Claims:CLAIMS
I/We, Claim,
1. A nutraceutical formulation comprising of the combination of extracts from the following herbs:
a)Crataeva nurvala
b)Boerhavia diffusa and
c) Piperine

2. A nutraceutical herbal formulation as claimed in claim 1 increases overall health of the urinary tract of a patient suffering from UTI (urinary tract infections).

3. A nutraceutical formulation as claimed in claim 1 is a health supplement in an ingestible form.

4. The health supplement as claimed in claim 2 comprising the nutraceutical composition claimed in claim 1; wherein the ingestible form is selected from a powder, capsule, tablet, syrup, granules, gel, spray or beverage. , Description:1. PREAMBLE TO THE DESCRIPTION

1. The following complete specification particularly describes the invention and the manner in which it is to be performed:

“HERBAL FORMULATION FOR THE MAINTENANCE OF URINARY TRACT HEALTH”

2. TECHNICAL FIELD
2. The present invention relates to the field of herbal formulation and composition; more particularly health and wellness supplements. The present invention facilitates the overall maintenance of our urinary tract system including kidneys.

3.1 BACKGROUND OF THE INVENTION
3. Infections of the Urinary Tract or in other terms called (UTI) is extremely common in people of all age groups. Urinary tract infections are the second most common type of infection in the body, accounting for about 8.1 million visits to health care providers each year. Women are more prone to UTIs than men mainly due to anatomical factors. One such factor is that a woman’s urethra is shorter, allowing bacteria quicker access to the bladder. Also, a woman’s urethral opening is near sources of bacteria from the anus and vagina. For women, the lifetime risk of having a UTI is greater than 50 percent. UTIs in men are not as common as in women but can be serious when they occur.

4. The human urinary tract consists of 3 parts that is Kidney, Bladder and Urethra. When the infection occurs in kidney, it is called acute pyelonephritis; when the infection occurs in the bladder it is called cystitis; when the infection occurs in the Urethra it is called urethritis. Each infection has its own symptoms like lower and upper back pain, nausea; pain in the lower pelvis, painful urination, blood in the urine, foul smelling urine etc.

5. Most UTIs are caused by bacteria that live in the bowel. The bacterium Escherichia coli (E. coli) cause the vast majority of UTIs. Microbes called Chlamydia and Mycoplasma can infect the urethra and reproductive system but not the bladder. Chlamydia and Mycoplasma infections may be sexually transmitted and require treatment of sexual partners.

6. The urinary tract has several systems to prevent infection. The points where the ureters attach to the bladder act like one-way valves to prevent urine from backing up toward the kidneys, and urination washes microbes out of the body. In men, the prostate gland produces secretions that slow bacterial growth. In both sexes, immune defenses also prevent infection. But despite these safeguards, infections still occur. Certain bacteria have a strong ability to attach themselves to the lining of the urinary tract. The urinary tract is the body's drainage system for removing wastes and extra water. The urinary tract includes two kidneys, two ureters, a bladder, and a urethra. Every minute, a person’s kidneys filter about 3 ounces of blood, removing wastes and extra water. The wastes and extra water make up the 1 to 2 quarts of urine a person produces each day.

7. UTIs in men are not as common as in women but can be serious when they occur. People with spinal cord injuries or other nerve damage around the bladder have difficulty emptying their bladder completely, allowing bacteria to grow in the urine. Anyone with an abnormality of the urinary tract that obstructs the flow of urine—a kidney stone or enlarged prostate, for example—is at risk for a UTI. People with diabetes or problems with the body’s natural defense system are more likely to get UTIs. Pregnant women seem more prone to UTIs than other women. However, when a UTI does occur in a pregnant woman, it is more likely to travel to the kidneys.

8. Most UTIs are not serious, but some infections can lead to serious problems, such as kidney infections. Chronic kidney infections—infections that recur or last a long time—can cause permanent damage, including kidney scars, poor kidney function, high blood pressure, and other problems. Some acute kidney infections—infections that develop suddenly—can be life threatening, especially if the bacteria enter the bloodstream, a condition called septicemia. Complicated UTIs occur when a person—for example, a pregnant woman or a transplant patient—is weakened by another condition. A UTI is also complicated when the person has a structural or functional abnormality of the urinary tract, such as an obstructive kidney stone or prostate enlargement that squeezes the urethra. Health care providers should assume that men and boys have a complicated UTI until proven otherwise.

9. Curing infections that stem from a urinary obstruction or other systemic disorder depends on finding and correcting the underlying problem, sometimes with surgery. If the root cause goes untreated, this group of patients is at risk for kidney damage. In addition, such infections tend to arise from a wider range of bacteria and sometimes from more than one type of bacteria at a time.

10. Urinary tract infections in men are often the result of an obstruction—for example, a urinary stone or enlarged prostate—or from a catheter used during a medical procedure. Prostate infections—chronic bacterial prostatitis—are harder to cure because antibiotics may be unable to penetrate infected prostate tissue effectively. For this reason, men with bacterial prostatitis often need long-term treatment with a carefully selected antibiotic. UTIs in men are frequently associated with acute bacterial prostatitis.

11. In Ancient days, people maintain their health through proper diet practices and Herbs. Herbs formed an integral part of their healthcare system. Herbalism was most popular in Asian Region whereas India has been popular for herbs and herbal healthcare system since time immemorial.

12. As the motherland for herbs we own a valuable healthcare system. Ayurveda as an Indian herbal care system paves its way to treat the people in many ways in ancient days. Charaka listed five hundred remedies and Sushruta over seven hundred vegetable medicine.

13. Furthermore, the translation of the Ayurvedic literature into Persian and Arabic in the eleventh century A.D. led eventually to further spread of Indian medical lore into Europe, as writings in Arabic became part of European culture in the middle ages. In fact, Ayurveda today, is believed to be the only complete medical system which still exists where as other forms of ancient medicine have lost parts of their original information. The glorified Ayurvedic history has proved that Ayurveda is the true science of life, prevention and longevity.

14. Likewise, we have brushed away the past and went in search of ancient treasure herbs and rejuvenated them with the modern technology. Here is to say the power of herbs to the western culture to draw an inspiration from ancient times and take advantage of best in modern science and technology. The present invention aims to give an excellent support to maintain the health of urinary tract thereby preventing the recurrence of UTIs and relieving the UTI patients from the painful symptoms associated with it. The present embodiment helps to rejuvenate and recovers from multiple UTIs that affect the urinary tract. The present embodiment is particularly effective in reducing the risk of kidney and gall bladder stone formation.

15. To maintain the health of urinary tract and to prevent the recurrence of UTIs, the herb Crataeva nurvala extract is enriched with the herb Boerhavia diffusa extract and Piperine to form this formulation.

3.2 PRIOR ART
16. 202011023562 - The phyto-amalgamation of any nanoparticle has attracted attentions of several researchers. The green synthesis has led to a new revolution in nanoparticle sciences. In this invention Cefotaxime for E. coli and P. aeruginosa was incorporated along with ZnO prepared by green synthesis using Oscimum sanctum. The composition was found to be active against antibiotic resistant microbes.

17. 202041024845 - A Novel, non-invasive herbal formulation for the effective prevention and management of Senile Urinary incontinence having Mimosa pudica and Mucuna pruriens in the ratio of 80% and 20% respectively as ingredients to be given in oral dosage form possessing Nervine tonic, Anti-convulsant and alterative properties as substantiated by In-vitro Calmodulin inhibition activity.

18. CA2727698A1 A- The present invention relates to a therapeutic agent for a lower urinary tract disease, wherein the agent comprises a thrombin-like enzyme.

19. WO 202195037A1 - The present invention relates to a pharmaceutical composition containing an effective amount of D-allose for the prevention or treatment of urothelial cancer by intracavitary injection of urinary organs.

20. US7465466B2 - A method including contacting a prostate cell with the composition including an aliquot of the herb Herba epimedii; and an aliquot of at least three supplemental herbs selected from the group consisting of Fructus Rosa laevigata; Fructus Rubi; Fructus Psoralea; Radix Morindae officinalis; Fructus Schisandra chinensis; Fructus Ligustri lucidi; Semen cuscutae; and Radix astragali. A method including identifying a subject with a prostate / kidney disorder; and establishing a regimen for administering a composition including an aliquot of the herb Herba epimedii, and an aliquot of at least three supplemental herbs selected from the group consisting of Fructus Rosa laevigatae; Fructus Rubi; Fructus Psoralea; Radix Morindae officinalis; Fructus Schisandra chinensis; Fructus Ligustri lucidi; Semen cuscutae; and Radix astragali.

21. US20160015763A1 - A nutraceutical formula and food-based medicinal composition is provided comprising homeopathic ingredients in combination with traditional herbal and nutraceutical ingredients for relieving the symptoms associated with presence or formation of kidney stones and gallstones. The formulation includes ingredients balanced in a synergistic manner to elicit complementary effects which both reduce the symptoms of kidney stones and gallstones and provide the potential to eliminate their occurrence in the body and prevent future recurrence. Methods of making and using core medicinal formulations and food-based compositions are also described.

22. US20160354436A1 - Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

4. TECHNICAL PROBLEM TO BE SOLVED
23. Urinary tract infections or UTI are the second most common type of infection in the body and is extremely common in people of all age groups. The present invention facilitates the overall maintenance of our urinary tract system including kidneys. It assists in checking frequent and repeated occurrence of urinary tract infections which are generally recurring by nature. The present embodiment is found to be very effective in reducing the risk of kidney and gall bladder stone formation. The present embodiment is target specific and increases overall health of the urinary tract of a patient suffering from UTI (urinary tract infections).
5. SUMMARY OF THE INVENTION
24. The following summary is provided to facilitate an understanding of some of the innovative features unique to the disclosed embodiment and is not intended to be a full description. A full appreciation of the various aspects of the embodiment disclosed herein can be gained by taking the entire specification, claims and abstract as a whole.

25. The prior arts are insufficiently suited for effective maintenance of the urinary tract. It is, therefore, one aspect of the present invention is to provide a novel herbal formulation that maintains the overall health of the urinary tract of people suffering from urinary tract infections.

26. The main aspect of the disclosed embodiment is to produce an herbal formulation to maintain the health of the urinary tract.

27. It is another aspect of the present invention to maintain normal kidney health by controlling the urea and creatinine level in the blood.
28. It is another aspect of the present invention to reduce the risk of renal stone formation.

29. It is another aspect of the present invention to check frequent and repeated occurrence of urinary tract infections which are generally recurring by nature.

30. Yet another aspect of the disclosed embodiments to provide herbal antimicrobial agents to the urinary tract which prevent urinary tract infections.

31. Yet another object of the invention is to be efficient, a one stop solution to improve renal health and to remain as cost efficient as possible.

32. Still another aspect of the disclosed embodiments is to be target specific and increases overall health of the urinary tract of a patient suffering from UTI (urinary tract infections).

33. The aforementioned aspects and other objectives can be achieved by combining the extracts of the following three herbs in an appropriate proportion as described in the detailed description.

1. Crataeva nurvala (Varuna Bark Extract).
2. Boerhavia diffusa (Punarnava Extract) and
3. Piperine (Extracted from Piper nigrum).

7. DETAILED DESCRIPTION
34. The present invention provides for the unique composition that maintains the overall health of the urinary tract with three herbs namely Crataeva nurvala (Varuna bark extract), Boerhavia diffusa (Punarnava extract) and Piperine (Extracted from Piper nigrum).

35. Crataeva nurvala (Varuna Bark Extract)
Botanical Description: Crataeva nurvala (Varuna) is a small tree, often cultivated throughout India, especially along the streams and riverbanks. It is distributed in sub-himalayan tracts and is indigenous to Tamil Nadu, Kerala and Karnataka. It is found in abundance, in Kerala, Madhya Pradesh, Bengal and Assam. The plant flowers mostly in March and fruits in June. Crataeva nurvala is a moderate sized deciduous tree. The outer surface of the bark is grey to greyish-brown and rough due to the presence of several small and rounded lenticels. The inner surface is smooth and whitish-brown to buff colored.

36. Phytoconstituents: Crataeva nurvala contains flavonoids, glucosinolates, and plant sterols, including lupeol, saponins and tannins. Tannins are acidic compounds that inhibit the absorption of calcium; Because of this property it is beneficial in preventing kidney stone formation. Lupeol reduces the risk of stone formation, by way of preventing crystal induced tissue damage and dilution of urinary stone forming constituents.

37. The major properties are
a.Improvement in the quality of urinary bladder tone and normalization of urination.

b.The phytochemicals present in Crataeva nurvala, help to relieve urological problems.

c.Lupeol, a pentacyclic triterpene from Crataeva nurvala stem bark, proved to be an effective herbal ingredient in treating, urolithiasis and renal inflammation.

d.Possesses anti-inflammatory, diuretic, lithotripsic, demulcent and tonic properties.

e.Alleviates problem in urination owing to swelling of the prostate.

f.Decrease in urinary enzymes levels.
g.Reduction in crystal deposition leading to minimized tubular damage.

h.Anti-microbial activity.

i.Responsible for antihepatotoxicity, antihyperglycemic & antioxidant activities - By antioxidant property; increase level of antioxidant enzymes.

38. Boerhavia diffusa (Punanrnava Extract)
Botanical Description: Boerhavia diffusa is found throughout India. It grows up to 70 centimeters in height. It has a large root system and produces yellow and white flowers. It is found throughout the warmer parts of the country up to an altitude of 2000 meters in the Himalayan region. It grows well on wastelands and in fields after the rainy season.

39. Phytoconstituents: Major components are sitosterol, esters of sitosterol, punarnavine, boerhavia acid, boerhavinone, palmitic acid and many other compounds. The seeds of this plant contain fatty acids and allantoin and the roots contain alkaloids. The green stalk of the plant contains boerhavin and boerhaavic acid.

40. The major properties are
a.Ayurvedic literature claims that Boerhavia diffusa possesses rejuvenative properties especially related to the urinary system.

b.It has been used in various formulations meant for inflammation, jaundice, asthma, rheumatism, nephrological disorders, ascites, anemia, and gynecological disorders.

c.It is a well-known diuretic and renoprotective plant in the traditional system of medicine.

d.Studies approving diuretic and kidney stone dissolving properties of Boerhavia diffusa extracts along with the isolation of a diuretic alkaloid, punarnavine, describe the use of Punarnava Extract in urinary disorders.
e.Effective diuretic, works well on the urinary system and it targets the damaged nephrons; increases the glomerular filtration process of kidneys.

f.Formulations containing Punarnava as the main ingredient are used in ascites, anasarca, dropsy, kidney troubles, urinary stones, and swelling of the legs.

g.Anti-microbial activity - Boerhavia diffusa has antimicrobial action owing to the presence of ß-sitosterol or the synergistic effect of ß- sitosterol with other active constituents in the plant. Boerhavia diffusa play a beneficial role managing bacterial urinary tract infections.

h.Also helps to protect the kidney from free radical damage.

i.Additionally, it exhibits anti-inflammatory properties which soothe and calm the urinary tract.

41. PIPERINE - Botanical Description: Piper nigrum, commonly called as black pepper, is a member of family Piperaceae. The genus piper includes 700 species distributed in northern and southern hemispheres. Piper nigrum is a perennial climbing shrub. Pepper, one of the oldest known spices, is native to tropical Asia. Black pepper has been used traditionally as a spice since time immemorial. It is considered an important healing spice in Ayurveda.

42. A recognized feature of the 6000-year-old practice of Ayurveda is its preoccupation with the proper functioning of the digestive tract, specifically the digestion and absorption of nutrients.

43. Phytoconstituents: Piperine is obtained from the black pepper fruit that is cultivated in the damp, nutrient-rich soil regions of southern India. The delicate pepper berries are harvested just prior to ripening and then sun dried to assure optimum maturity and quality. The extract of black pepper, called Piperine has been clinically tested in the United States. Piperine significantly enhances the bioavailability of various supplement nutrients through enhancing the absorption of active components.

44. The major properties of Piper nigrum are:
a. Piperine proves as an active component possessing antipyretic, analgesic and anti-inflammatory actions.

b. It is used as nervine tonic and against stultification and flatulency.

c. Antifungal & anti-bacterial activity.

d. This special ingredient has been added to enhance the bioavailability of bioactive phytochemicals from varuna bark and punarnava extract.

e. Piperine could be a potent natural herbal ingredient exhibiting nephroprotective effect. 

f. Piperine can prevent development of ischemia-reperfusion induced acute kidney injury.