OPEN LABEL SINGLE CENTRIC CLINICAL EXPLORATORY OF EFFICACY STUDY ON ASPAROSE CAPSULE, AN AYURVEDIC PROPRIETARY FORMULATION

Introduction: Polycystic Ovarian Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, often manifesting as irregular menstrual cycles, abnormal bleeding, and menstrual cramps. Ayurvedic medicine has been widely used for managing such conditions. This study aims to clinically validate the efficacy of the proprietary Ayurvedic Medicine, ASPAROSE Capsule, in alleviating the symptoms associated with PCOS. The primary objective of this Phase-II-A, single-center, open-label, therapeutic exploratory clinical trial was to evaluate the effectiveness of ASPAROSE Capsule in reducing PCOS-related symptoms, such as irregular menstrual cycles, abnormal bleeding disorders, vaginal pain, and menstrual cramps. Methods: A total of20 female patients aged 21-40 years with clinically diagnosed PCOS symptoms were enrolled in the study. Participants were administered 1-2 ASPAROSE Capsules twice daily with lukewarm water for 30 days. Baseline and post-treatment evaluations were conducted using clinical and laboratory assessments. Ethical approval was obtained, and patient consent was secured before study participation. Results: At the end of the 30-day trial period: 70% (14 patients) experienced significant improvement in symptoms. 10% (2 patients) showed moderate improvement. 10% (2 patients) had mild improvement. 10% (2 patients) exhibited no significant improvement. Laboratory investigations supported these findings, demonstrating improved hematological parameters posttreatment. No severe adverse effects were reported, indicating the safety of the medication. Conclusion: ASPAROSE CAPSULE was found to be highly effective in managing PCOS-related menstrual irregularities, abnormal bleeding, and associated pain. The study suggests that this proprietary Ayurvedic formulation may serve as a potential therapeutic option for PCOS management. Further large-scale studies are recommended to confirm these findings.