FIELD OF THE INVENTION
The present invention relates to development of a herbal anti-inflammatory composition for
curing inflammation due to shoulder pain, knee pain, back pain, headache, muscular strain,
joint pain, joint stiffness, foot sole pain and various arthritic disorders, including
rheumatism, osteoarthritis, gout and in sports injury also. More particularly, the present
invention relates to said herbal anti-inflammatory composition present in topical dosage
form selected from creams/ ointments/ lotions and the like forms for topical use comprising
selective ingredients of herbal origin in selective levels, which ingredients when present in
said selective levels in the composition synergistically interact with one another to deliver a
superior therapeutic effect in relieving pain/ inflammation and/or even curing it.
BACKGROUND OF THE INVENTION
Prior knowledge in this field of curing patient suffering from inflammation and arthritis from
the previously applied non steroidal anti-inflammatory drugs had produced toxic effects to
the patient adversely, in particular tissue cartilage and bone joints.
The present invention involves with the development of medicines from natural herbal
substances for curing inflammation and arthritis,
US Patent No 7,658,957 (Pushpangadan et al.) discloses a composition for treating arthritis
and inflammation comprises a combination of herbal extracts obtained from the plants
Terminalia chebula, Pluchea lanceolata, Desmodium gangeticum, Vitex negundo and
Zingiber officinale, optionally along with pharmaceutically acceptable additives in various
percentages.
US Patent No. 5,683,698 (Chavali et al.) discloses an herbal formulation and its use for
reducing/alleviating symptoms associated with rheumatoid arthritis, osteoarthritis, and
reactive arthritis and from the roots, rhizomes and/or vegetation of six herbal plant
varieties, specifically, Alpinia, Smilax, Tinospora, Tribulus, Withania, and Zingiber.
Though there are several widely prevalent herbal compositions for treating pain and
inflammation there still remains a need in the art to explore other possible herbal based
pain relieving compositions for topical use which would be therapeutically active and have

superior efficacy towards relieving/ curing various types of pain and inflammation, and be
stable at ambient temperatures and would also be safe to use without any allergic reactions
on the skin.
OBJECTS OF THE INVENTION
Thus the primary object of the present invention is to provide for a herbal anti-inflammatory
composition for topical use for relieving/ curing inflammation and pain due to shoulder pain,
knee pain, back pain, headache, muscular strain, joint pain, joint stiffness, foot sole pain
and various other pains associated with arthritic disorders, including rheumatism,
osteoarthritis, gout and pain due to sports injury.
Another object of the present invention is to provide for said herbal anti-inflammatory
composition for relieving/ curing inflammation and pain involving selective herbal extracts in
selective levels which would get easily adsorbed into the skin to provide fast, safe, effective,
long lasting pain relief.
Yet another object of the present invention is to provide for said herbal anti-inflammatory
composition comprising selective blend of ingredients of herbal origin in selective levels
wherein each ingredient present in said selective level would cooperatively interact with one
another also present in selective levels in the composition thereby working together in a
cream/lotion based composition for topical use to provide for a topical treatment that would
penetrate deeply into the skin, delivering components, such as herbal ingredients and other
nutrients and active agents, directly into the painful, inflamed areas.
Another object of the present invention is to provide for said anti-inflammatory topical
composition that would penetrate through the layers of skin, fat and muscle directly to the
root of pain to be highly efficacious in relieving/ curing inflammation and pain.
Yet another object of the present invention is to provide for said anti-inflammatory topical
composition that would be stable at ambient temperatures and would be safe to apply on
the skin without causing any allergic reactions on the skin.

SUMMARY OF THE INVENTION
Thus according to the prime aspect of the present invention there is provided a herbal anti-
inflammatory composition for reducing and/or curing inflammation and pain comprising
ingredients
(a) 40.0 - 60.0 weight % of plant extract derived from Aloe vera
(b) 0.5 - 2.0 weight % of plant extract derived from Anthocephalus cadamba
(c) 0.5 - 2.0 weight % of plant extract derived from Vitex negundo
(d) 3.0 - 5.0 weight % of essential oil derived from Eucalyptus globulus
(e) 3.0 -5.0 weight % of essential oil derived from the Gaultheria procumbens
(Wintergreen).
(f) 0.5 - 2.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
(g) 3.0 - 5.0 weight % of ingredient derived from the methyl sulphonyl methane and
(h) 4.0 - 6.0 weight % of menthol.
According to a preferred aspect of the present invention there is provided said herbal anti-
inflammatory composition wherein said plant extracts are obtained from leaf and other plant
parts or even the natural plant material itself.
According to another preferred aspect of the present invention there is provided said herbal
anti-inflammatory composition comprising pharmaceutically acceptable additives selected
from surfactants, thickening agent and preservatives.
According to yet another preferred aspect of the present invention there is provided said
herbal anti-inflammatory composition in topical dosage form selected from creams/
ointments/ lotions and the like forms adapted for topical use/ application for relieving
and/or cure pain and inflammation.
According to a preferred aspect of the present invention there is provided said herbal anti-
inflammatory composition providing antioxidant characteristics.
According to another aspect of the present invention there is provided a herbal anti-
inflammatory composition wherein the composition comprises
50.0 weight % of plant extract derived from Aloe vera

1.0 weight % of plant extract derived from Anthocephalus cadamba
1.0 weight % of plant extract derived from Vitex negundo
4.0 weight % of essential oil derived from Eucalyptus globulus
4.0 weight % of essential oil derived from the Gaultheria procumbens (Wintergreen).
1.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
4.0 weight % of ingredient derived from the methyl sulphonyl methane
5.0 weight % of menthol
0.5 weight % of sodium lauryl sulphate
0.2 weight % of methyl paraben
0.02 weight % of propyl paraben
1.5 weight % of carbomer
q.s of purified water
According to yet another aspect of the present invention there is provided a herbal anti-
inflammatory composition, wherein the composition comprises
40.0 weight % of plant extract derived from >4/oe vera
1.5 weight % of plant extract derived from Anthocephalus cadamba
1.5 weight % of plant extract derived from Vitex negundo
5.0 weight % of essential oil derived from Eucalyptus globulus
5.0 weight % of essential oil derived from the Gaultheria procumbens (Wintergreen).
2.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
5.0 weight % of ingredient derived from the methyl sulphonyl methane
6.0 weight % of menthol
0.5 weight % of sodium lauryl sulphate
0.2 weight % of methyl paraben
0.02 weight % of propyl paraben
1.5 weight % of carbomer
q.s of purified water
According to another aspect of the present invention there is provided a process for the
preparation of the said composition comprising the steps of (a) blending selectively plant
extracts actives comprising Aloe vera 40-60 wt.%, Vitex negundo 0.5-2.0 wt.%,
Anthocephalus cadamba 0.5-2.0 wt.% in combination with Eucalyptus oil 3.0-5.0 wt.%,
Wintergreen oil 3.0-5.0 wt.%, Turpentine oil 0.5-2.0 wt.%, Methyl sulphonyl methane 3.0-
5.0 wt.%, and menthol 4.0-6.0 wt.%, with or without other conventional additives to

obtain a topical dosage form selected from creams/ ointments/ lotions and the like forms for
topical use/ application.
DETAILED DESCRIPTION OF THE INVENTION
As discussed hereinbefore the present invention provides herbal anti-inflammatory
composition for topical use targeted to relieve/ cure inflammation and pain associated with
shoulder pain, knee pain, back pain, headache, muscular strain, joint pain, joint stiffness,
foot sole pain and various other pains associated with arthritic disorders, including
rheumatism, osteoarthritis, gout and pain due to sports injury. Advantageously, the herbal
anti-inflammatory composition for topical use comprises selective ingredients in selective
amounts of herbal origin comprising Aloe vera, Vitex negundo, Anthocephalus cadamba,
Eucalyptus oil, Wintergreen oil, Turpentine oil in combination with Methyl sulphonyl
methane and menthol that is efficacious in relieving pain and inflammation and/or even
curing such various types of pains.
The actives of the herbal anti-inflammatory composition of the present invention forms a
selective blend of actives only when present in selective amounts to interact with one
another in the composition present in topical dosage form leading to surprisingly and
unexpectedly special efficacy as a topical use/application to penetrate deeply into the skin
and to deliver components and other nutrients and active agents, directly into the painful,
inflamed areas. The herbal composition of the present invention therefore provides for a
much desired selectively special solution in attaining superior therapeutic efficacy in
relieving pain and inflammation and/or even curing it.
The composition of the invention is discussed hereunder in greater detail in relation to the
various select actives involved as described hereunder:
Aloe vera— Family: Liliaceae
Aloe vera is a stem less or very short-stemmed succulent plant growing to 60-
100 cm tall, spreading by offsets. The leaves are thick and fleshy, green to grey-green, with
white flecks on the upper and lower stem surfaces. The margin of the leaf is serrated and
has small white teeth. The flowers are produced in summer on a spike up to 90 cm tall,
each flower pendulous, with a yellow tubular corolla 2-3 cm long.
The plant contains flavonoids, terpenoids, lectins, fatty acids, cholesterol,
anthraquinones, Chromones, Isoaloeresin D, iso rabaichromone, neoaloesin A, mono and

polysaccharides (pectins, hemicelluloses, glucomannan, acemannan, and mannose
derivatives), tannins, sterols (lupeol, campesterol, and (3-sitosterol), salicylic acid, organic
acids, enzymes, saponins, vitamins, minerals, aloin, anthrone, aloe emodin, aloetinic acid,
choline and choline salicylate, complex muco polysaccharides similar to hyaluronic acid,
sapogenins and enzymes such as catalase, amylase, cellulase and alliinase. Minerals present
in the plant such as calcium, magnesium, potassium, sodium, aluminum, iron and zinc.
Amino acids such as arginine, asparagine, glutamic acid, aspartic acid and serine. Vitamins
such as A, Bl, B2, B6, C, (3-carotene, choline, folic acid, a-tocopherol are present. Mannose-
6-phosphate is a major sugar component in aloe vera.
Anti-inflammatory and antioxidant activity: Aloe vera gel had a dose-dependent
inhibitory effect on reactive oxygen metabolite production; Aloe vera inhibited the
production of prostaglandin but had no effect on thromboxane B2 production. The anti-
inflammatory actions of aloe vera gel in vitro provide support for the effect in inflammatory
bowel disease.
Wound healing activity: Aloe vera is effective in wound healing. A 62.5% reduction in
wound diameter was noted in mice receiving 100 mg/kg/day oral Aloe vera and a 50.80%
reduction was recorded in animals receiving topical 25% Aloe vera.
Anthocephalus cadamba --- Family- Rubiaceae
The Anthocephalus tree grows up to 45 m high. It is a large tree with a broad crown
and straight cylindrical bole. Leaves are 13-32 cm long. Flowering usually begins when the
tree is 4-5 years old. Kadam flowers are red to orange, occurring in dense, globe-like heads
of approximately 55 cm. The fruit of A. cadamba occur in small, fleshy capsules packed
closely together to form a fleshy yellow-orange infructescence containing approximately
8000 seeds.
Anthocephalus cadamba primarily consist of indole alkaloids, terpenoids, sapogenins,
saponins, terpenes, steroids, fats and reducing sugars. The bark also consists of tannins and
an astringent principle; which is due to the presence of an acid similar to cincho-tannic acid.
Glycosidic indole alkaloids; cadambine, 3a-dihydrocadambine, isodihydrocadambine and two
related non-glycosidic alkaloids; cadamine and isocadamine isolated from the leaves;
cadambagenic acid, along with quinovic acid and β- sitosterol have also been isolated.
Anthocephalus cadamba also contain an acid called chlorogenic acid (CGA). The flowers
yield an essential oil and the main constituents of oils are linalool, geraniol, geranyl acetate,
linalyl acetate, α-selinene, 2-nonanol, β-phellandrene, α-bergamottin, p-cymol, curcumene,
terpinolene, camphene and myrcene. The seeds composed of water-soluble polysaccharides
D-xylose, D-mannose and D-glucose.

Decoction of leaves is used as gargle in aphthae or stomatitis and in the treatment of
ulcers, wounds, and metorrhea. Bark of the plant is used in fever, inflammation, cough,
vomiting, diarrhoea, diabetes, burning sensation, diuresis, wounds, ulcers and in the
treatment of snake-bite.
Analgesic, Antipyretic and Anti-inflammatory activities: Extracts of the bark and leaf
of Anthocephalus cadamba possess the analgesic, antipyretic and anti-inflammatory
activities. The defatted aqueous extract of the leaves of Anthocephalus cadamba showed
significant analgesic and anti-inflammatory activity at varying doses (50, 100, 300 and 500
mg/kg). The methanolic extract of the bark of Anthocephalus cadamba was successfully
evaluated for analgesic, antipyretic and anti-inflammatory activities by some workers.
Antioxidant activity: The extract of Anthocephalus cadamba Syn. A. indicus Syn. A.
chinensis possesses potent antioxidant activity by inhibiting lipid peroxidation and increase
in the superoxide dismustase (SOD) and catalase activity.
Wound healing activity: The aqueous extract of A. cadamba shows potent wound
healing capacity.
Vitex negundo — Family - Verbenaceae
A small tree or a large shrub with an irregular trunk, stem and branches covered
with thin grey bark, the branches quadrangular. Leaves petiolate, shorter opposite,
diginately three to five foliate. Flower bracteolate, bracts 1.4 to 2.5 mm long, lanceolate,
and cauducou bisexual, bluish, purple. Fruit aglobose, ovoid or obovoid, four chambered,
four seeded drupe.
Patient with rheumatoid arthritis were treated with the plant and encouraging results
obtained. Nirgundi decoction has been used for steam bath for arthritis or joint pains. Oil
prepared with the juice is applied to sinuses and scrofulous sores. Oil is used also as bathing
oil for rubbing on the head and in cervical lymphadenitis. Oil is found to useful for sloughing
wounds and ulcer.
Alkaloids, reducing sugars, glycosides, flavonoids, sterol, resin, and tannins are
present. The essential oil from the leaves was found to have antifungal activity against
Trichoderma spp. Recently, it was reported that the ethyl acetate extract showed a
significant activity against carrageenin, 5-HT and bradykinin induced inflammatory oedema.
Eucalyptus oil-----Family - Myrtaceae
Eucalyptus oil is a volatile oil obtained from the fresh leaf of Eucalyptus globulus. The
oil is colourless or pale yellow liquid with characteristic aromatic odor.

The main chemical components of eucalyptus oil are cineole, a-pinene, b-pinene, a-
phellandrene, aromadendrene, epiglobulol, piperitone and globulol.
This volatile oil has an analgesic effect and is often used in preparations designed to
relieve muscle, nerve and joint pains.
Winter green oil-----Family - Ericaceae
The essential oil of Wintergreen is obtained from fresh leaves of Gaultheria
procumbens.
Methyl salicylate (a precursor to aspirin) chief constituent of wintergreen oil is a
colourless, yellow or red liquid with characteristic odour. Wintergreen oil contains, in
addition to methyl salicylate, an ester that split into enanthic alcohol and an acid. Enanthic
alcohol possess the characteristic odour that distinguishes natural wintergreen oil from
synthetic methyl salicylate.
This oil has anti-inflammatory, anti-rheumatic, and, astringent effect.
Turpentine oil------Family - Pinaceae
Turpentine is a fluid obtained by the distillation of resin from trees, mainly pine
trees. It is composed of terpenes, mainly the monoterpenes alpha-pinene and beta-pinene.
Turpentine distilled from the California pines such as Ponderosa Pine (Pinus ponderosa) and
Gray Pine (Pinus sabiniana) yield a form of turpentine that is almost pure Heptane.
Turpentine is also used as a source of raw materials in the synthesis of fragrant chemical
compounds. Commercially used camphor, linalool, alpha-terpineol, and geraniol are all
usually produced from alpha-pinene and beta-pinene, which are two of the chief chemical
components of turpentine.
Methyl sulfonyl methane (MSM)
Methylsulfonylmethane (MSM), is an organo sulfur compound with the formula
(CH3)2SO2. It is also known as dimethyl sulfone. It occurs naturally in some primitive plants
and is present in small amounts in many foods and beverages. MSM is promoted as a
natural source of sulfur and is commonly used in combination with glucosamine for helping
to treat or prevent osteoarthritis. MSM has anti-inflammatory effects.
As apparent from the aforesaid though each of the selective ingredients of the composition
of the present invention seems to have isolated effect on pain and inflammation, the
presence of the same said selective ingredients in selective levels over other like ingredients
in the herbal anti-inflammatory composition of the present invention is found to surprisingly
and unexpectedly superiorly enhance the efficacy in relieving pain and inflammation due to
some special synergy attained by the selective ingredients when present in selective levels.

Importantly, when used in isolation or at levels not within the selected range identified by
the present invention the same fail to provide the superior efficacy achieved by the selective
formulation of the present invention.
In one embodiment of the invention, plant extracts are produced from powder of plant parts
of Aloe vera, Vitex negundo, Anthocephalus cadamba in combination with Eucalyptus oil,
Wintergreen oil, Turpentine oil, Methyl sulphonyl methane. In another embodiment, the
plant extracts are obtained from plant parts selected from leaf and/ or other plant parts.
In a further embodiment, the additives, which are optional pharmaceutical additives, are
selected from surfactant, thickening agent and preservatives. In further embodiments the
surfactant used includes sodium lauryl sulphate (SLS), the thickening agent used includes
carbomer, and the preservatives used include methyl and propyl paraben.
In yet further embodiment, the actives of herbal origin comprising Aloe vera 40-60
wt.%, Vitex negundo 0.5-2.0 wt.%, Anthocephalus cadamba 0.5-2.0 wt.% in combination
with Eucalyptus oil 3.0-5.0 wt.%, Wintergreen oil 3.0-5.0 wt.%, Turpentine oil 0.5-2.0
wt.%, Methyl sulphonyl methane 3.0-5.0 wt.%, and menthol 4.0-6.0 wt.%, is blended to
yield a resultant mixture further blended with conventional additives to obtain a topical
dosage form selected from creams/ ointments/ lotions and the like forms for topical use/
application.
In yet still another embodiment, the anti-inflammatory composition of the present
invention in a topical dosage form selected from ointment or creams thus provides relief
and relaxation on massaging over muscle and joints, by removing stiffness and improving
mobility of limbs and is also found to be useful in relieving and/or curing shoulder pain, back
pain, knee pain, headache, muscular strain, rheumatic pain, joint pain, joint stiffness and
inflammation, foot sole pain and various arthritic disorders, including rheumatism,
osteoarthritis, and gout.
The herbal composition of the present invention improves the blood supply to the joints and
prevents breakdown of tissues affected by arthritis.
THE MODE OF ACTIONS OF THE HERBAL COMPOSITION
The invention is thus directed to a synergistic topical anti-inflammatory pain reliever
involving select combination of natural ingredients that absorb into the skin rapidly

providing fast, safe, effective, long lasting pain relief. The composition is designated to slow
and reverse the effect of pain and inflammation in any muscle group, thus improving
mobility and overall quality of life. In the present invention, blends of the high quality,
standardized ingredients work together in a cream to provide a topical treatment that
penetrates deeply into the skin, delivering components, such as herbal ingredients and
other nutrients and active agents, directly into the painful, inflamed areas. The topical
composition penetrates through the layers of skin, fat and muscle directly to the root of
pain.
The invention includes a cream that is a combination of the oil with a cream base.
The cream base (and thus the cream) includes an emulsifier, a surfactant, a pain relief
component, and/or cooling component. The presence of the cooling component and/or the
pain relief component in the cream base provides improved mixing of the cream base with
the oil that is, a stable emulsion of the final composition can be more readily achieved.
Pain Relief Component
Many patients with localized pain due to arthritis, sprain or strain, cannot be tolerate
conventional non-steroidal anti-inflammatory drugs particularly when administered orally. In
addition, topical administration of conventional NSAIDs has largely been effective because
only a therapeutically ineffective amount of the drug can penetrate into the skin. In
addition, indications such as acne, psoriasis and eczema are typically refractory to topical or
oral administration of NSAIDs. There is a need for compositions that include pain relief
agents other than NSAIDs particularly in a topically applied formulation. There is also a
need for anti inflammatory conditions by topical application of the composition. The anti-
inflammatory composition should not have the side effects associated with prior art NSAIDs.
The present invention addresses the needs in the prior art by providing a pain relief and
anti-inflammatory composition that avoids such drawback.
The pain relief component is used in combination includes aloe vera, vitex leaf
extract, kadam leaf extract, methyl sulphonyl methane (MSM). The pain relief agent is an
active ingredient present in the composition and thus is also present in the cream.
Aloe vera blocks pain in the deep layers of skin due to its active components and
their power to penetrate and ease inflammation. Aloe vera gel exerts its anti-inflammatory
activity through carboxypeptidase that inactivate bradykinin, an inflammatory agent.
Methyl salicylate, the main chemical constituent of the wintergreen oil (a precursor
to aspirin). The salicylates pass through the skin, entering the tissues to inhibit the
formation of prostaglandins, thereby reducing inflammation and pain.

The fresh leaves of Vitex negundo and Anthocephalus cadamba have anti-
inflammatory and pain suppressing activities possibly mediated via prostaglandin (PG)
synthesis inhibition, antihistamine, membrane stabilising and antioxidant activities.
Anti-inflammatory Component
A broad range of anti-inflammatory component is used in compositions of the
invention. In general any anti-inflammatory component will be present as part of the oil,
although they may also be part of the cream base or in the cream base alone. The anti-
inflammatory component includes eucalyptus oil, wintergreen oil, turpentine oil and
combination thereof. The amount of anti-inflammatory component is variable depending
upon its identity and strength.
Aloe gel contains a numbers of polysaccharides which externally soothes the skin,
reduces inflammation, promotes healing and helps to regenerate damaged tissue by
boosting the immune system and eliminates the toxins internally (Choi and Chung, 2001).
Aloe gel contains lots of minerals and essential amino acids that give supply of nutrients to
the damaged tissue at the infected area (MacKay and Miller, 2003).
1.8-cineol (eucalyptol) which is known as the major monoterpene of eucalyptus oil
suppressed arachidonic acid metabolism and cytokine (an anti-inflammatory agent)
production in human monocytes. (Juergens, 2003). Eucalyptus oil also reduce the
inflammation by stimulating the immune system response by affects on the phagocytic
ability of human monocyte, derived macrophages.
Alpha-pinene and beta-pinene, are two of the chief chemical components of
turpentine oil which inhibits arachidonic acid metabolism and cytokine (an anti-inflammatory
agent) production in human monocytes also.
Fibrinolytic component
As a result of injuries or insults that cause pain, particularly in the areas of joints,
bodies react by sending white blood cells to the area, causing inflammation and swelling.
This release fibrin, a natural substance in that helps to heal wounds. However, release of
fibrin seals of the area with a protective mesh. In the present invention aloe vera is used as
fibrinolytic component.
Aloe vera gel inhibits the production of thromboxane B2 and prostaglandin F2
through competitive inhibition.

Aloe vera drastically reduce the risk inflammation to the affected areas, it will
certainly remove symptoms such as redness or swelling due to presence of salicylic acid and
beta-sitosterol (anti-inflammatory agents) (Davis et al, 1986).
Cooling component
Compositions of the invention include a cooling component. This component
decrease burning and discomfort associated with pain perception. Menthol or its related
compounds known in the art, is an exemplary component used in the present formulation as
a cooling components for soothing pain relief and as a signal of efficacy.
L-menthol significantly suppressed the production of each of the three inflammation
mediators namely Lymphotoxin beta (LTB), Prostaglandins and Interleukin-1-beta.
Transducer
The transducer is used to enhance skin permeation or transdermal delivery of active
component and to carry other components of the invention into the skin. The transducer
component is thus a compound or composition (i.e. mixture of compounds) that enhances
skin permeation. The transducer that is used in the present invention include aloe vera. The
transducer component is prepared in a very pure form (extracted from fresh leaves).
Circulation increasing component
Composition developed according to the invention improve blood circulation. The
circulation increasing component is intended to effectuate increased oxygen uptake by
increasing blood supply at the point of pain, and also provide better penetration of the
active component to the skin and nerves. Many anti-inflammatory components are also
effective at increasing blood circulation, such as for example, wintergreen oil.
Joint or muscle soothing components and joint or membrane lubricants
The present invention is also effective to a joint or muscle soothing component,
which also has anti-inflammatory effects. An exemplary joint or muscle soothing
components includes methyl sulphonyl methane and aloe vera used in the present
invention.
NON-LIMITING ILLUSTRATIVE EXAMPLES OF THE INVENTION
The specified portion of the plant was collected and dried under shade at room temperature
(about 25°C to 40°C) for a period of 72 hours or more till the materials are dried. The
material was then grinded into a fine powder. A specified amount of the powdered materials

was then extracted exhaustively with aqueous medium by reflux condensing method for 3-4
hours. At the end of this stage, solvent was decanted and filtered to make it free from plant
debris. The individual plant extracts of the three ingredients are prepared and they are
mixed with addition of three essential oil, methyl sulphonyl methane and menthol. The
resultant composition of the ingredients in weight % is illustrated in the table 1. The final
product was then made into topical dosage form by using the resultant mixture for making
cream or ointment. Surfactant like sodium lauryl sulphate (SLS), thickening agent like
carbomer and preservatives like methyl and propyl paraben were added suitably to make
the final composition.

Aloe vera, Vitex negundo and Anthocephalus cadamba were collected and dried in
shade. The dried material (1kg) was then powdered and extracted with aqueous medium by
reflux condensing method for 3-4 h. The solvent was decanted and filtered to make it free
from plant debris. The weighted quantities of the plant extracts were then mixed with water
in combination with Eucalyptus oil, Wintergreen oil, Turpentine oil, Methyl sulphonyl
methane and menthol with surfactant like SLS and preservatives like methyl and propyl
paraben and then thickening agent like carbomer were added in sufficient quantity to form
cream base topical preparation..

Example 2
Table 2
Composition (F2):

Aloe vera, Vitex negundo and Anthocephalus cadamba were collected and dried in
shade. The dried material (1kg) was then powdered and extracted with aqueous medium by
reflux condensing method for 3-4 h. The solvent was decanted and filtered to make it free
from plant debris. The weighted quantities of the plant extracts were then mixed with water
in combination with Eucalyptus oil, Wintergreen oil, Turpentine oil, Methyl sulphonyl
methane and menthol with surfactant like SLS and preservatives like methyl and propyl
paraben and then thickening agent like carbomer were added in sufficient quantity to form
cream base topical preparation.
Table 3 shows the trial experiments on a number of patient suffering from arthritis,
inflammation and local pain shows the comparative effects of composition Fl and F2,
developed according to the invention.

From the above mentioned data Table 4 it is observed that the formulated compositions F3
and F4 involving same selective ingredients not within the stated selective levels show poor
results as compared to the compositions Fl and F2 involving same ingredients within the
workable levels as illustrated above. Comparative composition F4 involving lesser amount
of ingredients below the selective workable levels and composition F3 involving higher levels
of the ingredients beyond the selective levels is thus less efficacious and taking a much
longer time to provide relief to patients from inflammation, arthritis and local pain as
because it is surprisingly found by way of the present invention that said selective
ingredients only when present in said selective levels are found to synergize with one
another to provide for a synergistic effect in relieving pain and inflammation with superior
efficacy. Therefore, compositions Fl and F2 of the present invention are most effective
compositions for treating and/ or curing pain and inflammation with said selective
ingredients in selective levels as illustrated above which are thus found to be far more
effective when compared to the compositions F3 and F4. It is also a selective finding of the
present invention that when the range of ingredients in the composition as illustrated under
compositions Fl and F2 are changed the stability of the composition with regard to its
efficacy also changes thereby destabilizing the composition. Therefore based on the above
clinical data it is thus a selective and surprising finding of the present invention that an
efficacious, stable and synergistic herbal anti-inflammatory composition comprising Aloe
vera 40-60 wt.%, Vitex negundo 0.5-2.0 wt.%, Anthocephalus cadamba 0.5-2.0 wt.% in
combination with Eucalyptus oil 3.0-5.0 wt.%, Wintergreen oil 3.0-5.0 wt.%, Turpentine oil
0.5-2.0 wt.%, Methyl sulphonyl methane 3.0-5.0 wt.%, and menthol 4.0-6.0 wt.%, could
be attained to favour relief and/ or cure of pain and inflammation by way of superior
permeation ability of the ingredients, which said ingredients in its selective levels synergize
with one another to provide a synergistic effect in effectively reducing pain and
inflammation also curing it which could not be effected by the comparative compositions F3
and F4 as discussed above.
Though the present invention as claimed, has been described and illustrated with specific
embodiments and trial results on patients, the entire disclosure is non-limiting in respect to
the modifications relating to selection of various parts of the plants and processing of those
parts for the production of the composition in cream/ lotion/ ointment base falling within the
scope of the invention.
Advantages of the anti-inflammatory composition of the present invention are as follows:

1. can be used for curing arthritis and inflammation free of any synthetic drugs compared to
commercially available products in the market thus eliminating any toxicity and side effects;
2. can be used as a cream base material in which ingredients have analgesic and anti
inflammatory property and is administered in mild dosages for potentiating their activities.

3. can be used in diabetic condition and in conditions of high creatinine level, as
replacement of previously known commercially available non-steroidal anti-inflammatory
drugs resulting toxic effects;
4. can be used as a sports medicine also for example massaging the topical form in the
form of a cream formulated cream for a few minutes will relief from muscular convulsion.
5. has superior efficacy towards relieving pain and inflammation made possible due to the
cooperative effect of the selective ingredients present in the selective levels that provides
for higher permeation ability.
It is thus possible by way of the present invention to provide for a desired synergistic
herbal composition useful in the treatment of arthritis and/or inflammation and related
conditions wherein said synergistic herbal composition comprises a therapeutically potent
combination of select synergistically compatible extracts obtained from the plants Aloe vera,
Vitex negundo, Anthocephalus cadamba in combination with Eucalyptus oil, Wintergreen oil,
Turpentine oil, Methyl sulphonyl methane, menthol with or without other pharmaceutically
acceptable known additives all present in selective amounts. The present invention further
provides for a method of preparing said herbal composition for the treatment of arthritis and
inflammation.

We Claim:
1. A herbal anti-inflammatory composition for reducing and/or curing inflammation and
pain comprising ingredients
(a) 40.0 - 60.0 weight % of plant extract derived from Aloe vera
(b) 0.5 - 2.0 weight % of plant extract derived from Anthocephalus cadamba
(c) 0.5 - 2.0 weight % of plant extract derived from Vitex negundo
(d) 3.0 - 5.0 weight % of essential oil derived from Eucalyptus globulus
(e) 3.0 -5.0 weight % of essential oil derived from the Gaultheria procumbens
(Wintergreen).
(f) 0.5 - 2.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
(g) 3.0 - 5.0 weight % of ingredient derived from the methyl sulphonyl methane and
(h) 4.0 - 6.0 weight % of menthol.
2. The composition as claimed in claim 1, wherein the said plant extracts are obtained from
leaf and other plant parts or even the natural plant material itself.
3. The composition as claimed in claim 1, comprising pharmaceutically acceptable additives
selected from surfactants, thickening agent and preservatives.
4. The composition as claimed in claim 1, in topical dosage form selected from creams/
ointments/ lotions and the like forms adapted for topical use/ application for relieving
and/or cure pain and inflammation.
5. The composition as claimed in claim 1, providing antioxidant characteristics.
6. The composition as claimed in anyone of the preceding claims, wherein the composition
comprises
50.0 weight % of plant extract derived from Aloe vera
1.0 weight % of plant extract derived from Anthocephalus cadamba
1.0 weight % of plant extract derived from Vitex negundo
4.0 weight % of essential oil derived from Eucalyptus globulus
4.0 weight % of essential oil derived from the Gaultheria procumbens (Wintergreen).
1.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
4.0 weight % of ingredient derived from the methyl sulphonyl methane
5.0 weight % of menthol
0.5 weight % of sodium lauryl sulphate

0.2 weight % of methyl paraben
0.02 weight % of propyl paraben
1.5 weight % of carbomer
q.s of purified water
7. The composition as claimed in anyone of the preceding claims, wherein the composition
comprises
40.0 weight % of plant extract derived from Aloe vera
1.5 weight % of plant extract derived from Anthocephalus cadamba
1.5 weight % of plant extract derived from Vitex negundo
5.0 weight % of essential oil derived from Eucalyptus globulus
5.0 weight % of essential oil derived from the Gaultheria procumbens (Wintergreen).
2.0 weight % of essential oil derived from the plant Pinus spp (Turpentine)
5.0 weight % of ingredient derived from the methyl sulphonyl methane
6.0 weight % of menthol
0.5 weight % of sodium lauryl sulphate
0.2 weight % of methyl paraben
0.02 weight % of propyl paraben
1.5 weight % of carbomer
q.s of purified water
8. A process for the preparation of the composition as claimed in any of the preceding
claims comprising the steps of (a) blending selectively plant extracts actives comprising
Aloe vera 40-60 wt.%, Vitex negundo 0.5-2.0 wt.%, Anthocephalus cadamba 0.5-2.0 wt.%
in combination with Eucalyptus oil 3.0-5.0 wt.%, Wintergreen oil 3.0-5.0 wt.%, Turpentine
oil 0.5-2.0 wt.%, Methyl sulphonyl methane 3.0-5.0 wt.%, and menthol 4.0-6.0 wt.%, with
or without other conventional additives to obtain a topical dosage form selected from
creams/ ointments/ lotions and the like forms for topical use/ application.

ABSTRACT

A herbal anti inflammatory composition for reducing inflammation from a combination of
plant extracts comprising of (a) 40 to 60 weight % of plant extract derived from Aloe vera
(b) 0.5 to 2.0 weight % of plant extract derived from Anthocephalus cadamba (c) 0.5-2.0
weight % of plant extract derived from Vitex negundo (d) 3.0-5.0 weight % of essential oil
derived from Eucalyptus globules (d) 3.0-5.0 weight % of essential oil derived from the
Gaultheria procumbens (Wintergreen) (e) 0.5-2.0 weight % of essential oil derived from the
plant Pinus spp (Turpentine) (f) 3.0-5.0 weight % of ingredient derived from the methyl
sulphonyl methane and 4.0-6.0 weight % of menthol.