Randomized and double-blinded clinical trial of the safety and calcium kidney stone dissolving efficacy of Lapis judaicus

Abstract

Ethnopharmacological relevance: Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss. Because of the side effects and costs of current interventional procedures, researchers are interested in finding medicinal therapies. In this regard, some reports have focused on traditional medicines as a drug discovery resource. Iranian scholars in the medieval era recommended Lapis judaicus for the prevention and treatment of kidney stones. The present study assessed the efficacy and safety of Lapis judaicus on the size of calcium kidney stones and some related biochemical factors in blood and urine.

Materials and methods: Sixty patients with kidney stone disease were included in this double-blind randomized clinical study. Thirty patients received 2g of Lapis judaicus powder in hard capsules per day for 10 weeks, and another 30 patients received a placebo for the same period. Ultrasonography was performed on patients, and blood and urine samples were collected before and after the study to evaluate the efficacy and safety of Lapis judaicus in calcium kidney stone patients.

Results: The size of the kidney stones was reduced significantly (p<0.001) in the drug group. In 9 patients from the drug group, the stone was completely dissolved. Moreover, urine calcium concentration and specific gravity were reduced and urine magnesium was increased (p<0.05). Lapis judaicus did not affect BUN, creatinine, ALT, or AST.

Conclusion: Contrary to the placebo group, the size of kidney stones was reduced significantly in the treatment group after oral administration of Lapis judaicus. This preliminary study confirms traditional knowledge of the efficacy and safety of Lapis judaicus in kidney stone diseases and suggests a new method to treat calcium kidney stones. Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of Lapis judaicus and clinical studies involving a larger population of patients will be necessary to fully explain and confirm the results obtained in the present study.

Keywords: Calcium oxalate; Chemolysis; Clinical trial; Kidney stone dissolving; Lapis judaicus; Traditional Iranian medicine.