Claims:WE CLAIM
1. A herbal composition for treating erectile dysfunction comprising extracts of Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, Anacyclus pyrethrum, and pharmaceutically acceptable excipients.
2. A herbal composition for treating erectile dysfunction comprising extracts of: a) Tribulus terrestris in an amount of 140mg; b) Withania somnifera in an amount of 120mg; c) Asparagus racemosus in an amount of 80mg; d) Mucuna pruriens in an amount of 55mg; e) Asparagus adscendens in an amount of 50mg; f) Pueraria tuberosa in an amount of 20mg; g) Myristica fragrans in an amount of 20mg; h) Anacyclus pyrethrum in an amount of 15mg of the total weight of the composition and pharmaceutically acceptable excipients.
3. The herbal composition as claimed claim 1, wherein said composition comprising; a) Tribulus terrestris in an amount of 100 to 150mg; b) Withania somnifera in an amount of 90 to 150mg; c) Asparagus racemosus in an amount of 20 to 100mg; d) Mucuna pruriens in an amount of 20 to 80mg; e) Asparagus adscendens in an amount of 20 to 80mg; f) Pueraria tuberosa in an amount of 10 to 50mg; g) Myristica fragrans in an amount of 10 to 50mg; h) Anacyclus pyrethrum in an amount of 10 to 40mg; and pharmaceutically acceptable excipients.
4. The herbal composition as claimed in claim 1, wherein said composition acts as serum total testoterone enhancer.
5. The herbal composition as claimed in claim 1, wherein said composition acts as penile erection enhancer.
6. The herbal composition as claimed claim 1, wherein said composition acts as intra-vaginal ejaculation latency time enhancer.
7. The herbal composition as claimed in claim 1, wherein said composition is formulated into tablet or capsule.
8. The herbal composition as claimed in claim 1, wherein said composition is in a capsule form.
9. The herbal composition as claimed in claim 1, wherein said pharmaceutically acceptable excipients are selected from binder, binder solution, glidants, lubricants, disintegrants, and coating agents.
10. A process for preparing the herbal composition as claimed in claim 1 comprising: a) washing all the herbal extracts with water and drying the herbal extracts; b) powdering the herbal extracts with pulveriser or grinder to obtain the powdered form; c) sieving the powdered form of the herbal extracts; d) mixing the herbal extracts with excipients and drying sufficiently to obtain the final product; e) formulating the final product into capsules; f) sealing and storing the capsules in blisters or containers.
Dated this on 18th Day of September 2021

Asha P. Hole
Patent Agent (IN/PA2269) , Description:TECHNICAL FIELD OF THE INVENTION
This invention relates to an herbal composition useful for treatment of male sexual dysfunction. More particularly, the present invention relates to a herbal composition comprising a combination of extracts derived from natural sources preferably plants and minerals which are useful in treating male sexual dysfunction, specifically Erectile dysfunction.
BACKGROUND OF THE INVENTION
Millions of men worldwide are affected by Erectile Dysfunction (ED), defined as the inability to attain or maintain an erection sufficient for satisfactory sexual activity This is a common yet significant condition, with large prevalence in developed and developing countries. The global ED prevalence is expected to increase to 322 million by 2025 (Goldstein et. al. Sexual Medicine, 2020, 8(3), 338-349). Studies have reported that ED prevalence increases with age, being reported in approximately 1–10% of men aged <40 years, as compared with 20–40% of men in their sixties. Studies have also reported that men with ED are more likely to have comorbidities including hypertension, hypercholesterolemia, depression/anxiety, cardiovascular diseases, or diabetes as compared to men without. Thus, sexual dysfunction has considerable importance and form the subject of intensive biomedical research efforts.
ED may result from psychological, neurologic, hormonal, arterial, or cavernosal impairment or from a combination of these factors. ED is also viewed as a strong predictor for coronary artery disease, consequently cardiovascular assessment of a non-cardiac patient presenting with ED is now recommended by physicians across the globe. Any sexual dysfunction can be caused by physical or psychological stress and may be of any one: loss of libido, erectile dysfunction, premature ejaculation, delayed or inhibited orgasm, physical abnormalities of the penis.
Taking into account the above factors, therapy is aimed at restoration of the two vital sexual functions: the capacity to acquire and sustain penile erections; and the reactivation of libido. Over the past decades, substantial advances have occurred in the understanding of the pathophysiology of erectile dysfunction that ultimately resulted in the development the development of successful oral therapies, namely the phosphodiesterase type 5 inhibitors. Oral therapies include sildenafil (Viagra), Tadalfil (Adcirca, Cialis), Vardenafil (Levitra, Staxyn), Avanafil (Stendra). Several side effects are associated with continued use of the said medications. The most common side effects of these medications are headache, facial flushing, and upset stomach. Less commonly, bluish vision, blurred vision, or sensitivity to light may briefly occur. Vision change is considered the more serious potential side effects of ED pills like Viagra and Levitra. It has been reported that, taking the medication can sometimes cause sudden vision loss in one or both eyes. Additionally, the abovementioned ED drugs cannot be consumed with several other medications because of potential drug interaction issues. One of the biggest concerns about ED drugs is whether or not they can cause permanent erectile dysfunction. Further, the most serious side effects of ED medications like Viagra are heart attacks. Other therapies include Alprostadil self-injection, Alprostadil urethral suppository, Testosterone replacement. Surgical and penial prosthetic options are also available.
It is evident that existing treatments for male ED have side effects or are not very comfortable for usage. While research is being conducted on improving the safety profile of these drugs, these approved treatments do not show effect on all aspects of ED. There is therefore a need to provide a product to fill the lacunae in the current treatment options. The said product needs to be safe and efficient to treat various aspects of ED such as hardness of penis, improved orgasmic function, improved intercourse satisfaction, quality of penile erection, increase in serum total testosterone, intra-vaginal ejaculation latency time, the frequency of sexual intercourse.
Herbal or plant-based medicines offer an advantage over synthetic drugs generally in terms of little or no associated adverse effects and toxicities which add on to patients’ burden. National health policies of several countries have accepted herbal medicine as complimentary or alternate medicine. Herbal medicines have also long been used in the management of sexual dysfunction, including erectile dysfunction (Saxena et. al., International Journal of Green Pharmacy, 2012, 6(2), 109-117). Various herbs that can be used for the purpose of the present invention to treat various aspects of sexual dysfunction are described below:
a) Tribulus terrestris (Gokshur) is a plant-based drug used as an aphrodisiac, a diuretic, and has also proven utility in the treatment of urolithiasis, dysurea, impotence, and kidney dysfunction; b) Withania somnifera (Ashwagandha) also dubbed as the rejuvenating drug has been used for centuries as a popular remedy for many conditions. Withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative, and life-prolonging properties; c) Asparagus adscendens (Musali svet) roots are used in Unani medicine as an aphrodisiac as they are rich in glycosides. They are commonly used in modulation of various disorders such as leucorrhea, diarrhea, dysentery, diabetes, senile pruritus, asthma, fatigue antifilarial, antifungal, spermatorrhea, and sexual debility/seminal weakness; d) Mucuna pruriens (Kaucha) is considered as one of the most effective aphrodisiac, also used in treatment of liver and gall bladder disorders. Mucuna pruriens seeds have also proven to be effective in profuse menstruation, treat Parkinsonism and diabetes; e) Asparagus racemosus (Shatavari) holds the reputation of being an aphrodisiac which falls into the Ayurvedic category of drugs that ameliorate and potentiate sexual performance; f) Pueraria tuberosa (Vidarikand) is widely used in traditional Indian medicine as tonic, aphrodisiac, antirheumatic, diuretic, and galactagogue. Pueraria tuberosa is also reported to possess numerous activities like nootropic, antioxidant, and antifertility; g) Myristica fragrans (Jatiphal) is commonly consumed medicine and a potential source of polyphenols with strong antioxidant activity. It also inhibits enzymes relevant to erectile dysfunction; and h) Anacyclus pyrethrum (Akarkarabha) has been known as male sexual stimulant. It has traditionally been used as an aphrodisiac and fertility enhancing herb as well as brain tonic for the treatment of epilepsy, rheumatism, headache, and paralysis.
The individual extracts cited above of the present invention have been reported in the literature of traditional medicine for their aphrodisiac activity. Such extracts are available for the management of one or more symptoms of ED. Higher therapeutic dose of single extract and lack of selectiveness/effectiveness against various aspects of ED are of major concern. Compositions have been reported in the prior art that have been made to prepare the combinations of such extracts as a remedy for overall sexual satisfaction. US948648 reports one such composition containing Tribulus terrestris, Withania somnifera, Curculigo orchioides, Mucuna pruriens, Asparagus adscendens, Asteracantha longifolia and Asphaltum.md, Piper longum and Anacyclus pyrethrum in combinations. IN201941005346 reports a composition containing Mucuna pruriens, Cynara cardunculus, Trigonella foenum graecum, and Withania somnifera. IN-DEL-2011-00550 reports a composition containing Withania Somnifera, Asparagus Racemosus, Asparagus Adscendens, Cyperus Rotundus, Mucuna Pruriens, Myristica Fragrans, Ipomoeda Digitata, Zingiber Officinale, Tribulus Terrestris and Sida Cordifolia. IN201811047140 reports a composition containing Nigella sativa, Mucuna pruriens, Myristica fragrans houtt, Withania somnifera, Helianthus annus, Tribulus terrestris, Anacyclus pyrethrum, Syzygium aromatica meril & perry, Prunus amygdalus batsch, and Fuglans regia. It is evident that herbal compositions for treating various aspects of ED reported in the literature exhibit varied combinations of individual extracts. There is no consensus on the choice of specific extracts to be used in such a combination composition. Further, there is also no consensus on the dose of individual extracts required for such combination compositions. This points at the drawbacks of the prior art compositions - lack of standardization, variable concentration of active extracts, unacceptable pharmaceutical dosage form and most importantly, the lack of safety and efficacy background through preclinical and clinical studies.
Accordingly, the present inventors report a novel composition comprising of Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum with the ability to treat ED. A composition comprising all of these herbal extracts, in their respective therapeutic amounts for the treatment of ED has not been disclosed before in the literature. The instant composition exhibits the ability to treat all of the aforementioned aspects of ED such as hardness of penis, improved orgasmic function, improved intercourse satisfaction, quality of penile erection, increase in serum total testosterone, intra-vaginal ejaculation latency time, the frequency of sexual intercourse while maintaining drug compliance with no adverse events related to the therapy.
Therefore, the objective of the present invention is to provide an herbal composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum present in specific therapeutic amounts, useful for the treatment of various aspects of ED such as hardness of penis, improved orgasmic function, improved intercourse satisfaction, quality of penile erection, increase in serum total testosterone, intra-vaginal ejaculation latency time, the frequency of sexual intercourse.
SUMMARY OF THE INVENTION
In view of the foregoing, for overcoming the disadvantages of the prior art, the object of the invention is to provide a herbal composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum for the treatment of erectile dysfunction.
To achieve the above, the present invention includes a composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum and pharmaceutically acceptable excipients for treating erectile dysfunction in a subject in need thereof. The present invention can be administered in the dosage forms selected from capsule, tablet, granules, syrup and other suitable dosage forms. Preferably, the composition of the present invention can be administered in tablet or capsule dosage forms.
According to one embodiment, is provided a herbal composition comprising extracts of Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, Anacyclus pyrethrum and pharmaceutically acceptable excipients, for increasing serum total testosterone, enhancing penile erection, and improving intra-vaginal ejaculation latency time.
According to one embodiment, said herbal composition comprises: ; a) Tribulus terrestris in an amount of 100 to 150mg; b) Withania somnifera in an amount of 90 to 150mg; c) Asparagus racemosus in an amount of 20 to 100mg ; d) Mucuna pruriens in an amount of 20 to 80mg; e) Asparagus adscendens in an amount of 20 to 80mg; f) Pueraria tuberosa in an amount of 10 to 50mg; g) Myristica fragrans in an amount of 10 to 50mg; h) Anacyclus pyrethrum in an amount of 10 to 40mg of the total weight of the composition and pharmaceutically acceptable excipients; wherein said composition is ready for oral administration.
According to one embodiment, said pharmaceutical composition comprises: a) Tribulus terrestris in an amount of 140mg; b) Withania somnifera in an amount of 120mg; c) Asparagus racemosus in an amount of 80mg; d) Mucuna pruriens in an amount of 55g; e) Asparagus adscendens in an amount of 50mg; f) Pueraria tuberosa in an amount of 20mg; g) Myristica fragrans in an amount of 20mg; h) Anacyclus pyrethrum in an amount of 15mg of the total weight of the composition and pharmaceutically acceptable excipients.
According to one embodiment, said pharmaceutical composition is suitable for oral administration. According to one embodiment, said pharmaceutical composition is formulated into capsule. According to an alternate embodiment, said pharmaceutical composition is formulated into tablet. In a preferred embodiment, said composition is in a capsule form.
According to one embodiment, said herbal capsule composition shall comprise of at least one pharmaceutically acceptable excipient.
According to one embodiment, said herbal composition is prepared by: a) washing all the herbal extracts with water and drying the herbal extracts; b) powdering the herbal extracts with pulveriser or grinder to obtain the powdered form; c) sieving the powdered form of the herbal extracts; d) mixing the herbal extracts with excipients and drying sufficiently to obtain the final product; e) formulating the final product into capsules; f) sealing and storing the capsules in blisters or containers.
DETAILED DESCRIPTION OF THE INVENTION
To clarify the above and other purposes, features, and advantages of this invention, specific embodiment of this invention is especially listed and described in detail with the examples as follows. The principal and mode of operation of this invention have been described and illustrated in its embodiment. At the outset, a person skilled in the art will appreciate that this invention may be practiced otherwise than is specifically described and illustrated. The invention should not be limited by the above-described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention. Also, in the following description of the invention, certain terminology may be used for the purpose of reference only, and is not intended to be limiting.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value and/or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
The present invention provides a pharmaceutical composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum for treating various aspects of ED. The present invention can be administered in an oral dosage form, preferably a tablet or a capsule suitable dosage form.
Central to this invention is a composition comprising of herbal extracts for treating ED. Several herbs have been reported in the literature for their ability to treat or manage one or more aspects of ED (Saxena et. al., 2012). The ability of these extracts to treat ED has been well established in the literature. Albeit, the literature suggests that these herbs exhibit the ability to treat or manage the condition in varying degrees. Therefore, an important aspect of the invention is to select the most appropriate combination of herbs and their herbal extracts to achieve a composition that presents the best results for treating ED.
Accordingly, the present composition comprises a novel combination of 8 ingredients namely Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum for the effective management of male sexual dysfunctions. All the aforementioned herbs used in the composition help in improving libido. Some of these herbs help to release nitric oxide from the endothelium and nitrergic nerve endings, relaxes corpus cavernosum muscle, increases intracavernous pressure, thus improve penile erection. Some of these herbs help in maintaining androgen balance in the body. Some of these herbs also help to increase dehydroepiandrosterone-sulphate (DHEA-S) level and thereby improve sexual function in men. Ingredients effectively help improve an individual's resistance towards stress and help in relieving psychological element involved in erectile dysfunction. Ingredients also help in delaying the ejaculation thus sustain erection for longer duration. Almost all ingredients possess anti-oxidant activity which helps in improving spermatogenesis. Further, by virtue of synergistic action of various ingredients, the composition of the present invention is effective in treating loss of libido, erectile dysfunction, and premature ejaculation.
While several compositions containing herbs in different combinations have been reported in the literature, a composition comprising the combination of individual extracts cited in the present invention has not been reported for treating ED. Accordingly, the present invention reports a composition comprising of a novel combination of Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum for treating various aspects of ED.
According to one embodiment, said herbal composition comprises: a) Tribulus terrestris in an amount of 100 to 150mg; b) Withania somnifera in an amount of 90 to 150mg; c) Asparagus racemosus in an amount of 20 to 100mg ; d) Mucuna pruriens in an amount of 20 to 80mg; e) Asparagus adscendens in an amount of 20 to 80mg; f) Pueraria tuberosa in an amount of 10 to 50mg; g) Myristica fragrans in an amount of 10 to 50mg; h) Anacyclus pyrethrum in an amount of 10 to 40mg of the total weight of the composition and pharmaceutically acceptable excipients; wherein said composition is ready for oral administration.
According to one embodiment, said pharmaceutical composition comprises: a) Tribulus terrestris in an amount of 140mg; b) Withania somnifera in an amount of 120mg; c) Asparagus racemosus in an amount of 80mg; d) Mucuna pruriens in an amount of 55g; e) Asparagus adscendens in an amount of 50mg; f) Pueraria tuberosa in an amount of 20mg; g) Myristica fragrans in an amount of 20mg; h) Anacyclus pyrethrum in an amount of 15mg of the total weight of the composition and pharmaceutically acceptable excipients.
Another important aspect of the invention is selecting the therapeutic dose of each herbal extract. The existing literature reports varied amounts of each herbal extract, when viewed individually or in any combination. It is evident that there is no linear correlation between therapeutic doses of each herbal extract when used in a combination composition such as that described in the present invention. Both higher and lower dose of each drug may present potential issues of efficacy. A person skilled in the art shall appreciate that the most appropriate therapeutic dose of each herbal extract is vital to the optimal function of the combination. In other words, the therapeutic dose of each herbal extract should work synergistically so as to achieve a composition that fulfils the object of the invention. Therefore, even though the existing literature cites different doses of each herbal extract that may lead to a combination composition; the desired composition can be arrived at only after carefully selecting the therapeutic doses, and thus cannot be construed as a mere admixture of known extracts in known therapeutic doses.
A person skilled in the art shall appreciate that a mere comparison of amounts of herbal extracts present in prior art compositions may not be the best representation. For a more accurate comparison, human equivalent doses (HED) must be correlated. In other words, proven efficacy at a reduced human equivalent dose is a truer representation of ingenuity of the composition. Therefore, the HED of ingredients of the instant composition has been compared with prior arts as follows:
The instant composition comprises of 140 mg of Tribulus terrestris extract per 768 mg tablet i.e., 16.21 mg/ person/day (HED). This is significantly less than 1054 mg/ person/day (HED) of Tribulus terrestris reported by prior art (Singh and Gupta, Journal of Men's Health, 8(S1), S75-S77). Similarly, the instant composition comprises of 120 mg of Withania somnifera extract per 768 mg tablet comprising of 64 mg/person/day (HED). This is significantly less than 675 mg/ person/day (HED) reported by prior art (Ambiye et. al., Evidence-Based Complementary and Alternative Medicine Volume 2013). The instant composition comprises of 55 mg of Mucuna pruriens extract per 768 mg tablet i.e., 474.35 mg/ person/day (HED). This is significantly less than 5000 mg/ person/day (HED) of Mucuna pruriens reported by prior art (Shukla et. al., American Society for Reproductive Medicine,Vol. 92, No. 6, December 2009). The instant composition comprises of 20 mg of Myristica fragrans extract per 768 mg tablet i.e., 81.08 mg/ person/day (HED). This is significantly less than 5270 mg/ person/day (HED) of Myristica fragrans reported by prior art (Ahmed et. al., BMC Complementary and Alternative Medicine, 2005, 5(1), 1-7.). The instant composition comprises of 80 mg of Asparagus racemosus extract per 768 mg tablet i.e., 64.86 mg/ person/day (HED). This is significantly less than 4216 mg/ person/day (HED) of Asparagus racemosus reported by prior art (Singh et. al., Journal of Acute Disease, 2013, 2(3), 179-188.). The instant composition comprises of 15 mg of Anacyclus pyrethrum extract per 768 mg tablet i.e., 16.21 mg/ person/day (HED). This is significantly less than 1054 mg/ person/day (HED) of Anacyclus pyrethrum reported by prior art (Sharma et. al., Scientia pharmaceutica, 2009, 77(1), 97-110.). The instant composition comprises of 50 mg of Aspargus adscendens extract per 768 mg tablet i.e., 48.64 mg/ person/day (HED). This is significantly less than 3162 mg/ person/day (HED) of Aspargus adscendens reported by prior art (Bansode et. al., Pharmaceutical biology, 2015, 53(2), 192-200.). Lastly, the instant composition comprises of 20 mg of Pueraria tuberosa extract per 768 mg tablet i.e., 24.32 mg/ person/day (HED). This is significantly less than 1581 mg/ person/day (HED) of Pueraria tuberosa reported by prior art (Bansode et. al., The Scientific World Journal, 2013.).
All herbal extracts of the composition of the present invention are reported to be safe and well documented in literature. Plant extracts are extremely complex, multicomponent mixtures. The extraction and determination of quality and quantity of bioactive constituents from the most appropriate part of the plant is vital. It should be noted that herbs and plants need to be processed. Accordingly, a part of the plant may be used as a raw material, or a liquid and/or solid extract thereof. Suitable procedures include multiple steps, for example maceration, percolation, and extraction using supercritical fluids, liquefied gases or suitable solvents are used for the preparation of the material. The bioactive ingredients need to be extracted from the plant material such as roots, fruits, seeds etc., further purified and isolated in order to make it fit for the designated use in a composition for treating ED.
The herbal extracts used in the present composition are extracted using various parts of herbs, is described below:

Table 1: Bioactive ingredients of the composition

Bioactive Ingredient Botanical Name Part
Gokshur Extract Tribulus terrestris Fruit
Ashwagandha Extract Withania somnifera Root
Shatavari Extract Asparagus racemosus Root

Kaucha Extract Mucuna pruriens Seed
Musali Svet Extract Asparagus adscendens Root
Vidarikand Extract Pueraria tuberosa Tuber
Jatiphal Extract Myristica fragrans Seed
Akarkarabha Extract Anacyclus pyrethrum Root

The term "Tribulus terrestris" or “Gokshur Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term "Withania somnifera" or “Ashwagandha Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term "Asparagus racemosus" or “Shatavari Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term “Mucuna pruriens” or “Kuach Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term "Asparagus adscendens" or “Musali Svet Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term “Pueraria tuberosa” or “Vidarikand Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term “Myristica fragrans” or “Jatiphal Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. The term “Anacyclus pyrethrum” or “Akarkarabha Extract” disclosed herein comprises the cultivated or naturally grown plant and commercially available plant, but not intended to limit thereto herein. Raw materials procured from SupHerb Lifescieneces and R.S. International. Extracts from all raw materials were prepared in house.
An embodiment of the present invention provides a pharmaceutical composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, Anacyclus pyrethrum, and pharmaceutically acceptable carriers or excipients, for the treatment of ED wherein the said composition is ready for oral administration. The term "pharmaceutically acceptable carriers or excipients" defined herein comprises binder, binder solution, glidants, lubricants, disintegrants, and coating agents, and many more classifications used to prepare medications and which are well-known in the art or previous literature.
In an embodiment of the present invention, the pharmaceutical composition comprising Tribulus terrestris, Withania somnifera, Asparagus racemosus, Mucuna pruriens, Asparagus adscendens, Pueraria tuberosa, Myristica fragrans, and Anacyclus pyrethrum may be prepared as an oral dosage form for example, powder, tablet, capsule, soft capsule, aqueous medicine, syrup, elixirs pill, powder, sachet, granules. In a preferred embodiment, the pharmaceutical composition of the present invention in an oral dosage shall be a capsule.
In another embodiment of the present invention, the herbal composition shall further comprise of pharmaceutically acceptable excipients such as binder, binder solution, glidants, lubricants, disintegrants, and coating agents. It should be noted that the choice of excipients is not limited to those cited herein. A person skilled in the art shall appreciate that the choice of excipients and their respective amounts required for an optimal composition is arrived at after considerable research, and therefore, should not be deemed as a mere optimization of suitable excipients for the purpose of the composition. In a preferred embodiment, the disintegrants are selected from Crospovidone and Sodium starch glycolate; binder is Microcrystalline cellulose; binder solution is isopropyl alcohol; at least one lubricant selected from Microcrystalline cellulose, Crospovidone, Syloid 244 FP, Sodium starch glycolate, Magnesium stearate; and at least one coating agent selected from hydroxypropyl methyl cellulose, polyethyelene glycol 4000, purified talc, titanium dioxide, iron oxide red, iron oxide yellow, black oxide of iron, ispropyl alcohol, methylene chloride.
INCORPORATION BY REFERENCE
The publications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
The following examples are provided for illustrative purposes only, and are intended to be purely exemplary of the disclosure and are not intended to limit the scope of the claims provided herein.
Example 1. Preparation of capsule
All raw materials i.e., fruits of Tribulus terrestris, roots of Withania somnifera, roots of Asparagus racemosus, seeds of Mucuna pruriens, roots of Asparagus adscendens, roots of Pueraria tuberosa, seeds of Myristica fragrans, roots of Anacyclus pyrethrum were procured from SupHerbs Lifescinces and R.S. International, Bangalore. Extracts from all raw materials were prepared in house.
All extracts were dry mixed with Microcrystalline cellulose, Croscarmellose Sodium in a rapid mixer granulator, followed by mixing granulating fluid and granulating the blend. Granules were dried in Fluid bed dryer at the temperature 55oC to 65oC. Granules were passed through 20#. Sifted granules were further sifted in blender with excipients and lubricants. The final blend was analysed and the resultant granules were filled in capsule shells. Polished capsules were sealed and stored in blisters or containers. The bioactive constituents in tablets were quantified by performing HPLC assay.
Table 2: Composition of each capsule

Bioactive Ingredient Botanical Name Quantity of extract (mg/capsule)
Gokshur Extract Tribulus terrestris 140
Ashwagandha Extract Withania somnifera 120
Shatavari Extract Asparagus racemosus 80
Kaucha Extract Mucuna pruriens 55
Musali Svet Extract Asparagus adscendens 50
Vidarikand Extract Pueraria tuberosa 20
Jatiphal Extract Myristica fragrans 20
Akarkarabha Extract Anacyclus pyrethrum 15

Example 2. Evaluating efficacy of composition
An exploratory clinical study was conducted to evaluate safety and efficacy of the composition of the present invention on Male Infertility, specifically various parameters of Erectile Dysfunction (ED).
Methods: 98 sexually active and married males, 21 - 50 years of age, suffering from erectile dysfunction were recruited into the study. Subjects were either randomized to herbal composition or Placebo group in 1:1 ratio. Subjects administered with the herbal composition were categorized as Group A and those administered with Placebo were categorized in Group B. Subjects were advised to take given medication in a dose of 120 doses twice daily over a period of 90 days orally after meals with water. Observations were made until 90 days. Following parameters of spermatogenic activity were evaluated before treatment (Day 0) and Day 90:
1. Improvement in erectile function and sexual desire
2. Improvement in hardness of penis
3. Improvement in orgasmic function, intercourse satisfaction, overall satisfaction
4. Improvement in quality of penile erection
5. Increase in serum total testosterone
6. Increase in sexual encounters
7. Improvement in intra-vaginal ejaculation latency time
In this study Erectile function domain of International Index of Erectile Function (IIEF), Overall satisfaction (IIEF-OS) domain score of International Index of Erectile Function were assessed by non-parametric test by Wilcoxon sign rank, Mann Whitney u test or by chi square test. In this study all P values were reported base on two-sided test and these statistical tests were interpreted at 5% level of significance.
Results: The clinical study concluded that the composition tablet is safe and effective medicine for the treatment of patients with low sperm count. Further, results obtained are discussed with the help of tables and drawings as below:
2.1 Changes in mean erectile function between the groups:
Subjects administered with herbal composition (Group A) were significantly effective in improving erectile function and sexual desire than Placebo tablet (Group B) in subjects suffering from mild to moderate erectile dysfunction.
Table 4: Changes in mean erectile function
Days Mean Erectile Function (X ± SD)
Group A Group B
Baseline (0) 12.84 ± 1.76 12.98 ± 2.11
90 24.67 ± 4.52 17.50 ± 4.55
Mean diff (Baseline – 90)
(P value = 0.00) 11.84 ± 4.93
(0.001) 4.92 ± 4.86
(0.001)

2.2 Changes in erection hardness between the groups:
Subjects administered with herbal composition (Group A) were significantly effective in improving hardness of penis than Placebo tablet (Group B) in subjects suffering from mild to moderate erectile dysfunction.
Table 5: Changes in proportion of cases with erection hardness score between the
groups
Days Proportion of cases with Erectile Hardness Score (%)
Group A Group B
Baseline (0); Penis does not enlarge - -
90; Penis is completely hard and fully rigid
(P value = 0.00) 12
(0.001) -
(not significant)

2.3 Changes in mean orgasmic function between the groups:
Subjects administered with herbal composition (Group A) were significantly effective in improving orgasmic function, intercourse satisfaction and overall satisfaction than Placebo tablet (Group B) in subjects suffering from mild to moderate erectile dysfunction.

Table 6: Changes in mean orgasmic function between the groups
Days Mean Orgasmic Function (X ± SD)
Group A Group B
Baseline (0) 4.14 ± 0.41 4.40 ± 0.73
90 8.21 ± 1.81 5.76 ± 2.07
Mean diff (Baseline – 90)
(P value = 0.00) 4.07 ± 1.78
(0.001) 1.36 ± 1.96
(0.001)

Table 7: Changes in mean intercourse satisfaction between the groups
Days Mean Orgasmic Function (X ± SD)
Group A Group B
Baseline (0) 6.77 ± 1.09 6.90 ± 1.10
90 12.26 ± 2.14 9.43 ± 2.46
Mean diff (Baseline – 90)
(P value = 0.00) 5.49 ± 2.35
(0.001) 2.52 ± 2.54
(0.001)

Table 8: Changes in mean overall satisfaction between the groups
Days Mean Orgasmic Function (X ± SD)
Group A Group B
Baseline (0) 3.91 ± 0.75 3.60 ± 0.70
90 7.51 ± 2.16 5.50 ± 1.33
Mean diff (Baseline – 90)
(P value = 0.00) 3.60 ± 2.23
(0.001) 1.90 ± 1.48
(0.001)

2.4 Changes in mean serum total testosterone between the groups:
Subjects administered with herbal composition (Group A) exhibited significant increase in serum total testosterone more than Placebo tablet (Group B) in subjects.
Table 9: Changes in mean serum total testosterone between the groups
Days Mean Orgasmic Function (X ± SD)
Group A Group B
Baseline (0) 338.25 ± 160.16 348.21 ± 154.50
90 495.51 ± 176.14 359.54 ± 152.47
Mean diff (Baseline – 90)
(P value = 0.00) 157.26 ± 138.15
(0.001) 011.33 ± 23.23
(0.001)

2.5 Changes in mean number of sexual encounters between the groups:
Subjects administered with herbal composition (Group A) reported significant increase in sexual encounters than Placebo tablet (Group B) in subjects.
Table 10: Changes in mean number of sexual encounters between the groups
Days Mean Orgasmic Function (X ± SD)
Group A Group B
30 7.51 ± 2.24 5.98 ± 1.24
90 9.16 ± 1.88 6.19 ± 1.69
(P value = 0.00) (0.001) (0.001)

2.6 Changes intra-vaginal ejaculation latency time in between the groups:
Subjects administered with herbal composition (Group A) exhibited significantly better intra-vaginal ejaculation latency time (IELT) than Placebo tablet (Group B) in subjects.
Table 11: Changes in mean IELT between the groups
Days Mean IELT (seconds) (X ± SD)
Group A Group B
30 42.21 ± 23.36 22.98 ± 11.47
90 65.70 ± 54.70 28.10 ± 14.52
(P value = 0.00) (0.001) (0.001)