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Clinical Trials/NL-OMON34748
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

WALA Heilmittel GmbH0 sites10 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

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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