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(12) Patent Application Publication (10) Pub. No.: US 2015/0190446 A1 FOGEL (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2015/0190446 A1 FOGEL (43) Pub US 2015O190446A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0190446 A1 FOGEL (43) Pub. Date: Jul. 9, 2015 (54) HERBAL COMPOSITIONS FOR THE Publication Classification TREATMENT OF DABETES AND/OR (51) Int. Cl. CONDITIONS ASSOCATED THEREWITH A61E36/605 (2006.01) A61E36/282 (2006.01) (71) Applicant: Dov FOGEL, Savyon (IL) A61E36/54 (2006.01) A61E36/738 (2006.01) (72) Inventor: Dov FOGEL, Savyon (IL) A61E36/288 (2006.01) A61E36/76 (2006.01) A61E36/63 (2006.01) A61E36/85 (2006.01) (21) Appl. No.: 14/568,772 A61E36/48 (2006.01) (52) U.S. Cl. CPC ............. A61K 36/605 (2013.01); A61K 36/185 (22) Filed: Dec. 12, 2014 (2013.01); A61 K36/282 (2013.01); A61 K 36/54 (2013.01); A61K 36/48 (2013.01); A61 K 36/288 (2013.01); A61K 36/76 (2013.01); Related U.S. Application Data A61K 36/63 (2013.01); A61 K36/738 (2013.01) (57) ABSTRACT (62) Division of application No. 12/452,355, filed on Mar. The present invention provides a method for treating type II 17, 2010, now abandoned, filed as application No. diabetes, conditions associated therewith, or both, by admin PCT/IL2008/000880 on Jun. 26, 2008. istering to a subject in need thereofatherapeutically effective amount of a herbal composition comprising (i) an extract of (30) Foreign Application Priority Data leaves of at least one Morus species, (ii) at least one Urtica species or an extract thereof, and (iii) at least one Artemisia Jun. 28, 2007 (IL) .......................................... 184312 species or an extract thereof. Patent Application Publication Jul. 9, 2015 US 2015/O190446 A1 FIGURE 1 3OO Average 25O Fasting Blood - 2OO glucose levels 117 15 O Img/dl. 1 OO 50 O Months FIGURE 2 12.OO 11 OO 1 O.OO 9.OO 38 S2 8.00 ac 52 7.00 6.OO 6.20 5. OO 4.OO 3.OO T O Months 3 US 2015/O 190446 A1 Jul. 9, 2015 HERBAL COMPOSITIONS FOR THE 0008 Various Mulberry species (Moraceae family) are TREATMENT OF DABETES AND/OR known for therapeutical effects. For example, the branches CONDITIONS ASSOCATED THEREWITH and bark of M. alba (white Mulberry) are used for lowering blood pressure (Enkhmaa et al., J. nutr. 2005, Vol. 135, no. 4, 0001. This application is a divisional application of US pp. 729-734). M. indica L. leaves have been shown to possess 2010/0202980, which is a US national phase of International hypoglycemic, hypotensive, and diuretic properties, although Application No. PCT/IL2008/000880, filed Jun. 26, 2008 there was no apparent effect on the concentrations of the which designated the U.S., and claims priority to IL. Patent glycosylated hemoglobin (Hb A(1)c) in diabetic patients (An Application No. 184312, filed Jun. 28, 2007, the entire con dallu et al., Clin Chim Acta. 2001 December, 314 (1-2):47 tents of each of which are hereby incorporated by reference. 53). It is important to note that presently known Mulberry derived compounds have been derived from fruits, bark, and FIELD AND BACKGROUND OF THE in the case of leaves, have avoided extracting the leafin a way INVENTION that would include the latex covering the leaves. 0002 The present invention relates to the field of thera 0009 Canella winteriana (known by the common names: peutic natural products, particularly to plant extracts effective Canella, Cinnamon Bark, Cinnamonbark, Pepper Cinnamon, in treating and preventing diabetes and/or conditions associ Wild Cinnamon) and Cinnamomum cassia (Cinnamon) have ated therewith. been Suggested to be useful in maintaining healthy blood 0003 Diabetes mellitus is a common, serious disease sugar levels, and cholesterol levels as well (Aaron W. Jensen, characterized by hyperglycemia. The World Health Organi "Cinnamon Reduces Blood Sugar and Cholesterol Levels”, zation (WHO) estimates that more than 190 million people InsulifeTM). But, while daily doses of cinnamon did produce worldwide have diabetes and this number is constantly on the Some significant reductions in blood Sugar levels, total cho rise. The disease can be divided into two major subclasses: lesterol levels, triglyceride levels and even lower levels of insulin-dependent diabetes mellitus (IDDM), also known as LDL lipoproteins, the higher dose of cinnamon did not seem type I diabetes, and non-insulin-dependent diabetes mellitus to improve the actual reduction in the various serum levels (NIDDM), also known as type II diabetes or adult diabetes. mentioned above when compared to the lower doses of cin 0004. In adult (type II) diabetes, high levels of sugar in the namon (Alam et al., Diabetes Care 26:3215-3218, 2003). blood cause a recognizable increase in the osmolarity of the 0010 Artemisia is a large, diverse genus of plants with blood, causing confusion and difficult conditions such as between 200-400 species belonging to the daisy family Aster unconsciousness. Long-term complications usually appear in aceae, and grow in temperate climates, usually in dry or both small and large blood vessels, affecting the heart, kid semi-dry habitats. U.S. Pat. No. 6,350,478 discloses extracts neys and eyes, as well as damaging the sensory nerves (espe of Artemisia judaica and fractions thereof, and has found that cially in the legs). Damage also occurs in the autonomic Some fractions of are insulinomemetic and others have glu nervous system, and is expressed by impotence, infertility cagon antagonistic properties. and disturbances in the digestive system, heart and blood 0011. The stinging nettle (Urtica dioica) is the best known vessels. member of the Urtica genus, which has been widely used by 0005. A significant proportion of diabetic adults also suf herbalists around the world for centuries. In Brazil and Peru fer from high blood pressure. Both of these diseases must be herbal medicine the entire plant is used for various disorders, attended to because both accelerate degeneration with com including diabetes and inflammatory conditions. Farzami et plications, especially in the blood vessels and the heart. 41 al. (Journal of Ethnopharmacology 2003; 89:47-53) dis million Americans are suffering from pre-diabetes, a precur closed the induction of insulin secretion by a component of sor to diabetes type II. Another condition associated with Urtica dioica leaf extract and its in vivo effects in diabetic diabetes as a secondary cause, is hypertriglyceridemia, a ratS. commonly encountered lipid abnormality, which is fre 0012. A systematic review of herbs and dietary supple quently associated with additional lipid and metabolic ments for glycemic control in diabetes has been conducted by derangements. Yeh et al. (Diabetes Care. 2003 April, 26(4): 1277-94). This 0006. The regulation of diet and exercise and/or treatment review has concluded that the heterogeneity and Small num with insulin or hypoglycemia drugs have been used for con ber of studies per Supplement precluded formal meta-analy trol of both diabetes and triglycerides. Treatment with these ses and that thus there is still insufficient evidence to draw agents is successful in Some cases, but the mortality index definitive conclusions about the efficacy of individual herbs continues to rise. Insulin treatment and Hypoglycemic agents and Supplements for diabetes although the researchers have (such as Sulfonylureas, Biguanides and alpha glucosidase indicated that they appear to be generally safe. The best inhibitors) provide symptomatic relief rather than a cure for evidence for efficacy from adequately designed randomized diabetes and are associated with side effects. The side effects controlled trials (RCTs) is available for Coccinia indica and of Sulfonylureas include hypoglycemia, renal and heptic dis American ginseng. ease, gastrointestinal disturbance, increase cardiovascular 0013. In another study on the efficacy of dietary supple mortality, dizziness, drowsiness headache and others. The mentation with botanicals on carbohydrate metabolism in major side effects of Biguanides are lactic acidosis and humans (Cefalu et al., Endocr. Metab Immune Disord Drug increased cardiovascular mortality. The side effects of alpha Targets, 2008, 8(2):78-81), the efficacy of Bitter Melon (Mo glucosidase inhibitors include gastrointestinal side effects mordica charantia), Fenugreek (trigonella foenum graecum), and hypoglycemia. Gymnema Sylvestre, Ivy Gourd (Coccinia indica), Nopal or 0007. In addition to conventional treatments relying on Prickly Pear Cactus (Opuntia Streptacantha), Ginseng, Aloe insulin injections or oral medications, natural products, Vera, Russian Tarragon (Artemisia dracunculus), and Garlic including plant materials, have been reportedly tried in alter (Allium sativum) was evaluated and the researchers have con native treatments of conditions such as diabetes. cluded that there is insufficient evidence from clinical studies US 2015/O 190446 A1 Jul. 9, 2015 for any of the botanicals reviewed, and thus that it is prema 0028. According to still further features in the described ture to actively recommend use of any particular herb to treat preferred embodiments, the Taraxacum species is Taraxacum either glucose or other risk factors. Officinale. 0014 Thus, there is an ongoing need to find natural rem 0029. According to still further features in the described edies for diabetes and/or for hypertriglyceridemia, which preferred embodiments, the Rosa species is Rosa canina. exhibit high efficiency in lowering the glucose and/or triglyc 0030. According to still further features in the described eride levels in the blood, even in clinically tested experiments. preferred embodiments, the amount of the Morus extract ranges from about 50 weight percentage
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