Safety and efficacy (for the symptom remission) of the treatment adjuvant of the antibiotic therapy of the acute episode of sinusitis (acute, subacute, chronic)with Ecballium Elaterium (SINUclean DM): comparative, prospective, randomized, open study. - ND

Conditions: Acute sinusitis or exacerbation of subacute or chronic sinusitis.
MedDRA version: 9.1Level: LLTClassification code 10040753Term: Sinusitis

Registration Number: EUCTR2007-003739-22-IT

Lead Sponsor: GALSOR S.R.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

8.Male, females
9.Age > 18 years.
10.Clinica diagnosis of acute sinusitis, or of exacerbation of subacute or chronic sinusitis, confirmed radiologically with a CTA scan image
11.Presence of mucus in the paranasal sinuses
12.Facial pain and congestion of the mucosa of paranasal sinuses since at least three days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Clinical conditions (systemic pathologies, or other) that can interfere with the assessment of the safety and efficacy of the experimental product like for example:
-viral or allergic rhinitis, with active secretive symptoms
-presence of visible nasal polyps
-diagnosis of immobile cilia syndromes
-diseases causing immunodeficiencies
-cystic fibrosis
-immunocompromissione
-renal block
-dialysis
-other pathologies of other apparatus that, in the opinion of the investigator, are interfering.
Necessity of a supplemental antibiotic therapy, due to other pathologies, besides that for the treatment of sinusitis.
Smoke during the period of the study
History of intolerance or allergy to the components of SINUclean DM
Medical or surgery intervention that can jeopardize the complete effectuation of the experimentation, in the four weeks preceding the signature of the informed consent.