[0001] The present disclosure relates generally to the field of nutraceutical compositions. Specifically, the disclosure is directed to a nutraceutical composition for boosting immunity in a diabetic subject comprising Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini. The disclosure also relates to a method of preparing the nutraceutical composition.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Humanity is gradually becoming aware of the need for a great immunity to survive the challenges posed by the world of microorganisms. Generations after generations are going through an epidemic, or worse pandemic, caused by a new strain of bacteria or virus. With rise in multi-drug resistant bacteria, it is becoming difficult to treat bacterial invasions. Development, clinical study and consequent market release of a vaccine for any new virus takes a long time. While scientists constantly struggle with these issues, it is known that a healthy immune system goes a long way in helping evade a number of microorganisms.
[0004] Our body’s immune system can be divided into two kinds namely- innate and adaptive. Innate immunity is the natural immunity of the body that is the first layer of defense from external microbes. Adaptive immunity on the other hand is more specific and is grown overtime by memory and exposure to vaccines or the pathogen itself. Generally, immunity boosters are effective in raising the innate immunity of the body.
[0005] There are several drugs or compositions known in the art as immunity boosters. However, most of them are allopathic combinations which may be associated with side effects. Natural immunity boosters comprising plant extracts, along with lifestyle changes, provide a safer alternative to these allopathic formulations.
[0006] Subjects with co-morbidities like diabetes, chronic bronchitis etc. are more susceptible to micro-organism invasion. Diabetes mellitus is a metabolic disease resulted by high levels of sugar in the body. The hormone insulin is responsible for lowering glucose. In its absence or its insufficiency or in inability of the body to process glucose, the quantity of blood glucose spikes. High blood sugar may weaken the immune system making the subject more vulnerable. Therefore administering immunity boosters to such patients may be critical.
[0007] There is a need in the art to develop natural, safe and easy to prepare nutraceutical compositions that have immunity boosting ability and are suitable for diabetic patients.

OBJECTS OF THE INVENTION
[0008] An object of the present disclosure is to provide a nutraceutical composition for boosting immunity in a diabetic subject that satisfies the existing needs, as well as emerging ones, and generally overcomes the deficiencies found in the prior art.
[0009] An object of the present disclosure is to provide a nutraceutical composition for boosting immunity in a diabetic subject without side effects.
[0010] An object of the present disclosure is to provide a nutraceutical composition which is economical.
[0011] An object of the present disclosure is to provide a nutraceutical composition which is easy to prepare.

SUMMARY OF THE INVENTION
[0012] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0013] The present disclosure relates to a nutraceutical composition prepared with natural ingredients that is suitable for diabetic subjects. The composition improves the immunity of the diabetic patient.
[0014] In an aspect, the present disclosure relates to a nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini, wherein the composition comprises the unripe fruit of Syzygium cumini.
[0015] In an embodiment, the composition may further comprise a pharmaceutically acceptable excipient. The excipient may be selected from the group comprising of diluents, stabilizers, binders, flavoring agents, thickeners, coloring agents, humectants, preservatives, olfactory agents, and combinations thereof. Preferably the binding agent is tragacanth gum or gond katira.
[0016] In an aspect, the present disclosure relates to a medicament for boosting immunity in a diabetic patient, said medicament comprising of the nutraceutical composition along with a pharmaceutically acceptable excipient.
[0017] In another aspect, the present disclosure relates to a process of preparing a nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini, wherein the composition comprises the unripe fruit of Syzygium cumini.
[0018] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.

DETAILED DESCRIPTION OF THE INVENTION
[0019] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[0020] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0021] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0022] In some embodiments, numbers have been used for quantifying weights, percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0023] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0024] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[0025] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
[0026] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[0027] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0028] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0029] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0030] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[0031] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0032] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[0033] As described herein, the term ‘therapeutically effective amount’ refers to the amount of the composition required to bring about a change or improvement in the subject without side effects or overdosing.
[0034] In an embodiment, the present disclosure relates to a nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini.
[0035] Morus rubra or red mulberry is a deciduous tree native to North America. Its leaves are broad, alternate and have varied texture. The berries are plucked for consumption and are sweet and juicy. Its fruits may be used in wine making, baking, jams or may be eaten as such.
[0036] Stevia rebaudiana is a nutrient rich, seasonal plant belonging to the sunflower family (Asteraceae). It is grown extensively in South American countries of Brazil and Paraguay. The plant is known for its sweetness (over 300 times that of sugar) and its extracts are extensively sold as natural, low calories sweetener.
[0037] Phyllanthus emblica or amla or Indian gooseberry is one of the most important plants in the Indian traditional system of medicine. It is a deciduous shrub or small tree that is primarily grown in the Indian subcontinent. The leaves of the plant are closely and oppositely placed on the branches. The fruits of the plant are consumed both raw and uncooked and possess a strong and sour taste. It is one of the richest sources of Vitamin C and is known to possess anti-pyretic and diuretic properties.
[0038] Syzygium cumini or Black plum or Jambolan or jamun is a tropical and sub-tropical tree native to South East Asia, but is now grown across the globe. The leaves possess a turpentine smell and are opposite. Its fruits are clustered, round or oblong and change their shade with the growth stage. The fully ripe fruit is black in color and leaves a purple coloration on the tongue after consumption. These fruits may vary from being sweet to astringent.
[0039] In an embodiment, the present disclosure relates to a nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini; wherein the composition comprises unripe fruit of Syzygium cumini.
[0040] In an embodiment, the unripe fruit of Syzygium cumini may comprise seed, pulp or both seed and pulp of the fruit. The present invention overcomes the challenges of including ripe fruits of Syzygium cumini - in which seeds are difficult to grind. Further, drying the pulp of the fruit for generating a dry powder also involves additive steps thus increasing production costs. The present invention employs unripe fruit which is easy to crush, dry and powder. It decreases the number of processing steps, reduces efforts and makes the composition economical.
[0041] In an embodiment, the composition may comprise whole of Morus rubra, whole of Stevia rebaudiana and whole of Phyllanthus emblica.
[0042] In an embodiment, the composition may comprise a part of Morus rubra, a part of Stevia rebaudiana and a part of Phyllanthus emblica.
[0043] In an embodiment, the composition may comprise an extract of Morus rubra, an extract of Stevia rebaudiana and an extract of Phyllanthus emblica.
[0044] In an embodiment, the part or extract may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, or bud of the plant.
[0045] In a preferred embodiment, the composition may comprise leaves of Morus rubra, leaves of Stevia rebaudiana, dried powder of Phyllanthus emblica, and unripe fruit of Syzygium cumini.
[0046] In an embodiment, Phyllanthus emblica may also function as a preservative.
[0047] In an embodiment, the composition may comprise about 15% to about 40%, preferably about 20% to about 30% of Morus rubra by weight of the composition.
[0048] In an embodiment, the composition may comprise about 1% to about 20%, preferably about 2% to about 10% of Stevia rebaudiana by weight of the composition.
[0049] In an embodiment, the composition may comprise about 10% to about 35%, preferably about 15% to about 25% of Phyllanthus emblica by weight of the composition.
[0050] In an embodiment, the composition may comprise about 10% to about 35%, preferably about 15% to about 25% of Syzygium cumini by weight of the composition.
[0051] In an embodiment, the composition comprises about 20% to about 30% of Morus rubra, about 2% to about 10% of Stevia rebaudiana, about 15% to about 25% of Phyllanthus emblica and about 15% to about 25% of Syzygium cumini by weight of the composition.
[0052] In an embodiment, the composition may further comprise a pharmaceutically acceptable excipient. The excipient may be selected from the group comprising of flavonoids, diluents, stabilizers, binders, flavoring agents, thickeners, coloring agents, humectants, preservatives, olfactory agents, and combinations thereof.
[0053] In an embodiment, the excipient may be selected from the group comprising of tragacanth gum, starch, guar gum, cellulose, cellulose derivatives, agar, alginates, gelatin, pectin, acacia, xanthan gum, polysaccharides, essential oils, mannitol, carrageenan and combinations thereof.
[0054] In an embodiment, the composition may comprise an excipient in the range of about 10% to about 70%, preferably about 20% to about 50% by weight of the composition.
[0055] In an embodiment, the composition may be in an oral dosage form comprising of tablet, powder, capsule, gums, films, semi-solid, solution, suspension, syrup, decoctions, elixir, granules, microparticles, nano-particles, gel, or concentrates. Preferably, the composition may be a tablet, more preferably it may be a chewable tablet.
[0056] In an embodiment, the nutraceutical composition is safe for consumption for diabetic patients.
[0057] In an embodiment, the nutraceutical composition improves the immunity of a diabetic subject without causing any side-effects.
[0058] In an embodiment, the nutraceutical composition was noted to have unexpected, synergistic properties for boosting immunity of diabetic patient.
[0059] In an embodiment, the nutraceutical composition may be suitable for boosting immunity against a number of microbes or antigens. Preferably, it may increase immunity against respiratory diseases, including but not limited to acute respiratory distress syndrome, SARS, MERS, influenza, coronavirus or COVID-19.
[0060] In an embodiment, the composition employs natural components and is therefore economic. It is made of readily available sources, is easy to produce and is eco-friendly.
[0061] In an embodiment, the present disclosure relates to a medicament for boosting immunity in a diabetic patient, said medicament comprising the nutraceutical composition along with a pharmaceutically acceptable excipient.
[0062] In an embodiment, the composition or the medicament may be administered orally or by any other suitable route of administration.
[0063] In an embodiment, the composition or the medicament may be administered in a therapeutically effective amount to a subject. The therapeutically effective amount and the number of doses may be decided upon by an expert based on the subject and medical history.
[0064] In an embodiment, the composition or the medicament may be administered along with other anti-diabetic formulations and compositions.
[0065] In another embodiment, the present disclosure relates to a process of preparing a nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini, wherein the composition comprises the unripe fruit of Syzygium cumini.
[0066] In an embodiment, the process may comprise of steps of sieving, washing, drying, extracting, grinding or combinations thereof.
[0067] In an embodiment, the present disclosure relates to a process of preparing a nutraceutical composition for boosting immunity in a diabetic patient comprising:
(i) washing, drying and optionally sieving Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini independently;
(ii) powdering the dried Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini independently; and
(iii) mixing the powdered Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini and optionally one or more pharmaceutically acceptable excipients to give the composition.
[0068] In an embodiment, the powdered components may be sieved before mixing.
[0069] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
[0070] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
All the components are commercially available and have been purchased from the local vendor - Drishti Daily Need Stores, Ambala City.
EXAMPLE 1: NUTRACEUTICAL COMPOSITION
[0071] The following nutraceutical composition was prepared:
leaves of Morus rubra (red mulberry) - 0.25g, leaves of Stevia rebaudiana - 0.05g, dried powder of Phyllanthus emblica - 0.2g, unripe Syzygium cumini fruit - 0.20g, and dry Tragacanth gum (gond katira ) - 0.30g
[0072] The plant components were dried in an oven at 60-75 degree centigrade and then powdered separately. The dried components were weighed as per the composition disclosed above and were mixed thoroughly. Finally, the mixture was added into the binder – gond katira (which was in gel form after soaking overnight) and was mixed properly followed by drying. The obtained composition was made into tablet shape for easy consumption by chewing.
[0073] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVANTAGES OF THE PRESENT INVENTION
[0074] The present disclosure provides a nutraceutical composition that satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.
[0075] The present disclosure provides a nutraceutical composition for boosting immunity in a diabetic subject.
[0076] The present disclosure provides a nutraceutical composition for boosting immunity in a diabetic subject employing unripe Syzygium cumini which is easier to process.
[0077] The present disclosure provides a nutraceutical composition that improves respiratory health.
[0078] The present disclosure provides a nutraceutical composition that is eco-friendly, cost-effective and easy to produce.

Claims:1. A nutraceutical composition for boosting immunity in a diabetic patient comprising of Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini; wherein the composition comprises unripe fruit of Syzygium cumini.
2. The composition as claimed in claim 1, wherein the composition comprises whole of Morus rubra, whole of Stevia rebaudiana and whole of Phyllanthus emblica.
3. The composition as claimed in claim 1, wherein the composition comprises a part of Morus rubra, a part of Stevia rebaudiana and a part of Phyllanthus emblica.
4. The composition as claimed in claim 1, wherein the composition comprises an extract of Morus rubra, an extract of Stevia rebaudiana and an extract of Phyllanthus emblica.
5. The composition as claimed in claim 1, wherein the composition comprises 15% to 40% of Morus rubra, 1% to 20% of Stevia rebaudiana, 10% to 35% of Phyllanthus emblica and 10% to 35% of Syzygium cumini by weight of the composition.
6. The composition as claimed in claim 1, wherein the composition comprises a pharmaceutically acceptable excipient.
7. The composition as claimed in claim 6, wherein the pharmaceutically acceptable excipient is selected from the group comprising of flavonoids, diluents, stabilizers, binders, flavoring agents, thickeners, coloring agents, humectants, preservatives, olfactory agents, and combinations thereof.
8. The composition as claimed in claim 6, wherein the pharmaceutically acceptable excipient is present in the range of 10% to 70% by weight of the composition.
9. A process of preparing a nutraceutical composition for boosting immunity in a diabetic patient comprising:
(i) washing, drying and optionally sieving Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini independently;
(ii) powdering the dried Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini independently; and
(iii) mixing the powdered Morus rubra, Stevia rebaudiana, Phyllanthus emblica, and Syzygium cumini and optionally one or more pharmaceutically acceptable excipients to give the composition.