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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
MHAT "Heart and Brain"
Burgas, Bulgaria
RECRUITINGUMHAT "Dr. Georgi Stranski"
Pleven, Bulgaria
RECRUITINGUniversity Hospital for Active Treatment "Saint Marina"
Pleven, Bulgaria
Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
Percentage of subjects without stones or with fragments ≤ 2mm in diameter 3 months after fURS for laser lithotripsy of kidney stones, assessed by NCCT.
Time frame: 90 days + 5 days after endourological treatment.
Percentage, size and location of residual fragments.
The outcome will be categorized by radiologist via NCCT in 2 categories: ≤ 2mm, or \> 2mm.
Time frame: 90 days + 5 days after endourological treatment.
Number of subjects with complications associated with residual fragments or their elimination
Febrility, renal colic, protracted hematuria, hydronephrosis grade I, II, III, IV.
Time frame: at 30 days and 90 days + 5 days after endourological treatment.
Percentage of subjects receiving analgesics
Administration of antipyretics as reported on the patient diary - YES/NO
Time frame: Up to 90 days after endourological treatment.
Duration of analgesics administration
Administration of antipyretics as reported on the patient diary - YES/NO
Time frame: Up to 90 days after endourological treatment.
Severity of pain
Clinical assessment of pain is based on visual analogue scale (VAS) from 0 to 10
Time frame: Up to 90 days after endourological treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UMHAT "St. George"
Plovdiv, Bulgaria
RECRUITINGUMHAT Kaspela
Plovdiv, Bulgaria
RECRUITINGUMHAT "Alexandrovska"
Sofia, Bulgaria
RECRUITINGMilitary Medical Academy
Sofia, Bulgaria
RECRUITINGUMBALSM "N. I. Pirogov"
Sofia, Bulgaria
RECRUITINGUMHAT "Sofiamed"
Sofia, Bulgaria
RECRUITING