Indian Patents. 227558:HERBAL COMPOSITION TO RELIEVE OXIDATIVE STRESS

Title of Invention	HERBAL COMPOSITION TO RELIEVE OXIDATIVE STRESS
Abstract	N/A

Full Text	FORM 2 THE PATENT ACT 1970 (39 of 1970) & The Patents Rules, 2003 PROVISIONAL SPECIFICATION (See section 10 and rulel3) TITLE OF THE INVENTION: "Herbal compositions to relieve oxidative stress" 2. APPLICANT (a) NAME: Chopda, Chetan Ashok (b)NATIONALITY: Indian (c) ADDRESS: 635/1-B, New Gajra Society, Bibwewadi, Pune-411037, India. 3.PREAMBLE TO THE DESCRIPTION The following specification particularly describes the invention. Technical field of the invention: The instant invention relates to herbal supplemental dietary compositions, preferably a liquid supplement in the form of a health drink. Particularly the dietary composition is a combination of various herbal ingredients such as mangosteen extract, aloe vera juice, goji berry extract, green tea extract, grape seed extract and noni extract. The novel combination provides higher hydroxyl and superoxide radical scavenging abilities in comparison with conventional dietary supplements such as vitamins and is used to relieve oxidative stress. Background and prior art: Oxidative stress is a medical term for damage to animal or plant cells (and thereby the organs and tissues composed of those cells) caused by reactive oxygen species, which include (but are not limited to) superoxide, singlet oxygen, peroxynitrite or hydrogen peroxide. It is defined as an imbalance between pro-oxidants and anti-oxidants, with the former prevailing. This stress is gaining recognition as a key phenomenon and a central risk factor in modern chronic diseases such as cardiovascular disease, hypertension, diabetes mellitus, and some forms of cancer. Dietary recommendations for the prevention of cancer, atherosclerosis and other such chronic diseases have been established by various health agencies, which include substances exerting oxidative stress relieving properties. Many vegetables, fruits and food grains contain polyphenols, which possess such properties. But the current life-style followed by the vast majority of the world population such as consumption of oil and fat rich food-stuffs, sedentary life-style with little or practically no exercise and stress induced due to work pressures provide very little of these natural ingredients to the body to ward off these dangerous chronic diseases. Further there is evidence to show that such lifestyle related factors combined with oxidative stress lead to early aging effects in humans. Therefore there is a need to examine sources polyphenol like compounds and present them in a palatable, ready-to-use dosage form for the general masses to provide and equip their bodies against such progressions in chronic diseases. Vitamins such as vitamin C and E are the most popularly known dietary supplements that fight oxidative stress. But studies show that oligomeric proanthocyanidins, a class of 2 flavonoids, xanthones and other such polyphenols compounds also exert stress relieving effect. Research has shown that mangosteen fruit (Garcinia mangostana) widely grown in Thailand. Cambodia, Vietnam, India and several other countries is a rich source of xanthones, and can be useful even in the treatment of certain cancers, similar to grapes and berries. Grape seed (Vitis vinifera) is a rich source of oligomeric proanthocyanidins, working directly to help strengthen all the blood vessels and improve the delivery of oxygen to the cells. Another substantial source that helps the body rid itself of harmful free radicals and increase the user's energy levels is noni fruit (Morinda citrifolia). Lycium barbarum. popularly known as Chinese wolfberry or Tibetan goji berry, grown widely in parts of Asia and the Far East is known as "happy berry" because of the sense of well being it is said to induce. It is a rich source of various vitamins, minerals, amino acids and anti-oxidants. The health benefits of Green tea (Camellia sinensis) is well studied and documented amongst the populace that consumes it in huge quantities such as in China and Japan. Amongst various other health benefits, green tea is also attributed to preventing the degradation of cell membranes by neutralizing the spread of free radicals, which occurs during the process of oxidation. Aloe vera (Aloe barbadensis), a native of Africa, is again a rich source of vitamins and amino acids. US Patent 6730333 to Garrity et al discloses nutraceutical mangosteen compositions employing novel combinations of mangosteen fruit pulp and pericarp, and can be additionally complemented by selected juice concentrates to yield a composition for improving general health and wellness in humans. WO2006055550 discloses a nutritional beverage for various skin conditions comprising vitamins C and E as primary anti-oxidants and any one secondary anti-oxidant selected from the group consisting of a grape seed extract, a papaya extract, a guava extract, an acai extract, a green tea extract, a chamomile extract, a cherimoya extract, a longan extract, a lychee extract, a pomegranate extract, a walnut extract or a mangosteen extract. Prior art search reveals that there exists a need to provide a ready-to-use, enriched nutritional composition to arrest the progress of aging and chronic disease related conditions. There further exists a need to provide a combination of well-researched sources that can relieve stress caused due to oxidation resulting in immense benefits to 3 subjects in need of such a therapy. Prior art search shows that ingredients such as mangosteen extract, aloe vera juice, goji berry extract, green tea extract, grape seed extract and noni fruit have not been combined to provide a dietary liquid herbal supplement in the form of a palatable, ready-to-use health drink with high hydroxyl radical and superoxide anion radical scavenging abilities for the purposes of reducing oxidative stress in humans resulting in normalization of aging process and preventing several chronic disease conditions by reducing the adverse effects of oxidants. Sugar and sugar syrup are common ingredients in health drinks, making them non recommendable to a huge part of the population who are in need of such an oxidative stress relieving therapy, especially the diabetics and geriatric patients. It is therefore recommended to formulate them without sugar. Sugar substitutes, preferably form natural sources not only provide palatability to the composition, but also make them acceptable to this target group. The ill effects of the prolonged use of caffeine, such as dependency amongst a host of others, are well known. Since green tea is a rich source of compounds that can relieve oxidative stress and is a suitable candidate for nutritional health formula, it can be immensely beneficial to subjects who are in need of this therapy to be given green tea extract, but preferably the decaffeinated version. The process of decaffeination may deplete the content of flavonols, but this can be readily remedied by adjusting the dose of green tea to compensate for the loss in the therapeutic content, without worrying about any possible increase in toxic or addictive effects of caffeine. Aloin is the ingredient in aloe vera that is responsible for its laxative effect, which is undesirable in a nutritional composition. The inner leaf gel is responsible for the other therapeutic properties of aloe vera including its stress relieving effect. Therefore, aloin free, stabilized aloe juice based on inner gel alone is the ingredient of choice in such compositions. 4 Object of the invention: The main object of the instant invention is to provide herbal supplemental dietary compositions in the form of preferably liquid health drink comprising a novel combination of the extracts of mangosteen, aloe vera, goji berry, green tea, grape seed and noni to relieve oxidative stress. Another object of the invention is to provide a sugar-free, aloin-free, decaffeinated health drink composition, which can be recommended across all classes of the population. Yet another object of the invention is to substitute sugar with a natural source of sweetness such as monoamino glycerrhizinate (MAG) and supplement with fructose, xylitol, maltitol and such like. A further object of the invention is to provide a process for the preparation of the health drink composition. Another object of the invention is to provide a herbal supplemental dietary compositions with high hydroxyl and superoxide radical scavenging abilities that can combat oxidative stress which leads to chronic conditions such as cardiovascular disease, hypertension, diabetes mellitus, and some forms of cancer and advances the aging process. Summary of the invention: The instant invention discloses herbal supplemental dietary compositions preferably in the form of a health drink comprising a novel combination of the extracts of mangosteen, aloe vera, goji berry, green tea, grape seed and noni in combination with other ingredients such as purified water, natural sweetener, flavor and preservatives. The invention further provides the process of preparation of the herbal compositions. The composition comprises natural sugar substitutes such as monoamino glycerrhizinate (MAG), aloin-free aloe vera extract and decaffeinated green tea extract making it more acceptable across all groups of population. The superoxide radical and anion radical scavenging abilities of the composition have been found to be higher than those of the conventional dietary supplements such as vitamins. 5 Description of drawings: Figure 1 depicts the graphical comparison of the hydroxyl anion scavenging abilities (shown on the Y-axis) and Vitamins C, Vitamin E both at different concentrations with that of the composition of the instant invention across various concentration ranges (shown on the X-axis). Figure 2 depicts the graphical comparison of the super oxide anion scavenging abilities (shown on the Y-axis) and Vitamins C, Vitamin E both at different concentrations with that of the composition of the instant invention across various concentration ranges (shown on the X-axis). Detailed description of the invention: The instant invention describes herbal supplemental dietary compositions preferably in the form of a health drink comprising a novel combination of the extracts of mangosteen, aloe vera, goji berry, green tea, grape seed and noni in combination with other ingredients such as purified water, natural sweetener, flavor and preservatives. The invention describes dietary liquid herbal supplement in the form of a palatable, ready-to-use health drink with high hydroxyl radical and superoxide anion radical scavenging abilities for the purposes of reducing oxidative stress in humans resulting in normalization of aging process and preventing several chronic disease conditions by reducing the adverse effects of oxidants. Sugar and sugar syrup are common ingredients in health drinks, making them non recommendable to a huge part of the population who are in need of such an oxidative stress relieving therapy, especially the diabetics and geriatric patients. Therefore the present invention describes a composition without sugar. Rather sugar substitutes, preferably form natural sources will not only provide palatability to the composition, but also make them acceptable to this target group. Green tea is a rich source of compounds that can relieve oxidative stress and is a suitable candidate for nutritional formulation, it can be immensely beneficial to subjects who are in need of this therapy to be given green tea extract, but preferably decaffeinated. The 6 process of decaffeination may deplete the content of flavonols, but this can be readily remedied by adjusting the dose of green tea to compensate for the loss in the therapeutic content, without any possible increase in toxic or addictive effects of caffeine. Aloin is the ingredient in aloe vera that is responsible for its laxative effect, which is undesirable in a nutritional composition. The inner leaf gel is responsible for the other therapeutic properties of aloe vera including its stress relieving effect. The invention describes aloin free, stabilized aloe juice based on inner gel compositions. The invention further provides the process of preparation of the health drink compositions. The extracts of mangosteen in the range of 0.1-100 g/lt, aloin free aloe vera juice in the range of 0.1-500 g/lt, decaffeinated green tea extract in the range of 0.1-100 g/lt, grape seed extract in the range of in the range of 0.1-100 g/lt, goji berry extract in the range of in the range of 0.1-100 g/lt and noni extract in the range of 0.1-100 g/lt comprise the active ingredients in the composition. These active ingredients are combined with other ingredients such as sweeteners, flavours, thickeners or viscosity enhancers, preservatives and acidulants and purified water to formulate the composition as dietary liquid herbal supplement in the form of a health drink. The sweeteners are selected from the group comprising fructose, xylitol, maltitol, polydextrol, sorbitol and MAG, a natural sugar substitute. The composition may comprise any of these alone or in combination to provide the necessary sweetness to the drink. The sweeteners are employed in the range of 0.1-50 g/lt, while MAG is in the range of 0.001-50 gm/litre. The preferred viscosity enhancers are gum carrageenan and xanthan, alone or in combination in the range of 0.1-100 g/litre. The preservatives are selected from methyl paraben, propyl paraben, sodium benzoate and benxoic acid alone or in combination in the range of 0.1-1 g/litre. Anti microbial agent and an agent to prevent mold is selected from potassium sorbate, sorbic Acid. 7 The preferred acidulant is citric acid in the range of 0.001 -20g/litre, the preferred flavour is fruit flavour (berry) in the range of 0.01-10 g/litre and the composition also contains potassium sorbate and sorbic acid alone or in combination in the range of 0.1-1 g/litre. The herbal supplemental dietary compositions are preferably in ranges as follows: Ingredients Range in gm/lt Mangosteen Extract 0.1-100 Aloe vera juice (IX) 0.1-500 Green Tea Extract 0.1-100 Grape Seed Extract 0.1-100 Goji Berry Extract 0.1-100 Noni Extract 0.1-100 Purified water 100-950 Mono ammonium Glycerrhizinate (MAG) 0.001-50 Additional Sweetener 0.1-50 Citric Acid 0.001-20 Flavour 0.01-10 Gum 0.1-10 Preservatives 0.1-1 Potassium Sorbate / Sorbic Acid 0.1-1 The process for preparation of the herbal liquid composition is as follows: A] Process of preparation of Aloe Vera Juice: (i) Cleaning, sanitizing and collecting fillets of cut aloe leaves, (ii) Crushing the fillets, heating and filtering to prepare a juice and (iii) Heating, cooling the juice of step 2 and transferring to mangosteen processing vessel. B] Process of preparation of Mangosteen Juice: (i) Dissolving ingredients such as mangosteen fruit, goji berry, noni fruit, green tea, and grape seed in powder form in purified water with continuous stirring, 8 (ii) Adding aloe juice of step A to this mixture of step B (i) and heating with continuous stirring, (iii) Dispersing gum in this mixture, (iv) Adding other ingredients and preservatives, except flavour, (v) Homogenising natural flavour into the mixture of step iv and (vi) Filling in bottles. The hydroxyl anion superoxide anion scavenging abilities of the composition were studied in comparison with conventional dietary supplements such as vitamins C and vitamin E. The results of the test reveal that the composition of the instant invention possesses higher scavenging ability in comparison to these vitamins. At 50mg/lit vitamin E showed 36% hydroxyl radical and 43% superoxide radical scavenging ability, while at the same concentration the herbal liquid composition showed 78% and 74% respectively. At 100 mg/lit vitamin C showed 12% hydroxyl radical and 19% superoxide radical scavenging ability, while at the same concentration the herbal liquid composition showed 86% and 88% respectively. The test results show the enhanced ability of the composition to relieve oxidative stress in subjects, which can result in normalization of aging process and prevent several chronic disease conditions. By relieving the oxidative stress, the composition can fight the central risk factor leading to modern chronic diseases such as cardiovascular disease, hypertension, diabetes mellitus, and some forms of cancer. The present invention is illustrated by the way of the following non-limiting examples. The examples are not limited to the particular embodiments illustrated herein but include the permutations, which are obvious set forth in the description. Example 1: The process of preparation of preparing the herbal liquid composition comprises the following steps: (i) Cleaning, sanitizing and collecting fillets of cut aloe leaves, (ii) crushing the fillets, heating and filtering to prepare a juice, 9 (iii) heating and cooling the juice of step 2 and transferring to mangostene processing vessel, (iv) dissolving ingredients such as mangostene fruit, goji berry, noni fruit, green tea, and grape seed in powder form in purified water with continuous stirring, (v) adding aloe juice of step 3 to this mixture of step 4 and heating with continuous stirring, (vi) dispersing gum in this mixture, (vii) adding other ingredients and preservatives, except flavour, (viii) homogenising natural flavour into the mixture of step vii and finally (ix) filling in bottles. Example 2: Hydroxyl radicals scavenging ability of herbal composition in comparison to vitamin C and vitamin E. At concentrations of 5 and 100 mg/lit, vitamin C inhibited hydroxyl radical generation by approx. 9 and 12%, respectively. Vitamin E succinate (VES) at concentrations of 26.5, 50 and 75 mg/lit inhibited hydroxyl radicals by approximately 33, 35 and 36%, respectively. In the incubation of the hydroxyl radical generating system with 5, 25, 50, 100 and 200 mg/lit concentrations of health drink composition, approx. 12%, 64%, 78%, 86% and 95% inhibitions were observed (chemiluminescence's response) respectively. Thus, the composition of the invention provides an excellent concentration-dependent inhibitory effect on biochemically generated hydroxyl radicals. Example 3: Superoxide anion radical scavenging ability of herbal composition in comparison to vitamin C and vitamin E. At concentrations of 5 and 100 mg/lit, vitamin C inhibited superoxide anion generation by approx. 12% and 19%, respectively. Vitamin E at concentrations of 26.5, 50 and 75 mg/lit inhibited superoxide anion by approx. 40%, 43% and 44%, respectively. In the incubation of the superoxide anion generating system with 5, 25, 50, 100 and 200 mg/lit concentrations of health drink composition, approx. 27%, 56%, 74%, 88% and 10 94% inhibitions were observed (chemiluminescence's response). Thus, herbal compositions provide an excellent concentration-dependent inhibitory effect on biochemically generated superoxide anion also along with a similar action seen in inhibition of hydroxyl anion scavenging ability. While the preferred embodiment of the invention is described in the form a nutritional health drink, the extracts can be blended in the proportion similar to those in the health drink and formulated in various other dosage forms such as tablets, capsules, dry syrup, emulsion, powder and such like. Many changes, modifications, variations and applications of the subject invention will become apparent to those skilled in the art after consideration of the specification. All such changes, modifications, alterations and other uses and applications that do not depart from the spirit and scope of the invention are deemed to be covered by the invention. Dated this 2nd day of November 2006 Dr. Gopakumar G. Nair Agent for the Applicant 11

Full Text

FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rulel3)
TITLE OF THE INVENTION: "Herbal compositions to relieve oxidative stress"
2. APPLICANT
(a) NAME: Chopda, Chetan Ashok
(b)NATIONALITY: Indian
(c) ADDRESS: 635/1-B, New Gajra Society, Bibwewadi, Pune-411037, India.
3.PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention.

Technical field of the invention:
The instant invention relates to herbal supplemental dietary compositions, preferably a liquid supplement in the form of a health drink. Particularly the dietary composition is a combination of various herbal ingredients such as mangosteen extract, aloe vera juice, goji berry extract, green tea extract, grape seed extract and noni extract. The novel combination provides higher hydroxyl and superoxide radical scavenging abilities in comparison with conventional dietary supplements such as vitamins and is used to relieve oxidative stress.
Background and prior art:
Oxidative stress is a medical term for damage to animal or plant cells (and thereby the organs and tissues composed of those cells) caused by reactive oxygen species, which include (but are not limited to) superoxide, singlet oxygen, peroxynitrite or hydrogen peroxide. It is defined as an imbalance between pro-oxidants and anti-oxidants, with the former prevailing. This stress is gaining recognition as a key phenomenon and a central risk factor in modern chronic diseases such as cardiovascular disease, hypertension, diabetes mellitus, and some forms of cancer. Dietary recommendations for the prevention of cancer, atherosclerosis and other such chronic diseases have been established by various health agencies, which include substances exerting oxidative stress relieving properties. Many vegetables, fruits and food grains contain polyphenols, which possess such properties. But the current life-style followed by the vast majority of the world population such as consumption of oil and fat rich food-stuffs, sedentary life-style with little or practically no exercise and stress induced due to work pressures provide very little of these natural ingredients to the body to ward off these dangerous chronic diseases. Further there is evidence to show that such lifestyle related factors combined with oxidative stress lead to early aging effects in humans. Therefore there is a need to examine sources polyphenol like compounds and present them in a palatable, ready-to-use dosage form for the general masses to provide and equip their bodies against such progressions in chronic diseases.
Vitamins such as vitamin C and E are the most popularly known dietary supplements that fight oxidative stress. But studies show that oligomeric proanthocyanidins, a class of
2

flavonoids, xanthones and other such polyphenols compounds also exert stress relieving effect. Research has shown that mangosteen fruit (Garcinia mangostana) widely grown in Thailand. Cambodia, Vietnam, India and several other countries is a rich source of xanthones, and can be useful even in the treatment of certain cancers, similar to grapes and berries. Grape seed (Vitis vinifera) is a rich source of oligomeric proanthocyanidins, working directly to help strengthen all the blood vessels and improve the delivery of oxygen to the cells. Another substantial source that helps the body rid itself of harmful free radicals and increase the user's energy levels is noni fruit (Morinda citrifolia). Lycium barbarum. popularly known as Chinese wolfberry or Tibetan goji berry, grown widely in parts of Asia and the Far East is known as "happy berry" because of the sense of well being it is said to induce. It is a rich source of various vitamins, minerals, amino acids and anti-oxidants. The health benefits of Green tea (Camellia sinensis) is well studied and documented amongst the populace that consumes it in huge quantities such as in China and Japan. Amongst various other health benefits, green tea is also attributed to preventing the degradation of cell membranes by neutralizing the spread of free radicals, which occurs during the process of oxidation. Aloe vera (Aloe barbadensis), a native of Africa, is again a rich source of vitamins and amino acids.
US Patent 6730333 to Garrity et al discloses nutraceutical mangosteen compositions employing novel combinations of mangosteen fruit pulp and pericarp, and can be additionally complemented by selected juice concentrates to yield a composition for improving general health and wellness in humans.
WO2006055550 discloses a nutritional beverage for various skin conditions comprising vitamins C and E as primary anti-oxidants and any one secondary anti-oxidant selected from the group consisting of a grape seed extract, a papaya extract, a guava extract, an acai extract, a green tea extract, a chamomile extract, a cherimoya extract, a longan extract, a lychee extract, a pomegranate extract, a walnut extract or a mangosteen extract.
Prior art search reveals that there exists a need to provide a ready-to-use, enriched nutritional composition to arrest the progress of aging and chronic disease related conditions. There further exists a need to provide a combination of well-researched sources that can relieve stress caused due to oxidation resulting in immense benefits to
3

subjects in need of such a therapy. Prior art search shows that ingredients such as mangosteen extract, aloe vera juice, goji berry extract, green tea extract, grape seed extract and noni fruit have not been combined to provide a dietary liquid herbal supplement in the form of a palatable, ready-to-use health drink with high hydroxyl radical and superoxide anion radical scavenging abilities for the purposes of reducing oxidative stress in humans resulting in normalization of aging process and preventing several chronic disease conditions by reducing the adverse effects of oxidants.
Sugar and sugar syrup are common ingredients in health drinks, making them non recommendable to a huge part of the population who are in need of such an oxidative stress relieving therapy, especially the diabetics and geriatric patients. It is therefore recommended to formulate them without sugar. Sugar substitutes, preferably form natural sources not only provide palatability to the composition, but also make them acceptable to this target group.
The ill effects of the prolonged use of caffeine, such as dependency amongst a host of others, are well known. Since green tea is a rich source of compounds that can relieve oxidative stress and is a suitable candidate for nutritional health formula, it can be immensely beneficial to subjects who are in need of this therapy to be given green tea extract, but preferably the decaffeinated version. The process of decaffeination may deplete the content of flavonols, but this can be readily remedied by adjusting the dose of green tea to compensate for the loss in the therapeutic content, without worrying about any possible increase in toxic or addictive effects of caffeine.
Aloin is the ingredient in aloe vera that is responsible for its laxative effect, which is undesirable in a nutritional composition. The inner leaf gel is responsible for the other therapeutic properties of aloe vera including its stress relieving effect. Therefore, aloin free, stabilized aloe juice based on inner gel alone is the ingredient of choice in such compositions.
4

Object of the invention:
The main object of the instant invention is to provide herbal supplemental dietary
compositions in the form of preferably liquid health drink comprising a novel
combination of the extracts of mangosteen, aloe vera, goji berry, green tea, grape seed
and noni to relieve oxidative stress.
Another object of the invention is to provide a sugar-free, aloin-free, decaffeinated health
drink composition, which can be recommended across all classes of the population.
Yet another object of the invention is to substitute sugar with a natural source of
sweetness such as monoamino glycerrhizinate (MAG) and supplement with fructose,
xylitol, maltitol and such like.
A further object of the invention is to provide a process for the preparation of the health
drink composition.
Another object of the invention is to provide a herbal supplemental dietary compositions
with high hydroxyl and superoxide radical scavenging abilities that can combat oxidative
stress which leads to chronic conditions such as cardiovascular disease, hypertension,
diabetes mellitus, and some forms of cancer and advances the aging process.
Summary of the invention:
The instant invention discloses herbal supplemental dietary compositions preferably in the form of a health drink comprising a novel combination of the extracts of mangosteen, aloe vera, goji berry, green tea, grape seed and noni in combination with other ingredients such as purified water, natural sweetener, flavor and preservatives. The invention further provides the process of preparation of the herbal compositions. The composition comprises natural sugar substitutes such as monoamino glycerrhizinate (MAG), aloin-free aloe vera extract and decaffeinated green tea extract making it more acceptable across all groups of population. The superoxide radical and anion radical scavenging abilities of the composition have been found to be higher than those of the conventional dietary supplements such as vitamins.
5

Description of drawings:
Figure 1 depicts the graphical comparison of the hydroxyl anion scavenging abilities (shown on the Y-axis) and Vitamins C, Vitamin E both at different concentrations with that of the composition of the instant invention across various concentration ranges (shown on the X-axis).
Figure 2 depicts the graphical comparison of the super oxide anion scavenging abilities (shown on the Y-axis) and Vitamins C, Vitamin E both at different concentrations with that of the composition of the instant invention across various concentration ranges (shown on the X-axis).
Detailed description of the invention:
The instant invention describes herbal supplemental dietary compositions preferably in the form of a health drink comprising a novel combination of the extracts of mangosteen,
aloe vera, goji berry, green tea, grape seed and noni in combination with other ingredients
such as purified water, natural sweetener, flavor and preservatives. The invention describes dietary liquid herbal supplement in the form of a palatable, ready-to-use health drink with high hydroxyl radical and superoxide anion radical scavenging abilities for the purposes of reducing oxidative stress in humans resulting in normalization of aging process and preventing several chronic disease conditions by reducing the adverse effects of oxidants.
Sugar and sugar syrup are common ingredients in health drinks, making them non recommendable to a huge part of the population who are in need of such an oxidative stress relieving therapy, especially the diabetics and geriatric patients. Therefore the present invention describes a composition without sugar. Rather sugar substitutes, preferably form natural sources will not only provide palatability to the composition, but also make them acceptable to this target group.
Green tea is a rich source of compounds that can relieve oxidative stress and is a suitable candidate for nutritional formulation, it can be immensely beneficial to subjects who are in need of this therapy to be given green tea extract, but preferably decaffeinated. The
6

process of decaffeination may deplete the content of flavonols, but this can be readily remedied by adjusting the dose of green tea to compensate for the loss in the therapeutic content, without any possible increase in toxic or addictive effects of caffeine.
Aloin is the ingredient in aloe vera that is responsible for its laxative effect, which is undesirable in a nutritional composition. The inner leaf gel is responsible for the other therapeutic properties of aloe vera including its stress relieving effect. The invention describes aloin free, stabilized aloe juice based on inner gel compositions.
The invention further provides the process of preparation of the health drink compositions. The extracts of mangosteen in the range of 0.1-100 g/lt, aloin free aloe vera juice in the range of 0.1-500 g/lt, decaffeinated green tea extract in the range of 0.1-100 g/lt, grape seed extract in the range of in the range of 0.1-100 g/lt, goji berry extract in the range of in the range of 0.1-100 g/lt and noni extract in the range of 0.1-100 g/lt comprise the active ingredients in the composition. These active ingredients are combined with other ingredients such as sweeteners, flavours, thickeners or viscosity enhancers, preservatives and acidulants and purified water to formulate the composition as dietary liquid herbal supplement in the form of a health drink.
The sweeteners are selected from the group comprising fructose, xylitol, maltitol, polydextrol, sorbitol and MAG, a natural sugar substitute. The composition may comprise any of these alone or in combination to provide the necessary sweetness to the drink. The sweeteners are employed in the range of 0.1-50 g/lt, while MAG is in the range of 0.001-50 gm/litre.
The preferred viscosity enhancers are gum carrageenan and xanthan, alone or in combination in the range of 0.1-100 g/litre.
The preservatives are selected from methyl paraben, propyl paraben, sodium benzoate and benxoic acid alone or in combination in the range of 0.1-1 g/litre. Anti microbial agent and an agent to prevent mold is selected from potassium sorbate, sorbic Acid.
7

The preferred acidulant is citric acid in the range of 0.001 -20g/litre, the preferred flavour is fruit flavour (berry) in the range of 0.01-10 g/litre and the composition also contains potassium sorbate and sorbic acid alone or in combination in the range of 0.1-1 g/litre.
The herbal supplemental dietary compositions are preferably in ranges as follows:

Ingredients Range in gm/lt
Mangosteen Extract 0.1-100
Aloe vera juice (IX) 0.1-500
Green Tea Extract 0.1-100
Grape Seed Extract 0.1-100
Goji Berry Extract 0.1-100
Noni Extract 0.1-100
Purified water 100-950
Mono ammonium Glycerrhizinate (MAG) 0.001-50
Additional Sweetener 0.1-50
Citric Acid 0.001-20
Flavour 0.01-10
Gum 0.1-10
Preservatives 0.1-1
Potassium Sorbate / Sorbic Acid 0.1-1
The process for preparation of the herbal liquid composition is as follows:
A] Process of preparation of Aloe Vera Juice:
(i) Cleaning, sanitizing and collecting fillets of cut aloe leaves,
(ii) Crushing the fillets, heating and filtering to prepare a juice and
(iii) Heating, cooling the juice of step 2 and transferring to mangosteen processing vessel.
B] Process of preparation of Mangosteen Juice:
(i) Dissolving ingredients such as mangosteen fruit, goji berry, noni fruit, green tea, and grape seed in powder form in purified water with continuous stirring,
8

(ii) Adding aloe juice of step A to this mixture of step B (i) and heating with
continuous stirring,
(iii) Dispersing gum in this mixture,
(iv) Adding other ingredients and preservatives, except flavour,
(v) Homogenising natural flavour into the mixture of step iv and (vi) Filling in bottles.
The hydroxyl anion superoxide anion scavenging abilities of the composition were studied in comparison with conventional dietary supplements such as vitamins C and vitamin E. The results of the test reveal that the composition of the instant invention possesses higher scavenging ability in comparison to these vitamins. At 50mg/lit vitamin E showed 36% hydroxyl radical and 43% superoxide radical scavenging ability, while at the same concentration the herbal liquid composition showed 78% and 74% respectively. At 100 mg/lit vitamin C showed 12% hydroxyl radical and 19% superoxide radical scavenging ability, while at the same concentration the herbal liquid composition showed 86% and 88% respectively.
The test results show the enhanced ability of the composition to relieve oxidative stress in subjects, which can result in normalization of aging process and prevent several chronic disease conditions. By relieving the oxidative stress, the composition can fight the central risk factor leading to modern chronic diseases such as cardiovascular disease, hypertension, diabetes mellitus, and some forms of cancer.
The present invention is illustrated by the way of the following non-limiting examples. The examples are not limited to the particular embodiments illustrated herein but include the permutations, which are obvious set forth in the description.
Example 1:
The process of preparation of preparing the herbal liquid composition comprises the
following steps:
(i) Cleaning, sanitizing and collecting fillets of cut aloe leaves,
(ii) crushing the fillets, heating and filtering to prepare a juice,
9

(iii) heating and cooling the juice of step 2 and transferring to mangostene
processing vessel,
(iv) dissolving ingredients such as mangostene fruit, goji berry, noni fruit, green tea,
and grape seed in powder form in purified water with continuous stirring,
(v) adding aloe juice of step 3 to this mixture of step 4 and heating with continuous
stirring,
(vi) dispersing gum in this mixture,
(vii) adding other ingredients and preservatives, except flavour,
(viii) homogenising natural flavour into the mixture of step vii and finally
(ix) filling in bottles.
Example 2:
Hydroxyl radicals scavenging ability of herbal composition in comparison to vitamin C
and vitamin E.
At concentrations of 5 and 100 mg/lit, vitamin C inhibited hydroxyl radical generation by
approx. 9 and 12%, respectively. Vitamin E succinate (VES) at concentrations of 26.5, 50
and 75 mg/lit inhibited hydroxyl radicals by approximately 33, 35 and 36%, respectively.
In the incubation of the hydroxyl radical generating system with 5, 25, 50, 100 and 200 mg/lit concentrations of health drink composition, approx. 12%, 64%, 78%, 86% and 95% inhibitions were observed (chemiluminescence's response) respectively. Thus, the composition of the invention provides an excellent concentration-dependent inhibitory effect on biochemically generated hydroxyl radicals.
Example 3:
Superoxide anion radical scavenging ability of herbal composition in comparison to vitamin C and vitamin E.
At concentrations of 5 and 100 mg/lit, vitamin C inhibited superoxide anion generation by approx. 12% and 19%, respectively. Vitamin E at concentrations of 26.5, 50 and 75 mg/lit inhibited superoxide anion by approx. 40%, 43% and 44%, respectively.
In the incubation of the superoxide anion generating system with 5, 25, 50, 100 and 200 mg/lit concentrations of health drink composition, approx. 27%, 56%, 74%, 88% and
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94% inhibitions were observed (chemiluminescence's response). Thus, herbal compositions provide an excellent concentration-dependent inhibitory effect on biochemically generated superoxide anion also along with a similar action seen in inhibition of hydroxyl anion scavenging ability.
While the preferred embodiment of the invention is described in the form a nutritional health drink, the extracts can be blended in the proportion similar to those in the health drink and formulated in various other dosage forms such as tablets, capsules, dry syrup, emulsion, powder and such like.
Many changes, modifications, variations and applications of the subject invention will become apparent to those skilled in the art after consideration of the specification. All such changes, modifications, alterations and other uses and applications that do not depart from the spirit and scope of the invention are deemed to be covered by the invention.
Dated this 2nd day of November 2006

Dr. Gopakumar G. Nair Agent for the Applicant

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HERBAL COMPOSITION TO RELIEVE OXIDATIVE STRESS

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