Therapeutic compositions

FIELD OF THE INVENTION

The present invention relates to therapeutic compositions useful in the topical treatment, prevention, or mitigation of pain, inflammation, and swelling as well as to methods for their use and manufacture.

BACKGROUND OF THE INVENTION

Physical activity such as strenuous exercise can subject the human body to intense strains, which may cause pain to result in the muscles and/or joints. In the case of a baseball pitcher, pain can be experienced in the arm or the shoulder. The shoulder pain often occurs in the same area. Although there are a number of available topical compositions for treatment of such pain, the efficacy of such compositions is less than optimal. There is a need for more effective topical compositions for treatment of muscle pain, particularly pain in the arms of baseball pitchers.

Exercise causes the muscles to use more oxygen. If the circulation to the muscle is partially or totally blocked, activities of the muscle such as raising or swinging the arm may cause muscle fatigue, pain, or aching. Recurring muscle pain (for example, in the arm) may be at least partially a result of the muscles not receiving enough oxygen and nutrients or poor removal of metabolic products of exercise (such as lactic acid) due to poor or inefficient circulation.

Furthermore, localized inflammation and swelling may result from an injury to the human body or arthritic pain in a joint may result from breaking down of the cartilage that covers the ends of the bones comprising the joint. Again, it is thought that increased circulation of the blood around the muscle and joint may have a beneficial effect on such inflammation and swelling and may facilitate the restoration of damaged tissue in such instances.

SUMMARY OF THE INVENTION

It is an object of the invention to provide topical compositions to treat injured and inflamed parts of the body having superior efficacy to compositions known in the art, as well as methods of making and using the compositions.

According to one aspect of the present invention, there is provided a topical therapeutic composition comprising: achillea millefolium (yarrow) extract, aloe vera, arnica montana flowers, annatto seed extract, boswellia serrate extract, marigold flower extract, cetearyl olivate, cetyl myristoleate, sunflower seed oil, sorbitan olivate, turmeric root extract, methylsulfonylmethane (MSM), emu oil, devil's claw root extract, yerba mate leaf extract, magnesium sulfate, peppermint oil, menthol, skullcap root extract, vitamin E, and yucca root extract.

The composition may further comprise beeswax, gluconolactone, glycerine, glyceryl stearate SE, caprylic/capric triglyceride, stearic acid, xanthan gum, and sodium benzoate as moisturizers, carriers, or preservatives.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, inflammation, pain, and swelling in a subject are effectively mitigated, prevented, or treated by topically administering to the afflicted subject a therapeutically effective amount of the therapeutic composition of the invention. For treatment of existing pain, inflammation, or swelling, the therapeutic composition is topically applied to the site of the existing pain, inflammation or swelling. For prevention or mitigation of anticipated inflammation, pain, or swelling due to expected physical activity, the therapeutic composition is applied topically to the site of the anticipated inflammation, pain, or swelling.

The composition of the invention comprises the following relative amounts of ingredients. The yarrow extract may be present in the composition in the range of from about 0.01% to about 0.04% by weight, preferably about 0.01-0.03% by weight. The aloe vera may be present in the composition in the range of from about 1% to about 30% by weight, preferably about 4-6% by weight. The arnica montana extract may be present in the composition in the range of from about 0.05% to about 0.8% by weight, preferably about 0.05-0.15% by weight. The beeswax may be present in the composition in the range of from about 0.5% to about 10% by weight, preferably about 0.5-2% by weight. The annatto seed extract may be present in the composition in the range of from about 0.01% to about 0.2% by weight, preferably about 0.01-0.1% by weight. The boswellia serrate extract may be present in the composition in the range of from about 0.05% to about 0.2% by weight, preferably about 0.05-0.15% by weight. The marigold flower extract may be present in the composition in the range of from about 0.05% to about 0.2% by weight, preferably about 0.05-0.15% by weight. The carpylic/capric triglyceride may be present in the composition in the range of from about 0.5% to about 2% by weight, preferably about 0.75-1.25% by weight. The cetearyl olivate may be present in the composition in the range of from about 1% to about 4% by weight, preferably about 1.5-2.5% by weight. The cetyl myristoleate may be present in the composition in the range of from about 0.01% to about 15% by weight, preferably about 0.01-0.03% by weight. The turmeric root extract may be present in the composition in the range of from about 0.05% to about 1.5% by weight, preferably about 0.07-0.12% by weight. The methylsulfonylmethane (MSM) may be present in the composition in the range of from about 1% to about 20% by weight, preferably about 2-4% by weight. The emu oil may be present in the composition in the range of from about 0.01% to about 20% by weight, preferably about 0.01-1.0% by weight. The gluconolactone may be present in the composition in the range of from about 0.3% to about 1.5% by weight, preferably about 0.4-0.9% by weight. The glycerin may be present in the composition in the range of from about 1% to about 8% by weight, preferably about 3-5% by weight. The glyceryl stearate SE may be present in the composition in the range of from about 1% to about 10% by weight, preferably about 4-6% by weight. The devil's claw root extract may be present in the composition in the range of from about 0.01% to about 0.8% by weight, preferably about 0.05-0.15% by weight. The sunflower seed oil may be present in the composition in the range of from about 0.1% to about 2% by weight, preferably about 0.3-0.7% by weight. The yerba mate leaf extract may be present in the composition in the range of from about 0.01% to about 0.2% by weight, preferably about 0.07-0.15% by weight. The magnesium sulfate may be present in the composition in the range of from about 1% to about 30% by weight, preferably about 2-4% by weight. The peppermint oil may be present in the composition in the range of from about 0.03% to about 3% by weight, preferably about 0.1-0.2% by weight. The menthol may be present in the composition in the range of from about 1.25% to about 10% by weight, preferably about 1.25% by weight. The skullcap root extract may be present in the composition in the range of from about 0.01% to about 0.2% by weight, preferably about 0.01-0.03% by weight. The sodium benzoate may be present in the composition in the range of from about 0.1% to about 0.6% by weight, preferably about 0.2-0.4% by weight. The sorbitan olivate may be present in the composition in the range of from about 0.5% to about 4% by weight, preferably about 1-3% by weight. The steric acid may be present in the composition in the range of from about 1% to about 6% by weight, preferably about 2-4% by weight. The vitamin E may be present in the composition in the range of from about 0.05% to about 2% by weight, preferably about 0.08-0.12% by weight. The xanthan gum may be present in the composition in the range of from about 0.1% to about 2.5% by weight, preferably about 0.2-0.8% by weight. The yucca root extract may be present in the composition in the range of from about 0.01% to about 0.4% by weight, preferably about 0.01-0.03% by weight. The composition also comprises water.

One preferred composition of the invention comprises 0.02 wt. % yarrow extract, 5 wt. % aloe vera, 0.1 wt % arnica montana extract, 1 wt. % beeswax, 0.01 wt. % annatto seed extract, 0.1 wt. % boswellia serrate extract, 0.1 wt. % marigold flower extract, 1 wt. % carpylic/capric triglyceride, 2 wt. % cetearyl olivate, 0.01 wt. % cetyl myristoleate, 0.1 wt. % turmeric root extract, 3 wt. % methylsulfonylmethane (MSM), 0.05 wt. % emu oil, 0.65 wt. % gluconolactone, 4 wt. % glycerin, 5 wt. % glyceryl stearate SE, 0.1 wt. % devil's claw root extract, 0.5 wt. % sunflower seed oil, 0.1 wt. % yerba mate leaf extract, 3 wt. % magnesium sulfate, 0.15 wt. % peppermint oil, 1.25 wt. % menthol, 0.02 wt. % skullcap root extract, 0.3 wt. % sodium benzoate, 2 wt. % sorbitan olivate, 3 wt. % steric acid, 0.1 wt. % vitamin E, 0.5 wt. % xanthan gum, and 0.02 wt. % yucca root extract, plus sufficient water to make 100%.

The present therapeutic compositions may further enhance the activity of other pharmaceuticals (such as topical analgesic and anti-inflammatory compounds and other natural ingredients such a glucosamine and condroitin) combined with them because of their deeper penetration into the dermis. The composition will effectively pull the added topical pharmaceutical into the lower layers of the skin and thereby result in more effective topical action, such as treatment of pain or inflammation. For example, by adding a topical therapeutic compound such as ibuprofen to the composition, the effectiveness of the ibuprofen will be increased by being drawn further into the skin. In this way, a lower level of ibuprofen in a composition of the invention may achieve the same effectiveness as a higher level of ibuprofen delivered in a conventional manner. Such a combination of a topical therapeutic with the subject composition would deliver a significant medical benefit because a patient could be treated with lower levels of drug and thereby have fewer adverse events or adverse events that are less severe.

The composition is preferably applied by applying it to the skin and massaging it in. The formulation may be a cream, gel, ointment, or lotion. A cream formulation is preferred for ease of application.

According to another aspect of the invention, there is provided a method of treating muscle or joint pain in a subject in need of such treatment, which comprises topically applying a composition of the invention to the site of the existing or anticipated muscle or joint pain. That is, the present therapeutic composition may be topically applied to the site of existing pain, such as that due to strenuous exercise or arthritis. Alternatively, the present therapeutic composition may be applied to an area (such arms or legs) which the subject expects to exercise strenuously in order to prevent or lessen the pain expected to result from that exercise. With respect to a baseball pitcher, the method comprises applying the therapeutic composition to the arm and shoulder area of the pitcher (as by rubbing it in) either prior to or after a throwing session, or both.

According to another aspect of the present invention, there is provided a method of preparing a therapeutic composition comprising the steps of: 1) preparing an aqueous mixture of aloe vera, the botanical extracts, glycerin, and magnesium sulfate with heating to about 165.degree. C.; 2) preparing a mixture of sunflower oil, emu oil, caprylic/capric triglyceride, vitamin E, cetyl myristoleate, beeswax, and stearic acid with heating to about 165.degree. C.; 3) slowly adding the oil phase to the aqueous phase with agitation; 4) adding cetearyl olivate, sorbitan olivate, glyceryl stearate, and xanthan gum with mixing and allow to cool to about 110.degree. C.; 5) adding gluconolactone, sodium benzoate, peppermint oil and menthol; 6) mixing until homogeneous. The amounts of ingredients used in the method are within the ranges described above. The method may further comprise the step of adding a pharmaceutical drug at any of the above steps as noted above. By altering the quantity of carrier ingredients, the formulation may also be made as a gel, ointment, or lotion, as may be desired. Although the above method is the preferred way of making the therapeutic compositions, those of skill in the art will readily appreciate that other combinations of steps may be used to achieve the same result.

The ingredients of the therapeutic composition of the present invention are summarized in Table 1 below with respect to a description thereof, the active ingredients therein, percentages by weight range for each active ingredient, and the benefits thereof.

TABLE-US-00001 TABLE 1 Minimum Current Maximum Range % Range Ingredient % (w/w) % Description Contains Benefit ACHILLEA 0.01 0.02 0.40 Achille millefolium, known commonly as yarrow Sesquiterpene Lower fevers, MILLEFOLIUM common yarrow, is a flowering plant in the family lactones, induces (Yarrow) Asteraceae. It is native to temperate regions of the polyacetylenes, sweating, stops EXTRACT Northern Hemisphere in Asia, Europe, and North simple cramps, America. The plant also has a long history as a coumarins, and relieves powerful `healing herb` used topically for wounds, flavonoids. inflammation, cuts and abrasions. and stimulates the release of stomach acid to digest proteins and fats. ALOE 1.00 5.00 30.00 Aloe vera, otherwise known as barbados aloe vera Carrisyn, Anti- BARBADENSIS and curacao aloe vera, is a perennial plant found salicylates, enzyme inflammatory (Aloe Vera wild in East and South Africa. It is also cultivated in that inhibits and also helps Gel) JUICE the West Indies and other tropical areas. The bradykinin (pain conduct the strong, fibrous root produces a rosette of fleshy transmitter), active basal leaves as in the agave, but considerably magnesium ingredient of smaller. The narrow-lanceolate leaves are 1 to 2 lactate, compounds the herbs feet long and whitish-green on both sides, and that exhibit through the they bear spiny teeth on the margins. bacteriostatic and skin barrier. antifungal activity. ARNICA 0.05 0.10 0.80 Arnica montana is a perennial flowering plant Sesquiterpene Has an MONTANA native to southern Russia and other mountainous lactones that inhibit analgesic, (Arnica) areas in Europe. In Germany, it is a protected collagen-induced anticoagulation, EXTRACT species. Vernacular names include leopard's bane platelet aggregation and anti- and mountain tobacco. and thromboxane inflammatory formation. effect. BEESWAX 0.50 1.00 10.00 Beeswax is a natural wax produced in the bee None Thickener to hive of honey bees of the genus Apis. Chemically, strengthen and beeswax consists of mainly esters of fatty preserve acids and various long-chain alcohols. cream. BIXA 0.01 0.01 0.20 It is easily incorporated into creams, sunscreen, Tocotrienols, beta- UV protectant, ORELLANA and lip balms where it helps to condition hair and carotene, essential used as a (Annatto) protect against ultraviolet rays. It also has been oil, saturated and diuretic, SEED used as diuretic, laxative, antibilious, antiemetic, unsaturated fatty astringent and EXTRACT and astringent agents, as a blood purifier, in acids, flavonoids assists in tissue jaundice, in dysentery, and externally as scar- and vitamin C repair preventive. BOSWELLIA 0.05 0.10 0.20 Boswellia extract has been used for centuries to Boswellic acid Treatment for SERRATA treat a wide range of ailments, including arthritis, arthritis and as EXTRACT diarrhea, dysentery, lung disease and worms, such used as an Boswellia extract is best known among herbalists anti- as a treatment for arthritis. One of its primary inflammatory active ingredients, boswellic acid, is an anti- agent inflammatory that can be used in ointments to ease joint pain. CALENDULA 0.05 0.10 0.20 Calendula officinalis (pot marigold, ruddles, Triterpenoids, Has anti- OFFICINALIS common marigold, garden marigold, English flavonoids, and inflammatory, (Marigold) marigold, or Scottish marigold) is a plant in the saponin fractions immuno- FLOWER genus Calendula of the family Asteraceae. It is isolated from the stimulating, EXTRACT probably native to southern Europe, though its flower include antibacterial, long history of cultivation makes its precise origin oleanolic acid antiviral, unknown, and it may possibly be of garden origin. and ursolic acid. antiprotozoal, It is also widely naturalized in north to southern and England and elsewhere in warm temperate regions antineoplastic of the world. Calendula officianalis is a short-lived properties. aromatic herbaceous perennial, growing to 80 cm (31 in) tall, with sparsely branched lax or erect stems. CAPRY- 0.50 1.00 2.00 It is considered an excellent emollient and skin- Coconut oil and Emollient, skin LIC/CAPRIC repairing ingredient due to its mix of fatty acids glycerin repair, can TRIGLYC- that skin can utilize to repair its surface and resist function as a ERIDE moisture loss. Caprylic/capric triglyceride can also thickener, function as a thickener, but its chief job is to moisturizes and moisturize and replenish skin. replenishes skin. CETEARYL 1.00 2.00 4.00 Cetearyl Olivate is a natural PEG-free emulsifiers Olive oil by Facilitates the OLIVATE from Olive oil. It reduces skin water loss, have high esterification of retention of moisturizing effect, hypoallergenic and biomimics its fatty acid skin moisture the skin. groups and and increases combined with the active sorbitol and ingredient's ceteary lalcohol resistance to water and/or sweat. CETYL 0.01 0.01 15.00 Cetyl myristoleate is a chemical compound which Cetyl ester. Lubricates the MYRISTO- is a type of fatty acid ester or, more specifically, a joints and LEATE cetylated fatty acid (CFA). It is the cetyl ester of muscles, myristoleic acid. rebuilds cartilage, and is an immune system modulator. Also useful in relieving joint discomfort following exercise. CURCUMA 0.05 0.10 1.50 Turmeric (Curcuma longa) is a rhizomatous Curcuminoids and Highly anti- LONGA herbaceous perennial plant of the ginger family, Volatile Oils. inflammatory, (Turmeric) Zingiberaceae. It is native in southeast India, and analgesic, and EXTRACT needs temperatures between 20.degree. C. and 30.degree. C. contains (68.degree. F. and 86.degree. F.) and a considerable amount of antioxidant annual rainfall to thrive. properties. DIMETHYL 1.00 3.00 20.00 Methylsulfonylmethane (MSM) is an organosulfur Dimethyl Sulfone Helps deliver SULFONE compound. It is also known by several other names sulfur to the (MSM) including DMSO2, methyl sulfone, and dimethyl body to sulfone. This colorless solid features the sulfonyl maintain functional group and is considered relatively inert connective chemically. It occurs naturally in some primitive tissue structure plants, is present in small amounts in many foods as well as and beverages, and is marketed as a dietary reduce pain supplement. and provide anti- inflammatory effects. EMU OIL 0.01 0.05 20.00 Emu oil is oil derived from adipose tissue Essential Fatty A natural pain harvested from certain subspecies of the emu, acids: Omega-3, relieving, anti- Dromaius novaehollandiae, a flightless bird Omega-6, inflammatory, indigenous to Australia. Unadulterated emu oil can and Omega-9 moisturizing oil vary widely in color and viscosity anywhere from (Oleic acid) with a pH an off-white creamy texture to a thin yellow liquid, balance very depending on the diet of the emu and the refining close to human method(s) used. It is composed of approximately skin. 70% unsaturated fatty acids. GLUCONOLAC 0.30 0.65 1.50 Gluconolactone is often added to formulas Gluconic Acid Moisturizer and TONE because of its skin-conditioning properties. The antioxidant molecules that come together to form activity. gluconolactone are naturally attracted to water. When the ingredient is applied to the skin, these "water hungry" molecules pull moisture out of the air and allow it to be absorbed by the skin. By drawing water droplets from the air in this way, gluconolactone helps to soften and soothe dry skin and replenish lost moisture. In addition, gluconolactone forms a barrier on the skin, preventing moisture already present in the tissue from evaporating. As a result, the substance is often used as an active ingredient in moisturizers, hair conditioners, body lotions and body butters. GLYCERIN 1.00 4.00 8.00 Also called glycerol or glycerine; it is present in all Polyol (Sugar Prevents natural lipids (fats), whether animal or vegetable. Alcohol) dryness or It can be derived from natural substances by scaling. hydrolysis of fats and by fermentation of sugars. It can also be synthetically manufactured. Whether natural or synthetic, glycerin is a humectant and extremely hygroscopic, meaning it readily absorbs water from other sources. GLYCERYL 1.00 5.00 10.00 Glyceryl Stearate and Glyceryl Stearate SE are Glycerin and Acts as a STEREATE SE esterification products of glycerin and stearic acid. stearic acid lubricant on Glyceryl Stearate is a white or cream-colored wax- the skin's like solid. Glyceryl Stearate SE is a "Self- surface and Emulsifying" form of Glyceryl Stearate that also also slows the contains a small amount of sodium and or loss of water potassium stearate. from the skin by forming a barrier on the skin's surface. HARPA- 0.01 0.10 0.80 Harpagophytum, also called grapple plant, wood Harpogoside and Historically, it GOPHYTUM spider and most commonly devil's claw, is a genus Beta-sitosterol has been used PROCUMBENS of plants in the sesame family, native to southern (anti- to treat (Devil's Claw) Africa. It owes its common name Devil's Claw to inflammatory arthritis by ROOT the peculiar appearance of its hooked fruit. The properties). decreasing EXTRACT plant's large tuberous roots are used medicinally inflammation, to reduce pain and fever, and to stimulate swelling and digestion. European colonists brought devil's claw resulting pain. home where it was used to treat arthritis. Harpagophytum procumbens is mainly found in the eastern and south eastern parts of Namibia, Southern Botswana and the Kalahari region of the Northern Cape, South Africa. HELIANTHUS 0.10 0.50 2.00 Sunflower oil is a monounsaturated Palmitic acid Has smoothing ANNUUS (MUFA)/polyunsaturated (PUFA) mixture of mostly (saturated): 5%, properties and (Sunflower) oleic acid (omega-9)-linoleic acid (omega-6) group Stearic acid is considered SEED OIL of oils. Sunflower oil is high in the essential (saturated): 6%, noncomedogenic vitamin E and low in saturated fat. Oleic acid (monounsaturated omega-9): 30%, Linoleic acid (polyunsaturated omega-6): 59% ILEX 0.01 0.10 0.20 Yerba mate is made from the naturally caffeinated 24 vitamins and Yerba Mate is PARA- and nourishing leaves of the celebrated South minerals, 15 amino used as a

GUARIENSIS American rainforest holly tree (Ilex acids, antioxidants, stimulant to (Yerba Mate) paraguariensis). Of the six commonly used plus stimulants - relieve mental LEAF stimulants in the world: coffee, tea, kola nut, caffeine, and physical EXTRACT cocoa and guarana, yerba mate triumphs as the theophylline, tiredness most balanced, delivering both energy and and theobromine (fatigue) and to nutrition. relieve joint pain. MAGNESIUM 1.00 3.00 30.00 Magnesium, as a pharmaceutical preparation, is Magnesium A natural SULFATE used to treat conditions including magnesium sulfate muscle relaxant deficiency and hypomagnesemia, as well as also vital for eclampsia. Usually in lower dosages, magnesium is the normal commonly included in dietary mineral conduction of preparations, including many multivitamin electricity cell- preparations. to-cell. MENTHA 0.03 0.15 3.00 Peppermint (Mentha piperita) also known as M. Menthol, Used for PIPERITA balsamea is a hybrid mint, a cross between menthone, muscle and (Peppermint) watermint and spearmint. The plant, indigenous to menthyl acetate, nerve-related OIL Europe and the Middle East, is now widespread in 1,8-cineole, pains as well as cultivation in many regions of the world. It is found limonene, beta- contributing to wild occasionally with its parent species. pinene and beta- bringing caryophyllene. ingredients through the epidermis layers and into deeper tissues. MENTHOL 1.25 1.25 10.00 Menthol is an organic compound obtained from Menthol FDA active corn mint, peppermint or other mint oils. Menthol ingredient as a has local anesthetic and counterirritant qualities. topical Menthol's ability to chemically trigger the cold- analgesic. It is sensitive TRPM8 receptors in the skin is used to relieve responsible for the well-known cooling sensation it minor aches provokes when inhaled, eaten, or applied to the and pains, such skin. Menthol's analgesic properties are mediated as muscle through a selective activation of x-opioid cramps, receptors. Menthol also blocks voltage-sensitive sprains, sodium channels, reducing neural activity that may headaches and stimulate muscles. similar conditions SCUTELLARIA 0.01 0.02 0.20 Baikal skullcap is a plant. The root is used to make Baicalin Reduce BAICALENSIS medicine. Common substitutions for Baikal inflammation (Baikal skullcap in Chinese medicine include related plants Skullcap) whose scientific names are Scutellaria viscidula, ROOT Scutellaria amonea, and Scutellaria ikoninikovii. EXTRACT Baikal skullcap is used to treat respiratory infections, hay fever, and fever. It is also used for gastrointestinal (GI) infections, as well as liver problems including viralhepatitis and jaundice. SODIUM 0.10 0.30 0.60 Sodium benzoate is the sodium salt of Benzoic Benzoic acid Antifungal BENZOATE Acid. It is used as an antifungal preservative in preservative pharmaceutical preparations and foods. It may also be used as a test for liver function. SORBITAN 0.50 2.00 4.00 Sorbitan Olivate is a natural PEG-free emulsifiers Olive oil by Facilitates the OLIVATE from Olive oil. It reduces skin water loss, have high esterification of its retention of moisturizing effect, hypoallergenic and biomimics fatty acid groups skin moisture the skin. and combined with and increases sorbitol and the active cetearyl alcohol ingredient's resistance to water and/or sweat. STEARIC ACID 1.00 3.00 6.00 Stearic Acid is a saturated long-chain fatty acid Salts and esters Lubrication with an 18-carbon backbone. Stearic acid is found in various animal and plant fats, and is a major component of cocoa butter and shea butter. TOCOPHERYL 0.05 0.10 2.00 Tocopheryl acetate, also known as vitamin E Ester of acetic acid Increases ACETATE acetate, is a common vitamin supplement. It is the and tocopherol energy, (Vitamin E) ester of acetic acid and tocopherol (vitamin E). It is (vitamin E) reduces muscle often used in dermatological products such as skin damage after creams. Tocopheryl acetate is not oxidized and can exercise, and penetrate through the skin to the living cells. improves physical endurance and muscle strength. XANTHAN 0.10 0.50 2.50 Xanthan gum is a polysaccharide secreted by the None Thickening GUM bacterium Xanthomonas campestris, used as a agent and food additive and rheology modifier, commonly stabilizer. used as a food thickening agent and a stabilizer to prevent ingredients from separating. YUCCA 0.01 0.02 0.40 Yucca root comes from the flowering yucca plant Steroid-like It acts an anti- EXTRACT which is a member of the lily family that can grow saponins that inflammatory. to heights of 40 feet or more. elevate the body's production of cortisone.

Example 1

Composition 1

A therapeutic composition is prepared as described above using the following proportions of ingredients: 0.02 wt. % yarrow extract, 5 wt. % aloe vera, 0.1 wt % arnica montana extract, 1 wt. % beeswax, 0.01 wt. % annatto seed extract, 0.1 wt. % boswellia serrate extract, 0.1 wt. % marigold flower extract, 1 wt. % carpylic/capric triglyceride, 2 wt. % cetearyl olivate, 0.01 wt. % cetyl myristoleate, 0.1 wt. % turmeric root extract, 3 wt. % methylsulfonylmethane (MSM), 0.05 wt. % emu oil, 0.65 wt. % gluconolactone, 4 wt. % glycerin, 5 wt. % glyceryl stearate SE, 0.1 wt. % devil's claw root extract, 0.5 wt. % sunflower seed oil, 0.1 wt. % yerba mate leaf extract, 3 wt. % magnesium sulfate, 0.15 wt. % peppermint oil, 1.25 wt. % menthol, 0.02 wt. % skullcap root extract, 0.3 wt. % sodium benzoate, 2 wt. % sorbitan olivate, 3 wt. % steric acid, 0.1 wt. % vitamin E, 0.5 wt. % xanthan gum, 0.02 wt. % yucca root extract and water q.s. The composition is effective to treat localized pain, inflammation and/or swelling when applied topically.

Example 2

Evaluation of Composition 1 in Baseball Pitchers

A controlled clinical study was performed on 4 male baseball players between the ages of 12-15. Subjects were crossed-over between a no treatment study session and a treatment study session. Each study session consisted of pre-session arm pain score assessment prior to any activity to ensure no subject injuries. All pain score readings ranged from 0-9, with 0 meaning no pain to 9 meaning extremely painful. A standard baseball warm up activity was completed, consisting of general throwing and stretching warm-up. Subjects then took a pulse oximetry reading of their index finger followed by a throwing session of 5 warm up pitches (standard 60 ft baseball pitching distance) at approximately 50% power. A series of 15 fastballs were then thrown at the subject's maximum attempted velocity. Speed was captured via a station manager with a standard radar gun. Accuracy (ball or strike) was also recorded by a second station manager. At the completion of the 15 fastball pitches, a pulse oximetry reading was taken. The subject then rested for an approximate 5-10 minute period, following which he repeated the throwing session until 2 full sessions were completed (30 total fastballs recorded).

The entire group of subjects completed the session as described above for both the no treatment group and treatment group. For the treatment group the treatment composition was applied to the throwing arm prior to standard baseball warm up activity. The treatment composition was applied liberally to the arm and shoulder region of the subject's throwing arm and massaged into the area until absorbed (approximately 30 seconds). There were no subject complaints or adverse events from applying the treatment formula through the end of the treatment assessment period.

The treatment group exhibited an overall 0.03 oxygen saturation unit increase in the average pulse oximetry reading as compared to no treatment. This result, although a very small increase, may suggest the formula has a unique ability to improve blood flow over a period of muscle exertion. An improved average pulse oximetry score for the treatment group suggests a comparative reduction in swelling when compared to no treatment as more blood oxygen is found in the extremities. Subject's average full session velocity over the entire study group was increased by 1.2 mph and strike accuracy improved from 43% to 54% in the treatment group versus no treatment. These results suggest that the composition of the invention may exhibit a unique ability to improve flexibility and stamina in subjects, thereby improving throwing velocity and accuracy.

Although not statistically powered to prove treatment formula efficacy, results suggest a positive trend in the efficacy of the treatment composition to aid in the decrease of muscle pain and swelling. Results suggest that the compositions of the invention have a unique ability to aid in reduction of pain and swelling in any situation where these conditions are exhibited.

Example 3

Other Evaluations of the Composition

Case 1 is a 72 year old female with arthritic pain in her shoulder. Subject had complained of intense shoulder pain upon waking due to a documented history of arthritis. Subject was given the treatment composition to apply at bedtime to the affected shoulder region. Each morning after application of the treatment composition, the subject has reported no shoulder pain upon wakening. Without application of the treatment composition, shoulder pain upon wakening has returned.

Case 2 is a 42 year old male with general aches and pains following strenuous exercise. Subject reported severe pain and swelling of the ankle, calf and knee region within 12 hours following strenuous exercise. Subject applied the treatment composition to these regions after strenuous exercise and reported no pain or swelling in these regions through 24 hours post exercise. Subject discontinued use of the treatment composition and has reported resumed pain and swelling to these regions within 12 hours following similar strenuous exercise.

In the description and claims of this specification the word "comprise" and variations of that word, such as "comprises" and "comprising" are not intended to exclude other features, additives, components, integers or steps but rather, unless otherwise stated explicitly, the scope of these words should be construed broadly such that they have an inclusive meaning rather than an exclusive one.

Although the therapeutic compositions of the invention have been described in the present disclosure by way of illustrative examples, it is to be understood that the invention is not limited thereto and that variations can be made as known by those skilled in the art without departing from the teachings of the invention defined by the appended claims.