Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.

Inclusion Criteria: * Female subjects of reproductive age (18-40 years). * Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria. * Subjects with insulin resistance defined as HOMA-IR \> 2.00. Exclusion Criteria: * Pregnant or lactating women. * Subjects with known Cushing's syndrome. * Subjects with late-onset congenital adrenal hyperplasia. * Subjects with androgen-secreting tumors. * Subjects with uncontrolled thyroid disease. * Subjects with hyperprolactinemia. * Subjects with diabetes mellitus. * Subjects with uncontrolled hypertension. * Subjects with other cardiovascular diseases. * Subjects with acute or chronic infections. * Subjects with any known malignancy. * Subjects with impaired renal function (serum creatinine \> 1.5 × ULN). * Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).