An interventional study of Neorenal Forte and Placebo in Urolithiasis, sponsored by Neopharm Bulgaria Ltd.. Completed at 7 sites in Bulgaria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Neopharm Bulgaria Ltd. · Not applicable, Interventional, and Treatment
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 93 is close to the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Neopharm Bulgaria Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily
Dietary Supplement: Neorenal Forte
Up to Day 10 after the endourological procedure - 2 tablets 2 times daily Followed by 80 days after end date of 2X2 dose - 1 tablet 2 times daily
Dietary Supplement: Placebo
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.
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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