A Study to Evaluate the Efficacy Safety and Tolerability of New Formulation of Dolichos biflorus Seeds in Urolithiasis

Abstract

The aim of the present study was to assess the safety, tolerability and efficacy of dietary Dolichos biflorus seeds as a functional beverage and as natural dietary supplements for prevention and/or management of urolithiasis and explore the underlying pharmacological mechanisms responsible for this activity. We added some other dietary compounds to make study formulation more palatable. Antiurolithiatic potential of study formulation was evaluated using in vitro (synthetic and human urine model), in vivo (ethylene glycol induced wistar albino rat model) and clinical study (open-labelled, parallel, comparative randomised urolithiasis patient based trial). Our in vitro and in vivo studies reported that antioxidant, crystals aggregation inhibition and restoration of Slc26 transporters properties are mechanism for antiurolithiatic activity of study formulation. Inhibition of calcium oxalate aggregation was statistically significant with study formulation (pand#706;0.05) as compared to vehicle (p=0.31) treatment during our in vitro studies. Study formulation reported DPPH, hydrogen peroxide and reducing power activity comparable to standard ascorbic acid, suggested its antioxidant potential. During in vivo experiments, study formulation and cystone significantly reduced TBARS (pand#706;0.001) and increased GSH (pand#706;0.001), catalase (pand#706;0.001) and SOD (pand#706;0.001) activity in homogenized kidney tissue as compared to urolithiasis control and hydrochlorothiazide treated group and support the antioxidant potential of study formulation. Probenecid, a membrane organic anion transporter (Slc26) inhibitor, treatment has abolished antiurolithiatic activity of functional beverage and suggested Dolichos biflorus produce effect through restoration of membrane oxalate transporters activity. Fifty subjects of 18 to 75 years of age with diagnosis of urolithiasis, with renal stone burden (and#8804;8 mm), as determined by ultrasound/X-ray KUB were included in the study. All patients continued receiving standard of care. newline