A Process for manufacturing an herbal composition for curing Diabetes and herbal composition made thereof

Field Of Invention:

The present invention relates to process for manufacturing an herbal composition for curing Diabetes. Also it relates to an herbal composition manufactured by the aforesaid process.

Prior Art:

Diabetes mellitus is a worldwide problem with increasing number of affected population. Diabetes mellitus, in view of Western medicinal science, is characterized by- failure in glucose metabolism which is due to absolute or insufficient insulin production, or relative insensitivity to insulin which is the key hormone for glucogenesis. In people with diabetes, the pancreas produces little or no insulin, the hormone responsible for facilitating uptake of glucose by cells to give energy as ATP, resulting in a high level of glucose in the blood, causing excessive urination and constant thirst and hunger.

There are two main types of diabetes mellitus, Type I and Type II. In Type I, the more severe form and accounts for 5 to 10 percent diabetes, the body does not produce any insulin, most often occurring in children and young adults. Without regular injections of insulin the sufferer lapses into a coma and dies. Individuals suffering from Type I diabetes are totally insulin dependent.

Type II diabetes, the most prevalent type of diabetes, is usually of gradual onset and occurs mainly in people over 40. Type II diabetes is a metabolic disorder resulting from

the body's inability to make enough, or properly use, insulin to meet the body's needs, especially when the person is overweight. It is the most common form of the disease. Type II diabetes accounts for 90 to 95 percent of diabetes. Type II diabetes is nearing epidemic proportions due to a greater prevalence of obesity and sedentary lifestyles. Initially, the combination of dietary measures, weight reduction and oral medication can keep the condition under control for a period of time, but most people with Type II diabetes ultimately require insulin injections.

Medical complications arise from diabetes include athreosclerosis, hyperlipidemia, retinal damage, neurological damage, and blindness.

The trigger of the cause of diabetes is remained unknown and the common treatments include oral intake of medicine and insulin injection to restore the relative sensitivity to the insulin or supply a source of insulin for use. These treatments are for managing and control of the glucose level and ineffective in curing the disease and improving the gravity of the disease.

Other contemporary methods have been developed over time for treating diabetes. For example, exercise is one of the best treatments for diabetes, especially for type II diabetes, for increasing the body conditions and hence decreasing the gravity of diabetes. Even though the mechanism of effect of exercise in treatment of diabetes is not really clear at present, the direct correlation between exercise and blood glucose level are confirmative and widely accepted.

Diet management is another contemporary method for treating diabetes. Since the glucose cycle in our body is affected, the uptake of sugar, ranging from monosaccharide, disaccharide and polysaccharide requires special monitoring. However, glucose is the major energy source of our body, any deficiency or excess of

glucose is not good to our body. Thus, careful glucose control is required if the disease is not cured.

Some kinds of natural herb have been used for treating different diseases, together with the rise in Traditional Chinese Medicine and in the growing recognizable use of natural herbs for treatment of disease and improving the body conditions, the effectiveness of the use of natural herbs in treatment in medical science is convincing and promising.

For example, Heracleum lanatum, common name cow parsnip, is one of the natural herbs which is used for treatment in diabetes. In the U.S. Pat. No. 5,741,491, the use of an extract derived from Heracleum lanatum and a specie of Populus is disclosed wherein the direct relation between the administration of the extract and the effect of lowering blood glucose was shown. However, there must still much room for further development or breakthrough in the field of herbs science, especially with the increasing knowledge and understandings of Tradition Chinese medicine and herbs, for treatment of diabetes, partly because existing methods of treatment of diabetes are not really curing the disease and partly because the ever growing number of people are suffered from this disease.

On the other hands, there seems no trial or method for curing or lowering the gravity of the disease of diabetes based on the principles and understandings of diabetes. The present day treatments emphasize on management and control of the disease, which may be too disappointing for those who need to have lifetime management and control of the disease. A good control in every food intake and in every medication intake is somewhat a stress which may further deteriorate the health of the diseased. In fact, any effort or method trying to curing or lowering the gravity of the disease of diabetes is essential and necessary for those diseased.

U.S. Pregrant 20050175716 discloses a method and herbal composition of treatment for diabetes comprising the steps of providing a predetermined herbal composition in a predetermined form, providing an administration plan for a predetermined number of days; and administering the herbal composition according to the administration plan for a predetermined number of days. The herbal composition comprises Toona sinensis and Heracleum lanatum which is natural and does not have any adverse side effects. Toona sinensis is the major active ingredient for treatment of diabetes while Heracleum lanatum is used to provide an optimum body conditions for treatment.

Herbs and their extracts have also been used to control weight and hence the diabetes, for example U.S. Pat. No. 5,945,107 describes compositions and methods containing herbal plant extracts for weight reduction. Guarana which contains caffeine, as an active ingredient, has been incorporated into weight loss products (Hurel, J. -P., 1993, FR 2 712 191 -Al). Primez (Belgium Patent 100593A7) describes a phyto-active mixture referred to as Lycopodium, which contains Guarana and other plant extracts including Scillia maritime, Ephedra vulgaris, and Betula alba to produce weight loss.

Dietary supplements containing a thermogenic substance, an adrenal support substance, thyrogenic substance and a blood sugar regulation substance are disclosed in U.S. Pat. No. 6,277,396. The thermogenic substance, to increase metabolism and accelerate calorie expenditures, is selected from a group consisting of caffeine, catechins, MaHuang, ephedrine, synephrine, norephedrine, psuedoephedrine, and White Willow. The adrenal support substance, to maintain and/ or improve adrenal functions and to reduce stress, is selected from a group consisting of Cordyceps, Ashwagandha, Astragalus, ginseng, Schisandra, Siberian ginseng, licorice, Asian ginseng, Codonopsis, adrenal glandular extract, embryo extract. The thyrogenic substance, to support and/ or improve thyroid functions, is selected from a group consisting of Guggul (guggelsterones), thyroid glandular extract, and tyrosine.

The blood sugar regulation substance, to regulate or manipulate blood sugar levels and/ or glucose metabolism and to help stabilize normal sugar levels and increase the body's ability to lose stored body fat, is selected from a group consisting of Bitter Melon (Momordica charantia), vanadium, allano lactone, Fenugreek (Trigonella foenumgraecum), Garcinia (Garcinia cambogia), gymnema (Gymnema sylvestra), marshmallow (Althaea officinalis), chromium, chromium GTF, chromium picolinate, chromium polynicotinate, alpha lipoic acid, inula racemusa, zinc, magnesium, cyclo- hispor, Agaricus campestris (mushroom), Medicago sativa (Lucema), pinitol (Bougainvillea spectabilis).

U.S. Pat. No. 6,042,834 discloses an herbal composition comprising Trigonella foenumgraecum, Nigella sativa, Origanum vulgare, Rosemarinus officinalis, Lupinus termis, Lawsonia inermis and Foeniculum vulgare for the treatment of diabetes.

The conventional Herbal formulations, which are available, are not found effective for curing the above diseases. Also they all having up to some extent the risk of side effects. Therefore, there is a need to have different combination in full therapeutic effect of the active ingredients present in the different types of Herbs to give synergy effect with minimal or no side effect. Hence there is a need for a safe and effective treatment for diabetes with minimal side effects and without the invasive procedure, such as insulin injection.

Object of Invention:

The main object of the present invention is to provide a process for manufacturing an herbal composition for curing Diabetes.

Further object of present invention is to provide an herbal composition manufactured by the aforesaid mentioned process.

Another object is to provide herbal medicament for curing Diabetes with least or no side effect.

Another object is to provide herbal medicament for controlling Diabetes in a shorter span of time.

Accordingly there is provided a process for manufacturing an herbal composition comprises the steps of: a. selecting the extracts of the following Herbs in the given percentage by weight:

1. 20% by weight seed extract of Jamun (Syzygium cumini)

2. 14% by weight seed extract of Methi (Trigonella foenum graecum)

3. 7% by weight leaf extract of Neem (Melia azadirachta)

4. 10% by weight fruit extract of Aonla (Emblica officinalis)

5. 7% by weight flower & fruit extract of Tarwar (Cassia auriculata)

6. 20% by weight leaf extract of Gurmar (Zymnema sylvestre)

7. 7% by weight leaf extract of Kalmegh (Andrographis paniculata)

8. 5% by weight leaf extract of Giloya (Tinospora cardifolia)

9. 5% by weight fruit extract of Karela (Momordica charantia)

10. 5% by weight fruit extract of Gokharu (Tribuluf terristris) . wherein aforesaid mentioned herbal extracts are cultivated in red soil and harvested in non-sunlight after the maturity period and cut in non-sunlight in a hygienic condition probably on clean stone for hygienic purpose and dried in sunlight before grinding for one to two days;

b. grinding the above Herbs separately in a grinder at a speed of 1500 rpm;

c. pulversing/ blending the ingredients in their specific proportion as given above in a pulverizer/ blender run at a speed of 500 rpm for 30 to 60 minutes;

d. sieving the mixed powder through a sieve made of nylon cloth of 150 mesh size.

Also there is provided an herbal composition comprises:

1. 20% by weight seed extract of Jamun (Syzygium cumini)

2. 14% by weight seed extract of Methi (Trigonella foenum graecum)

3. 7% by weight leaf extract of Neem (Melia azadirachta)

4. 10% by weight fruit extract of Aonla (Emblica officinalis)

5. 7% by weight flower & fruit extract of Tarwar (Cassia auriculata)

6. 20% by weight leaf extract of Gurmar (Zymnema sylvestre)

7. 7% by weight leaf extract of Kalmegh (Andrographis paniculata)

8. 5% by weight leaf extract of Giloya (Tinospora cardifolia)

9. 5% by weight fruit extract of Karela (Momordica charantia)

10. 5% by weight fruit extract of Gokharu (Tribuluf terristris)

According to present invention the herbal composition is available in powder form.

Detailed description of the invention:

Now following description will explain the invention in details.

The herbal composition of the present invention essentially comprising of following main ingredients:

1. SYZYGIUM CUMINI

Common Name : Jamun

It removes stones in the bladder, increase blood percentage. It decreases sugar levels in body. Gives relief to the body.

2. TRIGONELLA FOENUM GRAECUM

Common name : Methi

The leaves are refrigerant, aperients and given internally for biliousness. They are useful in fever, vomiting, flatulence, colic, and dysentery. It makes you every rejuvenate and cooling effect to the body. It controls diabetes. It increases blood levels in the body.

3. MELIA AZADIRACHTA

Common name : Neem

This is used to cure skin diseases, prurigs, boils, uricaria, unhealthy ulcers, indolent ulcers, gangular swellings, leprosy and spasmodic infections. This is good for eyes, stomach. This is also used to cure remittent fever, eczema, hysteria. It gives mental strength. When this powder is used for shampooing, it not only keeps your hair free from nit & lice, but also keeps your hair free from falling.

4. EMBLICA OFFICINALIS

Common Name : Aonla

This amla powder is rich in vitamin C. This powder improves digestion and set right all your digestive problems. It gives strength to body and good for stomach, heart, and eye and for general health. If this powder is given to a person who is sick, he gets well soon. This is not only used to get relief from phlegm, vomiting sensation but also for many other purposes.

5. CASSIA AURICULATA

Common Name : Tarwar

It cures eye diseases. It kills bacteria. It is good in curing pain in diabetes. It gives strength to the bod)λ

6. ZYMNEMA SYLVESTRE

Common Name : Gurmar

It reduces blood sugar.

7. ANDROGRAPHIS PANICULATA

Common Name : Kalmegh

It reduces blood sugar.

8. TINOSPORA CARDIFOLIA

Common Name : Giloya

It reduces blood sugar.

9. MOMORDICA CHARANTIA

Common Name : Karela

It reduces blood sugar.

10. TRIBULUF TERRISTRIS

Common Name : Gokharu It reduces blood sugar

Above mentioned herbs are naturally occurring and cultivated through out India most preferably in Andhra Pradesh in forest. The selection of these herbs from the region as well as the climatic condition, soil, manure of all this have effects on the raw material used.

According to the present invention an herbal composition comprises the following ingredients in proper amount:

1. 20% by weight seed extract of Jamun (Syzygium cumini)

2. 14% by weight seed extract of Methi (Trigonella foenum graecum)

3. 7% by weight leaf extract of Neem (Melia azadirachta)

4. 10% by weight fruit extract of Aonla (Emblica officinalis)

5. 7% by weight flower & fruit extract of Tarwar (Cassia auriculata)

6. 20% by weight leaf extract of Gurmar (Zymnema sylvestre)

7. 7% by weight leaf extract of Kalmegh (Andrographis paniculata)

8. . 5% by weight leaf extract of Giloya (Tinospora cardifolia)

9. 5% by weight fruit extract of Karela (Momordica charantia)

10. 5% by weight fruit extract of Gokharu (Tiϊbuluf terristris)

Then according to process of the present invention above mentioned herbs are ground separately in a grinder at a speed of 1500 rpm. Then these are pulverized/ blended in their specific proportion as given above in a pulverizer/ blender run at a speed of 500 rpm for 30 to 60 minutes. Then the mixed powder is sieved through a sieve made of nylon cloth of 150 mesh size.

The formulation of the present invention is not a mere admixture resulting in mere aggregation of the properties of individual ingredients but in a synergistic mixture resulting in enhanced curative properties. Also the clinical trial has been conducted on this newly developed herbal composition and it is surprisingly found that efficacy is improved by using this formulation instead of using individual ingredients of the formulation. Also the clinical trials have been conducted on the patients suffering from the Diabetes. All have been administered by the formulation of the present invention orally once or twice a da)r depending on the extent of Diabetes and it has been found that patients get cured in a shorter span of time with least or no side effects. Extent of side effect is varying from person to person. No severe side effect is found.

Example:

The example tells about only the best method of performing the invention. Hence it is considered only for illustration purpose and not for limiting the scope of invention.

Firstly the herbs are selected and cultivated in the red soil using bio-fertilizer manure or all natural waste. These are harvested in Non-sunlight after the maturity period and cut after 10 or 12 days in a non-sunlight or shed with hygienic condition preferably on

stone. Subsequently dried in sunlight for 1 to 2 days. Then extracts of above herbs in following percentage by weight are selected:

1. 20% by weight seed extract of Jamun (Syzygium cumini)

2. 14% by weight seed extract of Methi (Trigonella foenum graecum)

3. 7% by weight leaf extract of Neem (Melia azadirachta)

4. 10% by weight fruit extract of Aonla (Emblica officinalis)

5. 7% by weight flower & fruit extract of Tarwar (Cassia auriculata)

6. 20% by weight leaf extract of Gurmar (Zymnema sylvestre)

7. 7% by weight leaf extract of Kalmegh (Andrographis paniculata)

8. 5% by weight leaf extract of Giloya (Tinospora cardifolia)

9. 5% by weight fruit extract of Karela (Momordica charantia)

10. 5 % by weight fruit extract of Gokharu (Tribuluf terristris)

Then herb extract are ground separately in a grinder with 1500 rpm to make powder form and pulverized/ blended in the specific proportion as given above in the pulverizer/blender for thorough mixing with speed of 500 rpm for 45 minutes. Then resultant mixture sieved through the nylon cloth of 150 mesh size to obtain the required particle size of the active ingredients. The formulation of the present invention is available in powdered form.

However, it should be understood that the invention is not limited in this regard, and the relative amounts of these ingredients can be varied to achieve similar results.

Industrial Applicability

The invention provides herbal composition for curing Diabetes which is very well used in the medicinal field and drug industries.