The effect of Citrus/Cydonia comp.® on hay fever

The effect of Citrus/Cydonia comp.® on hay fever - SuNa Hay Fever pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33622

Enrollment

Registered

2008-04-09

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

grass pollen allergy hay fever

Interventions

After a 2-week run in period the patients will be randomised to a 6 weeks treatment period. Treatment group A: Subcutaneous injections: twice a week, 1% Citrus/Cydonia comp. Treatment group B: Nasal

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Written informed consent 2. Age >= 18 and = 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
- immunological parameters: - IL-10, - IL-12, - IFN-g, - IL-4, en - IL-5	—

Secondary

Measure	Time frame
- symptom scores: - total symptom scores, - total non-nasal symptom scores, and - nasal symptom scores - adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)