The CiSAR Study
- Conditions
- grass pollenseasonal allergic rhinitisHooikoorts (graspollen)
- Registration Number
- NL-OMON27660
- Lead Sponsor
- ectoraat Antroposofische GezondheidszorgHogeschool LeidenCluster ZorgZernikedreef 11 (D0.036)Postbus 382, 2300 AJ LEIDENT: +31 71 51 88 769M: +31 6 468 468 04
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
1.Written informed consent
2.Age ≥ 18 and < 60 years
3.Seasonal allergic rhinitis:
-Duration of respective complaints at least 2 years
-Suffering from the following nasal symptoms: sneezing, itching nose, nasal obstruction and
watery nasal discharge
-Severity score of at least two of the four nasal symptoms ≥ 2 (ranging from 0 = not present to 3= severe)
-Suffering from the following non-nasal symptoms: itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat
-Severity score of at least two of the four non-nasal symptoms ≥ 2 (ranging from 0 = not present to 3 = severe)
-The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
-Average Total Symptom Score in the wash-out period ≥ 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20.
1.Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
2.Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.
3.Participation in a further clinical trial at the same time or within the previous 4 weeks prior to enrolment into this study
4.Previous use of medicinal products containing Citrus and/or Cydonia
5.Pregnancy or lactation
6.Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
7.A known history of drug, alcohol and/or medication dependence or addiction
8.Immunotherapy in the last two years
9.Use of cromoglycates
10.Other allergies (non seasonal allergies)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Days with symptom control” defined by:<br>a)A Total Symptom Score of ≤ 8 (while exposed to a mean pollen count of 20-50) or ≤ 12 (while exposed to a mean pollen count of > 50)<br>and<br>b)No use of rescue medication <br>in the verum groups compared to the placebo group in the last two weeks of treatment<br>
- Secondary Outcome Measures
Name Time Method 1.Total use of rescue medication throughout the whole treatment period.<br>2.Number of drop outs between verum groups and placebo group.<br>3.Safety: Adverse events.<br>4.Days with symptom control” in the verum groups compared to the placebo group in the third and fourth weeks of treatment or the fifth and sixth weeks of treatment in case of extended treatment.<br><br>