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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neorenal Forte | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days + 5 days after endourological treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage, size and location of residual fragments. | The outcome will be categorized by radiologist via NCCT in 2 categories: ≤ 2mm, or > 2mm. | 90 days + 5 days after endourological treatment. |
| Number of subjects with complications associated with residual fragments or their elimination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margarita Futekova | Contact | +359 888 151 579 | m.futekova@neopharm.bg | |
| Stefan Tunev, PhD | Contact | +359 888 786 540 | s.tunev@neopharm.bg |
| Name | Affiliation | Role |
|---|---|---|
| Marin Georgiev, Prof, PhD | UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University | Principal Investigator |
| Iliya Saltirov, Prof, MD, PhD, DSc | Military Medical Academy, Head of Department of Urology and Nephrology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT "Heart and Brain" | Recruiting | Burgas | Bulgaria |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
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Investigators will be provided with coded products which are identical in appearance. Each individual involved in the study will be blinded to the treatment assignment until study completion. Considering the established safety profile of the formula of phytotherapeutic extracts, emergency unblinding of treatment assignment will not be necessary. So no copies of the treatment assignments will be stored at the enrollment sites. No information about the subjects will be shared with the company conducting the randomization.
|
| 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. |
|
Febrility, renal colic, protracted hematuria, hydronephrosis grade I, II, III, IV. |
| 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 | Up to 90 days after endourological treatment. |
| Duration of analgesics administration | Administration of antipyretics as reported on the patient diary - YES/NO | 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 | Up to 90 days after endourological treatment. |
| Boyan Atanasov, Prof, PhD | UMHAT "Saint Marina", Head of Department of Urology, Medical University of Pleven | Principal Investigator |
| Madjid Kadim, Prof, PhD | UMHAT "St. George", Head of Department of Urology | Principal Investigator |
| Stanislav Valkanov, PhD | UMHAT "Kaspela", Department of Urology | Principal Investigator |
| Deyan Anakievski, Prof, PhD | MHAT "Heart and Brain", Head of Department of Urology | Principal Investigator |
| Kaloqn Davidov, Prof, PhD | UMHAT "Sofiamed", Head of Department of Urology | Principal Investigator |
| Boris Mladenov, PhD | UMBALSM "N. I. Pirogov" | Principal Investigator |
| Nikolay Kolev, Prof, PhD | UMHAT "Dr. Georgi Stranski", Head of Department of Urology | Principal Investigator |
| Tosho Ganev, PhD | MHAT "St. Anna - Varna",Head of Department of Urology | Principal Investigator |
| UMHAT "Dr. Georgi Stranski" | Recruiting | Pleven | 5800 | Bulgaria |
|
| University Hospital for Active Treatment "Saint Marina" | Recruiting | Pleven | 5800 | Bulgaria |
|
| UMHAT "St. George" | Recruiting | Plovdiv | 4000 | Bulgaria |
|
| UMHAT Kaspela | Recruiting | Plovdiv | 4001 | Bulgaria |
|
| UMHAT "Alexandrovska" | Recruiting | Sofia | 1431 | Bulgaria |
|
| Military Medical Academy | Recruiting | Sofia | 1606 | Bulgaria |
|
| UMBALSM "N. I. Pirogov" | Recruiting | Sofia | 1606 | Bulgaria |
|
| UMHAT "Sofiamed" | Recruiting | Sofia | 1797 | Bulgaria |
|
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |