Safety and Efficacy of an Ayurvedic Formulation Cystone in Management of Ureteric Calculi: A Prospective Randomized Placebo Controlled Study

Problem statement: Medical management of urolithiasis is still a challenge for modern medical practice. In the present study, Cystone tablet, an Ayurvedic formulation claimed to be useful in urolithiasis was evaluated for its safety and efficacy in reduction or expulsion of ureteric calculi and to assess the role of Cystone in relieving the clinical symptoms. Approach: This was a prospective randomized, double blind placebo-controlled trial amongst 52 patients with upper urinary tract calculi of 5-10 mm diameter. Patients were evaluated by plain abdominal film of the Kidneys, Ureter and Bladder (KUB) plus an ultrasound examination, for 6 months. Patients were equally divided into active treatment or placebo. The patients were advised to take Cystone or placebo in a dose of one tablet, thrice daily for 6 months. Patients kept a record of number of pain episodes; severity of pain was assessed by Visual Analogue Scale (VAS). In addition, other parameters such as fever, low backache and decrease in frequency of urine were evaluated to assess the relief of clinical symptoms. Urinary microscopy and hamatological parameters were also evaluated. Results: In active medication group, there was a significant reduction in the size of the calculi while there was an increase in the placebo arm. There was significant lower VAS score in the active medication arm as compared to placebo. On urine analysis, significant reduction in microscopic hematuria, pus cells (pyuria), bacteruia and crystalline sediments was seen. Significant disappearance of the calculi by both X-ray abdomen and ultrasonography and a significant reduction in the size of the stone was seen with Cystone treatment. There was no improvement in relief of clinical symptoms or investigations in the placebo treated subjects. Conclusion: This study suggested that the Ayurvedic formulation Cystone tablet had a therapeutic promise in the management of ureteric calculi. It probably helped in reducing the size of the calculi and facilitates in its passage and significantly relieves the symptoms with improvement in urine parameters. This formulation was well tolerated.