Primary objective:To investigate the effects of the three investigational products (1.Citrus e fructibus / Cydonia e fructibus as a whole, single preparations 2. Citrus e fructibus and 3. Cydonia e fructibus) on the changes in SAR related…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, TNFα, IFN-γ, IL-5, IL-13, IL17A
Secondary outcome
Not applicable
Background summary
Since the beginning of the 20th century the anthroposophic pharmaceutical
product Citrus/ Cydonia, which was first described in the book *Grundlegendes
für eine Erweiterung der Heilkunst* (Steiner and Wegman 1924), is produced and
prescribed to many patients with seasonal allergic rhinitis (SAR) or hay fever.
A survey on clinical experiences, carried out among a group of 39 general
practitioners in the Netherlands, indicated that Citrus/Cydonia is profoundly
effective (De Bruin and Baars, 2001). Firstly, a permanent effect from the
treatment with Citrus/Cydonia comp. was experienced, which indicates that the
patients in question are claiming to lastingly suffer less from hay fever or
even that they are free from complaints. Secondly, the effect occurred within a
period of two weeks, up to three months, after the actual treatment. Thirdly,
the effect was optimal after a treatment of several years. In a therapeutic
causality report, positive effects with Citrus/Cydonia were observed in a group
of 13 patients suffering from grass pollen mediated hay fever (Baars and De
Bruin, 2005). In most patients, Citrus/Cydonia comp. injections were given
before the onset of and during the grass pollen season and symptom severity did
not increase during the pollen season. Furthermore, 69% of the patients
reported an improvement of symptoms. In addition, a prospective, observational
study on the effect of a Citrus/Cydonia nasal spray on hay fever symptoms
reported positive results without side effects in 140 patients (Rother and
Oexle, 2008). In a recent randomized comparative clinical trial with two
parallel groups of grass pollen SAR patients, the clinical and immunological
effects of two routes of administration (nasal spray (NS) versus subcutaneous
injection (SI)) of Citrus/ Cydonia 1% were compared. The results demonstrate
that Citrus/ Cydonia 1% for the treatment group as a whole (both the NS group
and the SI group) and in both routes of administration separately are able to
execute both clinically and statistically significant SAR symptom severity
reduction. The SI route of administration induces a larger effect than the NS
route of administration (Baars et al., in prep.).
Recently, the immunological pathways underlying the positive effects of
Citrus/Cydonia in patients with seasonal allergic rhinitis were studied (Baars
and Savelkoul, 2008). Therefore, peripheral blood mononuclear cells (PBMCs)
were isolated from the blood of a healthy and an allergic donor and the effect
of Citrus/Cydonia comp. on differentiation capacity and Th1 (e.g. IFN-*) and
Th2 (e.g. IL-5) cells was examined. Citrus/Cydonia showed a selective effect on
the differentiation of T-cells by producing relatively more IL-10 than IL-12.
Furthermore, it also had an effect on the induction of regulatory (IL-10
producing) T-cell subsets. It was therefore concluded that the medicinal
product Citrus/Cydonia can potentially restore the disturbed immune state of
allergic rhinitis patients by modulation of the Th1-Th2 balance. In the
described randomized comparative clinical trial with two parallel groups of
grass pollen SAR patients, the immunological data are consistent with the
notion that Citrus/ Cydonia comp. 1% treatment will result in the induction of
a more regulatory capacity in the immune system. The pattern of immunological
data demonstrates that the treatment by the SI route of administration induced
a better controlled and anti-allergic immune responsiveness compared to the NS
route. The immunological results are in line with the clinical results of this
study (Baars et al., in prep.). This immunotherapeutic potency and the positive
results from the observed clinical cases, form the rationale to further
evaluate the effects of Citrus/Cydonia medicinal products in seasonal allergic
rhinitis.
Study objective
Primary objective:
To investigate the effects of the three investigational products (1.Citrus e
fructibus / Cydonia e fructibus as a whole, single preparations 2. Citrus e
fructibus and 3. Cydonia e fructibus) on the changes in SAR related
immunological parameters in PMBCs as isolated from seasonal allergic rhinitis
patients.
Secondary objective:
To investigate whether there are statistically significant differences between
each of the three investigational groups on the changes in immunological
parameters in PMBCs as isolated from seasonal allergic rhinitis patients and
healthy subjects.
Study design
A comparative in vitro laboratory study with peripheral blood mononuclear cells
(PBMCs) isolated from blood of participants
Study burden and risks
Possible risks that can be expected during blood withdrawal are very low and
well known. Since a little amount of blood will be drawn once, the burden for
the patients and healthy volunteers is very low as well.
Badstr. 62
73087 Bad Boll
DE
Badstr. 62
73087 Bad Boll
DE
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30944.081.10 |