Field of Invention:
The present invention pertains to herbal food/neutraceuticals and, more particularly,
to a composition for treating joint pains. More particularly, the invention relates to a
natural herbal remedy for treatment of chronic inflammatory and/or rheumatic
disorders, such as rheumatoid arthritis (chronic polyarthritis), osteoporosis and
osteoarthritis.
Background of Invention:
Rheumatoid arthritis is an inflammatory joint disorder which may lead to serious
impairments in daily life. It is the most common rheumatic disorder and affects about
0.5% of the population, women three times as often as men. It affects in particular
the finger joints where, in the initial stage of the disease, it causes pain at morning
and night along with prolonged joint stiffness. Possible later occurrences are
involvement of further joints, joint deformations and rarely organ involvement. In a
later stage, a so-called pannus develops which is a tumor-like tissue which, after a
certain time, destroys cartilage, bone and also other structures of the affected joint
develops from the inflamed synovial membrane (lining of the joint).
The reason for the development of rheumatoid arthritis is still not definitively clarified.
Genetic factors and autoimmune reactions are probably involved therein. As the
disease progresses further, inflammation of the synovial membrane, involving almost
all the cells of the immune system and the synovial cells, occurs. This inflammation
is controlled mainly by the cytokine tumor necrosis factor α (TNFα), whereas the
cytokine interleukin 1 (IL-1) is responsible for the destruction of cartilage tissue and
activation of the bone-destroying osteoclasts. The natural antagonist of IL-1, the IL-1
receptor antagonist IL-1Ra, is present in insufficient quantity in rheumatoid arthritis.
Medical therapy of rheumatoid arthritis is currently based primarily on so-called basic
therapeutics, which include cytostatics (e.g. methotrexate), immunosuppressants
(e.g. cyclosporin A) and gold preparations. However, these basic medicaments have
an effect only after weeks or months.
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Very recently, inhibitors of TNFα (infliximab and etanercept) and the recombinant IL-
1 receptor antagonist anakinra have been administered parenterally as basic
therapeutics.
Further substantial supports of the medical therapy of rheumatoid arthritis are the
glucocorticoids which rapidly inhibit inflammation and alleviate pain. Also employed
are non-steroidal antiinflammatory drugs (NSAID) (e.g. diclofenac and
indomethacin), which are antiinflammatory analgesics (antiphlogistics) that inhibit the
enzyme cyclooxygenase which is necessary for prostaglandin production.
Cyclooxygenase-2 (COX-2)-selective NSAIDs which inhibit only the production of
the prostaglandins involved in the inflammatory event but not the protective
prostaglandins are a new NSAID class.
Rheumatoid arthritis shows a gradual progression in most cases. Although the
progression can often be slowed down, and the inflammation and pain controlled
well over a long period by medicaments, nevertheless there is a certain risk of
permanent invalidity.
Botanicals are also widely being used to treat musculoskeletal diseases. Some
patented formulations composed of botanicals targeting musculoskeletal diseases
are disclosed.
US 2004/0161478 A1 discloses as an agent for the prevention and treatment of
arthritis a plant of the family Saxifragaceae or an extract thereof. A pharmaceutical
composition with this agent may comprise as further ingredients among many other
active ingredients recited selenium, oxidation-preventing vitamin, eicosapentaenoic
acid, Boswellia and devil's claw. However, the only demonstration of an effect
indicated was a preventive effect in an animal model of arthritis.
U.S. Patent No. 5,494,668 (Patwardhan) discloses a method of treating
degenerative musculoskeletal diseases such as rheumatoid arthritis and
osteoarthritis in an animal, typically a human, involving administering to the animal,
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typically enterally, in a convenient dosage form, a therapeutically effective amount of
the beneficiated extracts of the plants Ashwagandha, SallaiGuggul,
Turmeric, and Ginger, in a predetermined proportion relative to each other with or
without other biologically active inorganic ingredients.
U.S. 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 for reducing the production of proinflammatory
cytokines. The formulation contains an herbal extract from the roots,
rhizomes and/or vegetation of six herbal plant varieties, specifically, the species of
Alpinia, Smilax, Tinospora, Tribulus, Withania, and Zingiber. The patent further
discloses foods, beverages and medicaments in the form of capsules, tablets,
liquids, and the like, containing the herbal formulation.
U.S. Patent No. 5,916,565 (Rose et. al.) discloses an orally administered
composition for prophylaxis and therapy of joint and connective tissue disorders in
vertebrates, wherein the composition contains metabolic precursors, herbal
phytochemicals, and palatability agents. Suitable herbal phytochemicals are said to
include cayenne, ginger, turmeric, yucca, Devil's claw, nettle leaf, Black Cohosh,
alfalfa and celery seeds.
U.S. Patent No. 5,888,514 (Weisman) discloses a composition for treating bone
or joint inflammation in mammals, the composition contains a systemically
absorbable cartilage and an aminosaccharide and may optinally contain, among
other ingredients, one or more extracts of an herb of the genus Withania, of the bark
of an herb of the genus Salix, or of a root of an herb of the genus Panax.
U.S. Patent No. 5,908,628 (Hou) discloses compositions for treating osteoarthritis
and rheumatoid arthritis, containing talc, silkworm excrement, and ingredients of
plants of species of the genera stephania, oix, Pinellia, Prunus, Phellodendron,
Sophora, Tetrapanax, Stemona, Glycerrhiza, tripterygium, Forsythia, and
Siegesbeckia.
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U.S. Patent No. 5,788,971 (Togasaki) discloses an active oxygen free radical
scavenging agent composed of green tea leaf extract containing
epigallocatechingallate and sunflower seed extract containing chlorogenic acid.
U.S. Patent No. 5,910,307 (Kwak, et.al.) discloses a combined medicinal plant
composition for alleviating acute/chronic inflammation, composed of Clematis Radix,
Trichosanthes root, and Prunellaherba (which contains oleanolic acid ursolic acid) in
a certain ratio. The composition is also useful for inhibiting platelet/whole blood
aggregation and inflammation-inducing enzymes (5-lipoxygenase, cyclooxygenase-
1 and cyclooxygenase-2) and for scavenging toxic active oxygen species.
U.S. Patent No. 6,024,960 (Kharazmi et. al.) discloses a formulation for the
treatment of the symptoms associated with inflammation including arthritis and for
the prophylaxis of arthritic disease and inflammation. It further describes a
formulation derived from rose-hip for the treatment of symptoms associated with
inflammation, including arthritis.
U.S. Patent No. 6,187,314 (Xie et al.) discloses different compositions extracted
from Gingko biloba leaves. Said compositions comprise new active components.
This invention also provides a method of preparation of the compositions and
individual components of said compositions. Uses of the compositions for
arthritis and various other conditions are provided.
U.S. Patent No. 6,193,977 (Han et. al.) discloses a pharmaceutical composition
comprising an extract of a mixture of AnemarrhenaRhizoma, a member of family
Liliaceae and, Phellodendron bark, a member of family Rutaceae that produces
nalgesic and antiinflammatory effects, and its preparing method. The present
invention is applicable to act on inflammation and pain, for example, chronic
gastritis, arthralgia, benign prostrate hyperplasia, chronic and recurrent cystitis,
cervical disc, degenerative joint arthritis, rheumatoid arthritis, tennis elbow,
osteoporotic pain, migraine, diabetic neuropathy pain, right flank pain etc.
U.S. Patent No. 6,224,871 (Hastings, et. al.) discloses a dietary supplement for
nutritionally promoting healthy joint function in human subjects. The supplement
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includes as a major ingredient a protein derived from enzymatic hydrolysis of
collagen in combination with lesser proportions of glucosamine sulfate, gingko
biloba, borage oil powder, turmeric, Bosweliaserrata, ashwagandha, Piper nigrum
extract and a herbal blend.
U.S. Patent No. 6,264,995 (Newmark, et. al.) discloses a herbal composition
capable of reducing inflammation in bones and joints. The invention further relates to
methods of using such herbal composition to reduce inflammation. More,
particularly, the herbal composition of the present invention contains therapeutically
effective amounts of the supercritical extracts of ginger,
rosemary and oregano, and therapeutically effective amounts of extracts of holy
basil, turmeric, green tea, huzhang, Chinese goldthread, barberry,
rosemary and Scutellariaebaicalensis.
U.S. Patent No.6,274,176 (Tomer, et al) discloses an edible composition for use as
antiinflammatory agent for alleviation of arthritis and gout in mammals. The edible
composition is a mixture of at least three, preferably at least seven, herbs collected
from the group consisting of Tanacetumparthenium, Zingiberofficinale, Curcuma
longa, Coriandrumsativum, Centellaasiatica, Oenotherabiennis, Valeriana officinalis,
Tabebuiaimpetiginosa, Thymus vulgaris and Sambucusnigra.
U.S. Patent No. 6,541,045 (Charters et. al.) discloses a herbal composition for
combating inflammation, comprising therapeutically effective amounts of Japanese
knotweed, Devil's claw, grapeskin, and syzygium. Also provided is an herbal
composition for soothing muscles and joints, comprising therapeutically effective
amounts of Japanese knotweed, N-acetyl D- glucosamine, chondroitin sulfate, Dglucosamine
hydrochloride, methylsulfonylmethane, grapeskin, syzygium, andDevil's
claws. Methods of using the formulations are also provided.
U.S. Patent No. 6,576,271 (Nair et. al.) discloses a method for inhibiting
cydooxygenase enzymes and inflammation in a mammal using a cherry or cherry
anthocyanins, bioflavonoids and phenolics. In particular, a mixture including the
anthocyanins, the bioflavonoids and the phenolics is described for this use. The
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method and compositions of the present invention are useful for the treatment of
arthritis.
JP 11-071290 (Toshiyuki et. al.) discloses a hyaluronidase inhibitor improved in
inhibitory effects and high in safety, useful as a therapeutic agent for
rheumatism and deformant arthritis, containing an extract of Phyllanthusemblucus as
an active ingredient.
There is, therefore, a need for new treatments of ailments of the present invention to
provide new treatments for bone or joint inflammation that are able to relieve
pain and discomfort, and to restore significant use of inflammed joints, better than
known methods, while at the same time avoiding the side effects with the traditional
drugs.
Summary of the Invention:
It is an object of the invention to provide acomposition for treating joint pains, said
composition comprising extract of withaniasomniferain an amount ranging from
11.2% to 16.8%, extract of commiphorawightii in an amount ranging from 16% to
24% andasphaltum in an amount ranging from 1.6% to 2.4%, alongwith
pharmaceutically acceptable excipients making remaining of 100% w/w of the total
composition.
A further object of this invention is to provide a composition wherein the amount of
extract of withaniasomniferais 14% w/w of the total composition; extract of
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commiphorais 20% w/w of the total composition; and asphaltum is 2% w/w of total
composition.
Still another object of this invention is to provide a composition wherein the
excipients includes, vitamins, calcium, dicalcium phosphate, colloidal silicon dioxide,
amla, vitamin D3, dicalciumphosphate, purified talc.
Still another object of this invention is to provide a disease-specific composition, in
convenient dosage in the form of capsules.
It is another object of the invention to provide a composition wherein the extract of
WithaniaSomnifera is extract of plant Atropa Belladonna in the family Solanaceae
Another object of the present invention is to provide a composition wherein the
extract of commiphorais extract of the plant in the family Burseraceae.
Detailed Description of Invention:
The present invention provides a dietary supplement/nutraceuticals consisting of
natural ingredients: herb extracts, vitamins, minerals and trace elements.
The invention provides a method of treating degenerative musculoskeletal diseases
such as rheumatoid arthritis and osteoaarthritis in an animal, typically a human,
comprising administering to the animal, typically enterally, in a convenient dosage
form, a therapeutically effective amount of the beneficiated extracts of the plants
ASHWAGANDHA (Withaniasomnifera) SHUDH GUGGUL (Commiphorawightii) and
SHILAJIT (Asphaltum) in a predetermined proportion relative to each other alongwith
Vitamins (on a prophylactic dose) to maintains the body’s natural mechanism and to
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support the activity of the natural herbs extracts. It also contains inorganic
ingredients, such as Dicalcium phosphate, Colloidal Silicon Dioxide to enhance the
dissolution properties of the capsule in accordance with a novel process which is
hereinafter disclosed.
It is, therefore, an object of the invention to provide a composition containing blend
of Ayurvedic and Allopathic ingredients (on a neutraceutical dosage) to heals
naturally, the degenerative musculoskeletal diseases such as rheumatoid arthritis
and osteoarthritis.
According to an aspect of invention, the dietary supplement/neutraceuticalis in a
capsular form and can be delivered in physically manageable doses to provide a
complete treatment of ailments like rheumatoid arthritis, osteoporosis and
osteoarthritis by providing a perfect solution for weak joint flexibility.
Further to above mentioned aspects, the composition of present invention helps to
regain the lost joint mobility and also to build up the weak muscles and ligaments.
It has been proved that the consumption of the composition as a dietary supplement
or as a medicine minimizes inflammation and joint pain and also boosts bone and
joints strength.
Yet another aspect of present invention is that the composition when taken on daily
basis also helps controlling cholesterol and body weight.A nutraceutical dosage of
the present invention can be made of capsules, or any other convenient form of
dosage, such as tablets or simply in powdered form or in a solution such as syrup.
Examples:
Following composition was prepared for the study:
1. ShudhGuggul Extract: 20%
2. Ashwagandha Extract: 14%
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3. Shilajit Extract: 2%
4. Vitamin H: 0.002%
5. Calcium Elemental: 20%
6. Amla (Vitamin C): 10%
7. Vitamin D3: 0.04%
8. Dicalcium Phosphate: 10%
9. Purified Talc: 19.64%
10. Colloidal Silicon Dioxide: 4.31%
The above mentioned formulation is the perfect one to show maximum results in
regards of Joint pains and on the MEC (Minimum effective concentration).

Claims
We Claim:
1. Acomposition for treating joint pains, said composition comprising extract of
withaniasomniferain an amount ranging from 11.2% to 16.8%, extract of
commiphorawightii in an amount ranging from 16% to 24% and asphaltum in
an amount ranging from 1.6% to 2.4%, alongwith pharmaceutically
acceptable excipients making remaining of 100% w/w of the total
composition.
2. The composition as claimed in claim 1, wherein the amount of extract of
withaniasomniferais 14% w/w of the total composition; extract of
commiphorais 20% w/w of the total composition; and asphaltum is 2% w/w of
total composition.
3. The composition as claimed in claim 1, composition wherein the excipients
includes, vitamins, calcium, dicalcium phosphate, colloidal silicon dioxide,
amla, vitamin D3, dicalcium phosphate, purified talc.
4. The composition as claimed in claim 1, wherein the dosage is in capsule
form.
5. The composition as claimed in claim 1, composition wherein the extract of
WithaniaSomnifera is extract of plant Atropa Belladonna in the family
Solanaceae
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6. The composition as claimed in claim 1,wherein the extract of commiphorais
extract of the plant in the family Burseraceae.