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

April 2, 2010 updated by: Milsing d.o.o.
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Dubrava University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Dietary supplement: placebo
Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks
Active Comparator: 1
Dietary supplement: Lectranal

Dosage form: capsule

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in SARS (seasonal allergic rhinitis symptoms)
Time Frame: 6 weeks
6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)
Time Frame: 6 weeks
6 weeks
changes in specific IgE
Time Frame: 6 weeks
6 weeks
changes in specific IgG
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Prick test change
Time Frame: 6 weeks
6 weeks
change in eosinophilia in nasal secretion
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milsing d.o.o.

Investigators

  • Principal Investigator: Neven Tudoric, MD PhD, Dubrava University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 13, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2010

Last Update Submitted That Met QC Criteria

April 2, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIL-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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