The effect of Citrus/Cydonia comp.® on hay fever
- Conditions
- grass pollen allergyhay fever10001708
- Registration Number
- NL-OMON33622
- Lead Sponsor
- Weleda AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion criteria
1. Written informed consent
2. Age >= 18 and < 60 years
3. Seasonal allergic rhinitis:
a. Duration of at least 2 years
b. High RAST grass pollen (>= 2)
c. Suffering from the following symptoms: sneezing, itching (nose and eyes) and watery nasal discharge,
d. Severity score of at least two of the three symptoms >= 2; ranging from 0 = not present to 3= severe, as measured with the the Disease-specific severity Score questionnaire - nasal symptoms
e. The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for previous (at least two) years.
1. Chronic inflammatory autoimmune disease such as Type I - Diabetes Mellitus, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn*s disease
2. Allergic (hypersensitive) to one of the constituents of Citrus/Cydonia comp.
3. Pharmacological treatment of allergic rhinitis or use of other preparations containing Citrus and or Cydonia extracts within the last two weeks prior to enrolment into the study
4. Use of cromoglycates in the last month before study onset
5. Concomitant pharmacological treatment indicated for seasonal allergic rhinitis such as antihistamines, corticosteroids or other preparations
6. Participation in a further clinical trial at the same time or within the previous 4 weeks prior to enrolment into this study
7. Pregnancy or lactation
8. Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- immunological parameters:<br /><br>- IL-10,<br /><br>- IL-12,<br /><br>- IFN-g,<br /><br>- IL-4, en<br /><br>- IL-5</p><br>
- Secondary Outcome Measures
Name Time Method <p>- symptom scores:<br /><br>- total symptom scores,<br /><br>- total non-nasal symptom scores, and<br /><br>- nasal symptom scores<br /><br>- adverse events</p><br>