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

Milsing

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Dietary Supplement: Lectranal; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00460538

MIL-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Dietary Supplement: placebo

1

Active Comparator group

Treatment:

Dietary Supplement: Lectranal