Title of Invention

HERBAL COMPOSITION FOR TREATMENT OF OLIGOSPERMIA AND TO INCREASE SPERMMOTILITY

Abstract

ABSTRACT The invention relates to the mixture of seven herbal alcoholic extracts and three herbal fine powder to treat Oligospermia and related disorders. The extracts and powders were mixed in different ratio to make different compositions of 500 mg in each capsules. The composition containing alcoholic extracts of Withania somnifera (75 mg), Pueraria tuborusa (40 mg), Asparagus racemosus (50 mg), Mucuna pruriens (160 mg), Tribulus terrestris (30 mg) and Trychospermum ammi (30 mg), Chlorophytum arundinaceum (50 mg), and three directly fine powdered herbs, Shelajit (30 mg), Crocus sativus (10 mg), Myristica fragrans (25 mg), when orally feeded to rats in a calculated doses (16.67 mg) showed promising activity without side effects. The same composition on human volunteers (500 mg in capsule, 2 capsules/day) was found to increase the sperm count and motility, while reduces the percentage of abnormal sperms. 16

Full Text

FORM 2 THE PATENT ACT 1970 (39 OF 1970) & THE PATENTS RULES, 2003 PROVISIONAL/COMPLETE SPECIFICATION (See section 10 and rule 13) 1. TITLE OF THE INVENTION Herbal Composition and their use for Oligospermia and to increase sperm motility 2. APPLICANT(S) Name Nationality Address Sharad Pawar College of Pharmacy Wanadongri, Hingna Road, Nagpur-441 110(Maharshtra) 1. PREAMBLE TO HE DESCRIPTION PROVISIONAL COMPLETE The following specification describes the The following specification particularly invention, describes the invention and the manner in which it is to be performed. 2. DESCRIPTION (Description shall start from next page.) 3. CLAIMS (not applicable for provisional specification. Claims should start with the preamble-"I/we claim" on separate page) 4. DATE AND SIGNATURE (to be given at the end of last page of specification) 5. ABSTRACT OF THE INVENTION (to be given along with complete specification on separate page) Note.- * Repeat boxes in case of more than one entry. * To be signed by the applicants(s) or by authorised registered patent agent. * Name of the applicant should be given in full, family name in the beginning. * Complete address of the applicant should be given stating the postal index no./ code, state and country. * Strike out the column which is/are not applicable. 1 Description Field of the Invention The invention relates to the herbal compositions containing seven herbal alcoholic extracts and three directly fine powders of herbs and use of such compositions in the patients suffering from Oligospermia, lowered sperm density, diminished motility, impaired sperm forward progressions. Background of the Invention Oligospermia, lowered sperm density often is idiopathic but may be associated with decreased spermatogenesis as seen with varicoceles. A sperm density of less than 20 million/mi makes fertility statistically less likely in human. Diminished motility impaired sperm forward progressions are the most common of the isolated abnormal seminal parameters and the earliest abnormality seen with varicoceles. There is a need for herbal compositions, i.e., a natural, holistic edible composition that will serve to treat Oligospermia and increases sperm motility. Withania somnifera, Ashwagandha Withania somnifera also known as Ashwagandha, Indian ginseng or white cherry has been an important herb in the Ayurvedic and indigenous medicinal systems for over 300 Years. Historically, the plant has been used as an aphrodisiac, liver tonic, anti inflammatory agent, astringent, and more recently to treat bronchitis, asthma, ulcers, emaciation, insomnia and senile dementia. Ashwagandha is also used therapeutically as an adoptogen for patients with nervous exhaustion, insomnia and debility due to stress, and an immune stimulant to the patients with low white blood cell counts. ( Altern. Med. Rev. 2004, Jun., 9(2): 211-214). Decoction of root and methanolic extracts of Withania somnifera have been reported to cure sexual weakness and as an aphrodisiac activity. Withania somnifera is useful in arousing sexual desire ( Billore K.V. and Bhatt G.K., Sachitra Ayurved, 1978, 30 (12): 960-966). Dose: 3-6 Mashas, 3-6 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 393). Asparagus racemosus, Shatavari It is known as the Indian Female Rejuvenative, Shatavari is helpful for low sex drive, menopause, Post menopausal syndrome, and infertility. It is an herb that is commonly used in the Ayurvedic medicine. One of the well-known major therapeutic potentials of Asparagus racemosus ( Shatavari) is its effect on female reproductive system. It is also used as a general tonic, and as an aphrodisiac. Antioxytocic action of saponin isolated from Asparagus racemosus Wild ( Shatavari) on uterine muscle is confirmed.( Arch Int Pharmmacodyn. Ther. 1969 May, 179(l):121-9.) 2 Dose: 2 Tola, 24 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 392). Crocus sativus, Saffron Crocus sativus has hot and dry qualities, stimulant or inebriant depending on dosage, sun dried filaments ingested strengthen the uterus and treats menstrual problems, stimulates sexual desires for women. Essential oil evokes long, distinctive orgasms. In high doses saffron oil is abortive and toxic. (J. Clin. Physiol. 1979, Jan, 35(1): 212-7). Dose: 2-4 Ratti, 0.26-0.52 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 235). Mucuna pruriens, Kaunch Beej It is a good aphrodisiac and also a nervine tonic. It is used in the treatment of the spermatorrhea diseases of the genitourinary system. (J. Econ. Taxon. Bot, 1992,16(2): 383-390) (J. Econ. Taxon. Bot., 1991,15(3): 677-682) Dose: 2-6 Mashas, 2-6 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 357). Myristica fragrans, Nutmeg Nutmeg is reported to be an expectorant ,vermifuge,aphrodisiac, and as a nervine used by psychiatrists.it is used in tonic and electuaries and is recommened for the treatment of inflammations of bladder and urinary tract. In order to explore the sexual function improving effect of Myristica fragrans (nutmeg) and Syzygium aromaticum (clove) an experiment study was conducted in normal male mice. The extracts (50% ethanolic) of the nutmeg and clove were found to stimulate the mounting behaviour of male mice, and also to significantly increase their mating performance. The drugs were devoid of any conspicuous general short term toxicity. Dose: 2-8 Ratti, 0.260-1.04 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 216). Tribulus terrestris, Gokhru Apart from its claims for improvement of sexual function in men, the puncturevine plant {Tribulus terrestris:TT) has long been considered as an energizer and vitalizer in the indigenous system of medicine. (J. Altern. Complement. Med., 2003, April 9(2): 257-65) Tribulus terrestris (TT) has long been used in the traditional Chinese and Indian systems of medicine for the treatment of various aliment and is popularly claimed to improve sexual functions in man. TT extract appears to possess aphrodisiac activity probably due to androgen increasing property of TT.( Life Sci. 2002 Aug 9:71 (12),1385-98.) 10 3 Dose: 3-6 Mashas, 3-6 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 293). Pueraria tuborusa, Vidarikand It has a good aphrodisiac. Dose: '/4 - '/2 Tola, 6-12 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 388). Trychospermum ammi, Ajowan It helps in increasing the sexual desire and acts as a rejuvenator. Dose: 3-6 Mashas, 3-6 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 26). Styrax officinale, Shelajit It is used as a good aphrodisiac and act as a rejuvenator. Dose: 50 mg (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 612). Chlorophytum arundinaceum, Safed musali It is used as a good aphrodisiac and act as a rejuvenator. Dose: '/2 -1 Tola, 6-12 g (Chunekar, K.C., and Pandey, G.S., Bhavaprakasa Nighantu, Chaukhamba Bharati Academy, Varanasi, 2003, 391). Object of the Invention. The object of the invention to provide such herbal composition to the patient who are suffering from Oligospermia and decreased sperm motility, without any undesirable side effects. Details of the Invention Herbal raw materials used for the invention are Withania somnifera, Styrax officinale, Crocus sativus, Pueraria tuborusa, Asparagus racemosus, Mucuna pruriens, Tribulus terrestris, Chlorophytum arundinaceum and Myristica fragrans. The materials were identified with the help of Department of Botany, Rashtrasant Tukdoji Maharaj, Nagpur University, Nagpur and were used for the extraction. Except Styrax officinale, Crocus sativus and Myristica fragrans, all the herbs were defatted with petroleum ether (60-80) to remove primary metabolites, fats and oil fractions. After extraction with petroleum ether, the materials were dried at room temperature to remove the traces of petroleum ether. Again the defatted materials were extracted with alcohol (ethanol) using Soxhlet apparatus. After extraction, the liquid extracts were distilled on water bath to remove the solvent (ethanol). The semisolid extracts of Withania somnifera, Asparagus racemosus, Pueraria tuborusa, Mucuna pruriens, Trychospermum ammi, Chlorophytum arundinaceum, Tribulus terrestris were kept in separate container to check their purity. Phytochemical screening and thin layer chromatography was performed and to identify secondary metabolites. Crocus sativus, Styrax officinale and Myristica fragrans were grinded to form a fine powder. Using doses of each extract and fine powder as mentioned in Bhavaprakasa Nighantu, above extracts and fine powders were mixed in different ratio to form different compositions, which were then filled in gelatin capsule. 11 4 The doses mentioned in Bhavaprakasa Nighantu for each extract and fine powder are higher in comparison with the compositions. Since our composition are combination of extract and fine powder of similar activity, that reduces the doses of each extract or fine powder to obtain desirable effect in the reduced dosage. COMPOSITION- I Each capsules (500 mg) contains Sr. No. Contents Dose 1 Withania somnifera 75 mg 2 Styrax officinale 30 mg 3 Crocus sativus 10 mg 4 Pueraria tuborusa 40 mg 5 Asparagus racemosus 50 mg 6 Mucuna pruriens 160 mg 7 Tribulus terrestris 30 mg 8 Trychospermum ammi 30 mg 9 Chlorophytum arundinaceum 50 mg 10 Myristica fragrans 25 mg COMPOSITION IIEach capsules (500 mg) contains Sr. No. Contents Dose 1 Withania somnifera HOmg 2 Styrax officinale 30 mg 3 Crocus sativus 10 mg 4 Pueraria tuborusa 50 mg 5 Asparagus racemosus 75 mg 6 Mucuna pruriens 120 mg 7 Tribulus terrestris 20 mg 8 Trychospermum ammi 20 mg 9 Chlorophytum arundinaceum 40 mg 10 Myristica fragrans 25 mg COMPOSITION IIIEach capsules (500 mg) contains Sr. No. Contents Dose 1 Withania somnifera 120 mg 2 Pueraria tuborusa 60 mg 3 Asparagus racemosus 60 mg 4 Mucuna pruriens 175 mg 5 Tribulus terrestris 60 mg 6 Myristica fragrans 25 mg 12 5 COMPOSITION IV Each capsules (500 mg) contains Sr.No. Contents Dose 1 Withania somnifera 150 mg 2 Styrax officinale 25 mg 3 Crocus sativus 5mg 4 Pueraria tuborusa 70 mg 5 Asparagus racemosus 100 mg 6 Trychospermum ammi 50 mg 7 Chlorophytum arundinaceum lOOmg COMPOSITION V Each capsules (500 mg) contains Sr. No. Contents Dose 1 Withania somnifera 150 mg 2 Asparagus racemosus 50 mg 3 Mucuna pruriens 150 mg 4 Tribulus terrestris 50 mg 5 Trychospermum ammi 25 mg 6 Myristica fragrans 75 mg PHARMACOLOGICAL EVALUATION Sexual behavior study was done according to the method of Daniel Bitran. The following guidelines were followed in the experiment- (a) Males were kept individually but females were kept in groups. (b) Training of each male for 15 min. at a time, was done till they elicited sexual behaviour. Once the behaviour was noticed, males were exposed to receptive females. (c) Repeated training was given to overcome the lack of sexual response in the presence of observers. (d) The experiment was conducted in a dark and silent room. (e) Any jerking movements of the mating arena was avoided. (f) Sufficient space for animals in the mating arena was provided to enable them to chase each other. (g) Cleaning of the mating arena was done after each trial, since the urine trails left by one rat may have marked effects on the behaviour of his successor. Selection of the male rats Normal adult males of 90 days age were given training for sexual experience. Males were trained individually with normal adult females in estrous in a transparent arena. Only such males who attempted to mount any female were introduced into the cage were used for subsequent experiments. To provide sexual experience, each male rat was allowed 30 minutes exposure to a stimulus female 13 6 in behavioural estrous, several days before testing for copulatory performance. The animals were tested three times over 10 day period for copulatory behaviour and divided into three groups demonstrating comparable copulatory performance. Each group consist of six animals. The first group consists of composition I treated sexually active animals, while the second group consists of composition I treated sexually inactive animals and the third group was kept as control. Selection of the female rats Adult female rats of 90 days age were ovariectomised. They were allowed to recover from the effect of operation for 10 days. These ovariectomised females were divided into three groups. They were housed in a temperature controlled room (22±2°C) Ovariectomisation and confirmation of estrous were carried out according to standard procedure After overiectomisation, the animals were in diestrous stage. To bring them to estrous, they were given 2 µg/kg of estrogen 48 hr. before and 500 µg/kg of progesterone 6 hr. before copulatory test. Evaluation of the efficacy of compositions From 2 weeks prior to the screening tests until the end of the study, the rats were housed individually at 22°C under reversed light and dark cycle (with, light from 11.00 pm to 11 am). Food and water were given ad libitum. The composition was made into a suspension with water and administered to male rats orally in the dose of 16.67 mg/kg daily (calculated as per their body weight). Control group received water and food ad libitum. Female ovariectomised rats were given 2 mcg/kg estrogen 48 hr. before the experiment; 500 µg/kg progesterone was also given 6 hr. before the starting of the experiment. Six hours after administration of progesterone, the ovariectomised female rats were observed for estrous stage by observing the vaginal smear of the rat. The female rats which were in estrous stage were employed for the study. The highly receptive female was introduced into male's cage and each male rat was observed for 30 minutes for copulatory behaviour under dim red light. Similar procedure was followed for all groups. The following parameters were recorded (a) Mount frequency: Number of mounts in a series, or number of mounts in a given period of time (30 min). (b) Intromission frequency: Number of intromissions observed in 30 min. (c) Ejaculation frequency: Number of ejaculations in 30 min. (d) Mount latency: Time taken for the first mount from the introduction of the female into male's cage (e) Intromission latency: Time taken for first intromission from the introduction of female into male's cage, (f) weight was recorded on 0, 7th, 14th, 21st and 28th days. 14 7 Mounting Frequency Table A: Effect of composition I on mounting frequency in male albino rats. Group 0Day 7th Day 14th Day 21st Day 28"' Day 1. 4.33+1.10 8.33±1.79 11.6711.89 22.0012.77 28.00+3.92 2. 1.83+0.69 3.33+0.94 6.83+1.21 13.50+2.75 23.0012.83 3. 4.17+1.07 4.3310.74 4.5010.76 5.1711.07 6.0010.81 Values are the mean ± SD, n = 6 in each group. Mounting Latency Table B: Effect of composition I on mounting latency in male albino rats. Group 0Day 7th day 14"1 Day 21st Day 28th Day 1. 315.00118.45 260.00121.14 205.00+22.30 114.67115.69 73.67117.84 2. 493.1717.42 440.50114.30 336.67111.70 278.6719.48 141.8314.34 3. 306.00113.86 302.17+12.59 299.33113.68 294.33113.67 285.33114.84 Values are the mean ± SD, n = 6 in each group. Intromission Frequency Table C: Effect of composition I on intromission frequency in male albino rats. Group 0Day 7mDay 14th Day 21st Day 28th day 1. 0 1.1710.37 3.00+1.00 6.0011.15 6.33+1.37 2. 0 0 1.3310.47 3.0010.82 5.83+1.67 3. 0 0 0 0 0 Values are the mean ± SD, n = 6 in each group. Intromission Latency Table D: Effect of composition I on intromission latency in male albino rats. Group 0Day 7th Day 14th day 21st Day 28th day 1. 0 504.33136.77 440.00129.27 338.00128.37 245.67+28.28 2. 0 0 592.83113.69 496.00+5.03 336.67111.92 3. 0 0 0 0 0 Values are the mean ± SD, n = 6 in each group. Ejaculation Frequency Table E: Effect of composition I on ejaculation frequency in male albino rats. Group 0Day T Day 14th day 21st Day 28th day 1. 0 0 0.6710.47 0.8310.15 1.00+0.00 2. 0 0 0.6710.47 0.83+0.15 1.0010.00 3. 0 0 0 0 0 Values are the mean ± SD, n = 6 in each group. 8 15 Change in Weight Table F: Effect of composition I on change in weight in male albino rats. Group 0Day 7th Day 14th day 21* Day 28th day 1. 283.33136.02 288.67+35.67 294.17+35.26 304.17+20.04 306.00+26.97 2. 300.00+42.52 304.83+43.13 310.50+45.57 315.50+32.69 320.33+43.70 3. 296.67±14.04 298.67+14.30 300.00+14.24 302.00+14.61 303.66+14.77 Values are the mean ± SD, n = 6 in each group. There was significant increase in the mounting frequency while decrease in mounting latency on the 21st day in the composition I treated active and inactive animals. Comparison of 28th day observations with 0 day revealed that control group did not show any change in response. Considerable increase in the intromission frequency and decrease in intromission latency in the 21st day and 28th day in composition I treated animals (sexually active and inactive). Ejaculation frequency also increased remarkably on the 21st day and 28th day in case of both sexually active and inactive animals receiving composition I. Weights of animals receiving composition I increased significantly in the case of sexually active and inactive animals. Similar experiments were conducted for all the remaining compositions, it was observed that the composition I had promising activity. Photo 1. T.S. of rat testes of control group After experimentation although they had gained some weight but were more active as compared to control. In histopathology of their testes it was observed that sperm count and semen layers were increased in their seminal vesicles (Photo 1, 2 & 3), it was also observed that the composition had no adverse effect on liver (Photo 4 & 5). 16 On the basis of animals studies, human trials was performed on five groups containing six persons in each group suffering from Oligospermia and related disorders. Pre analysis of their semen and physical fitness was done. Groups were made on the basis of sperm count, motility of sperm and abnormal sperm morphology. Group I with sperm count varying below the 20 millions/ml with normal sperm motility and normal sperm morphology. Group II is similar to group I but with sperm count varying between 20-60 millions/ml. In Group III motility of sperm varying below 70% with normal sperm count and normal sperm morphology, while Group IV is similar to group III but with sperm count varying below the 60 millions/ml with below 70% motility of sperm and abnormal sperm morphology. Group V with abnormal morphology of sperm with normal sperm count and normal motility of sperm. After a dose of 2 capsules/day for 28 days of composition I again semen analysis were performed and results were noted. Table 1, Table 2, Table 3, Table 4 and Table 5, showed the result of human trials of Group I, Group II, Group III, Group IV and Group V respectively. Table 1 and Table 2 showed there were significant increase in sperm count and crosses the normal level of sperm count (60 millions/ml) within 28 days. Table 3 shows there were significant increase in the motility of sperm crosses the normal level of motility of sperm (more than 70%). Table 4 shows significant reduction in the abnormality of sperm. Table 5 comprising of all the problems mentioned in other tables. There was significant increase in sperm count above the normal level, increase in motility of sperm above the normal level and reduction in abnormality of sperm with 28 days treatment. 19 9 Table 1 : Sperm count varying below the 20 millions/ml with normal sperm motility of sperm and normal sperm morphology. Group I Age in Years Days Semen Analysis Volume (ml) Reaction (PH) Viscosity Motility (%) Sperm Count Morphology Other cells A 24 0 2.0 7.5 Decreased 75 98000 Normal OL 14 2.5 7.5 Normal 80 35 million/ml Normal OL 28 3.0 7.5 Normal 80 65 million/ml Normal OL B 20 0 2.5 7.5 Decreased 80 5 million/ml Normal OL 14 2.5 7.5 Normal 85 32 million/ml Normal OL 28 2.5 7.5 Normal 90 71 million/ml Normal OL C 25 0 3.0 7.5 Normal 65 5 million/ml Normal OL 14 2.5 7.5 Normal 75 40 million/ml Normal OL 28 2.5 7.5 Normal 50 75 million/ml Normal OL D 24 0 1.5 7.5 Normal 50 1 million/ml Normal OL 14 2.0 7.5 Normal 75 36 million/ml Normal OL 28 2.0 7.5 Normal 85 61 million/ml Normal OL E 26 0 2.0 7.5 Normal 45 1 million/ml Normal OL 14 2.5 7.5 Normal 70 35 million/ml Normal OL 28 2.0 7.5 Normal 75 65 million/ml Normal OL F 27 0 2.0 7.5 Normal 60 2 million/ml Normal OL 14 2.5 7.5 Normal 75 25 million/ml Normal OL 28 2.5 7.5 Normal 75 61 million/ml Normal OL 20 10 Table 2 : Sperm count varying between 20-60 millions/ml with normal sperm motility of sperm and normal sperm morphology. Group II Age in Years Days Semen Analysis Volume (ml) Reaction (pH) Viscosity Motility (%) Sperm Count (million/ml) Morphology Other cells A 48 0 2.0 7.5 Decreased 75 20 Normal OL 14 1.5 7.5 Normal 90 55 Normal OL 28 1.5 7.5 Normal 90 75 Normal OL B 24 0 1.5 7.5 Normal 65 25 Normal OL 14 2.0 7.5 Normal 85 75 Normal OL 28 2.5 7.5 Normal 90 80 Normal OL C 25 0 3.0 7.5 Normal 70 35 Normal OL 14 3.0 7.5 Normal 90 55 Normal OL 28 3.0 7.5 Normal 90 80 Normal OL D 26 0 2.5 7.5 Normal 60 40 Normal OL 14 2.0 7.5 Normal 90 90 Normal OL 28 2.0 7.5 Normal 90 90 Normal OL E 25 0 2.0 7.5 Normal 65 32 Normal OL 14 2.5 7.5 Normal 75 90 Normal OL 28 2.5 7.5 Normal 80 90 Normal OL F 27 0 3.0 7.5 Normal 80 33 Normal OL 14 2.5 7.5 Normal 85 55 Normal OL 28 2.5 7.5 Normal 80 80 Normal OL OL - Occasional leucocytes 21 11 Table 3 : Mobility of sperm varying below 70% with normal sperm count and normal sperm morphology. Group III Age in Years Days Semen Analysis Volume (ml) Reaction (pH) Viscosity Motility (%) Sperm Count (millions/ml) Morphology Other cells A 25 0 2.5 7.5 Normal 40 40 Normal OL 14 2.0 7.5 Normal 60 61 Normal OL 28 2.0 7.5 Normal 80 75 Normal OL B 25 0 2.5 7.5 Normal 30 61 Normal OL 14 3.0 7.5 Normal 50 65 Normal OL 28 2.5 7.5 Normal 90 75 Normal OL C 24 0 2.5 7.5 Normal 10 90 Normal OL 14 3.0 7.5 Normal 75 91 Normal OL 28 3.0 7.5 Normal 90 93 Normal OL D 24 0 2.0 7.5 Normal 10 85 Normal OL 14 2.5 7.5 Normal 65 87 Normal OL 28 2.5 7.5 Normal 85 90 Normal OL E 27 0 2.5 7.5 Normal 20 65 Normal OL 14 3.0 7.5 Normal 60 70 Normal OL 28 3.0 7.5 Normal 90 75 Normal OL F 26 0 2.0 7.5 Normal 10 60 Normal OL 14 2.5 7.5 Normal 75 61 Normal OL 28 2.5 7.5 Normal 90 64 Normal OL 22 12 Table 4: Sperm count varying below the 60 million/ml with below 70% motility of sperm and abnormal sperm morphology. GroupV Age in Years Days Semen Analysis Volume (ml) Reaction (pH) Viscosity Motility (%) Sperm Count Morphology (abnormal sperm%) Other cells A 25 0 3.0 7.5 Normal 10 98000/ml 16 4-6 LC 14 2.5 7.5 Normal 75 35 millions/ml 8 OL 28 2.5 7.5 Normal 90 65 millions/ml 4 OL B 25 0 2.5 7.5 Normal 40 20 millions/ml 20 OL 14 3.0 7.5 Normal 60 60 millions/ml 12 OL 28 3.0 7.5 Normal 90 75 millions/ml 7 OL C 26 0 3.5 7.5 Normal 40 25 millions/ml 25 7.8 14 3.0 7.5 Normal 65 55 millions/ml 15 OL 28 3.0 7.5 Normal 90 90 millions/ml 6 OL D 26 0 2.0 7.5 Normal 25 50000 /ml 16 OL 14 2.5 7.5 Normal 55 35 millions/ml 8 OL 28 2.5 7.5 Normal 70 70 millions/ml 4 OL E 24 0 3.5 7.5 Normal 10 1 millions/ml 17 5-6 LC 14 3.0 7.5 Normal 75 25 millions/ml 7 OL 28 2.5 7.5 Normal 90 75 millions/ml 6 OL F 26 0 2.0 7.5 Normal 40 15 millions/ml 22 OL 14 2.5 7.5 Normal 75 60 millions/ml 12 OL 28 3.0 7.5 Normal 80 90 millions/ml 6 OL OL - Occasional leucocytes, LC - Leucocyte 23 Table 5 : Abnormal morphology of sperm with normal sperm count and normal motility sperm. Group IV Age in Years Days Semen Analysis Volume (ml) Reaction (pH) Viscosity Motility (%) Sperm Count (millions /ml) Morphology (abnormal sperm%) Other cells A 31 0 3.0 7.5 Normal 70 90 20 OL 14 2.5 7.5 Normal 75 90 12 OL 28 2.5 7.5 Normal 80 90 4 OL B 30 0 2.0 7.5 Normal 90 61 16 OL 14 2.5 7.5 Normal 90 64 8 OL 28 2.5 7.5 Normal 90 65 4 OL C 30 0 3.0 7.5 Normal 60 70 25 OL 14 2.0 7.5 Normal 90 75 16 OL 28 2.5 7.5 Normal 90 80 5 OL D 30 0 1.5 7.5 Normal 75 80 16 OL 14 2.0 7.5 Normal 80 81 8 OL 28 2.5 7.5 Normal 90 84 4 OL E 32 0 2.5 7.5 Normal 65 70 20 OL 14 3.0 7.5 Normal 75 70 15 OL 28 3.0 7.5 Normal 90 70 8 OL F 31 0 3.5 7.5 Normal 65 90 21 OL 14 3.0 7.5 Normal 70 91 13 OL 28 3.5 7.5 Normal 75 92 3 OL OL - Occasional leucocytes 14 24 Claims 1. We claim, the herbal extract composition to treat oligospermia in mammals comprising 500 mg of a mixture in a hard gelatin capsule, of seven herb extract and three directly fine powdered material of plant. Among the different compositions, the composition I is useful in treatment of oligospermia, in a dose of 2 capsules/day for human. 2. We claim, the composition I as in claim 1 shows good aphrodisiac activity wherein the host is a human and non human animal (rats). 3. We claim, the composition I as in claim 1 increases the quantity of semen in a human. 4. We claim, there is increase in sperm count by using composition I as in claim 1 wherein the host is a human. 5. We claim, the composition I as in claim 1 reduces the abnormality of sperms wherein the host is a human. 6. We claim, the composition I as in claim 1 shows increase in motility of sperms wherein the host is a human. 7. We claim, by studying the morphology, healthy sperms are produced after treating with composition I as in claim 1 wherein the host is a human and non human animal (rats). 8. We claim, the composition I as in claim 1 shows increase in the weight wherein the host is a non human animal (rats). 9. We claim, the composition I as in claim 1 is nontoxic as observed in the transverse section of liver wherein the host is a non human animal (rats). 10. We claim, the dose of composition I as in claim 1 for claim 2, 7, 8 and 9 is 16.67 mg/day for non human animal (rats), orally. ABSTRACT The invention relates to the mixture of seven herbal alcoholic extracts and three herbal fine powder to treat Oligospermia and related disorders. The extracts and powders were mixed in different ratio to make different compositions of 500 mg in each capsules. The composition containing alcoholic extracts of Withania somnifera (75 mg), Pueraria tuborusa (40 mg), Asparagus racemosus (50 mg), Mucuna pruriens (160 mg), Tribulus terrestris (30 mg) and Trychospermum ammi (30 mg), Chlorophytum arundinaceum (50 mg), and three directly fine powdered herbs, Shelajit (30 mg), Crocus sativus (10 mg), Myristica fragrans (25 mg), when orally feeded to rats in a calculated doses (16.67 mg) showed promising activity without side effects. The same composition on human volunteers (500 mg in capsule, 2 capsules/day) was found to increase the sperm count and motility, while reduces the percentage of abnormal sperms. 16

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811-mum-2006-form 18(22-6-2006).pdf

811-MUM-2006-FORM 2(COMPLETE)-(26-5-2006).pdf

811-mum-2006-form 2(granted)-(26-5-2006).doc

811-mum-2006-form 2(granted)-(26-5-2006).pdf

811-MUM-2006-FORM 2(GRANTED)-(9-1-2009).pdf

811-MUM-2006-FORM 2(TITLE PAGE)-(26-5-2006).pdf

811-MUM-2006-FORM 2(TITLE PAGE)-(GRANTED)-(9-1-2009).pdf

811-mum-2006-form 3(26-5-2006).pdf

811-mum-2006-form 9(22-6-2006).pdf

811-mum-2006-form-1.pdf

811-mum-2006-form-2.doc

811-mum-2006-form-2.pdf

811-mum-2006-form-9.pdf

811-MUM-2006-SPECIFICATION(AMENDED)-(9-9-2008).pdf

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