A NUTRACEUTICALS FORMULATION WITH AN ENHANCED ORGANOLEPTIC PROPERTIES USED FOR SCALP AND HAIR CARE

Abstract

Nutraceutical formulations, which could be used for scalp and hair care purposes, with enhanced organoleptie properties have elements of biological origin more particularly a herbal formulation(s).

Claims

1. A herbal formulation for scalp and hair related disorders and diseases, comprising extracts from plant material selected from plants from the group consisting of Ipomoea batatas, Trichosanthes Anguina L, Eclipta prostrata, Murraya koenigii, Phyllanthus emblica, Prunus dulcis, Juglans regia, Arachis hypogaea, Linum usitatissimum, Salvia hispanica, Cicer arietinum, Cinnamomum Zeylanicum Blume, Psidium guajava. Trigonella foenum-graecum, Moringa oleifera, Cuminum cyminum, Spinacia oleracea, Citrus X Limon and combinations thereof.

2. The herbal formulation as claimed in claim 1, comprising TABLE-US-00018 Ipomoea batatas 0%-3.5%, Trichosanthes Anguina L 0%-5.3%, Eclipta prostrata 10%-38%, Murraya koenigii 7%-35%, Phyllanthus emblica 5.3%-15.5%,, Prunus dulcis 2.5%-12.5%, Juglans regia 0.5%-7.8%, Arachis hypogaea 3.0%-11.5%, Linum usitatissimum 0.75%-7.5%, Salvia hispanica 0.5%-7.0%, Cicer arietinum 0.5%-7.0%, Cinnamomum Zeylanicum Blume 0.5%-7.0%, Psidium guajava 7%-28%, Trigonella foenum-graecum 0.5%-7.0%, Moringa oleifera 5%-15%, Cuminum cyminum 0%-3.0%, Spinacia oleracea 0%-2.5%, and Citrus X Limon 0%-2.5% as weight percent of the herbal formulation.

3. The herbal formulation as claimed in claim 1, wherein the plant material comprises Ipomoea batatas tuberous roots, Trichosanthes Anguina L cucurbit vegetable, Eclipta prostrata leaves, stem and flowers, Murraya koenigii leaves, Phyllanthus emblica fruit, Prunus dulcis seeds, Juglans regia seeds, Arachis hypogaea seeds, Linum usitatissimum seeds, Salvia hispanica seeds, Cicer arietinum seeds, Cinnamomum Zeylanicum Blume bark, Psidium guajava leaves, Trigonella foenum-graecum seeds, Moringa oleifera leaves, Cuminum cyminum seeds, Spinacia oleracea leaves, Citrus X Limon fruit.

4. The herbal formulation as claimed in claim 1, comprising: TABLE-US-00019 Ipomoea batatas 0.5%, Trichosanthes Anguina L 0.5%, Eclipta prostrata 23.5%, Murraya koenigii 20%, Phyllanthus emblica 10.0%, Prunus dulcis 6.0%, Juglans regia 3.0%, Arachis hypogaea 6.1%, Linum usitatissimum 3.0%, Salvia hispanica 3.0%, Cicer arietinum 3.0% Cinnamomum Zeylanicum Blume 3.0%, Psidium guajava 15.2%, Cuminum cyminum 1.2%, Spinacia oleracea 1.0%, and Citrus X Limon 1.0% as weight percent of the berhal formulation.

5. The herbal formulation as claimed in claim 1, comprising: TABLE-US-00020 Ipomoea batatas 1.0%, Trichosanthes Anguina L 1.5%, Eclipta prostrata 20.0%, Murraya koenigii 16.5%, Phyllanthus emblica 8.5%, Prunus dulcis 6.0%, Juglans regia 3.0%, Arachis hypogaea 5.8%, Linum usitatissimum 3.0%, Salvia hispanica 3.0%, Cicer arietinum 3.0%, Cinnamomum Zeylanicum Blume 3.0%, Psidium guajava 11.4%, Trigonella foenum-graecum 3.0%, Moringa oleifera 9.1%, Cuminum cyminum 1.2%, Spinacia oleracea 0.5%, and Citrus X Limon 0.5% as weight percent of the herbal formulation.

6. (canceled)

7. (canceled)

8. (canceled)

9. A method of promoting hair growth and reducing hair loss comprising: administering to a subject an effective amount of herbal formulation as claimed in claim 1 for a time sufficient for hair treatment or a scalp treatment.

10. The method as claimed in claim 9, wherein the hair treatment is selected from the group consisting of male pattern baldness, female pattern baldness, male pattern hair loss, female pattern hair loss, reduction of hair loss, hair follicle strengthening, hair texture improvement, hair growth rate increase, and combinations thereof.

11. The method as claimed in claim 9, wherein the scalp treatment is selected from the group consisting of eczema, dermatitis, psoriasiss, dandruff, folliculitis, an inflammatory condition, and combinations thereof.

12. The method as claimed in claim 9, wherein the hair treatment is male pattern and/or female pattern baldness.

Description

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS

[0041] FIG. 1: Female Pattern Hair LossLudwig Scale Representation

[0042] FIG. 2: Male Pattern Hair LossNorwood Scale Representation

[0043] FIG. 3: Hair Pull TestPhotographic Representation

[0044] FIG. 4: Female Subject Hair Density photos from Phototrichogram

[0045] FIG. 5: Male Subject Hair Density photos from Phototrichogram

[0046] FIG. 6: Hair Density Test data plot for all subjects at the start and week 24 of clinical trial

[0047] FIG. 7: Hair Growth Rate data plot for all subjects at the start and week 24 of clinical trial

[0048] FIG. 8: Hair Thickness data plot for all subjects at the start and week 24 of clinical trial

[0049] FIG. 9: Hair Tensile Strength data plot for all subjects at the start and week 24 of clinical trial

[0050] FIG. 10: Hair Fall DataComb Test with Bulb data plot for all subjects at the start and week 24 of clinical trial

[0051] FIG. 11: Hair Fall DataComb Test without Bulb data plot for all subjects at the start and week 24 of clinical trial

[0052] FIG. 12: Hair Texture Rating data plot for all subjects at the start and week 24 of clinical trial

[0053] FIG. 13: Hair Shine Rating data plot for all subjects at the start and week 24 of clinical trial

[0054] FIG. 14: Hair Thinning (10-point Photonumerical Rating) data plot for all subjects at the start and week 24 of clinical trial

[0055] FIG. 15: Representative Photographs of hair thinning differences of two male subjects at the beginging and at week 24 of the clinical trial

[0056] FIG. 16: Representative Photographs of hair thinning differences of two female subjects at the beginging and at week 24 of the clinical trial

DETAILED DESCRIPTION

[0057] The following presents a detailed description of various embodiments of the present subject matter with reference to the accompanying drawings. The embodiments of the present subject matter are described in detail with reference to the accompanying drawings. However, the present subject matter is not limited to these embodiments which are only provided to explain more clearly the present subject matter to a person skilled in the art of the present disclosure.

[0058] As used herein, the singular forms a, an and the are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms includes, comprises, including and/or comprising when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term and/or includes any and all combinations of one or more of the described ingredients having similar properties.

[0059] The subject matter described herein relates to a method of improving functional and organoleptic properties of natural products and nutraceutical composition(s) thereof for hair care management including reducing hair fall, improving hair strength, hair density, hair shine and scalp conditions such as dandruff, folliculitis and Psoriasis.

[0060] The herbal formulation for scalp and hair related disorders and diseases, comprising extracts from Ipomoea batatas, Trichosanthes Anguina L, Eclipta prostrata, Murraya koenigii, Phyllanthus emblica, Prunus dulcis, Juglans regia, Arachis hypogaea, Linum usitatissimum, Salvia hispanica, Cicer arietinum, Cinnamomum Zeylanicum Blume, Psidium guajava, Trigonella foenum-graecum, Moringa oleifera, Cuminum cyminum, Spinacia oleracea, Citrus X Limon.

[0061] The preferred embodiment of the present invention, the herbal organoleptic formulation used for scalp and hair related disorders and diseases, comprising of Ipomoea batatas 0%-3.5%, Trichosanthes Anguina L 0%-5.3%, Eclipta prostrata 10%-38%, Murraya koenigii 7%-35%, Phyllanthus emblica 5.3%-15.5%, Prunus dulcis 2.5%-12.5%, Juglans regia 0.5%-7.8%, Arachis hypogaea 3.0%-11.5%, Linum usitatissimum 0.75%-7.5%, Salvia hispanica 0.5%-7.0%, Cicer arietinum 0.5%-7.0%, Cinnamomum Zeylanicum Blume 0.5%-7.0%, Psidium guajava 7%-28%, Trigonella foenum-graecum 0.5%-7.0%, Moringa oleifera 5%-15%, Cuminum cyminum 0%-3.0%, Spinacia oleracea 0%-2.5%, Citrus X Limon 0%-2.5%

[0062] As the embodiment of the present invention, the herbal formulation comprises plant extracts of parts of the plants preferably are Ipomoea batatas tuberous roots, Trichosanthes Anguina L cucurbit vegetable, Eclipta prostrata leaves, stem & flowers, Murraya koenigii leaves, Phyllanthus emblica fruit, Prunus dulcis seeds, Juglans regia seeds, Arachis hypogaea seeds, Linum usitatissimum seeds, Salvia hispanica seeds, Cicer arietinum seeds, Cinnamomum Zeylanicum Blume bark, Psidium guajava leaves, Trigonella foenum-graecum seeds, Moringa oleifera leaves, Cuminum cyminum seeds, Spinacia oleracea leaves, Citrus X Limon Fruit.

[0063] As the more preferred embodiment of the present invention, the formulation preferably comprising the herbal constituents in the ration of Ipomoea batatas 0.5%, Trichosanthes Anguina L 0.5%, Eclipta prostrata 23.5%, Murraya koenigii 20.0%, Phyllanthus emblica 10.0%, Prunus dulcis 6.0%, Juglans regia 3.0%, Arachis hypogaea 6.1%, Linum usitatissimum 3.0%, Salvia hispanica 3.0%, Cicer arietinum 3.0%, Cinnamomum Zeylanicum Blume 3.0%, Psidium guajava 15.2%, Cuminum cyminum 1.2%, Spinacia oleracea 1.0%, Citrus X Limon 1.0%.

[0064] As yet another embodiment, the formulation of the present invention, preferably comprises the herbal constituents in the ratio of Ipomoea batatas 1.0%, Trichosanthes Anguina L 1.5%, Eclipta prostrata 20.0%, Murraya koenigii 16.5%, Phyllanthus emblica 8.5%, Prunus dulcis 6.0%, Juglans regia 3.0%, Arachis hypogaea 5.8%, Linum usitatissimum 3.0%, Salvia hispanica 3.0%, Cicer arietinum 3.0%, Cinnamomum Zeylanicum Blume 3.0%, Psidium guajava 11.4%, Trigonella foenum-graecum 3.0%, Moringa oleifera 9.1%, Cuminum cyminum 1.2%, Spinacia oleracea 0.5%, Citrus X Limon 0.5%.

[0065] The herbal formulation used for the treatment of cosmetic condition selected from male pattern baldness, female pattern baldness, male pattern hair loss, female pattern hairloss, Hair fall reduction, hair follicle strength, hair texture, hair growth rate and scalp conditions including dandruff, folliculitis and Psoriasis.

[0066] The herbal formulation used for the treatment of hair loss resulting from skin condition selected from Eczema, dermatitis, Psoriasiss or other inflammatory condition and/or due to age. More particularly, the present herbal formulation used for the treatment of male pattern and female pattern baldness.

[0067] As an embodiment of the present invention, a method of promoting hair growth and reducing hair loss comprising administering to a subject an effective amount of herbal formulation of the present invention for a time sufficient for hair regrowth and reduce hair fall.

[0068] The foregoing and further objects, features and advantages of the present subject matter will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings.

[0069] It is to be noted, however, that the appended drawings illustrate only typical embodiments of the present subject matter, and are therefore, not to be considered for limiting of its scope, for the subject matter may admit to other equally effective embodiments.

Multi Herbal System Requirement

[0070] Most single herbs and spices to provide a particular functionality exhibit certain predominant mechanism of action. If we take hair care management, there are many factors that contribute towards hair loss. They include physiological factors, hormonal factors, environmental factors such as exposure to pollution and psychosomatic factors such as stress and general consequences of ageing.

[0071] A single herb or spice or plant may deliver one or more active ingredients that can impact a particular hair loss pathway. Due to diversity of physiology among humans, there could be one or more pathways that are deficient in the hair loss pathway. By consuming one herb they may or may not effectively address the needs of a particular individual in managing their hair loss. A multi-herbal system can address these short comings by simultaneously addressing various regulation pathways and therefore the probability of a multi-herbal system to address the hair loss management deficiencies increases significantly.

Consuming Many Herbs

[0072] While consuming multiple herbs would greatly help with addressing hair care management needs of many individuals, the challenges of developing and consuming multiple herbs daily poses several difficulties: 1. Identification of effective herbal formulation of multiple herbs; 2. Most of the herbs could only be effective when consumed in huge quantities lifelong which is practically not possible; 3. The organoleptics of most natural materials are not suitable for daily consumption to deliver benefits continuously, 4. Achieving compliance remains a challenge with herbal formulations. The above are the most primary roadblocks towards development and administration of a multi-herbal formulations from the all the other issues known to a person skilled in the art.

Quantity of Herbs

[0073] The quantity of each of the herbs to deliver the required functionality is often large.

[0074] Consuming large quantity of herbs and also herbs that have pungent taste like garlic makes it very difficult to comply. This is due to low solubility of active ingredients in water. Most beneficial properties are delivered to a particular organ in a water-soluble form to deliver the desired functionality.

[0075] The multi-herbal system developed by the inventors of the present invention, with the active ingredients in a water soluble form, the current invention delivers all the benefits of multiple herbs in a water soluble form that have shown to delivery benefits to a much larger cross section of subjects who may individually require assistance from specific target mechanisms which can differ from individual to individual. The formulation with multiple herbs addresses all aspects of hair fall including Hair Growth Rate, Hair Density, Hair Volume, Hair thickness, Hair Fall and scalp conditions such as dandruff, folliculitis and Psoriasis

Herbs & Spices Used in Current Invention

[0076] Ipomoea batatas or Sweet potatoes are a great source of beta-carotene. The body converts this compound into vitamin A, which is linked to good hair health. A medium sweet potato (about 114 grams) contains enough beta-carotene to provide more than four times the daily vitamin A needs. Research has shown that vitamin A promotes the production of sebum, which helps keep hair healthy. Further, vitamin A could also speed up the rate of hair growth and encourage the growth of thicker hair, all while preventing other hair follicles from regressing

[0077] Trichosanthes Anguina L or Snake Gourd is a vegetable which is a good source of Vitamin A, Vitamin B and Vitamin C. It also contains constituents like flavonoids, carotenoids, phenolic acids. For people suffering from alopecia, snake gourd is said to stimulate the growth of new hair and protect weakening follicles from hair loss. This can be attributed to it is rich mineral and vitamin content, particularly high levels of carotenes, which specifically delivers skin and hair benefits. It is also claimed that snake gourd can reduce the frequency and intensity of dandruff.

[0078] Eclipta prostrata or Flase Daisy is known improves blood circulation and is capable of revitalizing the hair follicles and facilitating hair growth. It is also known to show benefits with respect to reduction in dandruff and graying. False daisy plant oils are said to alleviate inflammation when massaged into the scalp or skin. It can also increase the thickness and luster of hair as well as prevent split ends.

[0079] Murraya koenigii or Curry leaves are rich in antioxidants. These antioxidants neutralize the free radicals and keep your hair healthy and strong. They are a good source of proteins and beta-carotene. Both of these nutrients prevent hair loss and thinning. The leaves are also rich in amino acids that help strengthen follicles and keep them healthy. Further, hair follicles get clogged due to factors, such as an oily scalp, pollution, and the build-up of products. The clogged follicles leave the scalp feeling irritated, causing itching, dandruff, and hair fall. Curry leaves can effectively treat these problems.

[0080] Phyllanthus emblica or Indian Gooseberry, also called Amla fruits have been long used as a hair growth nourishment in traditional Tibetan and Ayurvedic medicine. It has been shown to stimulate proliferation of Dermal Papilla (DP) cells in a concentration-dependent manner, promoting hair growth by effectively enlarging size and prolonging the anagen phase through the proliferative effect on DP cells.

[0081] Prunus dulcis or Almonds nourishes and moisturizes the scalp to reduce flakiness, nourishes hair strands, soften them & prevent the damage caused by hair styling products. Almonds contain vitamins B (particularly riboflavin, thiamine and niacin) and E, protein, fibre, calcium, magnesium, iron, phosphorus, zinc and folate, all of which are beneficial to hair health.

[0082] Juglans regia or Walnuts contains potassium, omega-3, omega-6, and omega-9 fatty acids which make the hair strong from the root to the tip. Walnuts are very effective to remove dandruff permanently from the scalp. Essential oils present in walnuts are beneficial to improve blood circulation in the scalp and enhance hair strength. Walnuts also offer anti-bacterial properties to address scalp infections.

[0083] Arachis hypogaea or ground nut are a rich source of biotin, also known as vitamin B7. They are also a good source of Vitamin E. Biotin and Vitamin E has been shown to not only stimulate hair growth, but also prevent hair loss.

[0084] Linum usitatissimum or Flaxseeds are rich in Vitamin E and Omega-3 fatty acids. Rich in Vitamin E, it promotes the health of the scalp by reducing free radical damage. It helps improve circulation in the head, thus promoting hair growth and slowing down hair breakage. It may also help prevent premature greying of hair. Some studies have shown that omega 3 may help prevent hair loss and thinning of hair, as well as dry scalp and even dandruff.

[0085] Salvia hispanica or Chia Seeds have a high content of phosphorous, an ingredient thought to encourage hair growth. Chia seeds contain building block of protein, 1-lysine is known to promote hair growth. Chia seeds also contains Omega-3 fatty acids that are critical to help prevent hair loss.

[0086] Cicer arietinum or Chick Peas or Besan is rich in antioxidants, folic acid, iron, copper, zinc, magnesium, selenium, and niacinall of these nourish hair follicles and improve growth. Chick peas are rich in antioxidants which protect the hair from damaging effects of free radicals. They are also rich in proteins which helps to nourish the hair and combat hair loss. Chick peas also contains molybdenum which is known to support the scalp tissue and surrounding hair follicles so the hair has a strong foundation to grow from.

[0087] Cinnamomum Zeylanicum Blume or Cinnamon, when applied to the scalp, increases circulation to the hair follicles and encourages the growth of new strands. Cinnamon is also a potent antimicrobial and can prevent buildup on the scalp from common problems that cause hair loss like dandruff and fungal infections.

[0088] Psidium guajava or Guava leaves contain vitamin B and C, which help boost collagen activity required for hair growth. The vitamin C content improves collagen activity aiding in hair growth and the lycopene content gives protection from sun's UV rays.

[0089] Trigonella foenum-graecum or Fenugreek seeds contains high protein and nicotinic acid content, which are known to be beneficial against hair fall and dandruff, and in treating a variety of scalp issues like dryness of hair, baldness and hair thinning.

[0090] Moringa oleifera or drumstick leaves, due to the presence of a multitude of vitamins and minerals, the leaf of the moringa provides hair with protection from damage, may reduce shedding, dandruff, and promote new hair growth.

[0091] Cuminum cyminu or Cumin seeds contains some nutrients and vitamins which enable healthy hair growth and also improves the overall health of hair. Cumin helps in reducing hair fall and baldness and also known to improve texture and increase shininess. Cumin seeds encourage hair growth and strengthen hair follicles. Cumin oil also acts as a natural moisturiser and reduces the dryness on the scalp and hence prevents hair fall

[0092] Spinacia oleracea or Spinach is rich in vitamins K, A, C, B2, B6, B1, E, manganese, zinc, iron, and omega-3 fatty acids. These nutrients help nourish scalp and hair, ensuring healthy hair growth. The high content of antioxidants in spinach helps avoid hair damage and boosts scalp health. Vitamin B and C contained in spinach are excellent for encouraging healthy hair growth. They speed up the rate of hair growth by increasing collagen and keratin levels. The rich iron content helps increase the supply of oxygen to the hair follicles, ensuring that they stay in top health. Spinach has anti-inflammatory properties that help soothe an aggravated scalp.

[0093] Citrus X Limon or Lemon Lemons are rich in vitamin C. This vitamin can improve the rate at which your hair grows by boosting the production of collagen. It helps clean the scalp and unclog hair follicles. Clogging of the follicles often leads to issues, such as dandruff and hair fall. Lemon has antifungal properties which can can help maintain scalp health and curb issues like dandruff and scalp acne.

Storage of Herbs & Spices, Grinding and Processes for Enhancing Organoleptic Properties of Herbs and Spices

[0094] The herbs and spices used in the present invention are being preferably stored under controlled conditions of temperature & humidity and are processed as discussed in detail in the Indian Patent application no: 202041041780. The formulation and the composition of the multiherb extract for current application in hair and/or scalp related illnesses and for a routine hair care regimen i.e. in a hair care management is accordingly modified.

[0095] As yet another embodiment of the present invention the instant formulation is based on supplying nutrients to hair follicles and the skin layers surrounding hair follicles. Skin conditions such as psoriasis, Acne, dandruff, eczema and psoriasis may also cause loss of hair.

[0096] Acne is a skin condition that occurs when your hair follicles become plugged with oil and dead skin cells. It causes whiteheads, blackheads or pimples. Acne is most common among teenagers, though it affects people of all ages. Effective acne treatments are available, but acne can be persistent.

[0097] Eczema, or dermatitis, is a skin condition that causes patches of itchiness, inflammation, swelling, and cracked skin.

[0098] Dandruff is a mild form of seborrheic dermatitis. The exact cause of seborrheic dermatitis is not known, but it's likely a combination of things like too much skin oil (sebum) in the oil glands and hair follicles, a type of yeast found on the skin called Malassezia, environmental & lifestyle factors such as stress, cold and dry winter weather, and some hair care products may make dandruff worse.

[0099] Psoriasis is an inflammatory condition and therefore, inflammation-fighting foods are recommended. Antioxidants like vitamin C, vitamin E, beta-carotene, and selenium are known to provide relief.

[0100] The current formulation can provide a boost and improve hair re-growth as they contain various compounds that reduce inflammation, provide rich sources of anti-oxidants and also other nutrients and minerals that are supplied to the hair follicles and adjoining skin cells to speed up the recuperation processes.

EXAMPLES

[0101] The present invention is represented below by the help of representative examples. The examples do not limit the scope of the present invention and are incorporated for the purposes of disclosing the best mode of the invention and workability.

Mixed Herbs Formulation

[0102] Herbs and spices were purchased and stored as per storage conditions specified in the Indian Patent application no: 202041041780. The following formulation 1 and 2 are summarized in Table 1 and Table 2 and covers the formulations used in the Examples 1 & 2 to demonstrate the various benefits in hair care herbal waters use.

TABLE-US-00001 TABLE 1 Weight % Herbal Ingredient Scientific Name Formulation 1 Ipomoea batatas 0.5% Trichosanthes Anguina L 0.5% Eclipta prostrata 23.5% Murraya koenigii 20.0% Phyllanthus emblica 10.0% Prunus dulcis 6.0% Juglans regia 3.0% Arachis hypogaea 6.1% Linum usitatissimum 3.0% Salvia hispanica 3.0% Cicer arietinum 3.0% Cinnamomum Zeylanicum Blume 3.0% Psidium guajava 15.2% Cuminum cyminum 1.2% Spinacia oleracea 1.0% Citrus X Limon 1.0% Total 100.0%

TABLE-US-00002 TABLE 2 Weight % Herbal Ingredient Scientific Name Formulation 2 Ipomoea batatas 1.0% Trichosanthes Anguina L 1.5% Eclipta prostrata 20.0% Murraya koenigii 16.5% Phyllanthus emblica 8.5% Prunus dulcis 6.0% Juglans regia 3.0% Arachis hypogaea 5.8% Linum usitatissimum 3.0% Salvia hispanica 3.0% Cicer arietinum 3.0% Cinnamomum Zeylanicum Blume 3.0% Psidium guajava 11.4% Trigonella foenum-graecum 3.0% Moringa oleifera 9.1% Cuminum cyminum 1.2% Spinacia oleracea 0.5% Citrus X Limon 0.5% Total 100.0%

Example 1

[0103] Mixed herbal powder Formulation 1 summarized in Table 2 was used in the test. 14 kg of this mixed herbal powder was dispersed in 56 litres of water. The slurry was kept in suspension with a motorized impeller for 12 hours. The resultant slurry was charged to a 100 litre glass batch distillation still along condenser with a 2.5 sq m condensing surface area. The condenser was water cooled where water circulating at 3 deg C inlet and 5 deg c outlet temperature. The glass vessel was immersed in a 50/50 ethylene glycol batch and heat input to the ethylene glycol was provided by an electrical heating element which was set at 150 deg C. The process was operated for 5 hours at a vacuum of 0.1 mm Hg (0.1 torr) and 30 litres of the herbal concentrate was collected. The boiling point of the batch was 41 deg C. Overall process yield from herbal water to herbal condensate was 53.6%. The herbal condensate was crystal clear and free of any color.

[0104] Herbal extract produced was used as an adjunctive supplement in hair care as the ingredients used in the formulation are well known to be effective in various aspects of hair care.

[0105] An open label, monocentric, safety and efficacy study to evaluate the safety and efficacy of hair health including hair growth, density, follicle strength and hair fall benefits in healthy subjects was undertaken. Total of 67 subjects were screened and 40 subjects were enrolled in the study and 36 subjects completed the study. Among 36 subjects 25 were female subjects and 11 were male subjects.

[0106] Subject selection inclusion and exclusion criteria was as follows:

Inclusion Criteria

[0107] Male and female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment. [0108] Subjects in the age group of 35-50 years (both ages inclusive). [0109] Subjects complaining of hair fall and damage. [0110] Hair density measurement between 150-250 hair follicle per square cm as per Trichoscan measurement. [0111] Male & female subjects falling under Grade 3-Grade 6 of hair loss severity grade evaluated as per photo numerical 10-point scale (Linear scale for assessment purpose-In use Scale). [0112] Subjects with normal thyroid range. [0113] Subjects who agrees not to use any other product/treatment/home remedy for hair except the provided product during the study period. [0114] Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration. [0115] Subjects who agree to refrain from using hair dye/hair colour during the study period. [0116] Subjects who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study. [0117] Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up. [0118] Subjects willing to abide by and comply with the study protocol.

Exclusion Criteria

[0119] Subjects who have undergone hair growth treatment within 3 months before screening into the study. [0120] Subjects having any active scalp disease which may interfere in the studydermatologist's judgement. [0121] Subjects who are anaemic (based on RBC count). [0122] Subjects who smoke or drink. [0123] Subjects who are on crash dieting. [0124] Subjects on oral medications such as vitamin supplements, including multi-vitamins which will compromise the study. [0125] Subjects under medical treatment for hair problems, prescription drugs such as Minoxidil, Finasteride, or any 5 -reductase inhibitor or light therapy. [0126] Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study. [0127] Subjects who have history of alcoholism, smoking, crash dieting and/or psychiatric disorder including trichotillomania. [0128] Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems. [0129] A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. [0130] Subjects on oral medications, undergoing any chemical hair salon treatment-straightening/perming/colour which will compromise the study. [0131] Subjects who are pregnant or lactating or nursing as established with medical history. [0132] Menopausal female subjects as determined by medical history. [0133] Subjects with chronic illness which may influence the cutaneous state. [0134] Subjects participating in other similar cosmetic or therapeutic trial within last three months. [0135] Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.

Herbal Water Administration

[0136] Each subject was administered 15 ml of herbal water described in Example 1 which was mixed with 500 ml of water and consumed throughout the day for 180 days.

Subject Investigation Schedule

[0137] Visit 1: Pre-screening: The subjects will be required to visit the site for blood collection for CBC and thyroid condition.

[0138] Visit 2: Screening visit, shaving and baseline assessment visit (day 1)

[0139] Visit 3: Baseline assessmentHair Density measurement (day 3) (to qualify a subject on inclusion criteria point 4.)

[0140] Visit 4: Shaving and assessment visit (day 60)

[0141] Visit 5: Assessment visit (day 62)

[0142] Visit 6: Shaving and assessment visit (day 120)

[0143] Visit 7: Assessment visit (day 122)

[0144] Visit 8: Shaving and assessment visit (day 178)

[0145] Visit 9: Assessment visit (day 180)

Parameters Investigated

[0146] Efficacy assessment parameters monitored during the study were as follows: [0147] Hair growth rate and hair density using Trichoscan [0148] Hair fibre thickness using Dinolite. [0149] Hair fall assessment by hair comb test, pull test. [0150] Hair strength assessment by tensile test. [0151] Hair fibre thinning assessment by dermatological assessment using global images. [0152] Dermatological assessment on hair quality and site application reaction. [0153] Health and fitness Monitoring

[0154] The study was registered CTRI (Clinical Trial Registry of India) after independent ethics committee approval of the study and before enrolment of first subject.

Tests Methods

Comb Test

[0155] When the hair is detangled with comb as a usual practice, it results in hair fall due to combing force.

[0156] The fallen hair can be characterized in two categories: [0157] 1. From the rootthe hair fibre seen with bulb. These are generally fibres in the telogen phase of the [0158] hair cycle that fall off easily. [0159] 2. From the shaftthe breakage of hair from shaft is a direct result of applied force on weaker and damaged hair. This can be identified by a shorter hair (shorter than actual hair length) without any bulb.

[0160] This test was performed on visits 2, 4 ,6 and 8.

Methodology of Hair Combing:

[0161] Subjects are asked to partition the hair in two equal halves left and right. They are given a standard tooth comb, to comb each half of the hair in continuous stroking. Number of strokes for each half of [0162] the scalp is fixed (to 10 strokes). The fallen hair is collected on a white sheet and are counted as with and without bulb.
Data recorded: [0163] Count of total number of hair fall with bulb. [0164] Count of total number of hair fall without bulb.

Hair Pull Test

[0165] From the vertex of the scalp, a bundle of about 50-60 hair is grasped between the thumb, index finger, and middle finger from the base near the scalp. The hair is firmly, but not forcibly, tugged away from the scalp as fingers slide along the hair shaft. Afterwards the number of extracted hair is counted. FIG. 3 shows is a photographic representation of the hair pull test.

[0166] To avoid the biased due to applied force, the assessment was performed by trained evaluators only under dermatologist's supervision. The subjects washed their hair in a manner that there was a minimum of 24 hrs gap between the last wash and the next visit.

[0167] This test was performed on visits 2, 4,6 and 8. The scores were given based on the following attributes as summarized in Table 3.

TABLE-US-00003 TABLE 3 Score Condition (No. Hair strands) 1 None (0) 2 Negligible (1-2) 3 Mild (3-4) 4 Moderate (5-6) 5 Severe (more than 6)

Hair Thinning Measurements

[0168] The hair thinning was graded using a 10-point photo numerical linear scale for male & female subjects on all assessment visits by the Dermatologists.

[0169] Norwood scale for male subjects (7-point scale) and Ludwig scale for female subjects was used for assessment. This test was performed on visits 2, 4 ,6 and 8.

Hair Growth Rate Measurements

[0170] The assessment was performed by Phototrichogram assessment using Cutiscope on Trichoscan software. An area on the vertex of the scalp was shaved by trimmer and captured using microscopic camera. This is a quantitative assessment technique to count hair growth rate as p.m/day. The assessment using Phototrichogram was performed on all visits except screening.

Hair Density Measurements

[0171] The assessment was performed by Phototrichogram assessment using Cutiscope on Trichoscan software. An area on the vertex of the scalp will be shaved by trimmer and captured using microscopic camera. Number of follicles in the area was counted by the software. An increased follicular density could be a result of prolonged hair cycle in anagen phase with less hair fall or higher rejuvenation of follicles. This assessment was performed on visit 3, 5,7 and 9. This is a quantitative assessment technique to count hair density as number of hair/cm2.

Hair Thickness Measurements

[0172] Hair thickness assessment was performed using Dinolite camera using Caselite software. This assessment was performed on visit 2, 4 ,6 and 8.

Hair Tensile Strength

[0173] Three hair samples were used to measure the hair tensile strength of the hair fiber. Three hair fibers or more were cut from each subject to perform tensile test. The hair fiber was attached in root to tip alignment and was pulled at a fixed force and speed. The force at which the hair breaks was recorded and analyzed. Higher the break force, higher the tensile strength of the hair. The method involved using Chatillon Motorized Force Tester. This assessment was performed on visit 2, 4 ,6 and 8.

Data analysis and Statistics

[0174] Table 4 below sumamrises the statistical analysis of the data from the clinical trial

TABLE-US-00004 TABLE 4 Statistical Significance Statistics test used Description level Normality Shapiro-Wilk p-value from Shapiro-Wilk 5% Checking Test normality test at baseline Efficacy Paired t-test/ Mean Value comparison 5% Checking Wilcoxon signed rank test for paired samples

[0175] All statistical tests used significance level of 0.5. Two tailed test was performed for all analysis. All p-values were rounded to 4 decimal places. All p-values that round to 0.000 was presented as <0.0001 and p-values that round to 1.000 was be presented as >0.9999. Any p-value 0.05 was considered statistically significant as sumamrised below: [0176] Suggestively significant for p-values 0.05<p<0.09 [0177] Statistically significant for p-value 0.05

Data Summary

Hair Density

[0178] The assessment was performed by Phototrichogram assessment using Cutiscope on Trichoscan software. An area on the vertex of the scalp was shaved by trimmer and captured using microscopic camera. Number of follicles in the area was counted by the software for hair density. An increased follicular density could be a result of prolonged hair cycle in anagen phase with less hair fall or higher rejuvenation of follicles. Increase in mean value is sign of improvement in hair density. Table 5 sumamrises the hair density test values. FIGS. 4 and 5 shows photographs of two clinical trial participants' hair density photos from phototrichogram along with measured density values. FIG. 6 is plot of hair density values of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00005 TABLE 5 Baseline Week 8 Week 16 Week 24 All Subjects Average 178.98 188.70 201.34 213.90 Change vs. baseline 5.4% 12.5% 19.5% p-value <0.0001 <0.0001 <0.0001 Female Subjects Average 178.05 188.27 200.53 212.71 Change vs. baseline 5.7% 12.6% 19.5% p-value <0.0001 <0.0001 <0.0001 Male Subjects Average 181.08 189.67 203.17 216.60 Change vs. baseline 4.7% 12.2% 19.6% p-value <0.0001 <0.0001 <0.0001

[0179] Data on hair density clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair density at all-time points in comparison with baseline. Every subject's hair density at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Growth Rate

[0180] The assessment was performed by Phototrichogram assessment using Cutiscope on Trichoscan software. An area on the vertex of the scalp was shaved by trimmer and captured using microscopic camera. This was a quantitative assessment technique to count hair growth rate as m/day. Increase in mean value is sign of improvement in hair growth rate. Table 6 summarises hair growth rate data for the subjects. FIG. 7 is plot of hair growth rate values of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00006 TABLE 6 Baseline Week 8 Week 16 Week 24 All Subjects Average 273.70 287.36 311.53 331.76 Change vs. baseline 5.0% 13.8% 21.2% p-values <0.001 <0.001 <0.001 Female Subjects Average 276.00 290.80 313.20 332.60 Change vs. baseline 5.4% 13.5% 20.5% p-values <0.001 <0.001 <0.001 Male Subjects Average 268.48 279.55 307.73 329.85 Change vs. baseline 4.1% 14.6% 22.9% p-values <0.001 <0.001 <0.001

[0181] Data on hair growth rate clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair growth rate was measured at all-time points in comparison with baseline. Every subject's hair growth rate at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Thickness

[0182] Hair thickness assessment was performed using Dinolite camera using Caselite software. Increase in mean value is sign of improvement in hair thickness. Table 7 sumamrises hair thickness data for the subjects. FIG. 8 is plot of hair thickness values of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00007 TABLE 7 Baseline Week 8 Week 16 Week 24 All Subjects Average 40.54 46.31 49.59 53.02 Change vs. baseline 14.2% 22.3% 30.8% p-values <0.0001 <0.0001 <0.0001 Female Subjects Average 40.09 45.94 49.10 52.47 Change vs. baseline 14.6% 22.5% 30.9% p-values <0.0001 <0.0001 <0.0001 Male Subjects Average 41.61 47.18 50.76 54.30 Change vs. baseline 13.4% 22.0% 30.5% p-values <0.0001 <0.0001 <0.0001

[0183] Data on hair thickness clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair thickness was measured at all-time points in comparison with baseline. Every subject's hair thickness at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Tensile Strength

[0184] Three hair fibers or more were cut from each subject to perform tensile test. The hair fiber was attached in root to tip alignment and was pulled at a fixed force and speed. The force at which the hair breaks was recorded and analyzed. Higher the break force, higher the tensile strength of the hair. The method involved using Chatillon Motorized Force Tester. Increase in mean value is sign of improvement in hair tensile strength. Table 8 summarises hair tensile strength data for the subjects. FIG. 9 is plot of hair tensile strength values of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00008 TABLE 8 Baseline Week 8 Week 16 Week 24 All Subjects Average 0.69 0.72 0.76 0.78 Change vs. baseline 4.9% 10.3% 13.7% p-value <0.0001 <0.0001 <0.0001 Female Subjects Average 0.68 0.72 0.75 0.78 Change vs. baseline 4.9% 10.3% 13.9% p-value <0.0001 <0.0001 <0.0001 Male Subjects Average 0.69 0.72 0.76 0.78 Change vs. baseline 5.0% 10.4% 13.3% p-value <0.0001 <0.0001 <0.0001

[0185] Data on hair thickness clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair tensile strength that was measured at all-time points in comparison with baseline. Every subject's hair tensile strength at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Comb Test

[0186] Subjects were asked to partition the hair in two equal halves left and right. A standard tooth comb was provided to comb each half of the hair in continuous stroking. Number of strokes for each half of the scalp was fixed (to may be 10 strokes). The fallen hair was collected on a white sheet and were counted as with bulb and without bulb. Decrease in mean value is sign of improvement in hair fall. Table 9 summarises hair comb test data for the subjects. FIG. 10 is plot of hair comb test values with bulb of each subject at the commencement of the trial and at the end of the week 24 of the trial. FIG. 11 is plot of hair comb test values with without bulb of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00009 TABLE 9 Number of hair with bulb Number of hair without bulb Baseline Week 8 Week 16 Week 24 Baseline Week 8 Week 16 Week 24 All Subjects Average 31.54 20.35 10.86 7.43 16.46 12.73 7.62 5.24 Change vs. baseline 35.5% 65.6% 76.4% 59.6% 75.8% 83.4% p-values <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 Female Subjects Average 38.35 24.69 13.46 9.42 20.35 15.42 9.54 6.73 Change vs. baseline 35.6% 64.9% 75.4% 59.8% 75.1% 82.4% p-values <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 Male Subjects Average 15.45 10.09 4.73 2.73 7.27 6.36 3.09 1.73 Change vs. baseline 34.7% 69.4% 82.4% 58.8% 80.0% 88.8% p-values <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

[0187] Data on comb test clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair fall (with and without bulb) at all time points in comparison with baseline. Every subject's hair fall (with and without bulb) at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Pull Test

[0188] From the vertex of the scalp, a bundle of about 50-60 hair was grasped between the thumb, index finger, and middle finger from the base near the scalp. The hair was firmly, but not forcibly, tugged away from the scalp as fingers slide along the hair shaft. Afterwards the number of extracted hairs was counted. Decrease in mean value is sign of improvement in hair fall. Table 10 summarises hair pull test data for the subjects. FIG. 12 is plot of hair pull test values of each subject at the commencement of the trial and at the end of the week 24 of the trial.

TABLE-US-00010 TABLE 10 Baseline Week 8 Week 16 Week 24 All Subjects Average 2.57 2.24 1.82 1.30 Change vs. baseline 12.6% 28.9% 49.2% p value <0.0001 <0.0001 <0.0001 Female Subjects Average 2.73 2.33 1.84 1.33 Change vs. baseline 14.8% 32.7% 51.4% p value <0.0001 <0.0001 <0.0001 Male Subjects Average 2.18 2.05 1.80 1.25 Change vs. baseline 6.3% 17.7% 42.7% p value <0.0001 <0.0001 <0.0001

[0189] Data on hair pull test clearly demonstrates that with daily intake of herbal water, significant improvement was noted in reduction in hair fall at all time points in comparison with baseline. The herbal water exhibited similar performance among male and female subjects.

Dermatological Assessments

[0190] Evaluation was done on comparative scales prepared using hair swatches to aid in subjective assessment. Higher mean value is sign of improvement

Hair Texture

[0191] The following scale was used for rating hair texture changes during the course of the clinical trial: Scale: 1=Very rough hair, 2=Rough hair, 3=Average hair texture (neither rough nor smooth), 4=Smooth hair, 5=Very smooth hair

[0192] Table 11 summarises the hair texture ratings among the clinical trial subjects. FIG. 12 shows the hair texture rating plots for all subjects at the start of the clinical trial and at the end of week 24 of the trial.

TABLE-US-00011 TABLE 11 Baseline Week 8 Week 16 Week 24 All Subjects Average 2.43 3.00 4.19 4.70 Change vs. baseline 23.3% 72.2% 93.3% p-value <0.0001 <0.0001 <0.0001 Female Subjects Average 2.42 3.00 4.23 4.69 Change vs. baseline 23.8% 74.6% 93.7% p-value <0.0001 <0.0001 <0.0001 Male Subjects Average 2.45 3.00 4.09 4.73 Change vs. baseline 22.2% 66.7% 92.6% p-value <0.0001 <0.0001 <0.0001

[0193] Data on hair texture ratings demonstrate that with daily intake of herbal water, significant improvement was noted in hair texture at all time points in comparison with baseline. Every subject's hair texture at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Shine

[0194] The following scale was used for rating hair texture changes during the course of the clinical trial: Scale: 1=No shine, 2=Slightly visible shine, 3=Moderately visible shine, 4=Visible shine, 5=Highly visible shine

[0195] Table 12 summarises the hair shine ratings among the clinical trial subjects during the course of the clinical trial. FIG. 13 shows the hair shine rating plots for all subjects at the start of the clinical trial and at the end of week 24 of the trial.

TABLE-US-00012 TABLE 12 Baseline Week 8 Week 16 Week 24 All Subjects Average 2.08 3.00 4.14 4.51 Change vs. baseline 44.2% 98.7% 116.9% p-value <0.0001 <0.0001 <0.0001 Female Subjects Average 2.08 3.00 4.15 4.62 Change vs. baseline 44.4% 100.0% 122.2% p-value <0.0001 <0.0001 <0.0001 Male Subjects Average 2.09 3.00 4.09 4.27 Change vs. baseline 43.5% 95.7% 104.3% p-value <0.0001 <0.0001 <0.0001

[0196] Data on hair shine ratings demonstrate that with daily intake of herbal water, significant improvement was noted in hair shine at all time points in comparison with baseline. Every subject's hair shine at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited similar performance among male and female subjects.

Hair Thinning Based on 10 Point Photo Numerical Linear Scale

[0197] The hair thinning was graded using a 10-point photo numerical linear scale for male & female subjects on all assessment visits by the Dermatologists. Lower value indicates improvement in hair thinning. Table 13 summarises the hair thinning ratings among the clinical trial subjects during the course of the clinical trial. FIG. 14 shows the hair thinning rating plots for all subjects at the start of the clinical trial and at the end of week 24 of the trial.

TABLE-US-00013 TABLE 13 Baseline Week 8 Week 16 Week 24 All Subjects Average 3.62 3.42 3.07 2.81 Change vs. Baseline 5.6% 15.3% 22.4% p-Value <0.0001 <0.0001 <0.0001 Female Subjects Average 3.65 3.38 3.02 2.73 Change vs. Baseline 7.4% 17.4% 25.3% p-Value <0.0001 <0.0001 <0.0001 Male Subjects Average 3.55 3.50 3.18 3.00 Change vs. Baseline 1.3% 10.3% 15.4% p-Value 0.3409 0.0004 <0.0001

[0198] Data on hair thinning demonstrate that with daily intake of herbal water, significant improvement was noted in hair thinning at all time points in comparison with baseline. Every subject's thinning at the end of the trial improved than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 36 clinical trial participants. The herbal water exhibited better performance among female than male subjects. The hair thinning score among female subjects was statistically significant by week 8 of the trial whereas for male subjects the data achieved suggestively significant between week 8 and week 16 and statistically significant from week 16 onwards.

Hair Thinning Based on Ludwig Scale (Female Subjects)

[0199] Assessments on hair thinning as per Ludwig Scale was performed. FIG. 1 schematically represents the Ludwig Scale. In this assessment, Lower grade indicates improvement in hair thinning. Table 14 summarises the Ludwig Scale hair thinning assessments conducted during the course of the clinical trial.

TABLE-US-00014 TABLE 14 Hair Thinning data of Female subjects (Frequency) Baseline Week 8 Week 16 Week 24 I-I 0 1 8 12 I-2 12 13 6 7 I-3 6 5 6 2 I-4 4 3 2 2 II-1 3 3 3 2 II-2 1 1 1 1

[0200] Observation: [0201] 1. At Week 8: 1 subject was noted to shift from 1-4 to 1-3, 2 subjects were noted to shift from 1-3 to 1-2 and 1 subject was noted to shift from 1-2 to I-I implying reduction in hair thinning [0202] 2. At Week 16: 1 subject was noted to shift from 1-4 to 1-3. 7 subjects were noted to shift from 1-2 to I-I implying reduction in hair thinning [0203] 3. At Week 24: 1 subject was noted to shift from II-1 to 1-4. 1 subject was noted to shift from 1-4 to 1-3. 5 subjects were noted to shift from 1-3 to 1-2. 4 subjects were noted to shift from 1-2 to I-I implying reduction in hair thinning

Hair Thinning Based on Norwood Scale (Male Subjects)

[0204] Assessments on hair thinning as per Ludwig Scale was performed. FIG. 2 schematically represents the Ludwig Scale. In this assessment, Lower grade indicates improvement in hair thinning. Table 15 summarises the Ludwig Scale hair thinning assessments conducted during the course of the clinical trial.

TABLE-US-00015 TABLE 15 Baseline Week 8 Week 16 Week 24 Type I-Grade 1 1 1 1 1 Type II = Grade 2 1 1 1 1 Type II-Grade 2 4 4 4 5 Type III Vertex = Grade 3 2 2 2 1 Type III = Grade 3 3 3 3 3

[0205] One (1) subject was noted to shift from Type III vertex=Grade 3 to type II=Grade 2 on the Norwood Scale implying reduction in hair thinning at week 24.

Hair Thinning Representative Photographs

[0206] FIGS. 15 & 16 shows representative photographs of Male and Female subjects respectively at the beginning and end of the trial. The data clearly pictorially demonstrates the improvement of hair thinning characteristics at the end of the week 24 of consuming herbal water formulation for hair care.

Example 2

[0207] Mixed herbal powder Formulation 2 summarized in Table 3 was used in the test. 14 kg of this mixed herbal powder was dispersed in 56 litres of water. The slurry was kept in suspension with a motorized impeller for 12 hours. The resultant slurry was charged to a 100 litre glass batch distillation still along condenser with a 2.5 sq m condensing surface area. The condenser was water cooled where water circulating at 3 deg C inlet and 5 deg c outlet temperature. The glass vessel was immersed in a 50/50 ethylene glycol batch and heat input to the ethylene glycol was provided by an electrical heating element which was set at 150 deg C. The process was operated for 5 hours at a vacuum of 0.1 mm Hg (0.1 torr) and 30 litres of the herbal concentrate was collected. The boiling point of the batch was 40.5 deg C. Overall process yield from herbal water to herbal condensate was 53.6%. The herbal condensate was crystal clear and free of any color.

[0208] Herbal extract produced was used as an adjunctive supplement in hair care as the ingredients used in the formulation are well known to be effective in various aspects of hair care.

[0209] A study with 10 subjects to evaluate the safety and efficacy of hair health using hair fall benefits in healthy subjects was undertaken. Each subject consumed 15 ml of herbal water mixed with 500 ml of water and consumed throughout the day for a period of 16 weeks.

[0210] Hair fall was quantified among the ten subjects with the comb test described in detail in Example 1. Hair fall was measured with and without the bulb. Table 16 summarizes data on hair fall during the course of the trial.

TABLE-US-00016 TABLE 16 Number of hair with bulb Number of hair without bulb Baseline Week 8 Week 16 Baseline Week 8 Week 16 All Subjects Average 35.00 23.00 10.32 18.30 11.76 7.32 Change vs. baseline 34.3% 70.5% 35.7% 60.0% p-values <0.0001 <0.0001 <0.0001 <0.0001

[0211] Data on comb test clearly demonstrates that with daily intake of herbal water, significant improvement was noted in hair fall (with and without bulb) at all time points in comparison with baseline. Every subject's hair fall (with and without bulb) at the end of the trial was higher than at the start of the trial, thereby indicating that the herbal water was 100% effective among all 10 participants.

[0212] By combining multiple herbs into an easily consumable water format with good organoleptic properties in addition to good functional properties, it allows easy consumption of the herbal waters on a daily basis by subjects.

[0213] The significant improvements on all aspects of hair care including hair density, hair thickness, hair fall, hair tensile strength, hair thinning among 100% of the 36 subjects who completed the test indicates the herbal water formulation delivers required efficacy. The product performance attributes were similar for male and female subjects.

Example 3

[0214] The performance of herbal eater extract of the present invention is compared against Minoxidil and a herbal supplement in a capsule form under the brand name Nutrafol.

[0215] Minoxidil (2,4-diamino-6-piperidinopyrimidine 3-oxide), is a medication used for the treatment of high blood pressure and pattern hair loss in males and females. It is an antihypertensive vasodilator which is also believed to improve blood flow to the scalp. It is available as a generic medication by prescription in oral tablet form and over the counter as a topical liquid or foam.

[0216] Nutrafol is a Nutraceutical Supplement containing Synergen Complex (Circumin, Ashwagandha, Saw Palmetto and tocotrenols) administered in a capsule form with 4 capsules administered once per day.

[0217] Table 17 compares the clinical data with Minoxidil administered in oral form at 5mg dose and Nutrafol along with comparative data from clinical trial with the present invention. Hair density changes for men shows equivalent performance of the current invention versus Minoxidil consumed in an oral form. Hair thickness of the present invention is shown to be over two times that of Oral Minoxidil.

[0218] The present invention clinical data showed almost twice higher density improvements versus Nurafol Herbal Supplement.

[0219] Further, the present herbal water has been tested to show very similar performance in male and female participants in not only hair density and hair diameter, as summarized in Example 2, hair growth rate, hair tensile strength, hair fall, hair texture has all shown very similar improvements.

TABLE-US-00017 TABLE 17 Comparative performance of Oral Minoxidil, Nutrafol Supplement & Herbal Water based Oral Nutraceutical Supplement from present invention Hair Density in 1 sq cm area Hair Diameter Clinical Week 12 Week 24 Week 12 Week 24 Treatment Trial Details Day 0 (Day 84) (Day 168) Day 0 (Day 84) (Day 168) Oral Minoxidil (1) 30 men consuming 182.5 208.5 217.6 58.5 64.7 67.4 Oral Minoxidil, 5 mg for 24 weeks Increase vs Day 0 14.2% 19.2% 10.6% 15.2% Day 0 Day 90 Day 180 Nutraceutical Supplement Randomized Double 141.7 151.4 156.4 (Nutrafol Capsules) Blind Study of 40 containing Synergen women Complex (containing (treatment n = 26, Circumin, Ashwagandha, Placebo n = 14 Saw Palmetto and tocotrenols) (2) Increase vs Day 0 6.8% 10.4% Day 0 Week 8 Week 16 Week 24 Day 0 Week 8 Week 16 Week 24 Present Invention Open Label, men (n = 179 188.7 201.3 213.9 40.5 46.3 49.6 53.0 (Herbal Water 11) & women (n = 26) - nutraceutical All Subjects oral consumption) Increase vs Day 0 5.4% 12.5% 19.5% 14.2% 22.3% 30.8% Male Subjects (n = 11) 181.1 189.7 203.2 216.6 41.6 47.2 50.8 54.3 Increase vs Day 0 4.7% 12.2% 19.6% 13.4% 22.0% 30.5% Female Subjects (n = 26) 178.1 188.3 200.5 212.7 40.1 45.9 49.1 52.5 Increase vs Day 0 5.7% 12.6% 19.5% 14.6% 22.5% 30.9% (1) Panchaprateep, R., Lueangarun, S. Efficacy and Safety of Oral Minoxidil 5 mg Once Daily in the Treatment of Male Patients with Androgenetic Alopecia: An Open-Label and Global Photographic Assessment. Dermatol Ther (Heidelb) 10, 1345-1357 (2020). https://doi.org/10.1007/s13555-020-00448-x (2) Ablon G, Kogan S. A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. J Drugs Dermatol. 2018 May 1; 17(5): 558-565. PMID: 29742189.

[0220] Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense as it will become apparent to persons skilled in the art upon reference to the description of the invention. It is therefore, contemplated that such modifications can be made without departing from the spirit or scope of the present invention as defined.