Comparative Study on Safety and Efficacy of the Decoctions of Sesamum Indicum, Nigella Sativa and its Combination on Polycystic Ovary Syndrome

Abstract

This study investigated the efficacy and safety of three herbal decoctions for managing Polycystic Ovary Syndrome (PCOS), a condition affecting 2–26% of women globally and considered incurable within allopathic medicine and offers symptomatic treatments. This randomized, single-blind clinical trial, conducted between February 2022 and June 2024, enrolled 90 PCOS patients diagnosed by the Rotterdam (2003) criteria. Participants were randomly allocated into three intervention groups: Nigella sativa (Arm I), Sesamum indicum (Arm II), and a combination of both (Arm III). Each group received 30 ml of the assigned decoction twice daily over three months. Clinical parameters were assessed using established grading scales, including androgenic alopecia, hirsutism, acne, and acanthosis nigricans. Additionally, ultrasound scans (USS) were performed pre- and post-treatment to evaluate changes in ovarian morphology. Results indicated a significant reduction in ovarian volume for Arms I (P=0.029) and II (P=0.008) and an increase in follicle size across all three arms. The number of participants with polycystic ovarian morphology significantly decreased in Arm I (P=0.016) and II (P=0.004). However, one-way ANOVA revealed no statistically significant differences between the three groups regarding subjective clinical symptoms or objective ultrasound parameters. The study concludes that all three interventions effectively regulate menstruation and enhance follicular maturity. Among the three, the combined therapy of Nigella sativa and Sesamum indicum (Arm III) demonstrated the most pronounced benefits. These findings suggest that Nigella sativa and Sesamum indicum, individually or in combination, hold potential as therapeutic options for PCOS management without any side effects.