patients with diagnosys of cystitis confirmed by urine culture MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: CIPROXIN*6CPR RIV 500MG
Pharmaceutical Form: Tablet
CAS Number: 85721-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 582-
Sponsors
NOVINTETHICAL PHARMA SAGL
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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;).;Timepoint(s) of evaluation of this end point: at the end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;;Timepoint(s) of evaluation of this end point: after 6 months from the start of the treatment | — |
Countries
Italy
Contacts
Public Contactinformazione sulla sperimentazione
fourpharma srl
Outcome results
None listed