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

Completed

• Conditions: hay fever; Seasonal allergic rhinitis; 10001708

• Registration Number: NL-OMON34748
• Lead Sponsor: WALA Heilmittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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:
•Written informed consent
•Sex: both men and women
•Age >= 18 and < 60 years
•RAST for grass and birch pollen = 0
•Absence of the following nasal symptoms during the pollen season: sneezing, itching nose, nasal obstruction and watery nasal discharge
•No history of SAR symptoms for at least 2 years

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
•Asthma
•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)
•A known history of drug, alcohol and/or medication dependence or addiction;Healthy volunteers:
•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
•Asthma
•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)
•Drug, alcohol and/or medication dependence or addiction

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified