DESC:FORM 2
The Patents Act 1970
(39 of 1970)
&
The Patent Rules 2003
COMPLETE SPECIFICATION
(See Section 10 and rule 13)

TITLE OF THE INVENTION:
DERIVATION OF FULL SPECTRUM EXTRACTION OF NATURAL
INGREDIENTS AND DEVELOPMENT OF FORMULATION TO
ADDRESS MALE WELLNESS
APPLICANT:
Name: SARVOTHAM CARE LIMITED
Nationality: Indian
Address: #1-20-248, 1st Floor, Umajay Complex, Rasoolpura, Secunderabad,
Telengana, India – 500003

PREAMBLE OF THE DESCRIPTION:
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED
CROSS- REFERENCE TO RELATED APPLICATION
This application claims the priority of the provisional application with serial number 202141058085 filed on 14th of Dec, 2021 with the title, “DERIVATION OF FULL SPECTRUM EXTRACTION OF NATURAL INGREDIENTS AND DEVELOPMENT OF FORMULATION TO ADDRESS MALE WELLNESS” and the contents of which is incorporated in entirety.

A) TECHNICAL FIELD OF INVENTION
[001] The present invention generally relates to an aphrodisiac composition, in particular to a polyherbal composition. The present invention more particularly relates to an aphrodisiac polyherbal composition for use in treatment of male sexual disorders. The present invention further relates to a method of synthesizing the same.

B) BACKGROUND OF INVENTION
[002] Normal sexual function is a complex interaction involving both the mind and the body. The nervous, circulatory, and endocrine (hormonal) systems all interact with the mind to produce a sexual response. A delicate and balanced interplay among these systems controls the male sexual response. Sexual dysfunction can affect men of all ages, but is especially common in older men. The most common problems related to sexual dysfunction include ejaculation disorders, erectile dysfunction and inhibited sexual desire. One or more conditions can coexist in an individual.
[003] The inability to achieve and/or maintain an erection sufficient for satisfactory sexual intercourse is a distressing and common symptom, affecting up to one-third of adult men. Currently, male impotence is a broad-ranging problem of social, psychologic, and medical significance. Among various causes of male impotence that are specifically implicated are: diabetes, surgery, vascular disease, hypertension and hardening of arteries, side-effects from drugs, and hormonal imbalance.
[004] Various remedies include treatment classified into two categories: surgical and non-surgical. The surgical category comprises implantation of a penile prosthetic device; revascularization of the penis; and incision or excision of Peyronie's plaques. The non-surgical category comprises sex therapy, endocrine therapy, pharmacologic therapy, and electrostimulation. Non-surgical therapies, when effective, are the treatments of choice. Of these, the favored treatment in most instances would be pharmacologic therapy if it was effective. Unfortunately, the use of pharmacologic agents in treatment of impotence has achieved little success.
[005] There are a large number of drugs for sexual dysfunction treatment— pharmacological group—inhibitors of phosphodiesterase of type 5 (PDEI-5). But the high cost of these drugs and significant risk of adverse drug reactions, especially in patients with cardiovascular disease limit their widespread use.
[006] Hence there is a need to develop an improved formulation for management of male sexual disorders with holistic approach and conventional modes of treatment along with improving male sexual well-being.
[007] The present disclosure is a unique formulation adopting ‘full-spectrum’ extraction of proprietary polyherbal composition for management of male sexual wellbeing which shows synergistic effect by ameliorating male fertility, without any side-effects.
[008] The value additions and above-mentioned shortcomings, disadvantages and problems are addressed herein, as detailed below.

C) OBJECT OF INVENTION
[009] The primary object of the present invention is to provide an aphrodisiac composition for male individual.
[0010] Another object of the present invention is to provide a novel polyherbal composition, for management of male sexual disorders, comprising extracts of Withania somnifera, Myristica fragrans, Mucuna pruriens, Tribulus Terrestris, Syzygium aromaticum, Hygrophila auriculata or its combination thereof, a pharmaceutically acceptable excipient and one or more herbal additives.
[0011] Yet another object of the present invention is to provide a polyherbal composition that enhances sexual well-being of an individual, increases the sperm count, vigour and vitality without causing any side effects.
[0012] Yet another object of the current invention is ‘full-spectrum extraction’ from admixture of selected herbs/plants.
[0013] Yet another object of the present invention is to provide a polyherbal composition which is absolutely free from synthetic chemicals.
[0014] Yet another object of the present invention is to provide a method of synthesizing the novel polyherbal composition for use in management of male sexual disorders.
[0015] These and other objects and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

D) SUMMARY OF INVENTION
[0016] The various embodiments of the present invention provide an aphrodisiac polyherbal composition for use in treatment of male sexual disorders. The aphrodisiac composition comprises a powdered admixture of root extract of Withania Somnifera, pericarp extract of Myristica fragrans, seeds of Mucuna pruriens, fruit extract of Tribulus terrestris, flower bud extract of Syzygium aromaticum and aerial part extract of Hygrophyla auriculata or its combination thereof; one or more herbal additives; and a pharmaceutically acceptable excipient.
[0017] According to an embodiment of the present invention, the herbal base additives are extracts of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine, and L-lysine.
[0018] According to an embodiment of the present invention, the root of Withania Somnifera is present in an amount of 30% (w/w).
[0019] According to an embodiment of the present invention, the pericarp of Myristica fragrans is present in an amount of 24% (w/w).
[0020] According to an embodiment of the present invention, the seed of Mucuna pruriens is present in an amount of 14% (w/w).
[0021] According to an embodiment of the present invention, the fruit of Tribulus terrestris is present in an amount of 14% (w/w).
[0022] According to an embodiment of the present invention, the flower bud of Syzygium aromaticum is present in an amount of 9% (w/w).
[0023] According to an embodiment of the present invention, the aerial part of Hygrophyla auriculata is present in an amount of 9% (w/w).
[0024] According to an embodiment of the present invention, the extract of Tagetes erecta is present in an amount of 2mg.
[0025] According to an embodiment of the present invention, the shilajeet powder is present in an amount of 30mg.
[0026] According to an embodiment of the present invention, the rutin, lycopene, L-arginine and L-lysine is present in an amount of 20mg.
[0027] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is sodium benzoate.
[0028] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is present in an amount of 0.928mg.
[0029] According to another embodiment of the present invention, a method of synthesizing an aphrodisiac poly-herbal composition for use in the treatment of male sexual disorders is provided. The method comprises: a) preparing a dried coarse powdered (20 – 30 mesh) admixture comprised of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata; b) preparing a hydro-alcoholic extract by soaking the dried powdered admixture in an aqueous alcohol, collecting and concentrating the pooled supernatant; c) rota-evaporating the pooled supernatant to obtain a concentrated hydro-alcoholic extract; d) lyophilizing the concentrated hydro-alcoholic extract at a lyophilizing temperature of -80?; e) adding one or more powdered herbal base additives and a pharmaceutically acceptable excipient; f) blending the said concentrated hydro-alcoholic extract of step (d) with one or more herbal base additives and the pharmaceutically acceptable excipient of step (e) to obtain a blend; and g) spray-drying the blend to obtain final composition.
[0030] According to an embodiment of the present invention, the full-spectrum extract was obtained from coarse powders of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata is added in a ratio of 30:24:14:14:9:9.
[0031] According to an embodiment of the present invention, the herbal base additives added are selected from the group consisting of extract of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine, and L-lysine.
[0032] According to an embodiment of the present invention, the ratio of ethanol to water is 50:50.
[0033] According to an embodiment of the present invention, the rota-evaporation is performed at a temperature of 400C, rotational speed of 60rpm, vacuum pressure of 300 mbarr pressure with a chilled water condenser for a period of 4 to 5 hours.
[0034] According to an embodiment of the present invention, the extract of Tagetes erecta is added in an amount of 2mg.
[0035] According to an embodiment of the present invention, the shilajeet powder is added in an amount of 30mg.
[0036] According to an embodiment of the present invention, the rutin, lycopene, L-arginine and L-lysine is added in an amount of 20mg.
[0037] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient added is sodium benzoate.
[0038] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is added in an amount of 0.928mg.
[0039] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.
E) BRIEF DESCRIPTION OF DRAWINGS
[0040] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:
[0041] FIG. 1 is a schematic representation showing the steps involved in the preparation of an aphrodisiac polyherbal composition for use in treatment of male sexual disorders, according to an embodiment of the present invention.
[0042] FIG. 2 demonstrates study design for in vivo acute oral toxicity testing, according to an embodiment of the present invention.
[0043] FIG. 3 shows the body weights of the rats in acute oral toxicity testing, according to an embodiment of the present invention.

F) DETAILED DESCRIPTION OF EMBODIMENTS
[0044] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. The embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical, electronic and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
[0045] According to an embodiment of the present invention, an aphrodisiac polyherbal composition for use in treatment of male sexual disorders is provided. The aphrodisiac composition comprises an extract obtained from coarse powdered (20 – 30 mesh) admixture of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata or its combination thereof; one or more herbal additives; and a pharmaceutically acceptable excipient.
[0046] According to an embodiment of the present invention, the herbal base additives are extracts of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine and L-lysine.
[0047] According to an embodiment of the present invention, the admixture comprises the dried pulverized coarse powder (20 to 30 mesh) of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata in the designated ratio.
[0048] According to an embodiment of the present invention, the admixture more particularly comprises the dried pulverized coarse powder (20 to 30 mesh) of root of Withania Somnifera, dried pulverized coarse powder (20 to 30 mesh) of pericarp of Myristica fragrans, dried pulverized coarse powder (20 to 30 mesh) of seeds of Mucuna pruriens, dried pulverized coarse powder (20 to 30 mesh) of fruit of Tribulus terrestris, dried pulverized coarse powder (20 to 30 mesh) of flower bud of Syzygium aromaticum and dried pulverized coarse powder (20 to 30 mesh) of aerial part of Hygrophyla auriculata in the ratio of 30:24:14:14:9:9.
[0049] According to an embodiment of the present invention, the root of Withania Somnifera is present in an amount of 30% (w/w).
[0050] According to an embodiment of the present invention, the pericarp of Myristica fragrans is present in an amount of 24% (w/w).
[0051] According to an embodiment of the present invention, the seed of Mucuna pruriens is present in an amount of 14% (w/w).
[0052] According to an embodiment of the present invention, the fruit of Tribulus terrestris is present in an amount of 14% (w/w).
[0053] According to an embodiment of the present invention, the flower bud of Syzygium aromaticum is present in an amount of 9% (w/w).
[0054] According to an embodiment of the present invention, the aerial part of Hygrophyla auriculata is present in an amount of 9% (w/w).
[0055] According to an embodiment of the present invention, the extract of Tagetes erecta is present in an amount of 2mg.
[0056] According to an embodiment of the present invention, the shilajeet powder is present in an amount of 30mg.
[0057] According to an embodiment of the present invention, the rutin, lycopene, L-arginine and L-lysine is present in an amount of 20mg.
[0058] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is sodium benzoate.
[0059] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is present in an amount of 0.928mg.
[0060] According to another embodiment of the present invention, a method of synthesizing an aphrodisiac poly-herbal composition for use in the treatment of male sexual disorders is provided.
[0061] FIG. 1 is a schematic representation showing the steps involved in the preparation of an aphrodisiac polyherbal composition for use in treatment of male sexual disorders, according to an embodiment of the present invention. With respect to FIG. 1, the method comprises: preparing an extract from dried powdered admixture of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata (101); preparing a hydro-alcoholic extract (102); rota-evaporating the pooled supernatant to obtain a concentrated hydro-alcoholic extract (103); lyophilizing the concentrated hydro-alcoholic extract at a lyophilizing temperature of -80? (104); adding one or more powdered herbal base additives and a pharmaceutically acceptable excipient (105); blending the said concentrated hydro-alcoholic extract of step (104) with one or more herbal base additives and the pharmaceutically acceptable excipient of step (105) to obtain a blend (106); and spray-drying the blend to obtain final composition (107).
[0062] According to an embodiment of the present invention, the roots of Withania Somnifera are taken, cleaned, and graded/crushed. The graded dried roots of Withania Somnifera are dried in sunlight to obtain a pulverized coarse powder (20 to 30 mesh).
[0063] According to an embodiment of the present invention, the fruits of Myristica fragrans are taken, cleaned, and graded. The pericarp of the fruits of Myristica fragrans is separated and made into pieces followed by subjecting to drying under shade. The dried pericarp is pulverized to obtain a pulverized coarse powder (20 to 30 mesh).
[0064] According to an embodiment of the present invention, the seeds of Mucuna pruriens are taken, cleaned and dried under shade. The dried seeds of Mucuna pruriens are pulverized or crushed to obtain a pulverized coarse powder (20 to 30 mesh).
[0065] According to an embodiment of the present invention, the fruits of Tribulus terrestris are taken, graded, and cleaned. The cleaned fruits of Tribulus terrestris are dried under shade and pulverized or crushed to obtain a pulverized coarse powder (20 to 30 mesh).
[0066] According to an embodiment of the present invention, the flower buds of Syzygium aromaticum are taken, graded and dried under shade. The dried flower buds are pulverized to obtain a pulverized coarse powder (20 to 30 mesh).
[0067] According to an embodiment of the present invention, the aerial part of Hygrophyla auriculata are taken, graded, and cleaned. The cleaned aerial part is made into pieces followed by subjecting to drying under shade. The dried aerial part is pulverized to obtain a pulverized coarse powder (20 to 30 mesh).
[0068] According to an embodiment of the present invention, the dried powdered admixture is prepared by mixing pulverized coarse powdered root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata in a ratio of 30:24:14:14:9:9.
[0069] According to an embodiment of the present invention, the herbal base additives added are selected from the group consisting of extract of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine, and L-lysine.
[0070] According to an embodiment of the present invention, the ratio of ethanol to water is 50:50.
[0071] According to an embodiment of the present invention, the rota-evaporation is performed at a temperature of 400C, rotational speed of 60rpm, vacuum pressure of 300 mbarr pressure with a chilled water condenser for a period of 4 to 5 hours.
[0072] According to an embodiment of the present invention, the extract of Tagetes erecta is added in an amount of 2mg.
[0073] According to an embodiment of the present invention, the shilajeet powder is added in an amount of 30mg.
[0074] According to an embodiment of the present invention, the rutin, lycopene, L-arginine and L-lysine is added in an amount of 20mg.
[0075] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient added is sodium benzoate.
[0076] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is added in an amount of 0.928mg.
[0077] According to an embodiment of the present invention, an efficacy of poly herbal compound (PHC) SurvoNutra-MTM for management of men sexual wellbeing or disorders is evaluated.

EXPERIMENTAL DETAILS
IN VIVO ACUTE ORAL TOXICITY STUDY
[0078] FIG. 2 demonstrates study design for in vivo acute oral toxicity testing, according to an embodiment of the present invention.
[0079] Table 1 illustrates test system used for in vivo acute oral toxicity testing, according to an embodiment of the present invention.

Table 1: Test system used for in vivo acute oral toxicity testing
Species Rat (Rattus norvegicus)
Strain Sprague Dawley
Sex Female (nulliparous and non-pregnant)

Number of
Animals Step I: 3 animals;
Step II: 3 animals; Step III: 3 animals; Step IV: 3 animals
Total 12 animals were used in the study

Age at the start of dosing Step I : 8 — 9 weeks,
Step II : 8 — 9 weeks, Step III : 9 — 10 weeks, Step IV : 9 — 10 weeks

Body weight at the start of dosing Step I : 192.01 to 203.61g,
Step II : 204.91 to 210.57g, Step III : 194.83 to 218.28g, Step IV : 190.40 to 210.79g,
The body weight variation did not exceed + 20% of the mean
weight of any previously dosed animal.
Source Animal Facility (AFT), Vanta Bioscience Limited.

Health status Prior to inclusion into the study, animals were examined by the
Study Veterinarian for the health status and their suitability for use in the experiment.

[0080] Vehicle Details
[0081] 0.1% Tween 80 in Type I Milli-Q water was selected as vehicle based on the in-house solubility check, as it formed a uniform suspension.
[0082] Preparation of test solution
[0083] The test item (300.0 mg, 300.0 mg, 2000.0 mg, and 2000.1 mg for Step I, Step II, Step III and Step IV) was weighed in a tared glass beaker and was transferred to mortar and triturated with pestle. 2 mL of vehicle was added to the mortar and again triturated with pestle, which was transferred to a measuring cylinder with a syringe. The mortar and pestle were rinsed twice with 2 mL of the vehicle and transferred to measuring cylinder. The required volume was made up using vehicle in the measuring cylinder and then transferred back to the glass beaker.
[0084] Animal Receipt and Acclimatization:
[0085] A total number of 12 female Sprague Dawley rats were received from the Animal Facility (AFT) of Vanta Bioscience Limited. Animals were acclimatized to the experimental conditions for a period of 7, 10, 14 and 17 days for step I, Step II, Step III, and step IV, respectively, prior to start of the administration.
[0086] Animal Identification:
[0087] Animals were identified with cage card having information such as species, strain, sex, number of animals per cage, study no., group, test item, dose, and signature of the study director. Individual animal number was marked with indelible marker pen on the tail.
[0088] Initial dose of Sarvonutra M™: 300 mg/kg body weight
[0089] Dose Volume: A dose volume of 10 mL/kg body weight was maintained to administer required dose.
[0090] Route of Administration: Oral route
[0091] Administration of the test solution:
[0092] Prior to dosing, animals were fasted (feed was withheld) for 13 hours 30 minutes, 13 hours 05 minutes, 12 hours 54 minutes and 12 hours 47 minutes for Step I, Step II, Step III, and Step IV, respectively, with free access to drinking water ad libitum. The test item was administered orally to animals based on the body weight recorded on dosing day (fasting body weight) using a stainless-steel ball-tipped intubation cannula attached to a calibrated 3 mL syringe.
[0093] Further, feed was withheld for a period of 03 hours 08 minutes, 03 hours 12 minutes, 03 hours 09 minutes and 03 hours 05 minutes for Step I, Step II, Step III, and Step IV, respectively, after administration of the test item.
[0094] Parameters evaluated:
[0095] Mortality and general clinical signs: Mortality and morbidity were observed twice daily and once on the day of terminal sacrifice during the experimental period. The animals were observed for toxic signs at various time points on the day of administration: at 30 minutes and at 1, 2, 3 and 4 hours after administration and once daily (from day 1) till day 14 of observation period.
[0096] Body weight: Individual animal body weight was recorded on dosing day (prior to test item administration) and on days 7 and 14 for all the treated animals.
[0097] Necropsy and gross pathology: All the surviving animals were necropsied at the end of the observation period. Animals were euthanized via CO2 asphyxiation. All necropsy observations were recorded.
Efficacy Evaluation of Innovative Natural Formulation (SARVONUTRA MTM) as Men Wellness Agent
[0098] Composition of Test Compound:
[0099] The test compound is developed based on Ayurvedic literature and recent scientific validations of the medicinal plant / herbal extracts for the assigned properties. In addition, to the extracts, few ingredients viz. lycopene, L Arginine and L Lysine were also used keeping in view of their nutritional role in wellbeing of men. The following are the key ingredients and composition of the Sarvonutra MTM.
[00100] Table shows the composition of the herbal formulation according to the present invention:

S. No. Name of the Ingredient Quantity
1 Ashaganda (Withnia somnifera) Rt. 100 mg
2 Jatripatra (Myristica fragrance) Ft. 80 mg
3 Atmagupta (Mucuna pruriens) Sd. 62 mg
4 Goskhura (Tribulus terrestris) Ft. 50 mg
5 Lavanga (Syzygium aromaticum) Fl. Bud 30 mg
6 Gokantaka (Hygrophylia auriculata) AP 30 mg
7 Sthulapuspa (Tagetes erecta) Extract Fl. 2 mg
8 Pdrs. Shilajeet 30 mg

9
Other Ingredients 9.1 Rutin 20mg
9.2 Lycopene 20 mg
9.3 L Arginine 20 mg
9.4 L Lysine 20 mg
9.5 Sodium Benzoate 0.928 mg

[00101] Pharmacology:
[00102] The selected extracts and ingredients of Sarvonutra MTM have been explored for various bioactivities. Individual ingredients were evaluated for their diversified potential activities. The following is the brief note about the pharmacological actions of individual extracts.
[00103] Withania somnifera: It is commonly called as Ashwagandha, Indian ginseng and Indian Winter Cherry. Ashwagandha, has been using more than 3000 years as medicinal herb in traditional system of preparations. Every part of Ashwagandha viz. leaf, flower, stem and root have vital proven activities against a wide variety of indications. It is well known as ‘stress management, energy rejuvenator, cognitive function improver, anti-inflammatory, anti-diabetic, anti-antioxidant etc.’ (Dutta et al., 2019). Consumption of 5g/day of root extract of Ashwagandha for 90 days have improved the ‘Sperm related parameters’ of idiopathic male infertility. Of all the phytoconstituents the Withanolides specially the ‘Withaferin A’ present in higher quantity (Azgomi et al., 2018).
[00104] Myristica fragrans: The seed of M. fragrans have been used in traditional medicine since ancient times. The ethnobotanical validation studies have proven its activities against various indications. The nutmeg powder activities such as antioxidant, antimicrobial, antidiarrheal, male infertility amelioration etc. were scientifically validated. The nutmeg extracts possess primary metabolites such as fixed oils (Myristic acid & trimyristin triglyceride), starch and protein. Whereas, the secondary metabolites include essential oils (terpenes), phenolic compounds, resins, and pigments. Afore mentioned activities were attributed to these primary and secondary metabolites.
[00105] Mucuna pruriens: It is commonly known as ‘Velvet Bean’, which widely distributed in Southern China and Eastern parts of India. The velvet bean has been widely used as ‘food source’ by various ethnic groups across the globe. As it is possessing considerable levels of L-dopa and hallucinogenic tryptamines, it has been used in treating the Parkinson’s disease (Lampariello et al., 2012). Apart from this, it has been used since ancient time in various indications such as ‘aphrodisiac, nervous disorders, arthritis, scorpion stings’ etc. The extracts obtained from seeds using different solvent systems have shown the ‘anti-oxidant, anti-epileptic, anti-microbial, anti-neoplastic activities’ etc. (Lampariello et al., 2012).
[00106] Tribulus terrestris: It is ‘crawling herbal plant’, grows up to one meter height in arid and sandy soils. The name ‘Tribulus’ derived from ‘Greek’ stands for the ‘Spike Fruit’. The fruit has been used in various traditional system of medicine such as ‘Indian Ayurveda, Chinese Medicine, and Bulgarian Medicine’ (?tefanescu et al., 2020). The extracts from leaves, fruits, and roots of T. terrestris have been used for herbal preparations against various conditions like infertility, low sexual desire, inflammatory, diabetic, athletic performance etc. A wide range of active phytoconstituents viz. steroidal saponins, flavonoids, tannins, terpenoids, polyphenol carboxylic acids, and alkaloids have been reported with different solvent system and part of the herb (?tefanescu et al., 2020).
[00107] Syzygium aromaticum: The fruit buds of S. aromaticum is one of the major sources of phenolic compounds as flavonoids, hidroxibenzoic acids, hidroxicinamic acids and hidroxiphenyl propens. Eugenol is the main bioactive compound of clove, which is found in concentrations ranging from 9.4 to 14.7 g per 100 g of fresh plant material (Cortés-Rojas et al., 2014). The presence of active phytoconstituents is responsible for the antioxidant activity of clove. The aqueous and lipid soluble portions of clove extracts have shown biphasic activity on male sexual function (Mishra, & Singh, 2013 and 2016).
[00108] Hygrophyla auriculata: It is annual herb, possessing hairy stem, violet flowers, leaves, and fruits. Grows throughout India, especially along the banks of fresh or stagnant water bodies and marshy soils. Seeds of H. auriculata have diuretic action, due to the higher quantities of tenacious mucilage and potassium salts. Linolic acid is another major phytoconstituent of seeds along with diastase, lipase and protease. Various solvent system extracts have anti-oxidant activity, hepatoprotective property, aphrodisiac action, spasmolytic and hypotensive in nature.
[00109] Tagetes erecta: The flower of genus Tagetes is commonly called as ‘marigold’. Lutein and lutein-fatty acid esters are a type of carotenoids present in marigold and responsible for the petal colours from light yellow to dark orange depending upon the content of lutein. The fresh petals, extracts as well as the dried powder of marigold flower are good sources of lutein. It has been the choice of food grade colorant; in addition it is being used extensively in poultry.
[00110] Shilajit: Shilajit is a blackish-brown powder or exudate of mountain rocks of Himalayas. It has been used in Ayurveda as rejuvenator and anti-aging compound (Carrasco-Gallardo et al., 2012). The humic and fulvic acids are the major components (60 – 80%) of the Shilajit along with certain elements such as selenium. It has been used in Ayurvedic preparations of cognitive function improves, longevity, anti-diabetic, etc. (Carrasco-Gallardo et al., 2012).
[00111] Lycopene: It is a type of non-provitamin A ‘Carotenoid’ attributes ‘red colour’ to various vegetables and fruits especially to tomatoes, watermelon, guava, papaya etc. Lycopene has the ‘anti-oxidant activity’ through scavenging the singlet oxygen of Reactive Oxygen Species (ROS). The dietary sources of lycopene are the fresh fruits and vegetable, however the processed foods also retain the lycopene in good quantities, as it is the relatively stable form of carotenoid (Story et al., 2010). The studies have proven that ‘thermal processing’, improves the bioavailability of lycopene through disruption of cellular membranes. Lycopene consumption was attributed in prevention and management of various ill health viz. cancer, cardio-vascular, gingivitis etc. (Story et al., 2010).
[00112] Rutin: The rutin is a glycoside of flavonoid. There are wide sources of rutin ranges from vegetables to herbal medicinal plants. Rutin has various pharmacological activities such as anti-microbial, anti-inflammatory, anti-oxidant etc. Studies have shown the protective activity of ruin against lipid peroxidation induced damage to human sperm (Moretti et al., 2012).
[00113] L Lysine & L Arginine: L Lysine is the essential amino acid, whereas L Arginine is the semi-essential or conditionally essential amino acid. L Lysine supplementation has suggested anxiety reduction in human population. L Arginine acts as precursor for the synthesis of Glutamate, Proline and creatinine and it involved in production of NO, an essential molecule in signaling and various biological process. In addition, supplementation of L Arginine resulted in amelioration of mild to moderate erectile dysfunction in men (Rhim et al., 2019). The supplementation of L Lysine and L Arginine together have shown significant decrease of long-term stress and stress induced anxiety in healthy individuals (Smriga et al., 2007).
[00114] Safety Data of Test Compound: The health hazards that are likely to arise from a single oral administration of Sarvonutra MTM were assessed in Sprague Dawley (SD) rats as per the OECD guidelines 423. The intended clinical route of administration of test compound is ‘oral’, hence a single dose of test compound was administered through oral route and observed for 14 days. Such data could be used to classify the test item to one of a series of toxicity classes defined by the LD50 cut-off values as per the Acute Toxic Class Method (OECD 423). A stepwise testing approach was adopted by using 3 female SD rats per every step, up to four steps. Handling of animals, test procedures, bleeding & euthanization, if necessary, etc., were performed as per the ‘Institutional Animal Ethical Guidelines’ with approval from IAEC.
[00115] Animals & Housing: A total of 12 SD female rats; of which 6 rats aged 8 – 9 weeks with body weights ranging from 192.01 to 210.57 g for low dose (Step I & II) and another 6 rats aged 9 – 10 weeks weighing about 190.40 to 218.28 g were selected for high dose (Step III & IV) studies. One animal per cage was housed in solid bottom ‘Individually Ventilated Cages’ (IVC) [Citizen # V4/V30/10]. Steam sterilized ‘clean corn cob’ was used as bedding material with periodic replacement on every 7th day. The temperature and relative humidity range of the experimental room was 20.6°C to 23.0°C and 42 to 65% respectively. Light and dark cycles of 12 hours each were maintained throughout the experimental phase. Rats have free access to purified water (Reverse Osmosis) and pelleted diet as ad libitum.
[00116] Test Compound Administration: Intended clinical route of Sarvonutra MTM administration is oral route, hence the compound was dissolved in 0.1% Tween 80 in Type I Milli-Q water was selected as vehicle based on the in-house solubility check, as it formed a uniform suspension.
[00117] A maximum dose volume of 10 mL/kg of test substance solution was administered to animals using gavage, based on body weight. Animals were fasted overnight and administered designated doses of Sarvonutra MTM. In addition, post-administration the feed was with-held for another 3 hours with free access for drinking water.
[00118] In view of the lack of the information/data about the safety/toxicity of Sarvonutra MTM; a dose of 300 mg of Sarvonutra MTM per kg body weight of animal was administered in Step-I. The test compound related effects, if any were further confirmed with same dose (300mg/kg b.wt) in Step-II. Similarly, a dose of 2000 mg/kg of Sarvonutra-DivaTM was administered to animals of Step-III and confirmed in Step-IV.
[00119] Mortality and General Clinical Signs:
[00120] All the animals were monitored for toxic signs related to test compounds, if any, post-administration of Sarvonutra MTM at 30 min and at 1, 2, 3 and 4 h., there after once daily up to 14 days. Similarly, the mortality and morbidity were monitored twice a day throughout the experimental period. Food intake & water consumption were also observed during the experimental period. The body weight of the animals was recorded on 0th day (before test compound administration), 7th and 14th day using weighing balance (Sartoriuos # GPA3202).
[00121] Necropsy and Gross Pathology: In case any pre-terminal mortality noticed during the experimental period, animals were subjected for gross necropsy to unveil the cause of death. Whereas, all surviving animals till the end of 14th day were euthanized by CO2 asphyxiation. The necropsy procedures such as gross examination of the animals, collection of organs was performed and recorded as per the guidelines.
[00122] Results and Study Impression:
[00123] Food Intake and Body weights: The food and water intake were normal among all the animals of low dose (300 mg / kg b.wt – Step I & II) and high dose (2000 mg / kg b.wt – Step III & IV) throughout the study period of 14 days. As the body weights recorded on 0th, 7th and 14th days indicate a progressive improvement of mean body weight was noted among all the groups (Fig. 3).
[00124] Morbidity and Mortality: ‘No morbidity’ in terms of cage side observation parameters were noted among the rats administered with low and high dose of Sarvonutra MTM right from the dosing to 14th day of experimental period. In addition, no pre-terminal mortality was noted in either of the low dose (300 mg/kg b.wt) and high dose (2000 mg/kg.b.wt) Sarvonutra MTM administered rats.
[00125] Gross Necropsy & Pathological Examination: All the animals sacrificed at the end of 14 days of observation, as there was no pre-terminal mortality. The animals were examined for gross necropsy procedures for external abnormalities, if any. The internal abnormalities, if any, related to the test compound administration were examined and reported. ‘No abnormalities’ were noted either externally or internally in animals administered with two different doses of Sarvonutra MTM.
[00126] Study Impression: Based on the above results and experimental condition used in this study, it could be concluded that the LD50 cut-off value of the test item SARVONUTRA MTM after single oral (gavage) administration in female Sprague Dawley rats is “5000 mg/kg body weight” and classified under “Category 5 or unclassified” according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Efficacy of Test Compound with Literature Survey:
[00127] Though the composition of Sarvonutra MTM was derived from the classic Ayurvedic literature, the exact composition with percentage of each ingredient doesn’t coincide with any of the commercially existing products. In view of this, the efficacy of the Sarvonutra MTM was illustrated with available literature survey for possible ingredients.
[00128] Withania somnifera: Clinical study conducted with W. somnifera root in the men of idiopathic infertility have shown significant improvement in sperm parameters. The study involved administration of 5g of W. somnifera root in three divided doses of two-colour coded capsules for 90 days along with pentoxifylline as comparator in another group of individuals. The results suggest W. somnifera increased mean sperm count (12.5%) and progressive motility (21.42%) and improved sperm morphology (25.56%) compared to the baseline (p = .04, p = .001 and p = .000 respectively) (Azgomi et al., 2018).
[00129] Myristica fragrans: Though the use of nutmeg has been documented in Unani and Ayurvedic medicines, the systematic clinical studies for its efficacy as aphrodisiac activity are not available. Hence, the data obtained from animals were documented widely viz. administration of ethanolic extract (500mg/kg) of nutmeg to rats have improved the libido and potency. This activity attributed to eugenol which acts as nervous system stimulant (Tajuddin et al., 2005).
[00130] Mucuna pruriens: The clinical study conducted in infertile men aged between 30 – 38 years by oral administration of M. pruriens seed powder (5 g day1), in a single dose for 3months with a cup of skimmed milk. Treatment with M. pruriens significantly ameliorated psychological stress and seminal plasma lipid peroxide levels along with improved sperm count and motility (Shukla et al., 2012).
[00131] Tribulus terrestris: The studies conducted in diabetic men with ED and non-diabetic with ED upon administration of T. terrestris (Libilov 250mg), 3 times daily for 3 weeks have shown 60% sexual drive among the ED men. As this improvement in sexual function is accompanied by a significant improvement in the DHEA levels of these patients (Adimoelja & Adaikan, 1997)
[00132] Syzygium aromaticum: The suspension of the extract obtained from S. aromaticum was administered orally at the dose of 100, 250, and 500 mg / kg, to different groups of male rats (n = 6) once a day for seven days. The dose of 500mg/kg have shown significant improvement of sexual activity in male rats (Tajuddin et al., 2004).
[00133] Hygrophylla auriculata: The ethanolic extract of H. auriculata was directed as 100, 150 and 200 mg kg?¹ doses to rats for a period of 28 days, and assessed the weight of organ, sexual behavior, histo-architecture, and fructose level of seminal vesicles. H. auriculata extracts were showed positive signs of the parameters along with ability to raise the development of mature spermatozoa.
[00134] L-Arginine: Supplementation studies of L Arginine involving human beings have shown various degree of effectiveness based on the dose of supplementation. The men suffering with erectile dysfunction (ED) were administered with 500mg have shown no considerable improvement over placebo. Whereas the doses of 1.67 g and 2.8 g of L arginine supplementation for a period of two weeks have shown significant improvement (Appleton, 2002).
[00135] Dosage: The test compound – Sarvonutra MTM is blend of extracts from various medicinal / spice /herbal plants along with few other ingredients. It was filled as capsules, wherein each capsule contains about 500 mg of blend. The intended route of administration is ‘Oral Route’.
[00136] The participant of the study needs to take 2 capsules daily, preferably 1 h before bed, further it is advised to consume before dinner. The duration of course to be followed is 45 days. In addition, the participants will be evaluated for primary and secondary outcomes at the end of 2 weeks of post-administration. It is strongly advised ‘not to take Tea / coffee and alcohol or any other fruit juices’, either prior or post administration of the capsules.
[00137] Adverse Reactions:
[00138] Withania somnifera: The W. somnifera extract effects were assessed using acute toxicity study at a dose of 2000 mg/kg and sub-acute study, with a dose of 500, 1000, 2000 mg/kg body weight/day for 28 days were conducted in Wistar rats (10/sex/group). At the end of study, the animals were sacrificed and their body weight, hematology, serum chemistry, and histopathology evaluation were done. No-observed-adverse-effect-level of WSE is 2000 mg/kg body weight, the highest level tested (Patel et al., 2016).
[00139] Myristica fragrans: The toxicity of nutmeg is uncertain, whereas case reports suggest, when the dose is higher may cause acute toxicity. Two tablespoons of ground nutmeg, one to three whole nutmegs, or 5 g of powdered nutmeg may cause clinical signs of hallucinations, nausea, and severe emesis (Elizabeth et al., 2013).
[00140] Mucuna pruriens: The studies conducted among Parkinson disease patients, have reported that gastrointestinal disturbances at a dose of 30 g of M. pruriens endocarp powder consumption (Lieu et al., 2012).
[00141] Tribulus terrestris: Studies on TT toxicity have been conducted only among animals. The LD50 of T. terrestris established in mice was 813 mg/kg. Symptoms of severe damage of cardiac muscle, liver and kidney were noted in native goats and sheep when their daily meals contained 80% fresh plants. The only case of acute poisoning by T.terrestris was reported in a young man, who consumed during two days a high dose of T.terrestris to prevent kidney stone formation. He was hospitalized, and after 7 days biochemical symptoms of hepatitis and kidney necrosis were decreased. As was shown, potential benefits and risks for human health as a result of supplementation of TT still remain unclear (Pokrywka et al., 2014).
[00142] Syzygium aromaticum: A study conducted in male mice by oral administration of S. aromaticum extracts at a dose of 250, 500 and 1000 mg/kg b.wt. / day for a period of 34 days, followed by assessment of sperm parameters. Results indicate that the high dosage of the S. aromaticum extract has a toxic effect on spermatogenesis in terms of reduced sperm count, motility, and sperm density in the seminiferous tubules. This was attributed to the effects of the extract on sex hormones at highest concentration i.e., 1000 mg/kg b.wt. (Dehghani et al., 2012)
[00143] Contra-Indications:
[00144] Withania somnifera: Ashwagandha is not recommended in case of hyperthyroidism or pregnancy and can in high doses provoke certain intestinal problems. In strong doses, Ashwagandha can have a hypnotic effect. Hence should be started with small doses then increased gradually. Ashwagandha is best taken in the evening, because in strong doses the plant can act as a sedative (Meher et al., 2016).

RESULT
IN VIVO ACUTE ORAL TOXICITY TESTING
[00145] Morbidity/Mortality and Clinical Signs
[00146] Table 2 shows animal mortality and morbidity rate, according to an embodiment of the present invention. With respect to Table 2, there was no mortality or clinical signs of toxicity observed throughout the observation period in all animals of step I and step II at 300 mg/kg body weight and in all animals of step III and step IV at 2000 mg/kg body weight.

Table 2: Animal Mortality and Morbidity

Step Dose
(mg/kg body
weight) Animal Number
Sex Mortality/ Morbidity

I

300 01 Female

0/3
02 Female
03 Female

II

300 04 Female

0/3
05 Female
06 Female

III

2000 07 Female

0/3
08 Female
09 Female

IV

2000 10 Female

0/3
11 Female
12 Female

[00147] Table 3 shows animal cage side clinical sign observation, according to an embodiment of the present invention. With respect to Table 3, no abnormal clinical sign observed in test animals up to 14 days.
Table 3: Animal Cage Side Clinical Sign Observation

Animal Number Observation days
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
30 mins. 1 hr 2 hr 3 hr 4 hr
1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
11 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
*Key: 0 = Normal

[00148] Body weight
[00149] Body weight gain was observed in all animals treated with test item at 300 mg/kg body weight (step I and II) and for animals treated with test item at 2000 mg/kg body weight (step III and step IV) on day 7 and day 14. Table 4 shows result of animal body weights and body weight gain (grams), according to an embodiment of the present invention.

Table 4: Animal Body Weights and Body Weight Gain (grams)

Step
Dose (mg/kg
B. Wt.)
Animal
Number

Sex
Dose Volume (mL) Dosing Day (Prior to Dosing)
(g)
Day 7 (g)
Dayl4 (g) Weight Change (0-7) Weight Change (7-14)

1
300 01 F 2.0 203.61 217.01 232.84 13.40 15.83
02 F 2.0 202.19 213.45 228.67 11.26 15.22
03 F 1.9 192.01 204.96 217.30 12.95 12.34
Mean 199.27 211.81 226.27 12.54 14.46
Standard Deviation 6.33 6.19 8.04 1.13 1.86

II
300 04 F 2.1 210.57 223.19 237.68 12.62 14.49
05 F 2.0 204.91 212.08 228.35 7.17 16.27
06 F 2.1 208.40 221.92 233.74 13.52 11.82
Mean 207.96 219.06 233.26 11.10 14.19
Standard Deviation 2.86 6.08 4.68 3.44 2.24

III
2000 07 F 2.2 218.28 232.49 250.85 14.21 18.36
08 F 2.0 201.84 214.64 229.06 12.80 14.42
09 F 1.9 194.83 208.54 225.48 13.71 16.94
Mean 204.98 218.56 235.13 13.57 16.57
Standard Deviation 12.04 12.45 13.73 0.71 2.00

IV
2000 10 F 2.1 210.79 221.16 236.08 10.37 14.92
11 F 1.9 192.48 206.74 219.56 14.26 12.82
12 F 1.9 190.40 203.57 219.73 13.17 16.16
Mean 197.89 210.49 225.12 12.60 14.63
Standard Deviation 11.22 9.38 9.49 2.01 1.69
Note: F — Female, mg/kg — milligram/kilogram, B. Wt. — Body Weight, g-gram

[00150] Necropsy and Gross Pathology
[00151] Table 5 shows animal gross pathology findings, according to an embodiment of the present invention. With respect to Table 5, necropsy observations revealed no abnormalities externally and internally in all the animals of step I, step II, step III and step IV.

Table 5: Animal Gross Pathology Findings
Step Dose (mg/kg body weight) Animal Number Sex Mode of death Gross pathology observations
External Internal
I 300 1 Female TS NAD NAD
2 Female TS NAD NAD
3 Female TS NAD NAD
II 300 4 Female TS NAD NAD
5 Female TS NAD NAD
6 Female TS NAD NAD
III 2000 7 Female TS NAD NAD
8 Female TS NAD NAD
9 Female TS NAD NAD
IV 2000 10 Female TS NAD NAD
11 Female TS NAD NAD
12 Female TS NAD NAD
*NAD = No abnormality detected; TS = Terminal sacrifice

DISCUSSION & CONCLUSION
[00152] Toxicity was validated with ‘acute oral administration’ testing at a concentration of 300 mg/kg and 2000 mg/kg body weight in rats. No morbidity and mortality were noted among the rats up to 14 days. Measurement of body weight and food consumption are being considered as two important and sensitive parameters for in vivo nonclinical toxicity/ safety evaluation studies, to assess the ‘illnesses, if any, related to test compound administration.
[00153] The results of the current study have shown a proportionate increase in body weight gain and food intake by the animals during the course of experiment suggesting no evidence of toxicity.

G) ADVANTAGES OF INVENTION
[00154] The present invention provides an aphrodisiac polyherbal composition for use in treatment of male sexual disorders. The additive effect of ‘admixture’ of plant extracts Withania Somnifera, Myristica fragrans, Mucuna pruriens, Tribulus terrestris, Syzygium aromaticum, Hygrophyla auriculata enhances male sexual well-being, increases the sperm count, vigour and vitality. The addition of one or more herbal additives an extract of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine and L-lysine promotes general health and wellbeing of the male individual and ameliorates male fertility.
[00155] The composition is eco-friendly since the ingredients utilized are natural and free from synthetic chemicals.
[00156] The method of synthesizing an aphrodisiac polyherbal composition is simple as it involves single extraction step in aqueous alcohol and less time consuming.
[00157] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the claims presented in the complete specification or non-provisional application.

Dated this 13th day of Dec, 2022

For SARVOTHAM CARE LIMITED
BY THEIR AGENT

(DR. BABITHA THARAPPAN)
IN/PA-1614

,CLAIMS:CLAIMS
We claim:
1. An aphrodisiac poly-herbal composition for use in the treatment of male sexual disorders, comprises:
a) An extract obtained from powdered admixture comprised of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata;
b) one or more herbal base additives, wherein the herbal base additives are extracts of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine, L-lysine; and
c) a pharmaceutically acceptable excipient.
2. The poly-herbal composition as claimed in claim 1, wherein the root coarse powder of Withania Somnifera is present in an amount of 30% (w/w).
3. The poly-herbal composition as claimed in claim 1, wherein the pericarp coarse powder of Myristica fragrans is present in an amount of 24% (w/w).
4. The poly-herbal composition as claimed in claim 1, wherein the seed coarse powder of Mucuna pruriens is present in an amount of 14% (w/w).
5. The poly-herbal composition as claimed in claim 1, wherein the fruit coarse powder of Tribulus terrestris is present in an amount of 14% (w/w).
6. The poly-herbal composition as claimed in claim 1, wherein the flower bud coarse powder of Syzygium aromaticum is present in an amount of 9% (w/w).
7. The poly-herbal composition as claimed in claim 1, wherein the aerial part coarse powder of Hygrophyla auriculata is present in an amount of 9% (w/w).
8. The poly-herbal composition as claimed in claim 1, wherein the extract of Tagetes erecta is present in an amount of 2mg.
9. The poly-herbal composition as claimed in claim 1, wherein the shilajeet powder is present in an amount of 30mg.
10. The poly-herbal composition as claimed in claim 1, wherein the rutin, lycopene, L-arginine and L-lysine is present in an amount of 20mg.
11. The poly-herbal composition as claimed in claim 1, wherein the said pharmaceutically acceptable excipient is sodium benzoate.
12. The poly-herbal composition as claimed in claim 1, wherein the said pharmaceutically acceptable excipient is present in an amount of 0.928mg.
13. A method of synthesizing an aphrodisiac poly-herbal composition for use in the treatment of male sexual disorders, comprises:
preparing a dried powdered admixture of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata (101);
preparing a hydro-alcoholic extract (102), wherein the hydro-alcoholic extract is obtained by soaking the dried powdered admixture in an aqueous alcohol and collecting and concentrating the pooled supernatant;
rota-evaporating the pooled supernatant to obtain a concentrated hydro-alcoholic extract (103);
lyophilizing the concentrated hydro-alcoholic extract at a lyophilizing temperature of -80? (104);
adding one or more powdered herbal base additives and a pharmaceutically acceptable excipient (105), wherein the herbal base additives added are selected from the group consisting of extract of Tagetes erecta, shilajeet powder, rutin, lycopene, L-arginine, L-lysine;
blending the said concentrated hydro-alcoholic extract of step (104) with one or more herbal base additives and the pharmaceutically acceptable excipient of step (105) to obtain a blend (106); and
spray-drying the blend to obtain final composition (107).
14. The method as claimed in claim 13, wherein the coarse powders of root of Withania Somnifera, pericarp of Myristica fragrans, seeds of Mucuna pruriens, fruit of Tribulus terrestris, flower bud of Syzygium aromaticum and aerial part of Hygrophyla auriculata is added in a ratio of 30:24:14:14:9:9.
15. The method as claimed in claim 13, wherein the ratio of ethanol to water is 50:50.
16. The method as claimed in claim 13, wherein the rota-evaporation is performed at a temperature of 40°C at rotational speed of 60rpm and vacuum pressure of 300 mbarr pressure with a chilled water condenser for a period of 4 to 5 hours.

Dated this 13th day of Dec, 2022

For SARVOTHAM CARE LIMITED
BY THEIR AGENT

(DR. BABITHA THARAPPAN)
IN/PA-1614