NL-OMON34748
Completed
Not Applicable
A comparative in vitro study on the effects of the product Citrus e fructibus / Cydonia e fructibus as a whole and the single agent drugs Citrus e fructibus and Cydonia e fructibus separately, on immunological parameters of seasonal allergic rhinitis - In vitro effects of Citrus/Cydonia versus only Citrus or only Cydonia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- WALA Heilmittel GmbH
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •SAR patients:
- •Written informed consent
- •Sex: both men and women
- •Age \>\= 18 and \< 60 years
- •Seasonal allergic rhinitis:
- •\*Duration of at least 2 years
- •\*High RAST grass pollen (\>\= 2\) and high RAST birch pollen (\>\= 2\)
- •\*Suffering from the following nasal symptoms during the pollen season: sneezing, itching nose, nasal obstruction and watery nasal discharge
- •\*Severity score of at least three of the four symptoms \>\= 2 (ranging from 0 \= not present to 3\= severe)
- •\*The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for previous (at least two) years.;Healthy volunteers:
Exclusion Criteria
- •SAR Patients:
- •Chronic inflammatory autoimmune disease such as Type I \- Diabetes Mellitus, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn\*s disease
- •Allergic (hypersensitive) to one of the constituents of Citrus e fructibus / Cydonia e fructibus
- •Use of other preparations containing Citrus and/or Cydonia extracts within the last two weeks prior to enrolment into the study
- •Use of cromoglycates in the last month before study onset
- •Concomitant pharmacological treatment indicated for seasonal allergic rhinitis such as antihistamines, corticosteroids or other preparations in the last two weeks before study onset
- •Anti\-allergy immunotherapy in previous years
- •Participation in a further clinical trial at the same time or within the previous 4 weeks prior to enrolment into this study
- •Pregnancy or lactation
- •Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
Outcomes
Primary Outcomes
Not specified
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