Health TrialsbyHealthPanel

Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

ConditionUrolithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeopharm Bulgaria Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neorenal Forte

    Dietary supplement

    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).

  • Placebo

    Dietary supplement

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Neorenal ForteExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

Duration of analgesics administration

Administration of antipyretics as reported on the patient diary - YES/NO

Time frame
Up to 90 days after endourological treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neopharm Bulgaria Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now