Description:AN AYURVEDIC SUPPLEMENT FOR IMPROVED SLEEP

Field of the invention:
The present invention relates to a medicinal formulation comprised of ingredients like Jatamansi,, Ashwagandha,,Jyotishmathi,,Tulasi,,Brahmi,,Shankhpushpi, Vacha and Sarpagandha, Garcinia indica and Mint. Some excipients and flavour were also mixed with it. More particularly, this invention relates to medicinal formulations composed of
pulp, pericarp, bark and roots of ingredients with added preservatives and flavoring agents in a capsule form. The purpose of the invention is mostly related to improved sleep, so it is beneficial for people with Short Sleep Syndrome (Insomnia).

Background art:
Medicinal plant extracts provide medical health benefits including the prevention and treatment of diseases. Herbal medicines can improve several physiological problems without any side effects. Several research works systematically investigated the efficacy and side effects of these herbal medicines in clinical trials. People with Insomnia suffer from inability to fall asleep or sleep for a short time duration. Most of the medicines recommended for treating insomniac patients are related to gamma-amino butyric acid (GABA)-synthesizing and GABA metabolizing enzymes that influence the sleep quality. Several medicinal plant extracts have the potential to activate the receptors of GABA, thereby enhancing sleep. Sleeping issues can be caused by several reasons, leading to disturbance of circadian rhythm. Continuous sleeping problems are cause of several neurological disorders like Alzheimer’s disease, anxiety, depression, suicidal ideation, obesity, hypertension etc.
Not only GABA, melatonin, a hormone produced by the pineal gland in the center of human brains also controls circadian rhythm as well as the sleep wake cycle. Melatonin can improve sleep latency (the time required to fall asleep), increases feelings of sleepiness, and may increase duration of sleep. Several plant extracts have the potential to improve the above-mentioned hormone and enzyme levels in human body.
However, like any other supplement or herb, it is important to be aware of side effects as follows: -
• Gastrointestinal upset
• Allergic reactions
• Effect on thyroid functions and hormones
Improved sleep can help to reduce stress, anxiety, hypertension and arthritis pain thus overall quality of life gets improved.
In our country, poor sleep is a major issue for people over the age of 60 yrs. Sometimes, it leads to other health complications. Herbal medicines with minimum side effects can be a natural solution for them to improve their quality of life -- in general.
Summary of the invention:
An extract is formulated to improve person’s sleep quality, with possible implications to reduce other neurological disorders. Several plant extracts are included in this formulation with some flavor and excipients. Insomnia is quite common issue in old age people where the person suffers from sleeping disorder. The symptoms are trouble in
(i) falling asleep,
(ii) staying asleep and
(iii) getting good quality sleep.
Short term insomnia can lead to fatigue, difficulty in concentration and other problems which may lead to neurological disorders in the human body. Thus, improvement of sleep with natural supplements can provide relief to insomniac patients.
Herbal products have the least side effects as compared to other commercially available medicines.
In the present case, the described novel composition of the herbal medicine is beneficial for insomniac patients.
In a preferred embodiment, there is provided a powdered plant extract composition in capsule form consisting of the following ingredients at a defined %w/w ratios- Jatamansi (12.5%w/w), Ashwagandha(9.37%w/w),Jyotishmathi(9.37%w/w),Tulasi(9.75%w/w),Brahmi (12.5%w/w),Shankhpushpi(12.5%w/w),Vacha (6.25%w/w),Sarpagandha(6.25%w/w), Garcinia indica (7.5%w/w) and Mint(1.87%w/w) with acceptable excipients and flavors to improve test and color. The present invention also provides a novel formulation of dry herb extract in capsulated form. Flavors and excipients are also added to the dried mixture of the herb extract before they are packed in a capsule format.
The homogeneity of the formulation is retained in such a way that the shelf-life of the final product is for at least three years.

Object of the invention:
The primary objective of the invention is to provide a medicinal supplement to improve the quality of sleep with possible implications to reduce the other neurological disorders. This novel mixture is derived from pericarp, pulp, juice, bark and root of the ingredients including Jatamansi, Ashwagandha, Jyotishmathi,Tulasi,Brahmi,,Shankhpushpi, Vacha, Sarpa Gandha, Garcinia Indica and Mint. The effectiveness of this mixture is enhanced by means of addition of flavoring agents and excipients as required.
The foregoing and other objects, advantages and characterizing features will become apparent from the following description of certain illustrative embodiments of the invention. The novel features which are considered characteristic of this invention are set forth in the attached claims.
Furthermore, the features and advantages of the invention may be learnt by practice of the invention or will be obvious to one skilled in the art from the description, as set forth hereinafter.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The above-described features and advantages of the present invention, as well as additional features and advantages, will be set forth or will become apparent in the description that follows as well as in the claims. The novel features which are considered characteristics of this invention are set forth in the claims. Furthermore, the features and advantages of the invention may be learnt by practice of the invention or will be obvious to one skilled in the art from the description, as set forth hereinafter.

Detailed description of the invention:
The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.
The present invention relates to herbal medicinal supplements more specifically capsules derived from the ingredients such as Jatamansi,,Ashwagandha,,Jyotishmathi,Tulasi,Brahmi,Shankhpushpi,
Vacha, Sarpagandha, Garcinia indica and Mint.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Preferred formulations and materials of the present invention are described herein, although any method and material similar or equivalent to those described herein can be used in the practice or testing of the present invention. All references cited herein are incorporated by reference in their entirety.

Brief description of the ingredients and their use:
(i) Jatamansi:
In Ayurveda, Jatamansi or Spikenard,is known as ‘tapaswani’. This small, rhizomatous, perennial herb is largely used in ayurved to treat several diseases. Due to its antioxidant property it can prevent cell damage, and thus recommended as memory enhancing tonic. Moreover, it has relaxing and calming attributes, which make it a perfect choice for herbal medicine. It helps calms down the brain and manages anxiety as well as insomnia. Jatamansi oil can induce sound sleep when applied on crown as well as on feet.

Jatamansi is used in various traditional herbal medicine formulations, as well as to treat neurological disorders like epilepsy, hysteria, syncope, convulsions, and mental weakness.
Free radicals have been implicated as a major player behind the neurological problems, including seizures and epilepsy. Antioxidant property of Jatamansi thus makes it a perfect defender to treat these diseases. Phenolic compounds like Protocatechuic acid (PCA) and Syringic acid are mainly responsible for the antioxidant property. It has been observed that PCA can also exert anti-inflammatory, anti-hyperglycemic, and anti-apoptotic effects.
On the other hand, Syringic acids are traditionally used in Chinese medicine and currently emerging as a nutraceutical.
Thus, Jatamansi, has large benefits for physical and mental health of human being. This is totally the high time to take advantage of this medicinal supplement for the well being of the human body.

(ii) Aswagandha:
Aswagandha, is widely grown plant in India, Africa, Middle East Asia and parts of Europe. This plant is a small shrub and used to relieve stress, anxiety, increase energy levels. It is classified as adaptogen as it helps our body to cope up with stress. Aswagandha helps to control mediators of stress, including heat shock protein (HSP70), cortisol, and stress activated c-Jun-N-terminal protein kinase. It can significantly enhance the oxygen consumption in body, which reduces the chances of heart diseases. This plant extract is also recommended to reduce the blood sugar levels in diabetic patients. It has been observed that taking Ashwagandha improves the cognitive function in old age people with schizopenia.
The roots of Aswagandha are enriched with several phytochemicals including flavonoids, phenolic acids, alkaloids, and terpenoids .
Flavonoids are phenolic compounds well known for its anti-inflammatory, anti-oxidative, anti-mutagenic, anti-carcinogenic properties. These compounds are widely used to treat neurological disorders like Parkinson’s disease, Alzheimer’s disease and other prion protein related neurological disorders.
Phenolic acids are represented by cinnamic and benzoic acid derivates. With their antioxidant property, these polyphenolic compounds can scavenge reactive oxygen species (ROS) and reactive nitrogen species (RNS). The beneficial effects of these secondary metabolites are attributed to reduce microbial infections, oxidative stress, inflammation, diabetes, cancers and cardiac disorders. Polyphenols can interact with other bioactive molecules to enhance their effectiveness and impart synergistic effects.
Terpenoids, Alkaloids along with flavonoids constitute the predominate part of the currently reported phytochemicals with antimicrobial properties. Both Terpenoids and Alkaloids are also secondary metabolites of plants having antioxidant property.
The anti-inflammatory, anti-fungal,anti-parasitic, anti-allergenic, anti-hyperglymcemic properties of these two secondary metabolites, make them an ideal choice for herbal therapy and medicines.
Thus, overall the phytochemical compositions of Ashwagandha suggest that this plant extract can be preferred choice to treat broad range of disesases including neurological disorders and sleeping issues.

(iii) Jyotishmathi:
Jyotismathi is a medicinal herb, which is scientifically known as Celastrus paniculatus . Commonly it is known as Staff tree or intellect plant. The leaves of this plant is enriched with glycoside, sterol (β-sitosterol,campesterol,stigmasterol,α-tocopherol,γ-tocopherol) some alkaloids including Celapanin,Celapanigin,Celapagin, Celastrine and Paniculatine. Along with these components terpenoids are also important phytochemical present in Jyotismathi.
All the alkaloids mentioned above possess anti-bacterial and anti-microbial activity whereas tmost other phytochemicals have anti-oxidant and anti-inflammatory properties.
Thus, Jyotismathi plant extract alone or in combination with other herbal extract can impart synergistic effects which can impart a huge beneficial impact on overall well being of human health.

(iv) Tulasi:
Tulasi or holy basil is an aromatic perennial plant in the family of Lamiaceae. Fresh leaves and stems of tulasi harbors several phenolic compounds such as cirsilineol, circimaritin, isothymusin, apigenin, rosameric acid and appreciable quantities of eugeno.
Cirsilineol inhibit proliferation of cancer cells whereas circimaritin has anti-proliferative, anti-oxidant and anti-microbial properties. The rest of phytochemicals mentioned above also possess the anti-cancer, anti-microbial properties. Isothymusin, is useful to reduce the blood pressure. So, the presence of these beneficial polyphenolic compounds suggest that the ‘Queen of herb’ can be effective to treat a broad range of human health issues in mixture with other herbal products or independently.

(v) Brahmi:
Brahmi, also called Bacopa monnieri , is a perennial ,creeping herb widely grown in Southern and Eastern India, Australia, Europe,Africa, Asia, North and South America.
This plant is characterized by its typical chemical constituent which predominantly includes compounds like dammarane-type triterpenoid saponins called as bacosides, with jujubogenin or pseudo-jujubogenin moieties as their aglycone units.
Apart from these mentioned components, alkaloids like brahmine, herpestine and nicotine have also been identified as important phytochemical of Bacopa monniera.
The important constituent bacosides have been shown to enhance nerve impulse transmission. They promote the repair of damaged neurons by up regulating the neuronal synthesis and kinase activity.
It has been proved that Bacopa, by virtue of its active constituents like bacosides, influences the synthesis and availability of the neurotransmitter,Serotonin; therefore , it helps to maintain neurotransmitter balance.
(vi) Shankhpushpi:
Shankhpushpi, is a perennial herb, native of India .They grow under rocky and sandy areas under xerophytic conditions. It is considered to be one of the most wonderful gifts of nature to mankind due to its high therapeutic values. It mainly takes care of nerves by supporting and promoting healthy brain and mind.
The phytochemical profile of this plant suggests that, it contains many bioactive phytoconstituents like alkaloid (convolamine), flavonoid (kaempferol) and phenolics (scopoletin, β-sitosterol and ceryl alcohol). These compounds contribute to the medicinal benefits of shankhpushpi. Several research work focused on the neuro-pharmacological profile of this plant, describe its neuroprotective, neuro-modulatory and neuro-degenerative roles.
Thus, in combination with other medicinal plant extract, efficiency of shankhpushpi can be improved or modified to treat sleeping issues.
(vii) Vacha:
Vacha or sweet flag is an ancient herb to improve intelligence and expression. This is an aromatic herb with creeping rhizomes. This plant has a pleasant and sweet odour due to its essential oils. Vacha plant extract contains glycosides and saponins, which make it a remedy for diarrhea and dysentery. The major phytochemical present in Vacha is a phenyl propanoid called β-asarone. This chemical compound possesses anti-carcinogenic property. To date 145 constituents have been isolated and identified from this herb including phenylpropanoids, sesquiterpenoids and monoterpenes.
The biopotential of the active molecules contributes to anti-convulsant, anti-depressant,anti-hypertensive,anti-inflammatory,immunomodulatory,neuroprotective, cardioprotective and anti-obesity effects of Vacha.
(viii) Sarpagandha:
Sarpagandha, the classical Sanskrit name means to snake root, since the roots of the plant are twisted and coiled like a snake. Scientific name of this plant is Rauwolfia serpentine. This herbal shrub grows widely in the sub-Himalayan moist forests Sikkim, Assam in India as well as in tropical parts of Sri Lanka, Malaysia, Indonesia, Bangladesh, Africa and the Americas. Three types of alkaloids are present in this shrub.
1. Weakly basic Indole Alkaloids: Tertiary indole alkaloids like The principal alkaloids are Reserpine, Rescinnamine,despiridine .
2. Indoline Alkaloids of intermediate basicity: Reserpiline, Ajmaline,Iso-Ajmaline, rauwolfinine are tertiary Indoline alkaloids.
3. Strong Anhydronium Bases: Serpentine, Serpentinine and Alsotonine are strongly basic anhydronium alkaloids.
This herbal root is imbued with the alkaloid reserpine, widely known for its antihypertensive and antipsychotic effects on human system. More than 90% of the total alkaloids present in root barks.
Sarpagandha is widely used herbal constituents in ayurvedic medicine. Broad range of alkaloids present in this plant contributes to its anti-inflammatory, anti-hypertensive, anti-diuretic, anti-proliferative, antioxidant properties. This plant extract is also recommended to treat neurological issues related to mental agitation, epilepsy, traumas, anxiety etc.
(ix) GARCINIA INDICA:
Garcinia indica is commonly known as Kokum and widely grown in Western Ghats of India including Maharashtra, Kerala, Goa, and Karnataka. Several studies reported about the phytochemicals present in this plant e.g. garcinol, hydroxycitric acid (HCA), Cyanindin-3-sambubioside, and cyaniding-3-glucoside. G.indica is recommended to treat inflammation, dermatitis, and diarrhea. Apart from these, it has antioxidant, anti-obesity,anti-arthritic,anti-inflammatory,antibacterial,hepatoprotective,cardioprotective,anti-depressant effects.
Among the bioactive molecules present in this plant garcinol is responsible for the antioxidant property as it can scavenge free radical like superoxide anion (O2-). This compound also imparts neuroprotective effect by functioning as a histone acetyltransferase inhibitor.
(x) Mint:
Mint is a popular herb with potential benefits. It improves digestion, reduce allergy and also help in soothing common cold. Mint leaves are widely used by the manufacturer of toothpaste, gums, candy, and beauty products. Moreover, it is also used during cooking to enhance the flavor in dishes.
The main constituents of this medicinal herb are- menthol. menthone, menthofuran, cis-carane,1,8-cineole,neo-menthol, and limonene. Apart from this, Rosmarinic acid is present as the anti-inflammatory, antioxidant agent present in mint leaves.
The said formulation is prepared by a process comprising the steps of Grinding the dried ingredients independently; extracting the powdered ingredient(s) with aqueous alcohol in the range of 5 to 95% v/v water to alcohol for 5 to 48 hours at a temperature of 20°C to 50°C; and Filtered and distilled said solvents under reduced pressure at 20°C to 80°C in order to obtain extract of the ingredients ; and finally mixing the extracts of all the ingredients in definite proportion with preservative and flavoring agents. In yet another embodiment of the invention, the said composition is prepared by a process comprising the steps of grinding or powdering the
dried ingredient(s); extracting the crushed or powdered herb with aqueous alcohol in the range of 5 to 95% v/v water to alcohol for 5 to 48hours at a temperature of 20°C to 50°C, distilling said alcohol under reduced pressure at of 20°C to 80°C in order to obtain extract the ingredient; and mixing extracts of all the ingredients in definite proportion with preservative and flavoring agents to obtain the product.

, Claims: CLAIMS

We claim:
1. A ayurvedic health supplement composition consisting of:
Jatamansi (100mg)
Ashwagandha (75mg)
Jyotishmathi (75mg)
Tulasi (75mg)
Brahmi (100mg)
Shankhpushpi (100mg)
Vacha (50mg)
Sarpagandha (50mg)
Garcinia indica (60mg) and
Mint (15mg)
with pharmaceutically acceptable excipients and flavouring agents.

2. The medicinal composition as claimed in claim 1, wherein the excipients are conventional pharmaceutically acceptable salts and carriers.

3. The medicinal composition as claimed in claim 1, wherein the flavoring agents are conventional pharmaceutically acceptable salts, esters and carriers.

4. The medicinal composition as claimed in claim 1 is capable to improve sleeping issues.