NCT06651294

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Neopharm Bulgaria Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Urolithiasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Neorenal Forte	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).
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-30
• Completion: 2026-11-30
• First posted: 2024-10-21
• Last updated: 2025-11-28

Locations

9 sites across 1 country: Bulgaria