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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 4

Locations

Croatia

Study Type

Interventional

Intervention

Lectranal

placebo

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal allergic rhinitis, lectranal, allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dubrava University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

changes in SARS (seasonal allergic rhinitis symptoms)

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

changes in specific IgE

changes in specific IgG

Secondary Outcome Measures

Prick test change

change in eosinophilia in nasal secretion

Full Information

NCT ID

NCT00460538

First Posted

April 13, 2007

Last Updated

April 2, 2010

Sponsor

Milsing d.o.o.

1. Study Identification

Unique Protocol Identification Number

NCT00460538

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Milsing d.o.o.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitis, lectranal, allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Lectranal

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

changes in SARS (seasonal allergic rhinitis symptoms)

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

Title

changes in specific IgE

Time Frame

6 weeks

Title

changes in specific IgG

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Prick test change

Time Frame

6 weeks

Title

change in eosinophilia in nasal secretion

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neven Tudoric, MD PhD

Organizational Affiliation

Dubrava University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dubrava University Hospital

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

12. IPD Sharing Statement

Citations:

PubMed Identifier

19504468

Citation

Matkovic Z, Zivkovic V, Korica M, Plavec D, Pecanic S, Tudoric N. Efficacy and safety of Astragalus membranaceus in the treatment of patients with seasonal allergic rhinitis. Phytother Res. 2010 Feb;24(2):175-81. doi: 10.1002/ptr.2877.

Results Reference

result

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

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