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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460538
First Posted: April 16, 2007
Last Update Posted: April 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Milsing d.o.o.
  Purpose
The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Condition Intervention Phase
Seasonal Allergic Rhinitis Dietary Supplement: Lectranal Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Resource links provided by NLM:


Further study details as provided by Milsing d.o.o.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Prick test change [ Time Frame: 6 weeks ]
  • change in eosinophilia in nasal secretion [ Time Frame: 6 weeks ]

Enrollment: 48
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460538


Locations
Croatia
Dubrava University Hospital
Zagreb, Croatia, 10000
Sponsors and Collaborators
Milsing d.o.o.
Investigators
Principal Investigator: Neven Tudoric, MD PhD Dubrava University Hospital
  More Information

Publications:
Responsible Party: Neven Tudoric MD PhD, Dubrava University Hospital, Zagreb, Croatia
ClinicalTrials.gov Identifier: NCT00460538     History of Changes
Other Study ID Numbers: MIL-002
First Submitted: April 13, 2007
First Posted: April 16, 2007
Last Update Posted: April 5, 2010
Last Verified: March 2010

Keywords provided by Milsing d.o.o.:
Seasonal allergic rhinitis
lectranal
allergy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases