AU2009201752B2 - Therapeutic or Pharmaceutical Compositions Containing Extract of Ailanthus - Google Patents

Description

5 THERAPEUTIC OR PHARMACEUTICAL COMPOSITIONS CONTAINING EXTRACT OF AILANTHUS OR ZANTHOXYLUM FIELD OF THE INVENTION This invention is directed to therapeutic compositions, and particularly to topical compositions which contain, as a component thereof, extract from plants. In 10 particular, the invention is directed to a composition which contains an extract obtained from the bark of either the ailanthus plant or the zanthoxylum plant, and more particularly in respect of a particular type of ailanthus being a form of ailanthus triphysa or a particular type of zanthoxylum being zanthoxylum rhetsa. BACKGROUND ART 15 Therapeutic compositions containing plant extracts are well-known. For instance, it is known to provide a skin cream which contains an effective amount of eucalyptus oil, a detergent composition, and a coconut oil. Various other therapeutic compositions are known which contain avocado oil, orange oil, watermelon oil, banana oil, lemon oil, beeswax, aloe vera, and the like. 20 However, to date, extracts obtained from ailanthus have not been formulated into a therapeutic composition. OBJECT OF THE INVENTION The present invention is directed to the realisation that a therapeutic composition can be obtained using an extract of either of two particular plants, more 25 particularly, an extract from the bark of an ailanthus or zanthoxylum plant, and most particularly, an extract from a form of Ailanthus triphysa or zanthoxylum rhetsa. In one form, the invention is directed to a therapeutic composition comprising, as a component thereof, an extract from an ailanthus plant. In another form, the invention is directed to a therapeutic composition 30 comprising, as a component thereof, an extract from the bark of the ailanthus plant. In another form, the invention is directed to a therapeutic composition comprising, as a component thereof, an extract from the bark of A ilanthus triphysa. In still another form, the invention is directed to a therapeutic composition comprising, as a component thereof, an extract from a zanthoxylum plant. 35 In another form, the invention is directed to a therapeutic composition comprising, as a component thereof, an extract from the bark of the zanthoxylum plant. In another form, the invention is directed to a therapeutic composition 2 5 comprising, as a component thereof, an extract from the bark of zanthoxylum rhetsa. The therapeutic composition may additionally comprise a diluent/solvent to form a suspension or solution. The diluent/solvent will normally be water. The composition may be formulated into a topical composition which can be applied to a person's skin. 10 Common names for A. Triphysa include white palle (English), and mattipal, peru, perumaram (Tamil). Ailanthus triphysa is a single stemmed tree or shrub. It has a cylindrical bole, attaining a height of approximately 30 m and diameter of approximately 1.2 m. Any branchlets are typically covered with many leaf scars. 15 The bark is normally grey and rough. The inner bark is approximately 1.3 cm thick, yellow and fibrous. The leaves are typically pinnate and quite large, at approximately 45-60 cm long. The leaves are also typically crowded at branch ends. There are usually 5-10 pairs of leaflets which are each ovate, oblong, sickle-shaped, and tapering from the 20 base. The leaflets are typically 7.5-15 x 2.5-5 cm, thin, shining, glabrous and glaucous beneath. They are typically very oblique at the base with of approximately petiolules 1 cm long. The flowers when they appear are normally white, the polygamous in lax axillary panicles and the pedicels short. The flowers have minute calyx lobes, which are 25 pubescent, triangular, acute. The petals are about 0.4 cm long, glabrous, and oblong lanceolate in shape. The fruit are normally 5-7.5 cm long, reddish-brown, membranous, and flat. Seeds are compressed and circular. The generic name 'Ailanthus' comes from 'ailanthos' (tree of heaven), 30 the Indonesian name for Ailanthus moluccana. Conventionally the wood of A. Triphysa is used for making boats, matches, fishing floats and weaponry accessories e.g. sword handles and spear sheaths. A dye obtained from the plant's leaves stains satin black. Aromatic oils are obtained from the bark. 35 Leaf litter of A. triphysa on decomposition restores soil fertility. The tree is often planted for aesthetic purposes. The tree is also used in intercropping as live stakes for supporting black pepper (Piper nigrum).

3 5 The zanthoxylum genus is a temperate zone genus of trees and shrubs. A member of the Rue family (same family as bitter orange). An aromatic shrub or small tree with short paired spines, compound leaves with 5-11 leaflets (hairy when young and smooth when old with resinous dots), tiny greenish-yellowish flowers appearing in spring on last year's wood before the leaves appear, and fruit with red-greenish berries 10 covered with lemon scented dots which appear in late summer/autumn. It is found growing in moist woods, thickets, along river banks.The plant is a small or medium-size tree reaching a height of 20 meters. The branchlets are usually spineless. The bark has prominent conical spines. The leaves are pinnately compound, up to 35 centimeters or more in length, and consist of 8 to 20 pairs of leaflets which are somewhat ovate, 5 to 15 12 centimeters long, with the two sides very unequal, particularly at the base, and with a tapering, pointed tip. The flowers are numerous, fairly small, yellowish white, with a red center, 4-parted, and borne in considerable number on terminal panicles which are 40 centimeters long. The fruit is solitary, 6 to 8 millimeters in diameter, finely tubercled, and red when ripe. The seeds are somewhat rounded; and bluish-black. 20 The extract can be used in any form including a tincture, infusion, decoction, a suspension or solution. The solution or suspension will typically be made in two forms, the first using water or similar potable liquid to form a tonic, infusion or tisane and the second using a form viscous liquid to form a topical application. The bark of either tree will typically form the raw material for isolating 25 the extract. Normally, the tree use chosen according to its maturity. The bark used according to the present invention is typically from a tree which is at least five years of age. Normally, only the external bark of the tree is used. The bark is typically removed from the tree and reduced to sections which are approximately 20 cm x 6 cm in dimension. Each piece of bark of this size 30 will typically weigh approximately 70 g although, the age of the tree will determine the thickness of the bark and therefore the size of the portions of bark used. In one alternative form, the bark pieces are used to form a suspension or solution. Preferably, approximately 200 g of bark are immersed in approximately 3 litres of liquid such as water. Preferably a relatively pure source of water such as 35 rainwater will spring water will be used. The liquid is preferably heated to boiling point and subsequently cooled or allowed to cool to approximately room temperature. The pieces of bark are then 4 5 placed directly into the water. The liquid containing the bark is being allowed to sit for a period to allow extracts from the bark to diffuse into liquid. The suspension will typically darken over time as more extract diffuses into the liquid. Further, using a more mature tree or will cause the liquid to be darker or darken more quickly and the suspension or solution will typically be stronger. 10 After a predetermined period of approximately 3 days (this period will vary according to the maturity of the tree from which the bark was taken), the bark pieces are removed from the liquid resulting in a stock suspension/solution. The suspension/solution will typically be undiluted to a light orange/brown colour. Normally, the stock suspension/solution will be diluted using approximately 1 L of 15 stock suspension/solution to 1.5 L of liquid, usually water. The diluted suspension/solution is then typically filtered or strained to remove any suspended solids and is ready to use. The mixture may be heated to facilitate the process of infusion. The heating may be between ambient temperatures up to the boiling temperature. If desired, 20 a heating profile may be established which may comprise initial heating to higher temperature and then a more prolonged heating at a lower temperature. The mixture is preferably stirred, agitated, blended, or otherwise mixed during this process. It is also been found surprisingly and unexpectedly, that the properties of the mixture can vary depending on the length of infusion of the plant material into the 25 carrier. For instance, a shorter infusion time may make the composition suitable for some purposes, while a longer infusion time may make the composition suitable for other purposes. In a further alternative form, the suspension or solution formed using the extract may be mixed with a carrier such as coconut oil for use as a topical application 30 to the skin. Typically the topical application will be approximately 50% solution and 50% coconut oil. The coconut oil can be isolated from the fruit of the coconut palm (Cocos nucifera) and contains, as the main constituents, 50 to 60% of caprilolauromyristin and 15 to 20% of myristodilaurine. In addition it contains small amounts of oleic acid 35 glycerides, palmitodimyristine and stearodipalmitine. With reference to the fatty acid composition (in percentage) of coconut oil, has 13 percent of CIO and lower saturated fatty acids, 45 to 50 percent of C 12 saturated fatty acids, 8 to 9 percent of C 1 6 saturated 5 5 fatty acids, and 2 to 3 percent of Ci 8 saturated fatty acids, traces of C14/ 1 unsaturated fatty acids, traces of C1 6

/

1 unsaturated fatty acids, 5 to 8 percent of C 181 unsaturated fatty acids, and 1 to 3 percent of C1 8

,

2 unsaturated fatty acids. The content of free fatty acids in coconut oil is 5 to 17 percent (calculated relative to oleic acid). Coconut oil, as used in this specification, is also designated coconut fat or coconut butter, both in the 10 literature and in commerce. It is preferred that the coconut oil employed be natural, but synthetic coconut oil can also be used for the present invention. The composition may contain an emulsifier. The emulsifier may comprise those which are pharmacologically and physiologically tolerated by the diseased skin surface to be treated and which impart a favorable consistency to the 15 compositions hereof for their topical application to the skin, and which facilitate the taking up of the therapeutic agent by absorption and/or resorption and/or persorption. Suitable emulsifiers and emulsifying mixtures which meet these requirements are known to those skilled in the art. Examples of emulsifiers which can be used are: wool fat, wool wax 20 alcohols, salts of pharmacologically permissible metals with aliphatic monocarboxylic acids with 10 to 22 carbon atoms, such as calcium stearate, magnesium stearate, aluminium stearate or zinc stearate, and emulsifier mixtures of mono- and/or diglycerides of aliphatic monocarboxylic acids with 10 to 22 carbon atoms. The compositions can also contain small amounts of antioxidants to 25 prevent oxidative destruction of those components of the composition susceptible thereto. Compounds which function as synergists to the antioxidants can also be used. In addition, the solution composition of the invention can comprise antioxidants (for example, ascorbic acid, BHA (butylated hydroxyanisole), BHT (butylated hydroxytoluene), vitamin E, vitamin E PEG 1000 succinate and the like) for chemical 30 stability. The compositions can also contain small amounts of preservatives to prevent microbiological degradation. Examples of preservatives can comprise methyl p-hydroxy benzoate, ethyl p-hydroxy benzoate, propyl p-hydroxy benzoate, and sorbic acid. In general, the addition of about 0.01 to 0.2 percent by weight of preservative, 35 relative to the weight of the total composition, suffices to prevent growth of moulds, yeasts and bacteria and consequent spoilage and loss of efficacy of the compositions. A particularly useful preservative consists of seven parts of methyl p-hydroxy benzoate 6 5 and three parts of propyl p-hydroxy benzoate, which mixture is effective at a total amount of 0.1 percent by weight, relative to the weight of the total composition. The composition may include other oils in addition to coconut oil, or instead of coconut oil. These oils may be pharmaceutically acceptable oils. The term "pharmaceutically acceptable oil" can include a mineral oil or a vegetable oil (for 10 example, safflower oil, peanut oil, olive oil, fractionated coconut oil (for example, mixed triglycerides with caprylic acid and capric acid) and the like. The composition may be used in a therapeutically effective amount. As used herein, the term "therapeutically effective amount" is meant an amount of a compound of the present invention effective to yield a desired therapeutic response. 15 The specific "therapeutically effective amount" will, obviously, vary with such factors as the particular condition being treated, the physical condition of the subject, the type of person or animal being treated, the duration of the treatment, the nature of concurrent therapy (if any), and the specific formulations employed and the structure of the compound or its derivatives. 20 The composition may comprise a pharmaceutical carrier. A "pharmaceutical carrier" is a pharmaceutically acceptable solvent, suspending agent or vehicle for delivering the pharmaceutically-active agent to the subject. The carrier may be liquid, solid, gel, cream and the like. The composition may be administered orally, topically, or parenterally in 25 dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants, and vehicles. The term parenteral as used herein includes subcutaneous injections, aerosol, intravenous, intramuscular, intrathecal, intracranial, injection or infusion techniques. The present invention also provides suitable topical, oral, and parenteral 30 pharmaceutical formulations for use in the novel methods of treatment of the present invention. The compounds of the present invention may be administered orally as tablets, aqueous or oily suspensions, lozenges, troches, granules, emulsions, capsules, syrups or elixirs. The composition for oral use may contain one or more agents selected from the group of sweetening agents, flavouring agents, colouring agents and preserving 35 agents in order to produce pharmaceutically elegant and palatable preparations. The tablets contain the active ingredient in admixture with non-toxic pharmaceutically acceptable excipients which are suitable for the manufacture of tablets.

7 5 These excipients may be, for example, (1) inert diluents, such as calcium carbonate, lactose, calcium phosphate or sodium phosphate; (2) granulating and disintegrating agents, such as corn starch or alginic acid; (3) binding agents, such as starch, gelatin or acacia; and (4) lubricating agents, such as magnesium stearate, stearic acid or talc. These tablets may be uncoated or coated by known techniques to delay 10 disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period. For example, a time delay material such as glyceryl monostearate or glyceryl distearate may be employed. Preparations for parenteral administration include sterile aqueous or non aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents are 15 propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable organic esters such as ethyl oleate. Aqueous carriers include water, alcoholic/aqueous solutions, emulsions or suspensions, including saline and buffered media. Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's intravenous vehicles include fluid and 20 nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. Preservatives and other additives may also be present such as, for example, anti-microbials, anti-oxidants, chelating agents, growth factors and inert gases and the like. It is envisioned that the invention can be used to prevent or treat any 25 disease associated with the use of pharmaceutically-active agents, including, for example, the following uses: Topical Applications Cancers * skin 30 * brain tumors * liver e bladder e breast * bowel 35 Diabetes e diabetic ulcers e in diabetic skin conditions 8 5 * diabetic rashes * diabetes Skin Conditions * rashes e sunburn 10 e insect bites * jellyfish stings * scalding * radiation bums e eczema 15 e psoriasis e mouth ulcers e eye irritations * heat rashes psychological/mental health 20 e bipolar disorder e depression e anxiety e stress Fertility imbalance particularly common in females. 25 Oral Applications - Humans e cancer e diabetes e cardiac problems * hypertension 30 e migraine e Meniere's disease e gastric/intestinal disorders in your mouth ulcers e mental health * women's fertility 35 Topical and Oral - Animals The composition or extract of the present invention can be used to treat a 9 5 variety of disorders in animals including dogs, cats, horses, snakes and birds. It can be used to treat conditions such as: e Cancer * Mange e Wounds, and 10 e skin conditions. Generally, the terms "treating", "treatment" and the like are used herein to mean affecting a subject, tissue or cell to obtain a desired pharmacologic and/or physiologic effect. The effect may be prophylactic in terms of completely or partially preventing a disease or sign or symptom thereof, and/or may be therapeutic in terms of a 15 partial or complete cure of a disease. "Treating" as used herein covers any treatment of, or prevention of disease in a vertebrate, a mammal, particularly a human, and includes: (a) preventing the disease from occurring in a subject that may be predisposed to the disease, but has not yet been diagnosed as having it; (b) inhibiting the disease, i.e., arresting its development; or (c) relieving or ameliorating the effects of the disease, i.e., 20 cause regression of the effects of the disease. The invention includes various pharmaceutical compositions useful for ameliorating disease. The pharmaceutical compositions may contain carriers, excipients and additives or auxiliaries. Frequently used carriers or auxiliaries include magnesium carbonate, titanium dioxide, lactose, mannitol and other sugars, talc, milk protein, 25 gelatin, starch, vitamins, cellulose and its derivatives, animal and vegetable oils, polyethylene glycols and solvents, such as sterile water, alcohols, glycerol and polyhydric alcohols. The pharmaceutical compositions according to the invention may be administered locally or systemically in a therapeutically effective dose. Amounts 30 effective for this use will, of course, depend on the severity of the disease and the weight and general state of the subject. Formulations for oral use may be in the form of hard gelatin capsules wherein the active ingredient is mixed with an inert solid diluent, for example, calcium carbonate, calcium phosphate or kaolin. They may also be in the form of soft gelatin 35 capsules wherein the active ingredient is mixed with water or an oil medium, such as peanut oil, liquid paraffin or olive oil. Aqueous suspensions normally contain the active materials in admixture 10 5 with excipients suitable for the manufacture of aqueous suspension. Such excipients may be (1) suspending agent such as sodium carboxymethyl cellulose, methyl cellulose, hydroxypropylmethylcellulose, sodium alginate, polyvinylpyrrolidone, gum tragacanth and gum acacia; (2) dispersing or wetting agents which may be (a) naturally occurring phosphatide such as lecithin; (b) a condensation product of an alkylene oxide with a 10 fatty acid, for example, polyoxyethylene stearate; (c) a condensation product of ethylene oxide with a long chain aliphatic alcohol, for example, heptadecaethylenoxycetanol; (d) a condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol such as polyoxyethylene sorbitol monooleate, or (e) a condensation product of ethylene oxide with a partial ester derived from fatty acids and hexitol anhydrides, for 15 example polyoxyethylene sorbitan monooleate. The composition can be used in an acceptable dose level. The specific dose level for any particular patient will depend upon a variety of factors including the activity of the specific compound employed, the age, body weight, general health, sex, diet, time of administration, route of administration, rate of excretion, drug combination 20 and the severity of the particular disease undergoing therapy. The compounds of the present invention may additionally be combined with other compounds to provide an operative combination. It is intended to include any chemically compatible combination of pharmaceutically active agents, as long as the combination does not eliminate the activity of the compound of this invention. 25 When the mixture is being taken as an oral tonic, the recommended dosage is approximately 20 to 30 mL daily, but the amount will also depend upon the condition that is being treated. For example, users with depression may be given 30 mL on a daily basis whereas users with some forms of cancer may be given a 30 mm twice daily and still further, users with diabetes may be given 20 mL twice daily. 30 The bark solution may also be used as a swim/bath or spray as part of the treatment process and will typically be given a small amount, normally 20 to 30 mL of the bark solution to drink after the bath/spray treatment. Use as a spray for example on severe sunburn areas of skin resulting reduction of redness and reduced exfoliation of the burnt skin. 35 The bark pieces removed from the infused liquid or informing the solution/suspension may also be used directly on a user's body. For example, the bark pieces may be heated and placed over a user's body to relieve muscular ache or similar 11 5 ailments. Users of the extract and composition according to the present invention may be made more receptive to the function of the extract or composition by providing an environment which is relaxing to the user. Thus, various prayers, chants, music, sounds, symbology or the like could be provided to prepare the user to be more 10 receptive to the activity of the extract or composition Another method of using the extract and composition of the present invention is through use of a stone or similar infused with the solution/suspension. For example, a porous stone may be placed into an amount of suspension/solution and normally, the stone will absorb a portion of the solution/suspension. Typically, the stone 15 may be immersed overnight. The stone is being typically removed from the liquid and heated, normally to a temperature of approximately 100*C. The stone may be maintained at approximately that temperature during use by repeatedly heating the stone. An insulating device may be wrapped around the stone before placing the 20 stone directly on an affected area of a user's body. The insulating device may be environmentally friendly such as a large leaf, for example a banana leaf or a fabric portion or the like. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of 25 the common general knowledge in the art in Australia or in any other country. BEST MODE An embodiment of the invention will now be described with reference to the Ailanthus triphysa tree illustrated in Figures 1 (main trunk) and 2 (leaves). The same forms and methods of preparation and use can be used with the 30 zanthoxylum rhetsa tree, portions of which are illustrated in Figures 3 to 8. In the embodiment, two different forms of the extract are used namely, a suspension/solution made from bark and water and a topical mixture of suspension/solution mixed with a carrier, which in the embodiment is coconut oil. In an alternative form, the bark pieces are used to form a suspension or 35 solution. Approximately 200 g of bark are immersed in approximately 3 litres of liquid such as water. A relatively pure source of water such as rainwater or spring water will be used.

12 5 The water is heated to boiling point and subsequently cooled or allowed to cool to approximately room temperature. The pieces of bark are then placed directly into the water. The water containing the bark is being allowed to sit for a period to allow extracts from the bark to diffuse into the water. The solution/suspension will darken over time as more extract diffuses into the water. 10 After a predetermined period of approximately 3 days (this period will vary according to the maturity of the tree from which the bark was taken), the bark pieces are removed from the liquid resulting in a stock suspension/solution. The suspension/solution will typically be diluted to a light orange/brown colour using approximately 1 L of stock suspension/solution to 1.5 L of water. 15 The diluted suspension/solution is then strained to remove any suspended solids and bottled ready to use. The coconut oil is prepared as follows: 1. Fresh coconut (approximately 10 coconuts will yield approximately I litre of oil) are decorticated (sometimes known as dehulling) to remove the oil-bearing 20 material from the rest of the coconut. 2. The oil bearing material is finely ground into particles. 3. The oil bearing material is pressed to separate the oil from the waste material. 4. The oil bearing material is heated with a small quantity of hot water 25 (typically I litre for the amount of oil released from 10 coconuts) to assist with the release of the oil. 5. The oil is extracted by way of a hot water floatation system. Firstly, the oil bearing material is heated to boiling. The temperature is then reduced by half and heating is carried out for between 4-5 hours reducing the temperature gradually until the 30 mixture separates with the waste material turning brown and settling and the oil rising to the surface. 6. The oil is then separated for use. The topical application is then formed using approximately 50% bark solution and 50% coconut oil for different skin conditions such as tropical skin fungus, 35 sun spots, age spots and as a general moisturizer with skin invigorating properties. The use of the suspension/solution will vary depending on its "strength" or "activity". This property can vary depending on how long the water/plant mixture is 13 5 left to blend at room temperature, the age of the tree from which the bark was obtained and the dilution factor of the stock solution/suspension. In a particularly preferred form, the present invention may be used according to the following treatment chart, using the following: * 4 litres of drinking solution; 10 e 2 x 25mls of bottlebrush oil; * Bark Wash solution e Stone * Water Date/Day Treatment Oil Bark Use Oral Day 1 Full body Apply Warm a piece 30 mls of wash with Bottle of bark and the bark warm Brush oil to place it over tonic twice heated bark affected the affected daily wash area whilst area. Warm a morning solution head is still small cloth or and (use 2-3 warm. Do towel in the evening. litres of not spill bark solution solution). into eyes. and place it Let solution over the bark dry on the area. Leave for body and do 20 minutes. not wipe off Day 2 Same process as Day I Day3 Same process as Day I Day 4 Wash head Warm a piece area with of bark and warm bark place it over solution the affected (use approx area. Warm a 2 Litres of small cloth or solution) towel in the bark solution and place it over the bark area. Leave for 20 minutes. Days 5 to Same 14 11 process as Day 4 Day 12 Full body wash with warm heated bark wash solution (use 2-3 litres of solution). Let solution dry on the body and do not wipe off. Same process as Day 4 Days 13 to Same 15 process as Day 4 Day 16 Water 30 mls of Healing. Bark Tonic Client is - morning required to and evening shave head and private areas prior to treatment. Discussion on sleeping position. Glass of water to be placed at bedside. Top up glass of water using water provided. Do not drink water. 5 On Day 17, client is reassessed and treatment evaluated. The head treatment is to be continued daily for Days 18 to 23. On Day 24, client is reassessed and treatment evaluated.

15 5 A carer will assist the client. The carer should cleanse themselves with the bark solution prior to assisting by washing their hands with the bark solution and allow to dry without removal. The head treatment is performed by placing heated bark over the area. A warm cloth or towel which has been soaked in bark solution is placed over the bark and 10 left therefore approximately 20 minutes. While not wishing to be bound by theory, it appears that the composition can at least partially assist with ailments including some skin cancers, some skin complications of diabetes, jellyfish stings, many types of skin conditions, mental fatigue, stress-related conditions and tired muscles. 15 It should be appreciated that various other changes and modifications can be made to any embodiment described without departing from the spirit and scope of the invention.

Claims (6)

1. A method of preparing a composition containing zanthoxylum plant extract and a diluent or solvent, the method comprising mixing the bark of a zanthoxylum plant with heated diluent or solvent, leaving the mixture for a predetermined period of 5 time, and separating the bark from the diluent or solvent, immersing a porous stone or similar into the mixture for infusion with a solution/suspension formed from the mixture, the infused stone for use in therapy.

2. The method as claimed in claim 1, wherein the bark is from zanthoxylum rhetsa.

3. The method of claim 1 or 2 wherein the diluent or solvent is water. 10

4. A method of treating a skin condition comprising applying the composition topically using the stone as claimed in any preceding claim to the skin.

5. A method of treating an ailment comprising applying an effective amount of the composition using the stone as claimed in any preceding claim.

6. A method according to any one of claims 1 to 5 wherein users of the extract and 15 composition are made more receptive to the function of the extract or composition by providing an environment which is relaxing to the user during treatment.