Claims:CLAIMS
I/We, Claim,
1. A nutraceutical formulation comprises of the combination of extracts from the following herbs:
a)Tinospora cordifolia,
b)Gymnema sylvestre,
c)Lagerstroemia speciosa or Banaba,
d)Cinnamon,
e)Eclipta alba,
f)Trigonella foenum-graecum,
g)Murraya koenigii and
h)Piper nigrum
2. A nutraceutical formulation as claimed in claim 1 is used in controlling symptoms of pre-diabetics and diabetes mellitus.
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, liquid, gel, spray or beverage.
, Description:
1. TITLE OF THE INVENTION:
“A NOVEL NUTRACEUTICAL FORMULATION FOR CONTROLLING THE SYMPTOMS OF PRE-DIABETES AND DIABETES”

2. APPLICANT
(a) NAME: ORIENS GLOBAL MARKETING PRIVATE LIMITED

(b) NATIONALITY: INDIAN
(c) ADDRESS : FC-3, AMBATTUR INDUSTRIAL ESTATE 9TH STREET, AMBATTUR, CHENNAI-600058, TAMILNADU, INDIA

DATE OF FILING: day of FEBRUARY 2021

3. PREAMBLE TO THE DESCRIPTION
1. The following complete specification particularly describes the invention and the manner in which it is to be performed:
“A NOVEL NUTRACEUTICAL FORMULATION FOR CONTROLLING THE SYMPTOMS OF PREDIABETICS AND DIABETICS”

4.1. 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 prevents nutritional disorders, reduces complications due to diabetes and further ameliorates the general health of pre-diabetics and diabetics.

4.2. BACKGROUND OF THE INVENTION
3. Diabetes is not a disease but a disorder of metabolism due to decreased or inefficient insulin production from pancreas. The cause of diabetes is either hereditary or due to environmental factors. Environmental factors are obesity, sedentary life style, fast food habits, stress factors and viral infections. Diabetes mellitus is highly prevalent and rapidly growing metabolic disease that is characterized by chronic hyperglycemia due to defective insulin secretion, signaling, reception or all of these. Diabetes is India's fastest growing disease: 72 million cases recorded in 2017, figure expected to nearly double by 2025. Diabetes can lead to complications in many parts of the body and increase the risk of dying prematurely. Over time, diabetes can damage the heart, blood vessels, eyes, kidneys and nerves. Diabetes also diminishes the immunity of a diabetic person thereby subjecting him to infections like tuberculosis, septicemia, pneumonia and skin sepsis, etc. Diabetes; though incurable, can be controlled adequately with diet, life style modification and drugs. Diabetes can also be prevented from occurring at a very young age, by preventing diabetic pregnancy, childhood obesity, by increasing physical activity, avoiding high calorie fatty diet and life style modification.
4. Most of the existing products are not accurate in their results. Moreover, they are very expensive and do not aim at prevention of nutritional disorder associated with metabolic abnormality of diabetes. Based on the foregoing, it is believed that a need exists for a novel herbal nutraceutical composition to prevent the symptoms of diabetic patients and pre diabetes, a condition exists before development of Diabetes. Hence, a product with novel combination of herbs for reducing the symptoms of pre diabetic and diabetes patients has been invented, which is described in detail below. The present invention aims at reducing and controlling the symptoms of pre diabetic and diabetes patients. The present invention further and aims at reversing the symptoms.

4.3 PRIOR ART
6. In 201911050420, the inventor discloses a phytosomal formulation for management of diabetes. The phytosomal formulation is prepared using soya lecithin and cholesterol. The formulation has enhances efficacy and bioavailability.
7. In US20060147561A1, the invention relates to an herbal nutraceutical formulation for diabetics, and also relates to a process for the preparation of the formulation. The formulation comprises the base product of a microwave roasted seed powder mixture from selected genera of Glycine, Cicer, Phaseolus, Cyamompsis, Mucuna, Hordeum, Amaranthus and Fagopyrum, fortified with herbs/medicinal plants selected from the genera of Gymnema, Momordica, Syzgium, Pterocarpus, Trigonella, Cinnamomum, Withania, Coccinia, Pueraria, Asparagus, Boerhaavia and Aegle. Other ingredients like Piper longum, Chlorophytum tuberosum, Curcuna longa and Elettaria cardamomum are also added to the product. The nutraceuticals are nontoxic, natural herbal plant products, easy to digest that ameliorate the general health and vigor of diabetics.
8. In US 20100062087 A1, the present invention, a nutraceutical formula comprising a combination of two or more substances from the group: berry extract, chromium, Zinc, trans-resveratrol, 1-arginine, chlorophyll, vitamin C and aloe Vera combined synergistically to reduce inflammation in mammals suffering from diabetes. In another embodiment of the present invention, a nutraceutical formula comprising a combination of two or more substances from the group: berry extract, chromium, Zinc, fr-CJUS-resveratrol, 1-arginine, chlorophyll, Vitamin C and aloe Vera combined synergistically to enhance wound healing in mammals suffering from diabetes. In an alternative embodiment of the present invention, a nutraceutical formula comprising a combination of two or more substances from the group: berry extract, chromium, Zinc, trans-resveratrol, 1-arginine, chlorophyll, vitamin C and aloe Vera combined synergistically to reduce inflammation in mammals not suffering from diabetes. In another embodiment of the present invention, a nutraceutical formula comprising a combination of two or more substances from the group: berry extract, chromium, Zinc, trans-resveratrol,1-arginine, chlorophyll, vitamin C and aloe Vera, combined synergistically to enhance wound healing in mammals not suffering from diabetes.
9. In WO2004060342A1, A nutritional supplement composition containing a mixture of whey protein, amino acids, and other beneficial constituents, and a method for making the composition in a nutritionally compact, easy-to-use form. The composition is made by processing a mixture of whey protein, amino acids, minerals, vitamins, and other selected ingredients at an appropriate temperature and pH. By adjusting the pH of the mixture to within the approximate range of 2.5 - 5.0, and by processing at an appropriate temperature, it is possible to obtain a gel composition that contains a surprisingly large fraction of whey proteins (and other beneficial constituents) in readily bio available form. The composition can be packaged into conveniently-sized containers that are as easy to store or transport as they are easy to use.

4.4 TECHNICAL PROBLEM TO BE SOLVED
10. The available herbal and health supplements are not target specific and hence are not very effective. The disclosed embodiments are target specific and will prevent the metabolic abnormalities of the diabetic patients. The potential use of dietary and health supplements for protection against the effects of oxidative stress and the progression of degenerative diseases and aging has been the subject of an increasing number of studies during the past two decades. In the market today, many products contain antioxidants at various levels. These come in the form of food, liquid and nutritional supplements. Synthetic antioxidants such as BHA (butylated hydroxy anisole), BHT (butylated hydroxy toluene) and NDGA (nordihydro-guaiaretic acid) have been developed to date. However, synthetic antioxidants may cause allergic reactions and oncogenesis due to their strong toxicity in the body, and can be easily disrupted by heat due to temperature sensitivity. On the other hand, natural antioxidants are safer than synthetic antioxidants. Nevertheless, they suffer from weak effect.
11. Therefore, the development of a new combination of natural antioxidants which are safe; as well as having excellent antioxidant activity are required for preventing and controlling symptoms of pre diabetics and diabetics. Moreover, patients with prolonged diabetes need an effective herbal health supplement in order to reduce the symptoms of diabetes and maintain a healthy nutritional status.

5. SUMMARY OF THE INVENTION
12. 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.
13. The prior arts are insufficiently suited for controlling symptoms of pre diabetics and diabetics. The object of the present invention is to provide a novel nutraceutical composition for controlling symptoms of pre diabetics and diabetics and method of preparing the same. The present invention treats and allows management of diabetes more efficiently than what the existing prior arts are capable of doing.
14. The main object of the present invention is to provide for a nutraceutical supplement for controlling symptoms of pre diabetics and diabetes mellitus.
15. 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.
16. It another object of the present invention is to provide optimum nutrition; health protective and disease preventive benefits for diabetic patients.
17. It is yet another aspect of the present invention to provide for healthy nutritional status to the diabetic patients and thereby control diabetics with the help of herbal health supplements.
18. It is yet another object of the present invention is to produce a novel herbal composition to improve the metabolic status of pre diabetics and diabetics.
19. 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.
20. The aforementioned aspects and other objectives can be achieved by combining the extracts of the following eight herbs in an appropriate proportion as described in the detailed description.
1.Tinospora cordifolia,
2.Gymnema sylvestre,
3.Lagerstroemia speciosa,
4.Cinnamon,
5.Eclipta alba,
6.Trigonella foenum-graecum,
7.Murraya koenigii and
8.Piper nigrum
7. DETAILED DESCRIPTION
21. The present invention is a novel formulation combining the following eight herbs;-
1.Tinospora cordifolia,
2.Gymnema sylvestre,
3.Lagerstroemia speciosa
4.Cinnamon,
5.Eclipta alba,
6.Trigonella foenum-graecum,
7.Murraya koenigii and
8.Piper nigrum.
22. The richest sources of vital phytonutrients are found in herbs, shrubs, fruits and vegetables. The present invention provides for herbal extracts which play a significant role in controlling symptoms of pre diabetics and diabetes mellitus.
23. TINOSPORA CORDIFOLIA: Tinospora cordifolia commonly named as “Guduchi” is known for its immense application in the treatment of various diseases in the Ayurvedic literature. Tinospora cordifolia (Guduchi) is a large, glabrous, perennial, deciduous, climbing shrub of weak and fleshy stem found throughout India. A myriad of biologically active compounds, including alkaloids, diterpenoid lactones, glycosides, steroids, sesquiterpenoid, phenolics, aliphatic compounds, and polysaccharides have been isolated from different parts of the plant body. These compounds have been reported to have different biological roles in disease conditions thus enabling potential application in clinical research. 

24. The major properties of Tinospora cordifolia are:
1.Immuno-modulatory property
2.Antidiabetic property
3.Anti-oxidant
4.Anti-microbial activity
5.Anti-allergic property
6.Hepato-protective activity
7.Diuretic activity.
25. GYMNEMA SYLVESTRE: Gymnema sylvestre is a woody climbing plant that grows in the tropical forests of central and southern India. The leaves are used in herbal medicine preparations. Gymnema sylvestre is known as “meshasringi” (meaning “ram’s horn”) in Sanskrit. The leaves, when chewed, interfere with the ability to taste sweetness, which explains the Hindi name gurmar — “destroyer of sugar”. The leaves of the Gymnema sylvestre plant contain gymnemic acids, which have been shown to slow the transport of glucose from the intestines to the bloodstream. Some research also suggests that Gymnema sylvestre extract can help repair and regenerate the beta cells in the pancreas that produce insulin.
26. The major properties are
1.Lower blood sugar
2.Lower hemoglobin A1c
3.Radio-protective activity
4.Anti-Inflammatory Activity
5.Free Radical Scavenging Activity
6.Anti-allergic activity
7.Cardiotonic
8.Diuretic
Gymnema sylvestre extract is an effective therapy for both type 1 and type 2 diabetes and it can lower serum cholesterol and triglycerides and prevent weight gain.
27. LAGERSTROEMIA SPECIOSA: Lagerstroemia speciosa or Banaba is a deciduous tropical flowering tree that grows in India, Bangladesh, Malaysia, Thailand, Philippines, Indonesia and Japan.
28. The parts of Banaba and its major properties are given below
1.Roots are used for stomach problems.
2.The leaves are used to heal diabetes and for weight loss.
3.The leaves have high levels of corosolic acid (terpenoid glycoside) that can lower blood sugar.
4.Banaba also contains concentrations of dietary fiber and minerals such as magnesium and zinc, it helps the body to handle glucose and as such, it's also effective in weight loss.
5.The hypoglycemic (blood sugar lowering) effect is similar to that of insulin (which induces glucose transport from the blood into body cells).
6.Its leaves are therapeutic against ailments such as kidney and urinary problems.
29. CINNAMON: Cinnamon is a highly delicious spice. Cinnamon is a spice that is made from the inner bark of trees called Cinnamomum. There are two main types of cinnamon:
a. Ceylon cinnamon: Also known as “true” cinnamon.
b. Cassia cinnamon: This is the more common variety today, what people generally refer to as “cinnamon.” The distinct smell and flavor of cinnamon is due to the oily part, which is very rich in a compound called cinnamaldehyde, which is responsible for most of cinnamon’s powerful effects on health and metabolism. Cinnamon contains large amounts of highly potent polyphenol antioxidants. The antioxidants in cinnamon have anti-inflammatory effects, which may help lower the risk of disease.
30. The therapeutic properties of Cinnamon are given below to understand its importance in nutraceutical supplements.
1.Cinnamon can improve some key risk factors for heart disease, including cholesterol, triglycerides and blood pressure.
2.Cinnamon has been shown to significantly increase sensitivity to the hormone insulin.
3.Cinnamon has been shown to both reduce fasting blood sugar levels, having a potent anti-diabetic effect at 1 to 6 grams per day.
4.Cinnamaldehyde has antifungal and antibacterial properties, which may reduce infections and help fight tooth decay and bad breath.
31. The cassia variety contains significant amounts of a compound called coumarin, which is believed to be harmful in large doses. All cinnamon should have health benefits, but cassia may cause problems in large doses due to the coumarin content. Ceylon (“true” cinnamon) is much better in this regard, and studies show that it is much lower in coumarin than the Cassia variety.
32. TRIGONELLA FOENUM GRAECUM: Trigonella foenum-graecum (fenugreek) has been used in traditional medicine for the treatment of diabetes. It is found all over India and in certain regions of China, the fenugreek seeds are usually used as one of the major constituents of Indian spices. T. foenum-graecum contains carbohydrate, steroids, alkaloids, diosgenin, trigonelline, trigocoumarin, trimecoumarine and 4-hydroxyleucine. 4-hydroxyleucine, a novel amino acid from fenugreek seeds with potential role in treatment of diabetes. Saponin compounds diosgenin alkaloids and trigonelline were shown to be associated with inhibition of intestinal glucose uptake in vitro. Fenugreek has been shown to increase erythrocyte insulin receptors and improve peripheral glucose utilization, thus showing potential pancreatic as well as extra pancreatic effects.
33. The major properties of Trigonella foenum-graecum are:
1.Anti-diabetic effect (T. foenum-graecum prevents the rapid uptake of glucose in the small intestine, aids in blood sugar retention in diabetic patients).
2.Anti-oxidant activity (The antioxidant circulating activity of T. foenum-graecum through significant lipid peroxide level decrease exerts beneficial effects in oxidative stress increased in patients with diabetes mellitus).
3.Anti-lipidemic effects and gastroprotective activity (T. foenum-graecum reduces the rate of glucose absorption and delays gastric empting, thereby preventing the rise in blood sugar levels following a meal).
4.Cardioprotective effects.
5.Anti-inflammatory effects.
6.Anti-bacterial and anti-fungal activity.
34. ECLIPTA ALBA: Eclipta alba (L.) commonly known as False Daisy and Bhringraj, is a medicinal plant belonging to the family Asteraceae. Eclipta alba (L.) is small branched annual herbaceous plant with a long history of traditional medicines uses in many countries mainly in tropical and subtropical regions. It is widely distributed throughout India, China, Thailand, and Brazil. The herb has been known for its curative properties and has been considered as a good rejuvenator. Many chemical compounds have been isolated from Eclipta alba such as resins, ecliptine, nicotine, glucosides, coumestans, alkaloids, thiopenes, flavonoids, polyacetylenes, triterpenes and their glycosides have been isolated from this species. The antioxidant property of Eclipta alba helps in reducing the post diabetic complications. In addition to the above the extracts of Eclipta alba have found to reduce blood glucose levels similar to glibenclamide which is known to enhance insulin secretion by a direct action on the pancreas.
35. The major properties of Eclipta alba are:
1. Anti-diabetic Activity/ Anti-hyperglycemic activity.
2. Hepato-protective/Anti-Hepatotoxic Activities
3. Hair Color and Growth Promoting Activity
4. Antimicrobial Properties
5. Anti-inflammatory Activity
6. Anti-diabetic Activity/ Anti-hyperglycemic activity
7. Anti-malarial activity
8. Anti-oxidant activity.
36. MURRAYA KOENIGII: Murraya koenigii commonly named as “Curry tree or curry leaf tree” is a culinary important plant of Indian origin. The leaves of Murraya koenigii contain proteins, carbohydrate, fiber, minerals, carotene, nicotinic acid, Vitamin C, Vitamin A, calcium and oxalic acid. It also contains crystalline glycosides, carbazole alkaloids, koenigin, girinimbin, iso-mahanimbin, koenine, koenidine and koenimbine. Triterpenoid alkaloids cyclomahanimbine, tetrahydro mahanimbine are also present in the leaves. Murrayastine, murrayaline, pyrayafoline carbazole alkaloids and many other chemicals have been isolated from Murrya koenigii leaves. Carbazole alkaloids which are abundantly present in the leaves, fruits, roots and bark of this plant, have been reported for their ant diabetic, anti-cancer, anti-bacterial, anti-nociceptive and antioxidant activities. Besides these activities, the plant is described to have a wide array of therapeutic activities.
37. The major properties of Murrya koenigii are:
1.Immuno-modulatory effect
2.Anti-diabetic effect
3.Antioxidant activity
4.Antibacterial effect
5.Hypolipidaemic activity
6.Nephroprotective effect
38. PIPER NIGRUM: 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. Piperine significantly enhances the bioavailability of various supplement nutrients through increased absorption.
39. The present invention produced a significant result on pre-diabetic and diabetic compared to the control group of diabetic patients. The present invention showed a very potent result of decrease of tiredness and increase of immunity among the diabetic patients and the result is highly effective.
40. Therefore, the composition is highly effective in controlling the symptoms of pre diabetics and diabetes mellitus. The present invention not only reduces the sugar level but also improves the immune system. The present novel composition is effective in providing multi-directional benefits and also supports whole body system to function normal.