Description
An aphrodisiac herbal composition for a female individual, tablet or a capsule comprising the composition and a method for self- administration of the composition
[1] The present invention relates to an aphrodisiac herbal basic composition for a female individual.
[2] During the years focus has been put on the male sexuality, which has been in¬ tensively investigated. The treatment of erectile dysfunction has been the subject of many studies and proposed treatments, one of them being VIAGRA® .
[3] Numerous male sexual enhancement drugs or pills has been developed and are commercially available today. In the past years also a few female products have been developed with the intention to regulate hormone levels, increase female sex drive, increase circulation and relieve anxiety. Such commonly known products are e.g. clitoris-stimulating creams for topical application in relation to or just before sexual in¬ tercourse. In addition a few oral compositions including amino acids are offered for sale via the Internet. Intake of large amounts of amino acids may have a negative influence on the health and should be avoided.
[4] Many women experience a loss of sexual vitality at some time in their lives.
External factors such as stress and fatigue may contribute to the decline in sexual interest, which often lead to problems in the relationship or even misconduct. However t oday's emancipated woman attempt to overcome this problem and seeks a solution to improved sexual pleasure and experience; and through the past few years the demand for female sexual desire promoting means have increased.
[5] In a first aspect according to the present invention is provided an oral aphrodisiac basic composition for the arousal of female sexual desire.
[6] In a second aspect according to the present invention is provided an oral aphrodisiac basic composition in combination with extracts from additional herbs for further arousal of female sexual desire.
[7] In a third aspect according to the present invention is provided a tablet or capsule including an aphrodisiac composition for a female.
[8] This is uniquely achieved according to the present invention by means of an aphrodisiac composition comprising extracts or particulate material from the plants Epimedium Grandiflorum , Turnera diffusa var. aphrodisiaca , Ilex paraguariensis, and Sarsaparilla.
[9] An aphrodisiac composition within the context of this invention arouses sexual desire.
[10] Epimedium Grandiflorum is a slow-growing creeping plant with semi-evergreen leaves on erect wiry stems. Many cultures have reported that Epimedium Grandiflorum (Horny Goat Weed) supports increased libido, improved erectile function, and relief from menopausal discomfort. The leaves is used in traditional botanical medicine in China and Japan and although it has a history of traditional use for disorders of the kidneys, joints, liver, back and knees, its principle use is as an aphrodisiaca. However no meaningful clinical evidence has been presented in support of this use.
[11] Turnera diffusavar. αphrodisiαcα is commonly known as Damiana and was used as an aphrodisiac in the ancient Mayan civilization. The Mexican Indians made a drink from the Damiana leaves, added sugar, and drank it for its purported power to enhance lovemaking. T he British Herbal Pharmacopoeia cites indications for the use of Turnera diffusavar. aphrodisiaca in anxiety neurosis with a predominant sexual factor, depression, nervous dyspepsia, atonic constipation, and coital inadequacy.
[12] Ilex pαrαguαriensis is an evergreen tree also also known as mate or Yerba mate.
The stiff and leathery leaves are used medicinally and as a natural, refreshing tea beverage throughout South America. Today Yerba mate is cultivated in many tropical countries to supply a world demand for its leaves. Yerba mate is used as a tonic, diuretic, and as a stimulant to reduce fatigue, improve appetite, and aid gastric function in herbal medicine systems throughout South America. It has also been suggested that Yerba mate stimulates the nervous and muscular systems and hence, can be used for digestive problems, renal colic, neurasthenia, depression, and obesity. Also t he British Herbal Phamacopoeia (1996) indicate the possibility for the treatment of fatigue, weight loss, and headaches.
[13] Smilax spp. or Sarsaparilla is a brambled, woody vine the long root of which was used by herbalists for treatment of e.g. rheumatism, cancer and skin diseases in ancient Mexico. Sarsaparilla contains steroidal saponins, such as sarsaponin or sarsasapogenin, which may mimic the action of some human hormones, e.g. pro¬ gesterone. To the knowledge of this inventor this property remains undocumented. Sarsaparilla root has been chewed by male Central and Southern Americans for sexual impotence and is used as an ingredient in commercial herbal preparations for libido en¬ hancement. However, their exist no evidence of the recipe of these preparations and clinical evidence of the effects. Also, a considerable amount of 2-4 grams must be ingested three times per day [Blumenthal M, Busse WR, Goldberg A, et al. (eds). The Complete Commission E Monographs: Therapeutic Guide to Herbal Medicines. Boston, MA: Integrative Medicine Communications, 1998, 372-3].
[14] U.S. Patent nr. 6,444,237 disclose an aphrodisiac composition of herbal in¬ gredients. The composition is comprised of extracts taken from Crataegus monogyna berry, Turnera diffusa, Pfaffla paniculata, Ginkgo biloba, Pygeum africanum, and gin-
senosides extract, which are combined with L-arginine, L-glutamic acid and L- theanine in amounts effective to produce sexual desire. About 15 g of the composition and a flavouring agent is dissolved in water and ingested. The final agent includes a large number of ingredients to obtain the intended sexual stimulation effect and moreover a huge amount of agent must be ingested which is inconvenient for the user.
[15] The present inventor has surprisingly found that the novel basic combination of extracts or particulate material from parts of the above-mentioned plants have a better and synergistic aphrodisiac effect than obtained with known herbal compositions or with the extracts or the plants alone. Comprehensive studies in support of this have been performed at King's College, University of London and will be further discussed in Example 1 below.
[16] Advantageously, the composition may further comprise an extracts or particulate material from at least one additional second plant.
[17] In a first embodiment according to the present invention said additional second plant can be Ginkgo biloba L. Extract from the dried leaf of Ginkgo biloba L has been recognized to have several pharmacological effects, such as e.g. improvement of hypoxic tolerance in the cerebral tissue, increased memory performance and learning capacity and improvement of blood flow in the region of microcirculation. Recent research have investigated Ginkgo biloba L benefits in patients suffering from anti- depression-induced sexual dysfunction [Cohen, A.J. and B. Bartlik. 1998. ' Ginkgo Biloba for antidepressant-induced sexual dysfunction', J. Sex Marital. Ther. 24(2): 139-143]. It was found that of 63 subjects, 33 women and 30 men, the women were more responsive to the sexually enhancing effects than the men. The relative success rates were 91% for the women compared to 76% for the men. The ginkgo (product brand not noted) was given at a dosage range of 60 to 120 mg twice daily, within the normal range for the usual applications of ginkgo. A positive effect on all four phases of the sexual response cycle: desire, excitement (erection and lubrication), orgasm, and resolution (afterglow) were reported. A daily intake as in the present study has a number of disadvantages for the patient. E.g. there is an annoying risk that the sexual organs are permanently stimulated. However, the above findings have encouraged the present inventor in the search for an improved aphrodisiac composition.
[18] In a second embodiment according to the present invention said additional second plant can be Eurycoma longifolia Jack, which is also known under its commercial name Tongkat AIi. Eurycoma longifolia Jack is a tall shrub-tree found in the Malyasian jungle. The root has been utilized as aphrodisiac for males. The effects of extracts from the root of Eurycoma longifolia Jack were studied on the libido of sexually experienced male rats after dosing them with 200, 400 and 800 mg/kg body
weight twice daily of different fractions of E. longifolia Jack for 10 days. Results showed that E. longifolia Jack produced a dose-dependent increase in mounting frequency of the treated male animals. The study provides evidence that E. longifolia Jack is a potent stimulator of sexual arousal in sexually vigorous male rats in the absence of feedback from genital sensation. [Hooi Hoon ANG and Meng Kwoon SIM; Eurycoma longifolia Jack enhances libido in sexually experienced male rats; Exp. Anim. 46(4), 287-290, 1997]. No clinical evidence is disclosed for female animals. This second embodiment constitutes a preferred alternative to the above-mentioned compositions and is preferred by many women.
[19] In a third embodiment according to the present invention said additional second plant can be Rhodiola rosea L.. Rhodiola rosea L. is also known as 'golden root' or 'roseroot' and belongs to the plant family Crassulaceae . Traditionally, the root were used to increase physical endurance, work productivity, longevity, resistance to high altitude sickness, and to treat fatigue, depression, anaemia, impotence, gastrointestinal ailments, infections, and nervous system disorders. A summary of these ancient uses is found in Herbal Gram. 2002; vol. 56, p 40-52; Journal of American Botanical Council; Rhodiola rosea: A Phytomedicinal Overview; Richard P. Brown, Patricia L. Gerbarg, and Zakir Ramazanov. This summary also describes a study of /?, rosea extract in women suffering from amenorrhea concluding that R. rosea is able to restore normal menses and increase tendency to become pregnant. The inventors of the present ap¬ plication know no report or clinical evidence of Rhodiola roseaL. having an aphrodisiac effect.
[20] In a fourth embodiment according to the present invention said additional second plant can be Tribulus terrestris , which has long been used in the traditional Chinese and Indian systems of medicine for the treatment of various ailments and is claimed to improve sexual functions in man. Extracts from the fruits are commercially used in variouscombinations with other sex-enhancing herbs than the ones used in the present invention.
[21] In a fifth embodiment according to the present invention said additional second plant can be Lepidum meyenii, also known commercially as Maca. Extracts from the root of Maca has traditionally been used for centuries in the Andes to enhance fertility in humans and animals.
[22] Optionally extracts or particulate material from Erythroxylum catuaba , which is a vigorous growing tree in the northern part of Brazil can be added. A bark decoction is known to be used for sexual impotency and weakness by the male Brazilian Indians but the prior art teachings lack clinical discussions and further evidence. It has been found by the inventor that some women have preference for this embodiment of the present invention rather than the basic herbal composition.
[23] As a variation extract or particulate material from Eriosema kraussianum may be included in the composition. Five pyrano-isoflavones have been isolated from the rootstock of Eriosema kraussianum N. E. Br (Papilionaceae). The most active of the compounds had an activity of 75% of that found in Viagra® in the erectile dysfunction test on rabbit penile smooth muscle. [Siegfried E. Drewes, Marion M. Horn, Orde Q. Munro, Jabu T. B. Dhlamini, J. J. Marion Meyer and N. Christopher Rakuambo; Pyrano-isoflavones with erectile-dysfunction activity from Eriosema kraussianum; PhytochemistryVol. 59, Iss. 7, April 2002, pp. 739-747]. No comparable study has been made for the female. This embodiment constitutes a preferred alternative to the compositions above and is preferred by many.
[24] Preferred amounts of extract from the plants of the basic composition is between
200 - 400 mg from Epimedium Grandiflorum, preferably from the leaves of Epimedium Grandiflorum, between 40 - 60 mg from Turnera diffusa var. aphrodisiaca , preferably from the leaves of Turnera diffusa var. aphrodisiaca, 40 - 60 mgllex paraguariensis, preferably from the leaves of Ilex paraguariensis, and 3 - 6 mg from Sarsaparilla, preferably from the root of Sarsaparilla.
[25] Preferred amounts of extract or particulate material from the at least one additional second plant is between 10 - 30 mg of Ginkgo biloba L, preferably from the leaves of Ginkgo biloba L, between 10 - 30 mg of Eurycoma longifolia Jack, preferably from the root of Eurycoma longifolia Jack, between 30 - 40 mg of Rhodiola roesea L., preferably from the root of Rhodiola roesea L., between 10 - 50 mg of Tribulus terrestris, preferably from the fruits of Tribulus terrestris and between 10 - 50 mg of Lepidum meyenii, preferably from the root of Lepidum meyenii.
[26] The novel herbal basic compositions according to the present invention have proved its superiority as a female aphrodisiac as will be evident from the enclosed Examples.
[27] When extract or particulate material from Erythroxylum catuaba is included in the composition it is preferred to include 400 - 1000 mg extract or particulate material from the bark of Erythroxylum catuaba .
[28] When extract or particulate material from Eriosema kraussianum is included in the composition it is preferred to include 300 - 400 mg extract or particulate material from the rootstock of Eriosema kraussianum .
[29] It may be advantageous to include at least one additive, such as a filling agent and/ or a flavouring agent and/or a vitamin. A preferred filling agent is lactose, as commonly used as bulk material in tablets. The filler serves for providing the composition with a suitable appearance. Any vitamin can be included in the composition within the scope of the present invention id desired.
[30] Some herbal extracts have an unpleasant taste, which can be camouflaged by
means of a flavouring agent to improved comfort for the woman during oral intake.
[31 ] The composition can be pressed into tablets or be encapsulated using techniques known to the person skilled in the art. As an example, a tablet may have a basic weight of 1 g with a content of the active ingredients represented by the inventive basic composition of herbal extracts in a total amount of 650 mg.
[32] A recommended prescription is 4 times 650 mg active basic herbal composition taken orally at least 1 hour before sexual activity. The advantage of sexual desire will sustain during approximately 48 hours after oral ingestion. No special reasons are needed before start of treatment. In contrast to the few known oral compositions the composition according to the present invention treatment is a short acute treatment. No permanent inexpedient increase in the oestrogenic level is released and consequently the women overall hormon balance remains substantially unaffected in the long term.
[33] No reports have been found on severe toxicity and the inventor of the present invention considers the present aphrodisiac herbal composition as extremely safe products.
[34] The various aphrodisiac herbal compositions according to the present invention induce a widespread feeling of vigour, sexual attraction and increased sexual pleasure. Female test persons expired an increased blood circulation to the clitoris and increased stamina and sex drive.
[35] All components used for manufacturing the basic composition have been obtained from Dansk farmaceutisk industri A/S (Danish Pharmaceutical Industries Ltd), Indus- triparken 4, 2750 Ballerup, Denmark.
[36] All tests were performed in co-operation with King's College London, University of London, Strand, London WC2R 2LS, England, United Kingdom under medical su¬ pervision.
[37]
EXAMPLES
[38] Example 1 : Test study of basic composition
[39] 48 voluntary healthy women aged between 25 and 60 years (mean age: 36,5 year) were randomised into two groups. Group A (24 test persons) received four capsules per 24 hours, each capsule contained 650 mg of the active basic composition [300 mg extract from the leaves of Epimediwn Grandiflorum, 35 mg extract from the root of Rhodiola rosea L., 50 mg extract from the leaves of Turnera diffusa vai.aphrodisiaca, 50 mg extract from the leaves of Ilex paraguariensis, 60 mg extract from the leaves of Ginkgo biloba L. and 5 mg extract from the root of Sarsaparilla], and Group B (24 test persons) received four placebo capsules per 24 hours each containing 650 mg lactose (total weight corresponding to the total weight of basic composition given to Group A). None of the test persons had expressed sexual problems. No additives were included in
any of the capsules.
[40] The tests persisted in 48 hours. After expiry of the test period the test persons filled in a questionnaire. The results is presented in Table 1 below: [41] Table 1
[42] The difference between the Group A and B has a statistical level of significance (0,01). [43] It should be noted that a completely objective answer to the questions put to the test persons are difficult to achieve. Some of the test persons of Group B also observed a level of effect. One explanation to this could be the intensified focus on the sex life of the persons involved. Test persons informing her partner of the test expired clearly improved effect of the placebo treatment. This finding has not been substantiated sta¬ tistically. However, the general indication is that the overall effect of the compositions surpasses the sum of the effect of the single constituents if administered alone, thereby indicating a synergistic reaction. Although not fully explainable one reason for the synergistic result is believed by the researcher to be occasioned by the effect of the composition on certain brain receptors.
[44] In Group A two persons reported nausea and four persons reported headache
during the test period of 48 hours. However, neither nausea nor headache was regarded as side effects from the herbal basic composition. [45] In Group B three persons noted transitory nausea related to the placebo intake, three persons noted headache and one person noted mild dyspectic nuisance. [46] The present test study is a clear indication that the herbal basic composition constitutes an attractive aphrodisiac for the female individual. [47] The tests of the following Examples 2, 3 and 4 were performed with 14 days intervals.
[48] Example 2: Comparative test study of basic composition + extract from Ery¬ throxylum catuaba [49] Extract from the bark of Erythroxylum catuaba was obtained from King's College
London, University of London, Strand, London WC2R 2LS, England, United
Kingdom. [50] The 24 test persons of Group A of Example 1 participated in the additional test study in which the aphrodisiac effect of the herbal basic composition was compared with the aphrodisiac effect of the herbal basic composition combined with extract from the bark from Erythroxylum catuaba . [51] Each person in Group A now received the same dose basic composition as in
Example 1 and in addition two capsules per 24 hours containing 600 mg extract from
Erythroxylum catuaba . Other test conditions were aimed at being the same as in
Example 1. [52] Immediately after expiry of the 48-hour test period 67 % of the test persons confirmed their experience of improved aphrodisiac effect of the combined composition in relation to the effect of the basic composition. [53] Example 3: Comparative test study of basic composition + extract from the root of
Eriosema kraussianum [54] Extract from the root from Eriosema kraussianum was obtained from King's
College London, University of London, Strand, London WC2R 2LS, England, United
Kingdom . [55] The 24 test persons of Group A of Example 1 participated in the additional test study in which the aphrodisiac effect of the herbal basic composition was compared with the aphrodisiac effect of the herbal basic composition combined with extract from the root from Eriosema kraussianum . [56] Each person in Group A now received the same dose basic composition as in
Example 1 and in addition two capsules containing 200 mg extracted kraussianone (1)
+ 200 mg extracted kraussianone (2) per 24 hours from the root of Eriosema kraussianum . The other test conditions were aimed at being the same as in Example 1.
[The kraussianone nomenclature is the one established and used in ' Pyrano-
isoflavones with erectile-dysfunction activity from Eriosema kraussianum ' ; Phyto- chemistryVol. 59, Iss. 7, April 2002, pp. 139-1 Al by Siegfried E. Drewes, Marion M.
Horn, Orde Q. Munro, Jabu T. B. Dhlamini, J. J. Marion Meyer and N. Christopher
Rakuambo]. [57] Immediately after expiry of the 48-hour test period 71 % of the test persons confirmed their experience of improved aphrodisiac effect of the combined composition in relation to the effect of the basic composition. [58] Example 4: Comparative test study of basic composition + extract from the root of
Eurycoma longifolia Jack [59] Extract from the root of Eurycoma longifolia Jack was obtained from Phytes
Biotek Sdn. Bhd, Lot 21, Jalan Ul/19 Section Ul, Hicom-Glenmarie Industrial Park,
40150 Shah Alam, Selangor, MaIy sia. [60] The 24 test persons of Group A of Example 1 participated in the additional test study in which the aphrodisiac effect of the herbal basic composition was compared with the aphrodisiac effect of the herbal basic composition combined with extract from the root of Eurycoma longifolia Jack. [61] Each person in Group A now received the same dose basic composition and two capsules per 24 hours containing 20 mg extract from the root of Eurycoma longifolia
Jack . Other test conditions were aimed at being the same as in Example 1. [62] Immediately after expiry of the 48-hour test period 79 % of the test persons confirmed their experience of improved aphrodisiac effect of the combined composition in relation to the effect of the basic composition. [63] The inventive compositions and combined compositions are all attractive natural treatments for female individuals suffering from lack of sexual desire an arousal disorders. The invention can bring incentive back to unhappy relationships. [64] The treatment of any female animal other than the human being is also considered within the scope of the present invention.