A Prospective, Open-label Non-Randomized Clinical Trial to evaluate the Safety and Efficacy of Calcury Tablets in Treatment of Renal calculi

Abstract

Background: Renal calculi, commonly referred to as kidney stones, are a prevalent urological condition characterized by the formation of solid mineral and salt deposits within the urinary tract. The management of renal stones involves a multifaceted approach, including hydration, dietary modifications, pain management, pharmacological interventions, and, in some cases, surgical procedures such as lithotripsy or ureteroscopy. Preventive strategies focus on addressing the underlying metabolic causes and promoting adequate hydration to minimize recurrence.

Materials and Methods: This non-randomized, prospective, open-label clinical trial involving 50 patients aimed to evaluate the clinical efficacy and safety of Calcury Tablets in managing renal calculi in patients aged 20–65 years, a demographic representative of the global population commonly affected by kidney stones.

Study Design: Participants were thoroughly informed about the study procedures, and written consent was obtained before enrollment. The study followed participants over a 4 weeks period to monitor treatment efficacy and safety. Assessments were conducted before and after treatment to evaluate changes in stone size, symptom relief, and recurrence prevention. Any adverse events or complications were carefully documented and analyzed.

Observations and Results: This clinical trial evaluated the safety and efficacy of Calcury Tablets in managing renal stones in 50 participants (mean age: 47.3 years; BMI: 27.2). Significant reductions were observed in stone size (6.5 ± 1.8 mm to 4.0 ± 1.2 mm, p = 0.001), stone number (3.5 ± 1.4 to 2.1 ± 1.0, p= 0.01), and pain levels (VAS: 6.5 ± 2.0 to 3.2 ± 1.4, p= 0.001). Stone passage increased from 60% to 90% (p = 0.03), and urine pH improved from 5.8 ± 0.6 to 6.3 ± 0.5 (p = 0.05). Quality-of-life scores rose significantly (48.2 ± 8.5 to 65.1 ± 7.2, p = 0.001), alongside hydration improvements (2.0 ± 0.5 to 2.5 ± 0.6 L/day, p = 0.04). Laboratory parameters remained stable, indicating safety, with no significant impact on renal, hepatic, or hematological markers.

Conclusion: The clinical evidence from this trial, combined with the promising preclinical findings on the individual herbs involved in the formulation, supports the use of Calcury Tablets as an effective, safe, and natural alternative for managing renal stones. This treatment offers a promising option for patients seeking a holistic approach compared to conventional medications.