The present invention relates to an herbal composition. More particularly, the present invention relates to a novel synergistic herbal composition for ameliorating the progress and symptoms of Alzheimer's disease (AD).
DESCRIPTION OF THE INVENTION
Alzheimer's disease (AD) is a progressive disorder with cognitive and memory decline, speech loss, personality changes, and synapse loss. Alzheimer's disease (AD) is a progressive inexorable loss of cognitive function associated with the presence of senile plaques in the hippocampal area of the brain. In Alzheimer's disease, brain cells start to deteriorate. The body attempts to stop this process by producing a protein called amyloid. However, amyloid deposits build up in the brain, leading to further deterioration. These deposits of amyloid are referred to as "plaques" and cause the brain cells to shrivel up and form "tangles", which in turn lead to changes in the brain structure and cause the brain cells to die. The formation of plaques and tangles also prevents the production of some important brain chemicals, called neurotransmitters. Over time the loss of brain cells causes the brain to shrink. (Ayurvedic medicinal plants for Alzheimer's disease: a review, Rao et al., Alzheimer's Research & Therapy, 2012, 4:22)
The disease is the most common form of dementing illness among middle-aged and older adults. Symptoms typically appear after age 60, and some early-onset forms of the disease are linked to a specific genetic defect. Although the etiology is unknown, genetic factors clearly play a role in 10% to 15% of cases. So far, efforts to find a cure for AD have been disappointing, and the drugs currently available to treat the disease address only its symptoms and with limited effectiveness. The underlying pathogenesis is a loss of neurons in the hippocampus, cortex, and subcortical structures. Early disease shows a loss of short-term memory, inability to learn new information, mood swings, and difficulty in finding words, forgetting names, and losing items. Frustration, hostility, and irritability are common emotional features exhibited by patients with AD. In severe cases, patients become totally incontinent, memory is completely

lost, and sense of time and place disappears. Patients become totally dependent upon others and eventually require comprehensive care. Herbal medicine offers several options to modify the progress and symptoms of AD.
Nature has endowed us with a variety of herbs that possess numerous medicinal properties, and that are used to prepare herbal medicines. There has been a new trend in the preparation and marketing of drugs based on medicinal plants, and their scientific and commercial significance appears to be gathering momentum in health-relevant areas. These plant-derived products are carefully standardized for their efficacy and safety.
Herbs with proven beneficial effects on brain function include Curcuma longa (Turmeric), Bacopa monnieri (Brahmi), Withania somnifera (Ashwagandha), Centella asiatica (Gotu kola), and Convolvuluspluricaulis (Shankhpushpi).
Bacopa monnieri
Bacopa monnieri (common names: water hyssop and Brahmi) is a creeping perennial that thrives in warmer temperate climates. The genus Bacopa includes over 100 species of aquatic herbs distributed throughout the warmer regions of the world. The plant is a profusely branched herb, rooting at the nodes and forming dense mats. B. monnieri extract is a standardized extract prepared from the leaves of the B. monnieri plant. It is standardized for a minimum of 50% bacosides, the active ingredients beneficial in the support of cognitive functions. The extracts of the B. monnieri plant standardized for a predetermined level of bacosides, useful in the compositions of the present invention, can be prepared by extraction techniques known in the art. The pharmacological effects of B. monnieri preparations/extracts also include antioxidant, anti-inflammatory, cardiotonic and anticancer effects. Extract of B. monnieri is also commercially available.
Withania somnifera
Ashwagandha, (also known as Withania somnifera) is used extensively in Ayurveda as a nervine tonic, aphrodisiac, and 'adaptogen' and helps the body adapt to stress. Ashwagandha is a member of the nightshade (Solanaceae) family,

and the root is the part that is widely used. It is categorized as a rasayana (rejuvenative) and is believed to possess antioxidant activity, free radical scavenging activity, and an ability to support a healthy immune system. Unlike other adaptogens, which tend to be stimulating, Ashwagandha has a calming effect and thus may be particularly indicated in people with AD. A total alkaloid extract of Ashwagandha root exhibited a calming effect on the central nervous system (CNS) in several mammalian species, suggesting the use of this herb to produce relaxation. A recent double-blind, randomized, placebo-controlled study of the effects of Ashwagandha on stress found that it reduced symptoms of stress and inability to concentrate and reversed forgetfulness in a dose-dependent manner, and 500 mg/day was more effective. No additional adverse effects were found.
Ashwagandha contains steroidal compounds of great interest to researchers, such as the ergostane-type steroidal lactones, including withanolides A to Y, dehydrowithanolide R, withasomniferin A, withasomidienone, withasomniferols A to C, withaferin A, and withanone. Other constituents include the phytosterols sitoindosides VII to X and beta-sitosterol as well as alkaloids (for example, ashwagandhine, cuscohygrine, tropine, pseudotropine, isopelletierine, and anaferine), a variety of amino acids (including tryptophan), and high amounts of iron. A subset of these components (withanamides) has been shown to scavenge free radicals generated during the initiation and progression of AD. Neuronal cell death triggered by amyloid plaques was also blocked by withanamides. Molecular modeling studies showed that withanamides A and C uniquely bind to the active motif of beta-amyloid (Ap 25-35) and prevent fibril formation. In the CNS, Ashwagandha has been reported to increase memory and learning. Aqueous extracts of this herb have been found to increase cholinergic activity, including increases in the acetylcholine content and cholineacetyl transferase activity in rats and this might partly explain the cognition-enhancing and memory-improving effects. In addition, recent reports have provided exciting information on the ability of this herb to stimulate neurite outgrowth. Treatment with the methanol extract of Ashwagandha caused neurite outgrowth in a dose- and time-dependent

manner in human neuroblastoma cells. The levels of two dendritic markers, MAP2 and PSD-95, were found to be markedly increased in cells treated with Ashwagandha, suggesting that it stimulates dendrite formation. In an extension of the above study, the same research group treated cultured rat cortical neurons with amyloid peptide that induced axonal and dendritic atrophy and loss of pre- and postsynaptic stimuli. Subsequent treatment with a methanol extract of Ashwagandha induced significant regeneration of both axons and dendrites. In addition to the reconstruction of presynapse and postsynapse in the neurons, methanol extracts of Ashwagandha reversed amyloid peptide-induced memory deficit in mice. These in-vivo effects of Ashwagandha were maintained even after the discontinuance of the drug administration. Similarly, preliminary studies from this laboratory revealed significant neurogenesis in the dentate gyrus region only in J20 mice - mice that express the mutant form of human amyloid precursor protein (APP) bearing both the Swedish (K670N/M671L) and the Indiana (V717F) mutations - that were fed a diet containing the whole herb (Ashwagandha root powder, 2.5 g/kg body weight) in comparison with J20 mice that received only normal chow. Although the data mentioned above are quite promising for the use of Ashwagandha as an anti-AD agent, additional clinical trials need to be conducted to support its therapeutic use. While the herb has been used successfully in Ayurvedic medicine for centuries, a systematic study of the acute or chronic toxicity of this herb or its various components is still lacking and additional studies are warranted to confirm the therapeutic significance of this herb (Ayurvedic medicinal plants for Alzheimer's disease: a review, Rao et al., Alzheimer's Research & Therapy, 2012, 4:22). Centella asiatica
In the Ayurvedic system of medicine, Centella asiatica (also known as gotu kola) is one of the important rejuvenating herbs for nerve and brain cells and is believed to be capable of increasing intelligence, longevity, and memory. Asiaticoside derivatives, including asiatic acid and asiaticoside, were shown to reduce hydrogen peroxide-induced cell death, decrease free radical concentrations, and inhibit beta-amyloid cell death in-vitro, suggesting a possible role for gotu kola in

the treatment and prevention of AD and beta-amyloid toxicity. Gotu kola extracts reversed the beta-amyloid pathology in the brains of PSAPP (APP/Sw x PSIM146L) mice and modulated the components of the oxidative stress response (Ayurvedic medicinal plants for Alzheimer's disease: a review, Rao et al., Alzheimer's Research & Therapy, 2012, 4:22). Convolvulus pluricaulis
The herbal medicinal plant, Convolvulus pluricaulis (also called as Shankhpushpi): a rasayana drug has been primarily advocated for use in mental stimulation and rejuvenation therapy. In ancient systems of Indian medicine, Ayurveda, the plant has been shown to act as a prominent memory improving drug, a psychostimulant and tranquiliser. The plant displays its biological activity due to the presence of several alkaloids, flavanoids and coumarins as active chemicals. Previous reports have demonstrated beneficial effect of extracts of this plant in in-vitro and in-vivo models of Alzheimer's disease (AD) (Convolvulus Pluricaulis as a cognition booster: Relevance to Alzheimer's disease, Bihaqi et al., International Journal of Pharmaceutical Sciences and Drug Research, 2016, 8(2), 68-74).
Curcuma longa
Turmeric extract 95% is prepared from the root or rhizome of the Curcuma longa plant (common names: Curcuma, Turmeric, Ukon, Goeratji, Kakoenji, Koenjet, Kondin, Kunir, Kunyit, Oendre, Rame, Renet, Temu kuning, Temu kunyit, Tius Curcumin). C longa is a perennial plant native to India. A compound called curcumin is a potent extract of the root, and has been attributed a wide range of therapeutic benefits. Turmeric extract is useful as an antioxidant, anti-inflammatory, anti-mutagenic agent, anti-cancer agent, cholagogueue, depurative, diuretic, fumitory, hemostatic agent, hepatoprotective agent, lactagogue, stomachic, tonic, and vulnerary. Turmeric preparations are useful to protect the liver from toxins, to reduce platelet aggregation, to prevent or treat inflammatory disease, inflammation, arthritis, psoriasis, cancer (e.g., prostate cancer and breast cancer), pain, Alzheimer's Disease, cardiovascular disease (e.g., arteriosclerosis

and atherosclerosis). Turmeric extract that is standardized to 95% curcumin contains turmeric (with 95% curcumin).
Turmeric oil is secondary metabolite of turmeric and obtained by steam distillation of its rhizomes. Turmeric oil a lipophilic fraction from turmeric, exhibits several therapeutic potentials. Turmeric oil chiefly comprises ar-turmerone and P-turmerone (Curlone). Turmeric oil ameliorates the ischemia induced neurological functional deficits, infarct and edema volumes measured after 24 hrs of ischemia. Immunohistochemical and Western blot analysis demonstrated that the expression of iNOS, cytochrome c and Bax/Bcl-2 were altered after the insult and antagonized by treatment with turmeric oil. Turmeric oil significantly reduces nitrosative stress; it tends to correct the decreased mitochondrial membrane potential and also affects caspase-3 activation. Turmeric oil reduced post-ischemic brain neutrophil infiltration in the ischemic area, controlled tissue nitric oxide levels and the neuronal levels of nitric oxide, peroxynitrite and reactive oxygen species (Pharmacological profile of Turmeric oil: A Review, Verma et al, LEK. SIROV. Vol. XXXV, No. 35, Page 3-21, Belgrade 2015).
The medicinal properties of curcumin obtained from Curcuma longa cannot be utilized because of poor bioavailability due to its rapid metabolism in the liver and intestinal wall. In a study, the effect of combining pipeline, a known inhibitor of hepatic and intestinal glucuronidation, was evaluated on the bioavailability of curcumin in rats and healthy human volunteers (Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers, Shoba et al, Planta Medica, 1998 May, 64(4), 353-6). The study shows that in the dosages used, piperine enhances the serum concentration, extent of absorption and bioavailability of curcumin in both rats and humans with no adverse effects. Piperine, along with its isomer chavicine, is the alkaloid responsible for the pungency of Piper nigrum (black pepper) and long pepper. Piper nigrum extract standardized to 95% Piperine is commercially available.

Zinc is an element that is essential for optimum brain function. Zinc plays an important role in axonal and synaptic transmission and is necessary for nucleic acid metabolism and brain tubulin growth and phosphorylation. Lack of zinc has been implicated in impaired DNA, RNA, and protein synthesis during brain development. For these reasons, deficiency of zinc during pregnancy and lactation has been shown to be related to many congenital abnormalities of the nervous system in offspring. Furthermore, in children insufficient levels of zinc have been associated with lowered learning ability, apathy, lethargy, and mental retardation (Zinc, the brain and behavior, Pfeiffer et ah, Biological Psychiatry, 1982 Apr, 17(4), 513-32).
Although the aforestated ingredients are known individually for their beneficial effects on brain function, such as learning, memory, judgement, concentration, cognition, behavior, etc., there are no reports on the combined effects, particularly synergistic effect, of the aforestated ingredients. A synergistic effect occurs when two or more components with or without the same overt effect, are used together to yield a combined effect that has an outcome greater than the sum of the single components alone. Synergistic effect may also occur, when only one component exerts an action that is made greater by the presence of a second component.
OBJECT OF THE INVENTION
The main object of the present invention is to provide a novel synergistic herbal composition beneficial in the prevention and management of age related neurodegenerative disorders related with Alzheimer.
Another object of the present invention is to propose a novel synergistic herbal composition effective in the prevention and management of memory and attention span in Alzheimer's patients.
Still another object of the present invention is to provide a novel synergistic herbal in form of pharmaceutical formulation.

Still yet another object of the present invention is to provide the pharmaceutical formulation in various dosage forms viz; tablets, capsules, syrups, sachet and powder for easy consumption.
Further, object of the present invention is to provide a novel synergistic herbal composition that improves memory and prevents progressive deterioration in cognitive, speech loss, personality changes and synapse loss.
SUMMARY OF THE INVENTION
Accordingly, the invention provides a novel synergistic herbal formulation having the property to prevent loss of vital brain function like memory loss, speech loss, and personality changes.
In an embodiment of the invention the novel synergistic herbal composition comprising extracts of Curcuma longa extract, Turmeric oil, Bacopa monnieri extract, Withania somnifera extract, Centella asiatica extract, Convolvulus pluricaulis extract, Zinc or Zinc derivatives, and Piper nigrum extract, wherein Curcuma longa extract is present in a range of 15 to 20% (w/w), turmeric oil is present in a range of 12 to 18% (w/w), Bacopa monnieri extract is present in a range of 10 to 15% (w/w), Zinc or Zinc derivatives is present in a range of 5 to 9% (w/w), Piper nigrum extract is present in a range of 0.6 to 0.9% (w/w), Withania somnifera extract is present in a range of 8 to 15% (w/w), Centella asiatica is present in a range of 5 to 15% (w/w), Convolvulus pluriacaulis is present in range of 7 to 15% (w/w), wherein the composition improves memory and prevents progressive deterioration in cognitive, speech loss, personality changes and synapse loss in Alzheimer disease.
In another embodiment of the invention the novel synergistic herbal composition comprises the Curcuma longa extract comprising 95% curcumin is present in a range of 15 to 20% (w/w).
In still another embodiment of the invention the novel synergistic herbal composition comprises the turmeric oil comprising 20% turmerone is present in a range of 12 to 18% (w/w).

In yet another embodiment of the invention the novel synergistic herbal composition comprises the Bacopa monnieri extract comprising 50% bacosides is present in a range of 10 to 15% (w/w).
In another embodiment of the invention the novel synergistic herbal composition comprises the Zinc or Zinc derivatives in form of Zinc gluconate is present in a range of 5 to 9% (w/w).
In still another embodiment of the invention the novel synergistic herbal composition comprises the Piper nigrum extract comprising 95% Pipeline is present in a range of 0.6 to 0.9% (w/w).
In another embodiment of the invention the novel synergistic herbal composition is in form of formulation comprising the aforesaid composition and pharmaceutically acceptable excipients.
In still another embodiment of the invention the pharmaceutical formulation is in form of oral formulation comprising of tablet, capsule, syrup, sachet and powder.
In another embodiment of the invention the pharmaceutical formulation has excipients which are selected from the group comprising of BHT/ BHA, Propyl gallate, soybean oil, Arachis oil, Gelatin, glycerin, starch, Dibasic calcium phosphate, talc, PVP-k30, silicon dioxide, purified water, sugar, sucralose , Magnesium stearate and Stevia.
In yet another embodiment of the invention the novel synergistic herbal composition ameliorates the symptoms of Alzheimer disease and to improve the general health of the patient.
In still another embodiment of the invention the process for preparation of pharmaceutical formulation comprises the step of (a) weighing the active ingredients in pre-determined ration and mixing to get a homogenized mixture; (b) adding BHA, BHT and propyl gallate to soybean oil or Arachis oil in a vessel and mix well; (c) preparing a gelatin mask in glycerin to be used as capsule shell; (d) adding mixture from (a) to (b) followed by mixing to get uniform slurry; (e) passing the slurry from (d) through roller mill to get a smooth texture; and (f)

slurry from (e) is encapsulated in gelatin capsules on automatic capsule filling machines.
DETAILED DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the current invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification, and appropriate equivalents.
It is to be noted, as used in the specification and the appended claims, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The expression of various quantities in terms of "%w/w" means the percentage by weight, relative to the weight of the total composition unless otherwise specified.
The expression of quantity in terms of "% w/w" or "%" means the percentage by weight, relative to the weight of the total solution or composition, unless otherwise specified.
The present invention provides a novel synergistic herbal composition useful in treatment and ameliorating the progress and symptoms of Alzheimer's disease. The herbal composition comprises of Curcuma longa extract comprising curcumin, turmeric oil comprising turmerone, Bacopa monnieri extract comprising bacosides, Zinc gluconate, Piper nigrum extract comprising piperine, Withania somnifera extract, Centella asiatica extract, and Convolvulus pluricaulis extract. The herbal composition of the present invention helps in improving memory and prevents the loss of vital brain function in Alzheimer's disease.

The novel synergistic herbal composition of the present invention may be administered to patients in form of pharmaceutical oral formulation, wherein the oral formulation is in form of tablet, capsule or syrup. The pharmaceutical oral formulation comprises herbal composition along with pharmaceutically acceptable excipients like BHT/BHA, Propyl gallate, Soybean oil, Arachis oil, gelatin, glycerin, starch, Dibasic calcium phosphate, talc, PVP-k30, silicon dioxide, purified water, sugar, sucralose , Magnesium stearate and Stevia.
The said formulation has the property of improving the brain power of memorizing and its use in treatment of dementia. The formulation is known to ameliorate the symptoms of disease and to improve the general health of the patient.
Butylated hydroxytoluene (BHT), also known as dibutylhydroxytoluene, is a lipophilic organic compound, chemically a derivative of phenol useful for its antioxidant properties.
Butylated hydroxyanisole (BHA) is an antioxidant consisting of a mixture of two isomeric organic compounds, 2-tert-butyl-4-hydroxyanisole and 3-tert-butyl-4-hydroxyanisole. It is prepared from 4-methoxyphenol and isobutylene. It is a waxy solid used as a food additive with the E number E320. The primary use for BHA is as an antioxidant and preservative in food, food packaging, animal feed, cosmetics, rubber, and petroleum products. BHA also is commonly used in medicines, such as isotretinoin, lovastatin, and simvastatin, among others. Like butylated hydroxytoluene (BHT), the conjugated aromatic ring of BHA is able to stabilize free radicals, sequestering them. By acting as free radical scavengers, further free radical reactions are prevented.
Propyl gallate or propyl 3, 4, 5-trihydroxybenzoate is an ester formed by the condensation of gallic acid and propanol. It has antioxidant property and is added to foods containing oils and fats to prevent oxidation. It protects against oxidation by hydrogen peroxide and oxygen free radicals. Propyl gallate is used to protect oils and fats in products from oxidation; it is used in foods, cosmetics, hair products, adhesives, and lubricants.

Soybean oil is a vegetable oil extracted from the seeds of the soybean (Glycine max). Soybean oil is a source of polyunsaturated and saturated fatty acids. It is a complex mixture of triglycerides where per 100 g, soybean oil has 16 g of saturated fat, 23 g of monounsaturated fat, and 58 g of polyunsaturated fat. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). It is used as a cooking oil and lipid emulsion for parenteral nutrition in clinical settings. It is one of the most widely consumed cooking oils. To produce soybean oil, the soybeans are cracked, adjusted for moisture content, heated to between 60 and 88 °C (140-190 °F), rolled into flakes, and solvent-extracted with hexanes. The oil is then refined, blended for different applications, and sometimes hydrogenated. Soybean oils, both liquid and partially hydrogenated are sold as "vegetable oil," or are ingredients in a wide variety of processed foods.
Arachis oil or Peanut oil is a mild-tasting vegetable oil derived from peanuts. The oil is available with a strong peanut flavor and aroma, analogous to sesame oil. Its major component fatty acids are oleic acid (46.8% as olein), linoleic acid (33.4% as linolein), and palmitic acid (10.0% as palmitin). The oil also contains some stearic acid, arachidic acid, behenic acid, lignoceric acid and other fatty acid. Peanut oil is used to lower cholesterol and prevent heart disease. It is also used to decrease appetite as an aid to weight loss. Some people use it to help prevent cancer. Peanut oil is sometimes applied directly to the skin for arthritis and joint pain, dry skin, eczema, scalp crusting and scaling without hair loss, and other skin disorders that cause scaling. Rectally, peanut oil is used in ointments and medicinal oils for treating constipation. Pharmaceutical companies use peanut oil in various products they prepare for internal and external use. Sometimes the less expensive soya oil is added to peanut oil.
Gelatin is an animal protein made by boiling the collagenous material from animal bones, hides, and skins. Pig and cattle bones are typically used to make gelatin. Gelatin has many uses, including use in cooking, industrial uses, cosmetics and photography. In the pharmaceutical industry, gelatin is used primarily to make

hard and soft gelatin capsules. Other uses include tablets, emulsions, suppositories and syrups. Gelatin is generally recognized as safe by the FDA.
Glycerin (C3H803), also known as glycerol and glycerin, is an odorless, colorless, oily, viscous liquid that has a sweet taste. Synthetic glycerin is used in food products, nutritional supplements, pharmaceutical products, personal-care products, and oral-care products. In the pharmaceutical industry, glycerin is used as a sweetener in syrups, lozenges, and as an excipient in eyewash solutions. It may also be found in eardrop products, jellies and creams for topical use, in expectorants for congestion, suppositories, and gel capsules.
The present invention is more particularly described in the following non-limiting examples that are intended as illustrations only since numerous modifications and variations within the scope of the present invention will be apparent to a skilled artisan. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained or made available from the chemical suppliers.
Example 1 Range of components of herbal composition
Curcuma longa extract comprising 95% curcumin (Sanat Products), turmeric oil comprising 20% turmerone (Sanat Products), Piper nigrum extract comprising 95%) piperine (Sanat Products), Bacopa monnieri extract comprising 50% bacosides (Sanat Products), Withania somnifera extract (Sanat Products), Centella asiatica extract (Sanat Products), Convolvulus pluricaulis extract (Sanat Products), and Zinc gluconate (Triveni Interchem Pvt; Ltd.) were commercially obtained from the market. The aforestated components were taken in required quantities as illustrated in Table 1 below weighed and transferred in a mixing vessel. The active ingredients are mixed under normal conditions of temperature and pressure to obtain a homogenous mixture.

Table 1 below illustrates the various concentration ranges of the components of the synergistic herbal composition

Synergistic herbal components Composition
Components Composition 1
(w/w) Composition
2
(w/w) Composition 3
(w/w) Composition 4
(w/w) Composition
5 (w/w)
Cur cumin 15% 17% 19% 20% 20%
Turmeric oil/Turmerones 18% 17% 16% 15% 18%
Bacopa
monnieri
extract 13% 15% 14% 13% 12%
Zinc gluconate 9% 8% 7% 9% 7%
Piper nigrum extract 0.6% 0.7% 0.8% 0.7% 0.6%
Withania
somnifera
extract 15% 14% 14% 13% 13%
Centella asiatica extract 15% 14% 14% 12% 14%
Convolvulus
pluricaulis
extract 15% 15% 14% 14% 12%
Example 2
Process for preparing the herbal composition with pharmaceutical excipients

The active ingredients of the herbal composition is taken in predetermined ratio as stated in example 1 and mixed in a mixer to get a homogenized mixture. A second mixture is obtained by adding BHA/BHT in amount 0.01-0.1 % (w/w) and propyl gallate to soybean oil in a vessel and mixed well. A gelatine mask in glycerine is prepared in a manner known per se for use as capsule shell. The mixture of active ingredients and the second mixture are mixed together to obtain a uniform slurry. The slurry so obtained is passed through roller mill to get, a smooth texture. The slurry so obtained is encapsulated in gelatin capsules on automatic capsule filling machines.
The composition of the present invention can be incorporated in tablets, syrup, sachet and powder in a manner known per se. It will thus be seen that there is provided a composition which achieve the various objects of the invention and are well adapted to meet the conditions of practical use.
While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.

We claim:

1.A novel synergistic herbal composition comprising of Curcuma longa
extract; Turmeric oil; Bacopa monnieri extract; Withania somnifera
extract; Centella asiatica extract; Convolvulus pluricaulis extract; Zinc or
Zinc derivatives; and Piper nigrum extract, wherein
- Curcuma longa extract is present in a range of 15 to 20% (w/w);
- turmeric oil is present in a range of 12to 18% (w/w);
- Bacopa monnieri extract is present in a range of 10 to 15% (w/w);
- Zinc or Zinc derivatives is present in a range of 5 to 9% (w/w);
- Piper nigrum extract is present in a range of 0.6 to 0.9 (w/w);
- Withania somnifera extract is present in a range of 8 to 15 % (w/w);
- Centella asiatica is present in a range of 5 to 15 (w/w);
- Convolvuluspluriacaulis is present in range of 7 to 15% (w/w);
wherein the composition improves memory and prevents progressive deterioration in cognitive, speech loss, personality changes and synapse loss in Alzheimer disease.
2. The novel synergistic herbal composition as claimed in claim 1, wherein the Curcuma longa extract comprising 95% curcumin is present in a range of 15 to 20% (w/w).
3. The novel synergistic herbal composition as claimed in claim 1, wherein the turmeric oil comprising 20% turmerone is present in a range of 12 to 18% (w/w).
4. The novel synergistic herbal composition as claimed in claim 1, wherein the Bacopa monnieri extract comprising 50% bacosides is present in a range of 10 to 15% (w/w).

5. The novel synergistic herbal composition as claimed in claim 1, wherein the Zinc or Zinc derivatives is present in form of Zinc gluconate in a range of5to9%(w/w).
6. The novel synergistic herbal composition as claimed in claim 1, wherein the Piper nigrum extract comprising 95% Pipeline is present in a range of 0.6 to 0.9% (w/w).
7. The novel synergistic herbal composition as claimed in claim 1, wherein the composition is in form of formulation comprising the aforesaid composition and pharmaceutically acceptable excipients.
8. The novel synergistic herbal composition as claimed in claim 7 is formulated in form of oral formulation selected from tablet, capsule or syrup, sachet, and powder.
9. The novel synergistic herbal composition as claimed in claim 7 wherein the excipients which are selected from the group comprising of BHT/ BHA, Propyl gallate, soybean oil, Arachis oil, gelatin, glycerin, starch, dibasic calcium phosphate, talc, PVP-k30, silicon dioxide, purified water, sugar, sucralose, magnesium stearate and Stevia.
10. The novel synergistic herbal composition as claimed in claim 1, wherein the composition ameliorates the symptoms of Alzheimer disease and improves the general health of the patient.
11. A process for preparation of pharmaceutical formulation of novel synergistic herbal composition comprises the step of

(a) weighing the active ingredients in pre-determined ration and mixing to get a homogenized mixture;
(b) adding BHA, BHT and propyl gallate to soybean oil or Arachis oil in a vessel and mix well;
(c) preparing a gelatin mask in glycerin to be used as capsule shell;

(d) adding mixture from (a) to (b) followed by mixing to get uniform slurry;
(e) passing the slurry from (d) through roller mill to get a smooth texture.
(f) slurry from (e) is encapsulated in gelatin capsules on automatic capsule filling machines.