Study to assess the efficacy of homeopathic 2LALERG on symptoms of allergy to grass polle

Phase 1

• Conditions: Patients: Allergic Rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000097-38-BE
• Lead Sponsor: abo'Life

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age =18 years, male and female
- Symptomatic since at least two seasons and confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE positive if at least class 3 (= 3.5 kU / L); these tests must have been performed at the latest at the first screening visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Patient with an acute exacerbation of allergic rhinitis
-Patient with uncontrolled asthma
-Immunotherapy received within the last two years
-Patient with a known lactose intolerance
-Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient’s records)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified