(19) United States (12) Patent Application Publication (10) Pub

US 20040180101A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0180101 A1 Dreyer (43) Pub. Date: Sep. 16, 2004

(54) HOMEOPATHIC FORMULATIONS USEFUL (57) ABSTRACT FOR TREATING PAIN AND/OR INFLAMMATION One of the objects of the present invention is directed to (76) Inventor: Lee R. Dreyer, White?sh, MT (US) homeopathic formulations (a) comprising tinctures and/or diluted extracts preferably subjected to potentiZation of at Correspondence Address: least 8 or 9 herbs selected from Bellis Perennis, Calendula ARENT FOX KINTNER PLOTKIN & KAHN O?icinalis, Hamamelis Virginiana, Arnica Montana, 1050 CONNECTICUT AVENUE, N.W. Hypericum Perforatum, Aconitum Napellus, Lea'um Palus SUITE 400 Ire, BryoniaAlba and Ruta Graveolens; or (b) consisting of, WASHINGTON, DC 20036 (US) as active ingredients, tinctures and/or diluted extracts sub jected to potentiZation of 5, 6 or 7 herbs selected from Bellis (21) Appl. No.: 10/797,009 Perennis, Calena'ula O?icinalis, Hamamelis Virginiana, Filed: Mar. 11, 2004 Arnica Montana, Hypericum Perforatum, Aconitum Napel (22) lus, Ledum Palustre, Bryonia Alba and Ruta Graveolens. Related US. Application Data The potentiZed homeopathics are in a base, preferably clear gel base. The homeopathic formulations are highly effective (60) Provisional application No. 60/454,308, ?led on Mar. in treating or relieving pain and in?ammation. The present 14, 2003. invention is also directed to a method of treating or relieving pain and in?ammation by administering any of the homeo Publication Classi?cation pathic formulations of the invention to a subject, preferably a subject in need of the treatment or relief. Within the scope (51) Int. C1.7 ...... A61K 35/78 of the invention is a method of making the homeopathic (52) US. Cl...... 424/725; 424/730; 424/764; formulation by mixing the homeopathically prepared herbal 424/769 active ingredients With a base, preferably a clear gel base. US 2004/0180101 A1 Sep. 16, 2004

HOMEOPATHIC FORMULATIONS USEFUL FOR [0009] 6. Some currently available homeopathic products TREATING PAIN AND/OR INFLAMMATION are reported to have limited therapeutic indications (e.g. arnica tincture and 1x potency may produce toxic symptoms [0001] This patent application claims the bene?t of US. With open cuts or ingestion); and some higher potency (i.e. Provisional Patent Application No. 60/454,308, ?led on more serially diluted) homeopathic products do not appear Mar. 14, 2003 by the same inventor, Lee R. Dreyer. to have strong or effective topical analgesic or anti-in?am [0002] The present invention is related to novel homeo matory properties. pathic over-the-counter (OTC) pain-relieving and/or anti [0010] An examination of existing OTC topical pain prod in?ammatory formulations containing (a) 8 or 9 different ucts in most pharmacies reveals, that although there are homeopathic herbal active ingredients described beloW, (b) many brands to choose from, they all basically use various 5, 6 or 7 homeopathic herbal active ingredients described combinations of the same active ingredients, namely: men beloW in addition to Bryonia Alba, or (c) 5, 6 or 7 homeo thol, methyl salicylate, camphor, and trolamine salicylate pathic herbal active ingredients described beloW excluding Which have the draWbacks mentioned above. There is a need Echinacea Augastifolia and Symphytum O?icinale, that can of novel formulations having analgesic and/or anti-in?am relieve external pain and/or in?ammation and that is ame matory properties that can avoid the draWbacks of the prior nable to self diagnosis and treatment. art analgesic products. The homeopathic formulations of the present invention ful?ll such a need. The formulations of the invention are not counterirritants and do not rely upon BACKGROUND OF THE INVENTION massage, heat, stimulation or counterirritation to allay pain. [0003] Currently knoWn OTC analgesic products for topi The formulations also do not require a trained classical cal uses have many problems. There is a need for an OTC homeopath to do caseWork diagnostics (costing signi?cant topical pain relieving product that relieves most external time) to attempt to discover the similimum (remedy most resembling the patient’s symptoms) and then attempt to acute or chronic pain Within a feW minutes, providing relief prescribe correct potency, dosage and duration of action. that lasts up to several hours (for uninterrupted sleep and When any of the formulations of the invention is used, no Work), and Without unpleasant physical and social side drug individualiZation using only one drug ingredient per effects such as strong odors, counterirritation, redness, itch dose for each person as practiced in classical homeopathy is ing, stinging, cooling, sensitiZation, staining, burning, per required. fumes, anesthesia, etc. Ideally such product Would also quickly relieve in?ammation, edema, redness, and sWelling SUMMARY OF THE INVENTION along With pain, thereby increasing pain free range of motion, even in difficult to treat pain cases, Without the [0011] One of the aspects of the invention provides patient needing strong topical and oral OTC or prescription homeopathic formulations having analgesic and/or anti drugs With poWerful undesirable and unpleasant side effects. in?ammatory uses. The homeopathic formulation of the Currently, most OTC topical pain relief counterirritant prod invention comprises ucts may not be used as frequently as needed because of six [0012] (a) the tinctures and/or homeopathic prepara problems listed beloW. tions of at least 8 or 9 herbs selected from Bellis [0004] 1. The currently available OTC topical analgesics Perennis, Calena'ula O?icinalis, Hamamelis Wrgini have limited effectiveness and duration in treating pain. ana, Arnica Montana, Hypericam Perforatam, Aconitum Napellus, Lea'um Palastre, Bryonia Alba [0005] 2. The currently available OTC topical analgesics and Rata Graveolens,‘ may have socially embarrassing odors after application because of the strong scent of menthol, Wintergreen (methyl [0013] (b) the tincture and/or homeopathic prepara salicylate), camphor, or strongly aromatic essential oils, etc. tion of BryoniaAlba and the tinctures and/or homeo pathic preparations of at least 5, 6 or 7 herbs selected [0006] 3. The currently available OTC topical analgesics from Bellis Perennis, Calena'ula O?icinalis, Hama may contain staining or allergenic arti?cial dyes (e. g. blue or melis Virginiana, Arnica Montana, Hypericam Per green) or synthetic perfumes. foratum, Aconitum Napellus, Lea'um Palastre, and Rata Grave‘olens,~ [0007] 4. The oil or fat contents (creams, salves and lotions, etc.) of the currently available OTC topical analge [0014] (c) the tinctures and/or homeopathic prepara sics, or plant pigments or dyes in the currently available tions of at least 5, 6 or 7 herbs selected from Bellis OTC topical analgesics may visibly stain clothing or leave Perennis, Calena'ula O?icinalis, Hamamelis Wrgini greasy spots, or be allergenic and/or sensitiZing to certain ana, Arnica Montana, Hypericam Perforatam, individuals. Aconitum Napellus, Lea'um Palastre, Bryonia Alba and Rata Graveolens, With the proviso that the [0008] 5. The currently available OTC topical analgesics formulation does not contain the tincture(s) and/or may contain substances that are irritating, allergenic, sensi homeopathic preparation(s) of Echinacea Augustifo tiZing, or toxic in excess or high concentrations that should lia and Symphytum O?icinale; or not be applied more than 3 or 4 times daily, or are dangerous if ingested. Such products may contain ingredients that [0015] (d) active ingredients and one or more inactive produce unpleasant or distracting physical sensations (coun ingredients, Wherein the active ingredients consist of terirritants) such as stinging or burning from capsaicin the tinctures and/or homeopathic preparations of 5, 6 (Which may occur for several days), hot or cold sensations or 7 herbs selected from Bellis Perennis, Calendula from menthol or Wintergreen, or the possibility of allergic O?icinalis, Hamamelis Virginiana, Arnica Montana, reaction to salicylate containing aspirin-like products (tro Hypericam Perforatam, Aconitum Napellus, Lea'um lamine salicylate, methyl salicylate). Palastre, Bryonia Alba and Rata Graveolens. US 2004/0180101 A1 Sep. 16, 2004

[0016] In one of the embodiments of the homeopathic ing an anti-in?ammatory amount of a homeopathic formu formulations of the invention, the formulation comprises the lation of the invention to the subject, Wherein the subject is tinctures and/or homeopathic preparations of Bellis Peren an animal. Preferably, the subject is a mammal. More nis, Calena'ula O?icinalis, Hamamelis Virginiana, Arnica preferably, the subject is a human. In the method, the Montana, Hypericam Perforatam, Aconitum Napellus, homeopathic formulation is administered, preferably, topi Lea'um Palastre, Bryonia Alba and Rata Graveolens. In cally. another embodiment of the homeopathic formulations of the invention, the formulation comprises the tinctures and/or DETAILED DESCRIPTION OF THE homeopathic preparations of Bellis Perennis, Calena'ula INVENTION O?icinalis, Hamamelis Virginiana, Arnica Montana, Hypericam Perforatam, Aconitum Napellus, Ledam Palas [0021] In addition to the herbal active ingredients tre, and Rata Graveolens. described above, the homeopathic formulations of the inven [0017] Alternatively, the invention provides a homeo tion optionally further contain one or more physiologically pathic formulation comprising the tinctures and/or homeo acceptable carriers and/or eXcipients. An eXample of the pathic preparations of Bellis Perennis, Hamamelis Wrgini physiologically acceptable carriers and/or eXcipients is puri ana, Arnica Montana, Hypericam Perforatam, Aconitum ?ed, preferably sterile, Water. The homeopathic formulations Napellus, Ledam Palastre, and Rata Graveolens, but eXclud of the invention preferably are made in a clear gel base. ing the tincture(s) and/or homeopathic preparation(s) of Preferably, the clear gel base comprises Water, glycerine Echinacea Augastifolia and Symphytam O?‘tcinale. The (preferably, vegetable glycerine USP), a polyacrylic acid invention also provides a homeopathic formulation compris resin thickener (preferably, CARBOPOL 940), triethanola ing the tinctures and/or homeopathic preparations of Bellis mine and methylparaben. Perennis, Arnica Montana, Hypericam Perforatam, Aconi tam Napellus, Lea'um Palastre, and Rata Graveolens, With [0022] The homeopathic formulations of the invention the proviso that the formulation does not contain the tinc solve the problems described above related to currently ture(s) and/or homeopathic preparation(s) of Echinacea available OTC topical analgesics by effecting very fast pain Augastifolia and Symphytum O?icinale. Within the scope of and/or in?ammation relief, as Well as long duration of relief the invention is a homeopathic formulation comprising the even after discontinuance of usage. Typically only a small tinctures and/or homeopathic preparations of Bellis Peren amount, such as about 5-20 mg of the formulation per square nis, Arnica Montana, Hypericam Perforatam, Aconitum inch of area to be treated (eg 10 mg/square inch), of the Napellus, and Rata Graveolens, but excluding the tinctures formulation is able to effectively treat a painful area, unlike and/or homeopathic preparations of EchinaceaAugastifolia currently available OTC topical analgesics Which require far and Symphytum O?icinale. greater quantities. For most acute and chronic cases, anal [0018] Yet another embodiment of the homeopathic for gesic relief is obtained Within approximately 30 seconds to mulations of the invention consists of the tinctures and/or 2 1/2 minutes after the ?rst topical application, Without homeopathic preparations of Bellis Perennis, Hamamelis massage, of a homeopathic formulation of the invention Virginiana, Arnica Montana, Hypericam Perforatam, Aconi With an average pain-free duration of 8 hours (or longer tam Napellus, Lea'um Palastre, and Rata Graveolens, miXed duration, e.g. days to months, With one to multiple applica With one or more inactive ingredients. Still another embodi tions). The formulations of the invention can also offer pain ment of the homeopathic formulations of the invention relief after discontinuance even in chronic pain cases. The consists of, as active ingredients, the tinctures and/or formulations of the invention can also treat even difficult homeopathic preparations of Bellis Perennis, Arnica Mon pain problems (e.g., Lyme disease pain, migraine headaches, tana, Hypericam Perforatam, Aconitum Napellus, Lea'um etc.) not normally considered topically treatable and also resolve many cases on a long term to permanent basis Palastre, and Rata Graveolens, miXed With one or more inactive ingredients. The invention also provides a homeo Without socially embarrassing odors, redness, stains, greasi pathic formulation consisting of, as active ingredients, the ness; or unpleasant physical sensations such as stinging, tinctures and/or homeopathic preparations of Bellis Peren itching, burning, cooling sensations, irritations, drying of nis, Arnica Montana, Hypericam Perforatam, Aconitum skin, or numbness, found in many, if not most, currently Napellus, and Rata Graveolens, miXed With one or more knoWn OTC topical analgesics or anti-in?ammatory agents. inactive ingredients. The formulations of the invention preferably are made in a gel base. [0019] The homeopathic formulations are useful in treat ing pain and/or in?ammation. Another object of the inven [0023] The homeopathic formulations of the invention are tion is a method of treating pain in a subject, preferably a not counterirritants and thus do not rely upon the principal subject in need of such treatment, Which method comprises of producing a less severe pain to counteract a more intense the step of administering a pain treating effective amount of pain; and consequently these formulations are not required a homeopathic formulation of the invention to the subject, to incorporate menthol, camphor, methyl salicylate, or tro Wherein the subject is an animal. Preferably, the subject is a lamine salicylate. The formulations of the invention can be mammal. More preferably, the subject is a human. In the novel homeopathic topical pain relief products preferably in method, the homeopathic formulation is administered, pref a nearly clear gel base. Each of the formulations of the erably, topically. invention can be legally sold as a homeopathic OTC drug per the requirements of the Food and Drug Administration, [0020] Another object of the invention is a method of or as a homeopathic prescription drug Where loWer potencies treating in?ammation in a subject, preferably a subject in of certain ingredients such as Aconitum as speci?ed in need of the treatment, Which method comprises administer HPUS can only be sold on a prescription basis. US 2004/0180101 A1 Sep. 16, 2004

[0024] Each of the formulations of the invention can be differently in a separate HPUS monograph from an extract applied as a small dab (eg about 100 mg) to the ?ngertip of “Arnica Montana radix,” because the extract of “Arnica and lightly spread across approximately 10 square inches of Montana radix” is prepared from the root of an Arnica skin surface over a painful area or in?ammatory region. Montana plant While the “tincture” and “homeopathic for Massage or pressure is unnecessary for the therapy. The mulation” of Arnica Montana are prepared from the Whole formulations of the invention are dry to touch in a feW Arnica Montana plant. minutes leaving the skin smooth, moist and soft. A feW [0027] The “potencies” given in Tables 1 and 2 beloW are chronic or dif?cult to treat conditions may require a second as de?ned in HPUS. For instance, an active drug at a potency or third application of any of the formulations of the of 1x means that a tincture, preferably as de?ned in HPUS, invention a feW hours apart. There does not appear to be of the active drug is diluted 1 in 10, eg 1 ml of the tincture another OTC topical product in any category that can stop is mixed With 9 ml of a diluent liquid, and then succussed at pain so quickly, and With such long lasting duration; that least 10 times, according to knoWn potentiZation procedures upon application is virtually “socially invisible”, and feels in homeopathy. A potency of 2x means that the active drug pleasant and soothing during application. Furthermore, having a potency of 1x is further diluted 1 in 10 and then those unable to get relief from topical pain relievers often succussed at least 10 times yielding the active drug at 2x resort to oral aspirin and non-steroidal anti-in?ammatory drugs Which dramatically increase the risk of peptic ulcer potency. Apotency of 3x means that the active drug having ation and renal failure When used chronically—and increase a potency of 2x is further diluted 1 in 10 and then succussed the risk of drug interaction. Thus, because of unique topical at least 10 times yielding the active drug at 3x potency. In some of the homeopathic formulations of the invention, the effectiveness, the formulations of the invention may prevent active drugs can be 8 herbs selected from, or all 9 homeo many adverse internal reactions from unnecessary overuse pathic herbs in, the list: Bellis Perennis, Calendala O?ici of non-steroidal anti-in?ammatory drugs. nalis, Hamamelis Virginiana, Arnica Montana, Hypericam [0025] In each of the formulations of the invention, there Perforatam, Aconitam Napellas, Lea'um Palastre, Bryonia is a polypharmaceutical combination of individual herbal Alba and Rata Graveolens. In yet some of the homeopathic active ingredients that are botanically derived. Preferably, formulations, the active drugs can be 5, 6 or 7 herbs selected the herbal active ingredients of the formulations of the from the list: Bellis Perennis, Calena'ula O?icinalis, Hama invention are prepared according to the Homeopathic Phar melis Virginiana, Arnica Montana, Hypericam Perforatam, macopoeia of the United States (HPUS), With accepted Aconitam Napellas, Ledam Palastre, BryoniaAlba and Rata methods of mother tincture preparation, and dilution and Graveolens, With the proviso that the formulations do not succusion to potentiZe such ingredients per HPUS instruc contain the tincture(s) and/or homeopathic preparation(s) of tions and requirements. Each herb of the formulations of the Echinacea Aagastifolia and Symphytam O?icinale. The invention can be succussed 20 to 30 times per dilution. The extracts of these herbs at the potencies disclosed beloW can herbal active ingredients in this formulation can be manu be used as active ingredients Which are mixed (optionally factured by a quali?ed homeopathic manufacturer folloWing one or more other active ingredients, if alloWed by the standard homeopathic industry guidelines, and preparation homeopathic formulation, and/or one or more physiologi of active ingredients per HPUS procedures. The homeo cally acceptable carriers and/or excipients may also be pathic active ingredients can then be combined With a base, added), and then the mixture can be blended With other preferably the unique gel base described beloW. ingredients in a base to form a homeopathic formulation of [0026] In this patent application, the terms “tincture” and the invention. “homeopathic preparation” of an herb refer to extracts of a [0028] Potency and Dosage Variations of the Homeo part, combinations of parts and/or the entirety of the herb, pathic Formulations: With the exception that the “tincture” and “homeopathic preparation” of Arnica Montana refer to extracts of the [0029] In the homeopathic formulations of the invention, Whole Arnica Montana plant. The “tincture” can be prepared each of the herbal active ingredients can exist in the form of by exposing a part, parts and/or the entirety of the herb in a a tincture or diluted tincture preferably subjected to poten solvent, e.g. alcohol and/or Water. The “tincture” of an herb tiZation based on procedures knoWn in homeopathy, Wherein preferably is a mother tincture of the herb prepared accord the tincture is preferably as de?ned in HPUS for the par ing to the procedures in HPUS. The “homeopathic prepa ticular herb. Examples of potency variations of the herbal ration” can be prepared by dilution of the “tincture” With an active ingredients in the homeopathic formulations of the appropriate liquid such as Water or alcohol. The “homeo invention that can be used are shoWn in Table 1 beloW. In pathic preparation” of an herb for the formulation of the other Words, if one of the herbal active ingredients in Table invention is preferably prepared per HPUS procedures, 1 is selected to be included in a homeopathic formulation of Wherein the mother tincture of the herb is serially diluted and the invention, the extract of the particular herbal active subjected to succussion according to the target potency ingredient at a potency that falls Within the potency range using potentiZation procedures knoWn in the art of home listed in Table 1 for the particular homeopathic herbal active opathy. Also, herbal or unof?cial preparations of the herbs ingredient may be used to make the homeopathic formula may be used. For example, non-homeopathically prepared tion for the corresponding use, either external or internal. tinctures, or dilution or infusions, or Water or alcohol The potencies in Table 1 are presented as decimal potencies, extracts, or poWdered plasters, decoctions, poultices, etc., or Which are preferred topically over centesimal, M or Q any other methods of herbal preparations, or Whole herbs potencies because decimal potencies offer more potency Whether unpotentiZed or undiluted or not can be used as the gradations than centesimal, M, or Q potencies, especially at herbal active ingredients in the formulations of the inven loWer potencies. Decimal potencies also generally receive tion. As used herein, as per HPUS, the “tincture” and tWice as many energiZing successions as centesimal poten “homeopathic preparation” of Arnica Montana is de?ned cies of the same total dilution US 2004/0180101 A1 Sep. 16, 2004

ethanol alcohol tincture, although more or less alcohol or TABLE 1* water will not affect the analgesic effectiveness of the ?nished homeopathic formulation. The active ingredient Potencies of Active Ingredients mixture is then put in a base, preferably a clear gel base. External Use Internal Use Preferably, isopropyl alcohol or propylparaben should not be Active Ingredients Potency Range Potency Range used in the homeopathic formulations of the invention. Bellis Perennis Tinct.**—400 X 1 X—400 X Calendula O?icinalis Tinct.—400 X 1 X—400 X [0033] If a clear gel base is used in some of the embodi Hamamelis Virginiana Tinct.—400 X 1 X—400 X ments of the homeopathic formulations, the clear gel base Arnica Montana Tinct.—400 X 3 X*—400 X may contain 1-99%, e.g. 8-10% or 50-99%, active ingredi Hypericum Perforatum Tinct.—400 X 3 X*—400 X Aconitum Napellus 3 X—400 X 3 X*—400 X ents by weight. However, other bases described may also be Ledum Palustre Tinct.—400 X 1 X—400 X substituted for the gel base, and other gel bases can also Bryonia Alba Tinct.—400 X 3 X*—400 X carry the active ingredients (see “Other Topical Delivery Ruta Graveolens Tinct.—400 X 3 X*—400 X Systems”), but without the same “social invisibility” emol *Note: lient and soothing properties of the preferred gel base. 1X or 2X may also be used if the formulation of the invention is used as a prescription drug. However, care must be taken to prevent toxicity by [0034] These embodiments of the homeopathic formula correct dosing and/or avoiding allergic reaction, when formulating and tions of the invention can be prepared by blending 1-99%, prescribing. HPUS should be consulted. **“Tinct.” means mother tincture as per HPUS. e.g. 1-50%, of the active ingredients into 99-1%, e.g. Decimal (X) potencies above may also be converted to centesimal poten 99-50%, clear gel base. The percentages may vary from cies (e.g., 4OOX = 200 C). Potencies higher than 4OOX (200 C), e.g. 1M, these numbers if bases (e.g. liniment) other than a clear gel 10M or 50M, can also be used in the homeopathic formulations of the invention — either topically or internally. However, higher potencies will be base are used. Preferably, violent agitation or high-speed more useful internally. blending should be avoided in order to prevent changing potencies of homeopathics. Also, any exposure to direct [0030] In the homeopathic formulations of the invention sunlight, higher temperatures, volatile organic compounds, having the herbal active ingredients at potencies falling with x-rays, and electromagnetic ?elds should be avoided while the potency ranges listed in Table 1, each of the herbal active processing, storing and shipping in order to prevent theo ingredients can be present in amounts expressed as percent retical change or neutralization in potencies. All other appro age by weight of the ?nished homeopathic formulation that priate delivery forms as mentioned in the HPUS, both vary from about 0.1% to about 50%, preferably about 0.2% internal and external, can be used to carry the active ingre to about 20%, more preferably about 0.3% to about 10%, dients of the homeopathic formulation of the invention. and even more preferably about 0.4% to about 8%, of the Preferably, the homeopathic formulations are put in plastic, total weight of the formulations. For instance, if Bellis glass or other containers following HPUS, GMP’s and all Perennis is used at a potency of 1x, the homeopathic OTC regulations. formulation can contain about 0.1% to about 50% by weight of the 1x Bellis Perennis. [0035] Each of the homeopathic formulations of the inven tion can be administered in standard homeopathic forms and [0031] In some of the homeopathic formulations of the dosages as determined by an individual seeking pain treat invention, the amounts of the herbal active ingredients can ment who is knowledgeable about homeopathy or by a vary from 1% to 10% of drug tincture for external use in gel homeopathic practitioner. For external uses, the homeo or other base. Higher percentages of tincture may be used up pathic formulation of the invention can be applied topically to about 50% before gels degrade. Equal amounts of the as needed, e.g. 1 to 6, preferably 1 to 4, times a day or every various homeopathic herbal active ingredients may be used, 30 minutes at the start of an injury for the ?rst 2 hours. For or some homeopathic herbal active ingredients may be instance, with each topical application, the homeopathic supplied in multiple potencies. There is no advantage in formulation can be applied in an amount suf?cient to cover varying the weight of each active ingredient within reason the skin of a painful area to be treated. For internal uses, the because homeopathic drugs operate on an energetic level, amount of the homeopathic formulation to be administered and are generally not dose dependent (except as internal LM can be 2 to 4 pilules or tablets a day in weight standardized potencies). Thus, twice as much of the effective resonant by a homeopathic pharmacy, e.g. according to homeopathic dose will not have twice a greater effect than the correct pharmaceutical necessities. With internal administration, the minimal dosage, as a basic concept in homeopathy is the use of the formulation should be discontinued once pain ef?cacy of minimal dosing. According to the Avogadro’s and/or in?ammation has stopped, according to classical number, beyond 12C (24x) not one molecule of the original homeopathic principles. substance can be found in a formulation. Higher potencies than 200C (400x) can also be used. However, such potencies [0036] One of the Preferred Formulations of the Invention: will have less local physiological effect and more of a psychological or systemic symptom effect and will be more [0037] Each 2 OZ or 56.7 g of this preferred formulation useful internally. Multiple potencies of the same drug may contains 4.536 ml of an active ingredient mixture and 52.16 g of a clear gel base, wherein the active ingredient mixture also be used, e.g. Arnica 3x, 6x and 12x, etc., for a potency chord. contains 1.81 g. ethanol. The components of the active ingredient mixture used to make the preferred homeopathic [0032] The homeopathic herbal active ingredients in the formulation are presented in Table 2, while the components form of tinctures or diluted tinctures subjected to potenti of two alternative clear gel bases that could be used to make Zation are combined to form an active ingredient mixture. the preferred homeopathic formulation are presented in The active ingredient mixture can be supplied as 40% Table 3. US 2004/0180101 A1 Sep. 16, 2004

[0040] Variations of the Formula: TABLE 2 [0041] There are many possible variations of the preferred formulation of the invention that will also have good anal Active Ingredient Mixture" gesic therapeutic properties, but have lesser ef?cacy and/or HPUS Active Ingredients Potency** % by Weight*** utility for reasons including: (1) Potential toxicity and/or allergic reaction when using lower potency (less diluted Bellis Perennis 1X 0.8889 tincture and IX) of Arnica, and/or Ruta, and/or Aconitum; Calendula O?icinalis 1X 0.8889 Hamamelis Virginiana 2X 0.8889 and (2) lesser topical analgesic strength if just used in higher Arnica Montana 3X 0.4445 potencies such as 12>< and higher. Although most homeo Arnica Montana 6X 0.4445 pathic philosophical literature indicates that the higher dilu Hypericum Perforatum 2X 0.8889 tions and potentiZations are more powerful when used Aconitum Napellus 3X 0.8889 “internally”, the literature does not describe higher potency Ledurn Palustre 3X 0.8889 as being more powerful topically. However, the effective Bryonia Alba 6X 0.4445 Bryonia Alba 12X 0.4445 ness of the preferred homeopathic formulation of the inven Ruta Graveolens 3X 0.8889 tion demonstrates that the lowest decimal potencies (1x, 2x, 3x) are more effective as an external topical analgesic when Total 8.000% combined with slightly higher low potencies (6x, 12><) as the right combination of drugs with correct analgesic properties. *The active ingredient mixture is supplied as 40% ethanol alcohol tincture. **The potency is as de?ned in HPUS. [0042] The homeopathic formulations of the invention can ***The per cent by weight is based on the total weight of the homeo be varied in terms of the potency and dosage, or in terms of pathic formulation of the invention. For instance, the ?nished homeopathic the ingredients. All requirements for manufacturing the formulation contains 0.8889% by weight of a Bellis Perennis extract at a other embodiments of the homeopathic formulations of the potency of 1X prepared as per HPUS. invention are the same as described for the preferred for mulation. [0038] [0043] Herbal Active Ingredient Variations of the Homeo pathic Formulations: TABLE 3 [0044] The preferred homeopathic formulation of the Clear Gel Base invention comprises 9 different herbal active ingredients in 11 different potency variations (see Table 2). Some of the Alternative 1 Alternative 2 formulations of the invention can also be made by not using Ingredients" % by Weight** % by Weight** one of the 9 herbal active ingredients (eg see Variation #1 Puri?ed Water 89.71% 89.85% in Table 4 below). As one or some of the 9 herbal active Vegetable Glycerine (USP) 0.92% 0.92% ingredients is excluded from the formulations, the formula Carbopol 940 0.60% 0.60% tions still have powerful pain relieving and anti-in?amma Triethanolarnine (Trolamine) 0.40% 0.40% tory properties. The homeopathic formulation of the inven Methylparaben (NF) 0.37% 0.23% tion can comprise 7 herbal active ingredients (eg see Total 92.00% 92.00% Variation #2, Table 4), 6 herbal active ingredients (eg see Variation #3, Table 4) or 5 herbal active ingredients (e. g. see *Preferably, no other ingredients are used in the clear gel base. Variation #4, Table 4), with the proviso that the formulation **The percent by weight is based on the total weight of the homeopathic does not contain any other active ingredient or the formu formulation of the invention. lation does not contain the tincture(s) and/or homeopathic preparation(s) of Echinacea Augustifolia and Symphytum [0039] This embodiment of the preferred formulation can O?icinale. However, each omission of an herbal active be made by gently blending 8% of the active ingredient ingredient from the list of 9 slightly lessens the total product mixture into 92% of the clear gel base. More preferably, effectiveness. The potency and dosage ranges for both precaution should be taken to avoid violent agitation or external and internal uses as well as the ranges of the amounts of the active ingredients in terms of percent by high-speed blending in order to avoid changing the poten weight (based on the total weight of the homeopathic cies of the active ingredients, and also to avoid exposure to formulation) described above in the “Potency and Dosage direct sunshine, high temperatures, volatile organic com Variations of the Homeopathic Formulation” subsection can pounds, x-rays, and electromagnetic ?elds while processing also apply to the embodiments of the homeopathic formu and storing in order to prevent a theoretical change or lations having herbal active ingredient variations described neutralization of potency. Optionally, the formulation can be herein (Table 4). The homeopathic formulations containing stored in a suitable plastic or glass container following Good the herbal active ingredient variations shown in Table 4 are Manufacturing Practices and all OTC regulations. all effective in treating pain and/or in?ammation.

TABLE 4

Examples of Variation of Active Ingredients

VARIATION #1 VARIATION #2 VARIATION #3 VARIATION #4

Bellis Perennis Bellis Perennis Bellis Perennis Bellis Perennis Calendula O?icinalis Hamamelis Virginiana Arnica Montana Arnica Montana Hamamelis Virginiana Arnica Montana Hypericum Perforatum Hypericum Perforatum Arnica Montana Hypericum Perforatum Aconitum Napellus Aconitum Napellus US 2004/0180101 A1 Sep. 16, 2004

TABLE 4-continued

E amnles of Variation of Active Ingredients

VARIATION #1 VARIATION #2 VARIATION #3 VARIATION #4

Hypericum Perforatum Aconitum Napellus Ledum Palustre Ruta Graveolens Aconitum Napellus Ledum Palustre Ruta Graveolens Ledum Palustre Ruta Graveolens Ruta Graveolens

[0045] The above variations of herbal active ingredients [0052] The homeopathic formulations of the invention are may be used in any potency or dosage or percentage also effective in treating pain and/or in?ammation when described in the subsection of “Potency and Dosage Varia administered parenterally, such as intravenously, or with any tions of the Homeopathic Formulations” (eg see Table 1 for other method of homeopathic and/or herbal and/or allopathic the potency examples). However, the potencies described in drug administration, such as intramuscular injections. Fur the preferred formulation are most effective (see Table 2). thermore, each of the homeopathic formulations of the invention can also be administered in suppository form (anal [0046] Drug Delivery Methods: or vaginal) where the ingredients can be actively and quickly [0047] Gels are the preferred vehicles of dispensing the absorbed, and would have a strong systemic effect on pain. homeopathic formulations of the invention. Gels are more However, in?uence on local pain will be less pronounced accurately called jellies because they are compounds of and focused than local topical application of the homeo water soluble ingredients, usually clear, of a uniform semi pathic formulation, especially if the homeopathic formula solid consistency. Gels maintain a uniformity that is useful tion is made in a gel base. The formulation could also be in keeping active ingredients in the homeopathic formula taken nasally, or as eyedrops, or eardrops for pain and tions evenly dispersed in their aqueous base. Brownian in?ammation. It would, of course, have to be prepared in motion builds up networks in gels and restores their shape appropriate potency, and carried in a safe and effective base when they have been ruptured by stresses (e.g. settling or as, for example, described in OTC and HPUS literature. shaking). The longer the dosage contacts the skin (i.e. nerve [0053] Human Test Results: endings), the longer the duration of action. As the preferred formulation of the invention is in a gel base that soothes and [0054] A homeopathic formulation containing the herbal smoothes the skin without socially objectionable odor, one active ingredients of Table 2 in a clear gel base of Table 3 is less likely to want to wash away the homeopathic formu was administered to at least 47 human adult subjects having lation from the skin. pain or pain associated with in?ammation to test the effec tiveness of the formulation in treating pain and/or in?am [0048] Other Topical Delivery Systems: mation. In the majority of the subjects, testing was con [0049] In addition to the preferred gel base, various other ducted under physician supervision (see Table 5), while gel base formulations can carry the active ingredients in the testing was done in the remaining 12 subjects not under homeopathic formulations of the invention with varying physician supervision (see Table 6). The formulation was degrees of success. However, the use of glycerine and applied topically to the affected area of the body. For calendula (1x) and other homeopathics in a water gel base headaches, the formulation was applied to the cervical area of the preferred formulation is very emollient, non-drying, and painful areas of the head. Except for 2 subjects, the and soothing to the skin. Other carrier bases may also be formulation was found to be highly effective in treating pain used to deliver the active ingredients topically such as: and/or in?ammation (see Tables 5 and 6). water, alcohol, water/alcohol, cream ointment, salves, [0055] Extremely rapid pain relief, within approximately lotion, liniment, tinctures, cream gel, lotion ointment, rub, 30 seconds to 21/2 minutes of an initial application, was spray, aerosol, lotion spray, balm rub, gel ointment, lotion detected in most test cases of either acute or chronic pain. cream, poultice, plaster, infusion, decoction and other herbal After the extremely rapid onset of pain relief, the degree of methods of preparation. However, the gel delivery system pain relief would keep increasing up to a maximum after does work best. about 10-40 minutes, depending on test subjects. Typically [0050] Internal Use of the Homeopathic Formulations: the ?rst application would relieve most pain. In some of the test subjects having di?icult-to-treat pain, total pain relief [0051] Any of the homeopathic formulations of the inven was achieved at 10 to 15 minutes. The formulation of the tion will also have similar pain relieving and/or anti-in?am invention worked with a rapidity not previously described in matory properties when taken internally, but the speci?c the topical homeopathic, allopathic or OTC literature. The local analgesic and/or anti-in?ammatory action will not be formulation was effective on both pain, e.g. arthritic pain or as pronounced. The active ingredients of the homeopathic muscle sprains, traditionally treated by OTC analgesics, as formulations may be used with any of the standard delivery well as di?icult-to-treat non-typical pain, e.g. pain associ systems used in oral homeopathy in any acceptable combi ated with Lyme disease, previously not described in the nation such as: tablets, drops, pills, sugar pills, water, literature for the individual herbal active ingredients in the glycerin, milk sugar and cane sugar vehicles, alcohol, medi formulation tested. cated powders, medicated globules (pellets, pilules), cones, etc. The delivery system is relatively unimportant. However, [0056] One application of the formulation of the invention liquid systems will retain more volatile essences found in the in most cases would yield about 4-16 hours of pain relief low potency botanical tincture starting materials, and will with an average of about 8 hours, enabling subject to get an contact more nerve endings in the mucosa. extended period of uninterrupted rest and sleep. Thus, the US 2004/0180101 A1 Sep. 16, 2004

homeopathic formulations of the invention are also effective ance of the application of the formulation, even Where pain in treating insomnia secondary to pain. This relief duration Was of months or years duration before the formulation Was far exceeds the relief times of other OTC topical allopathic used. Such a result had not been knoWn to be achievable analgesics, as Well as available homeopathic OTC topical With other topical agents in either OTC or prescription and oral products. Clinical testing shoWed many cases of status. OTC topical analgesics (both homeopathic and allo total or permanent local pain and in?ammation relief after pathic) typically only offer very limited short term tempo ?rst application, With pain intensity scores dropping from 10 rary relief. Often the sensitiZing, e.g. menthol, or irritating, (the Worst pain) to 5 or much less, and moving toWard total e.g. capsaicin, or allergenic, e.g. salicylate, nature of many pain resolution in many cases. Other subjects With pain not OTC drugs prevent their long term usage because the side regarded as normally treatable by topical analgesics effects of the drug Will Warrant their discontinuance. In obtained signi?cant long duration of pain relief With 1 or 2 contrast, multiple applications of the homeopathic formula tion of the invention over a long period, eg about 6 months or more applications of the formulation. to a year, are Well accepted by the users With no apparent [0057] Effective broad spectrum relief, including dif?cult side effects. Multiple cases of localiZed “permanent” reso to-treat cases, Was achieved With the formulation. The lution, or vast improvement lasting several months, Were formulation Was found to be effective in treating pain and observed With the formulation of the invention. in?ammation from Lyme disease, hematomas, degenerative [0059] Treatments With the formulation of the invention joint disease, migraine headache, insect bites, carpal tunnel also resulted in rapid anti-in?ammatory effects. Typically, syndrome, facial neuralgia, vagal nerve irritation, neuritis anti-in?ammatory effects Would start in approximately 30 from radiation burn, menstrual cramps, stomach pain from seconds to 30 minutes after a topical application of the in?uenza, etc. The formulation Was also found extremely formulation of the invention depending on the cause. When effective against pain, such as rheumatism, arthritis, stiff using the formulation, many test subjects had range of ness; head, neck and back injury; sprains, strains, etc., motion restored in restricted joints. The formulation helped customarily treated not very effectively With some prior art various cases of in?ammation, sWelling, redness, and edema topical analgesics. Many cases of acute and chronic pain, of various causes. Cases of successfully treated in?amma in?ammations, edema, bruises and injuries Were totally tion included rheumatoid arthritic knees, Lyme arthritis pain, resolved or signi?cantly relieved faster and better than any sWollen knee, sprains, stiffness, blisters, tendonitis, insect other topical therapy knoWn. bites (e.g. hornet bite), headaches associated With vagal [0058] The pain relief achieved With the formulation of the nerve irritation, facial neuralgia, and neuritis from radiation invention Was long lasting in most cases. Pain relief Was burn. obtained even after discontinuance of the application of the [0060] The formulations of the invention have additional formulation. Clinical testing shoWed many cases With a advantages over currently available OTC drugs. The formu permanent resolution for both acute and long term chronic lations do not have strong odors or irritating effects as some pain conditions. The formulation Was found to be effective of the OTC drugs, making the formulations more acceptable in several subjects having chronic pain of many years to users. Furthermore, currently available OTC drugs tend to duration or had tried various kinds of medical therapies lose their effectiveness upon repeated administrations. In Without signi?cant relief. For instance, in one case of 8 years contrast, the formulations of the invention do not exhibit any right shoulder pain from Lyme disease, “permanent” relief refractory period upon repeated administrations. The Within 3 minutes of ?rst topical application of the formula absence of reduced effectiveness upon repeated administra tion of the invention Was obtained. Several test subjects tions makes the formulations especially effective in long achieved complete pain relief for months after discontinu term therapies of pain and/or in?ammation.

TABLE 5

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PHYSICIAN SUPERVISION FOR PREVIOUSLY PHYSICIAN DIAGNOSED SYMPTOMS

Pain Duration of Duration Pain Relief Total Subjective Before Pain Relief After After Number of Outcome After Test Symptom Pain Product Product Product Product Discontinuance Subject3 Description Intensityb Application Application Application0 Applications(1 of Product Use

M/52 Left elboW pain 5 2 Hours Within <60 “Perm.” 1 Pain free (post trauma) seconds; complete relief in 5 min. F/53 Migraine 7 1 Hour Within approx. 3 min.; “Perm.” 1 Pain free headache complete relief & restful sleep F/72 Left knee severe 9 1 Year Within approx. 2 min.; “Perm.” 1 Pain free pain (Lyme complete disease) relief M/4O Right shoulder 6 6 Weeks Within <1 min.; 8 Hours 1 Pain returned pain complete relief gradually F/38 Fibromyalgia 5 3 Years Within <5 min.; 8 Hours 1 Pain returned moderate relief gradually F/55 Fibromyalgia 7 10 Years No relief N/A At least 1 N/A M/61 Right hand pain 6 2 Years Within <2 min.; “Perm.” 1 Pain free (Lyme disease) moderate relief US 2004/0180101 A1 Sep. 16, 2004

TABLE 5 -continued

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PHYSICIAN SUPERVISION FOR PREVIOUSLY PHYSICIAN DIAGNOSED SYMPTOMS

F/28 Right foot insect 6 1 Day Within <30 “Perm.” 1 Pain free bite seconds; total relief F/66 Neck pain 5 5 Years Within <2 24 Hours 1 50% Pain relief (degenerative minutes; joint disease) moderate relief M/61 Right knee pain 7 2 Years Within <5 24 Hours 1 Loved product. (Lyme disease) minutes; near Pain returned complete relief gradually F/23 Left flank pain 8 1 Year Within <5 10 Hours 1 Moderate, long (?bromyalgia) minutes; near term pain relief complete relief M/66 Right Shoulder 6 8 Years Within <3 “Perm.” 1 Pain free pain (Lyme minutes; disease) complete relief F/49 Right carpal 6-7 6 Month Within <5 8-10 Hours 7 Good tunnel syndrome minutes; improvement moderate relief F/48 Rheumatoid 7-8 1 Year Within <5 8-10 Hours. 1 Pain returned arthritis minutes; near gradually complete relief M/60 Legs (babesiosis) 4-5 1 Year No relief N/A At least 1 N/A F/27 Neck/shoulder 6-7 2 Months Within <1 24 Hours 1 Pain returned pain (Lyme minute; excellent gradually disease) relief F/46 Right knee pain 7-8 2 Months Within <60 “Perm.” 1 Pain free (Lyme disease) seconds; excellent relief M/31 Left Wrist sprain 6-7 1 Week Within <60 24 Hours 1 Moderate long seconds; excellent term pain relief relief F/60 Left elboW pain 7-8 6 Years Within <3 24 Hours 1 “Took the edge (Lyme disease) minutes; of’ moderate relief F/81 Right hip 8-9 3 Years Within <2 24 Hours 1 Pain returned (babesiosis) minutes; 75% gradually relief M/51 Pain in both 6-7 1 Year Within <2 12 Hours 1 Pain returned knees (degen. minutes; gradually joint disease) moderate relief F/36 Left ankle sprain 7-8 2 Weeks Within <1 8 Hours 1 Pain returned minute; 90% gradually better F Facial neuralgia 1 Multiple 50% Improved 2 Weeks One each on 2 — episodes office visits F Cervical spine 5 Intermittent 50% Relief at 10 — 1 Increased range pain minutes of motion M Vertex headache 5 Constant 15% Improved in — At least 1 — (vagal nerve 15 minutes irritation) Same Vertex headache 5 Constant 45% Improved — At least 1 — subject as (vagal nerve over a Week above irritation) F Pain in right 10 Constant 20% Relief in 3 — 1 — upper extremity minutes; 25% rhomboids & relief in 4 minutes trapeZius bilateral, left scapula F/31 Chronic migraine 9 1 Day 50% Relief in 20 min. — 2 — headache With 1 application; 80% relief in 30 mins. with 2M application Same One recurrence 5 — 100% Relief in 10 mins. — 1 — subject as of headache above US 2004/0180101 A1 Sep. 16, 2004

TABLE 5 -continued

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PHYSICIAN SUPERVISION FOR PREVIOUSLY PHYSICIAN DIAGNOSED SYMPTOMS

M Muscle 10 Constant After 8 days — Multiple Right ?ank pain strain/sprain in muscle strain intermittent right ?ank lessened by 75% quadriceps; at right ?ank; tendonitis in right pain lessened by knee 50% in right knee Same Stiffness and 5 Intermittent 10% Relief in 15 — Multiple Continued to subject as pain in minutes use product above quadriceps; tendonitis; clicking right knee M Right loWer rib 10 10 Days 50% Relief in 10 — 2 — cage, minutes; 60% 1. Intercostal relief neuritis With 2”“ 2”‘ radiation burn application F/52 Acute right ankle 10 Acute injury Relief started 1 Hour 1 — sprain/strain; Within 5 minutes; right forearm 40% relief after bruise & 35 minutes hematoma; left upper arm bruise & hermatoma Same — 1 — Bilateral upper 3 Weeks Multiple, at Minimal pain & subject as extremities least tWice discomfort above pain 95% daily resolved; edema 90% resolved F/72 Pain in left Moderate to 4 Months 40% Improved — 1 — trapeZius, left severe after about 10-20 teres minor, minutes left supra & infraspinatus muscles F/74 Shooting pain in 10 2 Days 50% Improved — 1 — right Wrist With after 10 minutes muscles Weakness, unable to lift objects F/95V2 Bilateral knee 5—10 4 Days 45% Improved — At least 1 — pain after 10-20 minutes M Supraspinatus 10 at start Persistent 10% Relief in 8 — 23 Continued to tendonitis right for 2-3 minutes; pain use product shoulder, right months dropped to ?eXor & eXtensor intensity level 4 muscles after 23 applications M Muscle spasms 5 — 50% Reduction in — 2 — bilateral loWer pain extremities pitting edema

3M = male, F = female/years of age if knoWn. bPain intensity scale from 1 to 10: 1 = barely noticeable, 5 = moderate, 10 = unbearable. C“Perm” stands for permanent pain relief at time of study. dWhere physicians did not specify the total number of applications, “at least 1” Was implied. US 2004/0180101 A1 Sep. 16, 2004 10

[0061]

TABLE 6

RESULTS OF TESTS DONE BY INDIVIDUALS FOR TREATMENT OF SYMPTOMS

F/36 Insomnia caused by 8 3 Hours, 100% Relief from 8 Hours of 8 Pain much neck & shoulder nightly insomnia each relief from reduced; rarely stiffness from stress night insomnia and had to be treated pain daily; one treatment per Week noW su?ices F/55 Head & neck pain 10 Hours 100% Relief in Days 6 Continued to use about 4 minutes as needed F/55 Insomnia from 8 2-3 Hours 100% Relief from Daily 20 Continued to use shoulder n b& neck insomnia in about as needed pain With lumps 20 minutes M/54 Blisters on hands 5 2 Hours 90% Relief 8 Hours 3 No pain on 2nd from friction day; complete healing F/68 Back injury, 6 10 Years 90% Relief 4 Days 8 Great Whiplash improvement; some pain remained F/59 Stomach pain/flu Moderate to Constant 90% Relief in 4-8 Hours 6 Stomach flu High about 1 minute pain stopped F/87 Chronic back pain High Constant — 6—8 Hours Multiple 85% Relief after 6 months F/58 Migraine headache, Severe 3 Days 100% Relief in Constant About 50 Symptom free in temporomandibular about 5 minutes 6 months joint syndrome F/77 SWollen knee With High Constant 95% Relief in 4-6 Hours 50 Highly knots about 15 minutes improved M/5 6 Right broken leg High 2 Weeks 80% Relief in 2-4 Hours About 120 Walking 2 about 15 minutes Weeks earlier than doctor’s prognosis, speeded healing time in half M/59 Hornet bite, neck Sharp A feW Pain stopped in a “Perm.” 2 or 3 No recurrence of shooting minutes feW seconds pain; no in?ammation Same Rheumatoid 5—6 Every day Pain stopped by Up to 4 hrs Multiple Can go days subject arthritic knee, for 3 years about 90%; Without treating as above sWelled every day, sWelling reduced uncomfortable to by 90% Walk F/53 Stomach cramps 5 10 Minutes 100% Relief in 5 “Perm.” 1 No further (menstrual) minutes cramping during rest of cycle aMale = male, F = female/years of age if knoWn. bPain intensity scale from 1 to 10: 1 = barely noticeable, 5 = moderate, 10 = unbearable. C“Perm.” stands for permanent pain relief at time of study.

1. A formulation comprising herbal active ingredients, O?icinalis, Hamamelis Virginiana, Arnica Montana, Wherein the herbal active ingredients comprise Hypericum Perforatum, Aconitum Napellus, Lea'um Palustre, and Ruta Graveolens; or (a) tinctures and/or homeopathic preparations of 8 or all of Bellis Perennis, Calendula O?icinalis, Hamamelis (c) tinctures and/or homeopathic preparations of at least 5, Virginiana, Arnica Montana, Hypericum Perforatum, 6 or 7 of Bellis Perennis, Calena'ula O?icinalis, Hama Aconitum Napellus, Lea'um Palustre, BryoniaAlba and melis Virginiana, Amica Montana, Hypericum Perfo Ruta Grave‘olens,~ ratum, Aconitum Napellus, Ledum Palustre, Bryonia Alba and Ruta Graveolens, With the proviso that the (b) tincture and/or homeopathic preparation of Bryonia formulation of (c) does not contain tincture(s) and/or Alba and the tinctures and/or homeopathic preparations homeopathic preparation(s) of Echinacea Augustifolia of at least 5, 6 or 7 of Bellis Perennis, Calena'ula and Symphytum O?icinale. US 2004/0180101 A1 Sep. 16, 2004

2. The formulation of claim 1, the herbal active ingredi Ledum Palustre at a potency ranging from 1><-400><, Bryonia ents comprising tinctures and/or homeopathic preparations Alba at a potency ranging from 3><-400>< and Rata Graveo of 8 or all of Bellis Perennis, Calena'ula O?icinalis, Hama lens at a potency ranging from 3><-400><. melis Virginiana, Arnica Montana, Hypericum Perforatam, 9. The formulation of claim 6, the herbal active ingredi Aconitum Napellus, Lea'um Palastre, Bryonia Alba and Rata ents comprising tinctures and/or homeopathic preparations Graveolens. of Bellis Perennis at a potency of 1x, Calena'ula O?icinalis 3. The formulation of claim 2, the herbal active ingredi at a potency of 1x, Hamamelis Virginiana at a potency of 2x, ents comprising tinctures and/or homeopathic preparations Arnica Montana at potencies of 3x and 6x, Hypericum of 8 or all of Bellis Perennis at a potency ranging from Perforatum at a potency of 2x, Aconitum Napellas at a tincture-400x, Calena'ula O?icinalis at a potency ranging potency of 3x, Lea'um Palustre at a potency of 3x, Bryonia from tincture-400x, Hamamelis Virginiana at a potency Alba at potencies of 6x and 12x and Ruta Graveolens at a ranging from tincture-400x, Arnica Montana at a potency potency of 3x. ranging from tincture-400x, Hypericum Perforatum at a 10. The formulation of claim 1, the herbal active ingre potency ranging from tincture-400x, Aconitum Napellus at a dients comprising tinctures and/or homeopathic preparations potency ranging from 3><-400><, Lea'um Palustre at a potency of at least 5, 6 or 7 of Bellis Perennis, Calendula O?icinalis, ranging from tincture-400x, Bryonia Alba at a potency Hamamelis Virginiana, Arnica Montana, Hypericum Perfo ranging from tincture-400x and Ruta Graveolens at a ratum, Aconitam Napellus, Lea'um Palastre, Bryonia Alba potency ranging from tincture-400x. and Ruta Graveolens, With the proviso that the formulation 4. The formulation of claim 2, the herbal active ingredi does not contain tincture(s) and/or homeopathic prepara ents comprising tinctures and/or homeopathic preparations tion(s) of EchinaceaAagustzfolia and Symphytum O?icinale. of 8 or all of Bellis Perennis at a potency ranging from 11. The formulation of claim 10, the herbal active ingre 1><-400><, Calena'ula O?icinalis at a potency ranging from dients comprising tinctures and/or homeopathic preparations 1><-400><, Hamamelis Virginiana at a potency ranging from of at least 5, 6 or 7 of Bellis Perennis at a potency ranging 1><-400><, Arnica Montana at a potency ranging from from tincture-400x, Calendula O?‘tcinalis at a potency rang 3><-400><, Hypericam Perforatum at a potency ranging from ing from tincture-400x, Hamamelis Vlrginiana at a potency 3><-400><, Aconitam Napellus at a potency ranging from ranging from tincture-400x, Arnica Montana at a potency 3><-400><, Lea'um Palustre at a potency ranging from ranging from tincture-400x, Hypericum Perforatum at a 1><-400><, Bryonia Alba at a potency ranging from 3><-400>< potency ranging from tincture-400x, Aconitum Napellus at a and Rata Graveolens at a potency ranging from 3><-400><. potency ranging from 3><-400><, Ledum Palustre at a potency 5. The formulation of claim 2, the herbal active ingredi ranging from tincture-400x, Bryonia Alba at a potency ents comprising tinctures and/or homeopathic preparations ranging from tincture-400x and Ruta Graveolens at a of 8 or all of Bellis Perennis at a potency of 1x, Calena'ula potency ranging from tincture-400x. O?‘tcinalis at a potency of 1x, Hamamelis Virginiana at a 12. The formulation of claim 1, the herbal active ingre potency of 2x, Arnica Montana at potencies of 3x and 6x, dients comprising the tincture and/or homeopathic prepara Hypericam Perforatum at a potency of 2x, Aconitum Napel tion of Bryonia Alba and the tinctures and/or homeopathic lus at a potency of 3x, Lea'um Palustre at a potency of 3x, preparations of at least 5, 6 or 7 of Bellis Perennis, Calen Bryonia Alba at potencies of 6x and 12x and Ruta Graveo dala O?lcinalis, Hamamelis Virginiana, Arnica Montana, lens at a potency of 3x. Hypericum Perforatam, Aconitam Napellus, Lea'um Palus 6. The formulation of claim 1, the herbal active ingredi tre, and Ruta Graveolens. ents comprising tinctures and/or homeopathic preparations 13. The formulation of claim 12, the herbal active ingre of Bellis Perennis, Calena'ula O?icinalis, Hamamelis Vir dients comprising the tincture and/or homeopathic prepara giniana, Arnica Montana, Hypericam Perforatam, Aconitum tion of Bryonia Alba at a potency ranging from tincture Napellus, Ledum Palastre, Bryonia Alba and Rata Graveo 400>< and the tinctures and/or homeopathic preparations of at lens. least 5, 6 or 7 of Bellis Perennis at a potency ranging from 7. The formulation of claim 6, the herbal active ingredi tincture-400x, Calena'ula O?icinalis at a potency ranging ents comprising tinctures and/or homeopathic preparations from tincture-400x, Hamamelis Virginiana at a potency of Bellis Perennis at a potency ranging from tincture-400x, ranging from tincture-400x, Arnica Montana at a potency Calena'ula O?‘tcinalis at a potency ranging from tincture ranging from tincture-400x, Hypericum Perforatum at a 400><, Hamamelis Virginiana at a potency ranging from potency ranging from tincture-400x, Aconitum Napellus at a tincture-400x, Arnica Montana at a potency ranging from potency ranging from 3><-400><, Ledum Palustre at a potency tincture-400x, Hypericum Perforatum at a potency ranging ranging from tincture-400x, and Ruta Graveolens at a from tincture-400x, Aconitum Napellus at a potency ranging potency ranging from tincture-400x. from 3><-400><, Lea'um Palustre at a potency ranging from 14. The formulation of claim 1, further comprising a gel tincture-400x, Bryonia Alba at a potency ranging from base comprising Water, glycerine, a polyacrylic acid resin tincture-400x and Ruta Graveolens at a potency ranging thickener, triethanolamine and methylparaben. from tincture-400x. 15. The formulation of claim 2, further comprising a gel 8. The formulation of claim 6, the herbal active ingredi base comprising Water, glycerine, a polyacrylic acid resin ents comprising tinctures and/or homeopathic preparations thickener, triethanolamine and methylparaben. of Bellis Perennis at a potency ranging from 1><-400><, 16. The formulation of claim 3, further comprising a gel Calena'ula O?icinalis at a potency ranging from 1><-400><, base comprising Water, glycerine, a polyacrylic acid resin Hamamelis Vlrginiana at a potency ranging from 1><-400><, thickener, triethanolamine and methylparaben. Arnica Montana at a potency ranging from 3><-400><, 17. The formulation of claim 6, further comprising a gel Hypericam Perforatum at a potency ranging from 3><-400><, base comprising Water, glycerine, a polyacrylic acid resin Aconitum Napellas at a potency ranging from 3><-400><, thickener, triethanolamine and methylparaben. US 2004/0180101 A1 Sep. 16, 2004

18. The formulation of claim 9, further comprising a gel 35. A method of treating in?ammation in a subject, base comprising Water, glycerine, a polyacrylic acid resin comprising administering an anti-in?ammatory amount of thickener, triethanolamine and methylparaben. the formulation of claim 1 to the subject. 19. The formulation of claim 10, further comprising a gel 36. A method of treating in?ammation in a subject, base comprising Water, glycerine, a polyacrylic acid resin comprising administering an anti-in?ammatory amount of thickener, triethanolamine and methylparaben. the formulation of claim 2 to the subject. 20. The formulation of claim 12, further comprising a gel base comprising Water, glycerine, a polyacrylic acid resin 37. A method of treating in?ammation in a subject, thickener, triethanolamine and methylparaben. comprising administering an anti-in?ammatory amount of 21. A method of treating pain in a subject, comprising the formulation of claim 6 to the subject. administering a pain treating effective amount of the formu 38. A method of treating in?ammation in a subject, lation of claim 1 to the subject. comprising administering an anti-in?ammatory amount of 22. A method of treating pain in a subject, comprising the formulation of claim 10 to the subject. administering a pain treating effective amount of the formu 39. A method of treating in?ammation in a subject, lation of claim 2 to the subject. comprising administering an anti-in?ammatory amount of 23. A method of treating pain in a subject, comprising the formulation of claim 12 to the subject. administering a pain treating effective amount of the formu lation of claim 6 to the subject. 40. A method of treating in?ammation in a subject, 24. A method of treating pain in a subject, comprising comprising administering an anti-in?ammatory amount of administering a pain treating effective amount of the formu the formulation of claim 14 to the subject. lation of claim 10 to the subject. 41. The method of claim 35, Wherein the formulation is 25. A method of treating pain in a subject, comprising administered topically to the subject. administering a pain treating effective amount of the formu 42. The method of claim 41, Wherein the administration of lation of claim 12 to the subject. the formulation achieves an anti-in?ammatory effect in 26. A method of treating pain in a subject, comprising about 30 seconds to about 30 minutes. administering a pain treating effective amount of the formu lation of claim 14 to the subject. 43. The method of claim 35, Wherein the in?ammation 27. The method of claim 21, Wherein the formulation is associated With an insect bite, degenerative joint disease, administered topically to the subject. sWollen knee, sprains, joint stiffness, Lyme disease, blisters, 28. The method of claim 27, Wherein the application of tendonitis, or neuritis from radiation burn, the administration the formulation results in pain relief Within approximately of the formulation obtaining relief from the in?ammation. 30 seconds to 2% minutes. 44. A method of treating in?ammation in a subject in need 29. The method of claim 27, Wherein the administration of of the treatment, comprising administering an anti-in?am the formulation results in pain relief lasting on an average of matory amount of the formulation of claim 1 to the subject. about 8 hours. 45. The method of claim 21, Wherein the formulation is 30. The method of claim 27, Wherein the administration of administered repetitively for about 6 months to about a year the formulation results in pain relief lasting for at least about With no side effects. 3 months. 46. The method of claim 21, Wherein the administered is 31. The method of claim 30, Wherein permanent pain repeated at least once With no refractory period in the relief is achieved. analgesic effect upon repeated administrations. 32. The method of claim 21, Wherein the pain is associ 47. The method of claim 35, Wherein the formulation is ated With Lyme disease, neuritis from radiation burn, inter administered repetitively for about 6 months to about a year costal neuritis, facial neuralgia, ?bromyalgia, vagal nerve With no side effects. irritation, migraine headaches, a degenerative joint disease, muscle sprain, muscle strain, tendonitis, blisters, menstrual 48. The method of claim 35, Wherein the administration is cramps or stomach ?u, the administration of the formulation repeated at least once With no refractory period in the obtaining pain relief. anti-in?ammatory effect upon repeated administrations. 33. The method of claim 27, the subject having insomnia 49. The method of claim 33, Wherein the formulation does caused by the pain, Wherein the administration of the for not have a strong odor or disturbing, burning, cooling or mulation achieves pain relief and the associated insomnia. stinging sensation and does not contribute to or cause 34. A method of treating pain in a subject in need of the insomnia because of a disturbing or aggravating sensation. treatment, comprising administering a pain treating effective amount of the formulation of claim 1 to the subject.