Title of Invention	"A HERBAL COMPOSITION FOR THE PREVENTION AND MANAGEMENT OF POTENTIAL DIABETES AND A PROCESS FOR THE PREPARATION THEREOF"
Abstract	The invention relates to a herbal composition and a process for preparation thereof wherein the composition is useful for prevention and management of blood glucose levels among the potential diabetes. The herbal composition comprises a mixture of organic extracts of Syzygium cumini (Jamboo), Momordica charantia (Karela), Trigonella foenumgraceum (Methika) and Leptadenia reticulata (Jeevanti) and with or without additive. The process comprises mixing of the organic extracts of the above herbs followed optionally mixture of additive.

Title of Invention

"A HERBAL COMPOSITION FOR THE PREVENTION AND MANAGEMENT OF POTENTIAL DIABETES AND A PROCESS FOR THE PREPARATION THEREOF"

Abstract

The invention relates to a herbal composition and a process for preparation thereof wherein the composition is useful for prevention and management of blood glucose levels among the potential diabetes. The herbal composition comprises a mixture of organic extracts of Syzygium cumini (Jamboo), Momordica charantia (Karela), Trigonella foenumgraceum (Methika) and Leptadenia reticulata (Jeevanti) and with or without additive. The process comprises mixing of the organic extracts of the above herbs followed optionally mixture of additive.

Full Text	Field of Invention : This invention relates to a herbal composition and a process for the preparation thereof wherein the composition is useful for prevention and management of blood glucose levels among the potential diabetics who exhibit variation in the blood glucose levels and are supposed to be at risk of developing full fledged diabetes mellitus in future. The composition of the present invention may also be advantageously used in the management of type I diabetes mellitus i.e. non-insulin dependent diabetes mellitus. Background of the invention: The individuals who are at risk of developing diabetes mellitus come under the range of potential diabetes. In such cases glucose tolerance is above the conventional normal range but lower than the level considered as diabetes range. Majority of such persons do have a risk of developing full-fledged diabetes mellitus. The impaired glucose tolerance is more frequent in obese than the non-obese. Certain class of medication, genetic background, autoimmune phenomena, life style including stress factor are responsible for the development of full-fledged diabetes mellitus. In this early phase of altered blood glucose levels, if persisting for longer time, there will be minor changes in the renal function resulting the micro albuminurea and other minor vascular changes. Till date no suitable drug therapy is available which can prevent or prolong the onset of full-fledged diabetes mellitus and related complications. It is well proven that early onset of diabetes required prolonged therapy to manage the diabetes and its complications. Drug resistance is the major problem as regards the autidiabetic therapy is concern. Therefore it was thought proper to provide a formulation, which can delay the onset of diabetes and thus the complications caused due to hyperglycaemia may be prevented or minimized without any side effect. Objects of the present invention : An object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for the prevention and management of potential diabetes or to prevent/manage the risk level of glucose intolerance. Another object of this invention is to propose a herbal formulation and a process for the preparation thereof useful to delay the onset of full fledged diabetes mellitus by managing the glucose intolerance at initial stage. Further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for the prevention of micro-albuminurea by regulating blood glucose level. Still further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for preventing the individuals who are at risk of developing diabetes in near future from drug resistance. A further object of this invention is to propose a herbal composition to enhance the body immunity among potential diabetes. Description of Invention : According to this invention there is provided a herbal preparation for the prevention and management of potential diabetes cases comprising: Organic extract of Syzygium Cumini (Jambulana) 150-400 mg Organic extract of Momordica Charantia (Karela) 250-600 mg Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg with or without known additives. In accordance with a preferred embodiment and without intending to imply any limitation, the weight ratio of the constituents varies from 1.5:2.5:3:4 to 2:3:4:4 and with or without an additive. Further according to this invention there is provided a process for the preparation of herbal formulation for the prevention and management of altered levels of variation in fasting and PP glucose levels found among the individuals and supposed to be at risk of developing fulfalged diabetes mellitus comprising in admixing: Syzygium cumini 150-400 mg Momordica charantia 250-600 mg Trigonella foenum-graceum 300-800 mg Leptadenia reticulata 400-800 mg With or without known additives. It is to be understood that the composition is not a mere admixture involving to aggregation of properties but the ingredients have synergistic effect on each other as none of the ingredients is individually effective against potential diabetes. The chemicals extracted out of the plants are used in the following dose range in a particular manner- Organic extract of Syzygium Cumini (Jamboo) 150-400 mg Organic extract of Momordica Charantia (Karela) 250-600 mg Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg with or without known additives. The drugs are administered with varying dose schedule and a careful monitoring of the clinical symptomatology present different results. On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of: Syzygium cumini (Jamboo) 100-300 mg Momordica charantia (Karela) 200-500 mg Trigonella foenum-graceum (Methika) 200-600 mg Leptadenia reticulata (Jeevanti) 150-500 mg The remainder is optionally known additive to make the required preparation. Syzygium cumini (Jambulana): This plaul is commonly known as Jamboo/Jamun belonging to family 'Myrtaceae' whose dried seeds are extracted to collect the mixture of two flavonoidal glycoside, steridal sapogenins and gallic acid compounds. Various studies have shown this mixture possessing hypoglycaemic property. It reduces the blood glucose level. Momordica charantia (Korela): This plant is commonly known as Karela. It belongs to the family "Cucurbilaccae" whose dried fruits arc extracted to collect the mixture of triterpene glycosides, momordxosides ABCDE, luteolin and cherantin compounds. Various studies on this mixture have indicated the hypoglycacmic property. It is known as a anti-diabetic agent. Trigonella foenum -graceum (Methi): This plant is commonly known as Methi belonging to family 'Papilionaceae' whose dried seeds are extracted to collect the mixture of sapogenins, saponins, flavonoids flavonoidal glycoside compounds. Studies have shown that this mixture possessing mild hypotensive and cardiotonic and thus useful in managing the complications like hypertension, cardiac involvement in diabetes mellitus. Leptadenia reticulata (Jeevanti): This plant is commonly known as Jeevanti belonging to family' 'Ascepiadeceae' whose roots are extracted to collect the mixture of various contents of the plant showed restorative (anabolic) and mild hypotensive property. The known additives are excipients such as calcium sulphte. Example -1: The preparation containing the organic extract of syzygium cumini administered in the dose of 150 - 400mg to the diagnosed cases of potential diabetes continuously for three months exerted regulation of blood glucose levels both fasting and post prandial among potential diabetes cases. Example-2: The preparation containing the organic extract of Momordica charantia in the dose of 250 - 600mg administered to the diagnosed cases of potential diabetes continuously for 3 months have also shown the blood glucose lowering effects. Example -3: The preparation containing the organic extract of trigonella foenumgraceum in the dose of 300 - 800 mg administered to the individuals showing altered levels of blood glucose both fasting and post prandial exhibited regulation of the levels and also improvement in mico-proteinurea present in urine. Example -4: The preparation containing the organic extract of leptidenia reticulata in the dose of 400 - 800mg administered to the individuals at risk of developing diabetes mellitus continuously for three months showed improvement in general body resistance and feeling of well being. Example-5: The preparation containing the organic extract of Syzygium cumini in the dose of 100 - 300mg and organic extract of Momordica charantia in the dose of 200 - 500mg administered continuously for three months to the individuals showing altered blood glucose levels exhibited reduction in both lasting and post, prandial blood glucose levels and the difference in the range of fasting and PP levels minimized significantly. Example-6: The preparation containing the organic extract of Syzygium cumini in the dose of 100 - 300 mg and organic extract Trigonella foenum in the dose of 200 - 600mg administered to the individuals of potential diabetes continuously for three months showed lowering effects of blood glucose levels alongwith improvement in proteinurea. Exunple-7: The preparation containing the organic extract of Momordica Charntia in the dose of 200 - 500mg and Leptadenia recticulata in the1 dose of 150 - 500 mg to the potential diabetes cases showed mild improvement in blood pressure and reduction in blood glucose levels. Example -8: The preparation containing the organic extract of Syzygium cumini in the dose of 150mg, organic extract of Momordica charantia in the dose of 250 mg, organic extract of Trigonella foenumgraceum in the dose of 300mg, Leptademia reticulata in the dose of 200mg administered to individuals showing higher range of variation between fasting and post prandial blood glucose levels and suppose to be at risk of developing fullflaged diabetes mellilus exhibited effective regulation of blood glucose levels, improvement in proteinurea along with feeling of well being. The present invention is a combination of organic extract of Syzygium cumini, Momordica charantia, Trigonella foenumgraceum and Leptadenia reticulata in an effective doses has shown better results than the use of single crude drug, used by traditional practitioners. This formulation prolonged the onset of fulflaged diabetes mellitus. Apart from the hypoglycemic effects of Syzygium cumini, Momordica charantia, Trigonella foenumgraceum including organic extract of Leptadenia reticulata the formulation exerted effects in enhancing the body immunity, management of micro-albuminurea and thus prevented the risk level of glucose intolerance. The present formulation has shown better results by overcoming the group of complaints and laboratory tests presented by potential diabetics, where as the single crude form of a plant is not sufficient to prevent/manage the multiple factors associated with potential diabetes. It is to be understood that the invention of the present invention is susceptible to modifications, adaptations, changes by those skilled in the art. Such variant compositions and the processes for preparation thereof are intended to be taken within the scope of the present invention, which is set forth under the following claims:- 1 CLAIM: 1. A herbal preparation for the prevention and management of potential diabetes cases comprising: Organic extract of Syzygium Cumini (Jambulana) 150-400 mg Organic extract of Momordica Charantia (Karela) 250-600 mg Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg with or without known additives. 2. A preparation as claimed in claim 1 comprising: Syzygium cumini 100-300 mg Momordica charantia 200-500 mg Trigonella foenum-graceum 200-600 mg Leptadenia reticulata 150-500 mg with known additive for a preparation of 300 mg/500 mg. 3. A preparation as claimed in claim 1 comprising the organic extract of Syzygium cumini containing mixture of two-flavonoidal glycoside, steridal sapogenins and gallic acid compound. 4. A preparation as claimed in claim 1 wherein the organic extract of Momordica charantia contains a mixture of triterpine glycosides, momordxosides, luteolin and cherantin compounds. 5. A preparation as claimed in claim 1 wherein the organic extract of Trigonella foenum-graceum contains a mixture of sapogenins, saponins, flavonoidal glycoside compounds. 6. A process for the preparation of herbal formulation for the prevention and management of altered levels of variation in fasting and PP glucose levels found among the individuals and supposed to be at risk of developing fulfalged diabetes mellitus comprising in admixing: Syzygium cumini 150-400 mg Momordica charantia 250-600 mg Trigonella foenum-graceum 300-800 mg Leptadenia reticulata 400-800 mg with or without known additives. 7. A process as claimed in claim 6 comprising: Syzygium cumini 100-300 mg Momordica charantia 200-500 mg Trigonella foenum-graceum 200-600 mg Leptadenia reticulata 150-500 mg with known additive for a preparation of 300 mg/500 mg. 8. A process as claimed in claim 6 comprising the organic extract of Syzygium cumini contains a mixture of two-flavonoidal glycoside, sistostrol, glycosides and gallic acid compound. 9. A process as claimed in claim 6 comprising the organic extract of Momordica charantia containing a mixture of triterpine glycosides, momordxosides, luteolin and cherantin compounds. 10. A process as claimed in claim 6 comprising the organic extract of Trigonella foenum-graceum containing a mixture of sapogenins, saponins, flavonois glycoside compounds. 11. A herbal composition substantially as herein described and illustrated. 12. A process for the preparation of a herbal composition substantially as herein described and illustrated.

Full Text

Field of Invention :
This invention relates to a herbal composition and a process for the preparation thereof wherein the composition is useful for prevention and management of blood glucose levels among the potential diabetics who exhibit variation in the blood glucose levels and are supposed to be at risk of developing full fledged diabetes mellitus in future. The composition of the present invention may also be advantageously used in the management of type I diabetes mellitus i.e. non-insulin dependent diabetes mellitus.
Background of the invention:
The individuals who are at risk of developing diabetes mellitus come under the range of potential diabetes. In such cases glucose tolerance is above the conventional normal range but lower than the level considered as diabetes range. Majority of such persons do have a risk of developing full-fledged diabetes mellitus. The impaired glucose tolerance is more frequent in obese than the non-obese. Certain class of medication, genetic background, autoimmune phenomena, life style including stress factor are responsible for the development of full-fledged diabetes mellitus.
In this early phase of altered blood glucose levels, if persisting for longer time, there will be minor changes in the renal function resulting the micro albuminurea and other minor vascular changes. Till date no suitable drug therapy is available which can prevent or prolong the onset of full-fledged diabetes mellitus and related complications. It is well proven that early onset of diabetes required prolonged therapy to manage the diabetes and its complications. Drug resistance is the major problem as regards the autidiabetic therapy is concern. Therefore it was thought proper to provide a formulation, which can delay the onset of diabetes and thus the complications caused due to hyperglycaemia may be prevented or minimized without any side effect.
Objects of the present invention :
An object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for the prevention and management of potential diabetes or to prevent/manage the risk level of glucose intolerance.
Another object of this invention is to propose a herbal formulation and a process for the preparation thereof useful to delay the onset of full fledged diabetes mellitus by managing the glucose intolerance at initial stage.
Further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for the prevention of micro-albuminurea by regulating blood glucose level.
Still further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for preventing the individuals who are at risk of developing diabetes in near future from drug resistance.
A further object of this invention is to propose a herbal composition to enhance the body immunity among potential diabetes.
Description of Invention :
According to this invention there is provided a herbal preparation for the prevention and
management of potential diabetes cases comprising:
Organic extract of Syzygium Cumini (Jambulana) 150-400 mg
Organic extract of Momordica Charantia (Karela) 250-600 mg
Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg
Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg
with or without known additives.
In accordance with a preferred embodiment and without intending to imply any limitation, the weight ratio of the constituents varies from 1.5:2.5:3:4 to 2:3:4:4 and with or without an additive.
Further according to this invention there is provided a process for the preparation of herbal formulation for the prevention and management of altered levels of variation in fasting and PP glucose levels found among the individuals and supposed to be at risk of developing fulfalged diabetes mellitus comprising in admixing:
Syzygium cumini 150-400 mg
Momordica charantia 250-600 mg
Trigonella foenum-graceum 300-800 mg
Leptadenia reticulata 400-800 mg
With or without known additives.
It is to be understood that the composition is not a mere admixture involving to aggregation of properties but the ingredients have synergistic effect on each other as none of the ingredients is individually effective against potential diabetes.
The chemicals extracted out of the plants are used in the following dose range in a
particular manner-
Organic extract of Syzygium Cumini (Jamboo) 150-400 mg
Organic extract of Momordica Charantia (Karela) 250-600 mg
Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg
Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg
with or without known additives.
The drugs are administered with varying dose schedule and a careful monitoring of the clinical symptomatology present different results.
On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of:
Syzygium cumini (Jamboo) 100-300 mg
Momordica charantia (Karela) 200-500 mg
Trigonella foenum-graceum (Methika) 200-600 mg
Leptadenia reticulata (Jeevanti) 150-500 mg
The remainder is optionally known additive to make the required preparation.
Syzygium cumini (Jambulana):
This plaul is commonly known as Jamboo/Jamun belonging to family 'Myrtaceae' whose dried seeds are extracted to collect the mixture of two flavonoidal glycoside, steridal sapogenins and gallic acid compounds. Various studies have shown this mixture possessing hypoglycaemic property. It reduces the blood glucose level.
Momordica charantia (Korela):
This plant is commonly known as Karela. It belongs to the family "Cucurbilaccae" whose dried fruits arc extracted to collect the mixture of triterpene glycosides, momordxosides ABCDE, luteolin and cherantin compounds. Various studies on this mixture have indicated the hypoglycacmic property. It is known as a anti-diabetic agent.
Trigonella foenum -graceum (Methi):
This plant is commonly known as Methi belonging to family 'Papilionaceae' whose dried seeds are extracted to collect the mixture of sapogenins, saponins, flavonoids flavonoidal glycoside compounds. Studies have shown that this mixture possessing mild hypotensive and cardiotonic and thus useful in managing the complications like hypertension, cardiac involvement in diabetes mellitus.
Leptadenia reticulata (Jeevanti):
This plant is commonly known as Jeevanti belonging to family' 'Ascepiadeceae' whose roots are extracted to collect the mixture of various contents of the plant showed restorative (anabolic) and mild hypotensive property.
The known additives are excipients such as calcium sulphte.
Example -1:
The preparation containing the organic extract of syzygium cumini administered in the dose of 150 - 400mg to the diagnosed cases of potential diabetes continuously for three months exerted regulation of blood glucose levels both fasting and post prandial among potential diabetes cases.
Example-2:
The preparation containing the organic extract of Momordica charantia in the dose of 250 - 600mg administered to the diagnosed cases of potential diabetes continuously for 3 months have also shown the blood glucose lowering effects.
Example -3:
The preparation containing the organic extract of trigonella foenumgraceum in the dose of 300 - 800 mg administered to the individuals showing altered levels of blood glucose both fasting and post prandial exhibited regulation of the levels and also improvement in mico-proteinurea present in urine.
Example -4:
The preparation containing the organic extract of leptidenia reticulata in the dose of 400 - 800mg administered to the individuals at risk of developing diabetes mellitus continuously for three months showed improvement in general body resistance and feeling of well being.
Example-5:
The preparation containing the organic extract of Syzygium cumini in the dose of 100 - 300mg and organic extract of Momordica charantia
in the dose of 200 - 500mg administered continuously for three months to the individuals showing altered blood glucose levels exhibited reduction in both lasting and post, prandial blood glucose levels and the difference in the range of fasting and PP levels minimized significantly.
Example-6:
The preparation containing the organic extract of Syzygium cumini in the dose of 100 - 300 mg and organic extract Trigonella foenum in the dose of 200 - 600mg administered to the individuals of potential diabetes continuously for three months showed lowering effects of blood glucose levels alongwith improvement in proteinurea.
Exunple-7:
The preparation containing the organic extract of Momordica Charntia in the dose of 200 - 500mg and Leptadenia recticulata in the1 dose of 150 - 500 mg to the potential diabetes cases showed mild improvement in blood pressure and reduction in blood glucose levels.
Example -8:
The preparation containing the organic extract of Syzygium cumini in the dose of 150mg, organic extract of Momordica charantia in the dose of 250 mg, organic extract of Trigonella foenumgraceum in the dose of 300mg, Leptademia reticulata in the dose of 200mg administered to individuals showing higher range of variation between fasting and post prandial blood glucose levels and suppose to be at risk of developing fullflaged diabetes mellilus exhibited effective regulation of blood glucose levels, improvement in proteinurea along with feeling of well being.
The present invention is a combination of organic extract of Syzygium cumini, Momordica charantia, Trigonella foenumgraceum and Leptadenia reticulata in an effective doses has shown better results than the use of single crude drug, used by traditional practitioners. This formulation prolonged the onset of fulflaged diabetes mellitus. Apart from the hypoglycemic effects of Syzygium cumini, Momordica charantia, Trigonella foenumgraceum including organic extract of Leptadenia reticulata the formulation exerted effects in enhancing the body immunity, management of micro-albuminurea and thus prevented the risk level of glucose intolerance. The present formulation has shown better results by overcoming the group of complaints and laboratory tests presented by potential diabetics, where as the single crude form of a plant is not sufficient to prevent/manage the multiple factors associated with potential diabetes.
It is to be understood that the invention of the present invention is susceptible to modifications, adaptations, changes by those skilled in the art. Such variant compositions and the processes for preparation thereof are intended to be taken within the scope of the present invention, which is set forth under the following claims:-

1 CLAIM:
1. A herbal preparation for the prevention and management of potential diabetes
cases comprising:
Organic extract of Syzygium Cumini (Jambulana) 150-400 mg
Organic extract of Momordica Charantia (Karela) 250-600 mg
Organic extract of Trigonella foenum-graceum (Methika) 300-800 mg
Organic extract of Leptadenia reticulata (Jeevanti) 400-800 mg
with or without known additives.
2. A preparation as claimed in claim 1 comprising:
Syzygium cumini 100-300 mg
Momordica charantia 200-500 mg
Trigonella foenum-graceum 200-600 mg
Leptadenia reticulata 150-500 mg
with known additive for a preparation of 300 mg/500 mg.
3. A preparation as claimed in claim 1 comprising the organic extract of Syzygium
cumini containing mixture of two-flavonoidal glycoside, steridal sapogenins and
gallic acid compound.
4. A preparation as claimed in claim 1 wherein the organic extract of Momordica
charantia contains a mixture of triterpine glycosides, momordxosides, luteolin and
cherantin compounds.
5. A preparation as claimed in claim 1 wherein the organic extract of Trigonella
foenum-graceum contains a mixture of sapogenins, saponins, flavonoidal
glycoside compounds.
6. A process for the preparation of herbal formulation for the prevention and
management of altered levels of variation in fasting and PP glucose levels found
among the individuals and supposed to be at risk of developing fulfalged diabetes
mellitus comprising in admixing:
Syzygium cumini 150-400 mg
Momordica charantia 250-600 mg
Trigonella foenum-graceum 300-800 mg
Leptadenia reticulata 400-800 mg
with or without known additives.
7. A process as claimed in claim 6 comprising:
Syzygium cumini 100-300 mg
Momordica charantia 200-500 mg
Trigonella foenum-graceum 200-600 mg
Leptadenia reticulata 150-500 mg
with known additive for a preparation of 300 mg/500 mg.
8. A process as claimed in claim 6 comprising the organic extract of Syzygium
cumini contains a mixture of two-flavonoidal glycoside, sistostrol, glycosides and
gallic acid compound.
9. A process as claimed in claim 6 comprising the organic extract of Momordica
charantia containing a mixture of triterpine glycosides, momordxosides, luteolin
and cherantin compounds.
10. A process as claimed in claim 6 comprising the organic extract of Trigonella
foenum-graceum containing a mixture of sapogenins, saponins, flavonois
glycoside compounds.
11. A herbal composition substantially as herein described and illustrated.
12. A process for the preparation of a herbal composition substantially as herein
described and illustrated.

Documents:

664-del-2002-abstract.pdf

664-del-2002-claims.pdf

664-del-2002-correspondence-others.pdf

664-del-2002-correspondence-po.pdf

664-del-2002-description (complete).pdf

664-del-2002-form-1.pdf

664-del-2002-form-18.pdf

664-del-2002-form-2.pdf

664-del-2002-form-3.pdf

664-del-2002-form-4.pdf

664-del-2002-form-5.pdf

664-del-2002-gpa.pdf

664-del-2002-petition-others.pdf

« Previous Patent

Next Patent »

Patent Number

220749

Indian Patent Application Number

664/DEL/2002

PG Journal Number

30/2008

Publication Date

25-Jul-2008

Grant Date

04-Jun-2008

Date of Filing

18-Jun-2002

Name of Patentee

RAVI PATODIA

Applicant Address

Inventors:

#	Inventor's Name	Inventor's Address
1	G.P. DUBEY

PCT International Classification Number

A61K 35/78

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA