Claims:CLAIMS
I/We, Claim,
1. A nutraceutical polyherbal formulation comprises of the combination of extracts from the following herbs:
1. Mangosteen Rind Extract rich in xanthones (Alpha-mangostin)
2. Grape Seed Extract rich in oligomeric proanthocyanidins
3. Policosanol
4. Rosemary extract (Rosemarinus officinalis) rich natural antioxidants
5. Lactobacillus acidophilus, a cholesterol lowering probiotic.
2. A nutraceutical polyherbal formulation as claimed in claim 1 is used in preventing, controlling and management of hypercholesterolemia.
3. A nutraceutical polyherbal 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, liquid, 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:

“POLYHERBAL NUTRACEUTICAL SUPPLEMENT TO PREVENT AND CONTROL HYPERCHOLESTEROLEMIA”

2. TECHNICAL FIELD
2. The present invention relates to the field of herbal nutraceutical formulations and compositions, more particularly health and wellness supplements. The present invention specifically relates to the field of cholesterol management and further ameliorates the general health of persons with the condition of hypercholesterolemia.

3.2. BACKGROUND OF THE INVENTION
3. Cholesterol is involved in many vital physiological processes, such as maintaining membrane integrity of eukaryotic cells, manufacturing vitamin D on the skin, Synthesis of steroid hormones, and formation of neural synapses in the brain. Due to unhealthy lifestyle & dietary practices people are more prone to high blood cholesterol and overweight. Hypercholesterolemia is one form of hyperlipidemia. Familial hypercholesterolemia is the most common inherited type of hyperlipidemia (high fat or lipid levels in blood). It predisposes to premature arteriosclerosis including coronary artery disease with heart attacks at an unusually young age. About half of men and a third of women suffer a heart attack by age 60.

4. Persons with familial hypercholesterolemia can reduce their risk by adhering to a very low cholesterol diet under a doctor's supervision, and may also need to take medications that reduce their cholesterol level. Familial hypercholesterolemia is recognizable in childhood. Children and other relatives at risk for familial hypercholesterolemia can be screened (checked) for the condition.

5. Familial hypercholesterolemia is due to a genetic defect in the receptor (the dock on the surface of cells) for LDL (low density lipoprotein).

6. However, abnormally elevated cholesterol levels in the blood can lead to health consequences and complications such as atherosclerosis, coronary artery disease and stroke etc. Specifically, coronary heart disease (CHD), one of the leading causes of death worldwide. Atherosclerosis is the pathological process that typically underlies CHD morbidity and mortality.

7. This process involves formation of plaques in the intima and media of the arterial wall. These atherosclerotic lesions result from the progressive accumulation of cholesterol and lipids, extracellular matrix material, and inflammatory cells along the arterial walls. The concentrations of the various types of cholesterol in the blood are predictive of the risk of atherosclerosis and coronary heart disease. Elevated levels of low-density lipoprotein cholesterol (LDL) and triglycerides (TC) represent risk factors for CHD, whereas high concentrations of plasma high-density lipo protein cholesterol (HDL) are considered healthy and protective against CHD. The cholesterol content per LDL molecule can exhibit a large variation between individuals; therefore, LDL particle size and number can provide independent measures of the risk of CHD.
8. Several treatments for elevated cholesterol are known in the art. Cholesterol-modifying regimens include drugs and nutritionally balanced diets that are low in saturated fat and cholesterol. Statins are the most commonly administered medications prescribed for lowering the concentrations of LDL cholesterol in the blood. It is known in the art that HDL levels can be increased and LDL levels can be reduced by aerobic exercise and dietary modifications. Oxidized low density lipoprotein (LDL) is a major correlate of oxidative stress in hypercholesterolemia patients and that statins may reduce oxidative stress by reducing enhanced plasma levels of LDL, which are more susceptible to peroxidation in hypercholesterolemia.

9. In recent years, nutraceutical and functional foods have attracted interest as possible alternative therapies for lowering plasma TC, including for patients who present with marginally elevated blood cholesterol concentrations that are not high enough to indicate the necessity for cholesterol-lowering medications.

10. Nutraceutical and functional foods lower the high cost of long-term treatment with cholesterol-lowering drugs and the requirement for physician monitoring is an impetus for self-directed, safe and effective means for patients to maintain or lower their blood cholesterol levels.

11. Most of the products available in market are not having accurate results. They are rather very expensive or difficult to attain desired results. Moreover, they do not aim at prevention of hypercholesterolemia and further decrease immunity.

12. Based on the foregoing, it is believed that a need exists for a novel nutraceutical composition to prevent the hypercholesterolemia among people. A need also exists for an effective health supplement for hypercholesterolemia patients. Hence, a polyherbal nutraceutical formulation for the prevention of hypercholesterolemia to the patients has been invented, which is described in detail below. Due to unhealthy lifestyle & dietary practices people are more prone to overweight and high blood cholesterol. These conditions lead to complications such as atherosclerosis, coronary artery disease and stroke etc.

3.3 PRIOR ART
13. In 399/CHENP/2007, the inventor discloses a method for the treatment of obesity, diabetes, high cholesterol and related diseases including hyperglycemia, lipid disorders, hyperglyceridemia, dyslipidemia and atherosclerosis in mammals using anthocyanins, anthocyanidins, ursolic acid and/or betulinic acid is described. Compositions adapted for these treatments are also described.

14. In IN201917018506A, the inventor discloses a composition comprising a therapeutically effective amount of polypeptide, peptide, or analog corresponding to one or more of SEQ ID NO(s) 1, 2, 3 or 4, and or more of a pharmaceutically acceptable carrier, pharmaceutically acceptable diluent, and/or pharmaceutically acceptable excipient. The polypeptide therapeutic of the present invention may be formulated for administration to a subject in need of treatment as an oral formulation, a parenteral formulation, a topical formulation, an aqueous formulation, a solid formulation, a lyophilized formulation, or a trans-dermal formulation. Also disclosed is a method for treating at least one of diabetes, and/or hyperglycemia, and/or hypercholesterolemia, and/or hypertension, and/or metabolic syndrome in a subject, comprising: administering to the subject a polypeptide of the invention or formulation of the invention.

15. In US 7.959,950 B2, the inventor discloses a human or animal dietary Supplement composition comprising one or more long chain (C24-C36) primary alcohols (policosanols) dispersed in food-grade oils or fats where the policosanol particle size is substantially less than ten (10) microns. The composition (NanocosanolTM) is effective and
convenient for supporting blood lipid health.

16. In US 8,017,147 B2, the inventor discloses A synergistic mixture (which may be utilized as a food or a drink or a Supplement or a drug or a cosmetic or a hygienic product) that is formulated and is capable of improving a person’s wellbeing, lowering the risks of cardiovascular and/ or Alzheimer's diseases and/or lowering blood Sugar using natural and synthetic ingredients. Numerous ratios may be formulated for aroma, color, flavor, flow (viscosity), taste and uniformity. Moreover, ingredients for Sugar Substitutes, natural preservatives, nano-dispersion, nano-emulsion, nano-en capsulation of ingredients and apparatus for personalized nutrition are also described herein.

17. In US 9,579,356 B2, the inventor discloses the methods and compositions for reducing blood cholesterol levels, and more particularly to dietary Supplements for reducing blood cholesterol levels. The dietary supplements for reducing cholesterol typically comprise at least one phytosterol source, at least one soluble fiber source, at least one guggulsterone Source, and at least one policosanol source.

18. In US 20140314729 A1, the inventor discloses the compositions of matter useful for the treatment of elevated blood cholesterol. In one embodiment a nutraceutical composition is administered to a patient in need of said composition comprising of the following combination of
ingredients: policosanol, niacin, guggul, garlic, Cynara SCO lymus, red yeast rice, ginger, holy basil, L-carnitine, chromium picolinate, coenzyme Q10, pantothenic acid, grape seed extract, momordica charantia, and garcinia indica.

3.4 TECHNICAL PROBLEM TO BE SOLVED
19. The available herbal supplements, health supplements and products are not target specific and hence are not very effective and do not produce accurate results. Moreover, they are rather very expensive or difficult to attain desired results. The disclosed embodiments are target specific and will prevent the hypercholesterolemia among people.

4. SUMMARY OF THE INVENTION
20. 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, drawings, and abstract as a whole.

21. The prior arts are insufficiently suited for prevention and control of hypercholesterolemia. The object of the present invention is to provide a novel nutraceutical composition to prevent, control and manage hypercholesterolemia. The present invention prevents and allows management of hypercholesterolemia more efficiently than what the existing prior arts are capable of doing.

22. It is one object of the present invention to produce a nutraceutical composition for the beneficiary of hypercholesterolemic individuals.

23. It is another object of the disclosed embodiments to develop natural product from the plant sources with bioactive compounds possessing proven health promoting properties.

24. It is another object of the disclosed embodiments to provide for a nutraceutical supplement to improve the blood circulation and prevent heart diseases.

25. It is another object of the disclosed embodiments derived from food industry waste such as peel (From Mangosteen rind) and seed extract (From Grapes) which are utilized inventively.

26. It is another object of the invention is to be remain a cost efficient health supplement using natural ingredients.
27. The composition in the present embodiment is considered to have anti-hyperlipidemic effect and can be widely used for the various new nutraceutical formulations.

28. It is another object of the present invention is to prepare custom made; tailored nutraceutical composition which is a proper combination of natural herbs and medicinal plants.

29. It is yet another object of the present invention is to provide natural antioxidants; health protective and disease preventive benefits for patients suffering from hypercholesterolemia.

30. It is still another object of the present invention is that the composition is suitable for use in the form of powder, granules, suspension, biscuits, tablets or capsules etc.

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

1. Mangosteen Rind Extract rich in xanthones (Alpha-mangostin)
2. Grape Seed Extract rich in oligomeric proanthocyanidins
3. Policosanol
4. Rosemary extract (Rosemarinus officinalis) rich natural antioxidants
5. Lactobacillus acidophilus, a cholesterol lowering probiotic.

5. DETAILED DESCRIPTION
32. The aforementioned aspects and other objectives and advantages can now be achieved as described herein.

33. The invention is related to the polyherbal nutraceutical formulation which can be used as a health supplement to prevent hypercholesterolemia especially among individuals with in working people which occurs due to their unhealthy diet practices and sedentary life style. The purpose of this invention was to formulate a natural supplement for hypercholesterolemic patients with or without nutritional awareness. The present embodiment is target specific and will help the hypercholesterolemia patients to control blood lipid levels. There is an increase in oxidative stress in hypercholesterolemia patients. The natural antioxidants present in the formula will help to improve the antioxidant balance during hypercholesteroloemia.

34. The present invention is a novel formulation combining the following five herbs:
1. Mangosteen Rind Extract rich in xanthones (Alpha-mangostin)
2. Grape Seed Extract rich in oligomeric proanthocyanidins
3. Policosanol
4. Rosemary extract (Rosemarinus officinalis) rich natural antioxidants
5. Lactobacillus acidophilus, a cholesterol lowering probiotic.

35. The present invention is having nutraceutical herbal ingredients with potential benefits of reducing hypercholesterolemia /hyperlipidaemia. The present invention is a novel polyherbal nutraceutical formula with Mangosteen Extract (Garcinia mangostana), Grape seed extract (Vitis vinifera), Policosanol, Rosemary extract (Rosmarinus officinalis) and a proven cholesterol lowering probiotic, Lactobacillus acidophilus.

GRAPE SEED EXTRACT
36. Botanical Description: Vitis vinifera, the common grape vine, native to the Mediterranean region, Central Europe, and Southwestern Asia, from Morocco and Portugal North to Southern Germany and East to Northern Iran. The leaves and fruits of Vitis vinifera have been used medicinally since ancient Greece. Today, grape seed extract is used as a folk or traditional remedy for conditions related to the heart and blood vessels, such as atherosclerosis (hardening of the arteries), high blood pressure, high cholesterol and poor circulation.

37. Phytoconstituents: Vitis vinifera contains large amounts of phenolic compounds such as resveratrol, epicatechin, quercetin, gallic acid and proanthocyanidins. Grape seed extract is a rich source of flavonoid compounds (oligomeric proanthocyanidins – OPCs) that perform as potent antioxidants and powerful blood vessel strengtheners. Polyphenols of grape seed has been known for its cholesterol-lowering properties.

38. The major biological properties of grape seed extract are,
a) Oligomeric proanthocyanidins from grape seed extract has significant effect on lowering blood cholesterol and improving lipid profile.
b) Proanthocyanins act as free radical scavengers and prevent the oxidation of LDL- cholesterol (LDL-c) and decrease the progression of cardiovascular diseases.
c) Grape seed extract also has significant anti-obesity effect
d) Grape seed extract possesses proven hypotensive, hypolipidemic and anti-atherosclerotic effects.

MANGOSTEEN EXTRACT
39. Botanical Description: Mangosteen or Garcinia mangostana Linn belongs to family Guttiferae (Clusiaceae) has a long history of use as a medicinal plant and it is widely cultivated throughout Southeast Asian countries. Garcinia mangostana is a small evergreen fruit tree that has a pyramidal crown. It is slow-growing, reaching up to 25 m in height and up to 37 cm bole diameter. The rind of the fruit can be used internally for dysentery, diarrhoea, cystitis and gonorrhea.

40. Phytoconstituents: The pericarp of the fruit contains considerable amounts of biologically active compounds, such as xanthones, terpenes, anthocyanins, tannins and phenols. More than 68 xanthones have been isolated from mangosteen fruit and majority of them a and ? mangostin. Xanthones are powerful antioxidants extracted from mangosteen which possess more potent antioxidant activity than vitamin E.

41. The major properties are
a) Most of the mangosteen compounds possess inhibitory action on pancreatic cholesterol esterase, an enzyme responsible for hypercholesterolemia.
b) Xanthones also possess inhibitory action on enzymes and processes responsible for the development of obesity.
c) Xanthones also prevent the formation of glycation end products formed in diabetic complications.
d) Xanthones reduce the level of blood LDL cholesterol (Bad Cholesterol) in hypercholesterolemia.
e) Xanthones also known to prevent the accumulation of triglycerides in liver and prevents hepatosteatosis.
f) All the above properties of xanthones are related to its free radical scavenging and anti-oxidant properties.
g) Xanthones possess anti-metastatic effect against various cell lines
h) Xanthones inhibit the oxidation of low-density lipoprotein(LDL-C)
i) Mangosteens possess antagonist activity against endogenous nitric oxide synthase inhibitors which in turn reduces the events associated with atherosclerosis.
POLICOSANOL
42. Policosanol is a mixture of long-chain primary alcohols isolated primarily from sugar cane wax (Saccharum officinarum). It’s a mixture of aliphatic alcohols with components that include tetratriacontanol, dotriacontanol, triacontanol, nonacosanol, octocosanol, heptacosanol, hexacosanol and tetracosanol. Among them octacosanol is the most abundant (about 60%) and considered to be the primary lipid lowering component.

43. Sugar cane–derived policosanol has the ability to lower total cholesterol and LDL cholesterol and even greater efficacy in raising HDL cholesterol without any significant side effects.

The major properties are
a) Policosanol safely down regulates cellular expression of 3-hydroxy-3-methylglutaryl-coenzyme CoA (HMG CoA) reductase enzyme responsible for the synthesis of cholesterol.
b) Policosanols reduces the risk atheroma (degeneration of the walls of the arteries due to fatty deposits and scar tissue) formation by reducing platelet aggregation, endothelial damage and foam cell formation.
c) Beneficial effects in the prevention of atherosclerosis and thromboembolic disorders stem from its capacity to inhibit platelet aggregation and to protect LDLs from lipid peroxidation.

ROSEMARY EXTRACT (ROSMARINUS OFFICINALIS)
44. Botanical Description: R. officinalis L., popularly known as rosemary, is a plant belonging to the family Lamiaceae and originated from the Mediterranean region. It is a perennial and aromatic plant, a shrub with branches full of leaves, having a height of up to two meters and green leaves that exude a characteristic fragrance. R. officinalis is also being used as a spice in cooking, as a natural preservative in the food industry, and as an ornamental and medicinal plant.

45. Phytoconstituents: Rosemary contains many phytochemicals including tannic acid, borneol, iso-bornyl acetate, carnosol, cineole, pinene and camphor, linalool, rosmanol, terpeniol and verbinol, rosmarinic acid, flavonoids and limonene. Antioxidant activity of R. officinalis is due to its phenolic compounds including carnosic acid, carnosol, rosmarinic acid and hydroxycinnamic acid ester.

46. The major properties are
a) Rosemary extract significantly reduces serum triglycerides, total cholesterol, LDL - cholesterol and elevates HDL-cholesterol.
b) Rosemary extract possess significant antioxidant and anti-inflammatory properties.
c) Rosemary extract enhance the activity of super oxide dismutase (SOD) and reduces peroxidation injury during hyperlipidemia.
d) Rosemary reduces the release of prostaglandin E2 due to oxidative stimulus, which is beneficial in atherosclerosis.
e) The phenolic compounds such as caffeic, ellagic and ferulic acids, sesamol and vanillin present in Rosemary extract has potent inhibitory effect on atherosclerosis.

LACTOBACILLUS ACIDOPHILUS
47. Probiotics have beneficial effects on human health especially in controlling the lipid profile. L. acidophilus belongs to the genus Lactobacillus. L. acidophilus is a homofermentative species, fermenting sugars into lactic acid. Generally, L. acidophilus strains are considered to have probiotic characteristics.

48. Strains of L. acidophilus have health effects and found to be effective in decreasing pediatric diarrhea, intestinal bowel syndrome, toxic amines and lactose-intolerance by helping lactose digestion. It reduces total cholesterol and LDL-cholesterol and thus possesses hypocholesterolemic effect.

49. Strains of L.acidophilus improve the expression of sterol regulatory element binding protein 2 (Srebp2) and LDL receptors in the liver and thereby improve the cellular uptake of cholesterol.

50. L. acidophilus were found to secrete an enzyme called bile salt hydrolase (BSH), which catalyze the hydrolysis of glycine or taurine conjugated to bile salts into amino acid residues and free bile salts. This results in reduction in cholesterol absorption through the intestinal lumen.

51. The BSH activity also helps to incorporate cholesterol into the bacterial cell wall and release of large amounts of deconjugated bile salts in the feces both results in reduction of serum cholesterol level (Hypocholestermic effect).

COMPOSITION:
52. The present embodiment consists of Garcinia mangostana, Grape seed extract, Policosanol, Rosemary extract (Rosmarinus officinalis) and Lactobacillus acidophilus. The above said composition produced a significant result with respect to hypercholesterolemia patients. The present composition showed a very potent multiple site metabolic alterations in hypercholesterolemia patients leading to highly effective natural way of maintaining normal blood cholesterol. Therefore, the composition is a highly effective solution to control hypercholesterolemia condition. The present composition not only reduces the cholesterol level but also improve the metabolic well-being and prevents the onset of atherosclerosis, a disastrous end point of an uncontrolled hypercholesterolemia. The present novel composition is effective in providing multi-directional benefits of health to support the whole body system to function normal.