DESC:FIELD
The present disclosure relates to a herbal formulation and a process for its preparation.
DEFINITIONS
As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicates otherwise.
Oligospermia: The term “Oligospermia” refers to oligospermia to a male fertility condition characterized by a low sperm count.
Herbal Formulation: The term “herbal formulation” refers to a synergistic combination of herbal ingredients in a manner that improves male fertility condition, oligospermia.
BACKGROUND
The background information herein below relates to the present disclosure but is not necessarily prior art.
Oligospermia is a male fertility issue characterized by a low sperm count. Other aspects of the sexual health of men with this condition are typical. This includes the ability to get and maintain an erection, as well as produce ejaculation at orgasm. The World Health Organization (WHO) classifies sperm counts at or above 15 million sperm per millilitre (mL) of semen as average. Anything below that is considered low and is diagnosed as Oligospermia.
• Mild Oligospermia is considered when sperm counts 10 to 15 million sperm/mL.
• Moderate Oligospermia is considered when sperm counts 5 to 10 million sperm/mL.
• Severe Oligospermia is diagnosed when sperm counts fall between 0 and 5 million sperm/mL.
Several conditions and lifestyle factors can increase a man’s risk for Oligospermia. Typically, the causative factors include varicocele, infection, retrograde ejaculation, hormonal imbalance, medication, exposure to chemicals and metals, overheating of testicles (due to placement of electronic gadgets on genitals), drug and alcohol abuse, and obesity.
Currently, the treatments include surgery to cure varicocele, antibiotics to treat infections, hormone therapy, and lifestyle changes. However, none of these methods can successfully increase the count of sperm in the semen.
Therefore, there is felt a need to provide a herbal formulation that mitigates the afore stated drawbacks.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
An object of the present disclosure is to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
Another object of the present disclosure is to provide a herbal formulation.
Yet another object of the present disclosure is to provide a herbal formulation which can be used to increase the sperm count in male.
Still another object of the present disclosure is to provide a simple process for the preparation of a herbal formulation.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY
The present disclosure provides a herbal formulation for oligospermia. The formulation comprises extract of Asparagus adscendens in an amount in the range of 10 % to 20 % by weight of the total mass of the formulation; extract of Asparagus racemosus in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Withania somnifera in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Tribulus terrestris in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Mucuna pruriens in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Asteracantha longifolia in an amount in the range of 6.7 % to 10 % by weight of the composition; an extract of Myrica esculenta in an amount in the range of 3 % to 5 % by weight of the total mass of the formulation; Asphaltum punja-bianum powder in an amount in the range of 6.7 % to 10 % by weight of the total mass of the formulation; Yashad Bhasma powder in an amount in the range of 1.3 % to 2 % by weight of the total mass of the formulation; and at least one excipient in an amount in the range of 3 % to 60 % by weight of the total mass of the formulation.
The present disclosure further provides a process for the preparation of the herbal formulation.
DETAILED DESCRIPTION
Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.
As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third, etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
Oligospermia refers to semen with a low concentration of sperm and is a common finding in male infertility. Often, semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility.
Treatment takes place within the context of infertility management, considering the fecundity of the female partner. Thus the choices can be complex. In a number of situations, direct medical or surgical intervention can improve the sperm concentration. However, in most cases of Oligospermia including its idiopathic form there is no direct medical or surgical intervention that has been found to be effective. Hence, there is a need for an effective medication that can be used to treat Oligospermia.
The present disclosure relates to a herbal formulation which can be used for the treatment of Oligospermia.
In an aspect of the present disclosure, there is provided a herbal formulation. The herbal formulation of the present disclosure comprises extract of Asparagus adscendens in an amount in the range of 10 % to 20 % by weight of the total mass of the formulation; extract of Asparagus racemosus in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Withania somnifera in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Tribulus terrestris in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Mucuna pruriens in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation; an extract of Asteracantha longifolia in an amount in the range of 6.7 % to 10 % by weight of the composition; an extract of Myrica esculenta in an amount in the range of 3 % to 5 % by weight of the total mass of the formulation; Asphaltum punja-bianum powder in an amount in the range of 6.7 % to 10 % by weight of the total mass of the formulation; Yashad Bhasma powder in an amount in the range of 1.3 % to 2 % by weight of the total mass of the formulation; and at least one excipient in an amount in the range of 3 % to 60 % by weight of the total mass of the formulation.
The parts of the plants from which the extracts are derived are selected from the group consisting of roots, shoots, leaves, seeds, bark, aerial parts, and fruits.
Asparagus adscendens is a suberect or curved prickly shrub. The plant is distributed in Punjab, Himachal Pradesh, Jammu and Kashmir, Uttar Pradesh, Bihar, West Bengal, Orissa, Madhya Pradesh, Gujarat, and Lower Himalayan hills up to an altitude of 2000 m msl. The root is demulcent and is used as a tonic and galactagogue. It is also useful in diarrhoea, dysentery, and general debility.
In an embodiment of the present disclosure, the extract of Asparagus adscendens (Shwet musali extract) is derived from the roots of the plant. In the present disclosure, the extract of Asparagus adscendens is obtained commercially from Valsad, Gujrat, India.
The saponin content in the extract of Asparagus adscendens (Shwet musali) is not less than 20%.
Asparagus racemosus is widely distributed across the globe and its distribution ranges from tropical Africa, Java, Australia, Sri Lanka, Southern parts of China and India, but it is mainly cultivated in India. In Ayurvedic formulations, Asparagus racemosus is used for digestive discomfort, indigestion, amoebiasis, piles and debility.
In an embodiment of the present disclosure, the extract of Asparagus racemosus (Shatavari extract) is derived from the roots. In the present disclosure, the extract of Asparagus racemosus is obtained commercially from Valsad, Gujrat, India.
The saponin content in the extract of Asparagus racemosus (Shatavari extract), is not less than 20%.
Withania somnifera, commonly known as Ashvagandha (winter cherry), is an important medicinal plant. The plant extract has many bioactive compounds and thereby exerts antioxidant, anti-inflammatory, and immunomodulatory activities. The plant extract and its bioactive compounds are used in the prevention and treatment of many diseases, such as arthritis, impotence, amnesia, anxiety, cancer, neurodegenerative and cardiovascular diseases, and others.
In an embodiment of the present disclosure, the extract of Withania somnifera (Ashvagandha extract) is derived from the roots of the plant. In the present disclosure, the extract of Withania somnifera is obtained commercially from Indore, Madhya Pradesh, India.
The withaferin A content in the extract of Withania somnifera (Ashvagandha extract), is not less than 0.3%.
Tribulus terrestris is an annual plant in the caltrop family (Zygophyllaceae) widely distributed around the world. It is adapted to grow in dry climate locations in which few other plants can survive. It is native to warm temperate and tropical regions in southern Eurasia, Africa, North America, and Australia. It is a small, flowering plant also known as puncture vine and goat's head. The plant yields a fruit that is covered with spines. The fruit, leaf, and roots are used as medicine to treat a number of conditions, most notably sexual dysfunction.
In an embodiment of the present disclosure, the extract of Tribulus terrestris (Gokshura extract) is derived from the fruit of the plant. In the present disclosure, the extract of Tribulus terrestris is obtained commercially from Indore, Madhya Pradesh, India.
The saponin content in the extract of Tribulus terrestris (Gokshura extract), is not less than 40%.
The plant Mucuna pruriens, widely known as “velvet bean,” is a vigorous annual climbing legume originally from southern China and eastern India. In India, the seeds of M. pruriens have traditionally been used as a nervine tonic, and as an aphrodisiac for male virility. The pods are anthelmintic, and the seeds are anti-inflammatory. Powdered seeds possess anti-parkinsonism properties, possibly due to the presence of L-dopa (a precursor of neurotransmitter dopamine). The seeds also demonstrate an anti-diabetic effect.
In an embodiment of the present disclosure, the extract of Mucuna pruriens (Kapikacchu extract) is derived from the seeds of the plant. In the present disclosure, the extract of Mucuna pruriens is obtained commercially from Indore, Madhya Pradesh, India.
The L-Dopa content in the extract of Mucuna pruriens (Kapikacchu extract), is not less than 10%.
Asteracantha longifolia is a spiny, stout, annual herb, common in waterlogged places. The plant is widely distributed throughout India, Sri Lanka, Burma, Malaysia, and Nepal. The whole plant, roots, seeds, and ashes of the plant are extensively used in traditional system of medicine for various ailments like rheumatism, inflammation, jaundice, hepatic obstruction, pain, urinary infections, edema and gout. The extract of the seeds shows inhibition of hepato-carcinogenesis and improves the histo-architecture of testis, increases the concentration of sperm count in epididymis, and also increases testosterone levels.
In an embodiment of the present disclosure, the extract of Asteracantha longifolia (Kokilaksha extract) is derived from the seeds of the plant. In the present disclosure, the extract of Asteracantha longifolia is obtained commercially from Indore, Madhya Pradesh, India.
The flavonoid content in the extract of Asteracantha longifolia (Kokilaksha extract), is not less than 2%.
Myrica esculenta (Myricaceae) commonly known as box berry or kaphal is an important Indian medicinal plant. It is found on foothill tracks of Eastern Himalayas, Meghalaya, Nepal, China, and Pakistan. Traditionally, the bark has been used for the treatment of cough, asthma, fever, chronic bronchitis, diarrhoea, rheumatism, and inflammation.
In an embodiment of the present disclosure, the extract of Myrica esculenta (Katphala extract) is derived from the bark of the plant. In the present disclosure, the extract of Myrica esculenta is obtained commercially from Indore, Madhya Pradesh, India.
The tannin content in the extract of Myrica esculenta (Katphala extract), is not less than 5%.
Asphaltum punja-bianum is a blackish-brown powder or an exudate from high mountain rocks, especially in the Himalayans mountains between India and Nepal, although it has been also found in Russia, Tibet, Afghanistan, and now in the north of Chile. Asphaltum punja-bianum is composed mainly of humic substances, including fulvic acid, that account for around 60% to 80% of the total nutraceutical compound plus some oligo elements including selenium, that provides antiaging properties. Asphaltum punja-bianum is a potent and very safe dietary supplement, potentially able to prevent several diseases, but its main medical application now appears to come from its actions in benefit of cognition and potentially as a dietary supplement to prevent Alzheimer's disease. In essence, this is a nutraceutical product. In the present disclosure, the extract of Asphaltum punja-bianum is obtained commercially from Mandal, Telangana, India.
The fulvic acid content in the powder of Asphaltum punja-bianum, is not less than 20%.
Yashad Bhasma is an ayurvedic mineral-based and immuno-modulatory medicine. It is also an ayurvedic zinc supplement. Pure zinc, processed with Aloe Vera, is used in the preparation of the Bhasma. Yashad Bhasma has several healing properties, including, antacid, anti-inflammatory, anti-arthritic, anti-pyretic, digestive stimulant, haematinic (increases haemoglobin levels), and hematogenic (helps in the formation of red blood cells). It is indicated for the treatment of hair fall, baldness, zinc deficiency, immune-deficiency, skin diseases, allergy, bronchitis, etc.
In the present disclosure, the powder of Yashad Bhasma is obtained commercially from Kasgannj, Uttar Pradesh, India. The zinc oxide content in the powder of Yashad Bhasma is not less than 70%.
In an embodiment of the present disclosure, the excipient is at least one selected from the group consisting of diluent, preservative, binding solvent, and glidant.
In an embodiment of the present disclosure, the excipient comprises a first diluent in an amount in the range of 6.5 % to 10 % by weight of the total mass of the formulation; a first preservative in an amount in the range of 0.15 % to 0.30 % by weight of the total mass of the formulation; a second preservative in an amount in the range of 0.01 % to 0.03 % by weight of the total mass of the formulation; a second diluent in an amount in the range of 15 % to 20 % by weight of the total mass of the formulation; a first glidant in an amount in the range of 0.3 % to 0.75% by weight of the total mass of the formulation; and a second glidant in an amount in the range of 0.3 % to 0.75 % by weight of the total mass of the formulation.
The first diluent is selected from the group consisting of dibasic calcium phosphate, anhydrous lactose, and lactose monohydrate.
The first preservative is methyl paraben. The second preservative is propyl paraben.
The second diluent is selected from the group consisting of microcrystalline cellulose, sorbitol, xylitol and mannitol.
The first glidant is selected from the group consisting of fumed silica, starch and talc.
The second glidant is selected from the group consisting of magnesium stearate, ascorbyl palmitate, calcium palmitate.
A binding solvent is selected from the group consisting of isopropyl alcohol and water is also used as an excipient. However, the binding solvent completely evaporates during the drying process of the preparation and hence does not contribute to the total weight of the final formulation.
In an embodiment of the present disclosure, the herbal formulation can be formulated in at least one dosage form selected from the group consisting of tablets, capsules, suspensions, solutions, syrups, elixirs, tinctures, and powders.
In an exemplary embodiment of the present disclosure, the herbal formulation is formulated in the form of capsules.
In an exemplary embodiment of the present disclosure, the herbal formulation is intended for oral administration.
In another aspect of the present disclosure, there is provided a process of preparing the herbal formulation for alleviating Oligospermia. The process comprises the steps of blending predetermined amounts of Asparagus adscendens extract, Asparagus racemosus extract, Withania somnifera extract, Tribulus terrestris extract, Mucuna pruriens extract, Asphaltum punja-bianum extract, Asteracantha longifolia extract, Myrica esculenta extract, Yashad Bhasma in a first diluent, for a time period in the range of 5 minutes to 25 minutes, to obtain a first mixture. Separately, a second mixture of a first preservative and a second preservative in a binding solvent is prepared and the second mixture is blended with the first mixture which is then passed through 8.0 mm stainless steel screen on a multi-mill to obtain a wet mass. Subsequent to this, the wet mass is air-dried in a fluidized bed dryer for a time period in the range of 5 minutes to 15 minutes, followed by drying at a temperature in the range of 50°C to 60°C till loss on drying is found between 4.0% to 6.0% to obtain dry granules. The dry granules are passed through 2.0 mm stainless steel screen on multi-mill obtain a first blend. A second blend of a second diluent, a first glidant and a second glidant is prepared by mixing and further mixed with the first blend, in a blender, for 5 minutes to 15 minutes to obtain the herbal formulation.
The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.
The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial scale.
EXPERIMENTAL DETAILS
Experiment 1: Preparation of the herbal formulation in accordance with the present disclosure.
The herbal formulation as disclosed in the present disclosure was prepared by blending Asparagus adscendens extract, Asparagus racemosus extract, Withania somnifera extract, Tribulus terrestris extract, Mucuna pruriens extract, Asphaltum punja-bianum extract, Asteracantha longifolia Extract, Myrica esculenta extract, Yashad Bhasma in dibasic calcium phosphate to obtain a first mixture for a time period of 15 minutes. A second mixture of methyl paraben and propyl paraben was prepared and added to the first mixture and blended with intermittent racking till a wet mass of suitable consistency was formed. The wet mass was passed through 8.0 mm stainless steel screen on a multi-mill. The wet mass was air dried in a fluidized bed dryer for 10 minutes and was then dried at a temperature of 60°C till loss on drying was found between 4.0-6.0%, on IR moisture (at 105°C, 10 minutes), to obtain dried granules. The dried granules were passed through 2.0 mm stainless steel screen on multi-mill and pass the sifted material through 20# (ASTM) stainless steel sieve on a vibratory sifter, to obtain a first blend. Microcrystalline cellulose 102, fumed silica and Magnesium stearate were weighed accurately and sifted through 40# (ASTM) S.S. sieve on a vibratory sifter to obtain a second blend. The second blend and the first blend were mixed in a blender for 10 minutes to obtain the herbal formulation. The herbal formulation was then filled in a size ‘00’ capsule shell with using capsule filling machine
The concentration of each of the ingredients are provided in the below table
TABLE I
Plant Name/Excipient name Ingredient Unit Qty (mg / Capsule ) %
Asparagus adscendens Shwet musali extract 75 11.03
Asparagus racemosus Shatavari extract 75 11.03
Withania somnifera Ashvagandha extract 75 11.03
Tribulus terrestris Gokshura extract 75 11.03
Mucuna pruriens Kapikacchu Seed Extract 75 11.03
Asphaltum punja-bianum Asphaltum punja-bianum Powder 50 7.35
Asteracantha longifolia Kokilaksha seed Extract 50 7.35
Myrica esculenta Katphala bark Extract 25 3.68
Yashad Bhasma Yashad Bhasma 10 1.47
First diluent Dibasic calcium Phosphate BP 50 7.35
First preservative Methyl paraben BP 1.23 0.18
Second preservative Propyl paraben BP 0.13 0.02
Binding solvent Isopropyl alcohol and Water 0 0.00
Second diluent Microcrystalline cellulose 112.04 16.48
First glidant Fumed Silica 3.4 0.50
Second glidant Magnesium stearate BP 3.2 0.47
Total 680 100

Experiment 2: Effectiveness of the herbal formulation and evaluation of the spermatogenic activity of the herbal formulation against cyclophosphamide induced Oligospermia in rats.
The formulation prepared above in table – I was studied for the spermatogenic activity of the herbal formulation against cyclophosphamide induced oligospermia in rats
Study Design:
The selected animals were assigned to different test groups as shown below:
Groups Dose Groups Route Duration
(in days) No. of animals (rats)
G1 Vehicle control p.o 28 8
G2 Cyclophosphamide @ 100mg / kg (Single Dose) + Normal Saline i.p 8
G3 Cyclophosphamide (Single Dose) + Herbal Formulation “O” @ 106mg/kg p.o 8
G4 Cyclophosphamide (Single Dose) + Herbal Formulation “O” @ 211mg/kg p.o 8
G5 Cyclophosphamide (Single Dose) + Herbal Formulation “P” @ 207mg/kg p.o 8
G6 Cyclophosphamide (Single Dose) + Herbal Formulation “H” @ 212mg/kg p.o 8
p.o. – Per oral; i.p. intra-peritoneal
Experimental procedures:
Rats in group 1 served as normal control; group 2 as an untreated positive / disease control; groups 3, 4, 5 & 6 received the herbal formulations at different doses p.o. respectively, once daily for 28 days. On day four, one hour after the respective treatment, Oligospermia was induced by administering a single dose of cyclophosphamide (100mg/kg body weight) through intraperitoneal route to all the groups except group 1. At the end of the study period, all the rats were euthanized and reproductive organs (Testes & Seminal vesicles) were weighed. The semen samples from epididymis were subjected to the enumeration of sperm. Weight of the reproductive organs and sperm count was performed.
Details on Study Drugs:

A). Herbal Composition of the present disclosure (Anti-Oligospermia Capsule): (Herbal Formulation “O”)
Composition: Each capsule contains:
Sr. No. Ingredients Quantity (mg)
1 Shwet musali extract 75
2 Shatavari extract 75
3 Ashwagandha extract 75
4 Gokshura extract 75
5 Kapikacchu Seed Extract 75
6 Shudha Shilajeet Powder 50
7 Kokilaksha seed Extract 50
8 Katphala bark Extract 25
9 Yashad Bhasma 10

B). Herbal Formulation ‘P’
Composition: Each capsule contains:
Sr. No. Ingredients Quantity (mg)
1 Ashwagandha extract 25
2 Shatavari extract 25
3 Guduchi extract 25
4 Kapikcchu extract 25
5 Safed Musali Powder 50
6 Asphaltum punja-bianum Powder 50
7 Kokilaksha Powder 50
8 Akarkara Powder 50
9 Karpoora Powder 30
10 Swarna makshik Powder 30
11 Makardhawj powder 30
12 Goksura Powder 25
13 Yastimadhu Powder 25
14 Jaiphal Powder 20
15 Lavanga Powder 20
16 Nagkeshar Powder 20

C). Herbal Formulation ‘H’:
Test Item H was a commercially available product.
Composition of commercially available product H
Sr. No. Ingredients Quantity (mg/Tablet)
1 Vriddhadaru extract 64
2 Jeevanti extract 64
3 Ashwagandha Powder 130
4 Gokshura extract 64
5 Shaileyam extract 32
6 Kapikacchu Powder 32
7 Kokilaksha Powder 64
8 Vanya Kahu 32
9 Svarnavanga 32

Results:
1. Sperm Count:
I). Effect of Cyclophosphamide on sperm count in Oligospermia control group:
Sperm enumeration on day 29 in group 2 was reduced with a statistical significance of p =0.001 when compared to normal control group 1.
II). Effect of polyherbal formulations on sperm count in cyclophosphamide induced rats:
a). Comparison Of Group 2 Vs. Treatment Groups: Statistical analysis done for test item treated groups has shown a significant increase in the sperm count levels of group 4 p=0.05, when compared to G2.
b). Comparison of Group1 vs. Treatment Groups: The sperm count was reduced in all the treatment groups and were statistically significant except group 4. Group 4 showed a marginal reduction of 18.14% and was not statistically significant compared to the control group. (p values of significance have been mentioned in table),
c). Comparison Of Group 4 Vs. Group 5 & Group 6: Group 4 animals were also evidenced with a significant increase in the sperm count at p=0.05 when compared to group 5 and p=0.01 on comparison with group 6.

Table III: Summary of Sperm count:
Groups Dose mg/kg Sperm count
G1 Vehicle Control Mean -52.13
SD -12.65
G2 CYP Control Mean -30.67###
SD -7.53
G3 106 Mean -31.33###
SD -4.63
G4 211 Mean -42.67*,†
SD -10.58
G5 207 Mean -31.71###
SD -6.50
G6 212 Mean -27.00####,††
SD -3.35
Male; Values are expressed as Mean ± SD. # -significance with respect to G1, *- significance with respect to G2,†- significance with respect to G4; */#/† = P=0.05 , **/##/†† = P=0.01, ***/###/††† =P=0.001, ****/####/†††† =P=0.0001
SD- Standard Deviation
2. Testosterone:
I). Effect of Cyclophosphamide on Oligospermia control group: Cyclophosphamide induced group 2 showed a statistically significant reduction in testosterone levels at p=0.01 when compared to normal control group 1 on day 29.
II). Effect of polyherbal formulations on testosterone in cyclophosphamide induced rats:
a). Comparison of group 2 vs treatment groups: Animals in group 4 were evidenced with a statistically significant increase in testosterone levels at p =0.05. However, group 3, group 5, and group 6 exhibited an increase in the testosterone percentage of 37.67, 12.64, and 13.88 respectively, when compared to group 2 on day 29.
b). Comparison of Group1 vs treatment Groups:
The testosterone levels were reduced in all the treatment groups and were statistically significant except for group 4. Group 4 showed a marginal reduction of 17% and was not statistically significant compared to the control group. (p values of significance have been mentioned in table)
c). Comparison of group 4 vs group 5 & group 6:
The values of testosterone of group 4 on day 29 had a statistically significant increase compared to group 5 p=0.05 (t-test) and though statistically non- significant, the increase was 37% when compared to group 6.
Table IV: Summary of Testosterone Hormonal Level:
Groups Dose mg/kg Testosterone Hormone
Day 07 Day 29
G1 Vehicle Control Mean -2.3338 Mean -2.2413
SD -0.6787 SD -0.6116
G2 CYP Control Mean -2.1850 Mean -1.0133##
SD -0.6896 SD -0.3268
G3 106 Mean -2.1888 Mean -1.3850#
SD -0.5118 SD -0.6626
G4 211 Mean -2.2550 Mean -1.8433*
SD -0.4171 SD -0.5672
G5 207 Mean -2.5363 Mean -1.1414##,†
SD -0.6228 SD -0.4585
G6 212 Mean -2.2688 Mean -1.1540#
SD -0.5482 SD -0.5684
Male; Values are expressed as Mean ± SD. # -significance with respect to G1, *- significance with respect to G2,†- significance with respect to G4; */#/† = P=0.05 , **/##/†† = P=0.01
SD- Standard Deviation
3. Luteinizing Hormone (LH):
I). Effect of Cyclophosphamide on Oligospermia control group:
Cyclophosphamide induced group 2 showed a statistically significant reduction in LH level at p=0.01 when compared to normal control group 1 on day 29.
II). Effect of polyherbal formulations on LH in cyclophosphamide induced rats:
a). Comparison Of Group 2 Vs. Treatment Groups: A statistically significant increase p =0.05 was noticed in group 4 animals. Further, the serum LH level in group 3, group 5, and group 6 were increased at a percentage of 17.78, 38.42, and 19.41 respectively, when compared to group 2 on day 29. Whereas, group 4 animals showed a 62.86% increase.
b). Comparison of Group1 vs. Treatment Groups: The serum LH levels were reduced significantly in group 3. The reduction was statistically non-significant in group 4, group 5, and group 6. (p values have been mentioned in table)
c). Comparison of Group 4 vs. Group 5 & Group 6: The percentage reduction of LH values when compared with group 4 was 15% and 26% in group 5 & 6 respectively on day 29.
Table V: Summary of Luteinizing Hormonal Level:
Groups Dose mg/kg Luteinizing Hormone
Day 07 Day 29
G1 Vehicle Control Mean -3.2538 Mean -3.1500
SD -0.7069 SD -0.6914
G2 CYP Control Mean -3.1500 Mean -1.6967##
SD -0.4978 SD -0.6576
G3 106 Mean -2.8075 Mean -1.9983#
SD -0.2601 SD -0.6412
G4 211 Mean -2.9475 Mean -2.7633*
SD -0.5237 SD -0.6186
G5 207 Mean -2.9763 Mean -2.3486
SD -0.3677 SD -0.7890
G6 212 Mean -2.8588 Mean -2.0260
SD -0.2796 SD -0.3979
Male; Values are expressed as Mean ± SD. # -significance with respect to G1, *- significance with respect to G2,
*/#/† = P=0.05 ,
**/##/†† = P=0.01
SD- Standard Deviation
4. Follicle Stimulating Hormone (FSH):
I). Effect of Cyclophosphamide on Oligospermia control group:
Cyclophosphamide induced group 2 showed a statistically significant reduction in FSH level at p=0.01 when compared to normal control group 1 on day 29.
II). Effect of polyherbal formulations on FSH in cyclophosphamide induced rats:
a). Comparison Of Group 2 Vs. Treatment Groups: Animals in group 4 were evidenced with a statistically significant increase (p =0.05). However, group 3, group 5, and group 6 exhibited an increase in the FSH percentage of 41.50, 17.99, and 0.14 respectively, when compared to group 2 on day 29.
b). Comparison of Group1 vs. Treatment Groups: The treatment groups of 5 & 6 exhibited a statistically significant reduction in FSH levels. The animals in groups 3 & 4 did not show any statistical significance.
c). Comparison of Group 4 vs. Group 5 & Group 6: The values of FSH in group 4 on day 29 had a statistically significant increase compared to group 5 p=0.05 (t-test). The group 6 animals showed a reduction of 38.48% in serum FSH levels in comparison with group 4. (p values of significance have been mentioned in table)
Table VI: Summary of Follicle stimulating Hormonal Level:
Groups Dose mg/kg Follicle stimulating Hormone
Day 07 Day 29
G1 Vehicle Control Mean -3.6225 Mean -3.3638
SD -0.4784 SD -0.5692
G2 CYP Control Mean -3.3275 Mean -1.8633##
SD -0.6299 SD -0.3938
G3 106 Mean -3.3338 Mean -2.6367
SD -0.6894 SD -0.5272
G4 211 Mean -3.4875 Mean -3.0333#,*
SD -0.7881 SD -0.7778
G5 207 Mean -3.6263 Mean -2.1986#,†
SD -0.5396 SD -0.4260
G6 212 Mean -3.0675 Mean -1.8660#
SD -0.3627 SD -1.3305
Male; Values are expressed as Mean ± SD. # -significance with respect to G1, *- significance with respect to G2,†- significance with respect to G4;
*/#/† = P=0.05 ,
**/##/†† = P=0.01
SD- Standard Deviation
5. Conclusion:
It was concluded from the results of the study that the herbal composition of the present disclosure at 211mg/kg is significantly effective in increasing sperm count, testosterone, LH & FSH in rats with CP induced Oligospermia under the testing conditions.
TECHNICAL ADVANCEMENTS & ECONOMIC SIGINIFICANCE
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a herbal formulation that:
- is used to treat oligospermia without any surgical intervention and other major side effects.
ECONOMIC SIGNIFICANCE, Section 2(1) (ja)
The applicant submits that the present disclosure will contribute in the country’s economy, which is one of the purposes to enact the Patents Act, 1970. The product in accordance with present disclosure will be in great demand in the country and worldwide due to novel technical features of the present disclosure which is a technical advancement in the field of herbal formulations for Oligospermia. The technology in accordance with present disclosure will provide product cheaper, saving in time of total process of manufacturing. The saving in production time will improve the productivity, and cost cutting of the product, which will directly contribute to economy of the country.
The product will contribute new concept in herbal formulation, wherein the patented product will be used. The present disclosure will replace the whole concept of herbal formulations for the purpose of alleviating heel fissures used for decades. The product is developed in the national interest and will contribute to country economy.
The economy significance details requirement may be called during the examination. Only after filing of this Patent application, the applicant can work publically related to present disclosure product/process/method. The applicant will disclose all the details related to the economic significance contribution after the protection of invention.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.
Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.
While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation
,CLAIMS:WE CLAIM:
1. A herbal formulation for alleviating oligospermia comprising:
i. extract of Asparagus adscendens in an amount in the range of 10 % to 20 % by weight of the total mass of the formulation;
wherein said extract of Asparagus adscendens has at least 20% of saponin content;
ii. extract of Asparagus racemosus in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation;
wherein said extract of Asparagus racemosus has at least 20% of saponin content;
iii. extract of Withania somnifera in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation;
wherein said extract of Withania somnifera has at least 0.3% of withaferin A;
iv. extract of Tribulus terrestris in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation;
wherein said extract of Tribulus terrestris has at least 40% of saponin content;
v. extract of Mucuna pruriens in an amount in the range of 10 % to 15 % by weight of the total mass of the formulation;
wherein said extract of Mucuna pruriens has at least 10% of L-Dopa;
vi. extract of Asteracantha longifolia in an amount in the range of 6.7 % to 10 % by weight of the composition;
wherein said extract of Asteracantha longifolia has at least 2% of flavonoid content;
vii. extract of Myrica esculenta in an amount in the range of 3 % to 5 % by weight of the total mass of the formulation;
viii. Asphaltum punja-bianum powder in an amount in the range of 6.7 % to 10 % by weight of the total mass of the formulation;
wherein said powder of Asphaltum punja-bianum has at least 20% of fulvic acid;
ix. Yashad Bhasma powder in an amount in the range of 1.3 % to 2 % by weight of the total mass of the formulation;
wherein said Yashad Bhasma powder has at least 70% zinc oxide; and
x. at least one excipient in an amount in the range of 3 % to 60 % by weight of the total mass of the formulation
2. The herbal formulation as claimed in claim 1, wherein the extract Asparagus adscendens is derived from the roots of the Asparagus adscendens.
3. The herbal formulation as claimed in claim 1, wherein the extract Asparagus racemosus is derived from the roots of the Asparagus racemosus.
4. The herbal formulation as claimed in claim 1, wherein the extract of Withania somnifera is derived from the roots of Withania somnifera.
5. The herbal formulation as claimed in claim 1, wherein the extract of Tribulus terrestris is derived from the fruits of Tribulus terrestris.
6. The herbal formulation as claimed in claim 1, wherein the extract of Mucuna pruriens is derived from the seeds of the Mucuna pruriens.
7. The herbal formulation as claimed in claim 1, wherein the the extract of Asteracantha longifolia is derived from the seeds of the Asteracantha longifolia.
8. The herbal formulation as claimed in claim 1, wherein the extract of Myrica esculenta is derived from the bark of the Myrica esculenta.
9. The herbal formulation as claimed in claim 1, wherein the excipient comprises:
a. a first diluent in an amount in the range of 6.5 % to 10 % by weight of the total mass of the formulation;
b. a first preservative in an amount in the range of 0.15 % to 0.30 % by weight of the total mass of the formulation;
c. a second preservative in an amount in the range of 0.01 % to 0.03 % by weight of the total mass of the formulation;
d. a second diluent in an amount in the range of 15 % to 20 % by weight of the total mass of the formulation;
e. a first glidant in an amount in the range of 0.3 % to 0.75% by weight of the total mass of the formulation; and
f. a second glidant in an amount in the range of 0.3 % to 0.75 % by weight of the total mass of the formulation.
g. a binding solvent in an amount in the range of 0.0 % to 0.75 % by weight of the total mass of the formulation
10. The herbal formulation as claimed in claim 9, wherein the first diluent is selected from the group consisting of calcium phosphate, anhydrous lactose, and lactose monohydrate.
11. The herbal formulation as claimed in claim 9, wherein the first preservative is methyl paraben.
12. The herbal formulation as claimed in claim 9, wherein the second preservative is propyl paraben.
13. The herbal formulation as claimed in claim 9, wherein the second diluent is selected from the group consisting of microcrystalline cellulose. sorbitol, xylitol and mannitol.
14. The herbal formulation as claimed in claim 9, wherein the first glidant is selected from the group consisting of fumed silica, starch and talc.
15. The herbal formulation as claimed in claim 9, wherein the second glidant is selected from the group consisting of magnesium stearate, ascorbyl palmitate, calcium palmitate.
16. The herbal formulation as claimed in claim 9, wherein the binding solvent is isopropyl alcohol and water.
17. A process for the preparation of an herbal formulation, the process comprising the following steps:
- blending predetermined amounts of Asparagus adscendens extract, Asparagus racemosus extract, Withania somnifera extract, Tribulus terrestris extract, Mucuna pruriens extract, Asphaltum punja-bianum extract, Asteracantha longifolia Extract, Myrica esculenta extract, Yashad Bhasma in a first diluent, for a time period in the range of 5 minutes to 25 minutes, to obtain a first mixture;
- separately blending a first preservative and a second preservative optionally in a binding solvent to obtain a second mixture;
- blending the second mixture with the first mixture and passing the blend of first mixture and second mixture through 8.0 mm stainless steel screen on a multi-mill to obtain a wet mass;
- air-drying the wet mass in a fluidized bed dryer for a time period in the range of 5 minutes to 15 minutes, followed by drying at a temperature in the range of 50°C to 60°C till loss on drying is found between 4.0% to 6.0% to obtain dry granules;
- passing the dry granules through a 2.0 mm stainless steel screen on multi-mill to obtain a first blend;
- mixing a second diluent, a first glidant and a second glidant to obtain a second blend; and
- mixing the second blend and the first blend, in a blender, for a time period in the range of 5 minutes to 15 minutes to obtain the herbal formulation.

Dated this 17th day of March, 2020

_______________________________
MOHAN RAJKUMAR DEWAN, IN/PA – 25
of R.K.DEWAN & CO.
Authorized Agent of Applicant

TO,
THE CONTROLLER OF PATENTS
THE PATENT OFFICE, AT MUMBAI