Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen
Status:
Completed
Trial end date:
2017-04-07
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate the superiority of 2L®ALERG over
placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic
rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to
rescue medication intake. The secondary objectives are to compare the allergy symptoms, the
rescue medication intake, the quality of life and the safety in patients treated with
2L®ALERG or with a placebo.
This is a multicentre, randomized, double-blind, two-parallel group, interventional
placebo-controlled study with a notified homeopathic medication, marketed since 2002.
Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a
total of 100 patients included for 80 cases completed.
Screening will be done before the peak of pollination and the treatment will be set up two
months before traditional pollen peak, then visits at 3 months and 6 months, or end of the
peak.
The treatment will consist of 1 capsule daily, fasting morning, following the numerical order
of 1 to 10 capsules for 6 months.
The placebo will have the same form, colour, taste and aspect. The allowed concomitant
treatments are the already established treatments for associated pathologies not liable to
have an impact on the proper conduct of the study and the rescue medications allowed in the
first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye
cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those
above]).
The prohibited treatments are the oral or injectable corticosteroids and the
anti-leukotrienes.