TITLE OF INVENTION: A HYPOGLYCEMIC HERBAL EXTRACT COMPOSITION FOR REDUCING BLO D SUGAR LEVELS IN MAMMALS

FILED OF THE INVENTION

The invention relates to herbal extract composition containing Motnordica Charantia and other biological additives and use of this composition as hypoglycemic composition for reducing blood sugar levels in mammals especially humans suffering from diabetes mellitus.

BACKGR OUND OF THE INVENTION

Diabetes mellitus;

The word diabetes was coined by Aretaeus (81-133CE) of cappadocia; The word is from the Greek word diabainein and literally means "passing through", or "siphon", a reference to one of diabetes 'major symptoms-excessive urine discharge. The word became diabetes from the English adoption of the medieval Latin diabetes, hi 1675 Thomas Willis added mellitus from the Greek word for honey (mel in the sense of "honey sweet") when he noted that a person with diabetes's urine and blood has a sweet taste. This had been noticed long before in ancient times by the Greeks, Chinese, Egyptians and Indians. In 1776 it was confirmed that the sweet taste was because of an excess of a kind of sugar in the urine and blood of people with diabetes. Passing abnormal amounts of urine is a symptom common to several disorders (most commonly of the kidneys) and the single word diabetes has been given to many of them. The most common of them are diabetes insipidus and the subject of this article, diabetes mellitus.

Diabetes mellitus is a medical disorder characterized by persistent variable hyperglycemia (high blood sugar levels) resulting either from inadequate secretion of the hormone insulin or from an inadequate response by the body's cells to insulin. There are three kinds of diabetes mellitus, called type 1, type 2 and type 3, and some authors in the field of diabetes research identify a type 4 diabetes. The three types of diabetes mellitus include:

* Diabetes mellitus type 1 (previously called juvenile onset diabetes, insulin-dependent diabetes mellitus—IDDM). Type 1 diabetes is precipitated by a currently unknown event that leads initially to decrease, and then to nil production of insulin. Type 1 diabetes mellitus accounts for about 10% of all people with diabetes mellitus.

* Diabetes mellitus type 2 (previously called adult onset diabetes, obesity related diabetes or non-insulin dependent diabetes mellitus— NIDDM), involves insulin resistance by the body's cells to the action of normal insulin levels found in the bloodstream, and as the disease progresses, the production and secretion of insulin may also diminish. Type 2 diabetes mellitus is the most common form of diabetes, especially in highly developed countries, where it may account for as much as 90% of all people with diabetes. Its causes are obscure, but are connected with heredity, body weight and lifestyle (e.g., Western diet and obesity).

* Gestational diabetes ('diabetes type 3 ' designation rarely used in medical practice) is a condition that occurs during pregnancy and is similar to type 2 diabetes in that it is related to a resistance of the body's cells to insulin. The elevated blood glucose levels may result in abnormal increased fetal (baby) weight, polyhydramnios (increased surrounding amniotic fluid caused by increased fetal urination), fetal jaundice and low blood sugars after delivery and rarely intra-uterine death. Approximately 40% of women who had gestational diabetes will develop full type 2 diabetes within 5-10 years after delivery.

Diabetes mellitus is an insidious disease for which there is presently no cure. Mammals afflicted with diabetes mellitus will, unless the glucose level in the blood is controlled, ultimately suffer heart attacks, strokes, loss of eyesight, loss of limbs and ultimately may die as the result of this disease.

Humans who suffer from this disease will usually have blood glucose levels in two principal categories, i.e. those who have glucose levels of higher than 150 and are thus termed "insulin-dependent" and those with glucose levels of 110-140 who are termed "non-insulin dependent".

Insulin-dependent diabetics must have insulin administered to them in a very rigorous,

disciplined manner and must have snacks between meals since it is necessary to maintain the proper level of insulin in the bloodstream, i.e. undesirable side effects are experienced if the insulin level is too high and the disease will continue unabated if the insulin level is too low.

The non-insulin dependent diabetes sufferer must follow a disciplined program of diet and exercise to avoid the necessity of taking medication to control blood glucose levels. However, many non-insulin dependent diabetes sufferers experience difficulty in conscientiously following such program and will ultimately fall into the insulin- dependent category sooner or later.

There is a long-felt need for an herbal composition, Le. a natural, holistic edible composition, which will serve as a hypoglycemic agent and maintain blood glucose levels below the levels obtainable by insulin administration. Such need has especially been true in respect to heavy-set persons as well as those who suffer side effects when taking insulin or synthetic hypoglycemic preparations as well as by those whose life styles are such that they are unwilling or unable to adhere to a rigorous exercise/ diet program throughout their lives. DESCRIPTION OF THE PRIOR ART

Many patents applications and Patents teaches use of the herbal compositions for the treatment of diabetes.

U.S. Patent No 7,014,872 teaches use of the extract otMomordica Charantia. The invention disclosed in this Patents is related to a herbal health protective, promotive and disease preventive nutraceutical herbal f ormulation(s) for diabetics, and also relates to a process for the preparation of a herbal health protective, promotive and disease preventive nutraceutical herbal formulation as food supplement to ameliorate the general health of diabetics, said formulation comprises the base product of microwave roasted seed powders mixture from selected genera of Glycine, Cicer, Phaseolus, Cyamompsis, Mucuna, Hordeum, Amaranthus and Fagopyrum, fortified with herbs/ medicinal plants used are selected from the genera of Gymnema, Momordica, Syzgium, Pterocarpus, Trigonella, Cinnamomum, Withania, Coccinia, Pueraria, Asparagus, Boerhaavia and Aegle and also some other ingredients like Piper longum,

Chlorophytum tuberosum, Curcuma longa and Elettaria cardamomum were also added to get the final nutraceutical product(s); the nutraceuticals are with optimum nutrition, non toxic, natural herbal plant products, easy to digest, have health protective and promotive properties to ameliorate the general health and vigor of diabetics. Patent application No. WO03055558 discloses use of the Enicostemma Littorale in the herbal composition. The invention relates to a synergistic herbal composition for the treatment of bronchial asthma and a process for preparing the same. The said composition comprises the following herbs: Achyranthes aspera, Woodfordia furiticosa, Solanum xanthocarpum, Justicia adhatoda, Acacia arabica Zingiber officinalis, Syzygium aromaticum bud, Curcuma longa, Holarrhena antidysentercia, Enicostemma littorale.

ILS.Patent application No. US2001021401 discloses use of the Eugenia Jambolana as herbal therapeutic product for controlling diabetes mellitus comprising at least one hypoglycemic compound extracted from the pulp of fruit Eugenia jambolina. The said product is prepared from the pulp of the fruit Eugenia jambolina comprising cleaning and drying the fruit to remove the extraneous material from the outer layer of the said fruit, deseeding the said fruit, soaking the de-seeded pulp in water, mixing the said mixture of water and pulp and keeping it overnight in controlled cooled conditions to maintain the activity of hypoglycemic compounds.

United States Patent No.6080401 teaches an improved preparation of a drug having a known efficacy at known therapeutic dosage in the treatment of a disease or disorder in humans and animals, wherein the improvement comprises Swertia Chirata and other herbs.

Korean Patent application No KR20040081733 is related to a pharmaceutical composition containing a fermentation product of the extract of Banaba (Lagerstroemia spesiosa L.), Fenugreek (Trigonella foenum-graecum L.) and Bitter Mellon as an effective ingredient is provided. The composition exhibits strong blood glucose-reducing activity and diabetic complications-reducing activity and has safety to the human body. Therefore, the composition is used for the prevention and treatment of diabetes and the reduction of diabetic complications

Another U.S. Patent discloses a medical composition comprising Trigonella foenum- graecum L for the purpose of a significant reduction in serum glucose due to the regeneration of pancreatic islet cells.

Patent application No. WO2006030426 discloses use of Azadirachta Indica in the herbal composition. The invention provides an herbal composition comprising a plant extract from Azadirachta indica, Aloe vera and cinnamon, useful for the treatment of diabetes and type II diabetes associated complications such as atherosclerosis, hypertension, diabetic retinopathy, diabetic nephropathy, diabetic polyneuropathies, thyroid disorders, leg ulcers, diabetic foot and liver diseases, and for improving the immune function in a diabetic patient.

Patent application No. WO2005076750 teaches about a novel synergistic herbal formulation for diabetes cure comprising extracts from selected Indian medicinal herbs Azadirachta Indica, Momordica Charentia, Embtica Officinalis, Gymnema Sylvestres, Trigonella Foenum-Gracum, Curcuma Longa, Garcinia Camboga, Commiphor Mukul and Ocimum Sanctum with active ingredients and mixed in proportion without using any external solvents to produce hypoglycemic effect without causing hypoglycemia. The invention relates to a method of extracting and standardizing the extract of claimed herbs into a synergistic herbal formulation. The invention further relates to the method of administering.

U.S.Patent No. US 5900240 teaches use of Gymnema Sylvestre in an edible composition comprising a mixture of at least two herbs selected from the group consisting of Syzygium curnini, Gymnema sylvestre, Momordica charantia and Solanum melongena. Preferably, the composition comprises a mixture of Syzygium cumini and Momordica charantia. A mixture of Syzygium cumini, Gymnema sylvestre and Momordica charantia is particularly preferred. The herbal mixtures are useful as dietary supplements and are especially useful for lowering the glucose level of the blood in mammals, particularly humans suffering from diabetes mellitus. United States Patent 7250181 discloses polyhebral composition containing Emblica Officinalis.

Patent application No. WO0172316 describes an edible Ayurvedic herbal composition for reducing blood sugar levels in humans, specially suffering from diabetes mellitus

comprising a mixture of ingredients selected from the group consisting of Cinnamomum zeylanicum, Artocarpus heterophyllus, Salacia reticulata, Tinospora cordifolia and Pterocarpus marsupium. The mixture of the ingredients of the five selected herbs present in therapeutically effective proportions depending on the required strength of the mixture to treat abnormal levels of blood sugar and diabetes mellitus. United States Patent 20070065456 tecahes use of Picrorhiza Kurroa as a constituent of Nutritional supplement formulations are disclosed, such as nutritional supplement formulations that include Wasabia japonica. Methods for using the same to supplement a human diet are also disclosed

U.S. Patent application US2007042062 teaches about a novel herbal preparation comprises of Glycine max active fraction containing 7S globulin protein extract, Curcuma longa and Zingiber officinale Linn, rhizome extract used in treatment of diabetes and diabetic related diseases.

In Chinese Patent No CN1631379 the invention provides a medicinal composition for treating diabetes, which is prepared from pancreatic of plateau yak, goldthread root, Swertia, curcuma longa, areca-nut, and tartary buckwheat by a predetermined weight proportion. The invention also provides the method for preparation and use of the pharmaceutical composition.

OBJECT OF THE INVETION

The main object of the present invention relates to the herbal composition contains Momordica Charantia for reducing blood sugar levels in mammals especially humans suffering from diabetes mellitus.

Another object of the present invention is to provide an herbal health protective nutraceutical formulation, which further comprises biological additives that forms synergistic effect for the treatment of diabetes.

Still another object of the present invention is to develop health protective and disease preventive nutraceutical formulation, to ameliorate the general health of diabetics, as

food supplements with specific functional attributes by fortifying nutritional base material with herbs/ medicinal plants.

SUMMARY OF THE INVENTION

The present invention is related to the herbal composition of Motnordica Charantia along with the other biological additives. The extract of the Motnordica Charantia is mixed with the other biological additives such as Enicostemma Littorale, Eugenia Jambolana,

Swertia Chirata, Trigonella Foenum, Azadirachta Indica, Gymnema Sylvestre, Emblica

Officinalis, Tinospora Cordifolia, Picrorhiza Kurroa, and Curcuma Longa.

The various parts of these plants are such as leaves, fruits, flowers, steam; roots are used for the extraction.

The extraction of the biological additives along with the main ingredients of the herbal composition is carried in water at the temperature around 100 ⁰ C till it reduces to the particular concentration.

The extracts/ residue such obtained after boiling the plant parts of the main ingredient and other biological additives are dried at room temperature. After drying all the residues of the plant extracts is pulverized to the fine powder, and mixed in the particular ratio. The mixture of the dried powder of the plant extracts which is pre- mixed in particular ratios is filled in the capsules of the various strength. The capsules are finally administered as the dosage forms. DETAILED DESCRIPTION

Accordingly, the present invention provides a herbal health protective, promotive and disease preventive extract composition useful as ameliorate the general health of people having diabetics with optimum nutrients and also help to control the blood sugar level, wherein the said composition comprising extract of plant parts leaves, fruits, seeds, steam, roots, flowers. The composition is varied in the mixture form 10- 90% by wt. Also, the present invention provide composition^) used as herbal health protective, promotive extract composition for diabetics, said composition(s) comprising boiled seed powders, of biological additives or herbs/ medicinal plants extract of Enicostemma Littorale, Eugenia Jambolana, Swertia Chirata, Trigonella Foenum, Azadirachta Indica, Gymnema Sylvestre, Emblica Officinalis, Tinospora Cordifolia, Picrorhiza Kurroa, and

Curcuma Longa

The present invention also provide a process for the preparation of herbal health protective, promotive and disease preventive nutraceutical composition^) useful as food supplement to ameliorate the general health of diabetics with optimum nutrients and also helps to control the blood sugar .

Momordica Charantia is the key ingredient of the herbal extract; the green young fruits of the plant are used in this herbal extract composition.

Bitter Melon, also known, as Karela is an herb that helps regulate blood sugar levels and keeps body functions operating normally. It contains Gurmarin, a polypeptide considered to be similar to bovine insulin, which has been shown in experimental studies to achieve a positive sugar regulating effect by suppressing the neural response to sweet taste stimuli. Momordica Charantia's principle constituents are lectins, charantin and momordicine. The fruits have long been used in India as a folk remedy for diabetes mellitus. Lectins from the bitter gourd have shown significant antilipolytic and lipogenic activities.

The herbal extract the fruits of Momordica Charantia the plant is prepared by boiling the fruits of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the fruits of Momordica Charantia.

Enicostemma littorale fresh green leaves of this plant are boiled in water to obtain the extract. Enicostemma littorale has curative property for the diabetes patient, which is evidenced form simple experiment such as Enicostemma littorale (Gentianaceae) is administered to 84 patients with Type 2 Diabetes for three months.

Estimation of various biochemical parameters showed that E. littorale reduced blood glucose as well as serum insulin levels and prevented the progression of complications in diabetic patients. Significant improvement in kidney function, lipid profile and blood pressure was observed suggesting that E. littorale is an effective herbal anti-diabetic.

The herbal extract the leaves of Enicostemma littorale the plant is prepared by boiling the leaves of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the leaves of Enicostemma littorale.

Eugenia Jamboϊana seeds are pulverized and boiled in water to obtain the herbal extract of the Eugenia Jambolana.

Leaves, seeds of the Eugenia Jambolana, posseses properties Extract of Eugenia jambolana leaves, seeds exhibited significant hypoglycemic activity in normal and hyperglycemic rabbits. 20-30 Percent reduction in blood sugars of two volunteer patients (who consumed decoction of 6 or 12 g of the leaves) was also observed. Maximum reductions in blood sugars of human volunteers were observed after 2 hours of administration. Seed powder of Eugenia jambolana given in a dose of 12 Gms daily in three divided doses for three months showed marked symptomatic relief, which progressively increased with the duration of treatment.

The herbal extract the seeds of the plant is prepared by boiling the seeds of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the seeds of Eugenia Jambolana.

Swertia Chirata fresh leaves of this plant are boiled in water to obtain the extract. Swertia chirayita (Chirata) has antidiabetic activity. Researchers studied the effects of the hypoglycemic agent; swerchinin in normal as well as diabetic rats. Except in rats with severe pancreatic damage, swerchinin showed effective glucose lowering. The ethanolic extract of S.chirayita exhibits hypoglycemic activity. The hexane fraction containing swerchirin, the main hypoglycemic principle, induced a significant fall in blood sugar in albino rats.

The herbal extract the leaves of Swertia Chirata the plant is prepared by boiling the leaves of the plant in the boiling water and reducing the contents to the 40% of the more

preferably to the 30% and most preferably to the 15% of the weight of the initial weight of the leaves of Swertia Chirata

Trigonella Foenum, seeds of this plant are pulverized to fine powder and boiled in water to obtain the extract.

Fenugreek is a spice commonly used in India and the Middle East in cooking. Numerous studies have shown that fenugreek can reduce blood sugar and cholesterol levels in individuals with diabetes. Fenugreek seeds exert hypoglycemic effects by stimulating glucose-dependant insulin secretion from pancreatic cells.

The herbal extract the leaves of Trigonella Foenum the plant is prepared by boiling the seeds of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the seeds of Trigonella Foenum.

Azadirachta Indica fresh leaves are crushed in to the small pieces and boiled in water to obtain the extract.

Diabetes is a disease of excess sweetness so bitter herbs and foods must be used to counteract the imbalance. Azadirachta Indica being very bitter was often used to treat diabetes in Ayurved. Modern clinical studies reveal that Azadirachta Indica has been affective in treating and preventing Diabetes. Azadirachta Indica significantly and consistently reduced insulin requirements for nonkeytonic, insulin fast, and insulin sensitive forms of Diabetes. Because of the numerous and successful clinical studies with

Azadirachta Indica on Diabetes.

The herbal extract the crushed leaves of Azadirachta Indica the plant is prepared by boiling the leaves of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the leaves of Azadirachta Indica.

Gymnema Sylvestre fruits are dried and grounded to the uniform size and boiled in water to obtain herbal extract.

Gymnema Sylvestre, also known as Gurmar and Meshashringi, whose Hindi name literally means 'sugar destroyer ¹ , has been used in Ayurveda for several centuries to regulate sugar metabolism. The hypoglycemic (blood sugar-lowering) action of gymnema leaves was first documented in the late 1920s. This action is gradual in nature,

differing from the rapid effect of many prescription hypoglycemic drugs. Gymnema leaves raise insulin levels by regeneration of the cells in the pancreas that secrete insulin. Other research has shown that gymnema also improves uptake of glucose into cells by increasing the activity of the glucose utilizing enzymes, and prevents adrenaline from stimulating the liver to produce glucose, thereby reducing blood sugar levels. The leaves are also noted for lowering serum cholesterol and triglycerides. It also abolishes the taste of sugar, which effectively suppresses and neutralizes the craving for sweets. The herbal extract the crushed fruits of Gymnema Sylvestre the plant is prepared by boiling the fruits of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the fruits of Gymnema Sylvestre.

Emblica Officinalis dried fruits of this plant are boiled in water to obtain extract. This herb, due to its high vitamin C content, is effective in controlling diabetes. It stimulates the pancreas and enables it to secret insulin, thus reducing blood sugar levels. The herbal extract the crushed dried fruits of Emblica Officinalis the plant is prepared by boiling the dried fruits of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the dried fruits of Emblica Officinalis. Tinospora Cordif olia fresh vines are dried and grounded. These are then boiled in water to obtain extract.

T. Cordif olia is widely used in Indian Ayurvedic medicine for treating Diabetes. Oral administration of T.Cordif olias' root extract to alloxan rats caused a significant reduction in blood glucose levels. It has been studied that the daily administration of T.Cordif olia decreases the blood glucose level, and increases glucose tolerance.

The herbal extract the crushed fresh vines of Tinospora Cordif olia the plant is prepared by boiling the fresh vines of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the fresh vines of Tinospora Cordif olia.

Picrorhiza Kurroa seeds are grounded and boiled water to obtain the extract.

Picrorhiza Kurroa is known to be useful in the maintaining good health of the liver is an extremely essential organ in maintaining glucose homeostasis in the body. It maintains a normal blood glucose concentration by controlling glycogenesis and glycogenolysis. Picorrhiza kurroa exerts its hepatoprotective & corrective actions due to its glycosides, picrosides II & I.

The herbal extract the crushed dried seeds of Picrorhiza Kurroa the plant is prepared by boiling the seeds of the plant in the boiling water and reducing the contents to the 30% of the more preferably to the 20% and most preferably to the 10% of the weight of the initial weight of the seeds of Picrorhiza Kurroa.

Curcuma Longa dried roots are pulverized and extracted in water to obtain the extract.

In the traditional system of medicine, Ayurveda, several spices and herbs are thought to possess medicinal properties. Among the spices, turmeric rhizomes (Curcuma Longa) are used as flavoring and coloring agents in the Indian diet everyday

Alloxan was used to induce diabetes. Administration of turmeric or curcumin to diabetic rats reduced the blood sugar, Hb and glycosylated hemoglobin levels significantly. Turmeric and curcumin supplementation also reduced the oxidative stress encountered by the diabetic rats. This was demonstrated by the lower levels of TBARS (thiobarbituric acid reactive substances), which may have been due to the decreased influx of glucose into the polyol pathway leading to an increased NADPH/ NADP ratio and elevated activity of the potent antioxdiant enzyme GPx.

Moreover, the activity of SDH (sorbitol dehydrogenase), which catalyzes the conversion of sorbitol to fructose, was lowered significantly on treatment with turmeric or curcumin.

The herbal extract the dried roots of Curcuma Longa the plant is prepared by boiling the leaves of the plant in the boiling water and reducing the contents to the 40% of the more preferably to the 30% and most preferably to the 15% of the weight of the initial weight of the dried roots of Curcuma Longa.

The extracts obtained of Momordica Charantia and other biological additives, which is in the form of the thick paste. Then it allows drying by evaporation in a complete hygienic environment.

After complete drying the extracts are pulverized in to the fine powder and mixed together in different ratio.

The mixture obtained after mixing the all the ingredients heated to dry in electric tray heaters. The finely derived mixed powder composition of herbal extracts is ready to put in capsulated dosage form.

Capsules of the different capacity are prepared from such composition, apart form the capsules form these may be directly used as the medicines or mixed other pharmaceutically acceptable vehicles.

EXAMPLES 1

Momordica Charantia is mixed with the other biological additives such as Enicostemma Iittorale, Eugenia Jambolana, Swertia Chirata, Trigonella Foenum, Azadirachta Indica, Gymnema Sylvestre, Emblica Officinalis, Tinospora Cordif olia, Picrorhiza Kurroa, Curcuma Longa,

Process to obtain the extracts

Following procedure is to create approximately 200 kg. of mix to produce about 2000 bottles (approx.4, 00,000 capsules).

STEP 1: Above named ingredients in their original forms are picked by experienced people, brought in our plant and thoroughly washed and steamed before processing 500 kilograms of Momordica Charantia (red or yellow once must be avoided) boiled till it becomes 1/10* i.e.50 kgs. Remains known as residue or extract 1. 100 Kgs. of Enicostemma Littorale fresh green leaves boiled till it remains 1/10* i.e. 10 kgs The remains is part of the biological additives.

100 kilograms of Eugenia Jambolana (seeds grounded) boiled till it becomes l/lO* i.e. 50 kgs. The remains is part of the biological additives.

100 kilograms of Swertia Chirata fresh green leaves boiled till it remains 1/6.5* i.e. 15 kgs .The remains is part of the biological additives.

100 kilograms of Azadirachta Indica fresh green leaves boiled till it remains l/lO* i.e. 10 kgs. The remains is part of the biological additives.

100 kilograms of Trigonella Foenum, (seeds grounded) boiled till it remains 1/10* i.e. 10 kgs. The remains is part of the biological additives.

100 kilograms of Gymnema Sylvestre (fruits dried and grounded) boiled till it remains

1/10* i.e.10 kgs. The remains is part of the biological additives.

100 kilograms of Emblica Officinalis (fruits dried and grounded) boiled till it remains

1/10* Le.10 kgs. The remains is part of the biological additives.

100 kilogram of Curcuma Longa (dried and grounded roots) boiled till it remains 176.5 ^th i.e. 15 kgs. The remains is part of the biological additives.

100 kilogram of Tinospora Cordifolia (seeds grounded) boiled till it remains 1/10* i.e. 10 kgs. The remains is part of the biological additives.

500 kilogram of Picrorhiza Kurroa, (fresh vines dried and grounded) boiled till it remains l/lO* i.e. 10 kgs. The remains is part of the biological additives.

We use stainless steel vessels for above boiling process.

STEP 2:

Now, this extracts/ residue which is in form of thick paste dried in natural heat (it can be dried in artificial heat in during different circumstances) While drying utmost care is taken to cover the residue avoiding dust and foreign particles. Once dried these ingredients are then again grounded to a fine powder and put in the mixture according to their formulation ratio.

Final mixture is now heated and dried in electric tray heaters. Now it is ready to be filled in capsules.

STEP 3:

Before filling the powder in the capsules and agreed quantity along with the batch no is sent to the recognized laboratory just to make sure that it is absolutely safe for human consumption.

Once satisfied, the mixture then is filled in vegetarian capsules (the size of the capsule is zero) each capsule contains 0.5 Gms. of the mixture.

Again about 500 capsules send to the laboratory for final check.

STEP 4:

Capsules are then packed in a polythene bag with drying agent and then sealed and packed and sealed in a plastic jar.

The normal suggested dose for diabetics is 2 capsules three times a day. The result has shown that the best possible result can be obtained to re-activate the pancreas within three months time.

The foregoing detailed description has been directed to particular embodiments of the invention for the purposes of illustration and explanation. It will be apparent, however, to those skilled in this art that modifications and changes in the compositions and processes set forth will be possible without departing from the scope and spirit of the invention.