EUCTR2007-003739-22-ITActive, not recruitingNot Applicable
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
GALSOR S.R.L.0 sitesStarted: November 15, 2007Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •-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.
Investigators
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