FIELD OF INVENTION
[001] The present disclosure broadly relates to a herbal composition having anti-glycemic effects and particularly discloses a composition comprising ginseng extract, lemon balm extract, and hops extract.
BACKGROUND OF INVENTION
[002] Diabetes mellitus is a major public health problem that affects approximately 5% of the world population. Type 2 diabetes is the most common form, accounting for more than 90% of patients, and is characterized by chronic hyperglycemia resulting from abnormalities in glucose metabolism and insulin secretion and activity. In case of type 2 diabetes, insulin produced by the human body is not able to stimulate body’s cells to efficiently absorb the glucose from blood for potential use. This leads to excess build-up of glucose in the blood which causes the symptoms characteristic of type 2 diabetes. In later stages of the disease, the body may also not be able to produce enough insulin for clearing the glucose from bloodstream, adding to the complexity of the disease.
[003] Treatments involving synthetic drugs are available in the market for tackling the challenges posed by type 2 diabetes. These types of treatments have their own side-effects and pose other challenges to a diabetic patient. Most importantly considering the socio-economic status of developing countries, these treatments are neither cheap nor are completely effective. Also, since these types of treatments are required throughout the life once a person has been diagnosed with type 2 diabetes, long term usage may cause adverse effects on a patient. Metformin is usually the first line of medication for patients diagnosed with type 2 diabetes. Some of the common side-effects of using the drug includes abdominal pain, diarrhea, and nausea (American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016). In case of uncontrolled blood glucose levels, synthetic insulin is also provided to the patient to lower the blood glucose levels.

[004] In addition, the individual suffering from diabetes becomes immune-compromised in due course of time and the metabolic activity of the whole body tends to get affected, leaving the body sensitive to other infections and disorders. Thus, diabetes is a life-threatening condition if proper and timely treatment is not provided to the afflicted individual. In light of the above-mentioned problems in the treatment of diabetes, highly effective anti-diabetic compositions are required which are natural rather than synthetic.
[005] Many recent studies on the treatment of type 2 diabetes have focused on the potential use of plant constituents with hypoglycaemic and hypolipidaemic effects (MJ Chung. et. al., 2010. British Journal of Nutrition, page no. 180-188, vol.104, issue 2).
[006] US20160206673A1 discloses a synergistic blend of ingredients (comprising ginseng, hops and lemon extract apart from other components) and a method of using the synergistic blend for benefiting health and improving sexual performance.
[007] CN104886471 discloses a sour and sweet calcium supplementing health¬care rice comprising ginseng extract, hops extract, and lemon balm extract apart from other components that can enhance human body immunity, and the health¬care rice is particularly suitable for the consumption of middle-aged and elderly people to supplement calcium.
[008] WO 2015039798 A1 discloses anti-diabetic composition comprising Inula racemosa extract and sitagliptin and a process for preparing the composition. [009] US9737559B2 discloses synergistic compositions comprising insulin preparations having a defined degree of polymerisation (DP) of below about 25 and sulfonylureas and/or a sulfonamide and/or derivatives and/or metabolite thereof used in the treatment of Type-2 Diabetes Mellitus (T2DM).
[0010] There still exists a lacuna for an effective anti-glycemic composition which is completely natural or comprises herbal sources and which does not display any side-effects.
SUMMARY OF THE INVENTION

[0011] In an aspect of the present invention, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition.
[0012] In an aspect of the present invention, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition.
[0013] In an aspect of the present invention, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; (v) obtaining at least one excipient; and (vi) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one excipient to obtain said composition.
[0014] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0015] The following drawings form a part of the present specification and are
included to further illustrate aspects of the present disclosure. The disclosure may
be better understood by reference to the drawings in combination with the detailed
description of the specific embodiments presented herein.
[0016] Figure 1 depicts the effect of varying concentrations of ginseng extract,
lemon balm extract and Hops extract on α-glucosidase inhibition, in accordance
with an embodiment of the present disclosure.
[0017] Figure 2 depicts the effect of different combinations on α-glucosidase
inhibition, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0018] Those skilled in the art will be aware that the present disclosure is subject to
variations and modifications other than those specifically described. It is to be
understood that the present disclosure includes all such variations and
modifications. The disclosure also includes all such steps, features, compositions,
and compounds referred to or indicated in this specification, individually or
collectively, and any and all combinations of any or more of such steps or features.
Definitions
[0019] For convenience, before further description of the present disclosure,
certain terms employed in the specification, and examples are delineated here.
These definitions should be read in the light of the remainder of the disclosure and
understood as by a person of skill in the art. The terms used herein have the
meanings recognized and known to those of skill in the art, however, for
convenience and completeness, particular terms and their meanings are set forth
below.
[0020] The articles “a”, “an” and “the” are used to refer to one or to more than one
(i.e., to at least one) of the grammatical object of the article.
[0021] The terms “comprise” and “comprising” are used in the inclusive, open
sense, meaning that additional elements may be included. It is not intended to be
construed as “consists of only”.

[0022] Throughout this specification, unless the context requires otherwise the
word “comprise”, and variations such as “comprises” and “comprising”, will be
understood to imply the inclusion of a stated element or step or group of element or
steps but not the exclusion of any other element or step or group of element or
steps.
[0023] The term “including” is used to mean “including but not limited to”.
“Including” and “including but not limited to” are used interchangeably.
[0024] Ratios, concentrations, amounts, and other numerical data may be presented
herein in a range format. It is to be understood that such range format is used
merely for convenience and brevity and should be interpreted flexibly to include
not only the numerical values explicitly recited as the limits of the range, but also
to include all the individual numerical values or sub-ranges encompassed within
that range as if each numerical value and sub-range is explicitly recited. For
example, a concentration range of about 15 g/L to about 25 g/L should be
interpreted to include not only the explicitly recited limits of about 15 g/L to about
25 g/L, but also to include sub-ranges, such as 16 g/L to 25 g/L, 15 g/L to 24 g/L,
and so forth, as well as individual amounts, including fractional amounts, within
the specified ranges, such as 19.5 g/L, 20.1 g/L, and 21.9 g/L, for example.
[0025] For the purposes of the present document, the terms ‘anti-diabetic’ and
‘anti-glycemic’ have been used interchangeably. Both the terms are directed to an
effect displayed by the composition of the present disclosure, the end result of
which is a reduction of glucose content. The composition of the present disclosure
exhibits anti-diabetic or anti-glycemic effect by inhibiting the activity of the
enzyme α-glucosidase.
[0026] For the purposes of the present document, vitamin premix refers to vitamins
selected from the group consisting of Vitamin A, D, E, K, Vitamin B complex, and
combinations thereof. Mineral premix refers to minerals selected from the group
consisting of sodium, magnesium, calcium, chloride, iron, and combinations
thereof.
[0027] For the purposes of the present document, carriers, and diluents may be
selected from among different dairy products, and solvents acceptable for general

consumption. The diluent can also be water into which the appropriate actives can be dissolved.
[0028] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference. [0029] A composition made up of natural elements is the best alternative to synthetic drugs to provide an effective anti-diabetic composition with minimal side-effects. Ginseng is said to facilitate blood flow, alleviate fatigue as well as relieve oxidative stress in diabetic conditions. Clinical studies have reported that American ginseng has the ability to lower blood glucose in diabetic patients (Luo JZ and Luo L. eCAM. 2009;6(4):423-427). Lemon balm (Melissa officinalis) is a well-known medicinal plant species used in perfumes, cosmetics, tea and food products. Lemon balm has medicinal properties, including hypolipidaemic and hypoglycaemic effects (Chung, M. et al., British Journal of Nutrition, 2010. 104(2), 180-188). Hops (Humulus lupulus) contain compounds that are readily modified to the family of isohumulones (e.g., iso-alpha acids). The isohumulones have been found to reduce metabolic inflammation and insulin resistance, and positively impact dyslipidemia and obesity. These effects are consistent across studies in multiple cell lines, animal model systems and human intervention trials (Bland JS. et al., Pharma Nutrition, 2015. Vol.3, issue 2).
[0030] The objective of the present invention is to provide a novel combination of three ingredients, namely, Ginseng extract, Lemon balm extract and Hops extract, which can be used for the inhibition of Glucosidase enzyme. The α-glucosidase enzyme is involved in the breakdown of complex carbohydrates to monomers. The inhibition of glucosidase enzyme can significantly reduce the level of glucose in blood and thus can be a critical strategy to control blood-glucose levels in an individual.

[0031] The present disclosure discloses a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition. The actives present in the composition are all herbal extracts. The additives comprising a part of the composition includes at least one additive selected from the group consisting of vitamin premix, mineral premix, and combinations thereof. The w/w ratio of ginseng extract to the lemon balm extract in said composition is in the range of 1:6 to 6:1. Similarly, the w/w ratio of ginseng extract to the hops extract is in the range of 1:6 to 6:1, and the w/w ratio of lemon balm extract to the hops extract is in the range of 1:6 to 6:1. The ability of the composition in inhibiting the α-glucosidase activity has been depicted in the examples section. The composition of the present disclosure thus exhibits anti-diabetic or anti-glycemic activity and can be used in relevant formulations. [0032] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of exemplification only. Functionally-equivalent products, compositions, and methods are clearly within the scope of the disclosure, as described herein. [0033] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition. In another embodiment of the present disclosure, the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 18 g/L to 22 g/L with respect to the composition.
[0034] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration of 20 g/L with respect to the composition.

[0035] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:6 to 6:1. In another embodiment of the present disclosure, wherein the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:4 to 4:1. In yet another embodiment of the present disclosure, wherein the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:2 to 2:1.
[0036] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the ginseng extract to the hops extract w/w ratio is in the range of 1:6 to 6:1. In another embodiment of the present disclosure, the ginseng extract to the hops extract w/w ratio is in the range of 1:4 to 4:1. In yet another embodiment of the present disclosure, the ginseng extract to the hops extract w/w ratio is in the range of 1:2 to 2:1.
[0037] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the lemon balm extract to the hops extract w/w ratio is in the range of 1:6 to 6:1. In another embodiment of the present disclosure, the lemon balm extract to the hops extract w/w ratio is in the range of 1:4 to 4:1. In yet another embodiment of the present disclosure, the lemon balm extract to the hops extract w/w ratio is in the range of 1:2 to 2:1.
[0038] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the

hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the ginseng extract to the lemon balm extract to the hops extract w/w/w ratio is 1:1:1.
[0039] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:6 to 6:1, the ginseng extract to the hops extract w/w ratio is in the range of 1:6 to 6:1, and the lemon balm extract to the hops extract w/w ratio is in the range of 1:6 to 6:1.
[0040] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof.
[0041] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof, and the vitamin premix comprises different vitamins selected from the group consisting of Vitamin A, D, E, K, Vitamin B complex, and combinations thereof.
[0042] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15

g/L to 25 g/L with respect to the composition, the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof, and the mineral premix comprises different minerals selected from the group consisting of sodium, magnesium, calcium, chloride, iron, and combinations thereof.
[0043] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, and the at least one excipient is selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof.
[0044] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, the at least one excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof, and the masking agents is selected from the group consisting of natural flavors of vanilla, natural flavors of chocolate, nature identical flavors of vanilla, nature identical flavors of chocolate, and combinations thereof. [0045] In an embodiment of the present disclosure, there is provided a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, the at least one excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof, and the emulsifier is selected from the group consisting of

citric acid esters of mono and di glycerides, soy lecithin, sodium alginate, potassium alginate, calcium alginate, and combinations thereof.
[0046] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition. In another embodiment of the present disclosure there is provided a process as described herein, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 18 g/L to 22 g/L with respect to the composition. In another embodiment of the present disclosure there is provided a process as described herein, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration of 20g/L. [0047] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:6 to 6:1.
[0048] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined

concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the ginseng extract to the hops extract w/w ratio is in the range of 1:6 to 6:1.
[0049] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the lemon balm extract to the hops extract w/w ratio is in the range of 1:6 to 6:1.
[0050] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the ginseng extract to the lemon balm extract to the hops extract w/w/w ratio is 1:1:1.
[0051] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration of 20 g/L with respect to the composition, said process comprising:

(i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition.
[0052] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof.
[0053] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; and (d) at least one additive, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; and (v) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition, wherein the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof, and the vitamin premix comprises different vitamins selected from the group consisting of Vitamin A, D, E, K, Vitamin B complex, and combinations thereof and the mineral premix comprises different minerals selected from the group consisting of sodium, magnesium, calcium, chloride, iron, and combinations thereof.

[0054] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; (v) obtaining at least one excipient; and (vi) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one excipient to obtain said composition.
[0055] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; (v) obtaining at least one excipient; and (vi) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one excipient to obtain said composition, wherein the at least one is excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof. [0056] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; (v) obtaining at least one excipient; and (vi) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one

excipient to obtain said composition, wherein the at least one is excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof, and the masking agents is selected from the group consisting of natural flavors of vanilla, natural flavors of chocolate, nature identical flavors of vanilla, nature identical flavors of chocolate, and combinations thereof.
[0057] In an embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) ginseng extract; (b) lemon balm extract; (c) hops extract; (d) at least one additive; and (e) at least one excipient, wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition, said process comprising: (i) obtaining ginseng extract; (ii) obtaining lemon balm extract; (iii) obtaining hops extract; (iv) obtaining at least one additive; (v) obtaining at least one excipient; and (vi) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one excipient to obtain said composition, wherein the at least one is excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof, and the emulsifier is selected from the group consisting of citric acid esters of mono and di glycerides, soy lecithin, sodium alginate, potassium alginate, calcium alginate, and combinations thereof.
[0058] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition exhibits anti-diabetic effect by inhibiting α glucosidase enzyme activity.
[0059] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is used in anti-diabetic formulations. [0060] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is used in anti-diabetic medications. [0061] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the ginseng extract comprises ginsinosides having a weight percentage in the range of 24%-26% with respect to the ginseng extract. In

another embodiment of the present disclosure, the ginseng extract comprises
ginsinosides having a weight percentage of 24.60% with respect to the ginseng
extract.
[0062] In an embodiment of the present disclosure, there is provided a composition
5 as described herein, wherein the lemon balm extract comprises rosmarinic acid
having a weight percentage in the range of 2.45%-3% with respect to the lemon balm extract. In another embodiment of the present disclosure, the lemon balm extract comprises rosmarinic acid having a weight percentage of 2.52% with respect to the lemon balm extract.
0 [0063] In an embodiment of the present disclosure, there is provided a composition
as described herein, wherein the composition is in a powder form which further is dissolved in at least one solvent. In another embodiment of the present disclosure, the at least one solvent is selected from the group consisting of dairy products, water, and combinations thereof. In yet another embodiment of the present
5 disclosure, the at least one solvent is milk.
[0064] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in a liquid form.
[0065] Although the subject matter has been described in considerable detail with reference to certain examples and implementations thereof, other implementations
0 are possible.
EXAMPLES
[0066] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless
5 defined otherwise, all technical and scientific terms used herein have the same
meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein.
0 It is to be understood that this disclosure is not limited to particular methods, and
experimental conditions described, as such methods and conditions may apply.

[0067] The present section will be elaborated by depicting working examples in which the activity of the composition in terms of inhibiting α-glucosidase enzyme has been discussed. The non-working examples depict the inability of the composition in inhibiting α-glucosidase enzyme activity if the components are present outside the disclosed concentration ranges. It highlights the importance of the combined concentration (within a range of 15 to 25 g/L) of the constituents of the composition. Thus, the examples clearly depict the scientific skill involved in arriving at a composition which is able to display anti-glycemic activity only at a particular concentration range of the constituents. The present examples depict that the actives to be dissolved in DMSO before testing for the anti-glycemic effects. It is construed that the actives can be dissolved in any other suitable solvents as far as the combined concentration adheres to the mentioned range.
Example 1
Dose response study of the actives in the composition
[0068] The composition of the present disclosure discloses the presence of three actives namely ginseng extract, lemon balm extract, and hops extract. The experiment for depicting the dose response activity of each of the component in inhibiting the activity of α-glucosidase has been discussed in the present example. The ginseng extract, lemon balm extract, and hops extract have been commercially procured. Ginseng extract comprises 24.60% of ginsinosides, the lemon balm extract comprises 2.50% of rosmarinic acid, and the hops extract comprises [0069] Assay for determining the inhibition of α-glucosidase enzyme: For performing the experiment, 100µl of α - glucosidase (1µl/ml) was added to 10µl of natural extract (actives of the composition). The mixture was incubated for 10 minutes. After the incubation, 50µl of 5mM p-nitro phenyl - α glucopyranoside solution was added and incubated further. After 5 minutes of incubation, absorbance was read at 405nm. The percentage inhibition was calculated as per the formula given below: % Inhibition = [Absorbance ctrl - Absorbance Test]/ Absorbance Ctrl X 100

[0070] Figure 1 depicts the dose response study for the individual actives of the composition. Each active was taken at a concentration of 5mg/ml, 10mg/ml, 20mg/ml, and 30mg/ml. It can be appreciated that ginseng extract fails to elicit inhibitory response towards the activity of α-glucosidase at any of the above-mentioned concentrations. In case of lemon balm extract, as the concentration increases from 5mg/ml to 30mg/ml, an increase in percentage of α-glucosidase inhibition from 5% to 30% can be observed. In case of hops extract, 30mg/ml is able to show 4% inhibition of the enzyme activity and all other concentrations fail to display any level of inhibition.
[0071] Subsequently, the composition comprising all the three actives were formulated and evaluated for the levels of α-glucosidase enzyme inhibition.
Example 2
Composition depicting anti-glycemic activity
[0072] The Table 1 discloses the active components of the present composition
[0073] Referring to Table 1, it is highlighted that all the three actives should be present in a combined concentration having a range of 15g/L to 25g/L. The composition to be tested for anti-glycemic effects were made by dissolving appropriate amounts of the extracts in DMSO (dimethyl sulfoxide). The three actives were tested in the w/w ratios as depicted in Table 2: Table 2:

[0074] Table 2 depicts the various w/w ratios along with the concentrations tested for each of the actives. The compositions A to J were prepared as per the concentrations depicted in Table 2. The inhibition assay as described in Example 1 was performed to assess the ability of the compositions to inhibit α-glucosidase enzyme activity.
[0075] Figure 2 depicts the α-glucosidase assay performed using the different compositions A to J. It can be observed that A, B, and C which comprises only one of the actives (individually) does not exhibit any significant ability to inhibit α-glucosidase enzyme activity. The highest inhibitory activity of 8% is depicted in case of composition D and composition H. The composition D comprises equal concentration (6.66mg/ml) of all the three actives whereas, the composition H

[0077] Referring to Figure 2 and Table 3, the other compositions E to G, and I and J also depict significant inhibition of α-glucosidase activity. On comparing with the individual dose response of the three actives as described in Example 1, it can be appreciated that all the compositions D to J depict synergistic inhibition of α-glucosidase enzyme activity. The synergistic activity of the compositions D to J can be affirmed by the observation that at a given ratio the inhibitory percentage displayed by the respective composition is significantly higher than the additive effect of the individual actives at that particular ratio. Also, the compositions comprising any one of the actives in a concentration of 20mg/ml does not provide the desired inhibitory activity.
Example 3
Non-working examples of the composition

[0078] The combined concentration of the three actives is crucial to achieve the desirable anti-glycemic effect of the composition as disclosed in the present disclosure. The non-working examples depict the anti-glycemic effect of various compositions comprising the three actives in varied combined concentration. Also, the effect of compositions which are devoid of any one of the actives. Non-working examples - Set 1:
[0079] Set 1 depicts the effect of compositions which are devoid of any one of the active components. The compositions of Set 1 have been depicted in Table 4 and Table 5 of the present example.
[0080] It can be observed from Table 4 and Table 5, the compositions comprising only two of the actives in a combined concentration of 20mg/ml are not able to display any synergistic effect in inhibiting the activity of α-glucosidase enzyme. Thus, the presence of all the three actives in the disclosed concentration range is critical to the activity of the composition (see Table 3). Table: 5

[0083] It can be appreciated from Table 6, that mere presence of the three actives does not give the desired results. It is clear from Table 6, that a combined concentration of 10mg/ml of the three actives does not inhibit activity of α-glucosidase enzyme in a synergistic manner. Hence, the compositions of Set 2 are non-working examples of the composition.
Non-working examples – Set 3:
[0084] Set 3 represents non-working examples of the compositions in which the combined concentration of the three actives is 5mg/ml. Table 7 depicts the compositions of Set 3.
[0085] Referring to Table 7, all the non-working examples comprises all the three actives in a combined concentration of 5mg/ml, and none of the examples are able to show a synergistic effect in inhibiting the activity of α-glucosidase enzyme. Thus, it can be inferred that in spite of the presence of all the three actives in the compositions the combined concentration is a critical factor. Therefore, all the compositions discussed in Set 3 are non-working.
Non-working examples Set 4:
[0086] The compositions of Set 4 have a combined concentration of the three
actives as 1mg/ml. Table 8 depicts the compositions of Set 4.
Table 8:

[0087] It can be appreciated from Table 8, that the compositions of Set 4 having a combined concentration of 1mg/ml does not display synergy in inhibiting the activity of the enzyme α-glucosidase. Hence, all the compositions of the present Set 4 are non-working.
[0088] Overall, the working and non-working examples as discussed in the examples section clearly reveal the critical aspects of the composition of the present disclosure. Firstly, the presence of all the three active components have been shown to be crucial for the synergistic effect of the composition in inhibiting the activity of the enzyme α-glucosidase. Secondly, even the mere presence of all the actives in any concentration have been shown to produce unimpressive results. Therefore, all the three actives have to be present in a combined concentration in a range of 15mg/ml to 25mg/ml in order to arrive at the synergistic composition having the desired anti-glycemic effect. The compositions of Set 2 to 4 specifically depict that the combined concentration of all the three actives below 15mg/ml does not exhibit synergistic inhibition of the enzyme activity. Furthermore, the compositions of Set 1 provide testimony to the criticality associated with the presence of all the three active components. As has been clearly depicted, the presence of any two actives within the range of 15 to 20mg/ml does not result in synergistic inhibition.
Advantages of the present disclosure

[0089] The composition of the present disclosure discloses the presence of ginseng extract, lemon balm extract, and hops extract along with presence of at least one additive, wherein the ginseng extract, lemon balm extract, and hops extract have a combined concentration in a range of 15g/L to 25g/L. The additives are selected from the group consisting of vitamin premix, mineral premix, SMP, and malt extract. The present composition displays synergistic inhibition of α-glucosidase enzyme activity. The present composition being a combination of herbal extracts is contemplated to be devoid of any side-effects which are generally associated with synthetic anti-glycemic drugs. Thus, the present composition can be a good alternative for the synthetic anti-glycemic drugs. Additionally, the disclosed herbal extracts are easy to procure indicating the economic feasibility associated with the product. Hence, the product derived out of the composition can be cheaper as compared to the present drugs which are highly priced.

I/We Claim:
1. A composition comprising:
a) ginseng extract;
b) lemon balm extract;
c) hops extract; and
d) at least one additive,
wherein the ginseng extract, the lemon balm extract, and the hops extract in said composition has a combined concentration in the range of 15 g/L to 25 g/L with respect to the composition.
2. The composition as claimed in claim 1, wherein the ginseng extract to the lemon balm extract w/w ratio is in the range of 1:6 to 6:1.
3. The composition as claimed in claim 1, wherein the ginseng extract to the hops extract w/w ratio is in the range of 1:6 to 6:1.
4. The composition as claimed in claim 1, wherein the lemon balm extract to the hops extract w/w ratio is in the range of 1:6 to 6:1.
5. The composition as claimed in claim 1, wherein the ginseng extract to the lemon balm extract to the hops extract w/w/w ratio is 1:1:1.
6. The composition as claimed in claim 1, wherein the combined concentration is 20 g/L with respect to the composition.
7. The composition as claimed in claim 1, wherein the at least one additive is selected from the group consisting of vitamin premix, mineral premix, and combinations thereof.
8. The composition as claimed in any of the claims 1-7, further comprising at least one excipient selected from the group consisting of skimmed milk powder, malt extract, flavors, masking agents, emulsifier, maltodextrin, carrier, diluent, and combinations thereof.
9. The composition as claimed in claim 8, wherein the masking agents is selected from the group consisting of natural flavors of vanilla, natural flavors of chocolate, nature identical flavors of vanilla, nature identical flavors of chocolate, and combinations thereof.

10. The composition as claimed in claim 8, wherein the emulsifier is selected
from the group consisting of citric acid esters of mono and di glycerides,
soy lecithin, sodium alginate, potassium alginate, calcium alginate, and
combinations thereof.
11. A process for preparing a composition as claimed in any of the claims 1-9,
said process comprising:
a) obtaining ginseng extract;
b) obtaining lemon balm extract;
c) obtaining hops extract;
d) obtaining at least one additive; and
e) contacting the ginseng extract, the lemon balm extract, the hops extract and the at least one additive to obtain said composition.
12. A process for preparing a composition as claimed in claim 10, said process
comprising:
a) obtaining ginseng extract;
b) obtaining lemon balm extract;
c) obtaining hops extract;
d) obtaining at least one additive;
e) obtaining at least one excipient; and
f) contacting the ginseng extract, the lemon balm extract, the hops extract, the at least one additive, and the at least one excipient to obtain said composition.
13. The composition as claimed in any of the claims 1-10, wherein the
composition exhibits anti-diabetic effect by inhibiting α glucosidase
enzyme activity.