US 20150297652A1 (19) United States (2) Patent Application Publication (10) Pub. No.: US 2015/0297652 A1 Balaraman (43) Pub. Date: Oct. 22, 2015 (54) COMPOSITIONS AND METHODS FOR A61R 36/79 (2006.01) THEIR DERMATOLOGICAL USE A61 K. 36/74 (2006.01) A61 K. 36/539 (2006.01) (71) Applicant: VITA NATURALE, LLC, St. Louis, A61 K. 36/53 (2006.01) MO (US) A61 K. 36/882 (2006.01) A61 K. 36/282 (2006.01) (72) Inventor: Brundha Balaraman, St. Louis, MO A61 K. 36/48 (2006.01) (US) A61 K. 36/23 (2006.01) - (52) U.S. CI. (21) Appl. No.: 14/646,049 CPC ............... A61K 36/074 (2013.01); A61K 36/48 (2013.01); A61K 36/489 (2013.01); A61 K (22) PCT Filed: Nov. 19, 2013 36/185 (2013.01); A61K 36/58 (2013.01); - A61K 36/23 (2013.01); A61K 36/74 (2013.01); (86) PCT No.: PCT/US13/70779 A61K 36/539 (2013.01); A61K 36/53 § 371 (c)(1), (2013.01); A61K 36/882 (2013.01); A61 K (2) Date: May 20, 2015 36/282 (2013.01); A61K 36/79 (2013.01) Related U.S. Application Data (57) ABSTRACT (60) Provisional application No. 61/728,386, filed on Nov. Compositions containing Albizia lebbeck and/or Sophora fla 20, 2012. vescens and/or Hibiscus rosa sinensis and/or Phyllanthus emblica (syn. Emblica officinalis) and/or Azadirachta indica Publication Classification and/or Centella asiatica and/or Ganoderma and/or Rubia cordifolia and/or Scutellaria baicalensis and/or Astragalus (51) Int. Cl. membranaceus and/or Ocimum tenuiflorum (syn. Ocimum A6 IK 36/074 (2006.01) sanctum) and/or Acorns and/or Artemisia and/or Rheum and/ A6 IK 36/489 (2006.01) or Schisandra and/or Ophiopogon japonicas and their use in A6 IK 36/185 (2006.01) preventing, treating, alleviating symptoms and/or mitigating A61K 36/58 (2006.01) skin disorders and/or disease are provided. US 2015/0297652 A1 Oct. 22, 2015 COMPOSITIONS AND METHODS FOR of the pancreas occurring after an acute attack (Sidhu et al. THEIR DERMATOLOGICAL USE Journal of Medicinal Food 2011 14 (1–2): 147-155). Prepa rations of leaves, bark and/or fruit have also shown potential [0001] This patent application claims the benefit of priority efficacy against inflammation, cancer, age-related renal dis from U.S. Provisional Application Ser. No. 61/728,386, filed ease and diabetes in disease models (Ganju et al. Biomed Nov. 20, 2012, the teachings of which are herein incorpo Pharmacother 2003 57 (7): 296-300; Yokozawa et al. JAgric ratred by reference in their entirety. Food Chem. 2007 55(19): 7744-52; Rao et al. J Med Food FIELD OF THE INVENTION 2005 8 (3): 362-8; and Qureshi et al. Pakistan Journal of Nutrition 2009 8 (2): 125-128) and a pilot study in humans [0002] The present invention relates to compositions con showed a reduction of blood cholesterol levels in both normal taining Albizia lebbeck and/or Sophora flavescens and/or and hypercholesterolemic men upon treatment with a berry Hibiscus rosa sinensis and/or Phyllanthus emblica (syn. extract (Jacob et al. Eur J Clin Nutr 1988 42 (11): 939-44). Emblica officinalis) and/or Azadirachta indica and/or Cen [0007] Azadirachta indica, also referred to as NEEM, has tella asiatica and/or Ganoderma and/or Rubia cordifolia and/ been disclosed to have anti-bacterial, anti-parasitic, anti-fun or Scutellaria baicalensis and/or Astragalus membranaceus gal, anti-protozoal and anti-viral properties. NEEM, when and/or Ocimum tenuiflorum (syn. Ocimum sanctum) and/or applied in the form of a powder or oil has been disclosed to Acorus and/or Artemisia and/or Rheum and/or Schisandra have exceptional results on external cuts or wounds and to to and/or Ophiopogon japonicus. The present invention also be very effective in relieving skin ailments such as eczema, relates to use of these compositions in preventing, treating, acne, skin allergy, rashes, itch, ringworms, etc. NEEM water alleviating symptoms and/or mitigating skin disorders and/or is also described as being very effective when used to treat disease. burn injuries. In addition, NEEM oil is suggested to prevent hair from graying and to be effective in treating dandruff, lice BACKGROUND OF THE INVENTION and hair loss. NEEM oil has also been suggested for use in [0003] Albizia lebbeck is a species of Albizia, fast-growing massaging muscle aches and joints to releive pain from con subtropical and tropical trees and shrubs, native to Indoma ditions such as rheumatoid arthritis, gout, osteoarthritis and laya, New Guinea and Northern Australia. Lebbeck is an lower back pain. Ingesting NEEM is suggested to be benefi astringent and has been used by some cultures in the treatment cial in restoring taste, curing constipation and relieving indi or alleviation of boils, cough, eye disordors, flu symptoms, gestion. It also eliminates the problem of acidity. See gingivitis, lung problems and pectoral problems. It has been soultemplemet with the extension .org/profiles/blogs/health suggested for use as an oral tonic in the treatment of abdomi benefits-of-azadirachta of the world wide web. nal tumors. (See, for example, Duke, Jame A., Dr. Duke’s [0008] Centella is used as a leafy green in various cuisines Phytochemical and Ethnobotanical Databases—Albizia leb and is considered quite nutritious. However, while Centella beck 2008). The bark is used medicinally to treat inflamma asiatica has been promoted for its health benefits, available tion (Lowry et al. (1994): 2.5 Albizia lebbeck—a Promising scientific evidence has not supported claims of its effective Forage Tree for Semiarid Regions. In: Gutteridge, Ross C. ness for treating cancer or any other diseases in humans and Shelton H. Mac (eds.):Forage Tree Legumes in Tropical (“Gotu Kola” American Cancer Society. 28 Nov. 2011). Agriculture. CAB Intemational). [0009] Ganoderma is a genus of polypore mushrooms [0004] Sophora flavescens is a species of plant in the genus which grow on wood, and include about 80 species. Collec Sophora. About fifteen species in this genus have been used in tively, the Ganoderma species are being investigated for a traditional Chinese medicines. Common suggested uses variety of potential therapeutic benefits including anticancer include treatment of viral hepatitis, enteritis, cancer, viral effects, immunoregulatory effects, antioxidant activities, myocarditis, gastrointestinal hemorrhage and skin diseases liver-protecting effects, hypoglycemic effects, antibacterial such as vaginitis, psoriasis and eczema. effects, antiviral effects, antifungal effects and reducing [0005] Hibiscus rosa-sinensis, also known as rose mallow, blood cholesterol (Yuen, J W and Gohel, M. D. Nutr Cancer Chinese hibiscus, China rose and shoe flower, is a species of 2005 53 (1): 11-7; Xu et al. American Journal of Chinese flowering plant in the family Malvaceae. Hibiscus rosa-sin Medicine 2011 39 (1): 15-27; Sliva D. Mini Reviews in ensis has also been used traditionally in Chinese medicines. Medicinal Chemistry 2004 4 (8): 873-9; and Sanodiya et al. An extract from the flowers of Hibiscus rosa-simensis has Current Pharmaceutical Biotechnology 2009 10(8): 717-42). been shown to function as an anti-solar agent by absorbing ultraviolet radiation (Nevade etal. 2011. Linn. Research Jour [0010) Rubia cordifolia, also known as Common Madder nal of Pharmacy and Technology 4(3): 472-473). or Indian Madder, is a species of flowering plant in the coffee [0006] Phyllanthus emblica (syn. Emblica officinalis), is a family, Rubiaceae. It has been cultivated for a red pigment deciduous tree of the family Phyllanthaceae. Preliminary derived from roots and has been described to have anti-in research has shown in vitro antiviral and antimicrobial prop flammatory properties and induce urolithiasis in cellular and erties of its berries (Saeed, S. and Tariq, P, Pak J Pharm Sci animal models (Joshan et al. Biomedical and Pharmacology 2007 2001): 32-5). There is also preliminary evidence in vitro Journal 2010 3:1 123-128; and Divakar et al. Food and that its berry extracts induce apoptosis and modify gene Chemical Toxicology 2010 48:4 1013-1018). expression in osteoclasts involved in rheumatoid arthritis and [0011] Scutellaria baicalensis and Astragalus propinquus osteoporosis (Penolazzi et al. BMC Complementary and are species of flowering plants in the Lamiaceae family and Alternative Medicine 2008 8: 59) and may prove to have family Fabaceae, respectively. Both are included in the 50 activity against some cancers (Ngamkitidechakul et al. Phy fundamental herbs used in traditional Chinese medicine. A. totherapy Research 2010 24 (9): 1405-1413). A recent study propinquus has been asserted to be a tonic that can improve in rats showed E. officinalis to reduce severity of acute pan the functioning of the lungs, adrenal glands and the gas creatitis and to promote spontaneous repair and regeneration trointestinal tract, increase metabolism and sweating, pro US 2015/0297652 A1 Oct. 22, 2015 mote healing, and reduce fatigue (Balch, P. 2006 Prescription Ocimum sanctum) and/or Acorus and/or Artemisia and/or for Nutritional Healing (4th ed.) Avery Penguin Putnam). Rheum and/or Schisandra and/or Ophiopogon japonicus for [0012] Ocimum tenuiflorum, also known as Ocimum sanc mulated in, for example, ointments, creams, lotions, solu tum, Holy basil, or tulasi, is an aromatic plant in the family tions, pastes (e.g. facial mask), gels, emulsions, sprays, aero Lamiaceae. In vitro and animal studies have indicated some sols, oils, patches, toothpastes, mouthwashes, deodorants, potential pharmacological properties of Ocimum tenuiflorum soaps, body and/or face washes, sponges, foams, semi-solids, or its extracts as painkillers, antihyperlipidemics, cardiopro cosmetics (e.g. solid, semisolid, liquid, or powder founda tectants, anti-cancer agents and mitigants of the effects of tion, eye shadow, lip balm), application sticks, sunscreens, radiation exposure, and antibacterial agents (Prakash, P.