Clinical Trials Directory

Trials / Completed

CompletedNCT00460538

Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Milsing d.o.o. · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Detailed description

Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLectranalDosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks
DIETARY_SUPPLEMENTplaceboDosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks

Timeline

Start date
2007-04-01
Primary completion
2007-10-01
Completion
2007-11-01
First posted
2007-04-16
Last updated
2010-04-05

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT00460538. Inclusion in this directory is not an endorsement.