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

Introduction: Chronic kidney disease (CKD) and urinary tract disorders such as Mutraghataroha (Urinary Tract Infection - UTI), Mutrakshyam (Anuria), Mutrakriccharam (Dribbling Urination), and Mutrashmari (Renal Calculi) are prevalent health concerns that significantly impact renal function and overall well-being. Conventional treatments, including antibiotics, diuretics, and dialysis, often lead to side effects and complications. Ayurvedic medicine offers a holistic and natural approach to maintaining kidney health and managing urinary disorders. This study clinically validates Nephrofit Capsule, a proprietary Ayurvedic formulation, for its efficacy in supporting renal function, alleviating urinary disorders, and improving prostate health. The primary objective of this Phase-IIA, single-center, open-label, therapeutic exploratory clinical trial was to assess the safety and efficacy of Nephrofit Capsule in managing kidney and urinary tract disorders. Methods: A total of 20 patients diagnosed with kidney and urinary disorders were recruited following ethical clearance. Patients were administered 1-2 capsules twice daily with lukewarm water for 30 days. Clinical and laboratory investigations were conducted on Day 1 (Baseline) and Day 30 (End of Trial) by qualified AYUSH practitioners. Symptoms such as frequent urination, painful urination, urinary retention, and kidney function markers were closely monitored. Results: After 30 days of treatment, 75% (15 patients) exhibited very good improvement, 15% (3 patients) showed moderate improvement, 5% (1 patient) had mild improvement, and 5% (1 patient) had no significant improvement. The study also found notable improvements in prostate health in male patients. Conclusion: The findings confirm that Nephrofit Capsule is an effective Ayurvedic intervention for kidney health, urinary tract infections, and prostate health. The formulation demonstrated significant symptom relief and improved renal function, making it a promising natural alternative for managing renal and urinary disorders. Further large-scale trials are recommended for broader validation.