The present invention relates to a synergistic novel herbal composition(s) with proven pharmacological activities such as anti stress, anti fatigue, adaptogenic and anti¬oxidant property.
BACKGROUND AND PRIOR ART OF THE INVENTION
In general, stress is subjective in the response of the organism to the stressor causing environmental stress, heat stress, cold stress, noise stress, stress from toxic chemicals etc. Response to stress is non-specific and independent of the nature of stressors so that the stress-induced state produced in subjects by diverse stressors is indistinguishable. The anti stress effect of the composition herein was determined by adopting a battery of tests (stress parameters) ex. Swimming performance stress, restraint stress in laboratory animals.
Despite the tremendous studies and intensive research by medical scientists, therapy to build up non-specific resistance to aging, various ailments and recovery after illness and environmental changes is still as elusive as it was decades ago. Adaptogens are pharmacological agents that induce a non-specific increase of resistance of the organism to aversive stimuli that threaten to perturb internal haemostasis. The response to stress is non-specific and independent of the nature of the stress as the stress induced state produced by diverse stresses is indistinguishable. A host of experimental stress situations were used to provoke measurable physiological responses.
The anti stress formulations known in the field or the antioxidants prevailing in the herbals though traditionally used, are not as much effective in the treatment of stress relief and that is the cause which incited the inventor to develop an anti tress herbal formulation with synergistic effect.
OBJECTS OF THE INVENTION
The main object of the present invention is to provide a novel and therapeutically effective herbal composition with proven pharmacological activities and it's processing for the preparation of suitable oral dosage form with synergistic effect.

The present invention relates to the use of a bio-availability and/or bio-efficacy and methods of their preparation which includes their isolation from natural source and obtaining the final products in their chemically characterized form.
The Present invention also related to a new approach of increasing the bio efficacy of drugs had been conceptualized at applicant's Research and Development division. One group of herbals which has been documented very frequently.
It is another object of the present invention to provide an alternative treatment option for subjects suffering from neurological disorders, anxiety and/or management of stress without any side effects.
SUMMARY OF THE INVENTION
Accordingly the present invention provides a novel, therapeutically effective herbal composition(s) useful in the treatment of anti fatigue, anti stress agent and provides vitality and energy. The novel herbal composition comprises of decoction/extracts of Withania somnifera, Myhstica fragrans. Piper longum. Zingiber officinalis. Piper nigrum Alpina carmomum, Piper chaba, Embelia ribes, Aplotaxis auricuiata, Myristica caryophyllus, Bamboomanna, Hemidesmus indicus, Vanda roxburghii, Hypoxis orchioides, Cuminum cyminum, Nigella sativa, Asparagus racemosus, Ptychotis ajowan, Piper officinarum, Ipomea digitata. Curcuma zedorea, Lavandula Carnasa and Boerhavia diffusa. In a battery of tests like hypoxia and swimming endurance the synergistic effect of the composition showed 90% potency confirms the adaptogenic activity.
The detail description of the plants used in the invention are having the following properties as reported.
Withania somnifera Family: Solanacea
Botanical description: An erect, evergreen, grayish tomentose shrub 0.3- 2 m tall, with fairly long, stout, fleshy, whitish-brown roots. Leaves simple, alternate or subopposite, broadly ovate, glabrous, 5-12 cm long and 2.5 - 7 cm wide, apex subacute, base un equal, marginsentire, finely stellate-pubescent beneath; main nerves about 6 pairs; petioles 0.3-1.7 cm *r>nn

Phytochemistry: Two new withnolides-5-de hydroxy withnolide R and with a somniferin A isolated and their structure established (Phytochemistry 1991). Isolation of two new withnolides - sominone and sominolide and their characterization as 1 alpha, 3beta,27- trihydroxy 14 alpha, 15 alpha - epoxy l-oxo-22(R) with a-2, 24 dienolide respectively (heterocycles 1992). Withasomidienone isolated and characterized as 27hydroxy-3-ozo-22(R)- with a-I, 4, 24- trienolide (J. Nat. Prod 199]).
Pharmacology: The roots are considered alternative, germicidal, aphrodisiac and diuretic; they are used in Ayurveda to treat ulcers, fever, dyspnoea, cough, consumption, dropsy, rheumatism, toxicosis and memory loss. The powdered roots mixed with equal parts of honey and ghee is thought to be beneficial for impotence or seminal debility. The roots as well as the bruised leaves are also used externally to treat ulcers, painful swellings and scabies. The total alkaloids present in the roots produce relaxant and anti spasmodic effects. The fruits and seeds are diuretic. The leaves are considered anthelmintic and bitter, and their infusion is given to relieve fever.
Asparagus racemosus Family: Asparagaceae
Botanical description: A tall climbing, much-branched, spiny shrub with annual woody, white - grey or brown stems armed with strong, straight or recurved spines 0.5' - 1.3 cm long; rootstock short, tuberous, bearing numerous fusiform, succulent tuberous roots 30 100 cm long and 1-2 cm thick. Flowers white, fragrant, small, crowded in simple and branched racemes 5 - 15 cm long. Fruits globose, red when ripe. 3-lobed, 0.4 - 0.6 cm in diameter.
Phytochemistry: Quercetin -3- glucuronide isoiared from leaves (CUIT, Sci 1969). Isolation of sitosterol, 4,6- dihydroxy -2- 0- (2-hydroxy isobutyl) benzaldehyde and undeconyl eetanoate from roots (1. Indian. Chern Soc. 1991). A new polycyclic alkaloid asperagonine A- isolated from roots and its structure determined by X-ray analysis (Chern. Pharm. Bull 1994).
Pharmacology: In Ayurveda, the roots are considered alterative, stomachic, tonic, aphrodisiac and astringent. They are used to treat dysentery, tumours and inflammations. In unani the roots are used in the treatment of kidney and liver

disorders. The fresh root juice mixed with honey is given to relieve dyspepsia. The leaf paste is used in combination with warm water baths to relieve scabies among the kadars of annamalai hills of Tamil Nadu.
Zingiber officinale Family: Zingiberaceae
Botanical description: It is a small plant. The leaves are green, slender, flat and elongated. The stem is smooth and solid. The bulbs are composed of several bulbils (cloves), encased in white or pink skin of the parent bulb. The inflorescence is an umbel initially enclosed in a spathe. Ginger has been under cultivation from times immemorial.
Medicinal uses: The therapeutic value of garlic in functional gastro- intestinal disorders was studied in 29 patients. A significant carminative effect, with a relief of nausea, gascolic, flatulence, belching and heaviness was observed. The effects of fried and raw garlic on blood showed an increase in fibrinolytic activity in 20 patients with ischaemic heart disease. A decrease in triglycerides and cholesterol has been observed. Garlic oil drops are put in the ears for infection and earache. Garlic is also used as an antiinfective agent topically and in other intercurrent infections.
Phytochemistry: The strong smelling juice of the bulbs contain a mixture of aliphatic mono and polysulphides. The chief constituent is allicin, diallyl disulphide oxide. The latter results from spontaneous enzymatic reduction of allin and 5-allylcystine sulphamide. Thio- glycoside, aminoacids, fatty acids, flavonols, vitamins, trace elements, volatile oils etc. have also been demonstrateds.
Pharmacology: Antibacterial and antifungal activity of garlic has been shown, by several investigators, against many common patho- genie organisms. Staphylococcus aureus, Escheiichia coli, Candida albicans, Shigella sonnei Salmonella typhi. Essential oils of garlic prevented an increase in a -lipoproteins, pre- a lipoproteins occurring after cholesterol-feeding in rabbits. Fibrinolytic activity was also significantly increased. Inhibition of platelet-aggregation in vitro and in vivo has also been demonstrated with garlic. There have been several studies showing the hypoglycaemic activity of garlic and allicin in animals.

CURCUMA LONGA

Family: Zingiberaceae

Botanical description: The genus Curcuma comprising about fifty species, distributed in tropical and subtropical regions of Asia, belongs to the tribe Hedychieae and consists of a rather homogenous group of rhizomatous perennials. Govindarajan (1980 Food Science and Nutrition, 14: 119-301 and 1982 Food Science and Nutrition, 17: 1-258) published critical reviews on turmeric C. longa. The taxonomic status of Curcuma heyneana was discussed by Firman et al (1988 Phytochem. 27: 3887-3891) based on essential oil analysis. Tomlinson's (1969) work based on the anatomical evidence, which has much relevance in the classification of the order Zingiberales.
Medicinal uses: Ethnobotanical details of some of the species of Curcuma has been reviewed and it was found that Curcuma is useful in the treatment of liver disorders and has a promising kind of broad spectrum hepatoprotective agent which is used in Indonesia (Lin et al., American J. Chin. Med.. ll;95 23:243-254). Curcuma longa was used predominantly for endoparasites, internal and external injuries and pregnancy related conditions in ethnic community of Trinidad and Tobago. Curcuma longa is used as dietary intake in Nepal (Eigner and Scholz, J Ethnopharmacol 1999, 67(1): 1-6).
Phytochemistry: Essential oils are complex mixtures of odorous and steam-volatile compounds that are deposited in the subcuticular space of glandular hair, cell organells, idioblasts, excretory cavities and canals or exceptionally in hemlwoods. In other \vords, they are very complex, aromatic, volatile mixture containing many different compounds. The constituents of essential oils belong to numerous classes of chemical substances, such as hydrocarbons,, alcohols, aldehydes, ketones, acids, esters, oxides and ether (Thappa et al, J. Essent. Oil Res., 1982,11 :97-l 03). Essential oils largely comprises of terpenoid compounds, which constitute two or more isoprene units. Based on this, terpenoids are mainly classified into four groups viz. monoterpenes (with 2 isoprene units i.e. 10 carbon atoms) sesquiterpenes (with 15 carbon atoms), diterpenes (with 4 isoprine units i.e. 20 carbon atoms) and polyterpenes (with 5 or more isoprene units). These terpenoid compounds provide aroma and pungency to plants. The essential oil forms the basic raw materials for, perfume and flavour making industries. They are also used in the cosmetics and pharmaceutical industries. Many natural essential oils are used in aromatherapy to cure and prevent illness due to their therapeutic properties and also because of their fragrance which can influence human thoughts and emotions. Many of the essential oils are reported to have antimicrobial, insect repellent and insecticidal properties.

Pharmacological use: The genus Curcuma exhibits diverse pharmacological activities against cancer and tumorgensis. Anto et al, Mutation Res., 1996, 370: 127-131, has reported the anticancer and antitumour properties of Curcuma longa. It was demonstrated that the inhibitory effect of curcumin on DNA and RNA synthesis in cultured HeLa cells. Dietary curcumin may inhibit azoxymethanol (40 M) induced colonic neoplasia in mice (Huang et al., Cancer Lett 1992, 64(2): 117-21). The antimicrobial properties are well known and the result reported by many researchers pointed out the antibiotic activities of Curcuma. Banerjee and Nigam (1. Res. Ind. Med. Yoga Homoeo., 1978, 13: 63-70) reported the antibacterial and antifungal activity of various species of Curcuma. Moliuscicidai property of C. longa was reported. The insecticidal property of different species of Curcuma. Curcumin showed anti-inflammatory effect in acute, subacute and chronic models of inflammation in mice and rat models. The oral ED50 in mice, against carrageenin-induced acute oedema was 100.2 mg/kg compared to 78 mg/kg of cortisone. Clinically curcumin did not produce any side effect up to ] 600mg/kg/day for 4 weeks in phase-I trials in male volunteers. Phase-II clinical trials have been conducted in patients with rheumatoid arthritis and osteoarthritis. Curcumin inhibited rat liver microsomal delta 5 and delta 6 desaturases (Shimizu et al., L pids 1992, 27(7):509- 1 2). Curcuma contains an active principle(s) other than curcuminoid, which can modify the metabolism of lipid and lipoproteins. Several reports suggest that curcumin as well as turmeric increase bile flow. Essential oils of turmeric have also been found to increase the bile flow. However, some investigators have found it to be ulcerogenic (Prasad et ai. J. Physiol. Phannocol, 1976, 20, 92). The gastric secretion was found to be reduced after 3 h in conscious rabbits by aqueous and methanolic extracts of turmeric (Sakai et al. Chern. Pharm. Bull. 1989,37,215). Curcumin and turmeric have been shown to protect liver against a variety of toxicants in vitro as well as in vivo. They include carbon tetrachloride, aflatoxin B-l, paracetamol iron, and cyclophosphamide in mouse, rat and duckling. Evidence for the hypocholesterolemic and hypolipidemic activities of curcumin has been provided when it was fed with diet to rats for 7 weeks at the concentration of O. 1 5% (Rao et al. 1970 1. Nutri. 100, 1307). Ethanolic extract of Curcuma has been shown to have hypoglycemic activity in normal as well as alloxan - induced diabeties in rats. They have also isolated a I ipo polysaccharide from the root of Curcumin, which is similar to bacterial lipopolysaccharides and is immunostimulant (Inagawa et ai. Chern Pharm Bull 1992, 40, 1994). The wound healing property of turmeric was investigated long back and its local application was found to be effective (Gu/jral et al., 3. Ind. Med. Association 22, 273 1958). A sum of

approximately 26 compounds has been isolated from different Curcuma sp. having high antioxidant activity. Curcumin did not produce any toxicity either on single administration or on repeated oral administration over a period of 6 months in rat and monkey at doses up to 800 and 1800-mg/kg day, respectively. Curcumin administered orally to patients suffering from chronic antieri or ureitis (CAU) at a dose of 375 mg three times a day for 12 weeks and all the patients who received curcumin alone improved (Lai et al., Phytother Res 13(4): 318-22, 1999).
Zingiber officnale Linn. Family: Zinfiberacea
Botanical description: A herbaceous rhizomatous perennial, reaching up to 90 cm in height under cultivation. Rhizomes are aromatic, thick lobed, pale yellowish, bearing simple alternate distiches narrow oblong lanceolate leaves. The herb develops several lateral shoots in clumps; which begin to dry when the plant matures. Leaves are long and 2-3 cm broad with sheathing bases, the blade gradually tapering to a point. Inflorescence solitary, lateral, radical, pendiculate oblong-cylindrical spikes. Flowers are rare, rather small, calyx superior, gamosepalous, three toothed, open splitting on one side, and corolla of three-sub equal oblong to lanceolate connate greenish segments. (The Wealth oflndia, NISCOM, D-23, C.S.I.R., New Delhi 1996).
Medicinal use: Ginger, is carminative, pungent, stimulant, used widely for indigestion. It is chiefly used to cure diseases due to morbidity of kapha and vata. Ginger with limejuice and rock salt increases appetite and stimulates the secretion of gastric juices. It is said to be used for chronic bronchitis, cold, chest congestion, cough, difficulty in breathing, dropsy, sore throat, throat ache, stomachache, vomiting and rheumatism. Zinger forms an important constituent of many pharmacopoeal ayurvedic formulations. (Misra B, Bhavaprakasha Nighantu, 5th edi., 1969, p. 14.; Sharma P, Dravyaguna vigyan, part 2, Chauukhamba Publications 1993, p. 331; Indian medicinal plant, a compendium of 500 sps., Part 5, orient Longman Publication, 1997, p. 431; Nadkarni, Indian Materia Medica, vol 1, 1993, p. 1308; Yogaratnakra, Chauukhamba Publications 1993, p. 320330; Bhavaprakasha with Vaidyotina commentary by Misra BS; Chikitsa Prakarana Madhyana Khadana-Chauukhamba Publications 1980. p. 683-70 I ).
Phytochemistry: Ginger has been reported to contain usually 1-3 % of volatile oil, pungent principles, viz. gingerols and shogaols and about 6-8 lipids and others.

Ginger oil contains zingiberene and bisaboline as major constituents along with other sesqui and mono terpines. Ginger oleoresin contains mainly the pungent principles gingerols and shogaoas as welt as zingeberine. Shogaols have recently been found twice as pungent as gingerols. (KiuchiF, et. al., Chern. Phann. Bull, 1982, 30, 754; waigner H, et al.. Plant drug analysis, springer, 1996, 300; Akhila A and Tewari CROMAP, 1984, 6(3), 143146).
Pharmacology: It is used for common cold, due to pathogenic wind cotd, characterized by severe intolerance to cold, slight fever, headache, general ache, congestion and running nose. Antihistaminic activity has been studied in ginger. Zingiber officinale was indicated in allergic conditions in traditional text. However they were following crude methods. Toyoda J, Chern. Abst., 1969, 71, 33425; Y ogaratnakra, Chauukhamba Publications 1993, p. 320-330; Bhavaprakasha with Vaidyotina commentary by Misra B. S; Chikitsa Prakarana Madhyana Khanda-Chauukhamba Publications 1980, p. 683-701).
Piper longum, L. Family-Piperacea
Description: A slender, aromatic climber with perennial woody roots; stems jointed, creeping, young shoots downy. Leaves simple, alternate, 5-12cm long and3-6cm wide, glabrous, ovate base cord ate with broad rounded lobes, apex sub acute, and margins entire. Flowers minute on unisexual, axillary, cylindrical spikes; green at first, turning yellow, up to 5 cm long; male spikes longer than female. Fruits ovoid, yellowish orange turning dark red to blackish, sunk in fleshy spikes 2.5-3.8 cm long. Flowers during the rainy season and fruits during the autumn.
Distribution and habitat: Considered native to tropical and subtropical India, Nepal, Bangladesh, Myannlar (Burma), and the Malay Peninsula. In India it is found from central Himalayan to Assam, the lower hills of west Bengal, and in the evergreen forest of peninsular India from konkan(Maharashtra) to Travancore(kerala).it is occasionally cultivated in north-eastern and southern India for its fruits, used as a spice and in pickles and preserves.
Medicinal properties and uses: The dried roots, as well as the immature and mature fruits, are used extensively, alone and in combination with other plant drug to treat a broad range of ailments in traditional Indian medicine. The dried roots and thicker stems, known commercially as piplamul, are an important drug in the ayurvedic and unani systems. The roots and fruits' are used to treat dysentery and leucoderma, as a cholagogue for treating bileduct and gallbladder obstruction, and as a counter -irritant

and analgesic for relieving muscularpains and inflammations. A decoction of dried immature fruit and root, or the powdered fruits mixed with honey, is used to treat chronic bronchitis, cough and cold. An infusion of the powdered fruits is given to women after childbirth to check bleeding and fever. It is as important ingredient in medicated oil used externally for sciatica and paraplegia.
Myristica fragrans Family: Myristicaceae
A dioecious or occasionally monoecious evergreen, aromatic tree, usually 9-12 m. high, but sometimes reaching a height of 20 m. or more. Bark grayish black, longitudinally fissured in old trees; leaves elliptic or oblong-lanceolate, coriaceous; flowers in umbellate cymes, creamy yellow fragrant; fruits yellow, broadly pyriform or globose, 6-9, cm. Long, glabrous, often drooping: pericarp fleshy, 1.25 cm, thick, splitting into 2 halves at maturity; seed broadly ovoid, arillate, albuminous, with a shell-like purplish brown testa; aril red, Heshy laciniate.
Chemical constituents: Nutmegs yield 5 to 15% of a volatile oil and also 30 to 405 of fat, photosterin, starch, amylodextrin, coloring matter, and a saponin (Trease and Evans, 1983). They yield about 3% of total ash and about 0.2% of acid-insoluble ash. Essential oil of mace is of a yellowish color with the odor of mace, and consists of macene. Mace (arillus) contains a volatile oil (8 to 17%), a fixed oil, resin, fat, sugar, destrin, and mucilage. The volatile oil (Oleum myristicae, British Pharmaacopoeia) contains pinene and camphene (80%), dipentene (8%), alcohols (about 6%), myristicin (about 4%), safrole (0.6%), and eugenol and isoeugenol (0.2%). By expression or by means of solvents, nutmegs yield a product known as "nutmeg butter" or expressed oil of nutmegs. This consists of 12.5% of volatile oil, 73%ofttimyristicin (the glyceride ofmyrisiic acid), small quantities of oleic, linoleic, and other acids, and about g.5% of unsaponifiable matter (Chopra et al., 1982). Varshney and Sharma (1968) found triterpenic saponin and 15% of free myristic acid in the seeds of M. fragrans. The arils yield a new neolignan, characterized as dl-dehydro-di- isoeugenol, and five other neolignans (Purushottaman and Sharda 1980), Raw nutmeg contained 1.5% of total polyphenols and 0.6% tannins. The extract of nutmeg revealed the presence of epicatechin and cyaniding (Gopalakrishnan and Mathew, 1983). Nutmeg is also reported to contain calcium, phosphorus, iron, thiamin, riboflavin and niacin (Gopalan etal., 1948).

Pharmacological action: Nutmeg is aromatic, stimulant, and carminative; in large doses, narcotic. Mace is carminative and aphrodisiac. The extract of thy seed and essential oil showed antibacterial activity. The seed oil exhibited a depressent effect on isolated frog rectus and a direct relaxant effect on rat ileum (Kapoor 2001).
Medicinal properties and uses: Essential oil is administered in atonic diarrhea and dysentery to relieve pain and is used in combination without stimulating oils for a stimulant action and in plasters for chronic rheumatism. A compound powder called Jatiphaladi churna made of nutmeg, Indian hemp, camphor, cardamon, cloves, bamboo manna and Plumbago zeylanica is used as a sedative, anodyne antispasmodic in asthma, colic, neualgia, menorrhagia, dysmenorrhea, spasmodic cough, and lumbago, in doses of 1 to 1.5 gr twice daily with honey. Mace is useful in low stages of fever, in consumptive complaints, and humoral asthma Roasted nutmeg is useful in obstructions of the liver and spleen.
Piper nigrum Family: Piperaceae
A branching, climbing, perennial shrub, mostly round cultivated in the hot moist parts of India, Ceylon and other tropical countries; Branches stout, trailing and rooting at the nodes; leaves entire, 12.5-17.5 by 5.0-12.5 cm. very variable in breadth, some times glaucous beneath, base acute rounded or cordate, equal or unequal; flowers minute in spikes, usually dioecious, but often the female bears 2 anthers, and the mate pistil/ode; fruiting very variable in length and robustness, rachis glabrous, fruits ovoid or globose bright and when ripe seeds usually globose, testa thin, albumin hard.
Chemical constituents: The black pepper contains an alkaloid piperine (5 to 9%), piperdine (5%), a balsamic volatile essential oil (1 to 2%), fat (7%); mesocarp contains chavicine, a balsamic volatile oil, starch, lignin, gum, fat (1 %); proteids (7%) and ash containing organic matter (5%). Chavacine is a soluble pungent concrete resin. The fruits yielded N-isobutyl eicosa-trans-2-trans-4-dienamide in addition to earlier reported pipenne, piperetine, piperidine amides, viz., piperlin, piperolein A, and piperolein B (Raina et al., 1976).
Pharmacological action: P. nigrum is acrid, pungent hot, carminative, also used as antiperiodic. Externally, it is rubefacient and stimulant to the skin and resolvent. The extract and essential oil of P. nigrum is reported to the antibacterial and antifungal. The fruits exhibited taenicidal activity (Satyavati et al., 1987).

Medicinal properties and uses: A paste of black pepper is a rubefacient and stimulant; it is locally used for boils, relaxed sore throat, piles, paralytic affections, rheumatic pain, headache, prolapsed rectum, and toothache. Black pepper is aromatic, given in
dyspepsia, flatulence, debility, diarrhea, cholera, disorders of the urinary system, cough, gonorrhea, and malarial fever (Nadkarni, 1954)
Hemidesmus indicus R.Br. Family: Asclepiadaceae
Botanical Description: A slender, twining or prostate perennial shrub with cylindrical stems, thickened at the nodes and aromatic roots. Leaves simple, opposite or whorled, short petioled, variable in shape bottom broadly ovate to oblong-elliptic, linear or linear-lanceolate, 3-10 cm long 0.33.8 cm wide, base acute, rounded or truncate, apex rounded or emarginated and apiculate, leathery, dark green, petioles 0.1-0.6 cm long. Flowers are small, greenish- yellow outside and purplish inside, 0.6-0.8 cm in diameter when expanded, lobes thick, ovateoblong.
Medicinal properties and uses:
The dried root and root bark are considered tonic, alternative, derfiulscent, diaphoretic, diuretic and blood purifying. They are used in several well-known Ayurvedic preparations for treating bowel complaints, elephantiasis, fever, hemiplegia, nausea, syphilis and vomiting. Administered in powdered from or as an infusion, decoction or syrup. The root paste is applied to the fore head to reduce fever among the Paharia in southern Bihar. A hot infusion of the root bark with milk and sugar is given to children to relieve chronic cough and diarrhoea.
Nigella sativa Linn. Family: Ranufuculaceae
A small herb, c. 45 cm. high, native of Levant, said to be cultivated or occasionally found as a weed of cultivation in Punjab, Himachal Pradesh, Bihar and Assam. Leaves 2-3 pinnatisect, 2.5-5.0 cm. long, cutinto linear-lanceolate segments; flowers pale blue, 2.0 2.5 cm. across, without an involucre, on solitary long peduncles; seeds trigonous, black, rugulose- tubercular.

Chemical constituents
Analysis of black cumin gave the following values: total ash, 3.8-5.3: ash insol. In HCL, 0.0-0.05; volatile oil, 0.5-1.6; either extr, (fatty oil), 35.6-41.6; and alcoholic acidity (as oleic acid), 3.4-6.3%. The seeds give on steam-distillation a yellowish brown volatile oil with an unpleasant odour. It has the following characteristics: d 15, 0.875-0.886; 1.48361.4844; [a]D, + 1.43° to +2.86°; acid val., up to 1.9; ester val., 1-31.6; ester val. after acetylation, 15-73; solution in 2-4.5 or more volumes of 90% alcohol. The oil contains carvone (45-60%), d-limonene and cymene. A carbonyl compound, nigellone (C H 0, m.p. 195-97°), which protects guinea pigs against histamine induced bronchospasm has been isolated from the oil. Preliminary clinical trials indicate its possible therapeutic use in some conditions of cough and bronchial asthma. The fatty oil obtained by the expression of seeds is reported to be used for edible purposes. The fatty acids of the oil are as follows: myristic, 0.26; palmatic, 6.31; stearic, 2.45; oleic, 44.45; and linoleic, 35.99%. the component glycerides of the oil are the following: trilinolein, 2: oleodilinolein, 25; dioleolinolein, 43; palmito-oleolinolein (containing small amount of myristic acid.), 24; and stearo-oleolinolein, 7%; glycerides of some volatile acids are also present in the oil in small quantities.
Vanda roxburghii Family: Orchidaceae
Description: An epiphytic orchid with a stout stem, 30-60 cm high. Leaves thickly coriaceous, linear-oblong, 15-20 cm and 1.3-2cm wide, recurved, un equally lobed at the apex. Flowers borne in 6-10 flowered racemes up to 25 cm long; sepals tessellated with brown lines and white margins; petals yellow with brown lines and yellow margins, shorter than sepals; lip 1.6 cm long, bluish dotted with purple, side lobes rising from the mouth of the straight, conical spur. Capsules oblong, winged 7-9 cm long, narrowly clavate-oblong with acute ribs and short pedicel.
Distribution: Native to tropical Asia from India, Nepal and Sri Lanka to Myanmar (Burma) and Southern china. In India it is found from Uttar Prgldesh to west Bengal southwards through Bihar, Madhya Pradesh and western peninsular India to Kerala and Tamilnadu to an elevation of 650 m.
Medicinal Properties and uses: The leaves, made into a paste, are applied externally to relieve fever in chota Nagpur, to promote healing of broken bones by the Bondo tribal inhabitants of southern Orissa, and to relieve rhematic pain among the Kondhs

of southwestern Orissa. The leaf juice is used as a eardrop to treat otitis and other inflammatory conditions. A paste of whole plant is used externally to treat acne by the bhils in Rajasthan. The roots (Rhizomes) are used in ayurveda for the treatment of dyspepsia, bronchitis, asthma, and other respiratory ailments, inflammations, rheumatism and fever; they reportedly possess antibacterial and anti tubercular properties. The roots are also used as an ingredient of medicated oils that are used externally for treating diseases of the nervous system and rheumatism. In Unani, the root is recommended for treating rheumatism and related conditions, inflammations, bronchitis, toothache, boils on the scalp and for healing bone fracture.
Hypoxis orchioides / Curculigo orchioides Garth Family: Amaryllidaceae
Description: A small perennial herb with a long, stout, cylindrical rootstock and copious fleshy root fibres. Leaves arising from the base, 15-45 cm long and 1.3-2.5 cm wide, linear or linear lanceolate, smooth or sparsely hairy, apex cute, often bearing bulbils. Flowers small bright yellow star shaped, borne on very short flattened scapes just above the ground, hidden in the leaf sheath. Fruit hypogeous 1.3 cm long, 1-4 seeded; seeds oblong, black, shiny, deeply grooved with wavy lines. In central India the plant appears during the rainy season.
Distribution: Native to subtropical and tropical Asia from India to Malaysia, in India it occurs in the subtropical Himalayas from Kumaon (UttarPradesh) eastwards to Assam and in western regions of peninsular India from Konkan (Maharastra) southwards to an altitude of about 2400 m, on marshy sites, in rock crevices and on lateritric soils.
Medicinal Properties and Uses: In Ayurvedic medicine the rhizome (tuberous root) is a reputed rejuvenative drug; it is considered bitter, sweet, demulscent, diuretic, tonic and aphrodisiac. It is used in the treatment of sprue, piles, blood disorders, as a tonic. The powdered rhizome is reportedly taken with milk to treat impotence. In unani, it is also used as an aphrodisiac and for treating diabetes, leucoderma and wasting diseases. The dried, powdered or fresh, crushed rhizome is applied to promote healing of cuts and wounds. In combinations with aromatics and bitters it is also used to treat piles, jaundice, asthma and diarrhea.

Lavendula carnosa/ Allisochilus camosllsi

Family: Labiatae

Description: An erect, annual herb up to 60 cm tali, with stout, quadrangular stems, often tinged with red. Leaves 2.5-6.3 cm long and 1.3-4 cm wide, ovate-oblong or rounded, apex obtuse, base subcordate or rounded, margine; crenate, usually pubescent beneath, prominently nerved and dotted with globose orange-red oil globules on both surfaces; petioles 0.6-6.6 em long. Flowers pale purple, borne in dense, long peduncled spikes 1.33.8 cm long; bracts 3 mm long, broadly ovate, acuminate, pubescent and glandular, ciliate, veined.
Distribution: Native to southern Asia from Pakistan to Sri Lanka and Myanmar (Burma); found throughout most of India in dry, rocky habitats to an altitude of 2400 m in the western Himalayas.
Medicinal properties and uses: The plant is considered stimulant, expectorant and diaphoretic. It is used in Bihar to dress wounds. The juice of the fresh leaves is credited with cooling properties and is used to relieve urticaria associated with liver disorders and other allergic reactions; mixed with sugar-candy, it is used as a home remedy for coughs and colds. Mixed with sugar and gingelly oil it is used as a cooling liniment for the head. In Siddha, the leaf is used for treating cough, digestive disorders and dropsy. The leaves can be eaten as a vegetable.
Boerhavia diffusa Linn Family: Nyctaginaceae
Description: A very variable, diffusely branched, pubescent or glabrous, prostate herb with a stout, woody root stock; stems creeping, often purplish, swollen at the nodes, up to 1.2m long. Leaves long - petioled , ovate or oblong- cordate, entire or sinuate, usually whitish and smooth beneath and rough green on upper surface. Flowers red, pink or white, borne in small bambles arranged in axillary and terminal panicles. Fruit ovate, oblong, 1.3 cm long.
Distribution: A common, pantropical weed found in grasslands, cultivated fields and orchards throughout India to an altitude of 2000 m in the Himalayas; it is occasionally cultivated in West Bengal.
Medical properties and uses: The roots are the source of the ayurvedic drug Punamava; they are considered stomachic, laxative, diuretic, expectorant, antipyretic and cardiotonic. They are considered useful for stimulating heart and kidney function

and are a specific for jaundice, diabetes, general debility and oedema. The roots are also used as a asthma and dropsy associated with Brights disease. The whole plant is reportedly used for treating inflammatory renal diseases and nephritic syndrome, abdominal tumors and cancer.
DETAILED DESCRIPTION OF THE INVENTION
Accordingly the present invention is of a novel herbal composition for relieving stress, capable of being used as a potent adaptogenic agent, antioxidant, anti stress, potent enzymatic super oxide dismutase enhancing agent, lipid peroxidation inhibiting agent and enzymatic enhancing catalase agent, comprising a therapeutically effective combination of Withania somnifera 8-10%, Myristica fragrans 8-12%, Piper longum 8-12%, Zingiber officinalis 8-10 %, Piper nigrum 3-8%, Alpina carmomum 4-8%, Piper chaba 0-6%, Embelia ribes 3-7%, Aplotaxis auriculata 3-6%, Myristica caryophyllus 2-4%, Bamboomanna 2-4%, Hemidesmus indicus 2-4%, Vanda roxburghii 1-3%, Hypoxis orchioides 1-3%, Cuminum cyminum 1-2%, Nigella sativa 0.5-2%, Asparagus racemosus 0.5-1%, Ptychotis ajowan 0.5-1%, Piper officinarum 0.5-2%, Ipomea digitata 1 -2%, Curcuma zedorea 1-2%, Lavandula carnasa 1-3% and Boerhavia diffusa 1-2%, the percentages described herein are in weight by weight to the total weight of the formulation and pharmaceutically acceptable excipients.
In still another embodiment a novel therapeutically effective poly herbal composition with synergistic effect useful in relieving stress, comprising the extracts/powder obtained from Withania somnifera. Myristica fragrans, Piper longum. Zingiber officinalis, Piper nigrum, Alpina carmomum, Piper chaba, Embelia ribes, Aplotaxis auriculata, Myristica caryophyllus, Bamboomanna, Hemidesmus indicus, Vanda roxburghii, Hypoxis orchioides, Cuminum cyminum, Nigella sativa. Asparagus racemosus, Ptychotis ajowan, Piper officinarum, Ipomea digtlata. Curcuma zedorea, Lavandula carnusa and Boerhavia diffusa with acceptable additives.
The effect of the anti stress ingredients including the potent adaptogenic agent, antioxidant, anti stress, potent enzymatic super oxide dismutase enhancing agent, lipid peroxidation inhibiting agent and enzymatic enhancing catalase agent enhances upto 200% - 300% when the composition is prepared in the ratio herein above described but without any side effects.

In still another embodiment, the invention is of a herbal composition wherein the said composition is in conventional form of tablets, capsules, eye drops, food supplements, liquids tonics, powder, concentrates or granule or any other form.
In still another embodiment, the Invention relates to a herbal composition wherein the composition is optionally a liquid composition wherein a suitable solvent, either aqueous or non-aqueous, preferably water thereof.
In still another embodiment, herbal composition wherein the solvent used for the extraction of plants is a suitable conventional solvent such as ethanol, methanol, chloroform, ethyl acetate and water or mixtures thereof and desired, converting the same into suitable formulation such as tablets, capsules, syrup and the like.
In yet another embodiment, herbal composition wherein the whole plant or parts thereof are powdered and extracted with water under reduced pressure and temperature below 50°C and if desired, the residue thus obtained is mixed with pharmaceutically accepted agents.
In still another embodiment, the invention is of a herbal composition wherein the residue mixed with water, kept overnight at 37°C with stirring and centrifuged, the solution thus obtained was vacuum dried and dissolved in a fixed volume of normal saline to make a stock solution of the plants.
In yet another embodiment, the invention relates to a herbal composition wherein the extract of said herbs is converted into any suitable forms such as powder, concentrates, granule or tablets.
In still another embodiment, herbal composition wherein the said composition comprises plant extract/plant powder about 20% - 40% wt of the total composition.
In yet another embodiment, herbal composition wherein the additives selected from starch, lactose, sugar, gum acacia and known lubricants or mixture thereof.
In still another embodiment, herbal composition wherein the lubricants used is selected from group of inert materials.

In yet another embodiment, herbal composition wherein the plant extracts are obtained: from plant parts selected from leaf, seeds, floral parts rhizome and aerial parts.
In another embodiment a method of preparing a herbal composition wherein the said method comprising:
■ obtaining the part of medicinal plants from a group comprising leaves, rhizome
and aerial parts including flowers,
drying the plant material in shade,
■ powdering the dried plant material into a coarse powder,
■ soaking the plant material into milk overnight and drying them in shade during day time.
■ soaking the plant material into ghee overnight and drying them in shade during day time.
■ preparation of decoction: the coarsely powdered plant material was sieved and added water organic solvent and boiled to concentrate,
■ the above is heated gently, followed by spray dried to attain proper consistency and stored at cool temperature ranging from -4°C to -20°C.
■ mixing the residue with water and keep the resulting mixture overnight at 37°C with stirring and centrifuged, the solution thus obtained was dried preferably vacuum dried and dissolved in a fixed volume of normal saline to make a stock solution of the plants and stored at cool temperature ranging from -4°C to -20°C.
In yet another embodiment, the effect of anti stress properties such as potent adaptogenic agent, antioxidant, anti stress, potent enzymatic super oxide dismutase enhancing agent, lipid peroxidation inhibiting agent and enzymatic enhancing catalase agent in the herbal composition enhances drastically when the composition is prepared in the method here below described.
In still another embodiment, herbal composition wherein the formulation has a shelf life of 2 years.
In yet another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent antioxidant activity.

In still another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent adaptogenic activity.
In yet another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent anti stress activity.
In still another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent enzymatic super oxide dismutase enhancing activity.
In yet another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent lipid peroxidation inhibition.
In still another embodiment, herbal composition as claimed in claim 1 wherein the formulation showed as a potent enzymatic enhancing catalase activity.
In yet another embodiment, herbal composition as claimed in claim 1 wherein the herbal formulation helpful in defending the body against the effects of stressful environment and provide vitality and energy.
In yet another embodiment, a herbal composition as claimed in claiml, when prepared in the method disclosed in the description showed synergism.
Accordingly A method of preparing a herbal composition for relieving stress comprising:
(a) obtaining the part of medicinal plants from a group comprising leaves, rhizome and aerial parts including flowers;
(b) drying the plant material dispensed with sunlight, preferably shade;
(c) powdering the dried plant material into a coarse powder;
(d) extracting the active ingredients from the coarsely powdered and sieved plant material using water and organic solvent wherein the said mixture is boiled to concentrate under reduced pressure and temperature below 50°C to residue;
(e) mixing the residue with water and keep the resulting mixture overnight at 37°C with stirring and centrifuged, the solution thus obtained was dried and dissolved in a fixed volume of normal saline to make a stock solution of the plants and stored at cool temperature ranging from -4°C to -20°C.

Following examples are given by illustration Formulation (Fl):
1. Withania somnifera - 10 %
2. Mynstica fragrans - 12 %
3. Piper iongum - 10%
4. Zingiber officinalis - 10%
5. Piper nigrum - 5%
6. Alpina carmomum - 4%
7. Piper chaba - 5%
8. Embelia ribes - 5%
9. Aplotaxis auriculata - 5%
i0. Mynstica caryophyllus - 3%
J j. Bamboomanna - 2%
J2, Hemidesmus indicus - 1%
J3. Vanda roxburghii - 1%
14. Hypoxis orchioides - 1%
15. Cuminum cyminum - 1%
16. Nigella sativa - 2%
17. Asparagus racemosus - 5%
J8, Ptychotis ajowan - 5%
J 9. Piper officinarum - 3%
20. Ipomea digitata - 0.5%
21. Curcuma zedorea - 0.5%
22. Lavandula carnasa - 0.5%
23. Boerhavia diffusa - 0.5%
24. Base - q.s 100%

Formulation (F2):

1. Withania somnifera
2. Mynstica fragrans
3. Piper Iongum
4. Zingiber officinalis
5. Piper nigrum
6. Alpina carmomum
7. Piper chaba
8. Embelia ribes

10 %
10 %
12%
10%
5%
5%
4%
4%



Formulation FI and F2 composition is Withania somnifera (8-10%), Myristica fragrans (8-12%), Piper longum(8-12%), Zingiber officinalis (8-10%), Piper nigrum(3-8%), Alpina carmomum(4-8%), Piper chaba (3-6%), Embelia ribes(37%), Aplotaxis auhculata(3-6%}, Myristica caryophyllus(2-4%), Bamboomanna(2-4%),Hemidesmus indicus(2-4%), Vanda roxburghii(l-3%), Hypoxis orchioides(l-3%}, Cuminum cyminum(l-2%), Nigella sativa (0.5-2%), Asparagus racemosus(0.5-l%),Ptychotis ajowan(0.5-l%). Piper officinarum(0.5-2%), Ipomea digitata(l-2%), Curcuma zedorea(l-2%), Lavandula carnasa (1 -3%) and Boerhavia diffusa (1-2%)
Accordingly a novel herbal composition for relieving stress comprising a therapeutically effective combination of extracts/powder/juice of Withania somnifera 8-10%, Myristica fragrans 8-12%, Piper longum 8-12%, Zingiber officinalis 8-10 %, Piper nigrum 3-8%, Alpina carmomum 4-8%, Piper chaba 0-6%, Embelia ribes 3-7%, Aplotaxis auriculata 3-6%,Myrista caryophyllus 2-4%, Bamboomanna 2-4%, Hemidesmus indicus 2-4%, Vanda roxburghii 1-3%, Hypoxis orchioides 1-3%, Cuminum cyminum 1-2%, Nigella sativa 0.5-2%, Asparagus racemosus 0.5-1%, Ptychotis ajowan 0.5-1%, Piper officinarum 0.5-2%, Ipomea digitata 1 -2%, Curcuma zedorea 1-2%, Lavandula carnasa 1-3% and Boerhavia diffusa 1-2%, and pharmaceutical^ acceptable excipients and additives.
Lipid peroxidation: The fundic part liver was homogenized (5%) in ice-cold 0.9% NaCI in glass homogenizer for 30 s. The homogenate was centrifuged for 10 min A volume of the homogenate (0.20 ml) was transferred to a vial and was mixed with 0.2 ml of a 8.1 % (w/v) sodium dodecyl sulfate solution, 1.50 ml of a 20% acetic acid solution (adjusted to pH 3.5 with NaOH) and 1.50 ml of a 0.8% (w/v) solution of thiobarbituric acid (TBA) and the final volume was adjusted to 4.0 ml with distilled water. Each vial was tightly capped and heated in a boiling water bath for 60 min. The vials were then cooled under running water. Equal volumes of tissue blank or test samples and 10% trichloroacetic acid were transferred into a centrifuge tube and centrifuged. The absorbance of the supernatant fraction was measured at 532 nm. Control experiment was processed using the same experimental procedure except the TBA solution was replaced with distilled water. 1,1,3,3-Tetraethoxypropan was used as standard for calibration of the curve and is expressed as nanomoles per milligram protein.

SOD and Catalase:
Decomposition of H2O2 in presence of catalase (CAT) was followed at 240 nm. One unit (U) of catalase was defined as the amount of enzyme required to decompose 1 umol of H202 per minute, at 25°C and pH 7.0. Results are expressed as units of CAT activity per milligram of protein. Superoxide dismutase (SOD) activity was estimated by the inhibition of nicotinamide adenine dinucleotide (reduced)-phenazine methosulphatenitrobluetetrazolium reaction system. One unit of the enzyme is equivalent to 50% inhibition in the formazan formation in 1 min at room temperature (25°C) and the results have been expressed as units of SOD activity per milligram of protein.
Table 2- Effect of formulation on hypoxia and swimming performance time in mice.

S.No Treatment Dose (mg/kg, p.o.) Hypoxia Time Swimming Endurance
1 Control + stress - 22.32 ± 1.05 238.85 ± 24.13
2 F 1 50 28.13 ± 1.65 301.12 ±27.85b
3 F 1 100 32.54 ± 2.11s 350.50 ± 28.97=
4 F2 50 46.55 ±2.79" 349.53 ±26.55b
5 F2 100 55.88 ±3.06' 450.68 ± 29.91c
6 Commerciall y available 100 26.21 ± 2.3 305.22 ± 28.11"
sample Values are mean ± S.E.M
P: a<0.05, b<0.01 and c<0.001 compared to respective control group. NOTE:
No mortality was found in any of the treated group.
No gross abnormality in behavior was observed in the animal exposed with herbal preparation.
Formulation FI and F2 composition is Withania somnifera (8-10%), Myristica fragrans (8-12%), Piper longum(8-12%), Zingiber officinalis (8-10%), Piper nigrum(3-8%), Alpina carmomum(4-8%). Piper chaba (3-6%), Embelia hbes(37%), Aplotaxis auriculata(3-6%}, Myristica caryophyiIus(2-4%), Bamboomanna(2-4%),Hemidesmus indicus(2-4%), Vanda roxburghii(l-3%), Hypoxis orchioides(l-3%}, Cuminum cyminum(l-2%), Nigeila sativa (0.5-2%), Asparagus racemosus(0.5-l%),Ptychotis ajowan(0.5-l%), Piper Officinarum(0.5-2%), Ipomea digitata(l-2%). Curcuma zedorea(l-2%), Lavandula carnasa (1 -3%) and Boerhavia diffusa (1-2%)

Commercially available sample did not significant activity in hypoxia time and swimming endurance tests of the adaptogenic activity.
Procedures for adaptogenic activity
Hypoxia time:
The animals were placed in an empty glass jar (If 300 ml capacity attached with an
electronic watch; the jars were made air tight with greased glass stoppers and the
time until the onset of convulsion was recorded (Singh B et al, 2001, Phytotherapy
Research, 15;311-318).
Swimming performance time:
The animals were allowed to swim inside a perpex glass beaker (30 cm high with 20 cm diameter containing water up to 25cm high) maintained at 26° C +/- 1° C with a continuous air current from the bottom. The end point of swimming endurance was taken as when the mice remained at the bottom for more than 10s (Singh B et a I. 200 I, Phytotherapy Research, 15; 311-318).

We claim:
1. A novel herbal composition for relieving stress, capable of being used as a potent adaptogenic agent, antioxidant, anti stress, potent enzymatic super oxide dismutase enhancing agent, lipid peroxidation inhibiting agent and enzymatic enhancing catalase agent, comprising a therapeutically effective combination of Withania somnifera 8-10%, Myristica fragrans 8-12%, Piper longum 8-12%, Zingiber officinalis 8-10 %, Piper nigrum 3-8°/o, Atpina carmomum 4-8%, Piper chaba 0-6%, Embelia ribes 3-7%, Aplotaxis auriculata 3-6%, Myristica caryophyllus 2-4%, Bamboomanna 2-4%, Herflidesmus indicus 2-4%, Vanda roxburghii 1-3%, Hypoxis orchioides 1-3%, Cuminum cyminum 1-2%, Nigella sativa 0.5-2%, Asparagus racemosus 0.5-1%, Ptychotis ajowan 0.5-1%, Piper officinarum 0.5-2%, Ipomea digitate 1 -2%, Curcuma zedorea 1-2%, Lavandula carnasa 1-3% and Boerhavia diffusa 1-2%, the percentages described herein are in weight by weight to the total weight of the formulation; and pharmaceutically acceptable excipients and additives.
2. The composition as claimed in claim 1, wherein the composition is formulated as tablets, capsules, eye drops, food supplements, liquids tonics, powder, concentrates or granule.
3. The herbal composition as claimed in claim 2 wherein the composition is optionally a liquid composition which consitsts a suitable solvent, either acqueous or non-acqueous, preferably water thereof.
4. The composition as claimed in claim 1, wherein the said composition comprises plant extract/plant powder about 20% - 40% wt of the total composition.
5. The composition as claimed in claim-1, wherein the lubricant used is selected from group of inert materials.
6. A method of preparing a herbal composition for relieving stress comprising:
(a) obtaining the part of medicinal plants from a group comprising
leaves, rhizome and aerial parts including flowers;
(b) drying the plant material dispensed with sunlight, preferably shade;
(c) powdering the dried plant material into a coarse powder;
(d) extracting the active ingredients from the coarsely powdered and sieved plant material using water and organic solvent wherein the said mixture is boiled to concentrate under reduced pressure and temperature below 50°Cto residue;

(e) soaking the plant material into milk overnight and drying them in shade during day time,
(0 soaking the plant material into ghee overnight and drying them in shade during day time.
(g) mixing the residue with water and keep the resulting mixture overnight at 37 °C with stirring and centrifuged, the solution thus obtained was dried preferably vacuum dried and dissolved in a fixed volume of normal saline to make a stock solution of the plants and stored at cool temperature ranging from -4°C to -20°C.
7. The method of preparing a herbal composition as claimed in claim 7, wherein the solvent used for the extraction of plants is a suitable conventional solvent such as ethanol, methanol, chloroform, ethyl acetate and water or mixtures thereof.
8. The method of preparing a herbal composition as claimed in claim 7, wherein the any parts of the plants or the whole plant are powdered and extracted with water under reduced pressure and temperature below 50°C and the residue thus obtained is optionally mixed with pharmaceutically accepted agents.
9. The composition as claimed in any preceding claim, wherein the therapeutically effective herbal formulation with synergistic effect, helpful in defending the body against the effects of stressful environment and provide vitality and energy.