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

Polycystic ovarian syndrome (PCOS) is one of the most common endocrinopathies among women of reproductive age affecting 2.2 to 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. An open labelled clinical study was carried out in PCOS patients (n = 30) aged between 20 and 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 and insulin sensitisers within 3 months of study enrolment were excluded. Decoction of 25 g 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 three consecutive cycles, 5 days prior to the last menstrual period. The primary outcome measure was the improvement in menstrual cyclicity, and the secondary outcome measures were a reduction in body mass index, waist circumference, ovarian volume, and serum insulin. Results were analysed by Student’s test. Menstrual cyclicity was achieved in 73.33% of patients and 26.67% had persistent irregular menstruation. Reduction in body mass index, waist circumference, ovarian volume, and serum insulin was achieved in 13.33%, 13.33%, 53.33%, and 36.67% of patients, respectively. This 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. [Display omitted]