Efficacy of shatapushpa taila matra basti with oral administration of yograja guggulu and kumaryasava in the management of polycystic ovarian syndrome A single arm clinical study

RESEARCH QUESTION- What is the effect of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles after menses with oral administration of Yograja Guggulu 500mg 2 BD and Kumaryasava 20ml BD for 90 days in the management of PCOS?

HYPOTHESIS- Administration of Shatapushpa Taila Matra Basti along with oral Yograja Guggulu and Kumaryasava is effective in improving clinical sign symptoms and hormonal profile in patients with Polycystic Ovarian Syndrome (PCOS).

NULL HYPOTHESIS- Administration of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles after menses with oral administration of Yograja Guggulu 500mg 2BD and Kumaryasava 20ml BD for 90days is not effective in improving clinical sign symtoms and hormonal profile in PCOS.

ALTERNATE HYPOTHESIS- Administration of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles after menses with oral administration of Yograj Guggulu 500mg 2BD and Kumaryasava 20ml BD for 90days is effective in improving clinical sign symtoms and hormonal profile in PCOS.

NEED OF STUDY- PCOS is a heterogeneous endocrine disorder that affects one in 15 women worldwide. It is the most frequent cause of hyperandrogenism & anovulation which have substantial psychological, social & economic consequences. Lifestyle changes & lack of awareness are considered to be the major factor leading to this phenomenon. In modern system of medicine oral contraceptives, ovulation induction agents, progestin, antiandrogens and surgical interventions remain standard therapies having a number of side effects like Depression, Weight gain, Hot flushes, Hepatotoxicity and Nephrotoxicity etc. If PCOS is not treated timely it may lead to cardiovascular disease, endometrial cancer and ovarian cancer. it may lead to infertility, Risk of miscarriages and a high risk of developing diabetes, high blood pressure and other health complications. Therefore there is increased demand to address the problem from view of Ayurvedic medicine which gives better relief, it becomes important in field of Ayurveda develop a safe, cost effective, conservative, non invasive treatment protocol for PCOS. In Ayurveda (PCOS) can be classified as Granthibhoot Artava Dushti due to Vatakaphaja dosha. To restore normal menstruation Vatakaphanashak chikitsa is equally important. The treatment should aim at the correction of obesity and clear the Aavarana by using Vata Kapha Shamaka drugs which certainly help in the proper ovulation and menstruation.

OBJECTIVES: Primary Objective: • To evaluate the efficacy of Shatpushpa Taila Matra Basti with oral administration of Yograja Guggulu and Kumaryasava in reduction of ovarian volume.

Secondary Objectives: • To observe changes(interval, duration, menstural blood flow, pain during mensturation) in menstrual cycle and improvement in hormonal profile. • To evaluate changes in the following • Acne • BMI • Hirsutism(Ferriman-Gallwey scale)