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

Introduction: Reproductive health and vitality decline with age, stress, and poor lifestyle choices, leading to conditions such as Sukrasthambana (sexual debility), Dhathuksheena (oligospermia), and Dourbalya (nervous weakness). Symptoms like fatigue, stress, loss of libido, and erectile dysfunction impact overall well-being and quality of life. Conventional treatments, including hormone therapy and synthetic aphrodisiacs, often lead to dependency and adverse effects. Ayurvedic medicine offers a holistic and natural approach to enhancing reproductive health, vitality, and stamina. This study clinically validates Shilajit Capsule, a proprietary Ayurvedic formulation, for its efficacy in improving sexual health, energy levels, and mental well-being. The primary objective of this Phase-II-A, single-center, open-label, therapeutic exploratory clinical trial was to assess the efficacy and safety of Shilajit Capsule in improving reproductive health, reducing stress, and enhancing stamina. Methods: A total of 20 male patients suffering from sexual debility and associated symptoms were enrolled following ethical clearance. Patients were administered 1-2 capsules twice daily with lukewarm water for 30 days. Clinical investigations and laboratory assessments were conducted on Day 1 (Baseline) and Day 30 (End of Trial) by qualified AYUSH practitioners. Parameters such as energy levels, libido, erectile function, anxiety reduction, and overall reproductive health were monitored. Results: At the end of 30 days, 75% (15 patients) exhibited very good improvement, 15% (3 patients) showed moderate improvement, and 10% (2 patients) had mild improvement. The formulation significantly enhanced mental calmness, reduced anxiety, and improved reproductive health. No adverse effects were reported. Conclusion: The study confirms that Shilajit Capsule is a potent Ayurvedic intervention for enhancing sexual wellness, vitality, and energy levels. The formulation demonstrated significant improvements in reproductive health, stress reduction, and stamina, making it a promising natural alternative. Further large-scale trials are recommended for broader validation.