Safety and efficacy of UNEX capsules in management of ureteric calculi : A prospective, randomised placebo-controlled study

Abstract

Renal calculi or urolithiasis is one of the most common problems in the society. In present study, the UNEX, an Ayurvedic herbal capsule, was evaluated for its safety and efficacy regarding Ureteric calculi. This was a phase III, double blind, randomised, placebocontrolled study on 64 patients suffering from upper ureteric calculi. Patients were evaluated by the X-ray KUB kidney, ureter, bladder (KUB) and ultrasonography (USG) renal pelvis for the size of calculi 5 to 10 mm and various clinical symptoms like pain, decrease in frequency of micturition, low backache, etc. The patients were equally divided in study group and control group and advised to take either study drug or placebo in a dose of two capsules b.d. for six months and follow up taken on every second month. Patients were assessed for clinical symptoms and size of stone on every second month. Microscopic evidences and urine analysis were also been evaluated. In the study group, there was a significant relief in the clinical symptoms assessed as compared to placebo group. Microscopic evidence also shows significant improvement and size of stone and its passage was also been significantly improved after six months of treatment as compared to before treatment. Hence, from this study, it was proven that the Ayurvedic herbal capsule UNEX significantly reduces the Ureteric calculi and symptoms associated with it.