Title of Invention	"A HERBAL PREPARATION AND A PROCESS FOR THE PREVENTION AND TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERTRIGLYCERDIEMIA"
Abstract	This invention relates to a herbal composition and a process for the preparation thereof wherein the composition is useful for prevention and management of atherosclerosis and coronary heart diseases. The composition comprises mixture of organic extracts of Terminalia arjuna (Arjun), Withania somnifera (Ashwagandha) and Tribulus terrestries (Gokshur), with or without additive The process for preparation of the composition comprises mixing of the organic extracts of the above herbs with optional addition of additives.

Title of Invention

"A HERBAL PREPARATION AND A PROCESS FOR THE PREVENTION AND TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERTRIGLYCERDIEMIA"

Abstract

This invention relates to a herbal composition and a process for the preparation thereof wherein the composition is useful for prevention and management of atherosclerosis and coronary heart diseases. The composition comprises mixture of organic extracts of Terminalia arjuna (Arjun), Withania somnifera (Ashwagandha) and Tribulus terrestries (Gokshur), with or without additive The process for preparation of the composition comprises mixing of the organic extracts of the above herbs with optional addition of additives.

Full Text	FIELD OF INVENTION This invention relates to a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia and a process for preparation thereof wherein the composition is useful for the prevention and management of atherosclerosis and coronary heart diseases (CHD). BACKGROUND OF THE INVENTION The risk factor concept implies that a person with a least one risk factor for coronary hear disease (CHD) is more likely to develop atherosclerotic event, which may appear quite earlier in comparison to a person without any risk factors. The presence of multiple risk factors further accelerates the high occurrence of atherosclerosis associated with different pathological conditions. A strong correlation between the cholesterol concentration and incidence of ischaemic heart disease has been establised which suggest that the increasing risk of CHD can be detected when the cholesterol level is higher than 200 mg/dl for the age of 40 to 49 years. The prevention and management of risk factors are the fundamental approach in minimizing the incidence of CHD Hypercholesterolemia and hypertriglyceridemia are the two important factors that have been very clearly indicated to be responsible for the development of atherosclerotic lesion of coronary artery leading to myocardial infarction. Hypercholesterolemia and dyslipidemia is significantly associated with obesity and hypertension, and both play a role in the manifestation of CHD. Further, it is observed that anxiety and stress of modern society precipitates the incidence of coronary heart disease. Thus, unless the risk factors associated with CHD are managed, it is not possible to prevent the incidence of coronary heart disease. In the recent past various available drugs used for the management of hypercholesterolemia and hypertriglyceridemia have been abused due to tremendous adverse effect which they produce on their long-term administration. Thus, there is an urgent need of some safer remedial measure for the management of lipid disorders. Objects of the present Invention: An object of this invention is to propose a herbal composition and a process for the preparation thereof useful for the prevention and management of atherosclerosis by regulating abnormal cholesterol metabolism. Another object of this invention is to propose a herbal composition and a process for the preparation thereof useful for reducing total cholesterol level among hypercholesterolemic subjects. Further object of this invention is to propose a herbal composition and a process for the preparation thereof useful for regulating the hypertriglyceridemia among individuals showing higher levels of triglycerides. Still further object of this invention is to propose a herbal composition and a process for the preparation thereof useful for modifying the different fractions of cholesterol (LDL-c, VLDL-c and HDL-c) Yet further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for minimizing the TC and HDL-c risk ratio by which the risk of CHD can be controlled. A still further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for prevention and management of obesity and hypertension by regulating the hypercholesterolemia and dyslipidemia which are also the causative factors of CHD Yet a further object of this invention is to propose a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia and a process for the preparation thereof useful for the management of anxiety and stress associated with CHD. STATEMENT OF INVENTION According to this invention there is provided a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia comprising: - dried stern bark of plant of Terminalia arjuna 100-150mg - dried roots of Withania somnifera 150-500mg - dried fruits and roots of Tribulus terrestries 100-350mg with or without known additives, which are excipients such as calcium sulphate. Further according to this invention there is provided a process for the preparation of a herbal preparation as claimed in claim 1 comprising in extraction of the said herbs such as herein described followed by admixing: - dried stem bark of plant of Terminalia arjuna 100-150mg - dried roots of Withania somnifera 150-500mg - dried fruits and roots of Tribulus terrestries 100-350mg and homogenization of the mixture thus obtained in a homogenizer at 20-28°C for 20-40 minutes. It is to be noted that the ingredients have synergistic effect on each other as none of the individual ingredient is effective against atherosclerosis and coronary heart diseases. The invention will now be illustrated with a working example which is intended to be an illustrative example and is not intended to be taken restrictively to imply any limitation on the scope of the present invention. The chemicals extracted out of the plants are used in the following dose range in a particular manner: 100-500 mg Terminalia arjuna 150-500 mg Withania somnifera 100-350 mg Tribulus terrestries The drugs administered with varying dose schedule and a careful monitoring of the clinical sumptomatology, presenting different results. On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of: Terminalia arjuna 150-250 mg Withania somnifera 200-300 mg Tribulus terrestries 150-250 mg The remainder is optionally known additive to make the required preparation. Identified pure herbs are pulverized and deeped in atleast 4 times aqueous EtOH for around 24 hrs. Then filtered and concentrated in reactor on low temp and high Vacuum of 70-85°C and 400-760 MMHg) up to dry paste level. Again extract is made with the help of trey dryer/vacuum dryer at same temp and pulverized followed by Alteration and packing. Thereafter, homogenization of the herbs is carried out for 20-40 minutes in a homogenizer at a temp of 20-28°C to prepare capsule. Terminalia arjuna (Arjun): This plant is commonly known as "Arjun" belongs to the family "Combretaceae". In accordance with this invention, the dried stem bark of the plant is extracted to an organic extract containing arjunic acid, two saponin i.e. arjunoglycoside, I, II compounds. Studies have shown this mixture possessing cardiotonic, astringent, cardiac stimulant, diuretic, laxative, hemostatic, anticholeterolemic and hypo-triglyceridemic properties and it has shown beneficial effect in the management of dyslipidemia and high triglyceride levels. Withania somnifera (Ashwagandha): This plant is commonly known as "Ashwagandha" belonging to family "Solanaceae" whose dried roots are extracted to collect the mixture of withanoloids, alkaloid, nicotine, somniferine, withanine, somniferinine, anaferine and anahygrine compounds. Various studies have shown this mixture possessing anti stress, adaptogenic cardioprotective and hypotensive properties useful in the regulation of neurotransmitters and improved the cardiac functions. Tribulus terrestris (Gokshur): This plant is commonly known as "Gokshur" belonging to family "zygophyllaceae" whose dried fruits and roots are extracted to collect the mixture of glycosides and sterols. Various studies have shown this mixture possessing diuretic property. The known additives are excipients such as calcium sulphate. Example 1: The preparation containing the organic extract of Terminalia arjuna in the dose of 250 mg continuously for 3 months in the diagnosed cases of hypercholesteralemia exhibited a mild reduction in total cholesterol and mild reduction in obesity index. Symptoms like elevated blood pressure, disturbed sleep, anxiety and stress remain least affected. Example 2: The preparation containing the organic extract of Withania somnifera in the dose of 300mg continuously for three months in the diagnosed cases of dyslipidemia and hypertriglyceridemia showed reduction in blood pressure and hypothalamic over arousibility. It also helped in reducing the anxiety and tensions by regulating various neurotransmitters. It is useful in the management of stress associated cardiovascular reactivity. Example 3: The preparation containing the organic extract of Tribulus terrestris in the dose of 200 mg continuously for three months in the diagnosed cases of hypercholesterolemia and hypertriglycridemia exhibited improvement in cardiac functions by improving the myocardial performance It also exerted improvement in cardiac load on left ventricles of the heart. Example 4: The preparation containing the organic extract of Terminalia arjuna in the dose of 300 mg and organic extract of Withania Somnifera in the dose of 200 mg continuously for three months exhibited reduction in total cholesterol and regulation of various fractions of cholesterol like LDL-c, VLDL-c and HDL-c among the hypercholeterolemic and dyslipidemic individuals. Example 5: The preparation containing the organic extract of Terminalia arjuna in the dose of 300mg and Tribulus terrestries in the dose of 200mg continuously for three months showed reduction in triglyceride and total choesterol levels among the cases having high total cholesterol and higher levels of Triglycerides. Example 6: The preparation containing the organic extract of Withania somnifera in the dose of 250 mg in the dose of 250 mg and Tribulus terrestries in the dose of 200mg continuously for three months exhibited significant fall in trilgycride levels and marked reduction in anxiety level among the cases showing evidences of abnormal lipid metabolism along with psychic involvement. A significant reduction in anxiety scores and blood pressure levels were recorded Example 7: The preparation containing the organic extract of Terminalia arjuna in the dose of 200 mg Withania somnifera in the dose of 300 mg and Tribulus terrestries in the dose of 250 mg continuously for three months to the cases showing evidence of hypercholetralemia and hypertriglyceridemia exhibited significant reduction in total cholesterol and triglycerides and correction of LDL-c, VLDL-c. The TC and HDL-c ratio also modified to a great extent. The psychic factors like nervousness, insomnia, anxiety also improved and subject reported feeling of well being In traditional medicine the crude powder of Terminalia arjuna is used for the treatment of Hrida-roga (cardiac problems). The crude dose of Terminalia arjuna used by traditional practitioners is 2-6 grams per day. In the present test formulation the dose of T.arjuna is 150-300 mg per day. The present invention envisages the use of the active ingredients of the Terminalia arjuna, Withania somnifera and Tribulus terrestris. The advantage of taking three drugs is to cover symptoms/complex cluster of symptoms associated with the atherosclerosis by which abnormal cholesterol and triglycerides have been regulated. Single herb only exerts influence on single causative factor of atherosclrosis. This condition is produced by hypercholesterolemia, hypertriglyceridemia, low HDL-c and high LDL-c as well as hyper excitability of central nervous system. The Terminalia arjuna is more specific for lowering cholesterol, Withania somnifera is specific for reducing hypertension due to its anti-stress property and Tribulus terrestris is more specific for having mild diuretic and reducing the triglycerides level The better results are obtained by the drug administered in a given effective doses with the combination of all the three drugs. Single drug can provide only partial effect in a specific causative factor. The coronary heart disease has a muitifactorial etiology. Atherosclerosis leading to hypertension is one of the major causes of CHD. The proposed formulation is prepared out of the combination of the organic extract of Terminalia arjuna, Withania somnifera and Tribulus terrestries. The quantity mentioned in terms of mg is indicative of weight of organic extracts. The organic extract, which contains the active ingredients is found onlyuseful in the quantity as described herein. This was tested and revalidated in pre-clinical studies and later on conducted in human model. With repeated trials and error the effective doses were determined as herein described. The specific action of each of theorganic extract is different. For examples the organic extract of Withania somnifera the dose given as herein described regulates the higher centre of the brain particularly the hypothalamus Thus, the action of Withania somnifera is different from Terminalia arjuna and Tribulus terrestries. It is apparent that through central nervous system Withania somnifera decreased the blood pressure level and indirectly minimizes the atherosclrotic process while the organic extract of Terminalia arjuna has a potential effect in regulating abnormal cholesterol metabolism. The organic extract of Tribulus terrestries if administered in a proportion of doses as herein described provides better result as observed in pre-clinical and clinical studies. The preferred dose was determined by observing the beneficial effects in animal models. The novelty is the proportion of the organic extract of the above three plants, which was found effective in reducing the total cholesterol, LDL-Cholesterol and triglycerides. When it is added with Tribulus terrestries, due to its synergetic effect the drug has shown its role in the regulation of abnormal lipid metabolism particularly dyslipidemia It is to be understood that the composition and process of the present invention are susceptible to changes, modifications and adaptations by those skilled in the art. Such variant embodiments are intended to be within the scope of the present invention which is further set forth under the following claims:- I CLAIM 1. A herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia comprising: - dried stem bark of plant of Terminalia. arjuna 100-150mg - dried roots of Withania somnifera 150-500mg - dried fruits and roots of Tribulus terrestries 100-350mg with or without known additives, which are excipients such as calcium sulphate. 2. A herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia as claimed in claim 1 comprising preferably Terminalia arjuna 150-250 mg Withania somnifera 200-300 mg Tribulus terrestries 150-250 mg with known additives for the preparation of 300mg/500 mg. 3. A herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia as claimed in claim 1 comprising Terminalia arjuna containing mixture of saponin, arjunoglycoside I and II presented hypocholesterolemic effects. 4. A herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia as claimed in claim 1 wherein Withania somnifera contains the mixture of withnaloids and alkaloids presented sedative and tranquilizing effects. 5. A herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia as claimed in claim 1 wherein Tibulus terrestries contains the mixture of glycosides and sterols. 6. A process for the preparation of a herbal preparation as claimed in claim 1 comprising in extraction of the said herbs such as herein described followed by admixing: - dried stem bark of plant of Terminalia arjuna 100-150mg - dried roots of Withania somnifera 150-500mg - dried fruits and roots of Tribulus terrestries 100-350mg and homogenization of the mixture thus obtained in a homogenizer at 20-28°C for 20-40 minutes. 7. A process as claimed in claim 6 comprising Terminalia arjuna 150-250 mg Withania sommifera 200-300 mg Tribulus terrestries 150-250 mg with known additives for a preparation of 300mg/500 mg. 8. A process as claimed in claim 6 comprising Terminalia arjuan containing mixture of saponin, arjunoglycoside I and II compounds presented lipid lowering effects. 9. A process as claimed in claim 6 wherein Withania somnifera contains the mixture of withanloids and alkaloids presented the anti-stress and adaptogenic effects. 10.A process as claimed in claim 6 wherein Tribulus terrestries contains the mixture of glycosides and sterols 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.

Full Text

FIELD OF INVENTION
This invention relates to a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia and a process for preparation thereof wherein the composition is useful for the prevention and management of atherosclerosis and coronary heart diseases (CHD).
BACKGROUND OF THE INVENTION
The risk factor concept implies that a person with a least one risk factor for coronary hear disease (CHD) is more likely to develop atherosclerotic event, which may appear quite earlier in comparison to a person without any risk factors. The presence of multiple risk factors further accelerates the high occurrence of atherosclerosis associated with different pathological conditions. A strong correlation between the cholesterol concentration and incidence of ischaemic heart disease has been establised which suggest that the increasing risk of CHD can be detected when the cholesterol level is higher than 200 mg/dl for the age of 40 to 49 years.
The prevention and management of risk factors are the fundamental approach in minimizing the incidence of CHD Hypercholesterolemia and hypertriglyceridemia are the two important factors that have been very clearly indicated to be responsible for the development of atherosclerotic lesion of coronary artery leading to myocardial infarction. Hypercholesterolemia and dyslipidemia is significantly associated with obesity and hypertension, and both play a role in the manifestation of CHD. Further, it is observed that anxiety and stress of modern society precipitates the incidence of coronary heart disease. Thus, unless the risk factors associated with CHD are managed, it is not possible to prevent the incidence of coronary heart disease.
In the recent past various available drugs used for the management of hypercholesterolemia and hypertriglyceridemia have been abused due to tremendous adverse effect which they produce on their long-term administration. Thus, there is an urgent need of some safer remedial measure for the management of lipid disorders.
Objects of the present Invention:
An object of this invention is to propose a herbal composition and a process for the preparation thereof useful for the prevention and management of atherosclerosis by regulating abnormal cholesterol metabolism.
Another object of this invention is to propose a herbal composition and a process for the preparation thereof useful for reducing total cholesterol level among hypercholesterolemic subjects.
Further object of this invention is to propose a herbal composition and a process for the preparation thereof useful for regulating the hypertriglyceridemia among individuals showing higher levels of triglycerides.
Still further object of this invention is to propose a herbal composition and a process for the preparation thereof useful for modifying the different fractions of cholesterol (LDL-c, VLDL-c and HDL-c)
Yet further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for minimizing the TC and HDL-c risk ratio by which the risk of CHD can be controlled.
A still further object of this invention is to propose a herbal formulation and a process for the preparation thereof useful for prevention and management of obesity and hypertension by regulating the hypercholesterolemia and dyslipidemia which are also the causative factors of CHD
Yet a further object of this invention is to propose a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia and a process for the preparation thereof useful for the management of anxiety and stress associated with CHD.
STATEMENT OF INVENTION
According to this invention there is provided a herbal preparation for the prevention and treatment of hypercholesterolemia and hypertriglyceridemia comprising:
- dried stern bark of plant of Terminalia arjuna 100-150mg
- dried roots of Withania somnifera 150-500mg
- dried fruits and roots of Tribulus terrestries 100-350mg
with or without known additives, which are excipients such as calcium sulphate.
Further according to this invention there is provided a process for the preparation of a herbal preparation as claimed in claim 1 comprising in extraction of the said herbs such as herein described followed by admixing:
- dried stem bark of plant of Terminalia arjuna 100-150mg
- dried roots of Withania somnifera 150-500mg
- dried fruits and roots of Tribulus terrestries 100-350mg
and homogenization of the mixture thus obtained in a homogenizer at 20-28°C for 20-40 minutes.
It is to be noted that the ingredients have synergistic effect on each other as none of the individual ingredient is effective against atherosclerosis and coronary heart diseases.
The invention will now be illustrated with a working example which is intended to be an illustrative example and is not intended to be taken restrictively to imply any limitation on the scope of the present invention.
The chemicals extracted out of the plants are used in the following dose range in a particular manner:
100-500 mg Terminalia arjuna
150-500 mg Withania somnifera
100-350 mg Tribulus terrestries
The drugs administered with varying dose schedule and a careful monitoring of the clinical sumptomatology, presenting different results.
On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of:
Terminalia arjuna 150-250 mg
Withania somnifera 200-300 mg
Tribulus terrestries 150-250 mg
The remainder is optionally known additive to make the required preparation.
Identified pure herbs are pulverized and deeped in atleast 4 times aqueous EtOH for around 24 hrs. Then filtered and concentrated in reactor on low temp and high Vacuum of 70-85°C and 400-760 MMHg) up to dry paste level. Again extract is made with the help of trey dryer/vacuum dryer at same temp and pulverized followed by Alteration and packing.
Thereafter, homogenization of the herbs is carried out for 20-40 minutes in a homogenizer at a temp of 20-28°C to prepare capsule.
Terminalia arjuna (Arjun):
This plant is commonly known as "Arjun" belongs to the family "Combretaceae". In accordance with this invention, the dried stem bark of the plant is extracted to an organic extract containing arjunic acid, two saponin i.e. arjunoglycoside, I, II compounds. Studies have shown this mixture possessing cardiotonic, astringent, cardiac stimulant, diuretic, laxative, hemostatic, anticholeterolemic and hypo-triglyceridemic properties and it has shown beneficial effect in the management of dyslipidemia and high triglyceride levels.
Withania somnifera (Ashwagandha):
This plant is commonly known as "Ashwagandha" belonging to family "Solanaceae" whose dried roots are extracted to collect the mixture of withanoloids, alkaloid, nicotine, somniferine, withanine, somniferinine, anaferine and anahygrine compounds. Various studies have shown this mixture possessing anti stress, adaptogenic cardioprotective and hypotensive properties useful in the regulation of neurotransmitters and improved the cardiac functions.
Tribulus terrestris (Gokshur):
This plant is commonly known as "Gokshur" belonging to family "zygophyllaceae" whose dried fruits and roots are extracted to collect the mixture of glycosides and sterols. Various studies have shown this mixture possessing diuretic property.
The known additives are excipients such as calcium sulphate.
Example 1:
The preparation containing the organic extract of Terminalia arjuna in the dose of 250 mg continuously for 3 months in the diagnosed cases of hypercholesteralemia exhibited a mild reduction in total cholesterol and mild reduction in obesity index. Symptoms like elevated blood pressure, disturbed sleep, anxiety and stress remain least affected.
Example 2:
The preparation containing the organic extract of Withania somnifera in the dose of 300mg continuously for three months in the diagnosed cases of dyslipidemia and hypertriglyceridemia showed reduction in blood pressure and hypothalamic over arousibility. It also helped in reducing the anxiety and tensions by regulating various neurotransmitters. It is useful in the management of stress associated cardiovascular reactivity.
Example 3:
The preparation containing the organic extract of Tribulus terrestris in the dose of 200 mg continuously for three months in the diagnosed cases of hypercholesterolemia and hypertriglycridemia exhibited improvement in cardiac functions by improving the myocardial performance It also exerted improvement in cardiac load on left ventricles of the heart.
Example 4:
The preparation containing the organic extract of Terminalia arjuna in the dose of 300 mg and organic extract of Withania Somnifera in the dose of 200 mg continuously for three months exhibited reduction in total cholesterol and regulation of various fractions of cholesterol like LDL-c, VLDL-c and HDL-c among the hypercholeterolemic and dyslipidemic individuals.
Example 5:
The preparation containing the organic extract of Terminalia arjuna in the dose of 300mg and Tribulus terrestries in the dose of 200mg continuously for three months showed reduction in triglyceride and total choesterol levels among the cases having high total cholesterol and higher levels of Triglycerides.
Example 6:
The preparation containing the organic extract of Withania somnifera in the dose of 250 mg in the dose of 250 mg and Tribulus terrestries in the dose of 200mg continuously for three months exhibited significant fall in trilgycride levels and marked reduction in anxiety level among the cases showing evidences of abnormal lipid metabolism along with psychic involvement. A significant reduction in anxiety scores and blood pressure levels were recorded
Example 7:
The preparation containing the organic extract of Terminalia arjuna in the dose of 200 mg Withania somnifera in the dose of 300 mg and Tribulus terrestries in the dose of 250 mg continuously for three months to the cases showing evidence of hypercholetralemia and hypertriglyceridemia exhibited significant reduction in total cholesterol and triglycerides and correction of LDL-c, VLDL-c. The TC and HDL-c ratio also modified to a great extent. The psychic factors like nervousness, insomnia, anxiety also improved and subject reported feeling of well being
In traditional medicine the crude powder of Terminalia arjuna is used for the treatment of Hrida-roga (cardiac problems). The crude dose of Terminalia arjuna used by traditional practitioners is 2-6 grams per day. In the present test formulation the dose of T.arjuna is 150-300 mg per day.
The present invention envisages the use of the active ingredients of the Terminalia arjuna, Withania somnifera and Tribulus terrestris. The advantage of taking three drugs is to cover symptoms/complex cluster of symptoms associated with the atherosclerosis by which abnormal cholesterol and triglycerides have been regulated. Single herb only exerts influence on single causative factor of atherosclrosis. This condition is produced
by hypercholesterolemia, hypertriglyceridemia, low HDL-c and high LDL-c as well as hyper excitability of central nervous system. The Terminalia arjuna is more specific for lowering cholesterol, Withania somnifera is specific for reducing hypertension due to its anti-stress property and Tribulus terrestris is more specific for having mild diuretic and reducing the triglycerides level The better results are obtained by the drug administered in a given effective doses with the combination of all the three drugs. Single drug can provide only partial effect in a specific causative factor.
The coronary heart disease has a muitifactorial etiology. Atherosclerosis leading to hypertension is one of the major causes of CHD. The proposed formulation is prepared out of the combination of the organic extract of Terminalia arjuna, Withania somnifera and Tribulus terrestries. The quantity mentioned in terms of mg is indicative of weight of organic extracts. The organic extract, which contains the active ingredients is found onlyuseful in the quantity as described herein. This was tested and revalidated in pre-clinical studies and later on conducted in human model. With repeated trials and error the effective doses were determined as herein described. The specific action of each of theorganic extract is different. For examples the organic extract of Withania somnifera
the dose given as herein described regulates the higher centre of the brain particularly the hypothalamus Thus, the action of Withania somnifera is different from Terminalia arjuna and Tribulus terrestries. It is apparent that through central nervous system Withania somnifera decreased the blood pressure level and indirectly minimizes the atherosclrotic process while the organic extract of Terminalia arjuna has a potential effect in regulating abnormal cholesterol metabolism. The organic extract of Tribulus terrestries if administered in a proportion of doses as herein described provides better result as observed in pre-clinical and clinical studies.
The preferred dose was determined by observing the beneficial effects in animal models. The novelty is the proportion of the organic extract of the above three plants, which was found effective in reducing the total cholesterol, LDL-Cholesterol and triglycerides. When it is added with Tribulus terrestries, due to its synergetic effect the drug has shown its role in the regulation of abnormal lipid metabolism particularly dyslipidemia
It is to be understood that the composition and process of the present invention are susceptible to changes, modifications and adaptations by those skilled in the art. Such variant embodiments are intended to be within the scope of the present invention which is further set forth under the following claims:-

I CLAIM
1. A herbal preparation for the prevention and treatment of
hypercholesterolemia and hypertriglyceridemia comprising:
- dried stem bark of plant of Terminalia. arjuna 100-150mg
- dried roots of Withania somnifera 150-500mg
- dried fruits and roots of Tribulus terrestries 100-350mg
with or without known additives, which are excipients such as calcium sulphate.
2. A herbal preparation for the prevention and treatment of
hypercholesterolemia and hypertriglyceridemia as claimed in claim
1 comprising preferably
Terminalia arjuna 150-250 mg
Withania somnifera 200-300 mg
Tribulus terrestries 150-250 mg
with known additives for the preparation of 300mg/500 mg.
3. A herbal preparation for the prevention and treatment of
hypercholesterolemia and hypertriglyceridemia as claimed in claim
1 comprising Terminalia arjuna containing mixture of saponin,
arjunoglycoside I and II presented hypocholesterolemic effects.
4. A herbal preparation for the prevention and treatment of
hypercholesterolemia and hypertriglyceridemia as claimed in claim
1 wherein Withania somnifera contains the mixture of withnaloids
and alkaloids presented sedative and tranquilizing effects.
5. A herbal preparation for the prevention and treatment of
hypercholesterolemia and hypertriglyceridemia as claimed in claim
1 wherein Tibulus terrestries contains the mixture of glycosides
and sterols.
6. A process for the preparation of a herbal preparation as claimed in
claim 1 comprising in extraction of the said herbs such as herein
described followed by admixing:
- dried stem bark of plant of Terminalia arjuna 100-150mg
- dried roots of Withania somnifera 150-500mg
- dried fruits and roots of Tribulus terrestries 100-350mg
and homogenization of the mixture thus obtained in a homogenizer at 20-28°C for 20-40 minutes.
7. A process as claimed in claim 6 comprising
Terminalia arjuna 150-250 mg
Withania sommifera 200-300 mg
Tribulus terrestries 150-250 mg
with known additives for a preparation of 300mg/500 mg.
8. A process as claimed in claim 6 comprising Terminalia arjuan
containing mixture of saponin, arjunoglycoside I and II compounds
presented lipid lowering effects.
9. A process as claimed in claim 6 wherein Withania somnifera
contains the mixture of withanloids and alkaloids presented the
anti-stress and adaptogenic effects.
10.A process as claimed in claim 6 wherein Tribulus terrestries contains the mixture of glycosides and sterols 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.

Documents:

662-DEL-2002-Abstract.pdf

662-del-2002-claims.pdf

662-del-2002-correspondence-others.pdf

662-del-2002-correspondence-po.pdf

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

662-DEL-2002-Form-1.pdf

662-DEL-2002-Form-18.pdf

662-del-2002-form-2.pdf

662-del-2002-form-3.pdf

662-DEL-2002-Form-4.pdf

662-DEL-2002-Form-5.pdf

662-del-2002-gpa.pdf

662-del-2002-petition- others.pdf

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Patent Number

226242

Indian Patent Application Number

662/DEL/2002

PG Journal Number

01/2009

Publication Date

02-Jan-2009

Grant Date

15-Dec-2008

Date of Filing

18-Jun-2002

Name of Patentee

RAVI PATODIA

Applicant Address

SARAIYYA, P.O.-BHADOHI, SANT RAVIDAS, BHADOHI-221 401, INDIA.

Inventors:

#	Inventor's Name	Inventor's Address
1	G.P. DUBEY	CENTRE OF PSYCHOSOMATIC & BIOFEEDBACK MEDICINE, FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY. INDIA.

PCT International Classification Number

A61P 009/10

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA