WO2012056475A2

WO2012056475A2 - Composition for improving sexual health

Info

Publication number: WO2012056475A2
Application number: PCT/IN2011/000743
Authority: WO
Inventors: K.V.S. Prasad; Jay L. Soman
Original assignee: Sanzyme Limited
Priority date: 2010-10-27
Filing date: 2011-10-27
Publication date: 2012-05-03
Also published as: WO2012056475A3

Abstract

The present invention provides a synergistic combination of extracts of plants and mineral which can improve sexual well being of an individual and which may also support the physical and physiological ability of an individual. The composition preferably comprises synergistic combination of extract of Withania somnifera, Tribulus terrestris, Mucuna pruriens, Moringa oleifera, Myristica fragrans, Ipomoea digitata, Peuraria tuberose, Chlorophytum borivillianum, Emblica officianalis, Vitis vinifera, Asparagus racemosus and Asphaltum present in an effective amount for improving sexual health.

Description

Title

COMPOSITION FOR IMPROVING SEXUAL HEALTH.

Field of the invention

The present invention relates to a composition for improving sexual health. More particularly the present invention relates to a composition comprising synergistic combination of extracts of plants and mineral for improving sexual health and support the physical and physiological ability of an individual.

Background of the Invention Sexual function is governed by various organ systems essentially to ensure neurotransmitters, hormones and the body's innate anti-oxidant system to be in place to support the physical and physiological ability of the individual. Sexual dysfunction problem in men or women could be the result of underlying psychological or physical conditions. Sexual dysfunction is more prevalent in case of conditions like diabetes as well as other conditions caused by disturbed life style.

Studies have shown that the occurrence of sexual dysfunction in diabetic patients is associated with increase in the age, the occurrence of complications from diabetes and the control of sugar level in blood. Other studies have linked the risk of sexual dysfunction in diabetics with the use of alcohol and antihypertensive medications. Diabetes mellitus is the most common cause of sexual dysfunction, about 28% of patients suffering from sexual dysfunction are diabetic and 50% of diabetic patients have sexual dysfunction. Thus, the diabetes is one of the major conditions associated with sexual dysfunction.

The disturbed lifestyle impairs individual's health physically, physiologically, psychologically, at neuronal levels and endocrine levels. The physical health of a person gets weakened by lifestyle habits such as smoking, alcohol and factors such as fatigue and stress caused by the disturbed life style. Factors that are responsible to hamper an individual at the psychological level are anxiety, depression and long office hours. Factors that are responsible to hamper an individual at the physiological level are hyperlipidemia, hypertension and other such syndromes. Factors that are responsible to hamper an individual at the Endocrine level are metabolic disorders like diabetes, drug induced hyperprolactinemia. Thus, disturbed lifestyle is another main cause which affects human beings at various levels and thereby hampers sexual well being of such individuals.

Therefore, to improve individual's sexual function, it's not only required just to boost his vigour but also required is to address root causes such as diabetes and other conditions caused by the disturbed life style. There are medication pills available that are often used by individuals to improve their sexual performance. Penile injections are other alternative for improving sexual function; this method is advised for people who do not find oral drugs effective. Such people could be those suffering from diabetes. Diabetes has been known to damage arteries and nerves and oral medications might not be very effective. However, penile injections can be painful and not user friendly. Besides, such options are only symptomatic and they do not work at the root cause to improve such causative conditions.

Hence, there is a need for a composition which can improve sexual well being of an individual and which may also work at various different levels for supporting the physical and physiological ability of an individual.

Summary of the Invention

Thus it is an object of the present invention to provide a composition that can improve sexual health and which may also support the physical and physiological ability of an individual.

Accordingly, in one aspect the present invention provides a composition comprising the synergistic combination of extracts of plants and mineral which can improve sexual well being of an individual and which may also support the physical and physiological ability of an individual.

In one embodiment the present invention provides a composition comprising of extracts of plants that may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Moringa oleifera, Peuraria tuberosa, Ipomea digitata and Vitis vinifera and purified asphalt as a mineral.

In other embodiment the present invention provides a composition optionally further comprises of extracts of plants Muira pauma, Turnera diffusa and Tinospora cordifolia. In another aspect there is provided a nutraceutical formulation comprising of extracts of plants that may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Moringa oleifera, Peuraria tuberosa, Ipomea digitata and Vitis vinifera; purified asphalt as a mineral and optionally nutraceutically or physiologically acceptable excipient(s).

In still another aspect there is provided a pharmaceutical formulation comprising of extracts of plants that may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Moringa oleifera, Peuraria tuberosa, Ipomea digitata and Vitis vinifera; purified asphalt as a mineral and optionally pharmaceutically or physiologically acceptable excipient(s). In yet another aspect the present invention provides a use of the composition of present invention for improving sexual health of an individual composition.

Detailed Description of the Invention The present invention is directed to provide a composition for improving sexual health which may also support the physical and physiological ability of an individual.

The present invention accordingly provides a composition comprising the synergistic combination of extracts of plants and mineral which can improve sexual well being of an individual and which may also support the physical and physiological ability of an individual.

The extracts of plants that may be used in the composition of the present invention may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Turnera diffusa, Muira pauma, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Tinospora cordifolia, Moringa oleifera, Peuraria tuberosa, Ipomea digitata, Vitis vinifera and/or combination thereof.

The extract of mineral that may be used in the present invention may be Asphaltum extract.

The extracts of plants or mineral may be whole extracts and/or purified extracts. The extracts may be standardized extract with regard to the presence of one or more marker compound and/or with regard to the strength for example in terms of percentage or ratio. The extracts of plants may be extracts of a particular part of the plant.

The extract of Tribulus Terrestris may be a fruit extract rich in saponin content, extract of Mucuna Pruriens may be a seed extract rich in L-Dopa content, extracts of Withania somnifera, Asparagus racemosus and Ipomea digitata may be root extracts, extract of Myristica fragrans may be a ethanolic fruit extract, extract of Emblica officianalis may be a fruit extract, extract of Chlorophytum borivillianum may be a tuber or root extract rich in saponin content, extract of Peuraria tuberosa may be a root tuber extract, extracts of Moringa oleifera and Vitis vinifera may be seed extracts, extract of Asphaltum may be a purified extract.

In one embodiment the composition of the present invention comprises synergistic combination of extract of Withania somnifera, Tribulus terrestris, Mucuna pruriens, Moringa oleifera, Myristica fragrans, Ipomoea digitata, Peuraria tuberose, Chlorophytum borivillianum, Emblica officianalis, Vitis vinifera, Asparagus racemosus and Asphaltum present in an effective amount for improving sexual function in an individual. The active constituents, that is extracts of plants and mineral may be included in the composition in an amount of that is at an effective concentration for obtaining the desired activity. The concentrations of active constituents are such that they are in optimum concentration that is neither too high concentration which may cause the undesirable and harmful side effects, nor at sub therapeutic or too low concentration which would require frequent or multiple dosing and hence not user or patient friendly and which may not provide the desired effect. The composition of the present invention may comprise of extract of Mucuna pruriens in an amount in the range of 30 mg to 100 mg, Withania somninfera in the range of 10 mg to 100 mg, Tribulus terrestris in the range of 30 mg to 200 mg, Myristica fragrans in the range of 10 mg to 100 mg, Asparagus racemosus in the range of 10 mg to 100 mg, Emblica officianalis in the range of 5 mg to 50 mg, Chlorophytum borivillianum in the range of 5 mg to 50 mg, Moringa oleifera in the range of 5 mg to 50 mg, Peuraria tuberosa in the range of 5 mg to 50 mg, Ipomea digitata in the range of 5 mg to 50 mg, Vitis vinifera in the range of 5 mg to 50 mg and Asphaltum in the range of 10 mg to 50 mg. In an embodiment the composition of the present invention optionally further comprises at least one extract selected from extract of Tumera diffusa, Muira pauma and Tinospora cordifolia. The extract of Tumera diffusa may be a leaf extract present in the range of 10 mg to 150 mg; Muira pauma may be the root extract present, in the range of 10 mg to 150 mg and Tinospora cordifolia may be the stem extract present in the range of 5 mg to 75 mg.

The composition of the present invention may optionally further comprise other plant or mineral extract, minerals or chemical active agents or combinations thereof to improve sexual function as well as support the physical and physiological ability of an individual.

The composition of the present invention may be formulated in a variety of formulations including but not limiting to nutraceutical or pharmaceutical formulations. In preferred embodiments the composition of the present invention may be formulated in the form of nutraceutical formulations or functional food supplements.

In one of the embodiment the present invention provides a nutraceutical formulation comprising of extracts of plants that may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Moringa oleifera, Peuraria tuberosa, Ipomea digitata and Vitis vinifera, purified asphalt as a mineral and optionally nutraceutically or physiologically acceptable excipient(s). The nutraceutical formulation of the composition according to the present invention, depending on the desired type of the formulation can include one or more ingredients selected from the group consisting of conventional supplements or excipients selected from the group consisting of but not limited to additives, stabilizers, preservatives, sweetening agents, flavoring agents, coloring agents or spices or other such agents in order to increase preference, taste, shelf life or other attributes of the composition.

It is preferable to use the above ingredient in about 0.01-90 weight % based on the weight of the total composition.

The composition of the present invention formulated in the form of nutraceutical formulation or food supplement can be prepared according to conventional processes in the art, for example, in the form of a powder, a capsule, a tablet, granules, or a liquid preparation like a drink, a drink additive or beverage form. The nutraceutical formulations of the composition of the present invention may be administered to the subject in an oral form. The pharmaceutical composition of the invention can be administered via a desirable route depending on the formulation.

The pharmaceutical formulations of the composition of the present invention can be administered orally or topically. The amount of the nutraceutical preparation to be administered may be determined according to the formulation, the administration route, the person's age, weight symptoms, frequency of treatment, or the effect desired.

In one embodiment the present invention provides a pharmaceutical formulation comprising of extracts of plants that may be selected from the group comprising of but not limited to extract of Mucuna pruriens, Withania somninfera, Tribulus terrestris, Myristica fragrans, Asparagus racemosus, Emblica officianalis, Chlorophytum borivillianum, Moringa oleifera, Peuraria tuberosa, Ipomea digitata and Vitis vinifera; purified asphalt as a mineral and optionally pharmaceutically or physiologically acceptable excipient(s). The pharmaceutical formulation of the composition according to the present invention, depending on the desired type of the formulation can include one or more pharmaceutically or physiologically acceptable excipients selected from the group consisting of but not limited to carriers, binders, fillers, disintegrants, lubricants, fluidity enhancers, sweetening agents, colouring agents, flavouring agent, surfactants, solvents, dispersants, emulsifiers, buffers, stabilizers, diluents, preservatives, ointment base, or the like. It is preferable to use the above ingredient in about 0.01-90 weight % based on the weight of the total composition.

The composition of the present invention in the form of pharmaceutical formulation may be formulated according to conventional processes in the art, for example in the form of a capsule, a tablet, granules, liquid, syrup, suspension, oils, cream, ointment, gel, lotion or spray. These formulations may also be made as dry preparations which can be used in liquid form by addition to a proper carrier before use.

The amount of the pharmaceutical composition to be administered can be determined according to the formulation, the administration route, the purpose of use and the person's age, weight, symptoms, frequency of treatment, or the effect desired.

The composition of the present invention can be used for a subject in need thereof. Such subject may include those suffering from sexual dysfunctions for example those suffering from other concomitant conditions such as diabetes or those caused by disturbed life style, which can have an adverse effect on sexual health as well as general health.

The composition of the present invention comprising the synergistic combination of plants and mineral extract may not only address symptomatic relief in improving the sexual function of an individual but also provide a systematic response, addressing the root causes. The composition may elicit biological activity or a host of activities for example those which can supplement demand of antioxidant for scavenging free radicals and to fight stress, provide phytoandrogens to boost up the deprived endocrine profile, boost neurotransmitter levels like serotonin, acetyl choline to support at psychological level as well as improve physiological profile to support early morning erections in a man, such as those being deprived due to hyperlipidemia or hyperglycemia, provide a complementary effect on various parameters to improve reproductive capability as well as the quality of life of an individual.

Example:

A detailed pre clinical study was conducted to show the efficacy of the composition of the present invention in improving the sexual function parameters (which are otherwise compromised) of a man. Materials & Methods:

In this study, the composition comprising of extracts of Tribulus terrestris 100 mg, Mucuna pruriens 50 mg, Withania somnifera 50 mg, Asparagus racemosus 30 mg, Chlorophytum borivillianum 30 mg, Emblica officianalis 30 mg, Ipomoea digitata 25 mg, Peuraria tuberosa 25 mg, Moringa oleifera 35 mg, Myristica fragrans 30 mg, Vitis vinifera extract 25 mg, and Purified Asphaltum 20 mg were mixed and blended with suitable excipient in q.s. and filled in 500 mg capsule. The same were administered to the individuals.

Sixty men, aged between 30 to 55 years complaining of mild to severe sexual dysfunction were enrolled in to the study. About 26% were in the age group of 30- 39 years, 57% between the age group of 40-49 years and about 17% were of the age group 50-55 years. They are evaluated for their sexual function parameters such as Erectile function, Desire, Intercourse satisfaction, Orgasmic function and overall satisfaction both at baseline and post three months of the study.

From the baseline investigations of IIEF scores, nine subjects suffered from mild sexual dysfunction, 20 suffered from mild to moderate, 19 suffered from moderate and 10 suffered from severe sexual dysfunction. The selection criteria for the patient enrolment into the study were as follows - Inclusion Criteria:

1. Poor sexual function parameters as assessed by IIEF scores.

2. Decreased physical ability.

3. Patient's age between 30

4. Decreased general well-being.

Exclusion Criteria: 1. Congenital penile disorder.

2. Cryptorchidism / Sperm cord disorder.

3. Varicocele.

4. STD s.

5. Infective Liver disorder.

6. No concomitant diseases.

To all the enrolled men, the daily dosage regimen of the herbal supplement differed depending on the degree of sexual dysfunction, which was evaluated through understanding their baseline scores. At baseline, the sexual function parameters of them were measured by International Index of Erectile Function (IIEF) scoring. For those whose baseline IIEF scores were < 20, it was advised to be taken one capsule twice in a day, with these patients experiencing or on the edge to experience, the symptoms of severe sexual dysfunction. For those whose scores were more than 20, the dosage advised was one capsule a day. The duration of the course was for a period of 90 days continuously. Results: Table 1

From the above observations, following were the mean improvements of sexual parameters of IIEF scores over baseline:

Table 2

5

Thus, from the above study it was concluded that 52% had improvement of erectile function, 70% showed improvement of intercourse satisfaction, 66% showed improvement in Orgasmic function, 55% showed improvement in Sexual desire, 59% showed improvement in overall satisfaction and 58% showed improvement in total scores.

While the particular embodiments of the present invention have been described with reference to particular embodiments, it would be obvious to those skilled in the art that various additions, substitution, changes and modifications can be made without departing from the spirit and scope of the appended claims.

Claims

1. A composition for improving sexual health comprising extracts of: Withania somnifera, Tribulus terrestris, Mucuna pruriens, Moringa oleifera, Myristica fragrans, Ipomoea digitata, Peuraria tuberose, Chlorophytum borivillianum, Emblica officianalis, Vitis vinifera, Asparagus racemosus and Asphaltum present in an effective amount.

2. The composition as claimed in claim 1, wherein the extract of Mucuna pruriens is in an amount in the range of 30 mg to 100 mg, Withania somninfera is in the range of 10 mg to 100 mg, Tribulus terrestris is in the range of 30 mg to 200 mg, Myristica fragrans is in the range of 10 mg to 100 mg, Asparagus racemosus is in the range of 10 mg to 100 mg, Emblica officianalis is in the range of 5 mg to 50 mg, Chlorophytum borivillianum is in the range of 5 mg to 50 mg, Moringa oleifera is in the range of 5 mg to 50 mg, Peuraria tuberosa is in the range of 5 mg to 50 mg, Ipomea digitata is in the range of 5 mg to 50 mg, Vitis vinifera is in the range of 5 mg to 50 mg, and Asphaltum is in the range of 10 mg to 50 mg.

3. The composition of claim 1 or 2, optionally comprising at least one extract selected from the extract of Turnera diffusa, Muira pauma and Tinospora cordifolia.

4. The composition of claim 3, wherein the extract of Turnera diffusa is in the range of 10 mg to 150 mg; Muira pauma is in the range of 10 mg to 150 mg; and, Tinospora cordifolia is in the range of 5 mg to 75 mg.

5. The composition of any one of claims 1 - 4, wherein the extracts of Withania somnifera, Asparagus racemosus and Ipomea digitata are root extracts; extracts of Myristica fragrans and Emblica officianalis are fruit extracts; extract of Chlorophytum borivillianum is a tuber or root extract; extracts of Peuraria tuberosa and Muira pauma are root tuber extracts; extract of Turnera diffusa is a leaf extract; extracts of Moringa oleifera and Vitis vinifera are seed extracts, extract of Tinospora cordifolia is the stem extract and extract of Asphaltum is a purified extract.

6. The composition as claimed in any one of claim 1 - 5 formulated in the form of nutraceutical or pharmaceutical formulation.

7. The composition as claimed in any one of claims 1 - 6, optionally comprising at least one nutraceutically, pharmaceutically or pharmacologically acceptable excipient selected from the group consisting of but not limited to additives; stabilizers; preservatives; sweetening agents; flavoring agents; coloring agents or spices or other such agents in order to increase preference, taste or other attributes of the composition; carriers, binders, fillers, disintegrants, lubricants, fluidity enhancers, surfactants, solvents, dispersants, emulsifiers, buffers, stabilizers, diluents, preservatives, and ointment base.

8. The composition as claimed in claim 7, wherein the composition is formulated in a the form of a capsule, a tablet, granules, powder, liquid, syrup, suspension, a drink, a drink additive, beverage, oils, cream, ointment, gel, lotion or spray.

9. Use of the composition as claimed in claim 1-8 for improving sexual function in an individual.