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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
314
1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
Immanuel Krankenhaus Berlin
Berlin, Germany
Site in Berlin
Berlin, Germany
Site in Bochum
Bochum, Germany
Rate of responders
Rate of responders which occur between baseline and 14 days after baseline (V4). A response is defined as stable reduction of MRSSpat (sum of 5 main rhinosinusitis symptoms daily assessed by the patient) by at least 50%, i.e. reduction by at least 50% and no subsequent change from baseline ≥ 50% up to treatment termination.
Time frame: 2 weeks
Rate of remissions
Rate of remissions which occur between baseline and V4. A remission is defined as complete disappearance of all 5 main rhinosinusitis symptoms with no subsequent reoccurrence of any symptom up to treatment termination.
Time frame: 2 weeks
Time to response
a) Time to response
Time frame: 2 weeks
Change in the overall MRSSinv (main symptoms)
Change in the overall MRSSinv (sum of 5 main rhinosinusitis symptoms, assessed by the Investigator) at V2 (7 days after baseline), V3 (10 days after baseline) and V4 (14 days after baseline), as well as in the time course of the study
Time frame: 2 weeks
Change in the overall MRSSinv (remaining symptoms)
Change in the overall MRSSinv (sum of the remaining symptoms, assessed by the Investigator) at V2, V3 and V4, as well as in the time course of the study
Time frame: 2 weeks
Time to disappearance
Time to disappearance in the individual MRSSpat symptoms (in case of positive baseline value)
Time frame: 2 weeks
Time to improvement
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Site in Chemnitz
Chemnitz, Germany
Site in Köln
Cologne, Germany
Site in Dresden
Dresden, Germany
Site in Duisburg
Duisburg, Germany
Site in Düren
Düren, Germany
Site in Essen
Essen, Germany
Site in Frankfurt am Main
Frankfurt am Main, Germany
...and 10 more locations
Time to improvement in the individual MRSSpat symptoms (in case of positive baseline value)
Time frame: 2 weeks
Time to remission
Time to remission
Time frame: 2 weeks
Change in the individual MRSSinv symptoms
Change in the individual MRSSinv symptoms, assessed by the Investigator, between baseline and V2, V3 and V4, as well as in the time course of the study
Time frame: 2 weeks
SNOT-20 GAV
1. Change in the Sino-Nasal Outcome Test, German Adapted Version (SNOT-20 GAV), in the Overall Score (OS) as well as in the sub scores PNS (Primary Nasal Symptoms), SRS (Secondary Rhinogenous Symptoms, and Quality of Life Score (GQOL), assessed by the patient between baseline and V2, V3 and V4 2. Change in the SNOT-20 GAV, score of 5 most important symptoms, assessed by the patient between baseline and V2, V3 and V4 3. Change in the SNOT-20 GAV, individual symptoms, assessed by the patient between baseline and V2, V3 and V4, respectively
Time frame: 2 weeks
VASpat
Change in the assessment of health status by patient using a Visual Analogue Scale (VASpat) using a 10-cm scale (0= best state of health to 10= worst state of health) between baseline and V2, V3 and V4
Time frame: 2 weeks
VASinv
Change in the assessment of the patient's health status by the investigator using a Visual Analogue Scale (VASinv) between baseline and V4
Time frame: 2 weeks
Change in the assessment of the patient's health status
Change in the assessment of the patient's health status by the investigator using a Visual Analogue Scale (VASinv) between baseline and V4
Time frame: 2 weeks
General assessment of efficacy
General assessment of efficacy by the investigator (on a 4-point rating scale) at each visit from V2 to V4
Time frame: 2 weeks
Rescue medication
Use of antibiotics / allowed rescue medication
Time frame: 2 weeks