Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
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.
Neopharm Bulgaria Ltd.
120 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- 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 10x10 mm to 15x10 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.
Exclusion Criteria22
- 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/m2.
- 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.
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Interventions
This specialized formulation of phytotherapeutic extracts consists of proprietary Betula pendula leaves dry extract, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens. The product contains supplementary ingredients: microcrystalline cellulose, povidone, magnesium stearate, colorant film (brilliant blue FCF, iron dioxide).
The placebo product will be identical to the active form and will have the same composition but without the proprietary extract from Betula pendula, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens.
Locations(9)
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NCT06651294