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AYUSHDHARA An International Journal of Research in AYUSH and Allied Systems Research Article ISSN: 2393-9583 (P)/ 2393-9591 (O) RASAYANA - AN ADVANCE THERAPY FOR THE MANAGEMENT OF MENOPAUSAL SYNDROME Chaudhari Krutika 1 *, Dei Laxmipriya 2, Thakar Anup 3 * 1 Ph.D. Student, 2 Professor and HOD, Dept. of Prasutitantra and Streeroga, I.P.G.T. & R.A., Jamnagar, India. 3 Professor and HOD, Panchakarma Department, I.P.G.T. & R.A., Jamnagar, India. KEYWORDS: Menopausal syndrome, Rajonivritti janya lakshana, Rasayana, Vayasthapana Gana. *Address for correspondence Dr Chaudhari Krutika PhD student, Dept. of Prasutitantra and Streeroga, I.P.G.T. & R.A., Jamnagar, India. Mobile: 9429012309 Email: chaudhari_krutika88@yahoo.com ABSTRACT Menopause is referring to end of reproductive period and starting of aging problems due to lack of ovarian hormones. There is no direct reference found in Ayurveda regarding menopause but Jaravastha can be correlated as Rajonivrittijanya Lakshanas. Rasayana drugs promote the regeneration of Dhatus, intelligence, mental wellbeing, immunity and longevity. So, Rasayana drugs are helpful to decrease aging related problems. Aim: Present study has been planned to evaluate the efficacy of Vayasthapana Gana having Rasayana effect on menopausal syndrome. Materials and methods: Total 18 known cases of menopausal syndrome patients in the age group between 45-55 years, minimum one year after cessation of menses were selected for the study, out of which 16 patients completed the treatment. Vayasthapana Gana Ghanavati 2 tablets (500mg each) were administered twice a day with milk for duration of two months with follow up period of one month. Improvement was monitored as per Menopausal Rating Scale. Result: 13 (81.25%) patients showed mild improvement and 3 (18.75%) patients had moderate improvement. No any significant changes were observed in serum follicle stimulating hormone and serum oestradiol and other laboratory findings. The score of menopausal rating scale was decreased from 27.50 to 14.75 after the treatment. Conclusion: Vayasthapana Gana Ghanavati is safe and effective in the management of menopausal syndrome. INTRODUCTION Menopause means permanent cessation of menstruation and ending of young age due to deficiency of hormone i.e., oestrogen which is denoted as female hormone. Menopause is the time when last and final menstruation occurs [1]. Though menopause is a physiological phenomenon many psychological changes occur those are not considered as disease condition, affecting multisystem and manifested with various symptomatology known as menopausal syndrome. This period usually occurs after 40 years [2] in most of the women. Menopause is an estrogen deficient phase of women s life which accelerates the ageing process resulting greater vulnerability to psychosomatic problems and make her life dependent. Characteristic features are hot flushes, bouts of rapid heartbeat, sleep disturbances, mood swings, night sweating, disturbing memory lapses, developing senile vaginitis due to dry vagina, loss of libido and osteoporosis etc. Variation in premenopausal phase leads to mood swing, depression, anxiety, obesity, hypertension, diabetes mellitus and cancer are more prone in menopausal women that need medical help. So in order to bring the women back in their independent routine life, this physiological stage invites attention of physicians to think over it. In India, menopausal population is increasing day by day and women suffering from menopausal syndrome are also increasing because of fast and stressful life in modern era. Menopausal symptoms increased more in this era because of empty nest syndrome [3] i.e. feeling of loneliness due to marriage of their children. Traditionally Indian women worked within family so, stress found only at emotional level, severity of menopausal symptoms may not found, but now in modern era, women need to perform both familial as well as professional life as severity of symptoms found more. There is no direct reference regarding menopause in Ayurveda but we can correlate with Jarapakvavastha mentioned by Sushruta. Jarapakvavastha [4] in female is widely known as Rajonivrittikala (menopausal stage). Rasayana Chikitsa (Rejuvenation therapy) is the unique therapy contributed by Ayurveda particularly effective in reducing the aggravating clinical features and problems during old age. Rasayana [5] nourishes and increases the immunity, keeps the body young and helps to promote healthy long life. Rasayana endowed with psychic excellence like sharp memory. All the drugs in Vayasthapana Gana [6] are having Rasayana properties and is indicated to restore the Vaya (youngness). So Vayasthapana Gana was selected for the present study to AYUSHDHARA September - October 2016 Vol 3 Issue 5 862

evaluate the efficacy of Vayasthapana Gana Ghanavati on various features of menopausal syndrome. Materials and Methods Total 18 patients fulfilling the selection criteria were selected from the O.P.D. of Prasuti Tantra and Stree Roga Department. Two patients were dropped out due to their personal reasons. Table 1: Total registration of patients Registered Completed Dropped out 18 16 2 1) Study was started after obtaining Ethical clearance from the Institutional Ethics Committee. (7/- A/Ethics/2013-2014/1767, 10/09/2013). 2) Study has been registered in CTRI (CTRI Reg. No: CTRI/2015/07/006044). Inclusion criteria 1) Age group between 40-55 years suffering from menopausal syndrome. 2) Amenorrhea at least for 12 months or more. 3) FSH 20 IU/L 4) Endometrial thickness 5 mm by USG finding. AYUSHDHARA, 2016;3(5):862-867 Exclusion criteria 1) Age below 40 years and age more than 55 years. 2) Women with uncontrolled medical conditions e.g. hypertension, heart disease, diabetes mellitus, cancer. 3) Patients having the h/o hormone replacement therapy (HRT). 4) Established case of mental illness. Investigations: (before and after treatment) Fasting blood sugar, S.Creatinine, S. Cholesterol, S.Triglyceride, High-density lipoprotein (HDL), S.Cholesterol/ HDL ratio. S. Oestradiol and S. Follicle stimulating hormone. Ultra Sonography - TVS (Transvaginal sonography) (before treatment). Study type and duration Open level clinical trial Vayasthapana Gana Ghanavati 2 tablets (500mg each) twice a day was administered for two months with milk before meal with follow up of one month. Table 2: Ingredients of Vayasthapana Gana Ghanavati No Name of Drug Botanical name (Latin name) Part used Part 1. Guduchi Tinospora cordifolia Willd. Stem 1 2. Haritaki Terminalia chebula Retz. Dried Fruit 1 3. Amlaki Emblica officinalis Gaertn. Dried Fruit 1 4. Rasna Pluchea lanceolata C.B.Clarke Root 1 5. Aparajita Clitoria ternetia Linn. Whole plant 1 6. Jeevanti Leptadenia reticulate W&A. Stem and leaves 1 7. Shatavari Asparagus racemosus Willd. Root 1 8. Mandukparni Centella asiatica Linn. Whole plant 1 9. Shalparni Desmodium gangeticum D.C. Whole plant 1 10. Punarnnava Boerhaavia diffusa Linn. Whole plant 1 Criteria of assessment 1) Subjective criteria The result was assessed on as per Menopausal Rating Scale (MRS). In MRS, there are 11 characteristic features of menopausal syndrome and are divided into three subscales: (1) Somatic scale includes hot flushes, palpitation, sleeping problems and muscle and joint problems; (2) Psychological scale includes depressive mood, irritability, anxiety and physical and mental exhaustion and (3) Urogenital scale includes sexual problems, bladder problems and dryness of vagina. Grading pattern is taken i.e. 0= No symptoms, 1= Mild, 2= Moderate, 3= Severe, 4= Very Severe. 2) Objective criteria S. Cholesterol, S. Triglyceride, HDL, S. Cholesterol /HDL S. Creatinine S.FSH, S. Oestrodiol Criteria for assessment of therapy The overall effect of therapy was assessed as follows: 1. Complete cured - 100% relief. 2. Marked improvement - 76% - 99% relief. 3. Moderate improvement - 51% - 75% relief. 4. Mild improvement - 26% - 50% relief. 5. Unchanged - Up to 25% relief. Statistical analysis The values were expressed as percentage of relief and mean, SEM (Standard Error Mean). MRS and both subjective and objective parameters were analyzed by applying students paired t test in sigma stat software. Result and Discussion General Observations (n=18) In the present study, maximum 50 % of patients were from the age group between 46-50 years, 77.77% of patients had menopause for last 1-5 years, 94.44% were married, 61.11% were from nuclear family, 44.44% patients were complaining of constipation, Vatapitta Prakriti was observed in 83.33% of patients, 81.25% of patients were having increased BMI (>25), While asking for Nidana Sevana (predisposing/aggravating factors) i.e. Ratrijagarana (Awaking at night), Divaswapna (Day sleep), Alasya (Laziness) and Katu-Amla Rasa Aharas Sevana (Use of excessive hot and sour diet) were AYUSHDHARA September - October 2016 Vol 3 Issue 5 863

Chaudhari Krutika et al. Rasayana-An Advance Therapy for the Management of Menopausal Syndrome observed in maximum patients i.e. 72.22%, 33.33%, of exercise) was observed in 66.66 %. 55.55% and 77.77% respectively; while Avyayama (Lack Observations on MRS Table 3: Observations on Somatic sub score Symptoms n=18 No. of Patients % None 1 5.56 Hot flushes Moderate 5 27.78 Severe 6 33.33 Very Severe 6 33.33 None 2 11.11 Mild 3 16.66 Palpitation Moderate 12 66.66 Severe 0 00 None 3 16.66 Sleep Problems Moderate 2 11.11 Severe 7 38.88 Very Severe 5 27.78 Table 4: Observations on Psychological sub score None 2 11.11 Depressive Moods Moderate 6 33.33 Severe 8 44.44 None 0 00 Irritability Moderate 10 55.55 Severe 7 38.89 None 1 5.56 Anxiety Moderate 6 33.33 Severe 9 50 Table 5: observation on Urogenital sub score None 0 00 Physical & Mental Exhaustion Moderate 1 5.56 Severe 14 77.77 Very Severe 3 16.67 None 3 16.67 Sexual Problems Moderate 3 16.67 AYUSHDHARA September - October 2016 Vol 3 Issue 5 864

Bladder Problems Vaginal Dryness Joint & Muscular discomfort AYUSHDHARA, 2016;3(5):862-867 Severe 10 55.55 None 1 5.56 Moderate 2 11.11 Severe 9 50 Very Severe 5 27.78 None 3 16.67 Moderate 5 27.78 Severe 8 44.44 None 0 00 Moderate 4 22.22 Severe 12 66.67 Very Severe 2 11.11 Table 6: Effect of Vayasthapana Gana Ghanavati on Menopausal Rating Scale Symptoms n Mean ± SEM Mean BT AT Diff % relief t P Hot flushes, Sweating 15 3.133±0.215 1.067±0.118 2.067 53.957 11.374 <0.001 Palpitation 15 1.933±0.182 1.067±0.067 0.867 44.827 6.5 <0.001 Sleep Problems 14 2.857±0.312 1.429±0.173 1.429 50 7.071 <0.001 Depressive Mood 14 2.571±0.646 1.357±0.133 0.214 47.222 5.667 <0.001 Irritability 16 2.438±0.128 1.125±0.085 1.313 53.846 8.720 <0.001 Anxiety 14 2.571±0.173 1.286±0.125 1.286 50 5.264 <0.001 Physical & Mental Exhaustion 16 3.063±0.111 1.438±0.128 1.625 53.061 10.498 <0.001 Sexual problems 13 2.769±0.201 2.154±0.296 0.615 22.222 3.411 <0.01 Bladder problems 15 3±0.218 1.4±0.19 1.6 53.333 8.411 <0.001 Vaginal Dryness 13 2.692±0.208 2±0.277 0.692 25.714 3.323 <0.01 Joint and muscular discomfort 16 3±0.129 1.938±0.143 1.063 35.416 5.506 <0.001 Total 16 27.5±1.336 14.75±0.977 12.75 46.363 13.053 <0.001 Table 7: Result on subscales Sub score n Mean ± SEM Mean BT AT Diff % relief t P Somatic sub score 16 10.25±0.602 5.188±0.277 5.063 49.390 10.989 <0.001 Psychological sub Score 16 10±0.612 4.875±0.375 5.125 51.25 9.373 <0.001 Urogenital sub score 15 7.333±0.613 5±0.625 2.733 35.345 5.909 <0.001 Table 8: Effect of therapy on laboratory investigations Investigations n Mean Mean B.T. A.T. Diff. % Change S.E. T P S. Cholesterol 16 179.88 189.44-9.563 5.32 4.625-2.068 >0.05 AYUSHDHARA September - October 2016 Vol 3 Issue 5 865

Chaudhari Krutika et al. Rasayana-An Advance Therapy for the Management of Menopausal Syndrome S. Triglyceride 16 155.69 143.63-27.94 24.15 32.30-0.865 >0.05 HDL 16 55.81 57.5-1.987 5.85 1.829-1.629 >0.05 S. Cholesterol /HDL 16 3.253 3.325-0.073 2.229 0.109-0.663 >0.05 S. Creatinine 16 0.94 0.86 0.075 8 0.035 2.158 <0.05 S.FSH 16 67.15 67.668-0.519 0.77 11.337-0.046 >0.05 S. Oestrodiol 16 106.9 103.67 3.235 3.026 6.671 0.485 >0.05 After treatment, no significant changes were observed in the biochemical and hormonal values. Menopause is a part of aging process of women s life. The majority of the symptoms of menopause are due to Mandagni, Dhatukshayavastha, Vata Vriddhi and Manovaha Srotasdushti (channels that connect the mind to the senses). Rasayana therapy seems to be line of treatment, to nourish the Dhatus. However Rasayana is not a complete cure for Rajonivritti Janya Lakshanas/ menopausal syndrome. It can only delay the process of aging and symptomatically relieve the menopausal discomforts for some time and also prevent the adverse effects in the post menopausal period. Probable mode of action of Vayasthapana Gana Ghanavati Most of the drugs have Tikta, Madhura and Kashaya Rasa Pradhana and having Madhura Vipaka, Tikta, Kashaya Rasa are Pittashamaka and also balance Kapha Dosha. Madhura Rasa having soothing effect promotes strength and pacifies Pitta and Vata Dosha. So, Vayasthapana Gana Ghanavati works as Tridosha Shamaka and reduce the Rajonivrittijanya Lakshanas by balancing Tridhosha. Tikta Rasa has direct action on promotion of Medha (Memory). Most of the drugs in Vayasthapana Gana Ghanavati have Deepana, Pachana property which improves the status of Agni. Vayasthapana Gana Ghanavati has properties of Vayasthapana, Balya (Tonic) and Rasayana which promote proper formation of Rasa Dhatu. Besides these properties, most of the ingredients helps in delaying the aging process and reduce the somatic symptoms of menopause. Amalaki, Shatavari, Jatamansi, Mandukparni, Guduchi, Shalparni and Punarnava have Hridya property and Amalaki, Shatavari, Jatamansi, Mandukparni, Haritaki, Jivanti have Medhya (promote intellect) property which help to reduce psychological symptoms of menopause. Punarnava, Jivanti and Satavari have Mutrala (Diuretic) properties which reduce the bladder problems. Antioxidant property of Guduchi [8], Haritaki [9], Amalaki [10], Aparajita [11] and Mandukparni [12] which helps to block or slow down a variety of neurodegenerative processes. Anti stress, adoptogenic activity of Punarnava [13], anti-anxiety and anti-depressant activity of Mandukparni and cardio protective activity of Amalaki and Guduchi helps to reduce psychological symptoms of menopause. Phytoestrogenic activity of Shatavari [14] also works on hot flushes and other menopausal symptoms. Table 9: Overall effect of therapy (n= 16) Effect of therapy No. of % patients Unchanged - 25 % relief 0 00 Mild Improvement -26-13 81.25 50% relief Moderate improvement - 3 18.75 51-75% Marked improvement - 76-99% relief 0 00 Complete cure -100% 0 00 relief CONCLUSION Vayasthapana Gana Ghanavati proving encouraging results in somatic complaints i.e. hot flushes, physical and mental exhaustion, bladder problems, joint and muscular discomfort and psychological complaints i.e. palpitation, sleep problems, depressive mood, irritability, anxiety. Vayasthapana Gana Ghanavati is administered for 60 days significantly decreased the severity of menopausal symptoms. The score of menopausal rating scale was decreased from 27.50 to 14.75 after the treatment. Hence, Vayasthapana Gana Ghanavati can be recommended in the menopausal syndrome. REFERENCES 1. Dutta DC. Textbook of Gynaecology including contraception. 5th edition. Calcutta; New Central Book Agency; 2009. p. 55. 2. Pratap Kumar, Narendra Malhotra. Jeffcoate s Principles of Gynecology. 7th edition. New Delhi; Jaypee brothers Medical Publishers (P) Ltd; 2008. p. 863. 3. Empty nest syndrome. [homepage on the internet] Wikipedia, The Free Encyclopedia. April 7, 2017, 07:02 UTC. Available at: https://en.wikipedia.org /w/index.php?title=empty_nest_syndrome&oldid= 774254858. Accessed April 10, 2017. 4. Kaviraja Ambikadutta Shastri. Sushruta Samhita- Ayurveda-Tattva-Sandipika. Reprint. Varanasi; Chaukhamba Sanskrit Sansthan; 2010. p. 27. 5. Anil Kumar Singh, Arvind Gupta, Manish, Pramod singh, Rasayana Therapy: A magic contribution of Ayurveda for healthy long life, International Journal of research in Ayurveda and pharmacy. 2014; 5 (1): 41-47. 6. Kashinath Sastri, Dr. Gorakha Natha Chaturvedi. Charaka samhita of Agnivesa. Reprint. Varanasi; Chaukhamba Visvabharati, 2013. p.98. AYUSHDHARA September - October 2016 Vol 3 Issue 5 866

7. Lothar AJ Heinemann, Peter Potthoff, Hermann PG Schneider, International version of the menopause rating scale (MRS), Health and Quality of Life Outcomes. 2003; 1(28): 1-4. https://www. researchgate.net/publication/10616353 8. Purandare H, Supe A, Immunomodulatory role of tinospora cordifolia as an adjuvant in surgical treatment of diabetic foot ulcers: A prospective randomized controlled study, Indian J Med sci.2007; 61 (6):347-55. 9. Prakash Chandra Gupta, Biological and pharmacological properties of Terminalia Chebula Retz. (Haritaki)-An Overview, International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(3): 62-68. 10. Ekta Singh, Sheel Sharma, Ashutosh Pareek, Jaya Dwivedi, Sachdev Yadav, Swapnil Sharma, Phytochemistry, traditional uses and cancer chemopreventive of Amala (Phyllanthus emblica): AYUSHDHARA, 2016;3(5):862-867 The Sustainer, Journal of Applied Pharmaceutical Science. 2011; 02 (01): 176-183. 11. Manju Lata Zingare, Prasanna Lata Zingare, Ashish Ku Dubey, Md. Aslam Ansari, Clitoria ternatea (Aparajita): A review of the antioxidant, antidiabetic and hepatoprotective potentials. International Journal of Pharmacy and Biological Sciences. 2013; 3(1):203-213. 12. Dora Bhavana, Khatri Jyoti, Centella Asiatica: The elixir of life, International journal of research in Ayurveda & Pharmacy. 2011; 2 (2):431-438. 13. Krishna Murti, Mayank A. Panchal, Vijay Lambole, Pharmacological potential of boerhavia diffusa: An overview, International journal of Pharmaceutical sciences review and research. 2010; 5(2): 107-110. 14. V. Ashajyothi, Dr. Rao. S. Pippalla, Dr. D. Satyavati, asparagus racemosus - A phytoestrogen, International Journal of Pharmacy and Technology, Dec- 2009;1(1): 36-47. Cite this article as: Chaudhari Krutika, Dei Laxmipriya, Thakar Anup. Rasayana-An Advance Therapy for the Management of Menopausal Syndrome. AYUSHDHARA, 2016;3(5):862-867. Source of support: Nil, Conflict of interest: None Declared AYUSHDHARA September - October 2016 Vol 3 Issue 5 867