Title of Invention

"A HERBAL COMPOSITION FOR THE PREVENTION AND MANAGEMENT OF LOSS OF COGNITIVE DECLINE AMONG THE AGED POPULATION AND A PROCESS FOR PREPARATION THEREOF"

Abstract This invention relates to a herbal composition and a process for preparation thereof wherein the herbal composition is useful for the prevention and management of senile dementia which involves loss of cognitive function among the ageds. The composition comprises mixture of organic extracts of Centella asiatica (Mandukparni), Hippophae salicifolia (Badriphal) and Convolvulus pluricaulis (Shankhapushpi), with or without additive. The process for preparation of the composition comprises mixing the organic extracts of the above herbs with optional addition.
Full Text FIELD OF INVENTION
This invention relates to a herbal composition and a process for preparation thereof wherein the composition is useful for the prevention and management of senile dementia which involves loss of cognitive functions among the ageds. The preparation of the present invention may also be advantageously used in arresting the further decline of cognitive function among the ageds particularly the present invention will help in slowing down the decline of memory performance among the ageds. BACKGROUND OF INVENTION
Degenerative changes occur throughout the body with increasing age, which are sufficient to constitute various pathological manifestations. Decline in cognitive function, loss of adaptive response to stress, decreased humoral as well as cell mediated immunity, slower metabolic clearance of drugs, increased susceptibility of infection, psychological involvement like cognitive impairment and depression all are observed most frequently among all ageds. Dependency due to physical and mental disabilities are the major factors responsible to adverse the quality of life and health care. Due to the above reasons the elderly population is the heavy user of medical and personal care services.
The decline in cognitive functions is an inevitably consequence of ageing. A broad range of modern nootropic and psychotropic agents are being used to manage the age related cognitive impairment and associated functional disorders. But the long-term intervention of such agents has there own limitations due to adverse effects on various biological system.

OBJECTS OF THE PRESENT INVENTION
An object of the present invention is to propose a herbal formulation and a process for preparation thereof useful for the prevention and management of senile dementia involving loss of cognitive function among the aged cases.
Another object of this invention is to propose a herbal formulation to check the further loss of cognitive functions among the ageds.
Further object of the present invention is to propose a herbal formulation to improve the quality of life among the ageds by improving the memory performance and concentration ability.
Still further object of the present invention is to propose a herbal preparation effective in maintenance of cognitive function by checking the further loss of memory and other mental functions.
Yet further object of this invention is to propose a herbal formulation for the prevention and management of anxiety and depression among the ageds which hamper the cognitive functions significantly.

DESCRIPTION OF INVENTION
According to this invention there is provided a herbal preparation for the prevention and management of loss of cognitive decline among the aged cases comprising
Organic extract of Centella asiatica (Mandukparni) 150-1000 mg
Organic extract of Hippophae salicifolia (Badriphal) 600-1000 mg
Organic extract of Convolvulus pluricaulis (Shankhpushpi) 100-400 mg with or without known additives.
In accordance with a preferred embodiment and without intending to imply any limitation the constituents are present in the weight ratio from 1.5:6:1 to 5:5:2 with or without additives.
Further according to this invention there is provided a process for the preparation of a
herbal preparation for the prevention and management of cognitive deficits among aged
population comprising of admixing :
Organic extract of Centella asiatica (Mandukparni) 150-600 mg
Organic extract of Hippophae salicifolia (Badriphal) 600-1000 mg
Organic extract of Convolvulus pluricaulis (Shankhpushpi) 100-400 mg
with or without known additives.
It is to be noted that compulsion is not a more mixture with aggregation of properties but different herbs have synergetre effect on each other which makes the composition effective in prevention and management of senile dementia.
The chemicals extracted out of the plants are used in the following dose range in a particular manner-
100-600 mg Centella asiatica
600 - 1000 mg Ilippophae salicifolia
100-400mg Convolvulus pluricaulis
The drugs are administered with varying dose schedule and a careful monitoring of the clinical symptomatology presented different results.
On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of:
Centella asiatica 250 - 450 mg
Hippophae salicifolia 300 - 600 mg Convolvulus pluricaulis 150-300 mg
The remainder is optionally known additive to make the required preparation.
Centella asiatica (Mandukparni):
This is a plant commonly known as 'Mandukparni' belonging tq family "Umbelliferae" whose dried whole plant are extracted to collect the
mixture of alkaloids and glycoside compound. Studies have indicated that it has memory improving and tranquilizing effects.
Hippophae salcipholia (Badriphal)
This plant commonly known as 'Seabuckthorn/Badriphal, belongs to family "Elacagnoceae" whose dried fruit, pulp are extracted to collect the mixture of flnvonoids, glycosidcs and lorpcnic compounds. Various studies have indicated that it improves the behavioural pattern and memory performance. II also enhances The .general body immunity in nine effective manner.
Convolvuls pluricaulis (Shankhpushpi):
This plant is commonly known as ' Shankhpushpi' belongs to family "Convolvulaceae" whose dried leaves and flowers are extracted to collect the alkaloids (shankhapushpine) compound. Several studies have
suggested that mixture possessing is effective in reducing anxiety and |
i
improving the mental functions. It has also hypotensive effects.
The known additives are excipients such as calcium sulphate Example -1:
The preparation containing the organic extract of Centella asiatica administered in the dose of . 3oo " mg continuously for three months ! to the aged showing cognitive decline, a mild improvement in behavioural I pattern was noticed. Improvement in sleep pattern was also reported by ' the aged cases.
Example -2:
The preparation containing the organic extract of Hippophae salcifolia administered in the dose of 300mg continuously for 3
months lo the agcd reporting loss of cognitive functions exhibited mild improvement in.short term memory and concentration ability.
Example -3:
The preparation containing the organic extract of Convolvulus pluricaulis administered in continuously for three months in the dose of 200 mg to the ageds complaining loss of cognitive functions exhibited improvement in mental ability and also modified behavioural pattern.
Example -4:
The preparation containing the organic extract of Centella asiatica in the dose of . 250 mg along with organic extract of Hippophae
. )
salcifolia in the dose of 350 mg administered to the ageds showing loss of cognitive function exhibited better mental performance and improvement in early mental fatigue than the earlier.
Example -5:
The preparation containing the organic extract of Centella asiatica in the dose of'.300 mg and Convolvulus pluricaulis in the dose of 200 nig continuously for three months to the ageds of cognitive deficits exhibited better feeling of well being due to reduction in anxiety scores and improved sleep pattern..
Example - 6:
The preparation containing Ihe organic extract of Hippophae salcifolia in the dose of : 400 mg aJong with the organic extract of Convolvulus pluricaulis in the dose of 200mg to the ageds of loss of cognitive functions showed improved body immunity and reduced anxiety and tension resulting in improvement in better mental performance and feeling of well being.
Example - 7:
The preparation containing the organic extract of Centella asitica in the dose of 250 mg., Hippophae salcifolia in the dose of 400mg and Convolvulus pluricaulis in the dose of 250 mg adminstered to the ageds complaining loss of mental performance exerted better results than the before therapy. A better short and long-term memory along with improved concentration ability was noted. The behavioural pattern also improved. A general body immunity and feeling of well being was also important results in this group.
In this formulation the combination of organic extracts of Centella asiatica, Hippophae salicifolia and Convolvulus pluricaulis has been added for the prevention and management of loss of cognitive fucntions among the aged people. Loss of cognitive functions among the ageds is not due to single factor but multiple factors. Centella asiatica increases the protein synthesis in the neurons thus it, prevents the rapid brain tissue loss among the ageds. Hippophae salcifolia having antioxident property prevents the rapid degenerative changes in the brain. The organic extract of Convolvulus pluricaulis improves the short-term memory among the ageds. Anxiety and depression are the main clinical presentation among the ageds whose association showed positive correlation with decline of concentration ability, short and long term memory among the ageds. The combined formulation, by regulating the neurotransmitter modifies the human behavior and thus prevents the cognitive deterioration among the ageds.
As far as the use of single drug in traditional practice the effectivity is minimized significantly and does not cover all the aspects of cognitive deficits.
The herbal formulation is useful for the prevention and management of senile dementia comprises mixture of organic extract of Centella asiatica (Mandukparni), Hippophae salicifolia (Badriphal) and Convolvulus pluricaulis (Shankhapushpi) in a prescribed doses. The proportion of the organic extract of the three herbs was determined on the basis of repeated trials and the effective dose was determined on the basis of therapeutic results. The preferred dose depends upon the therapeutic efficacy of the organic extract in the dose 7'as~.described'-': .' hereiri.. ' T; If the dose given in terms of mg is the weight of the organic extract of the drug found useful in regulating various sign and symptoms of the subjects. The proportion of the organic extract of three plants exerted significant results among the patients suffering from senile dementia and other age related neurological problems. The organic extract of Hippophae salicifolia has shown beneficial effect in the regulation of cholinergic system, which is a marker for ageing brain or senile dementia. Hippophae salicifolia can alone produce significant effects in arresting the ageing process but the mixture of Centella asiatica • ' shows better results by increasing protein synthesis in the cells playing part in memory and cognition. The Convolvulus pluricaulis regulates the various neurotransmitters like 5-HT in the brain. When the formulation is prepared in the specific weight of the organic extract of the three plants it has been observed that the decline in overall cognitive functions may be minimized. If the proportion is altered no beneficial effect could be achieved. The organic extract of single drug Convolvulus pluricaulis exerts effects only on the central nervous system. The administration of single Centella asiatica or Convolvulus pluricaulis has a little effect on the cognitive function but if given in the combination of Hippophae salcifolia the claims can be sustained.
It is to be understood that the present invention is susceptible to modifications, changes and adaptations by those skilled in the art. Such variant embodiments incorporating the concepts and features of the present invention, are intended to be within the scope of the present invention which is further set forth under the following claims:-









CLAIM:
1. A herbal preparation for the prevention and management of loss of cognitive
decline among the aged cases comprising:
Organic extract of Centella asiatica (Mandukparni) 150-lOOOmg
Organic extract of Hippophae salicifolia (Badriphal) 600- lOOOmg
Organic extract of Convolvulus pluricaulis (Shankhpushpi) 100-400mg with or without known additives.
2. A preparation as claimed in claim 1 comprising:
Centella asiatica (Mandukparni) 150-1 OOOmg
Hippophae salicifolia (Badriphal) 600-1200mg
Convolvulus pluricaulis (Shankhpushpi) 100-400mg
with or without known additives.
3. A preparation as claimed in claim 1 wherein the organic extract of Centella
asiatica contains a mixture of alkaloids and glycosides compound.
4. A preparation as claimed in claim 1 wherein the organic extract of Hippophae
Salicifolia contains a mixture of flavonoides, glycosides and terpenic compounds.A preparation as claimed in claim 1 wherein the organic extract of Convolvulus
pluricaulis contains alkaloids.
5. A process for the preparation of a herbal preparation for the prevention and
management of congnitive deficits among aged population comprising of
admixing.:
Organic extract of Centella Asiatic 150-600mg
Organic extract of Hippophae Salicifolia 600-lOOOmg
Organic extract of Convolvulus Pluricaulis (Shankhpushpi) 100-400mg with or witrhout known additives.
7. A process as claimed in claim 6 comprising:
Centella asiatic (Mandukparni) 250-450mg
Hippophae salicifolia (Badriphal) 300-600mg
Convolvulus pluricaulis (Shankhpushpi) 150-300mg
with known additive for a preparation of 300mg/500mg.
8. A process as claimed in claim 6 comprising the organic extract of Centlella
asiatica contains mixture of alkaloids and glycosides compound presented
improved sleep and behavioural pattern.
9. A process as claimed in claim 6 wherein organic extract of Hippophae salicifolia
contains mixture of flavonoids, glycosides and terpine compound.
10. A process as claimed in claim 6 wherein the organic extract of Convolvulus
pluricaulis, contains alkaloids effects.
11. A herbal composition for prevention and management of senile dementia as
substantially described and illustrated herein.
12. A process for preparation of herbal composition for prevention and management
of senile dementia as substantially herein described and illustrated.

Documents:

715-DEL-2002-Abstract.pdf

715-DEL-2002-Claims.pdf

715-del-2002-correspondenc others.pdf

715-del-2002-correspondence-po.pdf

715-DEL-2002-Description (Complete).pdf

715-DEL-2002-Form-1.pdf

715-del-2002-form-18.pdf

715-DEL-2002-Form-2.pdf

715-del-2002-form-3.pdf

715-del-2002-form-4.pdf

715-del-2002-form-5.pdf

715-del-2002-gpa.pdf

715-del-2002-patition-others.pdf


Patent Number 232507
Indian Patent Application Number 715/DEL/2002
PG Journal Number 13/2009
Publication Date 27-Mar-2009
Grant Date 17-Mar-2009
Date of Filing 03-Jul-2002
Name of Patentee RAVI PATODIA
Applicant Address SARAIYYA, P.O.-BHADOHI, SANT RAVIDAS, BHADOHI-221 401,
Inventors:
# Inventor's Name Inventor's Address
1 G.P. DUBEY CENTRE OF PSYCHOSOMATIC & BIOFEEDBACK MEDICINE,SCIENCE, FACULTY OF AYURVEDA, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY
PCT International Classification Number A61K 35/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA