Actively Recruiting
Efficacy and Safety of Neorenal Forte for Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Kidney Stones
Led by Neopharm Bulgaria Ltd. · Updated on 2025-11-28
120
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a specialized phytotherapeutic formula called Neorenal Forte in adults who have undergone flexible ureterorenoscopy (fURS) with laser lithotripsy for kidney stones (urolithiasis). The study aims to support healthcare specialists in deciding whether to use this treatment for at least three months after endourological procedures to help completely eliminate residual stone fragments and reduce related complications. Participants will receive either Neorenal Forte or a placebo in a randomized, triple-blind design. Treatment starts with 2 tablets twice daily up to 10 days after the procedure, followed by 1 tablet twice daily for 80 days. Both the active formula and placebo contain similar ingredients except the active proprietary extracts. This dosing schedule is designed to assess the formula's ability to clear residual fragments or fragments smaller than 2 mm. During the study, participants will undergo assessments including ultrasound to detect residual fragments, evaluation of fragment size and location, monitoring for complications, and pain assessments up to 90 days after treatment. Researchers will track analgesic use, pain severity, and safety outcomes. Participation includes regular visits and monitoring over approximately three months following the surgical treatment.
CONDITIONS
Brief Title
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Signed informed consent approved by an Ethics Committee
- Kidney stone confirmed by NCCT within 90 days before fURS
- Single or multiple kidney stones with total size between 10x10 mm and 15x10 mm
- Stone density between 1001 and 1400 Hounsfield units
- Underwent fURS for laser lithotripsy of kidney stone
- Residual fragments smaller than 4 mm confirmed by ultrasound on first postoperative day
- Only one fURS procedure performed
- fURS uncomplicated by serious injuries or bleeding
- No ureterorenoscopy within the last 6 months
- Body mass index between 17.0 and 29.99 kg/m2
- Able to comply with visit schedule and treatment regimen
- Owns and can use a smartphone
You will not qualify if you...
- Anatomical anomalies detected by ultrasound (e.g., stenosis of pyelo-ureteral junction, horseshoe kidney)
- Ureteral stenosis
- History of ipsilateral renal surgery
- Hydronephrosis
- Permanent JJ stent
- Contraindications for fURS
- Combined stones requiring simultaneous surgery
- Positive urine culture until resolved
- Prior endourological interventions before fURS
- Stone density less than 1000 or greater than 1401 HU
- Uncontrolled diabetes mellitus (HbA1c over 9%)
- Renal insufficiency
- Arterial hypertension
- Prostate adenoma
- Allergy or hypersensitivity to study product ingredients
- Body mass index 30 kg/m2 or higher
- Pregnancy or lactation, or planning pregnancy during study
- Alcohol or drug abuse in the last year
- Unstable medical conditions
- Inability to comply with study protocol or give informed consent
- Unable to understand or complete study documents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 90 days (10 days of higher dose followed by 80 days of lower dose)
Participants take Neorenal Forte or placebo tablets following endourological procedures to aid the elimination of residual kidney stone fragments.
Visits scheduled around treatment period to monitor progress
Duration - Up to 5 days after 90-day treatment
Participants are monitored for the presence of residual fragments and any complications after completing treatment.
1 to 2 visits for assessment after treatment completion
Trial Site Locations
Total: 9 locations
1
MHAT "Heart and Brain"
Burgas, Bulgaria
Actively Recruiting
2
UMHAT "Dr. Georgi Stranski"
Pleven, Bulgaria, 5800
Actively Recruiting
3
University Hospital for Active Treatment "Saint Marina"
Pleven, Bulgaria, 5800
Actively Recruiting
4
UMHAT "St. George"
Plovdiv, Bulgaria, 4000
Actively Recruiting
5
UMHAT Kaspela
Plovdiv, Bulgaria, 4001
Actively Recruiting
6
UMHAT "Alexandrovska"
Sofia, Bulgaria, 1431
Actively Recruiting
7
Military Medical Academy
Sofia, Bulgaria, 1606
Actively Recruiting
8
UMBALSM "N. I. Pirogov"
Sofia, Bulgaria, 1606
Actively Recruiting
9
UMHAT "Sofiamed"
Sofia, Bulgaria, 1797
Actively Recruiting
Research Team
M
Margarita Futekova
S
Stefan Tunev, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here