FIELD OF INVENTION
[001] The present disclosure is directed to the field of herbal compositions, and in particular relates to a composition for treating / ameliorating pain due to inflammation. The present disclosure is further directed to a process of preparation of said composition.
BACKGROUND OF THE INVENTION
[002] Rheumatic and musculoskeletal disorders, such as arthritis, and osteoarthritis, are associated with severe pain thereby severely impairing the quality of life. Current treatment of these disorders includes administering first line drugs, such as non-steroidal, anti-inflammatory drugs (NSAIDS) such as celecoxib, ibuprofen, aspirin etc, to control of pain and inflammation. All these drugs have severe side effects and most of them are cytotoxic. For example, non-steroidal anti- inflammatory drugs (NSAIDS) can have a variety of toxic side effects such as gastric erosion and adverse effects on kidneys and liver. [003] In the recent years herbal compositions are being increasingly used as desirable alternatives to synthetic drugs for treatment of these disorders. For example, US6264995B1 describes an herbal composition reducing inflammation in bones and joints by inhibiting the enzyme cyclooxygenase-2 is prepared from holy basil, turmeric, ginger, green tea, rosemary, huzhang, Chinese goldthread, barberry, oregano and Scutellariae baicalensis. US5494668 describes a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, by administering a therapeutically effective amount of the beneficiated extracts of the plants Withania somnifera, Boswellia serrata, Curcuma longa, and Zingiber officinale in a predetermined proportion relative to each other.
[004] US5120538 describes naturally occurring pharmaceutical compositions, more particularly, those compositions comprising essential oils extracted from tissues of Curcuma domestica or Curcuma xanthorrhiza or a combination of both oils and curcuminoid substantially free of bis-desmethoxycurcumin, which are useful as anti-inflammatory agents. US5707631 is directed to a therapeutic herbal composition including Trigonella foenum-graecum seed, Syzygium aromaticum fruit, Allilum sativum bulb, Cinnamomum zeylanicum bark, Saussurea costus root and Euphorbia lathyris bud together with sodium chloride for treatment of arthritis. Considering the above evidence, there exists a need to develop compositions which could be effective for treatment of musculoskeletal disorders with minimal/no side effects. SUMMARY OF THE INVENTION

[005] In an aspect of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1. [006] In an aspect of the present disclosure, there is provided a process for preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1, said process comprising the steps of: a) obtaining Mucuna pruriens extract; b) obtaining Adhatoda vasica extract; and c) contacting Mucuna pruriens extract with Adhatoda vasica extract to obtain the composition.
[007] 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 THE DRAWINGS
[008] The following drawings form part of the present specification and are included to
further illustrate aspects of the present disclosure. The disclosure may be better be understood
by reference to the drawings in combination with the detailed description of the specific
embodiments presented herein.
[009] Figure la depicts the effect of Mucuna pruriens on cell viability in chondrocytes, in
accordance with an embodiment of present disclosure.
[0010] Figure lb depicts the effect of Adhatoda vasica on cell viability in chondrocytes, in
accordance with an embodiment of present disclosure.
[0011] Figure 2 depicts the effect of natural actives and their combinations on LPS induced
prostaglandin E-2 (PGE-2) activity in human primary chondrocytes, in accordance with an
embodiment of present disclosure.
[0012] Figure 3 depicts the effect of natural actives and their ratio combinations on LPS
induced prostaglandin E-2 (PGE-2) activity in human primary chondrocytes, in accordance
with an embodiment of present disclosure.
[0013] Figure 4a depicts the effect of individual ratio combinations of Mucuna pruriens on
LPS induced prostaglandin E-2 (PGE-2) activity in human primary chondrocytes, in
accordance with an embodiment of present disclosure.

[0014] Figure 4b depicts the effect of individual ratio combinations of Adhatoda vasica on
LPS induced prostaglandin E-2 (PGE-2) activity in human primary chondrocytes, in
accordance with an embodiment of present disclosure.
[0015] Figure 5 depicts the effect of natural actives (Mucuna pruriens and Adhatoda vasica)
and their ratio combinations on RANK induced prostaglandin E-2 (PGE-2) activity in human
osteoclasts, in accordance with an embodiment of present disclosure.
[0016] Figure 6a depicts the effect of individual ratio combinations of Mucuna pruriens on
RANK induced prostaglandin E-2 (PGE-2) activity in human osteoclasts, in accordance with
an embodiment of present disclosure.
[0017] Figure 6b depicts the effect of individual ratio combinations of Adhatoda vasica on
RANK induced prostaglandin E-2 (PGE-2) activity in human osteoclasts, in accordance with
an embodiment of present disclosure.
[0018] Figure 7 depicts the effect of natural actives and their ratio combinations on LPS
induced prostaglandin E-2 (PGE-2) activity in muscle cells, in accordance with an
embodiment of the present disclosure.
[0019] Figure 8a depicts the effect of individual ratio combinations of Mucuna pruriens on
LPS induced prostaglandin E-2 (PGE-2) activity in muscle cells, in accordance with an
embodiment of the present disclosure.
[0020] Figure 8b depicts the effect of individual ratio combinations of Adhatoda vasica on
LPS induced prostaglandin E-2 (PGE-2) activity in muscle cells, in accordance with an
embodiment of the present disclosure.
[0021] Figure 9 depicts the effect of natural actives and their ratio combinations on wound
healing activity in muscle cells, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0022] 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

[0023] For convenience, before further description of the present disclosure, certain terms
employed in the specification, and examples are collected 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.
[0024] 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.
[0025] 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".
[0026] For the purpose of the present disclosure, the term "extract" is used to mean a
preparation containing the active ingredient of a substance in concentrated form. The extract
may be in the form of a powder, solution, tincture, or combinations thereof.
[0027] 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.
[0028] The term "including" is used to mean "including but not limited to". "Including" and
"including but not limited to" are used interchangeably.
[0029] The term "at least one" is used to mean one or more and thus includes individual
components as well as mixtures/combinations.
[0030] The term "PBS" refers to phosphate Buffer Saline.
[0031] The term "EDTA" refers to ethylenediaminotetraacetic acid.
[0032] The term "FBS" refers to fetal bovine serum.
[0033] The term "PGE2" refers to prostraglandin E2.
[0034] The term "composition" and "herbal composition" are used interchangeably
throughout the specification.
[0035] The term "alkaloid" refers to naturally occurring molecules, mostly isolated from
plants, containing carbon and hydrogen.
[0036] 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 temperature ranges of about 25-35 °C should be interpreted to include not only the explicitly recited limits of about 25 °C to about 35 °C, but also to include sub-ranges, such as 25-30 °C, 28-35 °C, and so forth, as well as individual amounts, including fractional amounts, within the specified ranges, such as 25.2 °C, and 32.5 °C, for example.
[0037] 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. [0038] The term "at least one" is used to mean one or more and thus includes individual components as well as mixtures/combinations.
[0039] The present disclosure is not to be limited in scope by the specific implementations 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.
[0040] A composition comprising "synergistic activity" or a "synergistic composition" is a combination of compounds which exhibits increased biological or functional activity as a non-linear multiple of the biological or functional activity of the individual compounds. In other words, the combined biological or functional activity of two or more compounds being tested is significantly greater than the expected result based on independent effects of the compounds when tested separately. Synergy may be apparent only at some ranges or weight percentages.
[0041] Excipients an inactive substance that serves as the vehicle or medium for a drug or other active substance.
[0042] Adhatoda vasica, commonly known as malabar nut is a small evergreen plant, of the Acanthaceae family. This shrub grows on the plains of India and in the lower Himalayans, and other tropical areas. It grows well in low moisture areas and dry soils. Although any plant part can be used to prepare the extract, fresh or dried leaves of Adhatoda vasica have been used in the present invention. The leaves, roots, flowers and stem bark find medicinal applications in treatment of leprosy, blood disorders, heart troubles, sore throat, cough, bronchitis, asthma, wound healing, pain, fever, vomiting, loss of memory, leucoderma, jaundice, tumors, mouth troubles, sore-eye, and gonorrhea.

[0043] Mucuna pruriens, a tropical legume also known as velvet bean, is herbaceous annual
plant grown worldwide, particularly in the tropical regions of Africa and Caribbean. It
belongs to the family Fabaceae. It is effective for treatment of parkinson's disease, infertility,
depression, stress, and antivenom. Although any plant part such as leaves, seed, bark, root,
flowers, fruit, or any other plant part can be used to prepare the extract, seeds of Mucuna
pruriens have been used to prepare the extract in the present invention.
[0044] Conventional approaches to alleviate/treat pain related disorders are based on using
synthetic drugs which cause severe side-effects. Although recent literature suggests a trend
towards use of herbal compositions that overcome the drawbacks associated with the use of
synthetic drugs, there still exists a need to develop novel compositions which can be used for
long term treatment of pain-related disorders, with minimal/ no side-effects.
[0045] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1.
[0046] In an embodiment of the present disclosure, there is provided herbal composition a
described herein, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w
ratio is 1:4
[0047] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:4.
[0048] In an embodiment of the present disclosure, there is provided composition a described
herein, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is
1:1.5
[0049] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1.5.
[0050] In an embodiment of the present disclosure, there is provided composition a described
herein, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is
1:1
[0051] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1.

[0052] In an embodiment of the present disclosure, there is provided a composition as
described herein, wherein the Mucuna pruriens extract has weight percentage in a range of
0.001 to 2% with respect to the composition.
[0053] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1,
and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2%
with respect to the composition.
[0054] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4, and
wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with
respect to the composition.
[0055] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:1.5,
and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2%
with respect to the composition.
[0056] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:1, and
wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with
respect to the composition.
[0057] In an embodiment of the present disclosure, there is provided a composition as
described herein, wherein the Adhatoda vasica extract has weight percentage in a range of
0.001 to 2% with respect to the composition.
[0058] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1,
and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2%
with respect to the composition.
[0059] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4, and

wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with
respect to the composition.
[0060] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:1.5,
and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2%
with respect to the composition.
[0061] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:1, and
wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with
respect to the composition.
[0062] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1,
wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with
respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in
a range of 0.001 to 2% with respect to the composition.
[0063] In an embodiment of the present disclosure, there is provided a composition as
described herein, wherein the Mucuna pruriens extract comprises L-3,4-
dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with
respect to the extract. In another embodiment of the present disclosure, the Mucuna pruriens
extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a
range of 10-11% with respect to the extract.
[0064] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1,
and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA)
having a weight percentage in a range of 10-12% with respect to the extract.
[0065] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:4, and wherein the
Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight
percentage in a range of 10-12% with respect to the extract.

[0066] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucunapruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1.5, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract. In another embodiment, the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage of 10.16% with respect to the extract.
[0067] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract.
[0068] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is a range of 1:4, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract.
[0069] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is a range of 1:4, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract.
[0070] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is a range of 1:4, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract.

[0071] In an embodiment of the present disclosure, there is provided a composition as
disclosed herein, wherein the Adhatoda vasica extract comprises alkaloid having a weight
percentage in a range of 2-4% with respect to the extract. In another embodiment, the
Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-3%
with respect to the extract. In yet another embodiment, the Adhatoda vasica extract comprises
alkaloid having a weight percentage of 2.11% with respect to the extract.
[0072] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is a range of 1:4 - 1:1,
and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a
range of 2-4% with respect to the extract.
[0073] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:4, and wherein the
Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4%
with respect to the extract.
[0074] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1.5, and wherein the
Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4%
with respect to the extract.
[0075] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1, and wherein the
Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4%
with respect to the extract.
[0076] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -
1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to
2% with respect to the composition, and wherein the Adhatoda vasica extract comprises
alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
[0077] In an embodiment of the present disclosure, there is provided composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the

Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract. [0078] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
[0079] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
[0080] In an embodiment of the present disclosure, there is provided composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
[0081] In an embodiment of the present disclosure, there is provided a composition as described herein wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract. In another embodiment of the present disclosure,

the alkaloid comprises vasicine having a weight percentage in a range of 1-1.8% with respect to the extract.
[0082] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract. [0083] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract.
[0084] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2%) with respect to the extract
[0085] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition further comprises at least one excipient. In an embodiment, the at least one excipient is selected from a group consisting of lactose-anhydrous, spray dried lactose, hydrolyzed starch, gelatine, polyethylene glycol, glycerol, lactates, polysorbates, sorbitan esters, simethicone, saccharin, aspartame, peppermint, lemon oils, butterscotch, methyl paraben, propyl paraben, sorbitol, carob bean gum, mannitol, gum tragacanth, guar gum, benzoic acid, sodium benzoate, garlic and oil of garlic, oil of

rue, propyl gallate, gum ghatti, gum arabic, sterculia gum, clove bud extract, clove bud oil, clove bud oleoresin, clove leaf oil, clove stem oil, cholic acid, desoxycholic acid, glycocholic acid, ox bile extract, taurocholic acid, sorbose (packaging), sodium thiosulfate, mustard oil , glycyrrhiza, ammoniated glycyrrhizin, licorice, caprylic acid, stannous chloride, ammonium bicarbonate, ammonium carbonate, ammonium chloride, ammonium hydroxide, ammonium phosphate dibasic, ammonium phosphate monobasic, ammonium sulfate, calcium iodate, potassium iodate, potassium iodide, aconitic acid, calcium carbonate, potassium bicarbonate, sodium bicarbonate, sodium carbonate, sodium sesquicarbonate, glycerin and glycerides, dextran, dextrins, corn, dextrins, calcium acetate, calcium chloride, calcium gluconate, calcium phytate, calcium hydroxide, calcium oxide, succinic acid, butylated hydroxytoluene (bht), ammonium phosphate dibasic calcium hexametaphosphate, calcium phosphate dibasic, calcium phosphate monobasic, calcium phosphate tribasic, calcium pyrophosphate, phosphoric acid, potassium phosphate dibasic, potassium phosphate monobasic, potassium phosphate tribasic, potassium polymetaphosphate, potassium pyrophosphate, potassium tripolyphosphate, sodium acid pyrophosphate, sodium hexametaphosphate, sodium metaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate, tetrabasic, sodium tetrametaphosphate, sodium tetraphosphate, sodium trimetaphosphate, sodium tripolyphosphate, sulfuric acid, alpha-tocopherol acetate, tocopherols, choline bitartrate, choline chloride, aluminum ammonium sulfate, aluminum hydroxide, aluminum oleate, aluminum palmitate, aluminum potassium sulfate, aluminum sodium sulfate, aluminum sulfate, sodium aluminate, sodium aluminum phosphate, acidic, sodium aluminum phosphate, basic, sodium phosphoaluminate, beeswax, japan wax, carnauba wax, corn sugar, corn syrup, invert sugar, inositol, calcium stearate, hydrogenated tallow, stearic acid, tallow, malic acid, 1-malic acid, calcium sorbate, potassium sorbate, sodium sorbate, sorbic acid, sulfamic acid, sodium hydrosulfite zinc hydrosulfite, tall oil, fish oil, hydrogenated, sucrose, agar-agar, ammonium alginate, calcium alginate, potassium alginate, propylene glycol alginate, sodium alginate, propylene glycol, propylene glycol monostearate, brown algae, red algae, calcium glycerophosphate, manganese glycerophosphate, magnesium glycerophosphate, potassium glycerophosphate, potassium hydroxide, sodium hydroxide, potassium metabisulfite, sodium bisulfite, sodium metabisulfite, sodium sulphite, sulfur dioxide, magnesium phosphate, dibasic, magnesium carbonate, magnesium chloride, magnesium hydroxide, magnesium oxide, magnesium stearate, magnesium sulfate, magnesium phosphate, tribasic, adipic acid, hydrogenated

soybean oil, ethyl formate, formic acid, sodium formate, carrageenan, nutmeg and mace, zinc acetate, zinc carbonate, zinc chloride, zinc oxide, zinc sulfate, caramel, lard, lard oil, papain, gum guaiac, coconut oil, linoleic acid, oleic acid, peanut oil, calcium hypophosphite, manganous hypophosphite, potassium hypophosphite, sodium hypophosphite, pectin, amidated, pectin, high ester, pectin, low acid, pectinates, pectinic acid, carboxymethyl cellulose, cellulose acetate, ethyl cellulose, hydroxypropylmethyl cellulose, methylcellulose, sodium carboxymethyl cellulose, rennet, tannic acid, acetic acid, sodium acetate, sodium diacetate, pyridoxine, pyridoxine hydrochloride, sodium oleate, sodium palmitate, ethyl acrylate, monomeric, methyl acrylate, monomeric, ethyl acrylate, polymeric, methyl acrylate, polymeric, bentonite, clay, corn silk, ammonium citrate, calcium citrate, citric acid, isopropyl citrate, potassium citrate, sodium citrate, stearyl citrate, triethyl citrate, biotin, enzymatically hydrolyzed casein, acid hydrolyzed proteins, enzymatically hydrolyzed protein, soy sauces, yeast autolyzates, caffeine, 1-glutamic acid, 1-glutamic acid hydrochloride, monoammonium 1-glutamate, monopotassium 1-glutamate, monosodium 1-glutamate, calcium lactate, l(+)-calcium lactate, d(-)-lactic acid, lactic acid, l(+)-lactic acid, butylated hydroxyanisole (bha), d- or dl- calcium pantothenate, d-pantothenyl alcohol, d- or dl- sodium pantothenate, urea, thiamine hydrochloride, thiamine mononitrate, magnesium gluconate, potassium gluconate, sodium gluconate, zinc gluconate, vitamin bl2, vitamin d2, vitamin d3, potassium chloride, sodium chloride, soy protein isolate, hydrochloric acid, copper (cupric) gluconate, copper (cupric) sulfate, cuprous iodide, calcium caseinate, casein, sodium caseinate, aluminum calcium silicate, calcium silicate, diatomaceous earth, magnesium silicate, perlite, potassium silicate, silica aerogel, silicon dioxides, sodium aluminosilicate, sodium calcium aluminosilicate, sodium silicate, basic magnesium silicate, tricalcium silicate, 1(+)-potassium acid tartrate, l(+)-sodium tartrate, l(+)-tartaric acid, manganous chloride, manganous citrate, manganous gluconate, manganous oxide, manganous sulfate, lecithin, lecithin, hydrogen peroxide bleached, riboflavin, riboflavin-5'-phosphate, calcium propionate, dilauryl thiodipropionate, propionic acid, sodium propionate, thiodipropionic acid, hydrogen peroxide, carbon dioxide, nickel, niacin, niacinamide, carotene, 1-ascorbic acid, ascorbyl palmitate, calcium 1-ascorbate, erythorbic acid, sodium erythorbate, sodium 1-ascorbate, acetylated distarch adipate, acetylated distarch glycerol, acetylated distarch phosphate, acetylated distarch oxypropanol, acid modified starch, arrowroot starch, bleached starch, cornstarch, distarch glycerol, distarch oxypropanol, distarch phosphate, high amylose cornstarch, hydroxypropyl distarch glycerol, hydroxypropyl distarch

phosphate, hydroxypropyl starch, hydroxypropyl starch, oxidized, milo starch, monostarch phosphate, potato starch, pregelatinized starch, rice starch, sodium hydroxide gelatinized starch, starch acetate, starch aluminum octenyl succinate, starch sodium succinate, starch sodium octenyl succinate, succinyl distarch glycerol, tapioca starch, waxy maize starch, wheat starch, phosphated distarch phosphate, starch, sodium hypochlorite oxidized, vitamin a, vitamin a acetate, vitamin a palmitate, diacetyl, starter distillate, carbonyl iron, carbonyl iron, electrolytic iron, ferric ammonium citrate, ferric chloride, ferric citrate, ferric oxide, ferric phosphate, ferric pyrophosphate, ferric sodium pyrophosphate, ferric sulfate, ferrous ascorbate, ferrous carbonate, ferrous citrate, ferrous fumarate, ferrous gluconate, ferrous lactate, ferrous sulfate, iron caprylate, iron linoleate, iron naphthenate, iron oxides, iron peptonate, iron polyvinylpyrrolidone, iron tallate, iron, elemental, reduced iron, reduced iron, sodium ferric edta, sodium ferricitropyrophosphate, dietary iron, ferric oxide, ammonium phosphate monobasic, potassium carbonate, calcium glycerophosphate, cellulose and cellulose, microcrystalline.
[0086] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the composition further comprises at least one excipient. [0087] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:4, and wherein the composition further comprises at least one excipient.
[0088] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1.5, and wherein the composition further comprises at least one excipient.
[0089] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is 1:1, and wherein the composition further comprises at least one excipient.
[0090] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is

in the range of 1:4 - 1:1, and wherein the Mucunapruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition.
[0091] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition.
[0092] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition. [0093] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract.
[0094] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2%) with respect to the extract.
[0095] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a

range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
[0096] In an embodiment of the present disclosure, there is provided a composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract.
[0097] In an embodiment of the present disclosure, there is provided a process for preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; and c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
[0098] In an embodiment of the present disclosure, there is provided a process for preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.
[0099] In an embodiment of the present disclosure, there is provided a process for preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:4, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the

Adhatoda vasica extract; and c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
[00100] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:4, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.
[00101] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:1.5, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; and c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
[00102] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:1.5, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.
[00103] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:1, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; and c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
[00104] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:1, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one

excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.
[00105] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.
[00106] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is 1:4, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; and c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
[00107] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, said process comprising the steps of: a) obtaining the Mucuna pruriens extract; b) obtaining the Adhatoda vasica extract; c) obtaining the at least one excipient; and d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.

[00108] In an embodiment of the present disclosure, there is provided a process for
preparing the composition comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica
extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in
the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a
range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens
extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a
range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has
weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the
Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4%
with respect to the extract, said process comprising the steps of: a) obtaining the Mucuna
pruriens extract; b) obtaining the Adhatoda vasica extract; and c) contacting the Mucuna
pruriens extract and the Adhatoda vasica extract to obtain the composition.
[00109] In an embodiment of the present disclosure, there is provided a composition as
described herein, wherein the composition inhibits prostaglandin (PGE-2) production.
[00110] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -
1:1, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00111] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00112] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00113] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a

range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00114] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00115] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00116] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00117] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00118] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with

respect to the extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00119] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00120] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -
1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2%
with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid
having a weight percentage in a range of 2-4% with respect to the extract, and wherein the
alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the
extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00121] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2%) with respect to the extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00122] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a

range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00123] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract, and wherein the composition inhibits prostaglandin (PGE-2) production.
[00124] In an embodiment of the present disclosure, there is provided a composition
as described herein, wherein the composition is a pain-relief composition.
[00125] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the composition is a pain-relief composition.
[00126] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one
excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is
in the range of 1:4 - 1:1, and wherein the composition is a pain-relief composition.
[00127] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -
1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to
2% with respect to the composition, wherein the composition is a pain-relief composition.
[00128] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one

excipient, wherein the Mucunapruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition is a pain-relief composition
[00129] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the
Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -
1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2%
with respect to the composition, wherein the composition is a pain-relief composition.
[00130] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition is a pain-relief composition.
[00131] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition is a pain-relief composition.
[00132] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the composition is a pain-relief composition.
[00133] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-

3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with
respect to the extract, and wherein the composition is a pain-relief composition.
[00134] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the composition is a pain-relief composition.
[00135] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract, and wherein the composition is a pain-relief composition.
[00136] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one
excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is
in the range of 1:4 - 1:1, and wherein the Adhatoda vasica extract has weight percentage in a
range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica
extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the
extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of
1-2%) with respect to the extract, and wherein the composition is a pain-relief composition.
[00137] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; and b) Adhatoda vasica extract, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 -1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12%) with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica

extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the
extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of
1-2% with respect to the extract, and wherein the composition is a pain-relief composition.
[00138] In an embodiment of the present disclosure, there is provided a composition
comprising: a) Mucuna pruriens extract; b) Adhatoda vasica extract, and c) at least one excipient, wherein the Mucuna pruriens extract and the Adhatoda vasica extract w/w ratio is in the range of 1:4 - 1:1, and wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract, and wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition, and wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract, and wherein the alkaloid comprises vasicine having a weight percentage in a range of 1-2% with respect to the extract, and wherein the composition is a pain-relief composition
[00139] In an embodiment of the present disclosure, there is provided a composition as
described herein, wherein the composition is dispensed as part of or in combination with food supplements, nutraceuticals and food products. In another embodiment of the present disclosure, wherein food products may be selected from tea, juices, smoothies, chewing gums, fermented products like yogurt, bars, candies, gummies, etc. EXAMPLES
[00140] The working as well as non-working examples of the present disclosure would
now be illustrated. These examples are neither restrictive nor intended to be limiting to the scope of the present invention. Unless 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. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.
[00141] Adhatoda vasica has long been known for pain reduction, and Mucuna
pruriens, a legume, is known for its reduction of stress levels in the body. The present invention describes a synergistically enhanced pain reduction of Adhatoda vasica when used in combination with Mucuna pruriens, and its ability to up-regulate expression of

prostaglandin E-2 (PGE-2) activity in human primary chondrocytes. Mucunapruriens extract and the Adhatoda vasica extract were obtained commercially from Sami labs. MATERIALS AND METHODS Human Osteoclast Culture
[00142] Human osteoclast precursor cells, osteoclast basal media and supplements
(SingleQuotes®), and trypsin/EDTA were purchased from Lonza India (Cat # 2T-110; PT-8201 USA). Osteoclasts were cultured in osteoclast basal media supplemented with SingleQuotes in a humidified incubator at 37 °C with 5% CO2. Cells were maintained in T-25 flasks, and the culture media was changed once every two days. When osteoclasts reached 80-90% confluence, they were trypsinized using trypsin/EDTA, and 1.5 x 105 cells were used to establish the next culture in another T-25 flask. Cells from the third passage were used for the experiments. Osteoclasts were counted using a haemocytometer, and 2 x 105 cells were seeded into each well in 12 well plates. For differentiation the osteoclasts were maintained in culture till 100% confluent in basal medium (Basal medium supplemented with FBS, GA-1000, 0.5ml.) at 37°C, in a humidified atmosphere of 5% C02. Subsequently, differentiation was induced for a week by the OCP differentiation medium (OCP medium supplemented with penicillin-streptomycin 10K/10K, Fetal Bovine Serum, L-glutamine M-csf for Opdm kit, Soluble rank ligand for Opdm kit, Lyophilized; Cat # PT-8001). Human Chondrocytes (HCH)Culture
[00143] Human Chondrocytes (HCH) obtained from PromoCell (Cat # C-12710). The
cells were cultured in Chondrocyte Growth Medium SupplementMix (Cat # C-39635) with 10%) fetal bovine serum (FBS, Gibco) and 1% of penicillin/streptomycin (Invitrogen) at 37°C in an incubator containing 5% C02. Muscle cells
[00144] Skeletal muscle cells (C2C12) obtained from ATCC -CRL-1772. The cells
were cultured in complete Dulbecco's Modified Eagle's Medium (DMEM) (Sigma Aldrich) with 10%o fetal bovine serum (FBS, Gibco) and 1% of penicillin/streptomycin (Invitrogen) at 37°C in an incubator containing 5% CO2. Cell viability:
[00145] Viability of cells were determined by reduction of (Thiazolyl Blue
Tetrazolium Blue (MTT) (Sigma) to formazan. Cells were seeded in culture plates and cultured for 24h. After treatment immediately changed serum free medium and cultured for 24 hours. MTT assay was performed. MTT (2 mg/ml in PBS) was added to each well. Cells were incubated at 37°C for 30 min and DMSO (100 ul) was added to dissolve the formazan

crystals. The absorbance was measured at 560 nm using an ELISA reader (Thermo Fisher,
Germany).
PGE2 immunoassay
[00146] Cells were seeded into each well of 12-well plates until 80% confluent. The
cells were then maintained in serum-free media and treated with natural compounds for 24 h.
After an incubation period of 16 h, the amount of PGE2 released into the medium was
determined. To measure PGE2, PGE2 EIA kit was used (Enzo Life sciences; Cat no- ADI-
900-001). Briefly, samples were incubated with PGE2 EIA conjugate (cat no- 80-0002) and
PGE2 EIA antibody (cat no- 80-0003) at room temperature for 2 hours at 500 rpm on a plate
shaker. Excess reagents were washed off and substrate (cat no- 80-0075) was added. After a
short incubation time the enzyme reaction was stopped, and yellow colour generated was read
on a microplate reader at 405 nm.
Wound healing assay
[00147] Wound healing assay performed with C2C12 cells. Cells were seeded into a
24-well culture dish until 90% confluent. The cells were then maintained in serum-free
medium for 12 h. The monolayers were carefully scratched using a 200-ul pipette tip. The
cellular debris were subsequently removed by washing with PBS, and the cells were treated
with natural compounds and incubated in medium with 2% fetal bovine serum (FBS, Gibco).
The wound closures were measured under microscope. The wound closures were
photographed at 0 and 24 hours to monitor the migration of cells into the wounded area, and
the closure of the wounded area was calculated.
RESULTS AND DISCUSSION
[00148] Mucuna pruriens extract and the Adhatoda vasica extract were obtained
commercially from Sami labs and used as a value-added product. Figure la depicts the effect
of Mucuna pruriens extract at various weight percentages on viability of chondrocyte cells.
Weight percentages ranging from 20 ug/ml to 400 ug/ml of Mucuna pruriens extract were
tested on osteoblast cells; and optical density (OD) was measured. The cell toxicity data of
Mucuna pruriens extract in chondrocyte is presented in Figure la. From figure la, it can be
observed that weight percentages of up to 40 (J,g/ml of Mucuna pruriens extract are non-toxic
to the cells, however, weight percentage from 80 ug/ml to 200 ug/ml causes significant
toxicity to cells.
[00149] Figure lb depicts the effect of Adhatoda vasica extract at various weight
percentages on viability of chondrocyte cells. Weight percentages ranging from 20 ug/ml to
400 ug/ml of Adhatoda vasica extract were tested on chondrocyte cells; and optical density

(OD) was measured. The cell toxicity data of Adhatoda vasica extract in osteoblast is
presented in Figure lb. From figure lb, it can be observed that weight percentages of up to
40 ug/ml of Adhatoda vasica extract are non-toxic to the cells, however, weight percentage
from 80 ug/ml to 200 ug/ml causes significant toxicity to cells. From figure la and figure lb,
it can be inferred that both Adhatoda vasica and Mucuna pruriens were non-toxic to cells
until concentration of 40 ug/ml. Hence 40 ug/ml was used for the further experiments.
[00150] Figure 2 depicts the percentage inhibition of prostaglandins (PGE2) by
Adhatoda vasica extract and Mucuna pruriens extract in isolation and in combination in human primary chondrocytes Curcumin was used as a positive control. The inhibition was 21.2 % and 23.1 % for Mucuna pruriens and Adhatoda vasica respectively. When Adhatoda vasica extract and Mucuna pruriens extract was used in combination, there was a 29.9 % inhibition of PGE2 in primary human chondrocytes. This indicates that although Adhatoda vasica extract and Mucuna pruriens extract can alleviate pain individually, their effect was found to be synergistic when used in combination.
[00151] Figure 3 depicts the effect of a combination of Mucuna pruriens extract and
Adhatoda vasica extract at various w/w ratios on % PGE2 inhibition on primary human
chondrocytes. The ratios used for the experiment were 1:4, 1:1.5, 1:1, 1:0.67 and 1:0.25.
Mucuna pruriens extract at a weight percentage of 40 ug/ml inhibits PGE2 by about 17.7%,
while Adhatoda vasica extract at a weight percentage of 40 ug/ml inhibits PGE2 by about
22%. However, for the various w/w ratios tested, unexpectedly and surprisingly, the
combinatorial effect in each case was more than the effect of either ingredient alone, the
combinatorial effect being synergistic. Of the various ratios tested, 1:4, 1:1.5, and 1:1 resulted
in 33.5, 30.2 and 28.2% inhibition of PGE2. The inhibition was maximum for ratio 1:4. It
was found to be 33.5%. It can be appreciated that the sum effect of the combinations is a
synergistic increase in PGE2 inhibition compared to the effect of either extracts alone.
[00152] The compositions were prepared conveniently by mixing the extracts {Mucuna
pruriens extract and the Adhatoda vasica extract). Optionally suitable excipients were added to the composition while mixing. In order to validate the experimental data observed in Figure 3, the individual ratios were further analysed and the results from both extracts were tabulated (Fig 4a and 4b). The representation of individual ratio's effect and combination ratio's on LPS induced prostaglandin E-2 (PGE-2) activity in human primary chondrocytes can be observed in Table 1. Table 1

In summary the ratios 1:4, 1:1.5, 1:1 and 1:0.67 found to be synergistic in reducing pain in human primary chondrocytes.
[00153] Figure 5 depicts the effect of Mucuna pruriens extract and Adhatoda vasica
extract, alone and in combination, at various w/w ratios on RANK induced prostaglandin E-2 (PGE-2) activity in human osteoclasts. Osteoclast are the bone dissolving cells. During aging or inflammatory condition, the pro-inflammatory cytokines and pain mediators (PGE-2) are

produced. These pro-inflammatory cytokines induce osteoclast and surrounding joint cells which results in the more and more bone dissolution, joint inflammation and pain. For this purpose, multiple ratios (1:4, 1:1.5, 1:1, 1:0.67 and 1:0.25) of Mucunapruriens and Adhatoda vasica were evaluated in osteoclast cells. Mucuna pruriens extract with RANK at a weight percentage of 40 ug/ml inhibits PGE2 by about 22.5%, while Adhatoda vasica extract with RANK at a weight percentage of 40 ug/ml inhibits PGE2 by about 23.7%. However, for the various w/w ratios tested, unexpectedly and surprisingly, the combinatorial effect was more than the effect of either ingredient alone, the combinatorial effect being synergistic for the ratios 1:4, 1:1.5, 1:1. Of the various ratios tested, 1:4, 1:1.5, and 1:1 resulted in 34.9, 32.2 and 32.5% inhibition of PGE2. The inhibition was maximum for ratio 1:4. It was found to be 34.9%). It can be appreciated that the sum effect of the combinations is a synergistic increase in PGE2 inhibition compared to the effect of either extracts alone.
[00154] In order to validate the experimental data observed in Figure 5, the individual
ratios were further analysed and the results from both extracts were tabulated (Fig 4a and 4b). The representation of individual ratio's effect and combination ratio's on RANK induced prostaglandin E-2 (PGE-2) activity in human primary chondrocytes can be observed in Table 2.

In summary the ratios 1:4, 1:1.5, 1:1 and 1:0.67 found to be synergistic in reducing pain in human primary chondrocytes.
[00155] Figure 7 depicts the effect of Mucuna pruriens extract and Adhatoda vasica
extract, alone and in combination, at various w/w ratios on prostaglandin E-2 (PGE-2)
activity in muscle cells. For this purpose, multiple ratios (1:4, 1:1.5, 1:1, 1:0.67 and 1:0.25) of
Mucuna pruriens and Adhatoda vasica were evaluated in muscle cells. Mucuna pruriens
extract at a weight percentage of 40 ug/ml inhibits PGE2 by about 15.6%, while Adhatoda
vasica extract at a weight percentage of 40 ug/ml inhibits PGE2 by about 21.7%. However,
for the various w/w ratios tested, unexpectedly and surprisingly, the combinatorial effect was
more than the effect of either ingredient alone, the combinatorial effect being synergistic for
every ratio tested. Of the various ratios tested, 1:4, 1:1.5, and 1:1 resulted in 30.3, 29.7 and
30.4%) inhibition of PGE2. It can be appreciated that the sum effect of the combinations is a
synergistic increase in PGE2 inhibition compared to the effect of either extracts alone,
thereby indicating that the extracts in combination were found to be good in inhibiting muscle
related pain which is in similar trend with joint and bone pain inhibition results.
[00156] In order to validate the experimental data observed in Figure 7, the individual
ratios were further analysed and the results from both extracts were tabulated (Fig 4a and 4b). The representation of individual ratio's effect and combination ratio's on LPS induced prostaglandin E-2 (PGE-2) activity in muscle cells can be observed in Table 3.

Interesting finding was among the ratios tried, from 1:4 to 1:0.25 all of the ratios were synergistic in alleviating pain in muscle cells.
[00157] Figure 9 depicts the effect of a combination of Mucuna pruriens extract and
Adhatoda vasica extract at various w/w ratios on wound healing on primary human chondrocytes. The ratios used for the experiment were 1:4, 1:1.5, 1:1, 1:0.67 and 1:0.25. From the figure 9 it can be observed that, Mucuna pruriens extract at a weight percentage of

40 ug/ml shows wound healing by 41.4%, while Adhatoda vasica extract at a weight percentage of 40 ug/ml shows wound healing by about 36%. Curcumin, which was used as a positive control, exhibited a 60.8% in wound healing. Unlike pain inhibition, the extracts of Mucuna pruriens and Adhatoda vasica, when used in combination, did not exhibit any synergistic effect in any of the ratios tested.
Advantages gained in the example illustrative process in this subject matter:
[00158] Overall, these data collectively show that a combination of Mucuna pruriens
extract and Adhatoda vasica extract at the various w/w ratios tested, particularly 1:4 -1:1 is/are a suitable alternative to Mucuna pruriens extract or Adhatoda vasica extract alone in alleviating pain and wound. It is envisaged that the combination could be a very useful component of various food products like tea, juices, smoothies, chewing gums, and nutraceutical fermented products like yogurt, etc., to alleviate pain induced by PEG2 related disorders.

I/We Claim:
1. A composition comprising:
a) Mucuna pruriens extract; and
b) Adhatoda vasica extract,
wherein the Mucuna pruriens extract, and the Adhatoda vasica extract w/w ratio is in a range of 1:4 - 1:1.
2. The composition as claimed in claim 1, wherein the Mucuna pruriens extract to the Adhatoda vasica extract w/w ratio is 1:4.
3. The composition as claimed in claim 1, wherein the Mucuna pruriens extract to the Adhatoda vasica extract w/w ratio is 1:1.5.
4. The composition as claimed in claim 1, wherein the Mucuna pruriens extract to the Adhatoda vasica extract w/w ratio is 1:1.
5. The composition as claimed in claim 1, wherein the Mucuna pruriens extract has weight percentage in a range of 0.001 to 2% with respect to the composition.
6. The composition as claimed in claim 1, wherein the Adhatoda vasica extract has weight percentage in a range of 0.001 to 2% with respect to the composition.
7. The composition as claimed in claim 1, wherein the Mucuna pruriens extract comprises L-3,4-dihydroxyphenylalanine (DOPA) having a weight percentage in a range of 10-12% with respect to the extract.
8. The composition as claimed in claim 1, wherein the Adhatoda vasica extract comprises alkaloid having a weight percentage in a range of 2-4% with respect to the extract.
9. The composition as claimed in any one of the claims 1 to 8, wherein the composition further comprises at least one excipient.
10. A process for preparing the composition as claimed in claim 1, said process comprising:

a) obtaining the Mucuna pruriens extract
b) obtaining the Adhatoda vasica extract; and
c) contacting the Mucuna pruriens extract and the Adhatoda vasica extract to obtain the composition.
11. A process for preparing the composition as claimed in claim 9, said process
comprising:
a) obtaining the Mucuna pruriens extract;

b) obtaining the Adhatoda vasica extract;
c) obtaining the at least one excipient; and
d) contacting the Mucuna pruriens extract, the Adhatoda vasica extract, with the at least one excipient, to obtain the composition.

12. The composition as claimed in any one of the claims 1 to 9, wherein the composition inhibits prostaglandin (PGE-2) production.
13. The composition as claimed in any one of the claims 1 to 9, wherein the composition is a pain-relief composition.