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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

Double blind, randomized, placebo-controlled clinical trial to proof the efficacy and tolerability of the homeopathic medicinal product Klosterfrau Allergin Globuli in comparison to placebo in children at the age of 6-11 years with hey fever

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002277-13-DE
Enrollment
Unknown
Registered
2009-01-30
Start date
2009-07-31
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis MedDRA version: 14.1 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Klosterfrau Allergin Globuli Product Name: Klosterfrau Allergin Globuli Pharmaceutical Form: Pastille INN or Proposed INN: Adhatoda vasica D2 Other descriptive name: Adhatoda vasica D2 Con

Sponsors

MCM Klosterfrau Vertriebs GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Demonstration of the efficacy of verum in comparison to placebo;Secondary Objective: Demonstration of the tolerability of verum in comparison to placebo;Primary end point(s): Difference in the reduction of the hay fever symptoms in the verum group compared to the placebo group (total sum score, pre/post comparison);Timepoint(s) of evaluation of this end point: Day 7 and 14 of treatment—

Secondary

MeasureTime frame
Secondary end point(s): Global evaluation of efficacy and tolerability; incidence of side effects ;Timepoint(s) of evaluation of this end point: Day 7 and 14 of treatment—

Countries

Germany

Contacts

Public ContactMedical Service Devision

MCM Klosterfrau Vertriebs GmbH

dialog@klosterfrau-service.de+492211652361

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026