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2 RESEARCH ARTICLE Impact Factor (2014) by International Scientific Indexing (ISI) UAE CLINICAL STUDY OF GHRITABHRUSHTADUGDHA SIDDHA MASHA (Phaseolus mungo Linn) IN OLIGOZOOSPERMIA Ramesh M. Bansode 1*, Vaibhav Biradar 2 1. Professor, Dept. of Sharirkriya, Govt. Ayurved College, Nanded (MS), Contact No , - rameshdrbansode@gmail.com 2. PG Scholar, Dept. of Sharirkriya, Govt. Ayurved College, Nanded (MS), Contact No Article Received on - 14 th Aug 2015 Article Revised on - 17 th Dec 2015 Article Accepted on - 31 st Dec 2015 All articles published in IJAAM are peer-reviewed and can be downloaded, printed and distributed freely for non commercial purpose (see copyright notice below). (Full Text Page IJAAM This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( which permits unrestricted non commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

3 RESEARCH ARTICLE CLINICAL STUDY OF GHRITABHRUSHTADUGDHA SIDDHA MASHA (Phaseolus mungo Linn) IN OLIGOZOOSPERMIA *Corresponding Author Ramesh M. Bansode Professor, Dept. of Sharirkriya, Govt. Ayurved College, Nanded, Contact No , QR Code IJAAM DIDS: ABSTRACT: Infertility is a problem of global proportions, affecting on an average 8-12% of couples worldwide. Low sperm count (Oligozoospermia) is one of the main causes of male infertility and it is correlated with KshinaShukra. The Ghritabhrushta Dugdha Siddha Masha are considered to act as an aphrodisiac; they used for sexual dysfunctions, and infertility. Hence, it was planned to study the effect of Ghritabhrushta Dugdha Siddha in the management of Kshina Shukra (Oligozoospermia), and to evade the preconception, a case control study was designed. In this study, eligible subjects between the age of 25 and 45 years, with a complaint of KshinaShukra (Oligozoospermia), were received Ghritabhrushta Dugdha Siddha Masha (Phaseolus mungo Linn) for 90 days. The primary outcome measures were percentage changes in the Pratyatmaka Lakshanas (cardinal symptoms) of Kshina Shukra, Agni bala, Dehabala, Satvabala, the semenogram, and in the Quality of the Sexual Health Questionnaire. The Ghritabhrushta Dugdha Siddha Masha (Phaseolus mungo Linn) showed 93.34% improvement in Rogibala (Agni bala, Dehabala, Satvabala, and the Quality of Sexual Health) and Rogabala (Semen Analysis and Pratyatmaka Lakshanas).The Ghritabhrushta Dugdha Siddha Masha (Phaseolus mungo Linn) has shown superior results in the management of Kshina Shukra. Key Words: Ghritabhrushta Dugdha Siddha Masha, Kshina Shukra, Oligozoospermia. INTRODUCTION Infertility is a problem of global proportions, affecting on an average 8-12% of couples worldwide [1]. Based on the National Women's Health Information Center (NWHIC), the annual incidence of male infertility is at least two million cases. Recent studies have indicated that the prevalence of Oligozoospermia is extremely high in the metropolis as well as in the smaller towns of India [2]. Infertility is defined as the inability to achieve pregnancy after one year of unprotected coitus [3]. Male infertility is considerably to be less complicated than female infertility, but can account for 30-40% of infertility [4]. Except for some physical defects, low sperm count (Oligozoospermia) and poor sperm quality are responsible for male infertility in more than 90% of the cases. Out of these, in about 30 to 40% the causes is unexplained, and in the rest of the cases critical illness, malnutrition, genetic abnormalities, pollution, side effects of some medicines, hormones, and chemicals play a major role [5]. More than 190 studies on Vajikarana (Aphrodisiac therapy) [6] have been carried out in various Ayurvedic Academic Institutes in India, at the PG and PhD level, wherein, researchers have considered various aspects of the problem, like its etiology, pathogenesis, and complications of the diseases related to the reproductive system, in both Ayurvedic and Modern parlance. Out of 190 studies more than 50 studies have been carried out on Oligozoospermia. The term Oligozoospermia is correlated in the research studies with Kshina Shukra (23 studies); Alpa Shukra (1 study); Shukra Dosha (3 studies); Shukra Dushti (13 studies); Shukra Kshaya (11 studies); Shukralpata (3 studies); Kshina Retas (1 study); Bijopaghata (1 study), and Shukradhatu Vikara (3 studies). Acharya Susruta has included Kshina Shukra under Shukra Dushti. Here, Vatadosha along with Pitta undergo vitiation and create a disturbance in the normal qualities and quantity of the Shukra Dhatu [7]. Oligozoospermia is a seminal disorder in which the sperm count is below 20 million/ml [8]. However, it is evident that several studies were conducted on this subject, but only few studies have been carried out to recognize the clinical efficacy of single herbs, in this subject. Ghritabhrushta Dugdha Siddha Masha (Phaseolus mungo Linn) is mentioned as a Vrishya (Aphrodisiac) [9] and also used to treat the malady Kshina Shukra. Page303

4 AIM The aim of this study is to find out the effect of Ghritabhrushta Dugdha Siddha Masha (Phaseolus mungo Linn) in the management of Kshina Shukra (Oligozoospermia). Godugdha. Heat was given till volume of water (150 ml) evaporates. 20 gm Sharkara (sugar) was mixed in remaining part of preparation, which was approximately 150 ml. The trial was carried out with following guidelines. Materials and Methods The methodology used for this study is explained as per the Consolidated Standards of Reporting Trials (CONSORT) Statement, 2010 [10]. A total of 52 patients with KshinaShukra were selected from the Outpatient Department of Govt. Ayurved College, Nanded. The study was approved by Institutional Ethics Committee (IEC- 3/4481/10). Out of them, 30 patients completed the treatment and taking into consideration the inclusion and exclusion criteria. Inclusion criteria Age group between 25 to 45 years Sperm count < 20 million/ml Patients presenting with Pratyatmaka Lakshana (Cardinal Symptoms) of Kshina Shukra, with semen samples suggestive of Oligozoospermia, were selected. Exclusion criteria Age below 25 or above 45 years Sperm count > 20 million/ml Patients with azoospermia and aspermia Genetic defects like Klinefelter's syndrome Patients with diseases like varicocele, accessory sex gland infection, sexually transmitted diseases, systemic diseases like diabetes mellitus (DM), and so on, were excluded from this study. Laboratory investigations Pratyaksha parikshana and semen analysis was carried out before treatment, on the thirtieth, sixtieth, and ninetieth, days of the study. Method of allocation concealment Ghritabhrushta Dugdha Siddha Masha (Kshirpaka) was given internally to all 30 members of this group. As per Bhaishjya Ratnawali [9], subjects were advised to prepare Ghritabhrushta Dugdha Siddha Masha (Kshirpaka) by following method. 10 gm of Vidal Masha (Phaseolus mungo Linn) was roasted by using adequate quantity of Goghrit. Godugddha (Cow milk) was used to prepare Kshirpaka of this 10 gm Ghritabhrushta Masha (Phaseolus mungo Linn), using procedure told by Yadavji Trikamji Acharya [11]. One part (10 gm) of Ghritabhrushta Masha (Phaseolus mungo Linn) was boiled with 15 parts (150 ml) of water and 15 parts (150 ml) of Period of Trial: 90 days. 30 Oligospermic subjects. Dose: 150 ml Ksheerpaka of Ghritabhrushta Masha (Phaseolus mungo Linn). Dose Schedule: Before meal in morning daily. Follow Up: 0, 30 th, 60 th and 90 th day. All volunteers are advised to follow proper dinacharya, it is to avoid biasness. Follow up The patients were advised to visit the hospital every fortnight during the treatment and for one month after the treatment for follow-up. Criteria for assessment Semen analyses have done and following observations are noted as objective parameters Semen Volume: Semen Volume per ejaculate is recorded in mili-liter (ml). Sperm Count: It is recorded in sperms counted as millions /ml Sperm Motility: Motility of sperms is noted in percentage. Criteria for Assessment Of Result Statistical analysis of changes in mainly three objective criteria Semen volume, sperm count and sperm motility are considered for final assessment of result in each volunteers. First of all score scale have been decided for proper assessment of changes found in each objective parameter. The score scale for each objective parameter is as Observed Change: 1) Semen Volume Score Scale A) No Increase or Deteriation 0 B) 0 to 0.5 Ml Increase 2 C) 0.5 to 1 Ml Increase 3 D) Increase 1 Ml and Onward 4 2) Sperm Count A) No Increase or Deteriation 1 B) 0 to 20 Million Ml Increase 2 C) 20 to 40 Million Ml Increase 3 D) 40 Million Ml and Onward 4 3) Motility A) No Increase or Deteriation 1 B) 0 to 10% Increase 2 C) 10 to 20% Increase 3 D) 20% and Onward Increase 4 Page304

5 STATISTICAL ANALYSIS OF FINDINGS All the clinical features of Shukralpata were observed thoroughly. Observations of subjective and objective parameters are statistically analyzed and interpreted for proper conclusion of the study. According to Sample size; student t test is applied to determine the significance of improvement in clinical feature. The sample size is 30 i.e. n=30. The level of significance was set at 5%. P < 0.05, calculated > table indicate significance of results. 1) Semen Volume Table 1 showing the effect of therapy on Semen Volume (BT and AT) Mean S.D. S.E. t p ttable P< The value of t calculated is more than t table. So the effect of therapy is statistically significant on Semen volume. 2) Sperm Count: Table 2 showing the effect of therapy on Sperm Count (BT and AT) Mean S.D. S.E. t p ttable P< The value of t calculated is more than t table. So the effect of therapy is statistically significant on Sperm count. 3) Sperm Motility %: Table 3 showing the effect of therapy on Sperm Motility % (BT and AT) Mean S.D. S.E. t p ttable P< The value of t calculated is more than t table. So the effect of therapy is statistically significant on Sperm motility. Mainly three objectives parameters Semen volume, Sperm count and Sperm motility are used for assessment of final results. Total score of improvement in volunteer s shows that, out of 30 only one volunteer i.e. 1.33% have no statistically significant improvement. 1 volunteer have partial improvement. The most important outcome of the trial is that 93.34% i.e. 28 out of 30 volunteers of trial group have shown statistically significant improvement. OBSERVATIONS Fifty-two patients were screened during this study. Among them 20 patients were excluded, as they did not fulfil the eligibility criteria. 32 patients fulfilling the eligibility criteria were taken for this study. 2 patients discontinued the study due to various reasons. Mandagni (43.05%) and Kapha Vata Prakruti (54.17%). All the patients of this study were found with a well-developed secondary character and they had a good relationship with their respective partners (94.44%). The maximum number of patients were habituated to tobacco (58.33%) and most of the patients wore cotton undergarments (80.77%), tight underwear (67.31%), had a habit of warm water bath (37.5%), were mentally depressed (30.56%), were unaware of the fertility period (38.89%); and practiced Vegadharana (Suppression of urges) (83.33%). It was observed that the maximum number of patients had primary infertility (66.67%) with severe oligozoospermic conditions (26.39%) for one to three years of chronicity (43.75%). With respect to symptoms of Kshina Shukra reported by the patients, they were Daurbalya (weakness), 52.78% Mukha Sosha (Dryness of Mouth), 47.22% Linga Shaithilya (Loss of Penile rigidity), and 45.83% Klaibya (Erectile dysfunction). Page305 In this study, the maximum number of patients belonged to the years age group (46.25%), belonging to the Hindu religion (93.05%). They belonged to the lower middle class (45.83%), had primary level education (27.7%), were labourers (43.06%), and were exposed to occupational heat (59.72%). The maximum number of patients had RESULTS Effect of therapy on symptoms The therapy has provided a highly and statistically significant (P < 0.001) result in Daurbalya (weakness) (78.26%), loss of penile erection (9.44%), loss of penile rigidity (17.02%), premature ejaculation (10.68%), lack of orgasm

6 (13.54%), and post-act exhaustion (13.33%). Significant (P < 0.05) results were observed in frequency of coitus (18.36%) and performance anxiety (10.81%) and insignificant (P > 0.05) results in Mukha Sosha (Dryness of mouth) (18.75%) and depression (15.38%). Effect of therapy in seminal parameter The percentage of relief in Seminal Parameters like Liquefaction time, volume, sperm total count, motility, RLP, SLP, NP, and abnormal forms was 3.32, 12.9, 86.31, 7.89, 20.1, 3.33, 7.53, and 12.25%, respectively. After subjecting the data to statistical analysis, the total sperm count and abnormal forms were found to be statistically highly significant (P 0.001). RLP was observed to be statistically significant, that is, P < Effect of therapy on quality of sexual health In this study 49.38% improvement was observed, which was highly significant (P 0.001). On comparing, there was a statistically significant difference found (P < 0.05) in the domain of sexual life, psychosexual, and Global index. Overall effect of the therapy The therapy showed 78.11% improvement in Rogibala (Agni bala, Dehabala, Satvabala, and Sexual QoL) and Rogabala (Semen Analysis and Lakshanas). DISCUSSION The etiological factors classified under various headings such as chromosomal anomalies (Bijadosha) have been postulated to be one of the principal genetic factors in male infertility. These disorders occur due to the vitiation of the Bijabhaga of parents, which is responsible for the formation of Bija in the fetus [12]. Several somatic chromosomal abnormalities are associated with male infertility. A specific defect in the male sex (Y) chromosome can cause the common form of male infertility, that is, oligozoospermia. Certain genetic disorders that cause oligozoospermia are Klinefelter's Syndrome, Kallmann's syndrome, Reifenstein's Sydrome, Testicular Malposition (Cryptorchidism), and so on. Dietetic factors are described as Shukravaha Srotodushtikara Nidanas, particularly Anashana (Fasting) [13], Alpa-Pramitaashana (Inadequate diet) [14], and Vishamaashana (Irregular diet) [15], which can impede the agni and may produce Shukradushti, which ultimately leads to impaired fertility. Deprived sustenance may alter the metabolism, which may result in dhatukshaya. Shukra is the essence of all the former dhatus. Thus, any disturbances in the digestive process may lead to defective formation of Shukra, that is, Majjakshaya leads to Alpa Shukra [16]. Very low caloric or protein deficiency causes hypogonadism and decreases the function of the Leydig cell and further leads to infertility [17]. Kshara (Alkali), lavana (Salt), and Amla (Sour) [18] may cover the drugs of chemicals/pesticides described in modern medicine. The factors can be listed as Khavaigunyakara for Shukravahasrotas. Viharaja Nidanas like excessive coitus (Atimaithuna), untimely coitus (Akalamaithuna), coitus in other than vagina (Ayouvanamaithuna), abstinence, intercourse with unaroused partner, coitus in old age (Jaraya Gamana), excessive exercise (Ati Vyayama), excessive exposure to heat (Ati-Ushnasevana) [19], and suppression of ejaculation (Shukravega Nigrahaha) are said to be responsible for the Shukravahasrotodushti, which leads to Kshina Shukra. The psychological causative factors are Chinta (worry), Bhaya (fear) [20], Krodha (anger), Shoka (depression), and so on, and unhealthy sexual/coital practices. Iatrogenic causative factors include improper Kshara (Alkali) [21], Agni (cauterization), and Shastra Karma (surgical procedures), anti-psychotic drugs such as [22] Cyproterone, Ketoconazole, and the like, disease- Induced factors include diseases such as Hemorrhoids, Varicocele and so on, and other factors like smoking and caffeine are also known causative factors of oligozoospermia. The pathogenesis of Kshina Shukra is not mentioned in the classics, but it is stated that the vitiation of Vata and Pitta Dosha, is responsible for the manifestation of Shukrakshaya [23]. Mithyahara Vihara Sevana leads to Agnimandya as well as Amotpatti, hence, leading to an improper formation of Ahara Rasa; which further leads to Rasa Kshaya due to the fault of Jatharagni, resulting in the depletion of the successive Dhatus and ending in Shukrakshaya. It has been said that the etiological factor affecting the Dhatus may also disturb the Doshas. Vice-versa may also occur. The Nidanas lead to Doshadushti, Khavaigunya, Dushyadaurbalya and Dhatvagnimandya. This may happen simultaneously or gradually. In this case of Kshinashukra, the provocation of Vata and Pitta damages the Shukradhatu also, causing Shukradhatu Daurbalya and Shukravaha Srotodushti. Acharya Sushruta has indicated that Lakshanas of Shukrakshaya should be considered as that of Kshina Shukra [7]. It must also be noted that Dalhanahas described Kshina Shukra as Swa- Page306

7 Maanat Alpibhuta Shukra, which means the Shukra is of sub-normal parameters and this may be in terms of Dravyataha (by substance), Gunataha (by property), or Karmataha (by action). Hence, it is clear that many other symptoms of Shukrakshaya or Kshina Shukra may not be available in the patients, due to the selective Kshaya of sperm count. Hence, it is clear that except for a decrease in sperm count; the symptoms of Kshina Shukra may not be well-appreciated in patients. The sperms are nowhere related to the sexual and physical parameters. Nidana Parivarjana (cessation of causative factors) [24] and Panchakarma are recommended for treating the malady Kshina Shukra, before administrating the Vajikarana therapy. The main line of treatment in Kshina Shukra has been suggested to be Kshine Shukrakari Kriya, [25] and Upachaya [26] is the primary line of treatment. It can also be managed by a line of treatment advocated for Shukravaha Srotodushti and Dushtashukra Rogas. Doshapratyanika Chikitsa can be adopted, that is, Vataja and Pittaja Shukradushti for the better management of Kshina Shukra. The drugs that have Madhura Rasa (Sweet), Snigdha, Guru Guna (unctuous and heavy quality), Jivana (promotes quality of life), and Brimhana (nourishing property) are highly recommended for the management of Kshina Shukra. Probable Mode of Action of Ghritabhrusta Masa (Phaseolus mungo Linn): Godugdha (cow-milk) is explained as excellent drug of Jiivaniya Gana. Both Godugdha and Goghrita (clarified butter) are having Madhura Rasa, Madhura Vipaka, Sheeta Veerya and with Guru, Snigdha, Shlakshna, Bahala properties, Which are similar to that of Shukra Dhatu. Hence the Samanya-Vishesha Siddhanta says, the properties of substance can be increased by addition of the substances having similar properties, Madhura, Sheeta, Guru, Snigdha, Shlakshna, Bahala properties of Shukra must be increased. As reference of Charaka [12] strongly supports this. Masha (Phaseolus mungo Linn) is also described as an excellent drug to increase Shukra Dhatu in short period of time [27].Vata Dosha is the most causative factor every movement in our body. Motility of Sperm is also governed by Vata Dosha. Masha (Phaseolus mungo Linn) is having Vata Shamak properties. So it increases Semen Volume as well as Sperm Count but fails to increase motility up to that extent. Further Scope of Study Present study was conducted on limited number of volunteers with limited facilities. Further study can be conducted on large population with advance techniques. One can add another relevant drug to the treatment given for the improvement of Sperm Motility. The different Panchakarma process can be added in trial for assessment of better results. The impact of different addictions likes Tobacco, Gutkha, Smoking; Alcohol etc. on Spermatogenesis should be studied. The effect of Rasayana and Vajikarana Dravyas mentioned in Ayurveda should be compared with Hormonal Therapy on Spermatogenesis given in modern medicine. CONCLUSION After detailed discussion on observations made and results achieved, this present study shows significant remission in the signs and symptoms of Kshina Shukra, vis-à-vis oligozoospermia, corroborated with definite improvement in the total sperm count. In to, from this study it can be concluded that the Alternate Hypothesis of this study is accepted. REFERENCES 1. Inhorn MC. Global infertility and the globalization of new reproductive technologies: Lllustrations from Egypt. SocSci Med. 2003;56: Mehta RH, Makwana S, Ranga GM, Srinivasan RJ, Virk SS. Prevalence of Oligozoospermia and azoospermia in male partners of infertile couples from different parts of India. Asian J Androl. 2006;8: Meletis CD, Barker J. Natural ways to enhance male fertility. Alternative and Complementary Therapies. 2004;10: Norris S. PRB-00-32E. Ottawa: Parliamentary Information and Research Service, Library of Parliament; [Accessed on 2011 October 30]. Reproductive infertility: Prevalence, causes, trends and treatments. Available from /prb0035-e.pdf. 5. Sharlip ID, Jarow JP, Belker AM, Lipshultz LI, Sigman M, Thomas AJ, et al. Best practice policies for male infertility. FertilSteril. 2002;77: Baghel MS. Researches in Ayurveda. In: Jain GK, editor. 2nd ed. Jamnagar: Mridu Ayurveda Publication and Sales; 2005.p Vaidya Jadavji Trikamji Acharya, Sushruta Samhita, 9th ed. Varanasi: Chaukhamba Orientalia; p World Health Organization. 4th ed. Vol. 10. Cambridge, United Kingdom: Cambridge University Press; WHO Laboratory Manual for the Examination of Human Semen and Sperm Cervical Mucus Interaction; p Govindadas Sen, BhaishajyaRatnavali, Vajikaran adhyaya, Chaukhamba Orientalia, p Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. 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8 17. Blair J, Simpson G. Effects of Antipsychotic drugs on reproductive functions. Dis Nerv Syst. 1966;27: Vaidya Jadavji Trikamji Acharya, Sushruta Samhita, 9th ed. Varanasi: Chaukhamba Orientalia; p Ibid, p Yadavji Trikamji Acharya, Charaka Samhita, 5th ed, Varanasi: Chaukhamba Surbharati Prakashan; p Vagbhata, Ashtanaga Hridaya, Chaukambha Surabharati prakashana, Varanasi:; p Anonymus. Part-I, Vol I. New Delhi: Ministry of Health And Family Welfare, Department of AYUSH, Government of India; The Ayurvedic Pharmacopoeia of India; p Yadavji Trikamji Acharya, Charaka Samhita, 5th ed, Varanasi: Chaukhamba Surbharati Prakashan; p Ibid, p Ibid, p Ibid, p Ibid, p.671 CITE THIS ARTICLE AS Ramesh M. Bansod & Vaibhav Biradar, Clinical Study of Ghritabhrushtadugdha Siddha Masha (Phaseolus mungo Linn) in Oligozoospermia, Source of Support Nil Conflict of Interest None Declared Page308

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