Effect of an Unani Formulation on Menstrual Cyclicity in Women With Polycystic Ovarian Syndrome—An Open Labelled Clinical Study

Abstract

Background & ObjectivesPolycystic Ovarian Syndrome (PCOS) is one of the most common endocrinopathies among women of reproductive age affecting 2.2-26% of the population. The objective planned for the study was to evaluate the effect of an Unani formulation on menstrual cyclicity in women with PCOS. MethodologyAn open labelled clinical study was carried out in PCOS patients (n=30) aged between 20-38 years meeting the Rotterdam criteria and patients with thyroid dysfunction, hyperprolactinemia, systemic illnesses, malignancy, morbid obesity, pregnancy, lactation, and those treated with hormonal pills & insulin sensitizers within 3 months of study enrolment were excluded. Decoction of 25g of research drug formulation {consisting of Aneesūn (Pimpinella anisum Linn.), Ḥulba (Trigonella foenum graecum, Linn.), Suddāb khushk (Ruta graveolens Linn.), Majeeth (Rubia cordifolia Linn.) and Lobia surkh (Vigna Unguiculata (Linn.) Walp.)} was administered orally on an empty stomach once daily for 5 days/cycle for 3 consecutive cycles, 5 days prior to last menstrual period. The primary outcome measure was the improvement in menstrual cyclicity, and the secondary outcome measures were a reduction in BMI, waist circumference, ovarian volume, and serum insulin. Results were analyzed by Student’s test. ResultsMenstrual cyclicity was achieved in 73.33% of patients and 26.67% had persistent irregular menstruation. Reduction in BMI, waist circumference, ovarian volume, and serum insulin was achieved in 13.33%, 13.33%, 53.33%, and 36.67% of patients respectively. Interpretation & conclusionThis novel trial provides evidence of improved effectiveness and safety of the research drug formulation in PCOS. Hence it can be used as an alternate remedy in its management.