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Abstract：
BACKGROUND: Urolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are kept under observation. Many herbal preparations are available for the same, but they lack proper scientific documentation.
OBJECTIVE: To study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm.
METHODS: This was a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in a tertiary care hospital in Pune, India. Patients with asymptomatic renal calculi of 4-9 mm size were randomized (1:1, block randomization) to one of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome included change in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion. Statistical analysis was performed using student\'s t-test and Chi-square test.
RESULTS: A total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, of which 65 patients completed the trial (treatment, n = 34; placebo, n = 31). The VAS score significantly decreased in the treatment group (6.9-1.8) than placebo group (7.2-6.8) (p < 0.001). The surface area and density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatment group than the placebo group. The expulsion of calculi was significantly higher in the treatment group than placebo group (20.59 vs. 3.23%, p < 0.03).
CONCLUSIONS: Patients treated with herbal formulation showed better expulsion rate and reduction in surface area and density than the placebo group.
OBJECTIVE: To study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm.
METHODS: This was a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in a tertiary care hospital in Pune, India. Patients with asymptomatic renal calculi of 4-9 mm size were randomized (1:1, block randomization) to one of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome included change in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion. Statistical analysis was performed using student\'s t-test and Chi-square test.
RESULTS: A total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, of which 65 patients completed the trial (treatment, n = 34; placebo, n = 31). The VAS score significantly decreased in the treatment group (6.9-1.8) than placebo group (7.2-6.8) (p < 0.001). The surface area and density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatment group than the placebo group. The expulsion of calculi was significantly higher in the treatment group than placebo group (20.59 vs. 3.23%, p < 0.03).
CONCLUSIONS: Patients treated with herbal formulation showed better expulsion rate and reduction in surface area and density than the placebo group.
摘要：
背景：尿石症是世界范围内日益严重的问题。很多次,无症状结石一直在观察。许多草药制剂都是一样的，但他们缺乏适当的科学文献.
目的：为了研究中草药制剂的抗尿路结石作用，SubapPlus（IP）胶囊治疗无症状肾结石，大小为4至9毫米。
方法：这是一个前瞻性的，随机化，双盲,在浦那的三级医院进行的安慰剂对照临床试验，印度。无症状肾结石大小为4-9毫米的患者被随机分配（1：1，分组随机分配）至SubapPlus组（治疗组）或安慰剂组（安慰剂组）之一。研究结果包括视觉模拟量表(VAS)的变化，结石表面积和密度的变化及其排出。采用t检验和卡方检验进行统计学分析。
结果：共筛选了120例符合资格标准的患者，纳入了84例，其中65名患者完成了试验(治疗，n=34；安慰剂，n=31）。与安慰剂组(7.2-6.8)相比,治疗组(6.9-1.8)的VAS评分显著降低(p<0.001)。表面积和密度分别降低了47.58%(p<0.008)和43.01%(p<0.001),分别,在治疗组优于安慰剂组。治疗组结石的排出率明显高于安慰剂组（20.59vs.3.23%,p<0.03)。
结论：与安慰剂组相比，用草药制剂治疗的患者表现出更好的排出率和表面积和密度降低。
目的：为了研究中草药制剂的抗尿路结石作用，SubapPlus（IP）胶囊治疗无症状肾结石，大小为4至9毫米。
方法：这是一个前瞻性的，随机化，双盲,在浦那的三级医院进行的安慰剂对照临床试验，印度。无症状肾结石大小为4-9毫米的患者被随机分配（1：1，分组随机分配）至SubapPlus组（治疗组）或安慰剂组（安慰剂组）之一。研究结果包括视觉模拟量表(VAS)的变化，结石表面积和密度的变化及其排出。采用t检验和卡方检验进行统计学分析。
结果：共筛选了120例符合资格标准的患者，纳入了84例，其中65名患者完成了试验(治疗，n=34；安慰剂，n=31）。与安慰剂组(7.2-6.8)相比,治疗组(6.9-1.8)的VAS评分显著降低(p<0.001)。表面积和密度分别降低了47.58%(p<0.008)和43.01%(p<0.001),分别,在治疗组优于安慰剂组。治疗组结石的排出率明显高于安慰剂组（20.59vs.3.23%,p<0.03)。
结论：与安慰剂组相比，用草药制剂治疗的患者表现出更好的排出率和表面积和密度降低。
