E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with diagnosys of cystitis confirmed by urine culture |
pazienti con diagnosi di cistite confermata da urino cultura |
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E.1.1.1 | Medical condition in easily understood language |
patients with infection of the tract urinary |
pazienti che presentano un infezione del tratto urinario |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021881 |
E.1.2 | Term | Infections and infestations |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To observe the safety of tablets containing an extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo as co adjuvant for the treatment of cystitis in patients > o =18 years |
Osservare la sicurezza di compresse contenenti estratto di Hibiscus sabdariffa (HS) e Proposol BNatural versus placebo come coadiuvante nel trattamento della cistite in pazienti di età uguale o superiore a 18 anni |
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E.2.2 | Secondary objectives of the trial |
To observe the effectiveness of tablets containing an extract of Hibiscus sabdariffa (HS) and Propoli versus placebo as co adjuvant for treatment of cystitis on terms of reductions of the symptoms and of reductions of recurrences |
Osservare l'efficacia di compresse contenenti estratto di Hibiscus sabdariffa (HS) Proposol BNatural versus placebo come coadiuvante nel trattamento della cistite in termini di riduzione della sintomatologia e riduzione del numero di recidive |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients > o =18 years ; • Caucasian origin; • Normal physical examination, vital signs and laboratory evaluations; • Diagnosis of cystitis; • Infection of the urinary tract confirmed by urine culture • Sensitivity demonstrated to Ciprofloxacina • Antibiotic treatment based on Ciproxin for 5 days after the diagnosis of cystitis |
Soggetti di ambo i sessi, di età uguale o superiore a 18 anni - Origine caucasica; - Esame fisico, segni vitali e valutazioni di laboratorio normali; - Diagnosi accertata di cistite - Infezione del tratto urinario confermato da urino coltura - Sensibilità dimostrata alla ciprofloxacina -Assegnato trattamento antibiotico con CIPROXIN per almeno 5 giorni al momento della diagnosi di cistite |
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E.4 | Principal exclusion criteria |
Patients < 18 years • No infection of the urinary tract confirmed by urine culture • No Sensitivity demonstrated to Ciprofloxacina • Impossibility to follow the antibiotic treatment with Ciproxin |
-Soggetti di età inferiore a 18 anni -No sensibilità alla ciprofloxacina -Urino coltura negativo -Impossibilità a seguire il trattamento antibiotico con CIPROXIN |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety will be evaluated in terms of: 1) Evaluation of the difference in terms of Frequency, intensity and relation with the treatments administered of adverse events between the two groups of treatment; 2) Results of clinical laboratory parameters monitored and vital signs examined between the screening visit and the end of study in the two groups;). |
La sicurezza sarà valutata in termini di: 1) valutazione di eventuali differenze nella comparsa di eventi avversi, frequenza, intensità e relazione con i trattamenti in studio fra i due gruppi di trattamento 2) valutazione di eventuali differenze clinicamente significative nei risultati degli esami di laboratorio e dei segni vitali tra la fase di screening e fine studio fra i due gruppi di trattamento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the treatment |
a fine di trattamento |
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E.5.2 | Secondary end point(s) |
The efficacy will be evaluate in terms of both objective and subjective criteria: 1) subjective urinary comfort (number of daily urinations and pain on daily urinations)after the day 3, 5, 20 of the first cycle and after the second and third month; 2) number of recurrences (from study day 0) based on clinical observations of symptomatic episodes of cystitis between the test treatment group and the inactive placebo group after 3 and 6 months; |
L’efficacia sarà valutata in termini di: 1) differenza nel numero di minzioni giornaliere e del dolore alla minzione al terzo, quinto e ventesimo giorno del primo ciclo di trattamento ed alle visite del secondo mese e del terzo mese (numero di minzioni giornaliere e dolore durante le minzioni)tra il braccio con trattamento attivo e il braccio con placebo 3) differenza del numero di recidive fra il trattamento attivo e il trattamento con placebo dopo 3 mesi di trattamento e dopo 6 mesi. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 6 months from the start of the treatment |
dopo 6 mesi dall'inizio del trattamento |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | 0 |