Efficacy and Safety of Neorenal Forte as Adjuvant Treatment for the Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Renal Calculi.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 18
- 主要终点
- Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.
详细描述
The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications.
By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators will be provided with coded products which are identical in appearance. Each individual involved in the study will be blinded to the treatment assignment until study completion. Considering the established safety profile of the formula of phytotherapeutic extracts, emergency unblinding of treatment assignment will not be necessary. So no copies of the treatment assignments will be stored at the enrollment sites. No information about the subjects will be shared with the company conducting the randomization.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 65 years of age.
- •The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
- •A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment of size, number, location and stone density, within 90 days of fURS.
- •Single or multiple kidney stones with total size of 10x10x10 mm to 15x10x10 mm.
- •Stone density 1001 - 1400 Hounsfield units (HU).
- •Subjects post fURS for laser lithotripsy of kidney stone.
- •Residual fragments < 4 mm after fURS confirmed by ultrasound on first postoperative day.
- •Subjects post one fURS.
- •fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
- •No recent ureterorenoscopy within the last 6 months.
- •Body mass index 17.0 - 29.99 kg/m2 118
- •In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
- •The subject has a smartphone and is capable of using it.
排除标准
- •Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
- •Ureteral stenosis.
- •History of ipsilateral renal surgery.
- •Hydronephrosis.
- •Permanent JJ stent.
- •Any conditional or absolute contraindications for fURS.
- •Combined ipsilateral stone in the ureter or contralateral stone in the upper urinary canal or a stone in the lower urinary canal, requiring simultaneous surgery.
- •Subjects with positive urine culture, until resolution.
- •History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
- •Stone density <1000 and >1401 HU;
- •Uncontrolled diabetes mellitus (HbA1c >9%).
- •Renal insufficiency.
- •Subjects with arterial hypertension.
- •Subjects with prostate adenoma.
- •Allergy or hypersensitivity to any of the ingredients of the investigational product.
- •BMI ≥ 30 kg/m
- •Women who are pregnant or lactating; women who plan on getting pregnant during the study.
- •Alcohol or drug abuse in the last year.
- •Unstable medical conditions, as determined by the Investigator.
- •Inability to comply with the study protocol.
- •Subjects who cannot understand or not capable of completing the study documents.
- •Inability to give informed consent.
研究组 & 干预措施
Neorenal Forte
Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily
干预措施: Neorenal Forte (Dietary Supplement)
Placebo
Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
时间窗: 90 days + 5 days after endourological treatment.
Percentage of subjects without stones or with fragments ≤ 2mm in diameter 3 months after fURS for laser lithotripsy of kidney stones, assessed by NCCT.
次要结局
- Percentage, size and location of residual fragments.(90 days + 5 days after endourological treatment.)
- Number of subjects with complications associated with residual fragments or their elimination(at 30 days and 90 days + 5 days after endourological treatment.)
- Percentage of subjects receiving analgesics(Up to 90 days after endourological treatment.)
- Duration of analgesics administration(Up to 90 days after endourological treatment.)
- Severity of pain(Up to 90 days after endourological treatment.)