跳至主要内容
临床试验/EUCTR2007-003739-22-IT
EUCTR2007-003739-22-IT进行中(未招募)不适用

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 个研究点开始时间: 2007年11月15日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
GALSOR S.R.L.

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