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

Milsing d.o.o.48 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

LectranalDIETARY_SUPPLEMENT

Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks

placeboDIETARY_SUPPLEMENT

Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dubrava University Hospital

Zagreb, Croatia

Outcomes

Primary Outcomes

changes in SARS (seasonal allergic rhinitis symptoms)

Time frame: 6 weeks

changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)

Time frame: 6 weeks

changes in specific IgE

Time frame: 6 weeks

changes in specific IgG

Time frame: 6 weeks

Secondary Outcomes

Prick test change

Time frame: 6 weeks

change in eosinophilia in nasal secretion

Time frame: 6 weeks

Data from ClinicalTrials.gov

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