FIELD OF THE INVENTION The present invention relates to novel herbal composition (A) and novel herbal composition (B) for treatment of renal stones and urinary disorders wherein composition (A) and composition (B) are synergistically administered to achieve enhanced efficacy and better results. BACKGROUND Kidney stones are formed in our body when there is a disturbance in the normal balance of water, minerals, salts and other constituents of urine. As a consequence, the salts and minerals in the urine form ‘pebbles’ which are also known as kidney stones. They may stay in the kidneys or travel out of the body through the urinary tract. Kidney stones are mostly not painful when they are in the kidneys but they can cause sudden, severe pain when they move out of the body. Kidney stones lead to increased urinary tract infections and may also cause kidney damage if they block the flow of urine out of both the kidneys. Kidney stones may lead to more serious consequences in persons with a single kidney, impaired immune system or kidney transplant. Small stones can be removed from the body by drinking lots of water but the larger stones require extensive treatment such as extracorporeal shock wave lithotripsy (ESWL) in which sound waves break the stones into smaller pieces so that they can pass out of urine. There are several other procedures also such as Ureteroscope, percutaneous nephrolithotomy etc. However, all such methods have disadvantages For E.g. ESWL may lead to blood in the urine, bleeding around the kidney and other adjacent organs. For this reason, herbal compositions are being developed with fewer or no side effects. Many herbal products are also available in the market. The product rensafe is a litholytic diuretic product. Similarly, there are other products in the market such as urifine, atmoflux, K-crush. Such products are herbal compositions for treatment of kidney stones and other related disorders. Indian Patent number 249299 discloses a synergistic herbal formulation comprising A) a homogenized powdered mixture of i) Varun extract prepared from barks of at least one plant selected from a group of plant consisting of Varun, Crataeva nurvala, Buch-Ham and Crataeva magna, ii) banana stem extract prepared from stems of at least one plant selected from the group of plants consisting of Musa paradisiacal L and Musa sapientum L, B) ash salt of banana root and C) a pharmaceutically acceptable carrier.
WO2012127498 discloses synergistic herbal composition comprising combination of therapeutically effective amount of herbal constituents/ingredients extracted from
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bark of Crataeva nurvala (Varuna); stem, kand i.e. yam and root of Musa sapientum (Banana); five different plant parts i.e. flower, leaves, seed, root, fruits of Achyranthus aspera (Aghada); and seeds of Hordeum vulgare (Yav/Satu), along with pharmaceutical acceptable additives, useful for the treatment of kidney stone and other urinary tract disorders like inflammation and urinary stent related problems. US20130177597 discloses a herbal composition made with interactive ingredients for treatment of kidney disorders such as nephrotic syndrome, comprising mango seed powder, Mangifera Indica and at least one other active ingredient from a group including dandelion, Taraxacum officinale, fennel seed, Foeniculum Vulgare, spreading hogweed, Boerhavia diffusa, and nettle plant, Urtica dioica. There is still a need for compositions that are natural with no side-effects, have enhanced efficacy and deliver better results than the existing ones. OBJECT OF THE INVENTION An object of the invention is to provide a novel herbal composition (A) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections. Another object of the invention is to provide a novel herbal composition (B) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections. Yet another object of the invention is to provide a method for treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the novel herbal composition (B) is administered synergistically along with the novel herbal composition (A). Another object of the invention is to provide safe and effective novel herbal compositions that work synergistically in the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections. Still another object of the invention is to provide safe and effective novel herbal compositions for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria and urinary tract infections which can be formulated in tablet, capsule or syrup form as per the dosages required.
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SUMMARY OF THE INVENTION In one embodiment, the present invention relates to a novel herbal composition (A) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the composition (A) comprises of therapeutically effective amounts of elettaria cardamomum, bergenia ligulata, crataeva nurvala, picrorhiza kurroa, tribulus terestris, boerhavia diffusa, sodh cloridis salt, sodium bicarbonate, coriandrum sativum, processed alum compound, jawakshar, dolichos biflorus, zea mays and raphanus sativus. In another embodiment, the present invention relates to a novel herbal composition (B) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the composition (B) comprises of therapeutically effective amounts of processed alum compound, lash of raphanus sativus, piper cubeba, rock salt, sajjikshar, bergenia ligulata, crataeva nurvala, tribulus terrestris, boerhavia diffusa, dolichos biflorus, solanum nigrum, zea mays, berberis aristata along with pharmaceutically acceptable additives. In another embodiment, the present invention relates to a process for preparation of the compositions (A) and (B). In a preferred embodiment, the present invention relates to a method for treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the novel herbal composition (B) is administered synergistically along with the novel herbal composition (A). Further, the present invention relates to a method for treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the novel herbal composition (B) and novel herbal composition (A) are administered separately such that the said compositions have a synergistic effect on the user. DETAILED DESCRIPTION OF THE INVENTION The invention will be described in more detail in accordance with the disclosure above; a brief description of the therapeutic ingredients of the compositions disclosed in the present invention is as follows:
Elettaria cardamomum: commonly known as ‘elaichi’ in India, and is a herbaceous perennial plant in the ginger family, native to southern India. It is the most common of the species whose seeds are used as a spice called cardamom. Elettaria shows potent
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property as aromatic stimulant and diuretic. This herb is being used as spice and medicine since 4th century. Bergenia ligulata: also known as ‘pashanbheda’ in ayurveda, Bergenia ligulata is a widely used plant in South Asia, mainly India and Pakistan, as a traditional medicine for treatment of urolithiasis or kidney stones. Bergenia has tannic acid and gallic acid as the active components. Bergenia has a high content of mucilage which renders the herb its demulcent property. It is an effective remedy for haemorrhoids, diarrhea, dysentery, heart diseases, raktapitta and splenic disorders. Crataeva nurvala: Known as ‘varuna’ in ayurveda, it is found throughout India, especially in sub-Alpine zones along streams and rivers. The key components of crataeva are saponins and tannins. The main health actions of crataeva nurvala are diuretic, antilithiatic, rubefacient (reddening the skin by producing hyperemia) and anti-inflammatory. Varuna is also to used to increase appetite while stimulating digestion and elimination and also as a herbal treatment for flatulence and abdominal pain. Picrorhiza kurroa: ‘kutki’ or ‘titkakul’ is one of the oldest medicinal plants traded from the Karnali zone. It normalizes uretheral peristalsis and facilitates the passage of calculi. It reduces inflammation and stimulates the immune system. Tribulus terrestris: is an annual plant in the caltrop family (Zygophyllaceae) widely distributed around the world that is adapted to grow in dry climate locations. Known as ‘gokshura’ in ayurveda, it decreases renal epithelial damage, inflammation and restores normal glomerular morphology. It exerts potent diuretic effect. Raphanus sativus: Commonly known as ‘radish’, it hails its origin from South East Asia. It is efficacious as a laxative and kidney stone crusher. It is rich in potassium and useful for controlling the disbursement of calcium in urine and thus reduces the risk of kidney stone. Boerhaavia diffusa: Known as ‘punarnava’ in ayurveda, it is widely dispersed, occurring throughout India, the Pacific, and southern United States. It exerts potent diuretic action, reduces pain and has potent immunomodulatory effects. Sodh cloridis: It corrects crystalloid colloid imbalance and propels out urinary stone faster. Sodium bicarbonate: also known as ‘baking soda or meetha soda” is a common house hold ingredients. It is used to relieve heartburn, sour stomach, or acid indigestion by neutralizing excess stomach acid.
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Coriandrum sativum: Also known as ‘cilantro or dhania’, it is a powerful herb having diuretic and detoxifying properties. It is a natural cleanser for kidneys and has antioxidant rich phytonutrients, minerals and vitamins that work significantly to boost the overall immune system of the body. Processed alum compound: Commonly known as ‘potassium aluminium sulfate’ it has antiseptic and anti-bacterial properties. It is also used for cosmetic purposes such as skin tightening and skin lightening. Jawakshar: Also known as ‘potassium carbonate’, it helps to treat difficulty in urination and urinary calculi. Dolichos biflorus: Known as ‘Kulthi’ in ayurveda, it is a genus of flowering plants in the legume family, Fabaceae, and the subfamily Faboideae and is distributed in Africa and Asia. It has diuretic and antilithiatic properties. Piper cubeba: Known as ‘kankola’ in ayurveda, the plant is cultivated, especially in Indonesia (mainly on Java and Sumatra) but also in other parts of the tropics, for its use as a medicinal plant, condiment and source of an essential oil. It has a marked diuretic action and helpful as an efficient germicidal for the urinary passage. Rock Salt: Commonly used in households as ‘sendha namak’, it plays an important role in replenishing the body electrolytes and maintaining the pH balance. Sajjikshar: Known by its chemical name ‘sodium carbonate’, it eases micturition and stimulates appetite. Solanum nigrum: ‘Kakamachi’ is an ayurvedic herb and is found in Shimla, Uttar Pradesh, Uttarakhand, Tamil Nadu and in many other regions in India. It is considered to possess antitumorigenic, antioxidant, anti-inflammatory, hepatoprotective, diuretic, and antipyretic properties. Berberis aristata: Also known as ‘daruharidra’ in ayurveda, the herb is rich in berberine and isoquinoline. It is a rich source of Vitamin C and is widely used to treat pain and inflammation. One of the best uses of berberis is in eye related disorders. Zea mays: Commonly known as “maize”, it produces contraction of smooth muscles which facilitates expulsion of renal and ureteric stones. For preparing the compositions of the present invention, extracts of the herbs of the composition were obtained, in a semi-solid form from Sricure Herbs Pvt. Ltd. which has a GMP certified state of the art manufacturing Facility at Panchkula, India.
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The present invention relates to a novel herbal composition (A) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the composition (A) comprises of therapeutically effective amounts of elettaria cardamomum, bergenia ligulata, crataeva nurvala, picrorhiza kurroa, tribulus terestris, boerhaavia diffusa, sodh cloridis salt, sodium bicarbonate, coriandrum sativum, processed alum compound, jawakshar, dolichos biflorus, zea mays and raphanus sativus. In one embodiment, the composition (A) comprises of elettaria cardamomum in an amount 1-10%, bergenia ligulata in an amount 10-20%, crataeva nurvala in an amount 10-20%, picrorhiza kurroa in an amount 2-12% , tribulus terrestris in an amount 5-15% boerrhavia diffusa in an amount 5-15%, sodh cloridis salt in an amount 5-15%, sodium bicarbonate in an amount 5-15%, coriandrum sativum in an amount 2-12%, processed alum compound in an amount 5-15%, jawakshar in an amount 5-15% , dolichos biflorus in an amount 10-20%, zea mays in an amount 10-20% and raphanus sativus in an amount 5-15% of the total composition for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections. Further, the present invention relates to a novel herbal composition (B) for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections wherein the composition (B) comprises of therapeutically effective amounts of processed alum compound, lash of raphanus sativus, piper cubeba, rock salt, sajjikshar, bergenia ligulata, crataeva nurvala, tribulus terrestris, boerhavia diffusa, dolichos biflorus, solanum nigrum, zea mays, berberis aristata along with pharmaceutically acceptable additives. In another embodiment, the composition (B) comprises of processed alum compound in an amount 5-15%, lash of raphanus sativus in an amount 5-15% , piper cubeba in an amount 2-10%, rock salt in an amount 1-10%, sajjikshar in an amount 1-10%, bergenia ligulata in an amount 10-20%, crataeva nurvala in an amount 10-20%, tribulus terrestris in an amount 11-20%, boerhaavia diffusa in an amount 15-25%, dolichos biflorus in an amount 10-20%, solanum nigrum in an amount 1-10%, zea mays in an amount 10-20% and berberis aristata in an amount 1-10% of the total composition used for the treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections. Although the ingredients in the said compositions are mixed in the proportions mentioned above, variations in their respective ratio and proportions are possible depending upon the type and complexity of the disorder and hence, can be used accordingly.
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In another embodiment, the present invention provides novel herbal composition (A) and novel herbal composition (B) suitable for oral use. In one embodiment, novel herbal composition (A) and novel herbal composition (B) can be administered to the subject either alone or synergistically together depending upon the requirement. Although herbal composition (A) and herbal composition (B) are effective when administered alone, it is preferable to administer the compositions synergistically to have a more potent action when used in the treatment of renal stones and other urinary disorders. In a preferred embodiment, the compositions (A) and (B) suitable for oral administration can be present in solid or liquid form. Solid preparations may take the form of tablets, capsules, powder or granules. Such solid preparations can be prepared by conventional means in the dosages as required. Liquid preparations may take the form of syrups, solutions or suspensions. The liquid preparations can be prepared by adding one or more suitable pharmaceutically acceptable additives such as food grade preservatives and stabilizers e.g. sodium benzoate, methyl paraben sodium, propyl paraben sodium, flavor enhancers such as sweet lemon F.G., coloring agents such as tartarazine F.G. and the like. For enhancing the palatability, sugar or natural sweetening agents may be added in desirable amounts. The composition (A) of the present invention is preferably in solid form such as a capsule or a tablet. The composition (B) of the present invention is preferably in liquid form such as syrups. In a preferred embodiment, the present invention comprises of a method of treatment of renal disorders such as kidney stones and urinary tract infections, cystitis, diuresis and dysuria wherein the method involves administering the compositions (A) and (B) in combination so as to achieve maximum efficacy of the herbs in the chosen mode of treatment. More preferably, the method of treating renal disorders such as kidney stones and urinary tract infections, cystitis, diuresis and dysuria comprises of administering composition (A) in solid form and composition (B) as liquid so as to achieve the desired result with enhanced efficacy. In a preferable embodiment, composition (A) is administered as tablet and composition (B) is administered as syrup to achieve maximum efficacy in the treatment method for the above mentioned disorders.
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In another embodiment, the present invention provides novel herbal compositions (A) and (B) which can be administered in combination for the treatment of kidney stones, kidney stone fragments, renal calculi, urinary disorders such as urinary tract infections, cystitis, diuresis and dysuria such that their efficacy increases multiple folds when administered together as compared to the efficacy when any one of the compositions is administered alone. For treatment purposes, the recommended dose of the herbal composition in the form of tablet or capsule is two tablets or capsules of 500mg daily. The recommended dose of the herbal composition in form of syrup or suspension is 10ml of the syrup or suspension with 100ml water twice daily. In another embodiment, the present invention relates to a method for preparing the compositions (A) wherein the ingredients of the composition are mixed with required quantity of water. The mixture is stirred continuously till a smooth mixture is formed. The composition is processed further to formulate it in solid form such as tablets, capsules and the like according to the methods known in the art. The composition (B) is prepared in a similar manner as composition (A). Pharmaceutically acceptable additives are then added to the mixture thus obtained and the said composition is formulated in liquid forms such as syrups, elixirs and the like. Various embodiments in this invention have been described to illustrate specific features of this invention which, in no way, limit the scope of the invention. Possible variations within the scope of the invention can be construed according to the requirement and purposes of the selected treatment method.

WE CLAIM:
1. A novel herbal composition (A) comprising of therapeutically effective amounts of elettaria cardamomum, bergenia ligulata, crataeva nurvala, picrorhiza kurroa, tribulus terestris, boerhaavia diffusa, sodh cloridis salt, sodium bicarbonate, coriandrum sativum, processed alum compound, jawakshar, dolichos biflorus, zea mays and raphanus sativus.
2. A novel herbal composition (B) comprising therapeutically effective amounts of processed alum compound, lash of raphanus sativus, piper cubeba, rock salt, sajjikshar, bergenia ligulata, crataeva nurvala, tribulus terrestris, boerhavia diffusa, dolichos biflorus, solanum nigrum, zea mays, berberis aristata along with pharmaceutically acceptable additives.
3. The composition (A) as claimed in claim 1 comprising of elettaria cardamomum in an amount 1-10%, bergenia ligulata in an amount 10-20%, crataeva nurvala in an amount 10-20%, picrorhiza kurroa in an amount 2-12% , tribulus terrestris in an amount 5-15% boerrhavia diffusa in an amount 5-15%, sodh cloridis salt in an amount 5-15%, sodium bicarbonate in an amount 5-15%, coriandrum sativum in an amount 2-12%, processed alum compound in an amount 5-15%, jawakshar in an amount 5-15% , dolichos biflorus in an amount 10-20% , zea mays in an amount 10-20% and raphanus sativus in an amount 5-15% of the total composition.
4. The composition (B) as claimed in claim 2 comprising of processed alum compound in an amount 5-15%, lash of raphanus sativus in an amount 5-15% , piper cubeba in an amount 2-10%, rock salt in an amount 1-10%, sajjikshar in an amount 1-10%, bergenia ligulata in an amount 10-20%, crataeva nurvala in an amount 10-20%, tribulus terrestris in an amount 11-20%, boerhaavia diffusa in an amount 15-25%, dolichos biflorus in an amount 10-20%, solanum nigrum in an amount 1-10%, zea mays in an amount 10-20% and berberis aristata in an amount 1-10% of the total composition.
5. The composition (B) as claimed in claim 2 wherein the pharmaceutically acceptable additives are selected from a group consisting of food grade preservatives and stabilizers, flavor enhancers, coloring agents, sweetening agents and the like.
6. The composition (A) as claimed in claim 3 is in solid form such as capsules, tablets or the like.
7. The composition (B) as claimed in claim 4 is in liquid form such as syrups, elixirs or the like.
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8. A method of preparation of composition (A) comprising of :
a) mixing the ingredients of the said composition in required quantities
b) stirring the mixture continuously to form a smooth mixture.
c) formulating the mixture in solid form such as tablets and capsules.
9. A method of preparation of composition (B) comprising of :
d) mixing the ingredients of the said composition in required quantities
e) stirring the mixture continuously to form a smooth mixture.
f) adding pharmaceutically acceptable additives to the said mixture
g) formulating the mixture in liquid form such as syrups and elixirs.
10. A method of treatment of renal stones and other urinary tract disorders such as diuresis, dysuria, and urinary tract infections using novel compositions (A) and (B) wherein the compositions (A) and (B) are administered separately such that they work in synergism with each other.