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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-11-30

Brief Summary

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

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Detailed Description

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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

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

1

Group Type ACTIVE_COMPARATOR

Lectranal

Intervention Type DIETARY_SUPPLEMENT

Dosage form: capsule

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

Interventions

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Lectranal

Dosage form: capsule

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

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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