A Prospective, Open-Label Non-Randomized Clinical Trial to Evaluate the Safety and Efficacy of Sumenta Tablets in Treatment of Anxiety

Background: Anxiety disorders, including GAD, panic disorder, phobias, OCD, PTSD, and social anxiety, significantly impact mood, cognition, and daily functioning. With a global prevalence of 3,895 cases per 100,000 in 2019, these disorders are more common in women and highly prevalent in regions like Latin America and North America. Conventional treatments primarily include SSRIs, SNRIs, and cognitive-behavioural therapy (CBT), though limitations like side effects and treatment resistance necessitate alternative options. Materials and Methods: This phase 3, prospective, open-label, multi-centric clinical trial assessed the efficacy and safety of Sumenta Tablets in managing anxiety. Conducted per Good Clinical Practice (GCP) guidelines, the study included 150 participants diagnosed with primary anxiety disorder. Study Design: A non-randomized, prospective, open-label, multi-centric, trial evaluated the safety and efficacy of Sumenta Tablets in anxiety disorder patients. The study enrolled 150 participants who provided informed consent. Baseline assessments included medical history, psychiatric evaluations (HAM-A scale), and laboratory tests for liver and renal function. Efficacy was measured through anxiety symptom reduction using HAM-A and secondary outcomes such as sleep disturbances, irritability, and quality of life. Results: Sumenta Tablets significantly reduced anxiety levels, as evidenced by a substantial decrease in the HAM-A score (23.5 ± 5.8 to 14.2 ± 4.1, p < 0.001), and also improved depression scores (BDI: 16.8 ± 6.3 to 10.4 ± 4.5, p < 0.01). Sleep quality improved (Pittsburgh Sleep Scale: 8.5 ± 3.2 to 5.0 ± 2.1, p < 0.001), and cognitive function increased (MoCA: 25.4 ± 3.5 to 27.1 ± 2.9, p = 0.02). Physical activity levels rose (120 ± 55.4 to 180 ± 70.2 minutes/week, p < 0.05), and fatigue and muscle tension decreased significantly. Patient-reported quality of life increased (EQ-5D: 53.2 ± 8.4 to 72.3 ± 9.5, p < 0.001). Biologically, serum cortisol (18.4 ± 5.2 to 12.1 ± 4.3 μg/dL, p = 0.03), vitamin D (14.6 ± 5.7 to 21.8 ± 6.3 mg/dL, p = 0.02), and inflammatory markers (CRP: 6.8 ± 2.3 to 4.0 ± 1.7 mg/L, p = 0.01) all improved. Patient satisfaction increased significantly (VAS: 4.2 ± 1.5 to 8.5 ± 1.2, p < 0.001), indicating high treatment acceptability and effectiveness.