A Clinical Study to Evaluate the Efficacy of a Unani Polyherbal Formulation in the Management of Kesae-Khusyatur Raham (Polycystic Ovarian disease)- An open label single arm study

This study is a open label single arm trial, to evaluate the efficacy and safety of the extract form of the Unani polyherbal formulation in the management of Polycystic ovarian syndrome, mainly secondary amenorrhea occurring due to PCOS and its manifestations by using modern parameters. PCOS is one of the most common cause of irregular periods and infertility. It starts to appear at 15-25 years of age and it may take years for its clinical appearance. The incidence of PCOS is 3-22%. Women with PCOS are at increased risk of infertility, recurrent miscarriages, endometrial cancer, late menopause and metabolic aberrations including type 2 Diabetes mellitus, dyslipidemia and cardiovascular diseases. Anxiety, depression and reduced quality of life are other complications associated with PCOS. Due to these complications, PCOS has become a distressing problem despite of advancement of modern science. Several agents are already being used such as hormone therapy for withdrawal bleeding and regulation of menstrual cycle and use of insulin sensitizing agents to reduce insulin resistance and androgens levels and Metformin, but these drugs have their own complications and side effects on long term use like venous thrombo-embolism, stroke, breast cancer, endometrial cancer and ovarian cancer, and long term use of metformin leads to Gastrointestinal side effects, etc. Therefore search for effective and safe drug is the need of the time especially from herbal source. Unani scholars have described principles of treatment for the management of secondary amenorrhea, acne and hirsutism. Many safe and effective single and compound drugs are identified in the classical Unani literature for the same purpose. Also in the recent past, few studies were conducted in the Indian subcontinent and the result of them were found very encouraging. Many single and also compound formulations are used in these studies. In the current study, we are planning to use the extract form of one such formulation to validate its efficacy and safety and to improve the quality of life of patients of Polycystic Ovarian Syndrome (PCOS).