Title of Invention	"A HERBAL COMPOSITION HAVING ANTI-STRESS AND ADAPTOGENIC PROPERTIES AND A PROCESS FOR THE PREPARATION THEREOF"
Abstract	This invention relates to a herbal composition having anti-stress and adaptogenic properties comprising organic extract as herein described of Terminalia chebula (Haritaki) 100-300 mg, organic extract as herein described of Withania somnifera (Ashwagandha) 150-500 mg, organic extract as herein described of Ocimum sanctum (Tulsi)100-300 mg, organic extract as herein described of Tinospora cordifolia (Guduchi)150-500 mg, With or without known additives.

Title of Invention

"A HERBAL COMPOSITION HAVING ANTI-STRESS AND ADAPTOGENIC PROPERTIES AND A PROCESS FOR THE PREPARATION THEREOF"

Abstract

This invention relates to a herbal composition having anti-stress and adaptogenic properties comprising organic extract as herein described of Terminalia chebula (Haritaki) 100-300 mg, organic extract as herein described of Withania somnifera (Ashwagandha) 150-500 mg, organic extract as herein described of Ocimum sanctum (Tulsi)100-300 mg, organic extract as herein described of Tinospora cordifolia (Guduchi)150-500 mg, With or without known additives.

Full Text	Field of Invention: This invention relates to a herbal composition having anti-stress and adaptogenic properties and process for preparation thereof. The composition of the present invention may also be advantageously used in class of various psychosomatic disorders where anxiety and stress are the prominently presenting clinical symptoms. Background of the Invention: The modern urban way of living produces constant stress to the living being due to uncertainties and competitive life style. The sociocultural and economic stress exerts profound influence on various organ systems including generalized immune suppression. It has been well substantiated that psychogenic factors can aggravate or ameliorate various psychosomatic diseases to a greater extent. In psychosomatic diseases, emotions or stress can function as a triggering factor to aggravate the condition and bring about an acute attack of psychosomatic diseases like migraine, ulcerative colitis, lower back pain as well as attacks of pain and stiffness in rheumatoid arthritis. Stress is the natural phenomenon in day to day life and causes an appropriate adaptive response to change. It is unavoidable and if it is sustained for longer time. It significantly affects the major organ systems of the body. Even mild stress, if sustained continuously for longer time, also adversely affects the normal physiological functions. If the stress factor is not managed properly it may produce a variety of disorders like neurosis, essential hypertension, early thyrotoxicosis, diabetes mellitus, peptic ulcer, coronary heart disease and many other neuroendocrine and autoimmune disorders. A variety of anxiolytics, tricyclic agents (anti depressants) are being used frequently for the management of anxiety and stress including stress related other disorders but their application is limited because of allergic hemopoietic, endocrine, metabolic side effects. Objects of the present invention: An object of this invention is to propose a herbal preparation and a process for the preparation thereof wherein composition is useful for the prevention and management of anxiety and stress and is having better adaptation properties. Another object of this invention is to propose a herbal preparation and a process for the preparation thereof useful in the prevention and management of anxiety and stress in the disease conditions where anxiety is one of the major presenting clinical symptoms. Further object of this invention is to propose a herbal formulation as a profllaxis and also for the management of anxiety and stress symptoms where surgical intervention takes place. Still further object of the present invention is to propose a herbal composition to improve the sleep and appetite among the individuals suffering from anxiety and stress and thereby prevent the future occurrence of ulcer/neuropsychitric illnesses. Yet further object of this invention is to propose a herbal formulation ensuring better adaption pattern among cases suffering from anxiety and stress of varying etiology. Description of Invention: According to this invention there is provided a herbal preparation for the prevention and management of anxiety and stress with poor adaptation comprising: Organic extract of Terminal ia chebula (Haritaki) 100-300mg Organic extract of Withania somnifera (Ashwagandha) 150-500mg Organic extract of Ocimum sanctum (Tulsi) 100-300mg Organic extract of Tinospora cordifolia (Guduchi) 150-500mg with or without known additives. Further according to this invention there is provided a process for the preparation of herbal preparation for the prevention and management of anxiety and stress with adaptation problems comprising in admixing: Organic extract of Terminalia chebula (Haritaki) 100-300mg Organic extract of Withania somnifera (Ashwagandha) 150-500mg Organic extract of Ocimum sanctum (Tulsi) 100-300mg Organic extract of Tinospora cordifolia (Guduchi) 150-300mg with or without known additives. It is to be noted that the composition of the present invention is not a mere admixture with aggregation of properties. The different ingredients have synergistic effect on each other as none of individual ingredient is effective for management of stress and anxiety. The chemicals extracted out of the plants are used in the following dose-range in a particular manner- Terminalia chebula 100-300mg Withania somnifera 150-500mg Ocimum sanctum 100-300mg Tinospora cordifolia 150-500mg 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 rang comprised of: Terminalia chebula 100-200mg Withania somnifera 150-350mg Ocimum sanctum 100-200mg Tinospora cordifolia 200-400mg The remainder is optionally known additive to make the required preparation. Terminalia chebula (Haritaki): This plant is most commonly known as 'Haritaki' belongs to family "Combretaceae" whose dried fruits are extracted to collect the mixture of alkaloids and glycosides compound. Various studies have shown this mixture possessing immunomodulating and anti-stress properties. Withania somnifera (Ashwagandha): This plant is commonly known as 'Ashwagandha' belonging to family "Solanaceae" whose dried roots are extracted to collect the mixture of alkaloids, withanloids compounds. Several studies have proven that this mixture possessing marked sedative, hypnotic, adaptogenic and rejuvantive properties, which provides survival under stress. Qcimum sanctum (Tulsi): This plant is very frequently known as 'Tulsi' belonging to family "Labiatae" whose dried whole plant are extracted to collect the mixture of various contents of the plant. Several studies have shown hypotensive and adaptogenic activity of this plant. Tinospora cordifolia (Guduchi); This plant is commonly known as 'Guduchi/Amrita' belonging to family "menispermaceae" whose dried stems are extracted to collect the mixture of diterpenoid-tinosporide, perberile heptacosanol compounds. Various studies have shown that this mixture possesses anti-stress and immunomodulating activities. The known additives are excipients such as calcium sulphate. Example-1: The preparation containing the organic extract of Treminalia chebula administered in the dose of 200 mg continuously for three months to the diagnosed cases suffering from anxiety and stress exhibited improved body resistance and better stress tolerance capacity. Example-2: The preparation containing the organic extract of Withania somnifera administered in the dose of 400 mg to the diagnosed cases showing high anxiety levels and stress symptoms continuously for 3 months showed improved sleep pattern and changes in behavioural pattern causing better adaptation under stress condition. Examnle-3: The preparation containing the organic extract of Ocimum snctum administered in the dose of 250 mg to the cases suffering from anxiety and stress with poor adaptation continuously for three months exhibited better adaptation towards stress and felling of well being. Example-4: The preparation containing the organic extract of Tinospora cordifolia administered in the dose of 400 mg to the individuals suffering from anxiety and stress of varying etiology continuously for three months showed enhanced body resistance and better tolerance capacity to stress situations. Example-5; The preparation containing the organic extract of Terminalia chebula in the dose of 250 mg and organic extract of Withania somnifera in the dose of 350 mg administered to the cases under study showed reduced anxiety score and marked changes in sleep pattern and better work performance capacity Example-6: The preparation containing the organic extract of Withania somnifera in the dose of 300 mg and organic extract of Ocimum sanctum in the dose of 200 mg to the diagnosed cases suffering from anxiety and stress with a poor adjustment, continuously three months exerted its effects in reducing anxiety level, better adaptation to stress and also improvement in systolic and diastolic blood pressure altered due to constant anxiety and stress. Example-7: The preparation containing the organic extract of Withania somnifera in the dose of 250 mg and organic extract of Tinospora Cordifolia in the dose of 400mg continuously for 3 months to the cases under anxiety and stress exhibited marked improvement in early mental and physical fatigue and cases reported performing the daily work in more effective manner than earlier. Example-8; The preparation containing the organic extracts of Terminalia chebula in the dose of 150mg, Withania somnifera in the dose of 300mg, Ocimum sanctum in the dose of 150mg and Tinospora cordifolia in the dose of 300mg administered orally to the cases suffering from anxiety and stress with poor adaptation continuously for three months exhibited marked influence in reducing anxiety scores, improvement in adaptation towards stress capability, improvement in early fatigue, better sleep pattern and marked change in work performance capacity which indicated the anti-stress and adaptogenic properties of the present test formulation. The invention which contain the organic extract of Terminalia chebula, Withania somnifera, Ocimum sanctujm and Tinospora cordifolia and given in an effective doses to subjects suffering from anxiety and stress exerted beneficial effect. The drug Withania somnifera has action on Central Nervous System. By regulating the neurotransmitters it reduced the anxiety level. Tinospora cordifolia and Terminalia chebula both acted as nervine tonic and produced general felling of well being by increasing the tolerance capacity to all kind of stress. Ocimum sanctum in effective dose increases the general threshold against any mental or physical stress. While the single drug treatment for the management of anxiety and stress which causes poor adaptation is not sufficient therefore a combination of herbal drugs is more effective as it overcome all the associated symptoms of anxiety and stress and ultimately provides better adaptation to the individuals suffering from various kind of anxiety and stress. It is to be understood that the herbal composition and process for the preparation thereof is susceptible to 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:- WE CLAIM: 1. A herbal preparation for the prevention and management of anxiety and stress with poor adaptation comprising: Organic extract of Terminalia chebula (Haritaki) 100-300mg Organic extract of Withania somnifera (Ashwagandha) 150-500mg Organic extract of Ocimum sanctum (Tutsi) 100-300mg Organic extract of Tinospora cordifolia (Guduchi) 150-500mg with or without known additives. 2. A preparation as claimed in claim I comprising: Terminalia chebula 100-300mg Withania somnifera 150-400mg Ocimum sanctum 100-250mg Tinospora cordifolia 200-450mg with known additive for a preparation of 300mg/600mg. 3. A preparation as claimed in claim I comprising of organic extract of Terminalia Chebula contains a mixture of alkaloids and glycosides compounds. 4. A preparation as claimed in claim I wherein the organic extract of Withania somnifera contains the mixture of alkaloids and withanoloids compound. 5. A preparation as claimed in claim I wherein the organic extract of Ocimum sanctum contains a mixture of biologically active contents of the plant. 6. A preparation as claimed in claim I wherein the organic extract of Tinospora corditblia contains a mixture of diterpenoid-tinosporide, perberilin heptacosanol compounds. 7. A herbal preparation for the prevention and management of anxiety and stress also showing adaptogenic properties substantially as herein described and exemplified in the examples. 8. A process for the preparation of herbal preparation for the prevention and management of anxiety and stress with adaptation problems comprising in admixing: Organic extract of Terminalia chebula (Haritaki) 100-300mg Organic extract of Withania somnifera (Ashwagandha) 150-500mg Organic extract of Ocimum sanctum (Tulsi) 100-300mg Organic extract of Tinospora corditblia (Guduchi) 150-300mg with or without known additives. 9. A process as claimed in claim 8 comprising: Terminalia chebula 100-300mg Withania somnifera 150-400mg Ocimum sanctum 100-250mg Tinospora cordifolia 200-450mg with known additive For a preparation of 300/500mg. 10. A process as claimed in claim 8 comprising the organic extract of Terminalia chebula containing a mixture of alkaloids and glycosides compound. 11. A process as claimed in claim 8 comprising the organic extract of Withania somnitera containing a mixture of alkaolids and withnoloids compound. 12. A process as claimed in claim 8 comprising the organic extract of Ocimum sanctum containing mixture of active contents of the plant. 13. A process as claimed in claim 8 comprising the organic extract of Tinospora cordifolia containing a mixture of diterpenoid, tinosporide, perbirilin, heptaconsanol compound. 14. A process for the preparation of a herbal formulation for the prevention and management of anxiety and stress with poor adaptation capabilities as herein described and exemplified in the examples.

Full Text

Field of Invention:
This invention relates to a herbal composition having anti-stress and adaptogenic properties and process for preparation thereof. The composition of the present invention may also be advantageously used in class of various psychosomatic disorders where anxiety and stress are the prominently presenting clinical symptoms.
Background of the Invention:
The modern urban way of living produces constant stress to the living being due to uncertainties and competitive life style. The sociocultural and economic stress exerts profound influence on various organ systems including generalized immune suppression. It has been well substantiated that psychogenic factors can aggravate or ameliorate various psychosomatic diseases to a greater extent. In psychosomatic diseases, emotions or stress can function as a triggering factor to aggravate the condition and bring about an acute attack of psychosomatic diseases like migraine, ulcerative colitis, lower back pain as well as attacks of pain and stiffness in rheumatoid arthritis.
Stress is the natural phenomenon in day to day life and causes an appropriate adaptive response to change. It is unavoidable and if it is sustained for longer time. It significantly affects the major organ systems of the body. Even mild stress, if sustained continuously for longer time, also adversely affects the normal physiological functions. If the stress factor is not managed properly it may produce a variety of disorders like neurosis, essential hypertension, early thyrotoxicosis, diabetes mellitus, peptic ulcer, coronary heart disease and many other neuroendocrine and autoimmune disorders.
A variety of anxiolytics, tricyclic agents (anti depressants) are being used frequently for the management of anxiety and stress including stress related other disorders but their application is limited because of allergic hemopoietic, endocrine, metabolic side effects.
Objects of the present invention:
An object of this invention is to propose a herbal preparation and a process for the preparation thereof wherein composition is useful for the prevention and management of anxiety and stress and is having better adaptation properties.
Another object of this invention is to propose a herbal preparation and a process for the preparation thereof useful in the prevention and management of anxiety and stress in the disease conditions where anxiety is one of the major presenting clinical symptoms.
Further object of this invention is to propose a herbal formulation as a profllaxis and also for the management of anxiety and stress symptoms where surgical intervention takes place.
Still further object of the present invention is to propose a herbal composition to improve the sleep and appetite among the individuals suffering from anxiety and stress and thereby prevent the future occurrence of ulcer/neuropsychitric illnesses.
Yet further object of this invention is to propose a herbal formulation ensuring better adaption pattern among cases suffering from anxiety and stress of varying etiology.

Description of Invention:
According to this invention there is provided a herbal preparation for the prevention and
management of anxiety and stress with poor adaptation comprising:
Organic extract of Terminal ia chebula (Haritaki) 100-300mg
Organic extract of Withania somnifera (Ashwagandha) 150-500mg
Organic extract of Ocimum sanctum (Tulsi) 100-300mg
Organic extract of Tinospora cordifolia (Guduchi) 150-500mg
with or without known additives.
Further according to this invention there is provided a process for the preparation of
herbal preparation for the prevention and management of anxiety and stress with
adaptation problems comprising in admixing:
Organic extract of Terminalia chebula (Haritaki) 100-300mg
Organic extract of Withania somnifera (Ashwagandha) 150-500mg
Organic extract of Ocimum sanctum (Tulsi) 100-300mg
Organic extract of Tinospora cordifolia (Guduchi) 150-300mg
with or without known additives.
It is to be noted that the composition of the present invention is not a mere admixture with aggregation of properties. The different ingredients have synergistic effect on each other as none of individual ingredient is effective for management of stress and anxiety.
The chemicals extracted out of the plants are used in the following dose-range in a particular manner-
Terminalia chebula 100-300mg
Withania somnifera 150-500mg
Ocimum sanctum 100-300mg
Tinospora cordifolia 150-500mg
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 rang comprised of:
Terminalia chebula 100-200mg
Withania somnifera 150-350mg
Ocimum sanctum 100-200mg
Tinospora cordifolia 200-400mg The remainder is optionally known additive to make the required preparation.
Terminalia chebula (Haritaki):
This plant is most commonly known as 'Haritaki' belongs to family "Combretaceae" whose dried fruits are extracted to collect the mixture of alkaloids and glycosides compound. Various studies have shown this mixture possessing immunomodulating and anti-stress properties.
Withania somnifera (Ashwagandha):
This plant is commonly known as 'Ashwagandha' belonging to family "Solanaceae" whose dried roots are extracted to collect the mixture of alkaloids, withanloids compounds. Several studies have proven that this mixture possessing marked sedative, hypnotic, adaptogenic and rejuvantive properties, which provides survival under stress.
Qcimum sanctum (Tulsi):
This plant is very frequently known as 'Tulsi' belonging to family "Labiatae" whose dried whole plant are extracted to collect the mixture of various contents of the plant. Several studies have shown hypotensive and adaptogenic activity of this plant.
Tinospora cordifolia (Guduchi);
This plant is commonly known as 'Guduchi/Amrita' belonging to family "menispermaceae" whose dried stems are extracted to collect the mixture of diterpenoid-tinosporide, perberile heptacosanol compounds. Various studies have shown that this mixture possesses anti-stress and immunomodulating activities.
The known additives are excipients such as calcium sulphate.
Example-1:
The preparation containing the organic extract of Treminalia chebula administered in the dose of 200 mg continuously for three months to the diagnosed cases suffering from anxiety and stress exhibited improved body resistance and better stress tolerance capacity.
Example-2:
The preparation containing the organic extract of Withania somnifera administered in the dose of 400 mg to the diagnosed cases showing high anxiety levels and stress symptoms continuously for 3 months showed improved sleep pattern and changes in behavioural pattern causing better adaptation under stress condition.
Examnle-3:
The preparation containing the organic extract of Ocimum snctum administered in the dose of 250 mg to the cases suffering from anxiety and stress with poor adaptation continuously for three months exhibited better adaptation towards stress and felling of well being.
Example-4:
The preparation containing the organic extract of Tinospora cordifolia administered in the dose of 400 mg to the individuals suffering from anxiety and stress of varying etiology continuously for three months showed enhanced body resistance and better tolerance capacity to stress situations.
Example-5;
The preparation containing the organic extract of Terminalia chebula in the dose of 250 mg and organic extract of Withania somnifera in the dose of 350 mg administered to the cases under study showed reduced anxiety score and marked changes in sleep pattern and better work performance capacity
Example-6:
The preparation containing the organic extract of Withania somnifera in the dose of 300 mg and organic extract of Ocimum sanctum in the dose of 200 mg to the diagnosed cases suffering from anxiety and stress with a poor adjustment, continuously three months exerted its effects in reducing anxiety level, better adaptation to stress and also improvement in systolic and diastolic blood pressure altered due to constant anxiety and stress.
Example-7:
The preparation containing the organic extract of Withania somnifera in the dose of 250 mg and organic extract of Tinospora Cordifolia in the dose of 400mg continuously for 3 months to the cases under anxiety and stress exhibited marked improvement in early mental and physical fatigue and cases reported performing the daily work in more effective manner than earlier.
Example-8;
The preparation containing the organic extracts of Terminalia chebula in the dose of 150mg, Withania somnifera in the dose of 300mg, Ocimum sanctum in the dose of 150mg and Tinospora cordifolia in the dose of 300mg administered orally to the cases suffering from anxiety and stress with poor adaptation continuously for three months exhibited marked influence in reducing anxiety scores, improvement in adaptation towards stress capability, improvement in early fatigue, better sleep pattern and marked change in work performance capacity which indicated the anti-stress and adaptogenic properties of the present test formulation.
The invention which contain the organic extract of Terminalia chebula, Withania somnifera, Ocimum sanctujm and Tinospora cordifolia and given in an effective doses to subjects suffering from anxiety and stress exerted beneficial effect. The drug Withania somnifera has action on Central Nervous System. By regulating the neurotransmitters it reduced the anxiety level. Tinospora cordifolia and Terminalia chebula both acted as nervine tonic and produced general felling of well being by increasing the tolerance capacity to all kind of stress. Ocimum sanctum in effective dose increases the general threshold against any mental or physical stress.
While the single drug treatment for the management of anxiety and stress which causes poor adaptation is not sufficient therefore a combination of herbal drugs is more effective as it overcome all the associated symptoms of anxiety and stress and ultimately provides better adaptation to the individuals suffering from various kind of anxiety and stress.
It is to be understood that the herbal composition and process for the preparation thereof is susceptible to 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:-

WE CLAIM:
1. A herbal preparation for the prevention and management of anxiety and stress
with poor adaptation comprising:
Organic extract of Terminalia chebula (Haritaki) 100-300mg
Organic extract of Withania somnifera (Ashwagandha) 150-500mg
Organic extract of Ocimum sanctum (Tutsi) 100-300mg
Organic extract of Tinospora cordifolia (Guduchi) 150-500mg
with or without known additives.
2. A preparation as claimed in claim I comprising:
Terminalia chebula 100-300mg
Withania somnifera 150-400mg
Ocimum sanctum 100-250mg
Tinospora cordifolia 200-450mg
with known additive for a preparation of 300mg/600mg.
3. A preparation as claimed in claim I comprising of organic extract of Terminalia
Chebula contains a mixture of alkaloids and glycosides compounds.
4. A preparation as claimed in claim I wherein the organic extract of Withania
somnifera contains the mixture of alkaloids and withanoloids compound.
5. A preparation as claimed in claim I wherein the organic extract of Ocimum
sanctum contains a mixture of biologically active contents of the plant.
6. A preparation as claimed in claim I wherein the organic extract of Tinospora
corditblia contains a mixture of diterpenoid-tinosporide, perberilin heptacosanol
compounds.
7. A herbal preparation for the prevention and management of anxiety and stress
also showing adaptogenic properties substantially as herein described and
exemplified in the examples.
8. A process for the preparation of herbal preparation for the prevention and
management of anxiety and stress with adaptation problems comprising in
admixing:
Organic extract of Terminalia chebula (Haritaki) 100-300mg
Organic extract of Withania somnifera (Ashwagandha) 150-500mg
Organic extract of Ocimum sanctum (Tulsi) 100-300mg
Organic extract of Tinospora corditblia (Guduchi) 150-300mg
with or without known additives.
9. A process as claimed in claim 8 comprising:
Terminalia chebula 100-300mg
Withania somnifera 150-400mg
Ocimum sanctum 100-250mg
Tinospora cordifolia 200-450mg
with known additive For a preparation of 300/500mg.
10. A process as claimed in claim 8 comprising the organic extract of Terminalia
chebula containing a mixture of alkaloids and glycosides compound.
11. A process as claimed in claim 8 comprising the organic extract of Withania
somnitera containing a mixture of alkaolids and withnoloids compound.
12. A process as claimed in claim 8 comprising the organic extract of Ocimum
sanctum containing mixture of active contents of the plant.
13. A process as claimed in claim 8 comprising the organic extract of Tinospora
cordifolia containing a mixture of diterpenoid, tinosporide, perbirilin,
heptaconsanol compound.
14. A process for the preparation of a herbal formulation for the prevention and management of anxiety and stress with poor adaptation capabilities as herein described and exemplified in the examples.

Documents:

665-del-2002-abstract.pdf

665-del-2002-claims.pdf

665-del-2002-correspondence-others.pdf

665-del-2002-correspondence-po.pdf

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

665-del-2002-form-1.pdf

665-del-2002-form-18.pdf

665-del-2002-form-2.pdf

665-del-2002-form-3.pdf

665-del-2002-form-4.pdf

665-del-2002-form-5.pdf

665-del-2002-gpa.pdf

665-del-2002-petition-others.pdf

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Patent Number

220688

Indian Patent Application Number

665/DEL/2002

PG Journal Number

30/2008

Publication Date

25-Jul-2008

Grant Date

02-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