FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]

COMPOSITION FOR RELEIVING
PSYCHOLOGICAL STRESS;
MARICO LTD., A COMPANY INCORPORATED UNDER THE COMPANIES ACT, 1956, WHOSE ADDRESS IS RANGSHARDA, KC MARG, BANDRA RECLAMATION, BANDRA (W), MUMBAI -400 050, MAHARASHTRA, INDIA
THE FOLLOWING SPECIFICATION
PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD OF THE INVENTION
The present invention relates to a composition comprising essential oil(s). More particularly, the present invention relates to a composition comprising essential oil(s) and optionally herbal extract(s) for relieving psychological stress.
BACKGROUND OF THE INVENTION
Psychological stress refers to the emotional and physiological reactions generated when an individual confronts a situation in which he is unable to cope with the demands or challenges of some kind. It can disturb an individual's mental and physical well-being. Psychological stress sets off extreme emotional stress such as anxiety, depression, obsessive compulsive disorder, mood swings, irritability and in some cases even death or suicide. It has been observed that emotional stress equals increased output by the sympathetic nervous system, which equals accelerated aging and breakdown of tissues. Thus, long term psychological stress is detrimental to health and can cause serious medical concerns, it interferes with the immune system, makes the body vulnerable to infectious diseases and aggravate conditions like gastric conditions, premature birth in expectant mothers, low birth weight, musculoskeletal problems, degeneration of brain neurons, heart complications, stroke due to high lipid levels, cancer and other disorders. Psychological stress can also trigger sever skin afflictions, increase seborrheic dermatitis and dandruff.
Stress management is important for everyone especially those that suffer from psychological stress because it can reduce the number of symptoms that are caused by stress. Various treatments are used to overcome psychological stress such as relaxation techniques like yoga and meditation, aromatherapy and administration of therapeutic drugs.

Relaxation techniques like yoga and meditation - require special training, practice and concentration.
Aromatherapy involves inhalation of essential oils. However, it is observed that inhalation may not be suitable to all, as it can cause irritation to sensitive mucous membranes and damage the smell receptors inside nose. Prolonged inhalation of concentrated essential oils can cause headaches, vertigo, dizziness, nausea, and lethargy. Besides, fragrances of aromatherapy essential oils may not suit people's sensory preferences and in such cases this can cause new stresses adding to the existing stress. On the other hand, even if inhalation of an essentia! oil could have the stress reducing effect, it may over-relax the treated individual thereby decreasing his/her attentiveness and work efficiency. Also, special equipment like vaporizers will be required for inhalation of essential oils and nonetheless where essential oil is to be inhaled through steam inhalation, it calls for extra precaution and utmost care. Such steam inhalation may not be suitable for sensitive individuals and may cause damage to mucous membrane and again may not be convenient to all.
Administration of therapeutic drugs by oral or intravenous route needs supervision and intervention of a doctor, posing limitations to their application. Further they have delayed onset of action and have adverse side effects including weight gain, nausea, diarrhea, headache, heart attack, and stroke. Besides, for treating psychological stress drugs needs to be taken for a long term and such drugs are habit forming. Thus there is a concern in taking drugs for relieving the psychological stress.
Therefore, there is a need for a simple and inexpensive method for relieving psychological stress; which requires no special assistance, supervision, equipment or training to use, is free from the adverse side-effects, has ease in application and relieves the psychological stress in a manner which can be measured.

SUMMARY OF THE INVENTION
Accordingly, it is an object of the invention to provide a simple and inexpensive means for relieving psychological stress.
In one aspect the present invention provides a composition for relieving psychological stress comprising; at least one essential oil as the active agent in combination with other essential oil(s), a carrier and optionally excipient(s).
In a preferred aspect the present invention provides a composition for relieving psychological stress comprising of an essential oil obtained from black pepper and atleast one more essential oil obtained from the group consisting of but not limited to rosemary, patchouli and thyme along with a carrier and optionally excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, or atleast 15%, or atleast 20%, or atleast 25%, or atleast 30%, or atleast 35%, or atleast 40% when applied topically.
In one specific aspect the present invention provides a composition for relieving psychological stress comprising combinations of essential oils of black pepper rosemary, patchouli and thyme along with a carrier and optionally excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, preferably by atleast 20% when applied topically.
In another aspect there is provided a composition for relieving psychological stress comprising essential oils of black pepper in combination with atleast one herbal extract, a carrier and optionally excipient(5) so as to reduce the salivary alpha amylase level by atleast 10%, or atleast 15%, or atleast 20%, or atleast 25% when applied topically.
In one specific aspect the present invention provides a composition for relieving psychological stress comprising combinations of essential oil of black pepper in combination with hibiscus leaf extract, ajowain extract, malakangni extract along

with a carrier and optionally excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, preferably by atleast 20% when applied topically. In another aspect the present invention provides a process for the preparation of composition for relieving psychological stress comprises the steps of:
i) mixing the black pepper essential oil with another essential oil(s) and/or herbal extract(s) and one or more excipient(s), and
ii) mixing a carrier to formulate a topical formulation.
In a further aspect the present invention provides a method of using the composition for relieving psychological stress and related disorders comprising massaging the said composition on scalp or body of the subject in the need of relieving of the psychological stress or related disorder. The composition provides warming sensation on the skin when applied.
DETAILED DESCRIPTION
The present invention provides a composition for relieving psychological stress comprising; at least one essential oil as an active agent either alone or in combination with other essential oil(s) and/or herbal extract(s), a carrier and optionally excipient(s). The compositions of the present invention are preferably administered by topical route.
In one embodiment of the present invention, the compositions for relieving psychological stress comprises an essential oil obtained from black pepper, in combination with atleast one more essential oil(s), a carrier and optionally excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, preferably atleast by 20% , when applied topically.
An essential oil which may be used in the composition may be obtained from the group consisting of but not limited to Agar, Ajwain, Allspice, Almond, Amla, Angelica, Anise, Apricot, Asafoetida, Avocado, Balsam, Basil, Bayleaf, Bergamot, Betal, Birch, Buchu, Cajuput, Calamus, Calendula, Camphor, Cannabis, Caraway,

Cardamom, Carrot, Cassia, Cedar, Cedar wood, Celery, Cinnamon, Cistus, Citronella, Clary, Clary sage, Clove, Coffee, Coriander, Costmary, Costus, Cranberry, Cubeb, Cumin, Curry, Cypress, Cypriol, Davana, Dill, Elecampane, Eucalyptus, Evening primrose, Fennel, Fenugreek, Fir, Frankincense, Galangal, Galbanum, Garlic, Gardenia, Geranium, Ginger, Goldenrod, Grapefruit, Hazelnut, Helichrysum, Henna, Hops, Hyssop, IdahoTansy, Jasmine, Jojoba, Juniper, Jyotishmati, Kewra, Lavender, Ledum, Lemon, lemongrass, Lime, Litsea cubeba, Lotus, Macadamia, Madarian, Manuka, Marjoram, Melissa, Mentha, Mountain Savory, Mugwort, Mustard, Myrrh, Myrtle, Neem, Neroli, Nutmeg, Olive, Onion, Orange, Oregano, Orris, Palmrose, Parsley, Patchouli, Pennyroyal, Peppermint, Perilla, Petitgrain, Pine, Ravensara, Red cedar, Roman chamomile, Rose, Rose hip, Rosemary, Rose wood, Saffron, Sage, Sandalwood, Sassafras, Savory, Schisandra, Spearmint, Spikenard, Spruce, Starartise, Tagetes, Tangerine, Tarragon, Tea tree oil, Thuja, Thyme, Tsuga, Turmeric, Vanilla, Valerian, Vetiver, Walnut, Western red cedar, Wintergreen, Wheat Germ, Yarrow, Ylang ylang, Zedoary or the line and/or combinations thereof.
Compositions for relieving psychological stress comprises an essential oil obtained from black pepper and atleast one more essential oil obtained from the group consisting of but not limited to rosemary, patchouli and thyme along with a carrier and optionally an excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, preferably 20% when applied topically. The amount of the essential oil of the black pepper present in the composition of the present invention is atleast 0.1%, preferably it is present in the range from about 0.1% to about 5%, more preferably it is present in the range from about 0.5% to 1.5% by volume of the total composition weight. The amount of the other essential oil(s) may be atleast 0.03%, preferably it may be present in the range from about 0.03% to about 3%.
In one preferred embodiment of the present invention, the composition for relieving psychological stress and related disorders comprises synergistic combination of essential oils obtained from black pepper, rosemary, patchouli

and thyme along with a carrier and optionally an excipient so as to reduce the salivary alpha amylase level by atleast 10%, or by atleast 15%, or by atleast 20%, or by atleast 25%, or by atleast 30%, or by atleast 35%, or by atleast 40%; preferably the salivary alpha amylase level is reduced by atleast 20%, more preferably by atleast 30% when applied topically.
The amount of the essential oil of black pepper present in the composition is atleast 0.5%, preferably it is present in the range from about 0.5% to about 5%, more preferably it is present in the range from about 0.5% to 1.5% by volume of the total composition weight by volume of the total composition weight. The amount of the essential oil of the rosemary is preferably from 0.03% to 0.5% by volume of the total composition weight. The amount of the essential oil of the patchouli is preferably from 0.03% to 0.5% by volume of the total composition weight. The amount of the essential oil of the thyme is preferably from 0.03% to 0.5% of the total composition weight.
The essential oil of black pepper is obtained from the fruits of plant Piper nigrum. The essential oil of rosemary is obtained from leaves of plant Rosmarinus officinalis. The essential oil of patchouli is obtained from leaves of species of plant Pogostemon, selected from but not limiting to Pogostemon cablin, P. commosum, P. hortensis, P. heyneasus and P. plectranthoides. The essential oil of thyme is obtained from herb Thymus vulgaris.
The composition for relieving psychological stress may comprise extract or bioactive derived from herb.
According to one embodiment, the present invention provides composition for relieving psychological stress comprising an essential oil obtained from black pepper and atleast one herbal extract along with a carrier and optionally excipient(s) so as to reduce the salivary alpha amylase level by atleast 10%, or by

atleast 15%, or by atleast 20%, or by atleast 25% or by atleast 30%; preferably by atleast 20% when applied topically.
The herbal extract that may be used in the composition may be selected from the group including but not limited to hibiscus, ajowain, malakangni or the like.
Hibiscus extract is obtained from the leaves of Hibiscus Rosa-sinensis, ajowain extract is obtained from seeds of Trachyspermum copticum and malakangni extract is obtained from seeds of Celastrus paniculatus.
The amount of the hibiscus leaf extract is preferably atleast 0.01%, the ajowain extract is preferably atleast 0.01% and malakangni extract is preferably atleast 0.1% by volume of the total composition weight.
The composition of the present invention for relieving psychological stress comprises a suitable carrier as a base for essential oils and/or herbal extracts. In one embodiment, the carrier may be a vegetable or a mineral oil or any other suitable carrier. In an embodiment, the vegetable oil useful in the present invention is selected from group comprising but not limited to a coconut oil, sunflower oil, soyabean oil, linseed oil, cottonseed oil, olive oil, palm oil, sesame oil, safflower oil, sweet almond oil, apricot kernel oil, avocado oil, borage oil, corn oil, evening primrose oil, hazelnut oil, jojoba oil, kukui nut oil, macadamia nut oil, peanut oil, pecan oil, rice oil, rice bran-oil, rosehip seed oil, shea butter oil, sunflower oil, wheat germ oil or the like and/ or the combinations thereof.
Other acceptable carriers useful in formulating the compositions of the present invention may be selected from the group including but not limited to lubricants such as carboxymethy! cellulose, sodium alginate, EDTA, natural vegetable oils, propylene glycol, glycerin, low melting temperature triglyceride, mineral oil, aqueous solutions of high molecular weight polyethylene oxides, or the like and/or mixtures thereof.

The excipient comprised in the composition for relieving psychological stress and related disorders may be selected from group including but not limited to fragrances, preservatives, bactericides, antifoams, dyes, pigments, surfactants, thickeners, suspending agents, fillers, moisturizers, humectants, smoothing agent, cooling agents, fats, oils, waxes, alcohols, polyols, polymers, foam stabilizers, electrolytes, organic solvents, silicone derivatives, or the line and/or combinations thereof.
In a further embodiment of the present invention there is provided a process for preparation of the composition for relieving psychological stress, which comprises the steps of:
i) mixing the black pepper essential oil with another essential oil(s} and/or herbal extract(s) and one or more excipient(s), and
ii) mixing a carrier to formulate a topical formulation.
The composition of the present invention may be formulated for topical application in the form of an oil, lotion, gel, cream, ointment, aqueous solution or suspension, or lubricant.
In a further embodiment of the present invention there is provided a method of using the composition for relieving psychological stress and related disorders comprising at least one essential oil(s), in combination with one or more another essential oil and/or herbal extract(s), a carrier and optionally excipient(s) which comprises massaging the said composition on scalp or body of the subject in the need of relieving of the psychological stress or related disorder. The composition provides warming or hot sensation on the skin when applied. Such warming or hot sensation is different from warm followed by icy feeling which is usually not preferred by individuals as it gives extreme feelings giving rise to discomfort. Further, such warm or hot sensation helps the topical formulation to penetrate easily and faster without any need of heating the formulation before its application thus making it very convenient and user friendly. Also, as no heating

is required there is no loss or deterioration of heat-sensitive constituents of the composition.
Any suitable method can be used for the topically applying the formulation, such methods include for example applying the topical preparation using the palms of the hands and/or fingers or a device or implement for example a cotton ball, swab, pad, applicator pen, spray applicator, brush, etc. Furthermore, the composition can be applied topically through the use of a patch or other delivery device. Delivery devices can include, but are not limited to, those that can be heated or cooled, as well as those that utilize iontophoresis or ultrasound. The formulation is preferably applied by massaging it on the body or scalp of a subject in the need thereof.
The compositions comprising combination of essential oils can be applied topically on the whole or any part of the body of the subject. The composition comprising of combination of essential oil of black pepper with herbal extract(s) is preferably used for applying on the scalp and hair.
The compositions of the present invention are useful in the relieving psychological stress is evident from the reduction in salivary alpha amylase levels. Salivary alpha amylase levels are used as a marker for sympathetic nervous system (SNS) activity. It is established that sympathetic nervous responds to acute psychosocial stress and stress-induced increases have been shown to be associated with increases in SNS marker that is salivary alpha amylase. The composition of the present invention helps to reduce the salivary alpha amylase levels atleast by 10%, preferably by atleast 20%. In the preferred embodiments, the composition comprising the synergistic combination of essential oils of black pepper, rosemary, patchouli and thyme reduces the salivary alpha amylases levels by atleast 20%, preferably by atleast 30%. In other preferred embodiments, the composition comprising the synergistic combination of essential oils of black pepper, with hibiscus leaf extract, ajowain extract and

malakangni extract reduces the salivary alpha amylases levels by atleast 20%, preferably by atleast 30%.
The compositions of the present invention may be used in relieving one or more disorders related to psychological stress.
In order to illustrate the embodiment of the present invention the following example is included. However, the same do not intend to limit the scope of present invention.
EXAMPLE
Example 1:
Composition comprising synergistic combination of essential oils:
Black pepper essential oil 1.25%, Rosemary essential oil 0.003%, patchouli
essential oil 0.003% and thyme essential oil 0.003% were mixed with coconut oil
90 %, to which fragrance 0.6% was added and mixed thoroughly to prepare the
oil preparation for topical application.
Example 2:
Composition comprising synergistic combination of black pepper essential oil
with herbal extracts:
Black pepper essential oil 0.75% was mixed thoroughly with Hibiscus leaf extract
0.05%. Ajowain extract 0.03% & Malakangni extract 0.5%. The mixture thus
prepared was mixed with coconut oil 90 %, to which fragrance 0.5% was added
and mixed thoroughly to prepare the oil preparation for topical application.
Example 3:
Determination of psychological stress reducing effect of different oils using
salivary alpha-amylase as an indicator of psychological stress:
Oils Used

1. Oil of Example 1 comprising synergistic composition
2. Oil of Example 2 comprising synergistic composition
3. 1% Black pepper oil in Coconut oil
4. Comparative Oil 1: consisting of 0.1% Rosemary essential oil, 0.1% patchouli essential oil and 0.1% thyme essential oil with coconut oil as a carrier.
5. Comparative Oil 2: consisting of Hibiscus leaf extract 0.05%, Ajowain extract 0.03% and Malakangni extract 0.5% with coconut oil as a carrier.
Method for evaluating Amylase activity
Participants:
40 Subjects were recruited for massage study.
Massage Study
Subjects were called thirty minutes prior to the collection of the basal saliva
sample.
After the collection of the first saliva sample, the subjects were given a head massage with respective oils mentioned above for 12 minutes. Again saliva sample was collected after the massage.
Amylase Assay
1. Saliva was centrifuged at 2000 rpm for 5 minutes.
2. Supernatant obtained was diluted 1000-fold with pH 6.9 phosphate
buffer
DNSA (3, 5 dinitrosalycylic acid ) Reagent
DNSA reagent was prepared by adding 10.6 g of 3, 5 dinitrosalycylic acid to 1416 ml Distilled water to which 19.8 g of NaOH was added and dissolved. To the resultant solution 306 g of sodium potassium tartarate, 7.6 ml of phenol and 8.3 g of sodium metabisulphite was added and mixed.

Assay
0.5ml of 1 % starch at 37°C was pre-incubated, 0-5ml of the diluted saliva sample
was added and kept at 37°C for 10 minutes, 3 ml DNSA Reagent was added and
tubes were kept in boiling water bath for 4 minutes. The absorbance was
measured at 575nm. Blank consisted of 0.5ml 1% starch and 0.5ml Distilled
Water
Observations

Oil used for Massage % reduction in alpha-amylase activity
Synergistic Composition of Example 1 44.21
Synergistic Composition of Example 2 30.89
1% Black pepper oil in Coconut oil 11.69
Comparative oil 1:0.1% Rosemary essentia} oil, 0.1% patchouli essential oil and 0.1% thyme essential oil with coconut oil as a carrier, -47.34
Comparative oil 2: Hibiscus leaf extract 0.05%. Ajowain extract 0.03% & Malakangni extract 0.5% with coconut oil as a carrier. -15.24
Result
Maximum reductions in salivary amylase activity were observed when the subjects were given head massage using oil as per Example 1 and 2 comprising synergistic compositions as per the present invention.
1% Black pepper oil in Coconut oil as a carrier showed only 11.69% reduction in salivary amylase activity. The Comparative Oil 1 consisting of mixture of 0.1% Rosemary essential oil, 0.1% patchouli essential oil and 0.1% thyme essential oil with coconut oil as a carrier showed the negative result of -47.34%, that is increase in salivary amylase activity. Similarly, the Comparative Oil 2 consisting of mixture of Hibiscus leaf extract 0.05%, Ajowain extract 0.03% and Malakangni extract 0.5% with coconut oil as a carrier also showed negative result of -15.24 meaning increase in salivary amylase activity. The increase in salivary amylase activity is the indication of increase in stress, thus it can be concluded that both

the Comparative Oils 1 and 2 increased the psychological stress rather than decreasing it.
The above results demonstrate that the Compositions of Example 1 and 2 are synergistic compositions which gave significant unexpected reductions in psychological stress evident from the maximum decrease in salivary amylase activity obtained with the respective oils.
While the particular embodiments of the present invention have been described and illustrated with reference to the specific examples and appended claims it would be obvious to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention.

WE CLAIM:
1. A composition for relieving psychological stress comprising black pepper essential oil and atleast one more additional essential oil(s) and/or atleast one herbal extract(s) along with a carrier and optionally an excipient, wherein the composition reduces the salivary alpha amylase levels by atleast 10%.
2. The composition as claimed in claim 1 wherein, the additional essential oil is selected from group consisting of rosemary essential oil, patchouli essential oil and thyme essential oil and/or combinations thereof.
3. The composition as claimed in claim 1 wherein, the herbal extract is selected from group consisting of hibiscus leaf extract, ajowain extract, malakangni extract and/or combinations thereof.
4. A composition for relieving psychological stress comprising synergistic combination of black pepper essential oil, rosemary essential oil, patchouli essential oil and thyme essential oil along with a carrier and optionally an excipient so as to reduce the salivary alpha amylase levels by atleast 10%.
5. A composition for relieving psychological stress comprising synergistic combination of black pepper essential oil, hibiscus leaf extract, ajowain extract and malakangni extract along with a carrier and optionally an excipient so as to reduce the salivary alpha amylase levels by atleast 10%.
6. The composition as claimed in any one of the claims 1, 4 or 5 wherein, the black pepper essential oil is atleast 0.1%, preferably in the range from about 0.5% to 1.5% of the total composition weight.
7. The composition as claimed in claim 1,2 or 4 wherein, the rosemary essential oil is atleast 0.03%, preferably in the range from 0.03% to 0.5% of the total composition weight, patchouli essential oil is atleast 0.03%, preferably in the range from 0.03% to 0.5% of the total composition

weight, the thyme essential oil is atleast 0.03%, preferably in the range from 0.03% to 0.5% of the total composition weight.
8. The composition as claimed in claim 1, 3 or 5 wherein, the hibiscus leaf extract is preferably atleast 0.01%, the ajowain extract is preferably atleast 0.01% and malakangni extract is preferably atleast 0.1% of the total composition weight.
9. The composition as claimed in claim 1, 4 or 5 wherein, the carrier is selected from group consisting of a vegetable oil, a mineral oil, lubricants such as carboxymethyl cellulose, sodium alginate, EDTA, propylene glycol, glycerin, low melting temperature triglyceride, aqueous solution of high molecular weight polyethylene oxide, and/or combinations thereof.
10. The composition as claimed in claim 9 wherein, the vegetable oil is selected from group consisting of coconut oil, sunflower oil, soyabean oil, linseed oil, cottonseed oil, olive oil, palm oil, sesame oil, safflower oil, sweet almond oil, apricot kernel oil, avocado oil, borage oil, corn oil, evening primrose oil, hazelnut oil, jojoba oil, kukui nut oil, macadamia nut oil, peanut oil, pecan oil, rice oil, rice bran-oil, rosehip seed oil, shea butter oil, sunflower oil, wheat germ oil and/ or the combinations thereof.
11. The composition as claimed in claim 10 wherein, the vegetable oil used as a carrier is coconut oil.
12. The composition as claimed in claim 1, 4 or 5 wherein, the excipient is selected from group consisting of fragrance, preservative, bactericide, antifoams dyes, pigment, surfactant, thickener, suspending agent, filler, moisturizer, humectant, smoothing agent, cooling agents, fat, oil, waxes, alcohol, polyol, polymer, foam stabilizer, electrolyte, organic solvent, silicone derivative, and/or combinations thereof.

13. The composition as claimed in claim 1, 4 or 5 wherein, the composition reduces the salivary alpha amylase levels preferably by atleast 15%, or by atleast 20%, or by atleast 25%, or by atleast 30%.
14. The composition as claimed in claim 1, 4 or 5 wherein, the composition provides warming sensation when applied topically.
15. A process for the preparing a formulation from composition as claimed in any one the claims 1 to 14 for relieving psychological stress comprising the steps of:
ii) mixing the black pepper essential oil with another essential oil(s) and/or
herbal extract(s) and one or more excipient(s), and ii) mixing a carrier to formulate a topical formulation.
16. The process for the preparing a formulation as claimed in claim 15, wherein the topical formulation is selected from but not limited to oil, lotion, gel, cream, ointment, aqueous solution or suspension, or lubricant.
17. A composition as claimed in anyone of the claims 1 to 16 or as substantially described in the detailed description or illustrated by examples 1 to 3.