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

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Lectranal

• Registration Number: NCT00460538
• Lead Sponsor: Milsing d.o.o.

Brief 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-13
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-16
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-04-02
• Last Update Posted: 2010-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• history of seasonal allergic rhinitis symptoms to pollen
• positive skin prick test to pollen
• negative history of seasonal allergic asthma
• male or female older than 18
• female participants must use appropriate contraception
• able to comply to study procedures

Exclusion Criteria

• pregnancy
• alcohol or drug abuse
• subject receiving antihistamines , immunotherapy or on hyposensibilisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	Lectranal	-

Primary Outcome Measures

Name	Time	Method
changes in SARS (seasonal allergic rhinitis symptoms)	6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)	6 weeks
changes in specific IgE	6 weeks
changes in specific IgG	6 weeks

Secondary Outcome Measures

Name	Time	Method
Prick test change	6 weeks
change in eosinophilia in nasal secretion	6 weeks

Trial Locations

Locations (1)

Dubrava University Hospital; 🇭🇷 Zagreb, Croatia