Phase 4Completed
Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen (LLB-2016-01)
Randomized, Double-blind, Placebo-controlled Study to Measure 2L®ALERG (Homeopathic Drug) Efficacy on Symptoms of Allergic Rhinitis and Allergic Rhinoconjunctivitis in Patients With a Seasonal Allergy to Grass Pollen
- Sponsor
- Labo'Life (Industry)
- Enrolment
- 102 enrolled
- Conditions
- Seasonal Allergy
- Interventions
- 2LALERG; Placebo
- Ages
- adults, older adults
- Registry
- NCT02690935
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)
History
Last registry update
Results first posted
Primary completion
Started
Registered