Safety and efficacy of a polyherbal formulation from traditional Persian medicine in patients with calcium kidney stones: A randomized, double‑blinded clinical trial

Abstract

Background: 10%–15% of the world’s population suffers from kidney stones. Nearly 50% increase was observed in diagnosing and treating nephrolithiasis in the last decades. Effective medical treatment for the disease is not yet well established. Moreover, there is an increasing global demand to manage diseases using complementary and alternative medicine. This study aimed to formulate and assess the safety and efficacy of a multi‑ingredient formulation from traditional Persian medicine (TPM) known as Mofatet powder in patients suffering from calcium kidney stones. Materials and Methods: The aqueous extract of Mofatet powder was prepared, freeze‑dried, and formulated as capsules. 26 patients in the drug group and 25 patients in the placebo group used 500 mg capsules of the drug/placebo twice daily for 5 weeks. Ultrasonography/kidney, ureter and bladder imaging, urine analysis, and biochemical parameters were evaluated before and after the intervention. Results: The imaging results showed a 60.73% decrease (P < 0.001) in stone size in the drug group. Moreover, the urinary calcium decreased (P = 0.02) and the urinary magnesium increased (P < 0.001) in the drug group. No remarkable changes were observed in the placebo group in these parameters. No significant effect was observed in aspartate transaminase, alanine transaminase, serum creatinine, and blood urea nitrogen levels in none of the groups. Conclusion: This study suggests that Mofatet powder was effective in reducing calcium kidney stones size with no potential nephro/ hepatotoxicity. After confirming these results in larger clinical trials with longer duration, this formulation can be considered a treatment for nephrolithiasis.