650 mg capsules three * QoL is Quality of Life times a day.

0079. It is significant to note that the herbaria treatment TABLE 7 prevented amputation in 40 patients (80% of the population) who were already diagnosed for Surgical removal of portions Severe Psoriasis Study of the foot. In contrast, in the usual course of standard medical Number of Clinical QoL Treatment Remission time treatment, almost 100% of these patients could have expected Patients Improvement Improvement tolerance s45 days to have a partial or complete amputation. Thus, these Superior 123 77.29% 66.3% 100% 82.9% results are quite unexpected and clearly demonstrate the (95 patients) (102 patients) novel and non-obvious qualities of the formulation. 0080. Likewise, 129 patients with chronic varicose ulcers I0083. In conclusion, these results indicate that synergistic were evaluated. The treatment (six 700 mg capsules three combinations of phytoceuticals, scientifically chosen from times a day) improved ulcers in 79% of the population, and each category of herbal tonics described in the next section, is remission was achieved in 21% of the population in only two suprisingly effective months (Table 5). The systemic treatment also significantly improved the most frequent symptoms (cramps 71.4%, pain 78%, and edema 88.7%). In contrast, most patients with EXAMPLE 9 chronic varicose ulcers do not achieve remission under exist ing pharmaceutical treatments and have high risk of amputa Principles for Selecting Synergistic Combinations tion. I0084. In order to expand the range of formulations encom passed by the invention, we have categorized beneficial plants TABLE 5 into one of three groups, each of which should be present for Chronic Varicose Ulcer Study synergistic effect. The classifications are Energy, Bio-Intelli Number of Clinical QoL Treatment gence and Organization. Plants classified under Energy are Patients Improvement Improvement tolerance Remission time associated with ATP synthesis (such as the Krebs cycle, oxi 129 79% 81.2% 99.2% 2 months dative phosphorylation, beta-Oxidation, etc.). Plants classi (102 patients) (105 patients) (128 in 21% of fied under Bio-Intelligence are those that regulate the neu patients) all patients roendocrine and immunological systems and cellular processes, thus controlling the interactions between the Vari ous systems in the body. Finally, plants classified under Orga 0081. In a study of 35 patients with Polycystic Ovary nization are those that relate to the structure and function of syndrome (PCOS), the treatment improved pelvic pain in all specific organs. Combinations of plants from these three clas 20 symptomatic patients, menstrual disorder (amenorrhea, sification groups have synergistic effect because they address dysmenorrhea, menometrorrhea, oligomenorrhea) in all 22 each necessary component of cellular and organic health—in symptomatic patients, asthenia and cephalea in all 17 Symp effect they provide the triangle on which healing is fully tomatic patients, as well as acne and hirsutism in 8 of 9 Supported. symptomatic patients. Pelvic echo Sonograms revealed that I0085. A large group of plants were classified (along with 29 patients (82.9%) experienced a total disappearance of Some vitamins, etc.) according to this system, based on what cysts, while another 6 (17.2%) showed a decrease in cyst size. is known in the literature about their active ingredients and In contrast, most patients with PCOS do not achieve symp mode of action. The classification is presented in Table 8. tomatic relief without surgical intervention, and very few, if Table 8 is representative only: based on the criterion any, have a complete disappearance of cysts (Table 6). The described herein, additional plants can easily be categorized dosage was six 650 mg capsules three times a day. as their mode of action is elucidated. US 2009/0155377 A1 Jun. 18, 2009

TABLE 8 Plant Categories Energy Bio-Intelligence Organization Acantopanacis Senticosits Agaricits blazei Angelica Sinensis Aiiiga turkestanica Aloe Vera Bupierum chinense Codonopsis piloStila Andrographispaniculata Clinicifiiga racemosa Cordyceps Sinensis Annona intificata Chitin fiber Cornu Cervipantotrichum Araia mandschurica Chondroitin Sulphate Ilex paragliariensis Astragalus membranacetis Crataegus Oxyacantha L-arginine Beta 1.3 glucan Croton lechieri Lepidium meyenii Beta 1.6 glucan Curcubitapepo Ocintin Sanctum Camelia Sinensis Circiima longa Panaxginseng Corioius versicolor Dioscorea viliosa Panax quinquefolius Echinacea angustifolia Equisetum arvense Pfafia paniculata Echinacea purpurea Eucominia bark Ptychopetalum oiacoides Ganoderma lucidum Fructus igustri lucidum Rhaponticum carthamoides Grifolia frondosa 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 itsitatissini in Sutherlandia frutescens Minerals Tabebuia a veianedae Mumiyo Turnera aphrodisiaca Opiinitia fictis indica Uncaria tonemiosa Picrorhiza kurroa Valeriana officinalis Plants enzymes Vitex agnus Castus Ptycopetallinoiacoides Pygeum africanum Rhamnus pairshiana Riiscus actileathis Saix aiba Sargassum fisiiforme Sena alejandrina Serenoa repens Siibun marianum Similax china Soiant in nigrum Tributius terrestris Ulmus fulva Urtica dioica Uva tipsi Vaccinium myrthillus Viburnum spp Vitamins

I0086. An illustrative example of synergy in medicinal already begun studying the expression profiles of various plants is an in vitro study that demonstrates how the activity of medicinal plants, thus providing a database of knowledge herbal Berberine alkaloids is strongly potentiated by the from which to build. E.g., Gohil, et al., mRNA Expression action of herbal 5'-methoxyhydnocarpin (5-MHC). It shows Profile of a Human Cancer Cell Line in Response to Ginkgo a strong increase of accumulation of berberine in the cells in Biloba Extract: Induction of Antioxidant Response and the the presence of 5'-MHC, indicating that this plant compound Golgi System, Free Radic Res. 2001 December; 33(6):831 effectively disabled the bacterial resistance mechanism 849. against the berberine antimicrobial, thus showing the synergy I0088 We may also test combinations of plants for syner of both substances. Stermitz FR, et al., Synergy in a medici gistic effects by using the mouse model for diabetic lesions, as nal plant: antimicrobial action of berberine potentiated by described in Mastropaolo, et al., Synergy in Polymicrobial 5'-methoxyhydnocarpin, a multidrug pump inhibitor. Proc Infections in a Mouse Model of Type 2 Diabetes Infection and Natl AcadSci USA. 2000 Feb. 15: 97(4): 1433-7. Immunity, September 2005, p. 6055-6063, Vol. 73, No. 9. 0087 We expect to further demonstrate synergistic effect Briefly, obese diabetic mouse strain BKS.Cg-m +/+ Leprodb/J on a molecular scale by studying the gene expression profile are injected Subcutaneously with mixed cultures containing changes in response to various plant ingredients and combi Escherichia coli, Bacteroides fragilis, and Clostridium per nations thereof. Experiments are already underway demon fringens. Progression of the infection (usually abscess forma strating the expression profile in response to the formulations. tion) is monitored by examining mice for bacterial popula We will be aided in this work because researchers have tions and numbers of white blood cells at 1, 8, and 22 days US 2009/0155377 A1 Jun. 18, 2009 post-infection. Various plant ingredients and combinations lucidum mushroom, Hydrastis Canadensis, Lepidium mey thereof can be used to show a synergistic effect. Further, the enii, Panax ginseng, Silibum marianum, Shark Cartilage, model can be used to show Synergy when the formulations of Tabebuia avellanedae, Uncaria tomentosa, Equisetum the invention are combined with existing pharmaceuticals, arvense, Fulvic Acid—Shilajit, Hydrocotile asiatica, Such as antibiotics. Picrorhiza kurroa, Smilax officinialis and Vaccinium mirtyl lus, together with pharmaceutically acceptable excipients. What is claimed is: 21. The phytoceutical composition of claim 20, comprising 1-19. (canceled) the composition of Table 3. 20. The phytoceutical composition, comprising a compo 22. The method of claim 20, comprising the composition of sition selected from the group consisting of the composition Table 3 used to treat skin disorders. of Rhaponticum Carthamoides, Rhodiola rosea, Szchisandra 23. The method of claim 21, comprising the composition of chinensis, Angelica sinensis, Astragalus membranaceus, Table 3 used to treat skin disorders. Echinacea angustifolia, Echinacea angustifolia radix, Echinacea purpurea, Echinacea purpurea radix, Ganoderma c c c c c