Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- kidney stone clearance with Renalof® treatment compared to placebo
研究概览
简要总结
Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.
With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.
详细描述
Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.
With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.
The treatment group consists of 120 patients over 18 years of age, of both sexes, with a diagnosis of urolithiasis less than 10 mm in diameter, present throughout the entire reno-uretero-bladder path, diagnosed by ultrasound, renal CT and urography . The Renalof® product was administered at a dose of 650 mg daily for 3 months and the presence of stones in any location of the reno-ureteral tract was evaluated using one of the diagnostic means mentioned in monthly consultations. The second group, treated with placebo corresponding to 35 people constituting 30% of the universe. The study period was from August 2019 to July 2020 at the Hospital Escuela Antonio Lenin Fonseca and the Seniors clinic, in the city of Managua, Nicaragua.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age, in all their mental and physical capacities to decide to be part of this study.
- •There are no comorbidities or associated diseases that put the stability of the patient at risk.
- •Not be diagnosed as Chronic Kidney Disease, in any stage.
- •Existence of non-obstructive stones smaller than 10 mm located in the renoureteral path.
- •No compromise of renal viability.
排除标准
- •Patients under 18 years of age.
- •Existence of comorbidities or associated diseases that put the stability of the patient at risk.
- •Existence of a diagnosis of Chronic Kidney Disease, at any stage.
- •Presence of non-obstructive or obstructive stones greater than 10 mm located in the renoureteral path.
- •Renal viability compromise.
结局指标
主要结局
kidney stone clearance with Renalof® treatment compared to placebo
时间窗: 4 months
kidney stone clearance with Renalof® treatment compared to placebo measured by ultrasound and tomography imaging
次要结局
- Quality of life of patients(4 months)
- Adverse events related with product of the trial(4 months)
- Number of colic(4 months)