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Completed

NCT Number: NCT00460538

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dubrava University Hospital

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lectranal

Dietary Supplement

Dosage form: capsule

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. changes in SARS (seasonal allergic rhinitis symptoms)

    Time frame: 6 weeks

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

    Time frame: 6 weeks

  3. changes in specific IgE

    Time frame: 6 weeks

  4. changes in specific IgG

    Time frame: 6 weeks

Secondary outcomes

  1. Prick test change

    Time frame: 6 weeks

  2. change in eosinophilia in nasal secretion

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Milsing d.o.o.

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 16, 2007
Registry last updated
Apr 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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