DESC:FIELD
The present disclosure relates to herbal compositions.
DEFINITION
As used in the present disclosure, the following term is generally intended to have the meaning as set forth below, except to the extent that the context in which it is used indicates otherwise.
Oligospermia: The term “oligospermia”, also known as oligozoospermia refers to semen with a low concentration of sperm. The World Health Organization (WHO) classifies sperm counts at or above 15 million sperm per milliliter (mL) of semen as average. Anything below this count is considered low and is diagnosed as oligospermia.
BACKGROUND
The quality of semen is of vital importance for the reproduction of both humans and animals. Many couples have difficulty in conceiving a child, which primarily can be due to infertile or sub-fertile males. A low sperm count, also known as oligospermia, is one of the major causes resulting in infertility in males. Male infertility may be caused by abnormalities in the testes or other areas of the male reproductive tract, as well as immune system defects. Yet the most common cause of male infertility is disordered sperm production. This happens due to poor or insufficient semen quantity and/or quality. In many of these cases, causes of infertility are treatable. Nutritional and lifestyle changes should be the first step to increasing chances for conception. Smoking and caffeine, drug and alcohol consumption, environmental toxicants, and stress are related to infertility in men and women.
Generally, a total sperm count of less than approximately 15 million, with adequate motility and morphology, is considered to be a low sperm count, and males exhibiting such characteristics are considered to be sub fertile or oligospermatic. Both the quality and the quantity of the sperms are influenced by numerous factors. Various environmental stresses (pollutants, heavy metals, etc.), stressful lifestyle factors (such as nicotine, alcohol, etc.) and changed circumstances of life (marked stress) nowadays place a burden on sperm development as well as on motility, appearance and number of sperm. Sperm production is a very complicated and biologically effortful process, which occurs over a period of several weeks and can easily be influenced in a negative manner.
Existing compositions for improving the sperm count are known. But most of them contain metals or minerals which have toxic side effects.
There is, therefore, felt a need to provide an herbal composition devoid of any toxic side effects for increasing sperm count.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
An object of the present disclosure is to provide an herbal composition which has spermatogenic properties.
Another object of the present disclosure is to provide an herbal composition which is devoid of any side effects and is non-toxic.
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 an herbal composition comprising extracts from various plants. The composition comprises Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, and Myristica fragrans. In an embodiment, the herbal composition comprises powder of Mucuna pruriens in an amount in the range of 42 % to 48 % with respect to the total weight of the composition, powder of Tribulus terrestris in an amount in the range of 20 % to 28 % with respect to the total weight of the composition, powder of Asparagus adscendens in an amount in the range of 8 % to 16 % with respect to the total weight of the composition, powder of Anacyclus pyrethrum in an amount in the range of 8 % to 16 % with respect to the total weight of the composition, and powder of Myristica fragrans in an amount in the range of 3 % to 9 % with respect to the total weight of the composition.
The composition of the present disclosure is effective in increasing the sperm count in individuals suffering from oligospermia.
DETAILED DESCRIPTION
Oligospermia is also known as a low sperm count or oligozoospermia. Oligospermia is one of the main causes of male infertility or sub-fertility. Sub-fertility is a reduced ability to achieve a pregnancy. Oligospermia can be the result of many factors, some are permanent and some are reversible. A decrease in sperm production is another cause of oligospermia. This can be due to such conditions as varicoceles, hormonal disorders, diseases of the testicles, and obesity. Other causes of oligospermia include stress, smoking, drug or alcohol use, some medications, exposure to some toxins, malnutrition, and being underweight.
The present disclosure envisages an herbal composition that is effective in increasing sperm count in individuals presented with oligospermia, without any negative side effects.
In an aspect of the present disclosure there is provided an herbal composition.
The composition comprises Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum and Myristica fragrans. In an embodiment, the herbal composition comprises powdered form of the plant parts.
Mucuna pruriens (Fabaceae), commonly known as kapikachhu, is a tropical legume native to Africa and tropical Asia.
Tribulus terrestris (Zygophyllaceae), commonly known as gokshur, is native to the Indian sub-continent, but also grows in southern Europe, southern Asia, throughout Africa, and Australia.
Asparagus adscendens (Asparagaceae), commonly known as shweta musli, is native to the Indian sub-continent, but also grows in the Asian sub-continent.
Anacyclus pyrethrum (Asteraceae), commonly known as akarakarabha, is native to the Indian sub-continent, but also grows in North Africa, the Mediterranean region, in the Himalayas, in North India, Arabian countries, Algeria and Morocco.
Myristica fragrans (Myristicaceae), commonly known as javitri, is native to the Indian sub-continent, but also grows in the tropics, including Guangdong and Yunnan in China, Taiwan, Indonesia, Malaysia, and Grenada in the Caribbean, Sri Lanka and South America.
The scope of the present disclosure is not only limited to Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, Myristica fragrans and products derived therefrom but also extends to botanically closely related plants specially belonging to the same family, preferably belonging to the same genes, still preferably belonging to the same species having substantially similar phenotypic and genotypic characteristics.
The plant powders may be derived from bark, roots, tubers, stolons, rhizome, leaves, seeds, fruits, stems and flowers, preferably, seeds of Mucuna pruriens, fruit of Tribulus terrestris, root of Asparagus adscendens, root of Anacyclus pyrethrum and aril of Myristica fragrans. Typically, the powders of Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, and Myristica fragrans are commercially purchased from the local market.
The desired plant part of Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, and Myristica fragrans may be taken in the form of a powder obtained by direct micronization of the plant material. Typically, the extracts are selected from the group that include, but is not limited to, alcoholic, hydroalcoholic, aqueous, ether, ester, ethyl acetate, acetone and hexane extract. Typically, the extracts are prepared by using techniques that include, but are not limited to, percolation, decoction, maceration, soxhlet extraction, trituration and supercritical fluid extraction.
In an embodiment of the present disclosure, the composition comprises powder of Mucuna pruriens in an amount ranging from 42 % to 48 % with respect to the total weight of the composition, powder of Tribulus terrestris in an amount ranging from 20 % to 28 % with respect to the total weight of the composition, powder of Asparagus adscendens in an amount ranging from 8 % to 16 % with respect to the total weight of the composition, powder of Anacyclus pyrethrum in an amount ranging from 8 % to 16 % with respect to the total weight of the composition, and powder of Myristica fragrans in an amount ranging from 3 % to 9 % with respect to the total weight of the composition. The particle size of the powder can be in the range of 180 µ to 250 µ.
In an embodiment of the present disclosure, the composition further comprises pre-determined amount of a pharmaceutically acceptable ingredient. Typically, the pharmaceutically acceptable ingredient can be selected from the group consisting of diluent, sweetening agent, binder, preservative, pharmaceutically acceptable flavoring agent, pharmaceutically acceptable disintegrant, pharmaceutically acceptable coating material, and pharmaceutically acceptable film forming polymer.
The herbal composition of the present disclosure is devoid of any negative side effects and is non-toxic. Moreover, the composition also has good stability and is suitable for commercial production.
The present disclosure also envisages a process for producing the herbal composition. Initially, the plant parts are dried under suitable conditions to obtain dried plant parts. The dried plant parts are then separately powdered followed by sifting, individually, the powders of Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, and Myristica fragrans.
The powders of Mucuna pruriens, Tribulus terrestris and Myristica fragrans are then mixed thoroughly in a vessel to obtain a first mixture.
Typically, the decoction of Asparagus adscendens and Anacyclus pyrethrum are triturated to the first mixture, in pre-determined amounts, to obtain a final mixture. It is then dried in tray dryer at constant temperature. The final obtained powder is then filled into capsule.
Capsulation, in general, is done by loading the capsules in a loader. Then the final dried mixture is spread uniformly to fill the capsules, and the capsules are sealed.
The herbal composition, of the present disclosure, can be in a dosage form selected from the group consisting of capsules, pills, tablets, mouth dissolving tablet, chewable tablet, effervescent tablet, paste, powder, and syrup.
In an embodiment, the herbal composition is in the dosage form of a capsule. Typically, the herbal composition of the present disclosure can be in a form of sustained release capsule or controlled release capsule.
The herbal composition of the present disclosure exhibits spermatogenic properties. The synergistic effect of the herbal composition aids in increasing the sperm count in individuals taking the herbal composition of the present disclosure. A marked increase in the sperm count is observed in individuals taking the herbal composition of the present disclosure as compared to those individuals undertaking the individual ingredients. The herbal composition of the present can also be used, as a rejuvenator and as an immunomodulator. Typically, herbal composition of the present disclosure is administered in an amount in the range of 500 mg to 1500 mg per day for enhancing the sperm count in a male individual.
The present disclosure is further described in light of the following laboratory scale 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/commercial scale.
Experimental Details
Experiment-1
The herbal composition in the form of a capsule (HPMC- Hydroxyproply methyl cellulose or hard gelatin) was prepared by using the following ingredients as given in Table-1. Powders of Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum, and Myristica fragrans were commercially purchased from the local market.
Table-1
S. No. Ingredients Plant part used Sample 1 Sample 2 Sample 3 Sample 4 Sample 5
Weight (mg)
1 Mucuna pruriens Seed 220 230 225 240 210
2 Tribulus terrestris Fruit 140 120 120 130 140
3 Asparagus adscendens Root 45 60 55 50 60
4 Anacyclus pyrethrum Root 50 60 60 50 60
5 Myristica fragrans Aril 45 30 40 30 30
Total (mg) 500 500 500 500 500

The effectiveness of the herbal composition in increasing the sperm count in individuals presented with oligospermia was demonstrated by the following study.
Healthy males between the ages of 25 to 35 years presented with oligospermia, i.e., having low sperm count (less than 15 million sperm/ml) were included in the study. Most of the candidates had a sperm count in the range of 1 million sperm/ml to 14 million sperm/ml. All the candidates were screened for ailments, such as HIV, active tuberculosis, diabetes, hypertension, Klinefelter syndrome, hydrocele, varicocele, mumps, rheumatoid fever, and sexually transmitted diseases (STDs); and candidates suffering from these ailments were excluded from the study. The study was carried out in 2 stages. In the first stage, 40 candidates were selected for the study and were randomly divided into 2 groups (Group-I and Group-II) containing 20 individuals each. Group-I and Group-II both exhibited a uniform bell curve for the reduced sperm count. The candidates taking part in the study had not taken any medication for oligospermia. All the candidates were told to avoid masturbation for the duration of the study. All the candidates were instructed to take 2 capsules of same color (yellow) daily. The candidates were instructed to take the capsules on an empty stomach, 15 minutes prior to the morning meal. The candidates were advised to take the capsules provided to them every day for 90 days and keep a record of the same. The sperm count was determined on the 0 day (1st day of the study), and thereafter the sperm count was periodically determined every month (after 30 days). The yellow colored capsule of given to Group-I candidates contained the composition (500 mg in each capsule) of the present disclosure. Group-II was the control group and was divided into 4 sub-groups of 5 candidates each. The detail of the composition given to Group-II candidates is summarized in Table-1. Each capsule contained 500 mg of the composition described in Table-1.
Table-1
Group-II Composition
II-A Placebo (sugar/glucose pills)
II-B Gokhru powder (Tribulus terrestris)
II-C Kapikachhu powder (Mucuna pruriens)
II-D Shweta musli powder (Asparagus adscendens)

The initial sperm count and the sperm count (million/ml), up to 90 days for all the candidates were recorded and are provided in Table-2.
Table-2
Candidate detail Initial sperm count Sperm count After 30 days Sperm count After 60 days Sperm count After 90 days
Group-I
I-1 10 x 106 22 x 106 29 x 106 36 x 106
I-2 7 x 106 18 x 106 27 x 106 31 x 106
I-3 11 x 106 17 x 106 29 x 106 34 x 106
I-4 8 x 106 15 x 106 28 x 106 31 x 106
I-5 12 x 106 22 x 106 28 x 106 33 x 106
I-6 5 x 106 16 x 106 26 x 106 32 x 106
I-7 9 x 106 15 x 106 28 x 106 34 x 106
I-8 2 x 106 16 x 106 28 x 106 30 x 106
I-9 13 x 106 25 x 106 Not available* Not available*
I-10 7 x 106 19 x 106 24 x 106 33 x 106
I-11 5 x 106 18 x 106 23 x 106 32 x 106
I-12 5 x 106 16 x 106 24 x 106 30 x 106
I-13 8 x 106 23 x 106 28 x 106 36 x 106
I-14 12 x 106 19 x 106 26 x 106 38 x 106
I-15 3 x 106 9 x 106 28 x 106 30 x 106
I-16 14 x 106 20 x 106 31 x 106 40 x 106
I-17 4 x 106 10 x 106 22 x 106 32 x 106
I-18 1 x 106 11 x 106 19 x 106 33 x 106
I-19 11 x 106 23 x 106 29 x 106 35 x 106
I-20 2 x 106 18 x 106 26 x 106 34 x 106
Group-II
II-A-1 2 x 106 2 x 106 2 x 106 2 x 106
II-A-2 13 x 106 13 x 106 13 x 106 11 x 106
II-A-3 11 x 106 11 x 106 11 x 106 11 x 106
II-A-4 7 x 106 7 x 106 6 x 106 6 x 106
II-A-5 7 x 106 7 x 106 7 x 106 7 x 106
II-B-1 9 x 106 12 x 106 15 x 106 16 x 106
II-B-2 12 x 106 15 x 106 18 x 106 20 x 106
II-B-3 8 x 106 9 x 106 11 x 106 19 x 106
II-B-4 13 x 106 15x 106 18 x 106 22 x 106
II-B-5 10 x 106 12 x 106 16 x 106 18 x 106
II-C-1 5 x 106 9 x 106 Not available* Not available*
II-C-2 4 x 106 9 x 106 Not available* Not available*
II-C-3 13 x 106 17 x 106 20 x 106 21 x 106
II-C-4 8 x 106 11 x 106 15 x 106 19 x 106
II-C-5 5 x 106 9 x 106 12 x 106 17 x 106
II-D-1 6 x 106 7 x 106 12 x 106 18 x 106
II-D-2 9 x 106 9 x 106 12 x 106 19 x 106
II-D-3 12 x 106 13 x 106 Not available# Not available#
II-D-4 7 x 106 11 x 106 15 x 106 21 x 106
II-D-5 4 x 106 7 x 106 13 x 106 19 x 106
*the candidate dropped out after 1 month, and further data is not available. #during the study, the candidate developed viral fever and therefore the study was terminated.
It is seen from Table-2 that there is a significant increase in the sperm count, when the composition of the present disclosure is taken by candidates presented with oligospermia. Further, the increased efficacy of the composition of the present disclosure proves that the ingredients, namely, Mucuna pruriens, Tribulus terrestris, Asparagus adscendens, Anacyclus pyrethrum and Myristica fragrans, exert a synergistic action. This is evident from the increased efficacy of the composition of the present disclosure as compared to the effect shown by the single ingredients in the control group.
Along with the increased sperm count, the candidates in Group-I reported improved vitality, improved sleep, less anxiety, more energy, less routine fatigue. Also, 3 sexually active candidates in Group-I reported better sexual performance and improvement in pre-mature ejaculation. None of the candidates reported any negative side effects.
After the completion of 3 months, the treatment was stopped for all the candidates, and the sperm count for all the candidates was monitored and the result obtained is summarized in Table-3.

Table-3
Candidate detail Sperm count after 90 days of taking the treatment Sperm count after 30 days after stopping the treatment Sperm count after 60 days after stopping the treatment
I-1 36 x 106 35 x 106 33 x 106
I-2 31 x 106 29 x 106 28 x 106
I-3 34 x 106 31 x 106 30 x 106
I-4 31 x 106 28 x 106 26 x 106
I-5 33 x 106 29 x 106 28 x 106
I-6 32 x 106 34 x 106 37 x 106
I-7 34 x 106 31 x 106 29 x 106
I-8 30 x 106 29 x 106 28 x 106
I-9 Not available* Not available* Not available*
I-10 33 x 106 29 x 106 25 x 106
I-11 32 x 106 30 x 106 29 x 106
I-12 30 x 106 27 x 106 26 x 106
I-13 36 x 106 36 x 106 36 x 106
I-14 38 x 106 35 x 106 31 x 106
I-15 30 x 106 29 x 106 28 x 106
I-16 40 x 106 40 x 106 40 x 106
I-17 32 x 106 31 x 106 29 x 106
I-18 33 x 106 32 x 106 29 x 106
I-19 35 x 106 34 x 106 30 x 106
I-20 34 x 106 31 x 106 29 x 106
Group-II
II-A-1 2 x 106 0.9 x 106 0.1 x 106
II-A-2 11 x 106 0.7 x 106 0.2 x 106
II-A-3 11 x 106 0.9 x 106 0.2 x 106
II-A-4 6 x 106 0.3 x 106 0.05 x 106
II-A-5 7 x 106 0.8 x 106 0.1 x 106
II-B-1 16 x 106 1 x 106 0.9 x 106
II-B-2 20 x 106 13 x 106 0.9 x 106
II-B-3 19 x 106 15 x 106 2.2 x 106
II-B-4 22 x 106 18 x 106 7 x 106
II-B-5 18 x 106 9 x 106 3 x 106
II-C-1 Not available* Not available* Not available*
II-C-2 Not available* Not available* Not available*
II-C-3 21 x 106 9 x 106 1 x 106
II-C-4 19 x 106 11 x 106 3 x 106
II-C-5 17 x 106 4 x 106 1 x 106
II-D-1 18 x 106 11 x 106 9 x 106
II-D-2 19 x 106 15 x 106 4 x 106
II-D-3 Not available# Not available# Not available#
II-D-4 21 x 106 15 x 106 3 x 106
II-D-5 19 x 106 8 x 106 4 x 106

It is seen from Table-3 that there is only a marginal decrease in sperm count for candidates (Group-I) who had taken the composition of the present disclosure, whereas there was a significant decrease in the sperm count for candidates of Group-II. It is also seen that there was no decrease in the sperm count in 2 candidates (I-13, I-16), and surprisingly an increase in sperm count was observed in one candidate (I-6).
5 candidates from Group-I volunteered to take the medication after the completion of the above study. After 30 days, all the 5 candidates reported an increase in the sperm count.
It is evident from the above studies that the composition of the present disclosure is effective in increasing the sperm count in an individual suffering from oligospermia, without any negative side effects. The ingredients of the composition of the present disclosure act synergistically to increase the sperm count.
TECHNICAL ADVANCEMENTS
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of an herbal composition that is capable of increasing sperm count, without triggering and negative side effect.
The embodiments as described herein above, and various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the description.
The foregoing description of specific embodiments so fully reveal the general nature of the embodiments herein, that others can, by applying current knowledge, readily modify and/or adapt for various applications of such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. 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 embodiments as described herein. Further, 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.
Having described and illustrated the principles of the present disclosure with reference to the described embodiments, it will be recognized that the described embodiments can be modified in arrangement and detail without departing from the scope of such principles.
While considerable emphasis has been placed herein on the particular features of this disclosure, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other modifications in the nature of the disclosure or the preferred embodiments 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. An herbal composition comprising:
- Mucuna pruriens;
- Tribulus terrestris;
- Asparagus adscendens;
- Anacyclus pyrethrum; and
- Myristica fragrans.

2. An herbal composition comprising:
- powder of Mucuna pruriens in an amount in the range of 42 to 48 % with respect to the total weight of the composition;
- powder of Tribulus terrestris in an amount in the range of 20 to 28 % with respect to the total weight of the composition;
- powder of Asparagus adscendens in an amount in the range of 8 to 16 % with respect to the total weight of the composition;
- powder of Anacyclus pyrethrum in an amount in the range of 8 to 16 % with respect to the total weight of the composition; and
- powder of Myristica fragrans in an amount in the range of 3 to 9 % with respect to the total weight of the composition.

3. The composition as claimed in claim 1 or claim 2, wherein the particle size of said powder is in the range of 180 µ to 250 µ.

4. The composition as claimed in claim 1 or claim 2 is in the form selected from the group consisting of capsules, pills, tablets, mouth dissolving tablet, chewable tablet, effervescent tablet, paste, powder, and syrup.

5. The composition as claimed in 4, wherein said composition is in the form of a capsule.

6. The composition as claimed in claim 1 or claim 2 administered in an amount in the range of 500 mg to 1500 mg per day for enhancing the sperm count in a male individual.