Clinical study on efficacy of Ashwagandha Vati and Satvavajaya chikitsa in the management of Chittodvega in Pre Menstrual Syndrome

The study titled “Clinical Study on Efficacy of Ashwagandha Vati and Satvavajaya Chikitsa in the Management of Chittodvega in Pre Menstrual Syndrome†is a open labelled single group exploratory clinical trial conducted in SDM College of Ayurveda and hospital, Hassan to evaluate the combined effect of Ashwagandha vati and Satvavajaya chikitsa in Chittodvega in PMS. The whole work is explained under the sections- Introduction, Review of literature, Materials and methods, Observation and results, Discussion and Conclusion. Introduction contains small description about the disease, Ashwagandha, Satvavajaya chikitsa and need for the study. Review of literature is explained first four chapters. The first chapter discuss in detail about the physiology of menstruation, Pre Menstrual Syndrome and its conventional management. The second chapter is about Chittodvega, its interpretation, and management in brief as per the authentic textual references. The third chapter explains about the drug Ashwagandha, its morphology, pharmacology and chemical constituents. Fourth chapter deals with the details of Satvavajaya chikitsa, its techniques, benefits and a brief description of modern psychotherapies. Material and methods contains the method of selection of samples, inclusion criteria, exclusion criteria, assessment criteria, intervention used, scale used and statistical tests used. 300 subjects were screened, 35 patients fulfilling the diagnostic criteria (ICD 10 N 94.3& DSM IV625.4) out of 191 subjects were selected within the age of 16-40 years. Subjects with systemic diseases, who are under medication, those having organic brain disorder or psychiatric diseases were excluded. The registered subjects were intervened with Ashwagandha vati 500mg twice daily with milk and Satvavajaya chikitsa for duration of 30 days. Satvavajaya chikitsa is defined under three titles Counseling, yoga & Pranayama and relaxation in specified schedule. Counseling was done in divided sessions by setting a goal in every session. Methods used were classical and strategies, techniques used in CBT. Yoga advised were Makarasana, Vajrasana and Shavasana. Pranayama technique selected was Nadishuddhi. The method of relaxation used here was toe to head progressive muscular relaxation, which was taught to the patient. The follow up was done during luteal phase of next cycle i.e., approximately 28th day and 56th day from the commencement of treatment. Assessment was done by using Moos Menstrual Distress Questionnaire, before treatment, after treatment (28-30 days of commencement of treatment) and in follow up (56-60th day of commencement of treatment). Observation and results is the section which explains the frequency of demographic data, frequency of symptoms, statistical test results and their tabular representations. Demographic data includes age, education, marital history, personal history etc. and frequency of symptoms shows the statistics of symptoms in percentage and number. Most registered were 21- 25 years 63% (22), hindus 83% (29), of upper middle class socio economic status 52% (18) students 94% (33) and were unmarried 74% (26). Menstrual history showed prevalence of menarche at the age of 13 years 46%(16) with 5 days of menstrual bleeding in 43%(15) having 28 days of interval between 2 cycles in 49%(17) without dysmenorrhea/clots/smell in 92% And Aggravation of symptoms on menstruation was absent in 97%(34). Personal history depicted mixed diet in 66%(23) having dominancy of katu rasa 57%(20), with dietetic habit vishamashana 54%(19). 97%(34) Subjects with irregular in exercise. Pareeksha showed prevalence of  vata pitta prakruthi 43%(15), with rajasika manasa prakrithi 74%(26) having vishama agni &madhyama koshta 63%(22) with madhyama shareera bala 74%(26) and avara satva 66%(23). Prevalence of symptoms were 90% in Mood swings, anxiety, loneliness, crying, irritability, tension restlessness of registered subjects. Feeling sad, confusion, distractibility, difficulty concentration, abdomen bloating, fatigue, backache, poor school or work performance was present in 80% of the subjects. Decreased efficiency, avoid social activity; feeling of suffocation was present in 70% of the subjects. All domain showed statistically significant result P<0.001 except Pain domain. Discussion section contains discussion regarding the study from selection of topic to interpretation of diseases. Here possible interpretation is given to each part of study and in every finding based on logic from basic principles of Ayurveda and authentic scientific articles. Justification regarding the selection of Ashwagandha, with milk as anupana and Satvavajaya as supportive therapy is given here. The effect of the combined therapy may be due to the anxiolytic and Adaptogenic action of Ashwagandha, nootropic and relaxation response effect of Satvavajaya chikitsa. The combined effect might have acted at biochemical level as well as biophysical level there by alleviating the symptoms of Chittodvega in Pre Menstrual syndrome. Conclusion contains the brief conclusion of results, the lacunae of the study, suggestion and scope for future researches.