NCT02296814

Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Hevert-Arzneimittel GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Sinusitis Hevert SL Tablet	1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
DRUG	Placebo for Sinusitis Hevert SL Tablet	1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-11-20
• Last updated: 2015-07-17

Locations

20 sites across 1 country: Germany