Efficacy of an Oral Solution Containing Five Herbal Extracts in the Treatment of Urolithiasis: A Randomized, Single-blind, Placebo-controlled Clinical Trial.

Objective: The high prevalence of urolithiasis and its recurrence entail the preparation of an efficient drug with the least side effects. Tribulus terrestris, Urtica dioica, Adiantum capillus-veneris, Stigma maydis (corn silk), and Cucumis melo are herbal remedies utilized in traditional medicine for urolithiasis. This study aimed to assess the efficiency of these plants' extracts in treating urolithiasis.

Methods: In a randomized, single-blind, placebo-controlled clinical trial, participants meeting inclusion criteria were randomly allocated to the drug (n = 27) and placebo (n = 27) groups to take herbal or placebo solutions, respectively, at a dose of 60 drops 3 times daily for 4 weeks with standard treatment. Before and after the intervention, 24-h urine volume and the quantities of calcium, sodium, citrate, oxalate, urea, creatinine, and uric acid in 24-h urine, and urinary pH were measured. The number and size (diameter in mm) of stones were determined by ultrasonography and recorded for each patient.

Findings: Except for 24 h urine volume, other urinary parameters did not alter significantly at the end of the intervention compared to baseline. Furthermore, the two groups had no significant difference regarding these indices. Regarding stone parameters, the stone size decreased significantly in the drug group compared to the placebo group (P = 0.049). The number of cases with complete stone expulsion in the drug group was significantly higher than in the placebo group (12 cases vs. 4 cases, respectively, P = 0.017).

Conclusion: Oral consumption of the herbal solution causes stone size reduction and stone expulsion in patients with urolithiasis.