Clinical trial to investigate the efficacy and tolerability of the homeopathic medicinal product Klosterfrau Allergin Globuli in children at the age of 6-11 years with hey fever

• Conditions: Allergic rhinitis; MedDRA version: 14.1Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2008-002277-13-DE
• Lead Sponsor: MCM Klosterfrau Vertriebs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

6 - 11 years of age
clinically diagnosed hay fever
At least 4 of the following symptoms (total sum score of at least 8 points): itchy nose, runny nose, blocked nose, sneezing, red eyes, itchy eyes, tearing
Are the trial subjects under 18? yes
Number of subjects for this age range: 260
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Sensitivity to components of the IMP
Severe diseases of the respiratory tract (e. g. Asthma bronchiale, chronic bronchial obstruction) as well as other severe organ diseases
Intolerability to sacchrose
Intake of cromones
Intake or topical application of antihistaminics
Intake or topical application of glucocorticoids
Nasal sympathomimetics
Atopic dermatitis (medium to severe grade)
Patients with food allergy
Person who is committed to a facility (home, psychiatric clinic)
Respiratory diseases requiring glucocorticoids
Heritable fructose intolerance
Specific immune therapy or change of antigen dose within the previous month

Study & Design

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