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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460538

Enrollment

Registered

2007-04-16

Start date

2007-04-30

Completion date

2007-11-30

Last updated

2010-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitis, lectranal, allergy

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.

Interventions

DIETARY_SUPPLEMENTLectranal

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

DIETARY_SUPPLEMENTplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Prick test change	6 weeks
change in eosinophilia in nasal secretion	6 weeks

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026