Ansari Ramin, Karimzade Iman, Nimrouzi Majid, Ezatzadegan Shahrokh, Hosseini Mohammad Mehdi, Zarshenas Mohammad Mehdi
Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
J Res Med Sci. 2024 Feb 23;29:12. doi: 10.4103/jrms.jrms_670_22. eCollection 2024.
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 powder in patients suffering from calcium kidney stones.
The aqueous extract of 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.
The imaging results showed a 60.73% decrease ( < 0.001) in stone size in the drug group. Moreover, the urinary calcium decreased ( = 0.02) and the urinary magnesium increased ( < 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.
This study suggests that 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.
全球10%-15%的人口患有肾结石。在过去几十年中，肾结石的诊断和治疗数量增长了近50%。针对该疾病的有效药物治疗方法尚未完全确立。此外，全球对使用补充和替代医学来管理疾病的需求日益增加。本研究旨在配制并评估一种源自传统波斯医学（TPM）的多成分制剂——粉末对患有钙结石的患者的安全性和有效性。
制备粉末的水提取物，冷冻干燥后制成胶囊。药物组的26名患者和安慰剂组的25名患者每天服用两次500毫克的药物/安慰剂胶囊，持续5周。在干预前后评估超声检查/肾脏、输尿管和膀胱成像、尿液分析及生化参数。
成像结果显示，药物组结石大小减少了60.73%（<0.001）。此外，药物组的尿钙降低（=0.02），尿镁升高（<0.001）。安慰剂组在这些参数上未观察到明显变化。在所有组中，天冬氨酸转氨酶、丙氨酸转氨酶、血清肌酐和血尿素氮水平均未观察到显著影响。
本研究表明，粉末在减少钙结石大小方面有效，且无潜在的肾/肝毒性。在更长时间的大型临床试验中证实这些结果后，该制剂可被视为肾结石的一种治疗方法。
