Safety and Efficacy of tablets containing extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo in the treatment of the cystitis with Ciproxi

• Conditions: patients with diagnosys of cystitis confirmed by urine culture; MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000938-19-IT
• Lead Sponsor: OVINTETHICAL PHARMA SAG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-02
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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