Acute Rhinosinusitis Clinical Trial
Official title:
Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase IV Study (Sinusitis Study)
Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal and paranasal sinuses).
Acute rhinosinusitis is one of the most common diseases worldwide with a prevalence of 6-15%
and a large impact on quality of life and socioeconomics. The majority of infections are of
viral origin, while acute bacterial infection occurs in only 0.5-2% of cases. Currently
available treatment includes a variety of remedies, like analgesic, inhalation with water
steam of diluted drugs, nasal douche or spray, decongestant and mucolytic remedies as well
as antibiotics.
Sinusitis Hevert SL is registered since 2003 for the treatment of inflammation of the nose
and throat region and the sinuses (sinusitis) and contains eleven homeopathic single
substances which are classically used in homeopathy for this condition, but has not been
evaluated in a randomized controlled clinical trial. In this multicenter, randomized,
double-blind, placebo-controlled, parallel group phase IV study the efficacy and safety of
Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated
rhinosinusitis shall be demonstrated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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