Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

NCT06651294 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • Urolithiasis

Interventions

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.

Sponsors & Collaborators

  • Neopharm Bulgaria Ltd.

    lead INDUSTRY

Principal Investigators

  • Marin Georgiev, Prof, PhD · UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University

  • Iliya Saltirov, Prof, MD, PhD, DSc · Military Medical Academy, Head of Department of Urology and Nephrology

  • Boyan Atanasov, Prof, PhD · UMHAT "Saint Marina", Head of Department of Urology, Medical University of Pleven

  • Madjid Kadim, Prof, PhD · UMHAT "St. George", Head of Department of Urology

  • Stanislav Valkanov, PhD · UMHAT "Kaspela", Department of Urology

  • Deyan Anakievski, Prof, PhD · MHAT "Heart and Brain", Head of Department of Urology

  • Kaloqn Davidov, Prof, PhD · UMHAT "Sofiamed", Head of Department of Urology

  • Boris Mladenov, PhD · UMBALSM "N. I. Pirogov"

  • Nikolay Kolev, Prof, PhD · UMHAT "Dr. Georgi Stranski", Head of Department of Urology

  • Tosho Ganev, PhD · MHAT "St. Anna - Varna",Head of Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-10-30
Completion
2026-11-30

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06651294 on ClinicalTrials.gov