WO2010086717A2

WO2010086717A2 - Herbal cleanser compositions and methods thereof

Info

Publication number: WO2010086717A2
Application number: PCT/IB2010/000160
Authority: WO
Inventors: Ramesh Surianarayanan; Uddagiri Venkanna Babu; Ekta Saxena; Anindita Das
Original assignee: Himalaya Global Holdings Ltd
Current assignee: Himalaya Global Holdings Ltd
Priority date: 2009-01-30
Filing date: 2010-01-29
Publication date: 2010-08-05
Anticipated expiration: 2011-07-30
Also published as: WO2010086717A3

Abstract

Disclosed herein a herbal cleanser composition and a method of preparing said composition. The composition comprising extracts of organically certified herbs and polyglucosides, wherein the extract is prepared employing a super critical fluid extraction or water extraction, and wherein the polyglucosides used herein is naturally derived.

Description

HERBAL CLEANSER COMPOSITIONS AND METHODS THEREOF

Field of the Invention

This invention, in general relates to a herbal cleanser composition and preparation methods thereof. In particular, the present invention provides a herbal cleanser composition comprising organically certified herbal actives in combination with polyglucosides and methods for preparing the same.

Background of the Invention Traditionally, cleansers are based on surfactants such as anionics, cationics, non- ionics and amphoterics. Of these, anionics constitute a major segment of the known cleansing formulations whereas cationics, non-ionics & amphoterics are used widely as conditioners, wetting agents and/or as secondary surfactants. One of the commonly used anionic surfactants is ethoxylated alkyl ether sulphonates e.g Sodium Lauryl Ether Sulphonate (SLES). SLES is used extensively in combination with cocamidopropyl betain, an amphoteric surfactants. These blends, while being effective in cleansing, are harsh in nature and contain impurities like dioxanes, nitrosamines etc.

Very often such formulations have herbal active ingredients. These herbal copoents are basically extracts of natural herbs grown conventionally with pesticides. However, existing natural cleaning products have met with minimal acceptance in the marketplace due to poor cleansing effects being recognized and similar instances/symptoms of skin irritancy experienced as with synthetically derived cleaning products.

It is therefore necessary to develop a herbal cleanser composition that is devoid of synthetic ingredients, that provides better cleansing and conditioning properties and proves safe to use.

Accordingly, the present invention provides a composition for various types of cleansers, which avoids the limitation(s) associated with the composition known in the art.

Related Art U.S. Patent application No. 20060286062 by Schep et al. discloses a natural hair shampoo or body wash or cleanser derived completely from plant materials to provide mild and non-irritating cleansing. The cleanser contains anti-oxidants, natural surfactants and conditioning agents that are extracted from plant or animal materials and no synthetic ingredients that are foreign to nature and skin are used. U.S. Patent No. 5,872,087 by Neelakantan et al discloses a dry shampoo composition which is 100% herbal, with no synthetic chemicals are used. The shampoo contains foaming accelerating agent, pigment recreating agent, foaming agent, conditioning agent, preservative and hair stimulating agent that are purely herbal. The process for preparation of the herbal dry shampoo composition is also disclosed in the art.

U.S. Patent No. 6,881,710 by O'Lenick et al discloses personal care products based upon a novel series of polyglucoside quarteraary compounds. These polyglucoside quaternary compounds are surprisingly extremely effective multi-functional surfactants used in shampoos and body wash products, providing the possibility of making a personal care product with only one surfactant. These polyglucoside quaternary compounds provide detergency, foam, conditioning, antimicrobial activity, wetting properties of formulations in a single molecule, and are derived from natural sugar compounds.

U.S. Patent No. 6,524,626 by Chen discloses novel combinations of ginseng berry juice and extracts combined with other skin nutrients and moisturizers which may be used to soften and moisturize the skin, while providing essential vitamins and nutrients to the skin in a natural way. The compositions deliver natural fruit and vegetable extracts to the skin so that the skin may benefit from natural vitamins, emollients and other healthful herbs to the skin in a topical application.

Summary of the Invention

It is a principal object of the present invention to provide a herbal cleanser composition comprising a combination of extracts of organically certified herbs and naturally derived polyglucoside.

Further the object of the present invention is to provide a method of preparing a herbal cleanser composition comprising extracts of organically certified herbs along with naturally derived polyglucoside as a combination, wherein the said method is devoid of using any solvent and synthetic surfactants. Another object of the present invention is to provide herbal cleansing compositions free from any synthetic residual impurities and that ensure complete safety to the user. Yet another object of the present invention is to provide a herbal cleanser composition, wherein the said composition is effective for moisturizing the skin and conditioning the hair while having antibacterial and antimicrobial properties. The above and other objects of the present invention are attended according to following preferred embodiments of the present invention; however the scope of the invention is not restricted to the particular embodiment.

In accordance with one embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the extract is prepared by employing super critical fluid extraction or water extraction, and wherein the polyglucosides used thereby are naturally derived.

In accordance with a further embodiment of the present invention, there is provided a herbal cleanser composition, comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs selected from Aloe barbadensis, Aegle marmelose, Benincasia cerifera, Rosa centifolia Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Sapindus trifoliatus, Trigonella foenum-graecum, Hibiscus rosa-sinensis,

Pogostemon cablin, Citrus medica limonum, Oryza sattva, Cinnamomum zeylanicum, Azhadirachta indica, Curcuma longa, Ocimum sanctum, Rosemarinus officinalis,

Cymbopogon flexuous, Vetiveria zizanioides, Centella asiatica, Camellia sinensis,

Conandrum sativum, in various combinations thereof.

In accordance with another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, the said extract of herbs is obtained from a blend of herbs and wherein the blend is used in the range of 0.1% to 5%.

In accordance with another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Aloe barbadensis, Aegle marmelose, Benincasia cerifera and Rosa centifolia.

In accordance with another embodiment of the present invention, there is provided a herbal cleanser composition, comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia bellerica, Sapindus trifoliatus, Trigonella foenum-graecum, Hibiscus rosa-sinensis, Aloe barbadensis, Pogostemon cablin and Rosa centifolia. In accordance with another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Citrus medica limonum, Oryza sativa, Rosa centifolia and Cinnamomum zeylanicum.

In accordance with a further embodiment of the present invention, there is provided a herbal cleanser composition, comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Azhadirachta indica and Curcuma longa. In accordance with yet another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Sapindus trifoliatus, Rosemarinus officinalis, Cymbopogon flexuous, Rosa centifolia and Vetiveria zizanioides.

In accordance with yet another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said extract of herbs is obtained from a blend of herbs and wherein the blend of herbs comprises Centella asiatica, Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Trigonella foeum-graecum, Hibiscus rosa-sinensis, Sapindus trifoliatus, Camellia sinensis and Coriandrum sativum.

In accordance with another embodiment of the present invention, there is provided a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said composition is formulated in various kinds of cleansers. In accordance with another embodiment of the present invention, provided is a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said composition is formulated into shampoo formulation or face wash formulation.

In accordance with another embodiment of the present invention, provided is a herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the said composition is formulated into hydrating shampoo, rejuvenating shampoo, voluminising shampoo, hydrating face wash, invigorating face wash and, Neem and Turmeric face wash etc. In yet another embodiment of the present invention, there is provided an organic hydrating face wash composition, wherein the said composition comprising a herbal extract blend containing effective amounts of the extracts of Aloe barbadensis, Aegle marmelose,

Benincasia cerifera, Rosa centifolia, and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

In accordance with another preferred embodiment of the present invention, there is provided a hydrating shampoo composition, wherein said composition comprising a herbal extract blend containing effective amount of the extracts of Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia chebula, Terminalia bellβrica, Sapindus trifoliatus, Trigonella foenum-graecum, Hibiscus rosa-sinensis, Aloe barbadensis, Pogostemon cablin, Rosa centifolia and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

In accordance with another preferred embodiment of the present invention, there is provided an organic invigorating face wash composition, wherein the said composition comprising a herbal extract blend containing effective amount of the extracts of Citrus medica limonum, oryza sativa, Rosa centifolia, Cinnamomum zeylanicum, and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

In accordance with another preferred embodiment of the present invention, there is provided an organic neem & turmeric face wash composition, wherein the said composition comprising a herbal extract blend containing an effective amount of organic neem leaf extract, organic turmeric oil and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

In accordance with yet another preferred embodiment of the present invention, there is provided a voluminizing shampoo composition, wherein said composition comprising a herbal extract blend containing an effective amount of the extracts of Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Sapindus trifoliatus, Rosemarinus officinalis, Cymbopogon flexuous, Rosa centifolia, Vetiveria zizanioides and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

In accordance with another preferred embodiment of the present invention, there is provided a rejuvenating shampoo composition, wherein said composition comprising a herbal extract blend containing an effective amount of the extracts of Centella asiatica, Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Trigonella foeum-graecum, Hibiscus rosa- sinensis, Sapindus trifoliatus, Camellia sinensis, Coriandrum sativum and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients. In accordance with yet another embodiment of the present invention, there is provided a method of preparing the herbal cleanser composition, wherein the said composition is prepared by the method comprises of blending the organically certified herbs and extracting the resultant herbal blend employing super critical fluid extraction (SCFE), mixing the resultant extract of blend with naturally derived polyglucoside, mixing naturally derived excipients and essential oils.

In accordance with yet another embodiment of the present invention, there is provided a method of preparing the herbal cleanser composition, wherein said composition is prepared by the method comprises of blending the organically certified herbs and extracting the resultant herbal blend employing percolation or hot-soxhlation using water, mixing the resultant extract of blend with naturally derived polyglucoside, mixing naturally derived excipients and essential oils.

Detailed Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples.

The present invention describes the preparation of various types of herbal cleansers such as face wash gels, scrubs and shampoos for moisturizing the skin and conditioning the hair along with benefits of antibacterial, antimicrobial etc. The preparation comprises various organically certified herbal actives along with naturally derived polyglucoside as a synergistic combination for improved conditioning and cleansing properties.

Naturally derived polyglucoside unlike traditional surfactants used in personal care products, are truly multi-functional materials that can be used to provide all the desirable properties of personal care products like shampoos and face washes. They are excellent conditioners and portray good cleansing as well as antimicrobial and antibacterial properties.

The present invention refers to a safe formulation based on a combination of surfactants derived from natural ingredients and certified organic herbal actives extracted from organically cultivated plants. These surfactants are basically from renewable natural sources like sugars and are known to be totally free from any synthetic residual impurities. Since these surfactants are free from any of the known impurities, they offer an excellent safety to the user. According to one of the examples, various Face Washes are developed preferably Hydrating Face wash and Neem and Turmeric Face wash.

According to one of the examples, various Shampoos are developed preferably Hydrating shampoo/Rejuvenating shampoo/Voluminising shampoo. According to one of the examples, various Face Scrubs are developed preferably

Walnut and Wood apple face scrub.

In accordance with one embodiment, provided is a process for preparation of various types of herbal cleansers wherein the process comprises of preparing the herbal blend by mixing herbs, extracting the resultant herbal blend, mixing the herbal active and naturally derived polyglucoside, adding other naturally derived excipients and formulating the same in various compositions.

The said extract of herbs according to the present invention is obtained from a blend of herbs selected from Aloe barbadensis, Aegle marmelose, Benincasia cerifera, Rosa centifolia, Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia chebulla, Terminalia bellerica, Sapindus trifoliatus, Trigonella foenum-graecum, Hibiscus rosa- sinensis, Pogostemon cablin, Citrus medica limonum, Oryza sativa, Cinnamomum zeylanicum, Azhadirachta indica, Curcuma longa, Ocimum sanctum, Rosemarinus officinalis, Cymbopogon flexuous, Vetiveria zizanioides, Centella asiatica, Camellia sinensis, Coriander sativum, in various combinations thereof. In accordance with another preferred embodiment, provided is a process for preparation of an extract from the cited herbs, wherein a process is performed using suitable extraction technique, preferably super critical fluid extraction, cold percolation method, hot- soxhlation method or percolation method, wherein the hot-soxhlation method or percolation method is preferably used for preparation of water extract from Vetiveria zizanoides. In accordance with the present invention, the said extract of herbs can be prepared by using any part of the herbs, preferably all parts of the plant Eclipta prostrata, preferably aerial parts of Centella asiatica, preferably roots of Vetiveria zizanoides, preferably rhizomes of Glycyrrhiza glabra and Curcuma longa, preferably bark of Cinnamomum zeylanicum, preferably leaves of Aloe barbadensis, Camellia sinensis, Ocimum sanctum and Azadirachta indica, preferably flower of Hibiscus rosa-sinensis, preferably flower petals of Rosa centifolia, preferably fruit rind of Aegle marmelos and Citrus medica limonum, preferably fruits of Benincasia cerifera, Terminalia chebula, Terminalia Bellerica, Sapindus trifoliatus and Phyllanthus emblica, seeds of Trigonella foenum-graecum and Coriandrum sativum. The naturally derived excipients used in the composition include water, emollient, foaming agent, preservative, thickener or viscosity enhancer, fixative, vegetable oil and antioxidant.

The following non-limiting examples illustrate in detail about the invention. However, they are, not intended to be limiting the scope of the present invention in any manner.

Example- 1

Formulation of Organic Hydrating Face Wash (Table- 1)

Example-2 Method of Manufacturing of Organic Hydrating Face Wash

1. Charge 'Phase A' ingredients in the main vessel and mix for 20 minutes with continuous stirring at 40 rpm. Apply Vacuum at 550 mm for 60 minutes, till a clear solution is formed.

2. Weigh the 'Phase B' DM Water in a side vessel containing a high-speed propeller stirrer. Take 'Glycerin' in a side vessel and add 'Amaze-XT' slowly into the glycerin with continuous stirring to form a slurry. Add the pre-mixed phase of Glycerin and Amaze-XT into the vortex of the water. Mix it at a very high speed for about 30 minutes to form a uniform gel till there are no lumps present in the solution.

3. Charge the 'Phase C ingredients into the side vessel and mix to form a uniform solution. 4. Transfer 'Phase C into a side vessel containing Amaze-XT gel to form 'Phase

BC, and continue stirring for some time till a clear gel is formed. 5. Transfer the Amaze-XT gel 'Phase BC into the main vessel to form 'Phase ABC and mix for 20 minutes at 80rpm until no lumps remain, and then continue mixing at a slow speed of 40rpm for 10 minutes. 6. Charge the 'Phase D' ingredients into the side vessel and mix with continuous stirring for 10 minutes.

7. Transfer the pre-mixed 'Phase D' to the main vessel by passing it through a nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCD'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the gel of the main vessel and continue mixing at same speed for another 10 minutes.

8. Charge the 'Phase E' ingredient into the main vessel to form 'Phase ABCDE' and mix with continuous stirring at 40 rpm for 10 minutes.

9. Charge the 'Phase F' ingredients into the side vessel and mix with continuous stirring for 10 minutes to form a uniform blend of perfume.

10. Transfer the pre-mixed 'Phase F'; Natural Vitamin E & Essential Oils blend mixture into the main vessel to form 'Phase ABCDEF' and mix for 20 minutes.

11. Apply Vacuum pressureat 550 mm for 60 minutes, till a clear transparent gel is formed 12. Check the pH of the product, which should be in the range of pH = 5.0-6.0. 13. Submit the sample to QA Dept. for analysis.

14. Fill the product after QA Dept.'s approval.

Example-3

Formula of Organic Hvdrating Shampoo: (Table-2)

Example-4 Method of Manufacturing of Organic Hydrating Shampoo

1. Charge 'Phase A' ingredients in the main vessel and mix for 20 minutes with continuous stirring at 40 rpm. Apply Vacuum pressure at 550 mm for 60 minutes, till a clear solution is formed.

2. Weigh the 'Phase B' DM Water in a side vessel containing high-speed propeller stirrer. Take 'Glycerine' in a side vessel and add 'Amaze-XT' slowly into the glycerin with continuous stirring to form slurry. Add the pre-mixed phase of Glycerin and Amaze-XT into the vortex of the water. Mix it at very high speed for about 30 minutes to form a uniform gel till there are no lumps found in the solution.

3. Charge the 'Phase C ingredients into the side vessel and mix to form a uniform solution.

4. Transfer 'Phase C into a side vessel containing Amaze-XT gel to form 'Phase BC, and continue stirring for some time till a clear gel is formed.

5. Transfer the Amaze-XT gel 'Phase BC into the main vessel to form 'Phase ABC and mix for 20 minutes at 80rpm till no lumps remain, and then continue mixing at a slow speed at 40rpm for 10 minutes.

6. Charge the 'Phase D' ingredients into the side vessel and mix with continuous stirring for 10 minutes.

7. Transfer the pre-mixed 'Phase D' to the main vessel by passing it through a nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCD'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the main vessel and continue mixing at same speed for another 10 minutes.

8. Charge the 'Phase E' ingredients into the side vessel and heat to 70⁰C with continuous stirring for 20 minutes. Mix well and cool to 40⁰C with continuous stirring. 9. Transfer the cooled pre-mixed 'Phase E' to the main vessel by passing it through a nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCDE'. Reduce the speed to 40 rpm once 'Phase D' is mixed completely into the main vessel and continue mixing at same speed for another 10 minutes.

10. Charge the 'Phase F' ingredients into the side vessel and mix with continuous stirring for 10 minutes to form a uniform blend of perfume.

11. Transfer the pre-mixed 'Phase F' Perfume, Natural Vitamin E & Essential Oil blend mixture into the main vessel to form 'Phase ABCDEF' and mix for 20 minutes.

12. Apply Vacuum Pressure at 550 mm for 60 minutes, till all the air bubbles are removed.

13. Check the pH of the product, which should be in the range of pH 5.0-6.0.

14. Submit the sample to QA Dept. for analysis.

15. Fill the product after QA Dept.'s approval.

Example 5

Formula of Organic Invigorating Face Wash (Table-3)

Example-6 Method of Manufacturing of Organic Invigorating Face Wash

1. Charge 'Phase A' ingredients in the main vessel and mix for 20 minutes with continuous stirring at 40 rpm. Give Vacuum at 550 mm for 60 minutes, till a clear solution is formed.

5. Transfer the Amaze-XT gel 'Phase BC into the main vessel to form 'Phase ABC and mix for 20 minutes at 80rpm till no lumps remain, and then continue mixing at slow speed at 40rpm for 10 minutes.

7. Transfer the pre-mixed 'Phase D' to the main vessel by passing it through nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCD'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the gel of the main vessel and continue mixing at same speed for another 10 minutes.

8. Charge the 'Phase E' ingredient into the main vessel to form 'Phase ABCDE' and mix with continuous stirring at 40 rpm for 10 minutes. 9. Charge the 'Phase F' ingredient, Natural Walnut Shell Powder (unsterilised), for steam sterilization at a temperature of 121°C, and a pressure of 1.2 Kg/cm , for a time period of about 20-30 minutes.

10. Charge the 'Phase F' ingredient (immediately after steam sterilization), into the main vessel to form 'Phase ABCDEF' and mix with continuous stirring at 40 rpm for 10 minutes.

11. Charge the 'Phase G' ingredients into the side vessel and mix with continuous stirring for 10 minutes to form a uniform blend of perfume.

12. Transfer the pre-mixed 'Phase G' Perfume, Natural Vitamin E & Essential Oil blend mixture into the main vessel to form 'Phase ABCDEFG' and mix for 20 minutes.

13. Apply Vacuum Pressure at 550 mm for 60 minutes, till a clear transparent gel is formed

14. Check the pH of the product, which should be in the range of pH = 5.0-6.0.

15. Submit the sample to QA Dept. for analysis.

16. Fill the product after QA Dept.'s approval.

Example 7

Formula of Or anic Neem & Turmeric Face Wash Table-4

Example-8 Method of Manufacturing of Organic Neem and Turmeric Face Wash

2. Weigh the 'Phase B' DM Water in a side vessel containing high-speed propeller stirrer. Take 'Glycerine' in a side vessel and add 'Amaze-XT' slowly into the glycerine with continuous stirring to form slurry. Add the pre-mixed phase of Glycerine and Amaze-XT into the vortex of the water. Mix it at a very high speed for about 30 minutes to form a uniform gel till there are no lumps found in the solution.

4. Transfer 'Phase C into side vessel containing Amaze-XT gel to form 'Phase BC', and continue stirring for some time till a clear gel is formed.

8. Charge the 'Phase E' ingredients into the side vessel and mix with continuous stirring for 10 minutes to form a uniform blend of perfume. 9. Transfer the pre-mixed 'Phase E' Perfume, Natural Vitamin E & Essential Oil blend mixture into the main vessel to form 'Phase ABCDE' and mix for 20 minutes.

10. Apply Vacuum Pressure at 550 mm for 60 minutes, till a clear transparent gel is formed

11. Check the pH of the product, which should be in the range of pH = 5.0-6.0.

12. Submit the sample to QA Dept. for analysis.

13. Fill the product after QA Dept.'s approval.

Example 9

Formula of Organic Volumizing Shampoo (Tabled

Example- 10 Method of Manufacturing Organic Volumizing Shampoo

2. Charge the 'Phase B' ingredients, Fuller's Earth Powder (unsterilized), for steam sterilization at a temperature of 121⁰C₅ and a pressure of 1.2 Kg/cm², for a time period of about 20-30 minutes.

3. Weigh the 'Phase B' DM Water in a side vessel containing moderate-speed propeller stirrer. Charge the 'Phase B' Fuller's Earth Powder (immediately after steam sterilization), into the side vessel, adding it slowly in small quantities into the DM water with continuous stirring to form a uniform slurry free of lumps into a smooth paste.

4. Charge the 'Phase C ingredients into the side vessel and mix to form a uniform solution.

5. Transfer 'Phase C into side vessel containing Fuller's earth Dispersion to form 'Phase BC, and continue stirring for some time till it is uniformly mixed.

6. Transfer the pre-mixed' 'Phase BC into the main vessel to form 'Phase ABC and mix for 30 minutes at 40rpm till no lumps remain, Mix it at a very low speed to avoid foaming for about 10 minutes, to ensure formation of smooth and uniform slurry.

7. Charge the 'Phase D' ingredients into the side vessel and mix with continuous stirring for 10 minutes.

8. Transfer the pre-rnixed 'Phase D' to the main vessel by passing it through a nylon muslin filter with continuous stirring, at 40 rpm for 20 minutes to form 'Phase ABCD'. Reduce the speed to 40 rpm once 'Phase D' is mixed completely into the main vessel and continue mixing at same speed for another 10 minutes.

9. Charge 'Phase E' ingredients into the side vessel and heat it to 70⁰C with continuous stirring for 20 minutes. Mix well and cool to 40⁰C with continuous stirring.

10. Transfer the cooled pre-mixed 'Phase E' to the main vessel by passing it through a nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCDE'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the main vessel and continue mixing it at same speed for another 10 minutes.

11. Charge the 'Phase F' ingredients into the side vessel and mix with continuous stirring for 10 minutes to form a uniform blend of perfume.

12. Transfer the pre-mixed 'Phase F' Perfume, Natural Vitamin E & Essential Oil blend mixture into the main vessel to form 'Phase ABCDEF' and mix for 20 minutes.

13. Apply Vacuum Pressure at 550 mm for 60 minutes, till all the air bubbles are removed.

14. Check the pH of the product, which should be in the range of pH 5.0-6.0.

15. Submit the sample to QA Dept. for analysis.

16. Fill the product after QA Dept's approval.

Example- 11

Formula of Organique Rejuvenating Shampoo (Table-6)

Example- 12 Method of Manufacturing of Organique Rejuvenating Shampoo

2. Weigh the 'Phase B' DM Water in a side vessel containing a high-speed propeller stirrer. Take 'Glycerine' in a side vessel and add 'Amaze-XT' slowly into the glycerine with continuous stirring to form slurry. Add the pre-mixed phase of Glycerine and Amaze-XT into the vortex of the water. Mix it at a very high speed for about 30 minutes to form a uniform gel till there are no lumps found in the solution. 3. Charge the 'Phase C ingredients into the side vessel and mix to form a uniform solution. 4. Transfer 'Phase C into a side vessel containing Amaze-XT gel to form 'Phase

BC, and continue stirring for some time till a clear gel is formed. 5. Transfer the Amaze-XT gel 'Phase BC into the main vessel to form 'Phase ABC and mix for 20 minutes at 80rpm till no lumps remain, and then continue mixing at slow speed at 40rpm for 10 minutes. 6. Charge the 'Phase D' ingredients into the side vessel and mix with continuous stirring for 10 minutes.

7. Transfer the pre-mixed 'Phase D' to the main vessel by passing it through nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form 'Phase ABCD'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the main vessel and continue mixing at same speed for another 10 minutes.

8. Charge the 'Phase E' ingredients into the side vessel and heat to 70⁰C with continuous stirring for 20 minutes. Mix well and cool to 40⁰C with continuous stirring.

9. Transfer the cooled pre-mixed 'Phase E' to the main vessel by passing it through nylon muslin filter with continuous stirring at 60 rpm for 20 minutes to form

'Phase ABCDE'. Reduce the speed to 40 rpm once the 'Phase D' is mixed completely into the main vessel and continue mixing at same speed for another 10 minutes.

13. Check the pH of the product, which should be in the range of pH 5.0-6.0.

14. Submit the sample to QA Dept. for analysis.

15. Fill the product after QA Dept.'s approval. Example- 13

AU the herbal materials used in the extraction were either USDA/NOP certified

Organic materials or natural materials. The essential oils and fixed oils used in the formulations are either natural or Organic certified materials. The extraction methods used for preparation of actives of the cleanser formulations are mainly super critical fluid extraction (SCFE) and water extraction as per the suitability of Organic (USDA) standards.

Example 14 Preparation of extract from Rosa centi folia by Super Critical Fluid Extraction

The dried material of flower petals of Rosa centifolia was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form.

Example 15 Preparation of extract from Eclipta prostrata by Super Critical Fluid Extraction

The dried material of whole parts of Eclipta prostrata was pulverized to a coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form.

Example 16 Preparation of extract from Aloe barbadensis by Super Critical Fluid Extraction

The dried material of the leaves of Aloe barbadensis was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the most pure form. Example 17

Preparation of extract from Glycyrrhiza slabra by Super Critical Fluid Extraction The dried material of rhizomes of Glycyrrhiza glabra was pulverized to a coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form. Example 18

Preparation of extract from Phyllanthus emblica by Super Critical Fluid Extraction The dried material of fruits of Phyllanthus emblica was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 19

Preparation of extract from Terminalia chebula by Super Critical Fluid Extraction The dried material of fruits of Terminalia chebula was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form. Example 20

Preparation of extract from Terminalia belleήca by Super Critical Fluid Extraction The dried material of fruits of Terminalia- bellerica was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 21 Preparation of extract from Sapindus trifoliatus svn. mukorossi by Super Critical

Fluid Extraction

The dried material of fruits of Sapindus trifoliatus syn. mukorossi was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 22 Preparation of extract from Camellia sinensis by Super Critical Fluid Extraction

The dried material of leaves of Camellia sinensis was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 23

Preparation of extract from Hibiscus rosa-sinensis by Super Critical Fluid Extraction The dried material of flowers of Hibiscus rosa-sinensis was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 24

Preparation of extract from Centella asiatica by Super Critical Fluid Extraction The dried material of aerial parts of Centella asiatica was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 25

Preparation of extract from Ocimum sanctum by Super Critical Fluid Extraction

The dried material of leaves of Ocimum sanctum was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor 'at the temperature of 40- 50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 26 Preparation of extract from Azhadirachta indica by Super Critical Fluid Extraction

The dried material of leaves of Azhadirachta indica was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the pure form.

Example 27

Preparation of extract from Curcuma longa by Super Critical Fluid Extraction The dried material of rhizomes of Curcuma longa was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the pure form.

Example 28

Preparation of extract from Trieonella foenum by Super Critical Fluid Extraction The dried material of seeds of Trigonella foenum was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 29

Preparation of extract from Vetiveria zizanoides by Super Critical Fluid Extraction

The dried material of roots of Vetiveria zizanoides was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 30 Preparation of extract from Coriander sativum by Super Critical Fluid Extraction

The dried material of seeds of Coriander sativum was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 31

Preparation of extract from Benincasia cerifera by Super Critical Fluid Extraction The dried material of fruits of Benincasia cerifera was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 32

Preparation of extract from Aegle marmelose by Super Critical Fluid Extraction The dried material of fruit rind of Aegle marmelose was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 33

Preparation of extraction from the herbal blend of Aloe barbadensis leaf, Aegle marmelose fruit rind. Benincasia cerifera fruit and Rosa centifolia petals by Super Critical Fluid Extraction

The dried material of herbal blend of Aloe barbadensis leaf, Aegle marmelose fruit rind, Benincasia cerifera fruit and Rosa centifolia petals was pulverized to coarse powder and about 50 Kg of powdered material was placed in a SCF extractor at the temperature of 40- 5OC at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residμes of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 34

Preparation of extraction from the herbal blend of Aloe barbadensis leaf, Aegle marmelose fruit rind, Benincasia cerifera fruit and Rosa centifolia petals by Cold Percolation method

The dried material of herbal blend of Aloe barbadensis leaf, Aegle marmelose fruit rind, Benincasia cerifera fruit and Rosa centifolia petals was pulverized to coarse powder and about 50 Kg of powdered material was placed in a percolator and soaked in natural glycerine for 24 hours at room temperature. The next day the glycerine extract was decanted and filtered through muslin cloth. The glycerine extract is then subjected to steam sterilization.

Example 35

Preparation of extraction from the herbal blend of Oryza sativa (Rice), Medica limonum peel. Benincasia cerifera fruit and Cinnamomum zeylanicum bark by Super Critical Fluid Extraction

The dried material of herbal blend of Oryza sativa (Rice), Citrus medica limonum peel rind, Cinnamom zeylanicum bark was pulverized to coarse powder and about 50 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in the purest form.

Example 36 Preparation of extraction from the herbal blend of Oryza sativa (Rice), Citrus medica limonum peel, Benincasia cerifera fruit and Cinnamom zeylanicum bark by Cold Percolation method

The dried material of herbal blend of Oryza sativa (Rice), Medica limonum peel, Rosa centifolia flower petals and Cinnamom zeylanicum bark was pulverized to coarse powder and about 50 Kg of powdered material was placed in a percolator and soaked in natural glycerine for 24 hours at room temperature. The next day the glycerine extract was decanted and filtered through muslin cloth. The glycerine extract is then subjected to steam sterilization.

Example-37 Preparation of water extract from Vetiveria zizanoids by percolation method

The dried materials of roots of Vetiveria zizanoids was pulverized to coarse powder and 25 Kg of powdered material was placed in percolator soaked with purified water for 24 hours at room temperature. The next day the extract was decanted from the percolator and filtered through muslin cloth and dried to fine powder. Example-38

Preparation of water extract from Vetiveria zizanoids by hot-soxhlation method The dried materials of roots of Vetiveria zizanoids was pulverized to coarse powder and 25 Kg of powdered material was placed in soxhalator and refluxed with purified water at steam temperature for 4-6 hours. The process was repeated for three cycles and the resultant extracts were filtered through muslin cloth and concentrated to dryness.

Example-39

Clinical and Dermal Safety Evaluation of Organic Hydrating Shampoo

A clinical evaluation of Organic Hydrating Shampoo and Organic conditioner for its beneficial effects of hair nourishment' and conditioner effect was carried out during 06.12.2008 and 23.12.2008 in 9 subjects with the prior consent from the volunteers. Dermal safety evaluation was carried out in 9 subjects twice a week application for one week. Evaluation of parameters like Appearance, Fragrance, Ease of Application, Ease of

Removal, Hair texture, Hair dryness/roughness, Maintaining hair frizziness, Split end minimization, Greasy/oily hair Itching scalp, Scaling, Dandruff, Nourishment of hair was done after using Organic Hydrating Shampoo and in combination with Organic conditioner on visual analogue scale of 0-3. (O-Unpleasant, 1 -Neutral, 2-Good, 3 -Excellent) Results

1. All the 9 subjects completed the study protocol and none of them withdrew from the study.

2. Subject's compliance was very good.

3. None of the subjects exhibited any adverse effects during the study period.

4. Clinical evaluation results are mentioned in the Table-7 and dermal safety results are mentioned in Table-8

Table-7

Example-40

Clinical and Dermal safety evaluation of Organic Rejuvenating Shampoo and Organic conditioner

A clinical evaluation of Organic Rejuvenating Shampoo and Organic Rejuvenating Shampoo + Organic Conditioner was carried out during -06.12.2008 and 23.12.2008 in 20 subjects with prior consent from the volunteers. Dermal safety evaluation of Organic Rejuvenating Shampoo was carried out in 20 subjects with twice a week application for one week.

Evaluation of parameters like Appearance, Fragrance, Ease of Application, Ease of Removal, Hair texture, Hair dryness/roughness, Maintaining hair frizziness, split end minimization, Greasy/oily hair Itching scalp, Scaling, Dandruff, Nourishment of hair was done after using an Organic Hydrating Shampoo in combination with an Organic conditioner on visual analogue scale of 0-3. (0-Unpleasant, 1 -Neutral, 2-Good, 3-Excellent)

Results

1. All the 20 subjects completed the study protocol and none of them withdrew from the study.

2. Subject's compliance was very good.

3. None of the subjects exhibited any adverse effects during the study period.

4. Clinical evaluation results are mentioned in Table-9 and Dermal Safety evaluation results are mentioned in Table- 10 Table-9

Table- 10

Example-41

Clinical and Dermal safety evaluation of Organic Volumizing shampoo

A clinical evaluation of Organic Volumizing shampoo was carried out during 03.12.2008 and 23.12.2008 in 10 subjects with prior consent from the volunteer. Dermal safety evaluation was carried out in 10 subjects with twice a week application for one week.

Evaluation of parameters like Appearance, Fragrance, Ease of Application, Ease of Removal, Hair bouncing effect, Hair texture, Hair dryness/roughness, Split end minimization, Effect on hair thickness was done after using Organic Volumizing on a visual Analogue scale of 0-3 (0-Unpleasant, l-Neutral, 2-Good, 3-Excellent).

Results

1. All the 10 subjects completed the study protocol and none of them withdrew from the study.

2. Subject's compliance was very good.

3. None of the subjects exhibited any adverse effects during the study period

4. Clinical evaluation results are mentioned in Table-11 and Dermal safety evaluation results are mentioned in Table- 12

Table-11

Table-12

Example-42 Clinical and Dermal Safety Evaluation of Organic Invigorating Face Wash

A clinical evaluation of Organic Invigorating Face Wash was carried out during - 01.10.2008 and 14.10.2008 in 15 subjects with prior consent from the volunteer. Dermal safety evaluation was carried out in 15 subjects with twice a week application for 2 weeks.

Evaluation was carried for the parameters like Fragrance of the product, Product consistency, Spread ability of the product, Foam, Skin conditioning, Ease of removal, Final skin feel and Overall likeability on a Visual Analogue Scale of 10 cm. Results 1. AU the 15 subjects completed the study protocol and none of them withdrew from the study. 2. Subject's compliance was very good.

3. None of the subjects exhibited any adverse effects during the study period.

4. Evaluation of the clinical parameters are mentioned in Table- 13 and Table- 14

Table-13

Table- 14

Example- 43 A clinical study to evaluate the efficacy and safety of Hvdrating Face Wash in Dry skin

The study was an open, non-comparative, non-randomized, clinical trial. Hundred patients of both sexes, from the age group of 18-60 years, and clinically diagnosed with Dry skin were included in the study. Hydrating Face Wash was given to all the subjects and instructed to wash the face with it daily. They were advised to visit at the end of every 2nd week. The patients were assessed on the basis of reduction in oiliness, moisturizing effect, soothing effect and cleansing effect. The duration of the study was 6 weeks.

The overall clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0 and also for any reactions of erythema, irritation swelling. Indications:

As a daily application to cleanse the skin, to provide moisturizing and protective effects throughout the day.

Directions of use:

Moisten face, apply a small quantity of Hydrating Face Wash and gently work up lather with circular motion. Wash off and pat dry.

Primary and secondary endpoints: The predefined primary efficacy endpoints were rapid clinical improvement in Dry skin. The predefined secondary endpoints for short- and long-term safety were assessed by incidence of adverse events and patient compliance to the therapy. Inclusion Criteria: Hundred patients of both sexes, from the age group of 18-60 years, and presenting with Dry skin and Subjects who were willing to give a written informed consent and follow the schedule and who had not participated in a similar investigation in past four weeks were enrolled in the study Exclusion criteria: Children below eighteen years of age, pre-existing systemic disease necessitating long-term medications, genetic and endocrinal disorders, subjects with known history or present condition of allergic response to any cosmetic/Pharmaceutical products, toiletries or its components or ingredients in the test products and those who refused to give informed consent, were excluded from the study. Pregnant and lactating women were also excluded from the study.

Criteria for evaluation:

The response to therapy was evaluated at weekly intervals for 2 weeks by calculating the reduction in oiliness and the efficacy determined by the percentage reduction in the condition at the end of two weeks of treatment.

Response to therapy is evaluated on following points, cleansing effect, Moisturizing effect, soothing effect, reduction in oiliness of skin, and after feel.

Response is evaluated on the visual analogue scale of 0-3. 0-nil: 1-mild, 2- moderate: 3- severe. The scoring will be in turn co related with response to the treatment as follows. 1. Poor response < 25% reduction

2. Moderate response 25-49%

3. Good response 50-74%

4. Excellent response >75%

FOLLOW-UP AND ASSESSMENT:

Subjects will be assessed on entry, at the end of the 2nd week and at the end of 6^th Week.

The patients were assessed on the Reduction in dryness, cleansing effect, and smoothing effect, moisturizing effect all clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: good: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0

At every check-up the clinical response to the condition, any adverse events, and patient compliance was assessed. All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration, and action taken regarding the study drug. Relation of adverse events to study medication was predefined as "Unrelated" (a reaction that does not' follow a reasonable temporal sequence from the administration of the drug), "Possible" (follows a known response pattern to the suspected drug, but could have been produced by the patient's clinical state or other modes of therapy administered to the patient), and "Probable" (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient's clinical state).

Patients were allowed to voluntarily withdraw from the study, if they had experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout.

STATISTICAL ANALYSIS:

Statistical analysis was undertaken according to intention-to-treat principles. The changes in various parameters from baseline values and the values after 6 weeks were evaluated by "Paired 'f Test". The minimum level of significance was fixed at 99% confidence limit and a 2-sided/) value of <0.0001 was considered significant.

RESULTS:

Ninety-four out of hundred subjects who had participated in the trial completed the 6 weeks of follow-up. Six patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time.

Demographic data including age, gender, and history of smoking, alcohol consumption, and diet were tabulated. Also history of previous injuries or trauma and previous medication was recorded in Table -15

Table- 15

At the end of 2nd week there were 7% patients with poor response, 16 % with fair response, 34 % with good response and 43 % with excellent response, which improved to 17% patients with fair response, 38 % with good response and 45 % with excellent response at the end of 4 weeks and 12% patients with fair response, 30 % with good response and 58 % with excellent response at the end of 6 weeks given in Table -16 Table -16

Thus, significant symptomatic relief was observed after 6 weeks of treatment with Hydrating Face Wash in this clinical trial indicate that Hydrating Face Wash is effective agent in patients with Dry skin.

ADVERSE EFFECTS:

There were no patients with a poor response by the end of the study period and none of the patients reported any adverse effects during the entire period of the trial. AU volunteers displayed an adequate acceptance to the trial medications. No worsening of wound was observed in any patient during the trial. None of the patients complained of any side effects or untoward reactions in Table -17

Table-17

CONCLUSION:

The present invention describes the possible options of developing herbal cleansers for skin and hair comprising three types of face washes viz. Organique Hydrating Face Wash, Organique Invigorating Face Wash, Organique Neem & Turmeric Face Wash and three types of shampoos viz. Organique Hydrating Shampoo, Organique Volumizing Shampoo and Organique Rejuvenating Shampoo. The examples shown in the detailed description are not limited to any particular composition was an outcome of year's research in personal care formulations to bring out natural cleansers using Organic Herbal materials as actives and natural foaming agents derived from natural sources. This was an attempt to provide 100% natural personal care products to the consumers which are free from side affects and safe for prolonged use. Organic materials including herbal extracts and essential oils are free from pesticides and heavy metals serving the purpose of both beneficial effects for skin and hair and preservation properties.

While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention.

Claims

We Claim:

1. A herbal cleanser composition comprising extracts of organically certified herbs and polyglucosides, wherein the extract is prepared employing a super critical fluid extraction or water extraction, and wherein the polyglucosides used herein is naturally derived.

2. The composition according to claim 1, wherein said extract of herbs is obtained from a blend of herbs selected from Aloe barbadensis, Aegle marmelose, Benincasia cerifera, Rosa centifolia, Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Sapindus trifoliatus, Trigonella foenum-graecum, Hibiscus rosa-sinensis, Pogostemon cablin, Citrus medica limonum, Oryza sativa, Cinnamomum zeylanicum, Azhadirachta indica, Curcuma longa, Ocimum sanctum, Rosemarinus officinalis, Cymbopogon flexuous, Vetiveria zizanioides, Centella asiatica, Camellia sinensis, Coriandrum sativum, in various combination thereof.

3. The composition according to claim 2, wherein the blend is used in the range of 0.1% to 5%.

4. The composition according to claim 2, wherein the blend of herbs is comprising Aloe barbadensis, Aegle marmelose, Benincasia cerifera and Rosa centifolia.

5. The composition according to claim 2, wherein the blend of herbs is comprising Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emblica, Terminalia chebula Terminalia bellerica, Sapindus trifoliatus, Trigonella foeum-graecum, Hibiscus rosa- sinensis, Aloe barbadensis, Pogostemon cablin and Rosa centifolia.

6. The composition according to claim 2, wherein the blend of herbs is comprising Citrus medica limonum, Oryza sativa, Rosa centifolia and Cinnamomum zeylanicum.

7. The composition according to claim 2, wherein the blend of herbs iscomprising Azhadirachta indica and Curcuma longa.

8. The composition according to claim 2, wherein the blend of herbs is comprising Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Sapindus trifoliatus, Rosemarinus officinalis, Cymbopogon flexuous, Rosa centifolia and Vetiveria zizanioides.

9. The composition according to claim 2, wherein the blend of herbs is comprising Centella asiatica, Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Trigonella foeum-graecum, Hibiscus rosa-sinensis, Sapindus trifoliatus, Camellia sinensis and Coriandrum sativum.

10. The composition according to claim 1, wherein the composition is formulated in various kinds of cleansers.

11. The composition according to claim 10, wherein the composition is formulated in a shampoo formulation.

12. The composition according to claim 11, wherein the shampoo is Hydrating shampoo, Rejuvenating shampoo, Voluminising shampoo.

13. The composition according to claim 12, wherein the Hydrating shampoo comprises a blend of herbs Eclipta prostrata, Glycyrrhiza glabra, Phyllanthus emhlica, Terminalia chehula, Terminalia bellerica, Sapindus trifoliatus, Trigonella foeum-graecum, Hibiscus rosa-sinensis, Aloe barbadensis, Pogostemon cablin, Rosa centifolia and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

14. The composition according to claim 12, wherein the rejuvenating shampoo comprises a blend of herbs Centella asiatica, Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Trigonella foenum-graecum, Hibiscus rosa-sinensis, Sapindus trifoliatus, Camellia sinensis, Coriandrum sativum and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

15. The composition according to claim 11, wherein the volumizing shampoo comprises a blend of herbs Ocimum sanctum, Eclipta prostrata, Phyllanthus emblica, Sapindus trifoliatus, Rosemarinus officinalis, Cymbopogon βexuous, Rosa centifolia, Vetiveria zizanioides and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

16. The composition according to claim 10, wherein the composition is formulated into face wash.

17. The composition according to claim 16, wherein the face wash is Hydrating Face wash, Invigorating Face wash and, Neem and Turmeric face wash.

18. The composition according to claim 17, wherein the hydrating face wash composition comprises a blend of herbs Aloe barbadensis, Aegle marmelose, Benincasia cerifera and Rosa centifolia, and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

19. The composition according to claim 17, wherein the invigorating face wash composition comprises a blend of herbs Citrus medica limonum, Oryza sativa, Rosa centifolia, Cinnamomum zeylanicum, and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

20. The composition according to claim 17, wherein the neem and turmeric face wash composition comprises a blend of herbs Azhadirachta indica, Curcuma longa and naturally derived polyglucoside and pharmaceutically acceptable naturally derived excipients.

21. The composition according to claim 1, wherein said composition is prepared by a method comprising blending the organically certified herbs and extracting the resultant herbal blend employing SCFE, mixing the resultant extract of blend with naturally derived polyglucoside, mixing naturally derived excipients and essential oils.

22. The composition according to claim 1, wherein the said composition is prepared by a method comprising blending the organically certified herbs and extracting the resultant herbs employing percolation or soxhalation using water, mixing the resultant extract of blend with naturally derived polyglucoside, mixing naturally derived excipients and essential oils.