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

This study has been completed.
Information provided by:
Milsing d.o.o. Identifier:
First received: April 13, 2007
Last updated: April 2, 2010
Last verified: March 2010
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 Blind (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.

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

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
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Please refer to this study by its identifier: NCT00460538

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

Responsible Party: Neven Tudoric MD PhD, Dubrava University Hospital, Zagreb, Croatia Identifier: NCT00460538     History of Changes
Other Study ID Numbers: MIL-002
Study First Received: April 13, 2007
Last Updated: April 2, 2010

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

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 28, 2017