WO2014197129A2 - Compositions et procédés pour le traitement et la gestion de la douleur - Google Patents

Compositions et procédés pour le traitement et la gestion de la douleur Download PDF

Info

Publication number
WO2014197129A2
WO2014197129A2 PCT/US2014/035222 US2014035222W WO2014197129A2 WO 2014197129 A2 WO2014197129 A2 WO 2014197129A2 US 2014035222 W US2014035222 W US 2014035222W WO 2014197129 A2 WO2014197129 A2 WO 2014197129A2
Authority
WO
WIPO (PCT)
Prior art keywords
extract
wgt
pain
amount
composition
Prior art date
Application number
PCT/US2014/035222
Other languages
English (en)
Other versions
WO2014197129A3 (fr
Inventor
Reza Ghorbani
Original Assignee
Reza Ghorbani
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/911,265 external-priority patent/US9028888B2/en
Application filed by Reza Ghorbani filed Critical Reza Ghorbani
Publication of WO2014197129A2 publication Critical patent/WO2014197129A2/fr
Publication of WO2014197129A3 publication Critical patent/WO2014197129A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/32—Burseraceae (Frankincense family)
    • A61K36/324—Boswellia, e.g. frankincense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/76—Salicaceae (Willow family), e.g. poplar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger

Definitions

  • This invention relates to compositions and methods for the treatment of pain and more particularly to herbal compositions and methods utilizing such compositions in the treatment and management of pain in human patients.
  • Acute and chronic pain is a major contributor to disability and is the cause of an untold amount of suffering.
  • the successful treatment of acute and chronic pain is a primary goal of the healthcare providers.
  • herbal extracts and compounds have also been used for the treatment and management of pain.
  • Herbal remedies often lack efficacy or an easy or pleasant mode of administration.
  • OTC over-the- counter
  • analgesic products for topical uses have many problems, such as strong odors, counter-irritation, redness, itching, stinging, cooling, sensitization, staining, burning, etc.
  • OTC topical pain relief products may not be used as frequently as needed because one or more of the following problems: (1) limited effectiveness and duration in treating pain; (2) socially embarrassing odors after application because of the strong scent of menthol, wintergreen (methyl salicylate), camphor, or strongly aromatic essential oils, etc.; (3) contain staining or allergenic artificial dyes (e.g., blue or green) or synthetic perfumes; (4) contain oil or fat contents (creams, salves and lotions, etc.), or plant pigments or dyes, that can visibly stain clothing or leave greasy spots, or be allergenic and/or sensitizing to certain individuals; (5) contain substances that are irritating, allergenic, sensitizing, or toxic in excess or high concentrations that should not be applied more than 3 or 4 times daily, or are dangerous if ingested.
  • such products may contain ingredients that produce unpleasant or distracting physical sensations (counter-irritants) such as stinging or burning from capsaicin (which may occur for several days), hot or cold sensations from menthol or wintergreen, or the possibility of allergic reaction to salicylate containing aspirin-like products (trolamine salicylate, methyl salicylate).
  • counter-irritants such as stinging or burning from capsaicin (which may occur for several days), hot or cold sensations from menthol or wintergreen, or the possibility of allergic reaction to salicylate containing aspirin-like products (trolamine salicylate, methyl salicylate).
  • trolamine salicylate methyl salicylate
  • Most of the existing OTC topical pain products use various combinations of the same active ingredients, namely: menthol, methyl salicylate, camphor, and trolamine salicylate, which have the drawbacks mentioned above.
  • U.S. Patents and Patent Application Publications disclose various herbal remedies for use in treating various ailments including pain.
  • a U.S. Patent Application Publication of Rosenbloom, No. 2003/0031737 discloses a medicinal composition and method of using it.
  • the composition is used to treat the symptoms of the common cold, a sore throat, congestion, laryngitis, mucous membrane inflammation and sialorrhea.
  • the composition includes ingredients obtainable from turmeric extract, ginger root powder, and horseradish root powder and is administered orally to a patient.
  • the composition may further include ingredients obtainable from slippery elm bark powder and green tea as well as pharmaceutically acceptable carriers for oral administration.
  • a second reference of Konishi is disclosed in a U.S. Patent No. 6,541,041 for a crude drug extracts and methods for making and standardizing same.
  • the extracts contain soluable silicon compounds as an effective component and are obtained by subjecting a crude drug to extraction with water or an aqueous solvent, preferably at an alkaline pH.
  • the crude drug subjected to extraction may be derived from animals, plants, etc.
  • the quality of the crude drug extract can be standardized using the soluble silicon compounds as an index. Those compounds exhibit inhibitory action towards the production of plasma kallikrein.
  • a third disclosure is contained in a U.S. Patent No. 6,949,260 of Krumhar for a method for treatment of inflammation and pain in mammals.
  • the composition contains effective amounts of a boswellic acid, a curcuminoid, a gingerol, a capsaicinoid, a bioflavonoid, and a vitamin C source. These compounds are taken from a biotanical source and are blended to form a dose for oral administration. Administration of the dose provides relief from pain and inflammation of connective tissue.
  • the dose may be administered as a tablet, a liquid, or a powder.
  • the composition comprises an effective amount of a never inhibiting component, including capsaicin, a capsaicinoid or a capsaicin analogue, which numbs or inhibits the nerve endings that signal pain.
  • an effective amount of inflammation control component which is designed to reduce immediate pain and discourage future pain in the joints and muscles
  • an effective amount of a cooling component an effective amount of a heat minimizing or blocking component
  • an effective amount of a circulation increasing component which effectuates better penetration of the actives to the skin and nerves and an effective amount of soothing and anti-inflammatory complex for the joints and/or muscles comprising Glusosamine sulfate or HCI, Zingiber officiniale (Ginger Root) extract, Methyl sulfonylmethane (MSM), Polygonum cuspidatum (Mexican Bamboo) extract, Alo barbadensis leaf, and Salix alba (white will) bark extract.
  • a U.S. Patent Application Publication No. 2007/0243270 of Evans et al. discloses methods for reducing cellular damage, inhibiting free radical production and scavenging free radicals in mammals.
  • the methods include (a) administering to the mammal an oral dosage form comprising a therapeutically effective amount of a first antioxidant, and (b) administering to the mammal a topical dosage from comprising a therapeutically effective amount of a second antioxidant, wherein at least one of the first antioxidant and the second antioxidant comprises acerola concentrate.
  • Methods of inhibiting free radical production, methods of scavenging free radicals, and kits for reducing cellular damage are also described.
  • a U.S. Patent No. 7,744,931 of Newmark et al. discloses a method for treating oral cancers with herbal compositions.
  • the method comprises administering a composition comprising therapeutically effective amounts of supercritical extracts of rosemary, turmeric, oregano and ginger and therapeutically effective amounts of hydroalcoholic extracts of holy basil, ginger, turmeric, Scutellaria baicalensis, rosemary, green tea, huzhang, Chinese goldthread, and barberry.
  • the inventive subject matter further relates to methods for modulating gene expression of genes selected from the group consisting of interleukin- 1 a, interluekin- ⁇ ⁇ , heme oxygennase 1, aldo-keto reductase family 1, member C2, colony stimulating factor 3, leukemia inhibitory factor, heat shock 70 kDa protein, and combinations thereof, by administration of an effective amount of said compositions.
  • a U.S. Patent No. 7,777,073 of Gupta discloses a topical delivery system for antiaging and skin whitening agents.
  • a certain hydroxyaryl alkanols, alkyl amines, alkyl amino alkanols (“Hydroxyaryl compounds") of formula (1).
  • a method of topical application of said hydroxyaryl compounds is also disclosed.
  • compositions and methods for the treatment and management of pain in human patients there is a need and a potential commercial market for improved compositions and methods for the treatment and management of pain in human patients.
  • compositions and methods have been shown to produce greater than expected results and a reduction of pain in over 72% of respondents who responded completely to somewhat less pain after using a topical pain relief cream for one to two weeks.
  • the present invention contemplates an herbal composition for the treatment and management of pain wherein the composition includes turmeric extract, Boswellia extract, ginger extract, holy basil extract, rosemary extract, white willow bark extract, and alpha lipoic acid.
  • the present invention relates to the unexpected discovery that particular combinations of herbal extracts and compounds can lead to improved management of pain in a subject, and improved ease of administration to a subject. It has also been found that a particular combination of seven ingredients is effective in unprecedented minute amounts.
  • the composition comprises turmeric extract, Boswellia extract, ginger extract, holy basil extract, rosemary extract, white willow bark extract and alpha lipoic acid.
  • the composition comprises between about 0.0002% by weight and 0.01% by weight active ingredients.
  • the composition comprises about 0.01% Turmeric Extract, wherein the extract comprises about 95% curcuminoids.
  • the composition comprises about 0.01% Boswellia Extract, wherein the extract comprises about 70% boswellic acids.
  • the composition comprises about 0.01% Ginger Extract, wherein the extract comprises about 5% gingerols.
  • the composition comprises about 0.01% Holy Basil Extract, wherein the extract comprises about 2.5% ursolic acid.
  • the composition comprises about 0.01% Rosemary Extract, wherein the extract comprises about 6% diterpenes. In this embodiment, the composition comprises about 0.01% Willow Bark Extract, wherein the extract comprises about 15% salicin. In this embodiment, the composition comprises about 0.01% Alpha Lipoic Acid Extract, wherein the extract comprises about 100% alpha lipoic acid.
  • One embodiment is directed to a method for treating pain in a subject, comprising: administering a therapeutically effective amount of a composition comprising the aforementioned ingredients.
  • the composition further comprises a pharmaceutically-acceptable carrier suitable for topical or oral administration.
  • the composition comprises three or more, four or more, five or more, or six or more ingredients selected from the group consisting of: turmeric extract, Boswellia extract, ginger extract, holy basil extract, rosemary extract, white willow extract and alpha lipoic acid.
  • the present invention relates to compositions and methods for the treatment and management of pain in a subject.
  • herbal extracts have been used for the treatment and management of pain
  • new and more effective formulations for the treatment and management of pain are provided herein.
  • pain refers to acute and chronic pain, including pain caused by trauma or inflammation such as back pain, toothache, headache, and menstrual cramps, sore throat, fever, and rheumatic pain such as joint pain, gouty arthritis, ankylosing spondylitis, rheumatoid arthritis, and pain associated with systemic connective tissue disorders, cancer, neuropathy and referred pain.
  • treatment and management of pain refers to pharmacologic measures that lead to the amelioration of the symptom. Such treatment or management of pain is sufficient to eliminate or significantly reduce pain or the effects of pain. More specifically, such pharmacological measures include the administration of the mixture described herein to a subject either topically or orally to ameliorate or relieve pain.
  • therapeutically effective amount refers to the amount (dose) of a composition sufficient for the treatment or management of pain in a subject. Determination of a therapeutically effective amount or dose is determined by one of skill in the art according to the desired effect, e.g., degree to which pain is treated or managed.
  • the term "subject" refers to an animal, in particular, a mammal, e.g., a human.
  • compositions of the present invention include, but are not limited to, white willow bark extract, rosemary extract, ginger extract, turmeric extract, Boswellia extract, holy basil extract and alpha lipoic acid. These components can be, for example, normalized to a particular active compound or compound present within the extract. Concentration of Ingredients per 3.5 oz. tubes of NoxicareTM
  • the white willow bark extract can be used to as an analgesic and antipyretic for the treatment of pain and inflammation.
  • An active constituent of the extract is salicin, an anti- inflammatory agent that is produced from all willow barks.
  • Salicin C is an alcoholic ⁇ - glycoside that contains glucose. Salicin is closely related in chemical makeup to aspirin and has a similar action in the human body. When consumed, it is metabolized to salicylic acid.
  • Rosemary Rosmarinus officinalis
  • rosemary extract has been used to treat a wide range of ailments. Orally, rosemary is used for upset stomach, digestive disorders and headaches, inducing abortion, increasing menstrual flow, gout, liver and gallbladder complaints, and for cardiovascular conditions such a high blood pressure.
  • rosemary is used for preventing baldness, alopecia areata, circulatory disturbances, toothache, eczema, joint or musculoskeletal pain such as myalgia, sciatica and intercostal neuralgia, balneotherapy, wound healing, and as an insect repellent.
  • Rosemary extract also allegedly helps prevent cancer and age-related skin damage, boosts the functioning of the liver and acts as a mild diuretic to help reduce swelling.
  • the applicable part of rosemary is the leaf.
  • the active constituent of rosemary leaves is the essential oil.
  • Dried leaves contain from 1-2.5% of the essential oil.
  • the oil consists primarily of cineole, bomeol, bomyl acetate, camphor, camphene, pinenes, and a-terpineol.
  • Other compounds are diterpenes (picrosalvin, carnosolic acid, rosinariquinone), poliphenols: caffeic acid and rosmarinic acid, flavonoids (apigenin, diosmetin, diosmin, genkwanin, hispidulin, sinensetin, luteolin), and triterpenes (ursolic acid).
  • Diterpenoids have been shown to be effective to protect biological systems against oxidative stresses.
  • Ginger is a tuber that is consumed whole as a delicacy, medicine or used for cooking or tea. It is the underground stem of the ginger plant, Zingiber officinale.
  • the medicinal form of ginger historically was called “Jamaica ginger”; it was classified as a stimulant and carminative, and used frequently for dyspepsia and colic. It was also frequently employed to disguise the taste of medicines.
  • Ginger is on the FDA's "generally recognized as safe” list, though it does interact with some medications, including warfarin. Ginger is contraindicated in people suffering from gallstones as the herb promotes the release of bile from the gallbladder.
  • Ginger also decreases joint pain from arthritis, though studies on this have been inconsistent, and may have blood thinning and cholesterol lowering properties that may make it useful for treating heart disease. Ginger and its extract have been used against diarrhea and nausea caused by seasickness, morning sickness and chemotherapy, though ginger was not found superior over a placebo for post-operative nausea.
  • Ginerrol or sometimes [6]-gingerol, is the active constituent of fresh ginger.
  • gingerol is a relative of capsaicin, the compound that gives chile peppers their spiciness. It is normally found as a pungent yellow oil, but also can form a low-melting crystalline solid. Cooking ginger transforms gingerol into zingerone, which is less pungent and has a spicy-sweet aroma. Gingerol may reduce nausea caused by motion sickness or pregnancy and may also relieve migraine. In the West, powdered dried ginger root is made into capsules and sold in pharmacies for medicinal use.
  • Turmeric extract is a bright yellow/orange polyphenol having the form of a dry powder that is fat-soluble.
  • the concentrate has neither flavor nor aroma. It colors food readily if there is oil present.
  • the medicinal properties and health benefits of turmeric extract are attributed partly to its strong anti-oxidant and anti-inflammatory characteristics.
  • Turmeric extract is derived from the root of the turmeric plant first by drying and then by separation using a solvent. There are 18 times more curcuminoids in the concentrate than in the natural spice, which is simply a powdered form of the dried root.
  • the concentrate is also known as Curcumin.
  • Turmeric extract has attracted the attention of researchers in the fields of Alzheimer's disease, memory deficits, arthritis, cancer (including breast cancer), and diabetes.
  • the plant has the botanical name of "Curcuma Longa Linn,” and is a member of the Zingiberaceae or ginger family. Its source is India but it is now cultivated in China and elsewhere. It grows to one meter in height and has long oblong leaves. Beneath the foliage, in the ground, are the rhizomes from which the food coloring is derived.
  • turmeric extract is as an anti oxidant, as anti-inflammatory, as anti-dyspepsia, to break up Alzheixner's ainyloid-beta oligomers and aggregates, for its anti-platelet effects, and to cause apoptosis (death) of various malignant cell types including skin, colon, forestomach, duodenum and ovary.
  • Turmeric extract can be obtained with a normalized curcuminoid content of 95% plus. Customary usage of turmeric extract is about 1-2.5 g per day.
  • Boswellia known also as Boswellia serrata, is a branching tree that is native to India. It grows in dry, hilly regions of the country and produces a resin that can be extracted and purified for medicinal preparations.
  • Boswellia extract is best known among herbalists as a treatment for arthritis.
  • One of its primary active ingredients, boswellic acid is an anti-inflammatory that can be used in ointments to ease joint pain.
  • Boswellia extract can also be taken internally as an antiinflammatory agent, much like NSAIDs (non-steroidal anti-inflammatory agents), such as ibuprofen, which is commonly used to treat pain.
  • NSAIDs non-steroidal anti-inflammatory agents
  • Boswellia extract can be used for significant periods of time without causing stomach upset.
  • Boswellia extract is available in capsules, with extracts standardized for boswellic acids.
  • the recommended dosage to treat arthritis is the amount that contains 150 mg of boswellic acids, taken three times per day.
  • the extract is standardized to 2% Ursolic Acid and is taken 1-2 times daily, preferably with meals.
  • Alpha Lipoic Acid is also called lipoic acid, thioctic acid, or ALA. It is a fatty acid found naturally inside every cell in the body. Alpha lipoic acid converts glucose (blood sugar) into energy.
  • Alpha lipoic acid is also an antioxidant, a substance that neutralizes potentially harmful chemicals called free radicals. What makes alpha lipoic acid unique is that it functions in water and fat, unlike the more common antioxidants vitamins C and B, and it appears to be able to recycle antioxidants such as vitamin C and glutathione after they have been used up. Glutathione is an important antioxidant that helps the body eliminate potentially harmful substances. Alpha lipoic acid increases the formation of glutathione.
  • Alpha lipoic acid is made by the body and can be found in very small amounts in foods such as spinach, broccoli, peas, Brewer's yeast, brussel sprouts, rice bran, and organ meats.
  • Alpha lipoic acid supplements are available in capsule form at health food stores, some drugstores, and online. For maximum absorption, the supplements should be taken on an empty stomach.
  • Alpha lipoic acid may help treating peripheral neuropathy that can be caused by injury, nutritional deficiencies, chemotherapy or by conditions such as diabetes, Lyme disease, alcoholism, shingles, thyroid disease, and kidney failure.
  • Alpha lipoic acid is thought to work as an antioxidant in both water and fatty tissue, enabling it to enter all parts of the nerve cell and protect it from damage. The dose that is best tolerated while still providing benefit is 600 mg, once daily.
  • Alpha lipoic acid can cross the blood-brain barrier, and pass easily into the brain. It is thought to protect brain and nerve tissue by preventing free radical damage.
  • alpha lipoic acid can neutralize free radicals that can damage cells, and helps age-related conditions and chronic illnesses.
  • Alpha lipoic acid has also been suggested for use to treat or manage cataracts, glaucoma, multiple sclerosis, burning mouth syndrome, Alzheimer's disease and stroke.
  • the extracts and alpha lipoic acid can be used as ingredients, for example, in compositions that can be used to treat or ameliorate pain or conditions associated with pain. Two, three, four, five, six or more of the extracts can be used as ingredients in such compositions, with or without alpha lipoic acid. Such compositions can also comprise additional extracts as determinable by one of skill in the art.
  • extracts can be purified and used, complications and impurities associated with synthesis and/or purification of the purified active agents make purified active agents undesirable.
  • extracts as described herein, allows for the safe administration of naturally occurring compositions.
  • extracts contain a combination of other compounds that can also have therapeutic or ameliorative benefits.
  • the extracts described herein can be normalized such that the extract contains a certain percentage of a particular compound, e.g., an active agent.
  • Boswellia extract for example, can be normalized to comprise about 50% to about 95% boswellic acids, about 60% to about 80% boswellic acids, about 65% boswellic acids, about 70% boswellic acids, or any normalized percentage suitable for use in the compositions described herein.
  • Ginger extract for example, can be normalized to comprise about 0.5% to about 10% gingerols, about 0.25% to about 8% gingerols, about 1% gingerols, about 2% gingerols, or any normalized percentage suitable for use in the compositions described herein.
  • Holy basil extract for example, can be normalized to comprise about 0.5% to about 20% ursolic acid, about 1% to about 10% ursolic acid, about 2% ursolic acid, about 1% ursolic acid, or any normalized percentage suitable for use in the compositions described herein.
  • Rosemary extract for example, can be normalized to comprise about 5% to about 40% diterpenes, about 10% to about 30% diterpenes, about 20% diterpenes, about 25% diterpenes, or any normalized percentage suitable for use in the compositions described herein.
  • Willow extract for example, can be normalized to comprise about 2% to about 35% salicin, about 5% to about 20% salicin, about 15% salicin, about 20% salicin, or any normalized percentage suitable for use in the compositions described herein.
  • compositions described herein contain a therapeutically effective amount of six extracts and lipoic acid.
  • a normalized extract for example, can comprise about 1%, about 0.5%, 2.5%, 5%, 7.5%, 10%, 15%, 25°7o, 35%, 50% or greater, of the therapeutic compositions described herein.
  • compositions described herein can comprise, for example, ingredients that aid in the delivery and/or preservation of the active agents.
  • Compositions can comprise, for example, excipients, pharmaceutically-acceptable carriers, preservatives and/or delivery agents/vehicles.
  • An excipient is an inactive substance used as a carrier for the active ingredients of a medication. In some cases, an active substance may not be easily administered and absorbed by the human body. In such cases the substance in question can be mixed with an excipient.
  • Excipients can also be used to bulk up formulations that contain very potent active ingredients, to allow for convenient and accurate dosage. In addition to their use in the single dosage quantity, excipients can be used in the manufacturing process to aid in the handling of the active substance concerned. Depending on the route of administration, and form of medication, different excipients may be used, as determined by one of skill in the art.
  • Pharmaceutically-acceptable carriers can include, for example, creams and compositions that allow for the diffusion or active transport of active agents across the skin for use in, for example, compositions that are to be administered topically.
  • carriers can be suited to oral administration, for example, by allowing diffusion of active agents from capsules or tablets.
  • Such carriers are known to those of skill in the art and can be selected according to the mode of administration.
  • compositions of the present invention can be administered in any pharmaceutically- acceptable manner.
  • Compositions for topical and oral administration are described, however the compositions described herein can also be administered, for example, rectally, intravenously or subcutaneously using, for example, an implantable device.
  • a clinical comparison study was conducted to test the efficacy of a topical herbal medication for inflammatory and chronic pain relief in adults over the age of 18.
  • the participants tested the products over a 7-day period and then evaluated them for the efficacy of the herbal medication through pre and post study questionnaires. Conclusions were drawn based on the responses of the participants regarding pain relief at the end of the 7-day period.
  • Subjects who have inflammatory joint pain due to Rheumatoid Arthritis, and/or other inflammatory conditions, chronic muscle pain and spasms, and neuropathic joint pain due to diabetes were considered for the study.
  • Subjects with medical condition that contradicted the use of herbal medications were not included in the study.
  • the subjects were recruited from all races/ethnicities to the extent possible. Participants were recruited from across the Washington, DC, Maryland and Virginia area, and were afflicted by chronic and inflammatory joint pain, chronic muscle pains and spasms. The study made every attempt to assure adequate representation of each minority/ethnic group. A total of 50 subjects were recruited for the study, with 25 participants being used in a control group, and 25 in a treatment group.
  • Subjects were included as part of the study only after they read and understood the informed consent form, which was available in English only. The subjects were informed about the objective of the study - to evaluate the efficacy of a newly formulated herbal medication to relieve chronic and inflammatory joint pain. Instructions to use the medications were provided separately to the group and subjects were informed of the risks involved in improper use of the medication, and given written instructions on using the products. The informed consent forms were required to be read and signed personally by the subjects before being included in the study.
  • a pre and post study survey was created to gather participant feedback on the all natural pain-relief cream created to treat chronic and inflammatory joint pain.
  • the pre study questionnaire probed the level of pain each participant experienced through a variety of questions designed to capture as much information as possible on the type of pain, location, and severity.
  • the post study questionnaire asked participants to rate their pain experience after having used the topical pain relief cream, and was designed to capture information on type of pain relief experienced, and perceptions and intent towards the topical pain cream after having used it for the 7-day period.
  • Muscular pain included acute muscle aches from a sporting injury, pain from conditions such as fibromyalgia or cancer treatments, and involved ligaments, tendons, bones and organs. Chronic or acute pain and inflammation, which included side-effects like burning or swelling, accounted for over 48% of respondents, while 20% reported their pain as nerve pain - burning, throbbing or stinging.
  • the survey also captured consumer feedback on the ingredients, formulation, and feel of the product. Overall, respondents liked this natural pain relief cream. 72% somewhat to completely agreed that the natural formulation was important to them, and 80% agreed with the statement, "I like the way the product feels on my skin”. 100% of respondents agreed that it was important the product was non-greasy, and 96% agreed that was important the cream had no side-effects. Of the entire group, 72% were interested in continued use of this product. When asked again asked to assess their level of pain on a scale of 1-10 (1 being zero pain and 10 being unbearable pain), the majority of uses reported pain at a level 2-3, little to mild pain. Even more important, only 20% indicating a level 5-6, moderate to severe pain— down from 50% at the start of the trial.
  • a total of 30 subjects with a variety of musculoskeletal diagnoses were chosen for the study.
  • the diagnoses included: cervical strain, lumbar strain, knee sprain, shoulder sprain, knee OA, hand OA and tendinitis of the knee, elbow and shoulder.
  • All subjects received an initial week of therapy without the use of the topical herbal formulation. Pain and irritation was evaluated at the start of treatment and at the end of the initial week using the visual analog scale (VAS). Following the initial week of therapy, no changes were made in the plan of care except for the addition of the topical herbal formulation, which was used during each treatment for a period of two weeks. Each subject was also given a tube for use at home. Subjects were instructed to apply liberally 2-3 times per day for a period of two weeks. Return demonstration was required by each subject to ensure proper application. Pain assessments were performed weekly using the VAS. The results are shown in Table I below:

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne des compositions et des procédés pour le traitement et la gestion de la douleur chez un sujet, comprenant ou consistant en l'administration topique ou orale d'une quantité thérapeutiquement efficace d'une composition. La composition est constituée de très petites quantités d'extraits d'herbes et de mélanges de composés pour un sujet. La composition comprend de l'extrait de curcuma, de l'extrait de Boswellia, de l'extrait de gingembre, de l'extrait de basilic sacré, de l'extrait de romarin, de l'extrait de saule blanc et un acide alpha-lipolique, chacun en très petites quantités.
PCT/US2014/035222 2013-06-06 2014-04-24 Compositions et procédés pour le traitement et la gestion de la douleur WO2014197129A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/911,265 2013-06-06
US13/911,265 US9028888B2 (en) 2010-10-01 2013-06-06 Compositions and methods for treatment and management of pain

Publications (2)

Publication Number Publication Date
WO2014197129A2 true WO2014197129A2 (fr) 2014-12-11
WO2014197129A3 WO2014197129A3 (fr) 2015-09-17

Family

ID=52008725

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/035222 WO2014197129A2 (fr) 2013-06-06 2014-04-24 Compositions et procédés pour le traitement et la gestion de la douleur

Country Status (1)

Country Link
WO (1) WO2014197129A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022175856A1 (fr) * 2021-02-18 2022-08-25 Lyrus Life Sciences Pvt Ltd Nouvelle composition d'émulgel contre l'arthrose et son procédé de préparation

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6534086B1 (en) * 2000-03-06 2003-03-18 Metagenics, Inc. Composition and method for treatment of inflammation and pain in mammals
US20080107747A1 (en) * 2006-10-23 2008-05-08 Roederer Joy E Pain relief composition
US8192768B2 (en) * 2007-04-03 2012-06-05 Laila Impex Synergistic anti-inflammatory and antioxidant dietary supplement compositions
US20120082739A1 (en) * 2010-10-01 2012-04-05 Reza Ghorbani Compositions and Methods for Treatment and Management of Pain
US8852653B1 (en) * 2013-03-29 2014-10-07 Reza Ghorbani Herbal/organic composition for the management of pain

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022175856A1 (fr) * 2021-02-18 2022-08-25 Lyrus Life Sciences Pvt Ltd Nouvelle composition d'émulgel contre l'arthrose et son procédé de préparation

Also Published As

Publication number Publication date
WO2014197129A3 (fr) 2015-09-17

Similar Documents

Publication Publication Date Title
Rondanelli et al. Clinical trials on pain lowering effect of ginger: A narrative review
Mahboubi Zingiber officinale Rosc. essential oil, a review on its composition and bioactivity
Hajimonfarednejad et al. Cinnamon: A systematic review of adverse events
Razavi et al. A review of therapeutic potentials of turmeric (Curcuma longa) and its active constituent, curcumin, on inflammatory disorders, pain, and their related patents
Akaberi et al. Therapeutic effects of Aloe spp. in traditional and modern medicine: A review
US20120082739A1 (en) Compositions and Methods for Treatment and Management of Pain
Wirth et al. Use of herbal therapies to relieve pain: a review of efficacy and adverse effects
Bedi et al. Herbal therapy in dermatology
Prucksunand et al. Phase II clinical trial on effect of the long turmeric (Curcuma longa Linn.) on healing of peptic ulcer
AU2004222357C1 (en) Homeopathic formulations useful for treating pain and/or inflammation
US20120219621A1 (en) Composition with Enhanced Thermogenic Activity and the Use Thereof in the Prevention and Treatment of Obesity
US8962045B2 (en) Herbal/organic composition for the management of pain
US9028888B2 (en) Compositions and methods for treatment and management of pain
Prasad et al. Role of herbs in the management of asthma
Spiteri Herbal monographs including herbal medicinal products and food supplements
WO2009092040A2 (fr) Formulation de douleur topique
Abraham et al. Management of psoriasis-ayurveda and allopathy—A review
Teymouri et al. The comparative effect of hydro alcoholic and hydro distillation extracts of Melissa officinalis on acne and pimple
EP3009013B1 (fr) Compositions nutritionnelles et thérapeutiques pour le traitement du syndrome du côlon irritable
WO2014197129A2 (fr) Compositions et procédés pour le traitement et la gestion de la douleur
US20160030498A1 (en) Herbal compositions for treating pain and skin disorders
Kumar et al. Safety and Toxicity of Botanical Medicines: A critical Appraisal
Gouthami et al. Exploring the Neutraceutical Effects of Brahmi (Bacopa monnieri) in Agriculture: Potential Applications and Benefits
Chen et al. Sugemule-10: Source of prescription and modern clinical application
CN114767772B (zh) 一种治疗痤疮的药物组合物

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14808143

Country of ref document: EP

Kind code of ref document: A2

122 Ep: pct application non-entry in european phase

Ref document number: 14808143

Country of ref document: EP

Kind code of ref document: A2