Claims:I/We, Claim,
1. A nutraceutical formulation comprising of the combination of extracts from the following herbs:
a. Silybum marianum
b. Picrorhiza kurroa
c. Phyllanthus amarus
d. Terminalia arjuna and
e. Tinospora cordifolia
2. A nutraceutical herbal formulation as claimed in claim 1 maintains overall liver health.
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:3. PREAMBLE TO THE DESCRIPTION
1. The following complete specification particularly describes the invention and the manner in which it is to be performed:
“HERBAL NUTRACEUTICAL FORMULATION FOR THE MAINTENANCE OF OVERALL LIVER HEALTH”

4. TECHNICAL FIELD
2. The present invention relates to the field of herbal nutraceutical formulation and composition; more particularly health and wellness supplements. The present invention facilitates the overall maintenance of liver health.

5.1. BACKGROUND OF THE INVENTION
3. The invention is related to the unique herbal and phytochemical composition used to maintain and manage overall liver health. The invention further aids in detoxification of the liver and protects the liver from various liver ailments like Hepatitis, Fatty liver, Liver cirrhosis, Non-alcoholic fatty liver disease (NAFLD) and Drug induced liver damage.

4. The liver can be considered a factory; and among its many functions include the following:
a. Production of bile that is required in the digestion of food, in particular fats
b. Storing of the extra glucose or sugar in the body into stored glycogen in liver cells; and then converting it back into glucose when the body needs it for energy
c. Production of blood clotting factors
d. Production of amino acids (the building blocks for making proteins), including those used to help fight infection
e. The processing and storage of iron necessary for red blood cell production
f. Manufacture of cholesterol and other chemicals required for fat transport
g. Conversion of waste products of body metabolism into urea that is excreted in the urine; and
h. Metabolizing medications into their active structures in the body
i. Any disturbance of liver function that causes illness is referred to as liver disease. The liver is responsible for many critical functions within the body and any disease or injury, hinders the various functions of the liver. This will result in significant damage to the body. Liver disease is also referred to as hepatic disease.

5. Liver disease is a broad term that covers all the potential problems that cause the liver to fail to perform its designated functions. Usually, more than 75% or three quarters of liver tissue needs to be affected before a significant decrease in function occurs.

6. The liver is the largest solid organ in the body; and is also considered a gland because, among its many functions, it also makes secretion known as, bile. The liver is located in the upper right portion of the abdomen protected by the rib cage. It has two main lobes that are made up of tiny lobules. The liver cells have two different sources of blood supply. The hepatic artery supplies oxygen rich blood that is pumped from the heart, while the portal vein supplies nutrients from the intestine and the spleen.

7. Normally, veins return blood from the body to the heart, but the portal vein allows chemicals from the digestive tract to enter the liver for "detoxification" and filtering prior to entering the general circulation. The portal vein also efficiently delivers the chemicals and proteins that liver cells need to produce the proteins, cholesterol and glycogen required for normal body activities.

8. As part of its function, the liver makes bile, a fluid that contains among other substances, water, chemicals, and bile acids (made from stored cholesterol in the liver). Bile is stored in the gall bladder and when food enters the duodenum (the first part of the small intestine), bile is secreted into the duodenum, to aid in the digestion of food. Liver is the only organ in the body that can easily replace damaged cells, but if enough cells are lost, the liver may not be able to meet the needs of the body.

MAJOR CLASS OF LIVER DISEASES
9. Cirrhosis is a term that describes permanent scarring of the liver. In cirrhosis, the normal liver cells are replaced by scar tissue that cannot perform any liver function.

10. Acute liver failure may or may not be reversible, meaning that on occasion, there is a treatable cause and the liver may be able to recover and resume its normal functions.

CAUSES OF LIVER DISEASES
11. Cells can become inflamed (such as in hepatitis: hepa = liver + itis=inflammation). Bile flow can be obstructed (such as in cholestasis: chole=bile+ stasis=standing). Cholesterol or triglycerides can accumulate (such as in steatosis; steat=fat + osis=accumulation). Blood flow to the liver may be compromised. Liver tissue can be damaged by chemicals and minerals, or infiltrated by abnormal cells.

12. Alcohol Abuse:Alcohol abuse is the most common cause of liver disease in North America. Alcohol is directly toxic to liver cells and can cause liver inflammation, referred to as alcoholic hepatitis. In chronic alcohol abuse, fat accumulation.

13. Drug-induced liver disease: Liver cells may become temporarily inflamed or permanently damaged by exposure to medications or drugs. Some medications or drugs require an overdose to cause liver injury while others may cause the damage even when taken in the appropriately prescribed dosage.

14. Infectious Hepatitis: The term "hepatitis" means inflammation, and liver cells can become inflamed because of infection.
a. Hepatitis A
b. Hepatitis B
c. Hepatitis C
d. Hepatitis D
e. Hepatitis E
f. Other Viruses
15. Non-Alcoholic Fatty Liver Disease: NASH or non-alcoholic steatohepatitis (also referred to as "fatty liver") describes the accumulation of fat within the liver that can cause inflammation of the liver and a gradual decrease in liver function.

16. Hemochromatosis: Hemochromatosis (iron overload) is a metabolic disorder that leads to abnormally elevated iron stores in the body. The excess iron may accumulate in the tissues of the liver, pancreas and heart and can lead to inflammation, cirrhosis, liver cancer and liver failure. Hemochromatosis is an inherited disease.

RISK FACTORS FOR LIVER DISEASES
17. Some liver diseases are potentially preventable and are associated with lifestyle choices. Alcohol-related liver disease is due to excessive consumption and is the most common preventable cause of liver disease.

18. Hepatitis B and C are viral infections that are most often spread through the exchange of bodily fluids (for example, unprotected sexual intercourse, sharing unsterilized drug injecting equipment, using non-sterilized equipment for tattoos or body piercing).

19. Hereditary liver disease can be passed genetically from generation to generation. Examples include Wilson's disease (copper metabolism abnormalities) and hemochromatosis (iron overload).

20. Chemical exposure may damage the liver by irritating the liver cells resulting in inflammation (hepatitis), reducing bile flow through the liver (cholestasis) and accumulation of triglycerides (steatosis). Chemicals such as anabolic steroids, vinyl chloride and carbon tetrachloride can cause liver cancers.

21. Medications may irritate the blood vessels causing narrowing or formation blood clots (thrombosis). Birth control pills may cause hepatic vein thrombosis, especially in smokers liver disease and liver failure occurs.

Treatment options for Liver Diseases
22. Each liver disease will have its own specific treatment regimen. For example, hepatitis A requires supportive care to maintain hydration while the body's immune system fights and resolves the infection. Patients with gallstones may require surgery to remove the gallbladder. Other diseases may need long-term medical care to control and minimize the consequences of their disease.

23. In patients with cirrhosis and end-stage liver disease, medications may be required to control the amount of protein absorbed in the diet. The liver affected by cirrhosis may not be able to metabolize the waste products, resulting in elevated blood ammonia levels and hepatic encephalopathy (lethargy, confusion, coma). Low sodium diet and water pills (diuretics) may be required to minimize water retention.

24. In those patients with large amounts of ascites fluid (fluid accumulated in the abdominal cavity), the excess fluid may have to be occasionally removed with a needle and syringe (paracentesis). Using local anesthetic, a needle is inserted through the abdominal wall and the fluid is withdrawn. The ascites fluid can spontaneously become infected and paracentesis also may be used as a diagnostic test looking for infection.

25. Operations may be required to treat portal hypertension and minimize the risk of bleeding. Liver transplantation is the final option for patients whose liver has failed.

26. Most of the prior art products are not accurate in results. They are very expensive and difficult to attain results. Moreover, they do not aim at prevention of nutritional disorder and further decrease immunity.

27. Based on the foregoing, it is believed that a need exists for a novel herbal nutraceutical formulation to maintain and manage the overall liver health and thereby preventing occurrence of the above mentioned diseases, which is described in detail below.

5.2 PRIOR ART
28. WO2011074001A2 –The present invention provides a herbal composition comprises potent liver specific herbs which improves the liverfunction and also helpful in cleaning the toxic accumulations and detoxifying poisons in liver. The herbal composition of¾ present invention comprises extract of Andrographis paniculata; extract of Curcuma longa; extract of Glycyrrhiza glabra; and ex-S tract of Terminalia chebula.

29.US9730951B2- The present invention is directed to pharmaceutical compositions and methods of treatment that relate to the inhibition, resolution and/or prevention of an array of the manifestations of metabolic syndromes, including Type 2 diabetes, hyperlipidemia, weight gain, obesity, insulin resistance, hypertension, atherosclerosis, fatty liver diseases and certain chronic inflammatory states that lead to these manifestations, among others. In additional aspects, the present invention relates to compositions and methods which may be used to treat, inhibit or reduce the likelihood of hepatitis viral infections, including Hepatitis B and Hepatitis C viral infections, as well as the secondary disease states and/or conditions which are often associated with such viral infections, including hepatic steatosis (steatohepatitis), cirrhosis, fatty liver and hepatocellular cancer, among other disease states or conditions.

30. 202147016154 - COMBINATION THERAPY FOR THE TREATMENT OF LIVER DISEASE
The invention relates to pharmaceutical compositions, and more specifically to pharmaceutical compositions comprising at least one fatty acid-bile acid conjugate and at least one thyroid hormone receptor agonist or thyroid hormone mimetic or 5 pharmaceutically acceptable salts thereof, and use of such compositions in methods of treating, stabilizing or lessening the severity or progression of a liver disease including fibrosis, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and comorbidities associated with a liver disease.

31. IN201821050059 - HERBAL FORMULA CONTAINING GYMNOSPORIA MONTANA LEAF EXTRACT FOR THE TREATMENT OF LIVER DISEASES
The present invention relates to a herbal formula containing Gymnosporia montana leaf extract for the treatment of liver diseases which may optionally contain one or both among Piperine extracted from the fruits of Long pepper and alcoholic extracts of roots of Oroxylum indicum. This formulation can be used for effective treatment of a number of liver diseases. This formulation can be made in different compositions and dosage forms. Being an herbal formulation, it has minimal side effects and is economical thereby making it affordable. The formulation also possesses antibacterial and antimutagenic activity along with having hepatoprotective and immunomodulatory activity.

32. IN201641010849- AN HERBAL DRUG COMPOSITION POSSESSING MULTIPLE THERAPEUTIC EFFECTS The present invention mainly relates to herbal composition and more particularly to the herbal drug composition possessing multiple therapeutic effects as analgesic, anti-inflammatory, hepatoprotective and anti-oxidant. In one embodiment the composition comprising: a hot ethanolic extract from roots of Tetracera akara, a cold ethanolic extract from roots of Tetracera akara and a stem powder of Tetracera akara Merr. The herbal drug composition present in the form of herbal granules and herbal ointment comprising of natural and herbal constituents devoid of any harmful effects. Herbal drug composition used for the treatment of inflammation, pain, liver diseases and act as anti-oxidant. The composition or formulation is perfectly balanced and blended for superior results.
5.3. TECHNICAL PROBLEM TO BE SOLVED

33. The present invention aids in detoxification of the liver and protects the liver from various liver ailments like Hepatitis, Fatty liver; Liver cirrhosis, Non-alcoholic fatty liver disease (NAFLD) and Drug induced liver damage. The invention further aids in detoxification of the liver and protects the liver from various liver ailments like Hepatitis, Fatty liver, Liver cirrhosis, Non-alcoholic fatty liver disease (NAFLD) and Drug induced liver damage.

6. SUMMARY OF THE INVENTION
34. 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.

35. The prior arts are insufficiently suited for effective maintenance of the liver health. It is, therefore, one aspect of the present invention is to provide a novel herbal nutraceutical formulation that maintains the overall health of the liver.

36. The main aspect of the present invention is to provide for a nutraceutical supplement to prevent the occurrence of various liver diseases.

37. It is another aspect of the disclosed embodiments to provide for a supplement to maintain overall health of the liver.

38. It is another aspect of the disclosed embodiments to provide for an invention to detoxify the liver effectively.

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

40. Still another aspect of the disclosed embodiments is to be target specific and increases overall health of the liver of a patient suffering from liver diseases.

41. The aforementioned aspects and other objectives can be achieved by combining the extracts of the following five herbal extracts rich in specific active ingredients in an appropriate proportion as described in the detailed description.
1. Silybum marianum
2. Picrorhiza kurroa
3. Phyllanthus amarus
4. Terminalia arjuna and
5. Tinospora cordifolia

7. DETAILED DESCRIPTION

42. The present invention provides for the unique composition that maintains the overall health of liverwith five herbal extracts namelySilybum marianum, Picrorrhiza kurroa, Phyllanthus amarus, Terminalia arjuna and Tinospora cordifolia.

43. Silybum marianum : Silymarin is a unique flavonoid complex—containing silybin, silydianin, and silychrisin— that is derived from the medicinal plant Silybum marianum, milk thistle plant. It is well known for its use as a liver protectant and decongestant. It also supports carrying off used bile to cleanse the liver and spleen, and to treat diseases like jaundice and gallstones. It has been traditionally used for supportive treatment for inflammatory liver conditions such as cirrhosis, hepatitis and fatty infiltration caused by alcohol and other toxins.

44. Silymarin is used to:
a. Regenerate liver cells damaged by alcohol or drugs.
b. Decongest the liver (A liver decongestant stimulates bile flow through the liver and gallbladder, thus reducing stagnation and preventing gallstone formation and bile-induced liver damage.)
c. Increase the survival rate of patients with cirrhosis
d. Complement the treatment of viral hepatitis
e. Protect against industrial poisons, such as carbon tetrachloride (a colorless gas that leaks into air, water and soil near manufacturing and waste sites).
f. As an antioxidant, silymarin scavenges for free radicals that can damage cells exposed to toxins. Silymarin has been said to be at least ten times more potent in antioxidant activity than vitamin E
g. Silymarin also increases the level of the important antioxidant enzyme superoxide dismutase in cell cultures.

45. Picrorhiza kurroa: Picrorhiza kurroa is an herb from Ayurveda System Medicine that is commonly called as Kutki or Kutaki. It contains a 'bitter principle' which is a mixture of two molecules, the irioid glycosides known as picroside I and picroside II (picroside II also being called kutkoside) and the mixture overall is then called kutkin or picroliv. Overall, these are the active components. The herb itself, due solely to the kutkin molecules, appears to be potential hepatoprotective (protective of the liver) when ingested prior to or taken after exposure to a toxin. It is effective in treating Jaundice, Cirrhosis of the liver, asthma, immune disorders, fever, dysentery/diarrhea and indigestion.

46. Picrorhiza kurroa is benefiting for patients suffering from dyspepsia. It helps in strengthening the stomach and in promoting its action efficiently. It improves the appetite and helps in the secretion of gastric juices. Picrorhiza kurroa has been commonly used and well investigated for the treatment of jaundice. The plant has also been shown to be hepatoprotective in various animal models of hepatotoxicity like carbon tetrachloride, d-galactosamine, paracetamol, and thioacetamide.

47. Constipation: Picrorhiza kurroa is useful for relieving constipation and inducing the active movement of bowel in our body. It is a proven purgative.

48. Ascites: Picrorhiza kurroa is benefiting for patients of ascites.

49. Phyllanthus amarus: Phyllanthus amarus is a medicinal herb found in coastal areas. It is a tropical plant that has several medicinal values. It is abundantly found in fields, agricultural lands and gardens. It is a short plant with tiny leaves. It is traditionally known as Bhui Amla. Phyllanthus amarus is widely used to tone-up sluggish liver and also given in chronic liver condition and jaundice. In Unani medicine, the plant is used in jaundice as deobstruent, diuretic, cooling and astringent. In recent studies, the herb and its root have exhibited antiviral actions on Hepatitis-B. Phyllanthus amarus (P. amarus) is a broad-spectrum medicinal plant in traditional medicine to treat chronic liver disease.
50. Terminalia arjuna : Arjuna is a dense and tall tree and has long, cone shaped round leaves and white bark used in medicines. This tree is called nadisarjja in Sanskrit and its bark is described as a cardiac tonic. The tree is indigenous to India. Terminalia arjuna (usually simply referred to as Arjuna) is a tree bark that is used medicinally in Ayurveda for the purposes of cardiovascular health pertaining to the heart itself.
51. Terminalia arjuna is alternative, astringent, cardiac stimulant, hemostatic, rejuvenative tonic and lithotriptic. It is also helpful in bilious affections. It is cardio-tonic thus providing nutrition to heart muscles and strengthening them. It normalizes the disturbed rhythms of heart and also reduces the heart rate. This is found to be helpful in edema as well. It reduces the clotting tendency of blood. It reduces the stress and nervousness of the heart. It helps in reversing the hardening of the blood vessels. It can be given as the adjuvant in chronic fevers, particularly tuberculosis. On prolonged use it is good for obese persons, in chronic poisoning and general debility.
52. Arjuna herb works as a heart tonic that helps maintain heart health. Arjun helps to maintain normal blood pressure. Arjuna promotes proper blood flow and normal homocysteine levels. Arjuna supports the blood's absorption of lipids indicating it has cholesterol-regulating properties. Arjuna herb helps to reduce the effects of stress and nervousness on the heart. COQ10 in Arjuna supports the heart's energy output and enhances overall energy levels, stamina, immunity and cellular health.

53. Tinospora cordifolia commonly named as “Guduchi” in Sanskrit belonging to family Menispermaceae is a genetically diverse, large, deciduous climbing shrub with greenish yellow typical flowers, found at higher altitude. In racemes or racemose panicles, the male flowers are clustered and female are solitary. The flowering season expands over summers and winters. A variety of active components derived from the plant like alkaloids, steroids, diterpenoid lactones, aliphatics, and glycosides have been isolated from the different parts of the plant body, including root, stem, and whole plant. Recently, the plant is of great interest to researchers across the globe because of its reported medicinal properties like anti-diabetic, anti-periodic, anti-spasmodic, anti-inflammatory, anti-arthritic, anti-oxidant, anti-allergic, anti-stress, anti-leprotic, anti-malarial, hepatoprotective, immunomodulatory and anti-neoplastic activities. Tinospora cordifolia stem and leaves extract has shown hepatoprotective effect in Swiss albino male mice against lead nitrate induced toxicity.

54. Hepato-protective potential validated with respect to T. cordifolia by scientific research includes a clinical study for normalization of altered liver functions; antihepatotoxic activity in CCl4 induced liver damage, normalizing liver function in goats.

55. The present embodiment consists of five herbs Silybum marianum, Picrorhiza kurroa, Phyllanthus amarus, Terminalia arjuna and Tinospora cordifolia produced a significant improvement in the liver health of people suffering from various kinds of liver ailments. The present composition showed a very potent result of improved liver functions and reduced symptoms of liver diseases. Therefore, the composition is highly effective in prevention of various liver disorders. 59. The present composition not only reduces the liver abnormalities but also improve the metabolism and immune functions. The present novel herbal nutraceutical formulation is effective in providing multi-directional benefits towards liver and also supports whole body system to function normal.