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NCT00460538 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00460538
Other study ID # MIL-002
Secondary ID
Status Completed
Phase Phase 4
First received April 13, 2007
Last updated April 2, 2010
Start date April 2007
Est. completion date November 2007

Study information
Verified date March 2010
Source Milsing d.o.o.
Contact n/a
Is FDA regulated No
Health authority Republic of Croatia: Ethic Committee of Dubrava University Hospital
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Lectranal
Dosage form: capsule 1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks
• placebo
Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks

Locations
Country Name City State
Croatia Dubrava University Hospital Zagreb

Sponsors (1)
Lead Sponsor Collaborator
Milsing d.o.o.

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary changes in SARS (seasonal allergic rhinitis symptoms) 6 weeks No
Primary changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) 6 weeks No
Primary changes in specific IgE 6 weeks No
Primary changes in specific IgG 6 weeks No
Secondary Prick test change 6 weeks No
Secondary change in eosinophilia in nasal secretion 6 weeks No
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