WO2010119294A2

WO2010119294A2 - Composition

Info

Publication number: WO2010119294A2
Application number: PCT/GB2010/050632
Authority: WO
Inventors: Ronald Fields
Original assignee: Ron Fields Nutrition
Priority date: 2009-04-16
Filing date: 2010-04-16
Publication date: 2010-10-21
Also published as: GB201006350D0; GB0906548D0; WO2010119294A3; GB2469577A

Abstract

The invention provides a composition for oral administration comprising as active ingredient a combination of material derived from the plants Andrographis paniculata, Tinospora Cordifolia, Eclipta alba, Tephrosia purpurea, Vitex negundo, Zinzibar officinale, Terminaliai chebula and Withania somnifera. Methods for preparing such a composition and the use of such a composition in therapy of animals are also provided.

Description

COMPOSITION

Field of the Invention

The present invention relates to a composition for oral administration comprising as active ingredient a combination of materials derived from plants, a process for preparing such a composition and its use in improving the general health of animals. In particular, the invention relates to an orally administrable composition comprising as active ingredient a combination of materials derived from plants which improves hepatic function in animals and is also useful in treating or preventing arthritis, urinary tract infections and respiratory infections .

Background of the Invention

Compositions based on plants or plant materials have been used for treating a variety of conditions in humans and animals. Combinations of herbs have traditionally been used in Ayurvedic medicine, for example.

Various combinations of plants or plant materials have been advocated for use in a variety of conditions, such as treating disorders of the immune system, cardiovascular diseases and as hepatoprotective agents.

Commercially available products comprising combinations of herbal components of use in improving the general health of animals include anti-arthritic preparations such as Elastin™ feed supplement suitable for use with dogs, cats and horses which comprises a combination of Boswellia Serrate gum, Glycyrrhiza Glabro roots, Curcuma longa, Tinospora Cordifolia stems, Trigonella foerum-graecum seeds, Vitex negundo , Withania Somnifera, Zingibar Officinale and Phyllanthus embelica fruits and Hepasan ™ feed supplement , a liver tonic for dogs comprising a combination of Boehaaria diffusa, Terminalia arjuna, Eclipta alba, Terminalia chebula , Achyranthes aspera and Andrographis paniculata (all of which products are available from Ron Fields Nutrition, Hereford, UK) .

Although feed supplements based on such specific combinations of herbal components for use in treating specific ailments in specific animals are commercially available, there remains a continuing need for the development of animal health products with improved effectiveness and range of applicability. In particular, there remains a need for the development of improved compositions for treating ailments in animals such as cats for which it is often considered that effective and commercially viable treatments are not available.

Summary of the Invention

The present invention is concerned with compositions which are effective in improving the general health of animals including humans. In particular the compositions are effective in improving the health of domestic animals such as dogs and especially cats, as well as horses and cattle. The compositions are effective in improving liver function, as anti-arthritis agents in improving joint mobility and freedom of movement, and are also useful in protecting animals against infection.

In a first aspect, the invention provides a composition for oral administration comprising as active ingredient a combination of materials derived from the plants Andrographis paniculata , Tinospora Cordifolia, Eclipta alba, Tephrosia purpurea, Vitex negundo, Zinzibar officinale , Terminaliai chebula and Withania somnifera .

The invention also provides a method for preparing such a composition and the use of such a composition in therapy of animals, and in protecting animals against infection. Further provided is a method of treating animals comprising administering to the animal an orally administrable composition as described above.

Also provided is an animal feed or animal chew composition comprising a composition according to the first aspect of the invention .

Detailed description of the invention

As used herein, a material derived from plants may comprise a whole plant or any constituent part thereof, such as a stem, leaf, seed, bark or root, which contains the biologically active component of the plant.

Suitable such constituent parts containing the biologically active component of the plant will depend on the particular plant concerned, as will be understood by the average skilled person in the art. Where the plant is Tephrosia purpurea or Vitex negundo, for example, then in one embodiment the composition according to the invention suitably comprises the leaves of the plant. In the case of Terminalia chebula, the fruits of the plant are conveniently used. Zingiber officinale and Withania somnifera may suitably be used in the form of their roots .

The plant material may be present as fragments of the plant, which may be obtained by chopping up the plant, or the material may be ground or otherwise processed by conventional techniques well known in the art to reduce the fragment size.

Conveniently, the plant material may be formulated into an orally administrable preparation by suspending the fragments of plant material in water or some other suitable orally acceptable carrier conventional in the art. In another embodiment, an extract of the plant materials may be prepared, for example by dissolving the plant material in a suitable solvent and filtering to remove unextracted plant matter

In one embodiment, the active ingredient may be prepared by mixing the constituent plant materials in the dry state and the pre-mixed active ingredient added to, or otherwise incorporated into, an animal feed composition.

Suitably, the pre-mixed active ingredient may be formed into pellets which may be added as a supplement to the normal diet or the active ingredient may be provided in powder form for use with an animal meal or treat.

In an alternative embodiment, the active ingredient may be incorporated into an animal chew such that the active ingredient is delivered to the animal during chewing.

In another embodiment, the active ingredient may be formulated as a liquid which may be added to, sprayed onto or otherwise incorporated into, an animal feed composition. Alternatively, the liquid formulation may be sprayed directly into the mouth of the animal to which it is to be administered.

In one embodiment, the active ingredient of the compositions of the invention consists only of material from the plants Andrographis paniculata , Tinospora Cordi folia, Eclipta alba, Tephrosia purpurea , Vitex negundo, Zinzibar officinale , Terminalia chebula and Withania somnifera .

In another embodiment, the composition according to the invention may comprise additional active ingredients such as material derived from one or more of the plants Phyllanthus embelica, Terminalia arjuna, Boswellia Serrate, Boehaaria diffusa and Achyranthes aspera.

Andrographis paniculata , commonly known in Ayurvedic medicine as Kalmegh, is a herbaceous plant of the Acanthaceae family, which is well known for treating infections and as an immunostimulant agent amongst other pharmacological activities. In the active ingredient according to the present invention, the Andrographis paniculata is suitably present in an amount of from 10 to 20 % of the total weight of plant-derived material in the composition, for example 15% of the total weight of plant- derived material in the composition.

Tinospora Cordifolia, a herbaceous vine of the family Menispermaceae which is indigenous to tropical India, is known as a hepatoprotectant and has been suggested for use in the treatment of arthiritis, jaundice and diabetes. In the active ingredient according to the present invention, Tinospora Cordifolia is suitably present in an amount of from 10 to 20 % of the total weight of plant-derived material in the composition, for example 15% of the total weight of plant- derived material in the composition.

Eclipta alba is reputed to improve hair growth and colour and is indicated for use in viral hepatitis and memory disorders amongst many other indications . In the active ingredient according to the invention, the Eclipta alba is suitably present in an amount of from 5 to 15 % of the total weight of plant- derived material in the composition, for example 10% of the total weight of plant-derived material in the composition.

Tephrosia purpurea, commonly known as Wild Indigo is used in Ayurvedic medicine for the treatment of a variety of disorders including rheumatism, asthma and urinary disorders. In the active ingredient according to the invention, the Tephrosia purpurea is suitably present in an amount of from 5 to 15 % of the total weight of plant-derived material in the composition, for example 10% of the total weight of plant-derived material in the composition.

Vitex negundo is reputed to have activity against rheumatic disorders and is indicated in the treatment of sciatica and to relieve catarrh and headache. In the active ingredient according to the invention, the Vitex negundo is suitably present in an amount of from 10 to 30 % of the total weight of plant-derived material in the composition, for example 20% of the total weight of plant-derived material in the composition.

Zinzibar officinale , also known as ginger, is widely used in digestive, antitussive, antiflatulent, laxative and antacid compositions. In the active ingredient according to the invention, the Zinzibar officinale is suitably present in an amount of from 5 to 15 % of the total weight of plant-derived material in the composition, for example 10% of the total weight of plant-derived material in the composition.

Terminalia chebula , known as Black Myrobalan, is a deciduous tree native to southern Asia which is reputed in Ayurvedic medicine to cure blindness and to inhibit the growth of malignant tumours. In the active ingredient according to the invention, the Terminalia chebula is suitably present in an amount of from 5 to 10 % of the total weight of plant-derived material in the composition, for example 7.5% of the total weight of plant-derived material in the composition.

Withania somnifera , commonly known as Ashwagandha, is traditionally used as an aphrodisiac, a diuretic and for treating memory loss. In the active ingredient according to the invention, the Withania somnifera is suitably present in an amount of from 5 to 10 % of the total weight of plant-derived material in the composition, for example 7.5% of the total weight of plant-derived material in the composition. The compositions according to the invention may also suitably comprise one or more additional orally acceptable excipients conventional in the art such as sweeteners, colouring agents and preservatives.

The present inventor has found that compositions comprising as active ingredient a combination of materials derived from the above mentioned plants are particularly effective in improving liver function in animals, in particular domestic animals such as dogs and especially cats, without adverse effects. In addition, the compositions according to the invention improve joint mobility and freedom of movement and are useful in the treatment of urinary tract infections, thereby contributing to the overall improvement in general health of the animal concerned. The compositions of the invention are not limited in their applicability to cats and dogs, however, and are also effective in treating other animals, such as cattle and horses.

The compositions of the invention have been found to be effective in promoting recovery where animals show general symptoms of disease, even where the underlying cause has not been diagnosed. Thus, for example, the compositions of the invention are effective in treating cats suffering from a wide range of symptoms including loss of fur, itching, abdominal spots, lethargy, loss of appetite, diarrhea, digestive problems, abscesses and sores. These symptoms are often associated with feline AIDS and the compositions of the invention are therefore useful in ameliorating symptoms in cats suffering from this disease .

The compositions of the invention are also effective in treating a range of conditions in dogs, such as blister and hair loss, and also hoof problems in horses including blisters, cracking and fungal infections. In cattle, the compositions of the invention have been found to be particularly effective in preventing the development of pneumonia and in treating mastitis.

Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of the words, for example "comprising" and "comprises", mean "including but not limited to", and do not exclude other moieties, additives, components, integers or steps.

As used herein, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Preferred features of each aspect of the invention may be as described in connection with any of the other aspects.

Other features of the present invention will become apparent from the following example. Generally speaking the invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims and drawings) . Thus features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.

Examples

A composition according to the invention has the composition as shown in table 1 Table 1

Material Amount ow/w)

Andrographis paniculata plant 15 Tinospora Cordifolia stems 15 Eclipta alba plant 10 Tephrosia purpurea leaves 10 Vitex negundo leaves 20 Zinzibar officinale roots 15 Terminaliai chebula fruits 7.5 Withania somnifera roots 7.5

Example 1 Treatment of various symptoms in cats

The composition of table 1 when formulated as a liquid and sprayed onto cat food has been found to improve liver function and also to treat urinary tract infections and improve joint mobility. Cats suffering from impaired liver function and which would otherwise normally not be expected to survive have been found to make full recoveries.

Ten cats suffering from a range of symptoms, including loss of fur and itching, urinary tract infections, lethargy, diarrohea, digestive problems and general illness, abcesses and oozing sores, some of which are associated with feline AIDS, were fed twice a day with feed sprayed with the above composition. Eight of these cats had previously been treated with antibiotics but had failed to recover.

After being treated with the composition of the invention, all ten cats recovered within a few days, some within 24 hours. Their general appearance was observed to have improved and lethargy and nervousness disappeared. Appetite also returned generally and abcesses cleared up within a week to ten days. Example 2

Protection against pneumonia in cattle

In a trial lasting a month, six calves were fed with the above composition added in an amount of 5ml/day to their milk. The incidence of pneumonia occurring in the group was monitored and compared to the incidence of pneumonia in a control group of six calves not fed with the composition.

Of the six calves treated with the composition according to the invention, only one developed pneumonia whereas in the control group, three out of the six calves developed pneumonia. Following administration of 5cc of chloramphenicol, all of the calves on the trial that developed pneumonia recovered.

In a further trial, eight calves were fed the composition in an amount of 5 ml/day added to their milk every day for a month and another group of calves were fed the composition in an amount of 10 ml/day every day for a month. Only one of the calves in the group having 5 ml composition/day added to their milk developed pneumonia and none of the calves being administered with 10 ml/day of the composition developed pneumonia. By contrast, four out of the eight calves in the control group which were not fed with the composition developed pneumonia.

Example 3

Reduction of high cell count in cattle

A herd of two hundred cows brought into housing for the winter months was treated with the above composition. Prior to being treated with the composition, the cows had very high cell counts, averaging 2,000,000 for each of the three months prior to treatment. After treatment with the composition (at a rate of 4 kg per ton of feed) for a month, the cell count was found to have dropped to a normal level of 800,000 and this level was maintained with continued administration of the composition over the following three months. When administration of the composition was stopped, the next monthly cell count retuned to the previous high count of 2,000,000.

In another test group on a different farm, five cows with individual high cell counts were fed with 25 ml/day of the above composition. After one month, each cow's cell count was found to have been reduced by 70%, rendering it normal.

Experiment 4

Treatment of various symptoms in dogs

Five dogs suffering from blisters and/or losing hair were treated with the above composition formulated as a liquid. Within one month, the coats of all of the dogs were found to have recovered.

Experiment 5

Treatment of various symptoms in horses

In four separate trials, horses suffering from various hoof problems such as fungus, blisters and cracking hooves which had proved resistant to treatment with conventional veterinary antibiotics were treated with the above composition formulated as a liquid. All of the treated horses recovered within a month.

Claims

1. A composition for oral administration comprising as active ingredient a combination of materials derived from the plants Andrographis paniculata , Tinospora Cordi folia , Eclipta alba, Tephrosia purpurea , Vitex negundo, Zinzibar officinale , Terminaliai chebula and Withania somnifera .

2. A composition according to claim 1 further comprising an additional active ingredient comprising material derived from one or more of the plants Phyllanthus embelica, Terminalia arjuna, Boswellia Serrate, Boehaaria diffusa and Achyranthes aspera .

3. A composition according to claim 1 wherein the active ingredient consists of a combination of material derived from the plants Andrographis paniculata , Tinospora Cordifolia , Eclipta alba, Tephrosia purpurea , Vitex negundo, Zinzibar officinale , Terminaliai chebula and Withania somnifera .

4. A composition according to any of claims 1 to 3 wherein the material derived from the plants Tephrosia purpurea or Vitex negundo comprises the leaves of the plant.

5. A composition according to any preceding claim wherein the material derived from the plant Terminalia chebula is the fruit of the plant.

6. A composition according to any preceding claim wherein the material derived from the plants Zingiber officinale and

Withania somnifera is the root of the plant.

7. A composition according to any preceding claim wherein the active ingredient comprises, by % weight of the total weight of plant-derived material in the composition, from 10 to 20% of material derived from Andrographis paniculata , from 10 to 20% of material derived from Tinospora Cordifolia _f from 5 to 15% of material derived from Eclipta alba , from 5 to 15% of material derived from Tephrosia purpurea , from 10 to 30% of material derived from Vitex negundo, from 5 to 15% of material derived from Zinzibar officinale , from 5 to 10% of material derived from Terminalia chebula and from 5 to 10% of material derived from Withania somnifera .

8. A composition according to claim 7 wherein the active ingredient comprises, by % weight of the total weight of plant- derived material in the composition, 15% of material derived from Andrographis paniculata , 15% of material derived from Tinospora Cordifolia ,10% of material derived from Eclipta alba, 10% of material derived from Tephrosia purpurea , 20% of material derived from Vitex negundo, 10% of material derived from Zinzibar officinale , 7.5% of material derived from Terminalia chebula and 7.5% of material derived from Withania somnifera .

9. A composition according to any preceding claim further comprising one or more orally acceptable excipients selected from sweeteners, colouring agents and preservatives.

10. A composition according to any of claims 1 to 9 in the form of a dry mixture

11. A composition according to any of claims 1 to 9 in the form of a liquid or spray.

12. A composition according to any of claims 1 to 9 in the form of a pellet.

13. An animal feed composition comprising a composition according to any preceding claim.

14. An animal chew comprising a composition according to any of claims 1 to 12.

15. A method for preparing a composition according to any of claims 1 to 9 comprising mixing the constituent plant materials and optional additional orally acceptable excipients.

16. Use of a composition according to any of claims 1 to 12 for use in therapy in animals.

17. Use of a composition according to any of claims 1 to 12 as a feed supplement for an animal feed composition.

18. Use of a composition according to any of claims 1 to 12 in the manufacture of a medicament for use as a hepatoprotective agent or in the treatment of arthiritis, urinary tract infections or respiratory infections in animals.

19. A feed composition according to claim 13 for use in improving liver function in animals or in the treatment of arthiritis, urinary tract infections or respiratory infections in animals .

20. A method of treating animals comprising administering to the animal an orally administrable composition according to any one of claims 1 to 12.

21. A method of treating animals comprising feeding the animal with a feed composition according to claim 13.