| PATENT ASSIGNEE'S COUNTRY | Australia |
| UPDATE | 03.00 |
| PATENT NUMBER | This data is not available for free |
| PATENT GRANT DATE | 21.03.00 |
| PATENT TITLE |
Herbal compositions for treatment of gastrointestinal disorders |
| PATENT ABSTRACT |
Herbal formulations are disclosed for the treatment of gastrointestinal disorders, in particular Irritable Bowel Syndrome (IBS). The compositions are formulated preferably with powdered herbs however combined extracts of herbs are also contemplated. |
| PATENT INVENTORS | This data is not available for free |
| PATENT ASSIGNEE | This data is not available for free |
| PATENT FILE DATE | 24.03.99 |
| PATENT REFERENCES CITED | This data is not available for free |
| PATENT CLAIMS |
What is claimed is: 1. A composition comprising the herbs Ledebouriellae Sesloidis, Bupleurum Chinense, Artemesiae Capillaris, Fraxini, Plantaginis, Paeoniae Lactiflorae and Schizandrae. 2. A composition according to claim 1, which is formulated with powdered herbs. 3. A composition according to claim 1, which includes extracts of the herbs. 4. A composition according to claim 1, in a capsule or table dosage form. 5. A composition according to claim 1, further including pharmaceutically acceptable excipients, adjuvants, solvents, carriers, flavours, colourings or coatings. 6. A composition comprising at least two herbs selected from the group consisting of Codonoposis Pilosulae, Atractylodis Macrocephalae, Poriae Cocos and Olycyrrhizae Uralensis, any two herbs selected from the group consisting of Agastaches seu Pogostemi, Magnoliae Officinalis, Citri Reticulatae and Saussureae sue Vladimiriae, at least two herbs selected from the group consisting of Phellodendri, Coptidis, Coicis Lacluyma-jobi, Zingiberis Offinicinalis and Angelicae Dehuricae, and at least two herbs selected from the group consisting of Ledebouriellae Sesloidis, Bupleurum Chinense, Artemesiae Capillaris, Fraxini, Plantaginis, Paeoniae Lactiflorae and Schizandrae. 7. A composition according to claim 6, which is formulated with powdered herbs. 8. A composition according to claim 6, which includes extracts of the herbs. 9. A composition according to claim 6, in a capsule or tablet dosage form. 10. A composition according to claim 6, further including pharmaceutically acceptable excipients, adjuvants, solvents, carriers, flavours, colourings or coatings. 11. A composition comprising the herbs Codonoposis Pilosulae, Agastaches seu Pogostemi, Ledebouriellae Sesloidis, Coicis Lachyrmna-jobi, Bupleurum Chinense, Artemesiae Capillaris, Atractylodis Macrocephalae, Magrioliae Officinalis, Citri Reticulatae, Zingiberis Offinicinalis, Fraxini, Poriae Cocos, Angelicae Dehuricae, Plantaginis, Phellodendri, Glycyrrhizae Uralensis, Paeoniae Lactiflorae, Saussureae seu Vladimirae, Coptidis and Schizandrae. 12. A composition according to claim 11, which is formulated with powdered herbs. 13. A composition according to claim 11, which includes extracts of the herbs. 14. A composition according to claim 11, in a capsule or tablet dosage form. 15. A composition according to claim 11, further including pharmaceutically acceptable excipients, adjuvants, solvents, carriers, flavours, colourings or coatings. 16. A method of treating gastrointestinal disorders comprising administering to a subject requiring such treatment a therapeutically effective amount of a composition according to claim 1, thereby treating the disorder. 17. A method according to claim 16, wherein the gastrointestinal disorder to be treated is Irritable Bowel Syndrome (IBS). 18. A method according to claim 16, wherein the treatment is administered orally. 19. A method according to claim 16, wherein the treatment is therapeutic or prophylactic and may be administered in a single bolus dose, multiple doses or via a slow release device. 20. A method of treating gastrointestinal disorders comprising administering to a subject requiring such treatment a composition according to claim 6, thereby treating the disorder. 21. A method according to claim 20, wherein the gastrointestinal disorder to be treated in Irritable Bowel Syndrome (IBS). 22. A method according to claim 20, wherein the treatment is administered orally. 23. A method according to claim 20, wherein the treatment is therapeutic or prophylactic and may be administered in a single bolus dose, multiple doses or via a slow release device. 24. A method of treating gastrointestinal disorders including the administration to a subject requiring such treatment a composition according to claim 11, thereby treating the disorder. 25. A method according to claim 24, wherein the gastrointestinal disorder to be treated is Irritable Bowel Syndrome (IBS). 26. A method according to claim 24, wherein the treatment is administered orally. 27. A method according to claim 24, wherein the treatment is therapeutic or prophylactic and may be administered in a single bolus dose, multiple doses or via a slow release device. -------------------------------------------------------------------------------- |
| PATENT DESCRIPTION |
FIELD OF THE INVENTION This invention relates to new medicinal compositions and methods for treating gastrointestinal disorders, in particular the treatment of Irritable Bowel Syndrome. BACKGROUND OF THE INVENTION Irritable bowel syndrome (IBS) is a common functional bowel disorder accounting for a significant proportion of patients seen in gastroenterologly practice..sup.1 it is charecterised by chronic or recurrent abdominal pain and disturbed defecation. studies in the U.S.A. and Australia suggest that between 10% and 20% of the population suffer from this disorder..sup.2,3,4,5 There is no single treatment available that is reliably effective for this condition..sup.6,7 Patients use a variety of approaches to assist in its management including drugs, dietary modifications, counselling, and more recently Chinese herbal medicine (CHM)..sup.8 According to the fundamental principals of practice in traditional Chinese medicine, treatment should be tailored to the individual clinical presentation of patients, even though they may all have the same western medical diagnosis..sup.8,14,15 Furthermore, treatment needs to be modified at different stages of the patient's illness or recovery. However, such an approach to treatment of disease can be cumbersome and is not entirely compatible with conventional pharmaceutical and medical practice. Thus, there is a need for effective standardised Chinese herbal medicinal preparations for the treatment of gastrointestinal disorders such as irritable bowel syndrome and for appropriately rigorous clinical study design for assessing their efficacy. It is an object of the present invention to provide an effective treatment for gastrointestinal disorders, such as Irritable Bowel Syndrome (IBS), which would ameliorate at least some of the disadvantages of the prior art therapies and methods, or at least provide useful alternatives. SUMMARY OF THE INVENTION A Chinese herbal formulation disclosed herein for treatment of gastrointestinal disorders, in particular Irritable Bowel Syndrome (IBS), was compared against a placebo (made to taste, smell and look like Chinese herbs) using a randomised, double-blind, placebo controlled study design. According to a first aspect there is provided a composition including the herbs Ledebouriellae sesloidis, Supleurum chinense, Artemesiae capillaris, fraxini, plantaginis, Paeoniae lactiflorae and schizandrae. According to a second aspect there is provided a composition including any two herbs selected from the group consisting of Codonopsis Pilosulae, Atractylodis Macrocephalae, Poriae Cocos and Glycyrrhizae Uralensis, any two herbs selected from the group consisting of Agastaches seu Pogostemi, Magnoliae Officinalis, Citri Reticulatae and Saussureae seu Viladimiriae, any two herbs selected from the group consisting of Phellodendri, Coptidis, Colcis Lachryma-jobi, Zingiberis Offinicinalis and Angelicae Dehuricae, and any two herbs selected from the group consisting of Ledebouriellae Sesloidis, Bupleurum Chinense, Artemesiae Capillaris, Fraxini, Plantaginis, Paeoniae Lactiflorae and Schizandrae. According to a third aspect there is provided a composition including the herbs Codonopsis Pilosulae, Agastaches seu Pogostemi, Ledebouriellae Sesloidis, Coicis Lachryma-jobi, Bupleurum Chinense, Artemesiae Capillaris, Atractylodis Macrocephalae, Magnoliae Officinalis, Citri Reticulatae, Zingiberis, Offinicinalis, Fraxini, Poriae Cocos, Angelicae Dehuricae, Plantaginis, Phellodendri, Glycyrrhizae Uralensis, Paeoniae Lactiflorae, Saussureae seu Vladimiriae, Coptidis and Schizandrae. Preferably, the compositions are formulated with powdered herbs. If the moisture content of the herbs is high, the herbs can be baked before being powdered by for example grinding, or by other suitable means. Even more preferred are formulations which include extracts of the herbs. For such formulations each individual herb can be extracted either with water or an organic solvent (eg. alcohol) and the extracts combined in an appropriate formulation. Alternatively all the dry herbs can be combined, boiled together and then concentrated by spray drying or other means known in the art, into a dry granulated formulation. Preferably, the compositions are prepared in a capsule dosage form, however it will be understood by those skilled in the art that other dosage forms may also be suitably prepared by known methods, for example tablets, powders, pastes, liquids and similar dosage forms. Also it will be understood that the compositions of the present invention may also contain one or more conventional pharmaceutically acceptable excipients, adjuvants, solvents or carriers and may also include flavours, colourings, coatings, etc. According to a fourth aspect there is provided a method of treating gastrointestinal disorders including the administration to a subject requiring such treatment a composition according to any one of first to third aspects. Preferably, the gastrointestinal disorder to be treated is Irritable Bowel Syndrome (IBS). The treatment is preferably administered orally and may be therapeutic or prophylactic. The treatment may be delivered in a single bolus dose, multiple doses or via a slow release device. The term "herb" as used herein includes the whole herb or tuber, as well as the root, stem, flower or fruit of the herb. DETAILED DESCRIPTION OF THE INVENTION In a preferred embodiment of the invention, the composition of the invention includes a combination of any two herbs selected from Groups 1, 2 and 3 and any three herbs selected from Group 4, depicted in Table 5. The herbs may each be included in concentration of from 1% to 30% of the total weight of the herbal composition. In another preferred embodiment the composition of the invention includes the herbs Ledebouriellae Sesloidis, Bupleurum Chinense, Artemesiae Capillaris, Fraxini, Plantaginis, Paeoniae Lactiflorae and Schizandrae, each herb included in a concentration of from 1% to 30%, the balance being made up for example by other herbs, preferably Codonopsis Pilosulae, Agastaches seu Pogostemi, Coicis Lachryma-jobi, Atractylodis Macrocephalse, Magnoliae Officinalis, Citri Reticulatae, Zingiberis Offinicinalis, Poriae Cocos, Angelicae Dehuricae, Phellodendri, Glycyrrhizae Uralensis, Saussureae seu Vladirniriae and Coptidis. Although the administration of compositions including a selection of herbs from each of the four groups depicted in Table 5, or the key herbs discussed above and depicted in Table 6, are useful in the treatment of Irritable Bowel Syndrome, the synergism between all the herbs renders the administration of a combination containing each of the herbs mentioned desirable. Thus, in a more preferred embodiment, the composition of the present invention includes each herb combined in the proportions given in Table 2. In addition to providing for the first time an effective and well tolerated treatment for Irritable Bowel Syndrome, the availability of the herbs and ease of formulation (powdering, extraction, etc.) provides a less costly alternative medicament. The treatment may also be individualised as well as prepared as a standard formulation, making the treatment more broadly applicable and effective over both short and long term administration. The invention will now be described with reference to the following examples to illustrate preferred embodiments only and does not serve to limit the invention. |
| PATENT EXAMPLES | This data is not available for free |
| PATENT PHOTOCOPY | Available on request |
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