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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lectranal | Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks |
| DIETARY_SUPPLEMENT | placebo | Dosage 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.