Patent Application
20240074964
The subject matter described herein, in general, relates to a nutraceuticals formulation, which could be used for Skin care purposes, with an enhanced organoleptic properties. Said formulation have elements of biological origin more particularly a herbal formulation(s).
Sunlight is a major cause of the skin changes we think of as aging—changes such as wrinkles, dryness, and age spots. As people age skin changes in many ways. For example, one tends to sweat less, leading to increased dryness. As skin ages, it also becomes thinner and loses fat, so it looks less plump and smooth. Underlying structures—veins and bones in particular—become more prominent. Skin can take longer to heal when injured.
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes we inherit is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by the following:
The epidermis, dermis and subcutaneous tissues are the top, middle and bottom layers of the skin respectively. The top layer shows the wrinkles, age spots, deep lines, and depressions. The skin dermis contains macromolecules, polysaccharides, glycosaminoglycans (GAGs), fibrous protein (collagens, elastin), salts and water which together are known as the extra cellular matrix, responsible for tissue cohesion.
The subcutaneous tissues contain fatty deposits. Another part of the skin is the sebaceous glands that produce sebum which lubricates the skin and keeps it soft and smooth. All three skin layers contribute to the aging process. As a person gets older, less sebum is produced, and this makes the epidermis drier. Dry skin is more prone to wrinkling.
Signs of ageing includes facial wrinkles, pigmentation, fine lines, crow's feet and Nasolabial folds. Ageing also impacts texture and elasticity of the skin.
Pigmentation errors like uneven skin tone, blemishes, blotchiness and spots also results in varied reflectance of light from the skin surface and results in dullness of the skin. It is also known that skin hydration, skin texture and pigmentation concerns can impact the skin glow.
Wrinkles
Over time, the sun's ultraviolet (UV) light damages the fibers in the skin called elastin. The breakdown of these fibers causes the skin to lose its ability to snap back after stretching. As a result, wrinkles form. Most wrinkles associated with aging appear on the parts of the body where sun exposure is greatest. These sites are the face, neck, the backs of the hands, and the tops of the forearms. Wrinkles come in two categories: fine surface lines and deep furrows related to muscular contraction. Gravity also is at work, pulling at the skin and causing it to sag, most noticeably on the face, neck, and upper arms.
Cigarette smoking also contributes to wrinkles. People who smoke tend to have more wrinkles than nonsmokers of the same age, complexion, and history of sun exposure. The reason for this difference is not clear. It may be because smoking also plays a role in damaging elastin. Facial wrinkling increases with the number of cigarettes and number of years a person has smoked.
Dry Skin and Itching
Many older individuals suffer from dry skin, particularly on their lower legs, elbows, and forearms. The skin feels rough and scaly and often is accompanied by a distressing, intense itchiness. Low humidity—caused by overheating during the winter and air conditioning during the summer—contributes to dryness and itching. The loss of sweat and oil glands as you age also may worsen dry skin. Anything that further dries your skin—such as overuse of soaps, antiperspirants, perfumes, or hot baths—will make the problem worse. Dehydration, sun exposure, smoking, and stress also may cause dry skin.
Dry skin and itching can affect sleep, cause irritability, or be a symptom of a disease. For example, diabetes and kidney disease can cause itching.
One thing that we cannot change is the natural aging process. It plays a key role. With time, we all get visible lines on our face. It is natural for our face to lose some of its youthful fullness. We notice our skin becoming thinner and drier. Our genes largely control when these changes occur. The medical term for this type of aging is “intrinsic aging.”
We can influence another type of aging that affects our skin. This relates to our environment and lifestyle choices which can cause our skin to age prematurely. The medical term for this type of aging is “extrinsic aging.” By taking some preventive actions, we can slow the effects that this type of aging has on our skin.
Ways to Reduce Premature Skin Aging
There are many ways to reduce premature ageing. These methods normally are temporary and are summarized below:
Several interventions described above work on protective mechanisms and use of topical solutions that basically address skin health superficially. Further many surgical interventions that have become popular involve surgical/plastic surgery procedures and injecting serums, Botox treatments to provide foundational base of fats and saccharides to the inner layers of the skin. These interventions only achieve superficial and temporary results.
The present invention pertains to use of herbal extracts from various herbs and spices that are consumed in a water-soluble form that modifies the intrinsic properties of the skin by addressing the fundamental mechanisms that cause skin conditions such as wrinkles, blemishes, pigmentation, and other disorders such as eczema and psoriasis. These conditions may arise from variety of factors including normal ageing process, exposure to sun light, hormonal imbalances and inflammation.
While wrinkles are formed as a natural part of the ageing process, which tend to be accentuated by UV exposure, many hormonal changes also tend to accelerated skin wrinkles. Estrogen stimulates collagen, one of the proteins responsible for the elasticity and smoothness of the skin. With less estrogen circulating in the bloodstream, women are more likely to develop fine lines, wrinkles, and loose skin. In men, lower testosterone levels can cause a similar effect on the skin. Many of the commonly consumed foods, herbs, and spices contain phytoestrogens and phytoprogestins that act as agonists and antagonists in vivo.
The biggest risk factors for general hyperpigmentation are sun exposure and inflammation, as both situations can increase melanin production. Hormonal influences are the main cause of a particular kind of hyperpigmentation known as melasma or chloasma. It's particularly common among women and is thought to occur when the female hormones estrogen and progesterone stimulate the overproduction of melanin when skin is exposed to the sun. Many natural materials including various herbs have shown to be effective to address hyperpigmentation.
Psoriasis is a skin disorder that causes skin cells to multiply up to 10 times faster than normal. This makes the skin build up into bumpy red patches covered with white scales. Psoriasis is thought to be an immune system problem. Topical ointments, light therapy, and medications can offer temporary relief. By addressing immunity related issues at the root cause level such as nutraceuticals that deliver antioxidants the herbal formulations can address these issues holistically.
While the exact cause of eczema is unknown, researchers do know that people who develop eczema do so because of a combination of genes and environmental triggers. When an irritant or an allergen from outside or inside the body “switches on” the immune system, it produces inflammation. It is this inflammation that causes the symptoms common to most types of eczema. So in many cases herbal nutraceuticals tend to address the causative environmental factors that may cause inflammation such as allergens and tend to address root causes of eczema
Wound & Burn Healing and Scarring:
Wound healing is a complex biological process that consists of hemostasis, inflammation, proliferation, and remodeling. Large numbers of cell types—including neutrophils, macrophages, lymphocytes, keratinocytes, fibroblasts, and endothelial cells—are involved in this process. Multiple factors can cause impaired wound healing by affecting one or more phases of the process and are categorized into local and systemic factors.
Burn injuries are caused by fires or flames, hot liquids or steam, contact with a hot object or agent like grease or tar, chemicals, or electricity. First-, Second- or Third-degree burns are classified based on the layers of skin that are impacted. Treatments can range from simple at home treatments to ointments & bandages to surgery and grafting to address more severe third-degree burns.
Herbal extract ingredients contain anti-bacterial, anti-fungal, anti-viral, anti-microbial, anti-inflammatory and anti-oxidant properties. These ingredients can also assist in treating skin wounds and burns by preventing infection, speeding up the healing process and reducing bruising and scarring. They promote faster healthy skin rejuvenation and hydration while helping the immune system fight bacteria. Active ingredients in turmeric (Curcuma longa), long pepper (Curcuma longa), guava leaves (Psidium guajava), basil (Ocimum basilicum) and chia seeds (Salvia hispanica) are known to possess the desired properties to enhance wound & burn healing, skin rejuvenation, increase in wound breaking strength while protecting the skin layers from infections as an adjuvant therapy.
Skin Dryness and Itchiness
As we age, sweat and oil glands don't produce as much moisture. Fat and collagen, substances that gives skin its elasticity, decrease and Skin becomes thinner. Skin that's too dry may crack open and bleed. These cracks expose the body to germs that can cause infections. Some illnesses, including diabetes and kidney disease, can cause dry, itchy skin. As a result, the cumulative effect of these changes results in dry skin on our legs, elbows, arms or other parts of the body. The medical term for dry skin is xerosis. Allergies (dermatitis), irritants and skin conditions like eczema can also make skin dry and itchy.
Moisturizers are the mainstay of treatment for most types of dry skin. They smooth and soften dry skin to help prevent cracking and work to recreate your natural skin barrier. Moisturizing products come in ointments, creams, lotions and oils.
The ingredients used in the current invention and the accompanying examples show significant impact of consuming the herbal waters on various parameters pertaining to skin health and particularly skin hydration, glow, elasticity characteristics and described in detail in Example 1. These ingredients therefore will assist in lowering skin dryness and itchiness.
Vitiligo
Vitiligo occurs when immune cells destroy the cells that make brown pigment called melanocytes. This destruction is thought to be due to an autoimmune problem. An autoimmune disorder occurs when the body's immune system, which normally protects the body from infection, attacks and destroys healthy body tissue instead. The exact cause of vitiligo is unknown.
There is no cure for vitiligo but several treatment options are available. Therapies include steroids and the combination of ultraviolet light in combination with creams. Due to the higher risks of skin cancer, phototherapy is used only if primary treatments are ineffective.
The ingredients found in current formulation are known to possess immunity boosting and anti-inflammatory properties. The current formulation has shown to address other autoimmune based disorders such as eczema and psoriasis and therefore could also address Vitiligo as an adjunctive therapy.
Skin & Hair Conditions in Chemotherapy
Cancer treatment can affect a person's skin, hair, and nails. The reason chemotherapy can cause hair loss is that it targets all rapidly dividing cells—healthy cells as well as cancer cells. Hair follicles, the structures in the skin from which hair grows, include some of the fastest-growing cells in the body. Other conditions that occur as a result of chemo therapy include, rashes, dry & itchy skin, nail conditions that cause nails to lift, break, or develop light or dark streaks or grooves.
Acne, also known as acne vulgaris, is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and possible scarring which mostly impacts teenage population. It primarily affects skin with a relatively high number of oil glands, including the face, upper part of the chest, and back. Treatments for acne are available, including lifestyle changes, medications, and medical procedures. Treatments applied directly to the affected skin, such as azelaic acid, benzoyl peroxide, and salicylic acid, are commonly used. Antibiotics and retinoids are available in formulations that are applied to the skin and taken by mouth for the treatment of acne. However, resistance to antibiotics may develop as a result of antibiotic therapy. Herbal ingredients with anti-inflammatory, anti-bacterial, immunity enhancing and exfoliating properties have been shown the be effective in treatment of Acne.
By consuming nutraceuticals from herbs and spices, the required ingredients for skin health are supplied to various layers of the skin to provide and inside out solution to skin health versus topical solutions which tend to be external and temporary in nature. Further, Acanthosis nigricans (AN), is a skin condition that causes small patches of skin, often near the knuckles, to darken, thicken, and become velvety to the touch.
Splits may occur in the fingernails, resulting in thin layers of the nails peeling back. There are many different causes of peeling or splitting nails. This condition is called Onychoschizia. Nails consist of layers of a protective fibrous protein called keratin that also occurs in skin and hair. Keratin makes the nails strong, but various underlying health conditions can cause thin layers of the nail to peel away.
By consuming nutraceuticals from herbs and spices, the required ingredients for skin health are supplied to various layers of the skin to provide and inside out solution to skin health versus topical solutions which tend to be external and temporary in nature.
In the last three decades, a lot of concerted efforts have been channeled into researching into local plants with therapeutic values to address various health and wellness issues. The beneficial effects of some of these plants, herbs or spices have been validated and others disproved.
It is an object of the present invention to provide for a water based herbal formulation that addresses skin care management, skin related disorders and diseases among human subjects. The product formulation is prepared using the embodiments described in the Indian Patent application no: 202041041780 and the same is incorporated herewith by reference.
A herbal formulation for skin care management comprising essentially of a therapeutically effective amount of Daucus carota, Amaranthus gangeticus L., Eclipta prostrata, Phyllanthus emblica, Curcuma longa, Piper longum, Psidium guajava, Ocimum basilicum, Salvia hispanica, Juglans regia, Linum usitatissimum, Prunus dulcis, Piper nigrum, Murraya koenigii, Glycyrrhiza glabra, Cinnamomum Zeylanicum Blume, Cuminum cyminum, Trigonella foenum-graecum, Beta vulgaris, Punica granatum.
The aforesaid herbal formulation broadly comprises of the herbal constituents in the range of Daucus carota 0%-2.0%, Amaranthus gangeticus L 0-0.5%, Eclipta prostrata 0%-1.5%, Phyllanthus emblica 1.5%-10.5%, Curcuma longa 1.0%-11.0%, Piper longum 0.5%-6.5%, Psidium guajava 7.0%-30%, Ocimum basilicum 5.0%-28.0%, Salvia hispanica 0.5%-6.5%, Juglans regia 2.0%-27.5%, Linum usitatissimum 0.75%-6.5%, Prunus dulcis 1.75%-15.0%, Piper nigrum 1%-10%, Murraya koenigii 1.25%-7.5%, Glycyrrhiza glabra 1.0%-11.0%, Cinnamomum zeylanicum Blume 2%-13.5%, Cuminum cyminum 0.25%-6.0%, Trigonella foenum-graecum 3.5%-22.0%, Beta vulgaris 0%-1.5%, Punica granatum 0%-2.85%.
The herbal formulation of the present invention could be manufactured using parts of the plants used for preparing the extracts are Daucus carota seeds, Amaranthus gangeticus L leaves, Eclipta prostrata leaves & stem, Phyllanthus emblica fruit, Curcuma longa root, Piper longum fruit, Psidium guajava leaves, Ocimum basilicum leaves, Salvia hispanica Seeds, Juglans regia Seed, Linum usitatissimum Seeds, Prunus dulcis Seeds, Piper nigrum flower, Murraya koenigii leaves, Glycyrrhiza glabra root, Cinnamomum zeylanicum Blume bark, Cuminum cyminum seeds, Trigonella foenum-graecum seeds, Beta vulgaris taproot, Punica granatum seeds & fruit.
As another embodiment the herbal formulation of the present invention comprises of the herbal constituents present in the range of Daucus carota 1.0%, Amaranthus gangeticus l 0.1%, Eclipta prostrata 0.70%, Phyllanthus emblica 6.0%, Curcuma longa 6.0%, Piper longum 2.4%, Psidium guajava 18.0%, Ocimum basilicum 17.7%, Salvia hispanica 3.6%, Juglans regia 6.0%, Linum usitatissimum 3.0%, Prunus dulcis 6.0%, Piper nigrum 4.0%, Murraya koenigii 2.8%, Glycyrrhiza glabra 5.8%, Cinnamomum zeylanicum Blume 5.5%, Cuminum cyminum 3.0%, Trigonella foenum-graecum 7.0%, Beta vulgaris 0.4%, Punica granatum 0.9%.
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.
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.
The subject matter described herein relates to a method of improving functional and organoleptic properties of natural products and nutraceutical composition(s) thereof for the better skin care management.
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.
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
Most single herbs and spices to provide a particular functionality exhibit certain predominant mechanism of action. If we take skin care management, there are multiple processes that impact quality of skin care including skin elasticity, skin texture, skin hydration, pigmentation. These are complex processes that impact the skin tone and texture attributes known to those skilled in human physiology. A single herb or spice or plant may deliver one or more active ingredients that can impact a particular beneficial pathway. Due to diversity of physiology among humans, there could be one or more pathways that are deficient in the skin health pathway. By consuming one herb they may or may not effectively address the needs of a particular individual in skin care management. A multi-herbal system can address these short comings by simultaneously addressing various pathways and therefore the probability of a multi-herbal system to address the skin care management deficiencies increases significantly.
Consuming Many Herbs
While consuming multiple herbs would greatly help with addressing skin 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 or in topical applications in huge quantities lifelong which is humanly not possible; 3. The organoleptics of most natural materials are not suitable for daily consumption to deliver benefits continuously, 4. Achieving patient 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
The quantity of each of the herbs to deliver the required functionality is often large. Further, consuming large quantity of herbs and also herbs that have pungent tast'1q3w2e like ginger 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 needed benefit.
The multi-herbal system developed by the inventors of the present invention, with the active ingredients in a water-soluble form. All the benefits of multiple herbs in a water-soluble form have shown to deliver benefits to a much larger cross section of subjects.
Herbs & Spices Used in Current Invention
The object of the present invention is to provide a herbal composition comprising herbs from different families such as Daucus carota, Amaranthus gangeticus L, Eclipta prostrata, Phyllanthus emblica, Curcuma longa, Piper longum, Psidium guajava, Ocimum basilicum, Salvia hispanica, Juglans regia, Linum usitatissimum, Prunus dulcis, Piper nigrum, Murraya koenigii, Glycyrrhiza glabra, Cinnamomum zeylanicum Blume, Cuminum cyminum, Trigonella foenum-graecum, Beta vulgaris, Punica granatum.
Daucus carota Seeds or carrot seeds has several skin care benefits, together with the ability to rejuvenate dry and mature skin. “Carotol,” a key component found in carrot seed oil is known to help firm and tone skin.
Amaranthus gangeticus L or Purple Amaranth are a storehouse of essential phytonutrients and antioxidants which help to reduce inflammation. The presence of an essential amino acids called lysine along with other elements are said to help fight against free radicals that result in wrinkles and signs of premature ageing, eczema and acne.
Eclipta prostrata or False Daisy is rich in anti-oxidants. Clinical studies indicate its benefits in skin care through lowering oxidative stress, including Ultraviolet (UV) irradiation-induced skin damage. False daisy extract contains an important flavonoid known as Luteolin. Luteolin penetrates the skin easily and reduces inflammation, promotes wound healing, and protects skin cells from damage caused by free radicals.
Phyllanthus emblica, commonly called as Indian Gooseberry or Amla helps protect the skin from the damaging effects of free radicals, non-radicals and transition metal-induced oxidative stress. Phyllanthus emblica is used in anti-aging, sunscreen and in general-purpose skin care products.
Curcuma longa or Turmeric is a commonly used spice throughout the world. It has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, and anti-neoplastic properties. Growing evidence shows that an active component of turmeric, curcumin, may be used medically to treat a variety of dermatologic conditions and diseases. Overall, there is evidence that turmeric/curcumin products and supplements, both oral and topical, may provide various therapeutic benefits for skin health.
Piper longum or Long Pepper which contains piperine and analogues or derivatives has shown re-pigmenting de-pigmented skin and for the treatment of skin. The piperine and analogues or derivatives are known to promote or enhance the natural coloration of the skin.
Psidium guajava leaves or Guava leaves extracts when applied on skin are known to loosen the dead skin cells, break the bonds between the dead skin cells and the base layer, thus helping to peel it from skin. When the dead skin layer is removed from skin, the skin becomes brighter, clear and free from any blemishes. Also, the high levels of anti-oxidants contained in Psidium guajava leaves provide diverse health and wellness benefits including reduction of oxidative stress in skin thereby providing anti-ageing benefits including wrinkle reduction.
Ocimum basilicum or Sweet Basil has been shown to provide various benefits in skin health including hydration, reduction in skin roughness, reduction in wrinkles. Ocimum basilicum provides an effective base to medicate topical acne-causing inflammation.
Salvia hispanica or Chia Seeds are a rich source of fatty acids, including omega-3 (as alpha-linoleic acid) plus unsaturated fatty acids linolenic and palmitic acids. They can help skin fight irritation, dehydration and in reducing blemishes.
Juglans regia or Walnut polyphenols, unsaturated fatty acids such as alpha linolenic acid and linoleic acid, essential amino acids, and minerals. The most abundant flavonoid in walnut is quercetin which exhibits anti-oxidant and anti-inflammatory activities. Juglans regia has skin protective effect by down-regulating the inflammatory response and anti-oxidant effects due to its polyphenolic compounds.
Linum usitatissimum or Flax Seed are packed with Omega-3 fatty acids, lignans and antioxidants. Omega-3 fatty acids help skin stay smooth and hydrated, while the lignans help reconstruct broken blood vessels and skin cells, and antioxidants protect the skin from free radicals and UV rays.
Prunus dulcis or Almonds are rich in anti-oxidants and vitamins which nourish skin and, keep it soft and supple. Prunus dulcis is also used as an exfoliator to get rid of impurities and to increase the smoothness of skin. Clinical studies have also shown that Prunus dulcis could prevent progression of normal ageing, including wrinkles through trans epidermal water loss and sebum production.
Piper nigrum or Black Pepper is used in natural skin care products for its analgesic, antiseptic, antispasmodic, antitoxic, diaphoretic, diuretic, and rubefacient properties. Studies have also shown Piper nigrum protects skin from skin pigmentation and helps to maintain the original colour of skin.
Murraya koenigii or Curry Leaves are rich in anti-oxidants. They fight off free radicals in the skin and contribute in keeping the skin texture healthy and firm.
Glycyrrhiza glabra or Licorice contains Glabridin which helps maintain smooth, lighter tone and prevents the skin from darkening after sun exposure. And since sun damage is a primary cause of discoloration of the skin, Liquorice also contains UV blocking enzymes that help protect you from UV exposure damage.
Cinnamomum zeylanicum Blume or Cinnamon possesses anti-fungal, antioxidant and antibacterial properties and makes it useful against acne and skin blemishes. Cinnamon can also help remove acne by drying out the skin and by supporting blood flow to the skin.
Cuminum cyminum or Cumin is high in inflammation-fighting antioxidants to repair skin damage and keep skin looking young. Cumin is also naturally anti-bacterial, anti-microbial and anti-inflammatory to soothe skin and keep it blemish free. The essential oils contained in cumin help tone the skin and boost circulation.
The compounds in Trigonella foenum-graecum or Fenugreek help with skin elasticity by tightening and firming up the skin. The vitamin C content in Fenugreek also enhances skin texture. Studies also indicate fenugreek helps with lowering blemishes and acne.
Beta vulgaris or Beetroot is rich in antioxidants such as beta carotene, vitamin C, and E, which aids in the regeneration of skin cells. Regular application of beet juice also helps to make the skin tone better by reducing blemishes, dark circles, and pigmentation of the skin.
Punica granatum or Pomegranate protect against premature aging by helping reduce the signs of skin aging caused by sun damage and exposure, such as wrinkles and fine lines. Pomegranates also help prevent hyperpigmentation and age spots.
Storage of Herbs & Spices, Grinding and Processes for Enhancing Organoleptic Properties of Herbs and Spices
The storage of herbs and spices under controlled conditions of temperature & humidity, grinding of herbs and organoleptic processes enhancement via making slurry, filtration and distillation, ion exchange and carbon bed adsorption processes are discussed in detail in the Indian Patent application no: 202041041780 and the same is incorporated herewith by reference. The current invention uses the same steps discussed in this application. The formulation and the composition of the multiherb extract for current application in skin care management is accordingly modified. The processing conditions and ranges specified in the aforementioned patent application remain the same.
In the last three decades, a lot of concerted efforts have been channeled into researching into local plants with therapeutic values to address various health and wellness issues. The beneficial effects of some of these plants, herbs or spices have been validated and others disproved.
It is an object of the present invention to provide for a water based herbal formulation that addresses skin care management, skin related disorders and diseases among human subjects. The product formulation is prepared using the embodiments described in the Indian Patent application no: 202041041780 and the same is incorporated herewith by reference.
A herbal formulation for skin care management comprising extracts from Daucus carota, Amaranthus gangeticus L., Eclipta prostrata, Phyllanthus emblica, Curcuma longa, Piper longum, Psidium guajava, Ocimum basilicum, Salvia hispanica, Juglans regia, Linum usitatissimum, Prunus dulcis, Piper nigrum, Murraya koenigii, Glycyrrhiza glabra, Cinnamomum zeylanicum Blume, Cuminum cyminum, Trigonella foenum-graecum, Beta vulgaris, Punica granatum.
The aforesaid herbal formulation broadly comprises of the herbal constituents in the range of Daucus carota 0%-2.0%, Amarantus Gangeticus L 0-0.5%, Eclipta prostrata 0%-1.5%, Phyllanthus emblica 1.5%-10.5%, Curcuma longa 1.0%-11.0%, Piper longum 0.5%-6.5%, Psidium guajava 7.0%-30%, Ocimum basilicum 5.0%-28.0%, Salvia hispanica 0.5%-6.5%, Juglans regia 2.0%-27.5%, Linum usitatissimum 0.75%-6.5%, Prunus dulcis 1.75%-15.0%, Piper nigrum 1%-10%, Murraya koenigii 1.25%-7.5%, Glycyrrhiza glabra 1.0%-11.0%, Cinnamomum zeylanicum Blume 2%-13.5%, Cuminum cyminum 0.25%-6.0%, Trigonella foenum-graecum 3.5%-22.0%, Beta vulgaris 0%-1.5%, Punica granatum 0%-2.85%.
The herbal formulation of the present invention could be manufactured using parts of the plants used for preparing the extracts are Daucus carota seeds, Amaranthus gangeticus L leaves, Eclipta prostrata leaves & stem, Phyllanthus emblica fruit, Curcuma longa root, Piper longum fruit, Psidium guajava leaves, Ocimum basilicum leaves, Salvia hispanica Seeds, Juglans regia Seed, Linum usitatissimum Seeds, Prunus dulcis Seeds, Piper nigrum flower, Murraya koenigii leaves, Glycyrrhiza glabra root, Cinnamomum zeylanicum Blume bark, Cuminum cyminum seeds, Trigonella foenum-graecum seeds, Beta vulgaris taproot, Punica granatum seeds & fruit.
As another embodiment the herbal formulation of the present invention comprises of the herbal constituents present in the ratio of Daucus carota 1.0%, Amaranthus gangeticus l 0.1%, Eclipta prostrata 0.70%, Phyllanthus emblica 6.0%, Curcuma longa 6.0%, Piper longum 2.4%, Psidium guajava 18.0%, Ocimum basilicum 17.7%, Salvia hispanica 3.6%, Juglans regia 6.0%, Linum usitatissimum 3.0%, Prunus dulcis 6.0%, Piper nigrum 4.0%, Murraya koenigii 2.8%, Glycyrrhiza glabra 5.8%, Cinnamomum zeylanicum Blume 5.5%, Cuminum cyminum 3.0%, Trigonella foenum-graecum 7.0%, Beta vulgaris 0.4%, Punica granatum 0.9%.
The embodiments of current invention have been shown to provide effective benefits to various aspect of skin health and wellness as described in following examples 1 to 5. They include overall improvement in skin conditions/properties including medical and/or cosmetic condition(s) like skin tone, texture, elasticity, hydration, spots, pigmentation, clarity, smoothness, open pores or pore size reduction, firmness, stretchmark reduction, Crow's feet, blackheads or whiteheads, pimples, oily skin, and possible scarring, acne, wrinkles, fine lines, Acanthosis nigricans (AN) or darkening of kunckles, Onychoschizia, splitting and chipping of nails and/or combination of the conditions. The formulation has demonstrated significant improvement in the treatment of autoimmune based conditions such as eczema, psoriasis and/or combination of the conditions or skin concerns for patients undergoing chemo therapy. Or skin ailments in general. A method of skin care management comprising administering to a subject an effective amount of herbal formulation as claimed in claim 1 for a time sufficient for skin revival.
As yet another embodiment, the present invention includes method of skin care management comprising administering to a subject an effective amount of herbal formulation as discussed in the examples for a time sufficient for skin revival.
Further, as yet another embodiment of the present invention, as described in the embodiments in international patent filing application, PCT/IN2021/051194, the formulation and accompanying embodiments of the application also show benefits relating to overall hair health including reduction in hair fall, improvements in hair density, hair follicle strength, hair density, hair tensile strength. Thus, a combination adjunctive therapy consisting of administering herbal waters in the current application along with herbal waters for hair care benefits as described in international patent filing application, PCT/IN2021/051194, could address both skin care and hair care issues encountered by patients undergoing chemo therapy. The two herbal water formulations may be administered together or sequentially—skin care herbal water administration followed by hair care herbal water administration or reverse sequence of administration.
The combination adjunctive therapy or sequential therapy is not just limited to conditions from chemo therapy, but can be applied to other conditions where skin and hair health are adversely effected.
The present invention is represented below by the help of representative examples. The examples do not limit the scope of the present invention.
Mixed Herbs Formulation
Herbs and spices were purchased and stored as per storage conditions specified in the Indian Patent application no: 202041041780. The following formulation summarized in Table 1 and covers the formulation used in the human clinical trial to demonstrate the benefits in terms of skin care management.
Daucus carota
Amaranthus gangeticus L.
Eclipta prostrata
Phyllanthus emblica
Curcuma longa
Piper longum
Psidium guajava
Ocimum basilicum
Salvia hispanica
Juglans regia
Linum usitatissimum
Prunus dulcis
Piper nigrum
Murraya koenigii
Glycyrrhiza glabra
Cinnamomum Zeylanicum Blume
Cuminum cyminum
Trigonella foenum-graecum
Beta vulgaris
Punica granatum
Mixed herbal powder Formulation summarized in Table 1 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 41.6 degrees C. Overall process yield from herbal water to herbal condensate was 53.6%. The herbal condensate was crystal clear and free of any color.
Herbal extract produced was used as an adjunctive supplement in adjunctive nutraceutical therapy for skin care management as the ingredients used in the formulation are well known to be effective in skin care and specially to improve skin texture, tone, elasticity, hydration and pigmentation properties.
A single centric, open-label study to evaluate the efficacy of Skin Care Herbal Solution in the study participants was undertaken. Study was conducted for a period of 3 months for each subject and included a total of four (4) visits
After obtaining informed consent, subjects who satisfied inclusion and exclusion criteria were enrolled. 40 subjects were enrolled in the study. A total of 39 subjects completed the study. Each subject was administered 15 ml of above mentioned herbal water mixed with 500 ml of water and consumed throughout the day.
A study-specific Informed Consent Form was signed by all subjects prior to screening. Sufficient time was provided to read and understand the information provided and ensuring that subjects were cognizant of the implications of enrolling in the study. The informed consent was obtained under ICH-GCP code of ethics. A written informed consent was taken from subjects willing to participate in the study. During the informed consent procedure, Clinical coordinators assisted the respective Dermatologists involved in the study.
The efficacy of the herbal water intervention was measured through three independent evaluations. They are:
Dermatological Assessments: Dermatological assessment was done and recorded on dermatological assessment form on visits baseline (day 1), day 30, day 60, day 90. Parameters for assessment included:
Instrument Assessments: Instrument Assessment to measure the elasticity, wrinkle & texture and skin hydration were performed using Cutometer, Antera and Corneometer respectively. Table 2 below shows the various instrument measurements performed during the clinical trial along with the frequency of measurements.
In addition, detailed image analysis was performed using VISIA CR 2.2. Table 3 summarises the visual analysis procedures employed with the VISIA CR 2.2.
Data Analysis: The data of all 39 subjects who successfully completed the study was considered for the statistical analysis. Table 4 summarises the statistical analysis and criteria employed in the test. All statistical tests used significance level of α≤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.
i.e.,
Dermatological Assessment Data Analysis:
Table 5 sumamrises skin texture score & statistics by dermatologist during various points during the study
Skin texture evaluation by the dermatologist indicated there was a significant improvement in skin texture observed at all time points posttest herbal water usage when compared to baseline. The improvement was seen as early as one month (Day 30) and was progressive with time.
Table 6 sumamrises skin firmness/elasticity & statistics by dermatologist during various points during the study.
There was a significant improvement in skin firmness observed at all time points post test herbal water usage when compared to baseline.
This was graded using a photonumeric scale of standards. Lower mean value indicates reduction in wrinkles.
Scale: 0=none (best possible condition), 1 to 3=mild, 4 to 6=moderate, 7 to 9=severe (worst possible condition)
Table 7 summarises mean Crows Feet grading scale for all clinical trial participants during the course of the clinical trial.
There was a significant improvement in wrinkles observed at day 90 post test herbal water usage when compared to baseline.
Instrument Assessments:
Subject Assessments:
Questionnaire: The following seven questions were asked to each subject during their visits to the organization administering the clinical trial. Subjects were asked to look at their face in mirror and score the attributes on Day 1, Day 30, Day 60 and Day 90
Scale:
Questionnaire:
Results and Statistical Analysis of Questionnaire:
The Herbal solution described in example 2 was administered to a 6 year female subject suffering from acute Eczema. 15 ml of the herbal water was admixed in 500 ml of water and consumed in equal proportions at breakfast, lunch and dinner.
The herbal water appears to effectively address eczema condition. The herbal nutraceuticals are addressing inflammation that could be arising from external factors such as allergens effectively.
The Herbal solution described in example 2 was administered to a 52 year old male subject suffering from Psoriasis conditions in the back. 15 ml of the herbal water was admixed in 500 ml of water and consumed in equal proportions at breakfast, lunch and dinner.
The herbal water appears to effectively address immune system issues that are causative factors for psoriasis.
The Herbal solution described in example 2 was administered to a 18 year old female subject suffering from Acne. 15 ml of the herbal water was admixed in 500 ml of water and consumed in equal proportions at breakfast, lunch and dinner.
The herbal water appears to effectively address acne by addressing the causative factors of Acne which may be a combination of anti-inflammatory and anti-bacterial properties.
lution described in example 2 was administered to a 18 year old female subject suffering from splitting and chipping of toe nail and also Acanthosis nigricans (AN) on the knuckles on the feet. 15 ml of the herbal water was admixed in 500 ml of water and consumed in equal proportions at breakfast, lunch and dinner.
The herbal water appears to effectively address acne by addressing the causative factors of nail health and it marked improvement in the nail appearance can be seen visually. Further, the dark pigmentation on the kunckles is shown to be reduced. The herbal water supplement appears to effectively address both nail condition or Onychoschizia and the dark pigmentation on knuckles or Acanthosis nigricans.
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 to achieve skin care management improvements.
The significant improvements on all aspects of skin care including skin elasticity, wrinkles, brightness, hydration, de-pigmentation has been uniquely addressed by consuming a nutraceutical rich water based herbal extract. The intervention appears to consistently deliver benefits as assessed by three independent sources—professional assessment by dermatologist, scientific instrument measurements and assessment and subject's personal assessment based on their own perception of the various skin attributes.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202141002108 | Jan 2021 | IN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IN2022/050034 | 1/17/2022 | WO |
