Randomized single-blind clinical evaluation of Safoof-e-Pathar phori in urolithiasis patients

Abstract

Objective: Safoof-e-Pathar phori (SPP), a unani polyherbomineral formulation, used for antilithiatic activity since long time. This study was aimed to evaluate the clinical efficacy of SPP in adult human patients with urolithiasis. The study was a randomized, placebo-controlled, and single-blind, clinical trial. Materials and Methods: Forty-five patients who have stone size below 15 mm in the age group of 15-55 years with diagnosis of calcium oxalate renal calculi were taken in the study. Out of which, only 30 patients fulfilled the criteria and completed the study. Twenty patients received SPP (Group I) and ten patients were given placebo (Group II) for 2 months. The patients were investigated for routine, hemogram, blood urea, serum creatinine, calcium, phosphorus, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, and uric acid levels at definite time intervals. Similarly, routine and microscopic urine examination was done with radio-imaging KUB and ultrasound KUB examination, etc., which were repeated on completion of the study. Results: All patients received the same dosage of SPP or placebo for a 2-month period. On starting SPP, symptomatic relief was reported by patients. The disappearance of stones was noted in patients as confirmed by X-ray KUB and Ultrasound KUB examination. Totally, 56.67% of patients showed reduction in size of stone and 49.31% showed litho expulsive effect. Conclusion: The use of SPP in the treatment of calcium oxalate stone as noninvasive remedy for the urolithiatic patients is validated and proved. Since the dose of formulation is too high, further study on dose reduction followed by preclinical evaluation may be attempted for development of scientific data.