Efficacy of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi Kwatha in ovulation induction in obese polycystic ovarian syndrome: open labelled randomized controlled clinical trial

‘‘EFFICACY OF VIRECHANA KARMA AND LEKHANA BASTI ALONG WITH PATHADI YOGA GHANAVATI AND PHALATRIKADI KWATHA IN OVULATION INDUCTION IN OBESE POLYCYSTIC OVARIAN SYNDROME: OPEN LABELLED RANDOMISED CONTROLLED CLINICAL TRIAL’’ Introduction: Polycystic Ovarian Syndrome [PCOS] is the most common endocrine and metabolic disorder in a woman of reproductive age. Majority of cases with PCOS are obese/overweight in the population. Obesity or overweight affects between 38 and 88% of women with PCOS. It is a complex syndrome showing the clinical features of an endocrine/metabolic disorder, including hyperinsulinemia and hyperandrogenism. Clinically it is characterized by menstrual abnormalities, hirsutism, acne, obesity, insulin resistance. It is also the most frequent condition for anovulatory cycles leading to infertility. In Kashyapa Samhita, Lakshanas of Vrithapushpa (anovulation) has been mentioned in the context of Pushpaghni Jataharini. Rationality For the Selection of The Topic: Ashtanga Sangraha has clearly mentioned role of Virechana Karma in Granthi Chikitsa. Granthi is a Bahu Dosha Janya Vikara, for Prabhuta Dosha in the body Samshodhana therapy is indicated. In Obese PCOS Vata-kapha predominance is there & there is Aavarana due to kapha Dosha. As Lekhana Basti possesses Lekhana, Pachana, Ushna and Tikshna properties. It offers Vatakapha Shamaka, Srotoshodhaka and Amapachana actions. Lekhana Basti lower LH level and normalize the FSH level to encourage the growth and development of follicles in PCOS patient. Pathadi Choorna is primarily mentioned in treatment of Vata-Kaphaja type of Artava Dushti in Sushruta Samhita Sharira Sthana,which have shown encouraging results in clinical features of PCOS. Arogyavardhini Rasa possesses Deepana-Pachana, Tridoshahara, Rasayana, Vrushya, Medovinashini, and Lekhana properties. It is indicated in Rogadhikara Jwara, Prameha, and Kushtha and is useful in metabolic disorders. As acharya Charaka has mentioned this Kwatha for Prameha, so considering the Insulin resistance condition in PCOS patient, this drug will be beneficial. Aims and Objectives Aim:

1. To evaluate the efficacy of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi Kwatha in ovulation induction in obese polycystic ovarian syndrome and compare it with standard drug Letrozole and Metformin. Objectives: 1.To assess the effect of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi Kwatha in follicular development and ovulation in obese polycystic ovarian syndrome. 2.To assess the effect of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi Kwatha on ovarian morphology, obesity and regulation in menstrual pattern. Materials And Methods: Diagnosed 20 patients of obese PCOS, fulfilling the Rotterdam criteria (2018) from the O.P.D. of P.T.S.R. Dept. of ITRA, Jamnagar will be screened with transvaginal sonography for anovulation for two consecutive cycles and patients having anovulatory cycles will be registered for clinical trial. Results And Discussion: Data generated during the above study will be presented in a systemic methodical manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study, Pharmacological study will be discussed. Follow up periods: Patients will be advised to visit the hospital every 15 days during the treatment period & every 15 days for 1 Cycles after the treatment as follow-up. Side Effects: These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar