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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34748

Enrollment

Registered

2010-07-13

Start date

2010-05-24

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

hay fever Seasonal allergic rhinitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: SAR patients: •Written informed consent •Sex: both men and women •Age >= 18 and = 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Analysis in the culture supernatants of PBMCs: •Proliferation capacity •Cell viability •Cell toxicity •Total production capacity of seasonal allergic rhinitis related cytokines: IL-10, IL-12, IL-1ß, TNFa, IFN-γ, IL-5, IL-13, IL17A	—

Countries

Netherlands

Outcome results