Clinical trial NCT07016763: Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis
Official title: Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis: a Multicentre, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
intranasal corticosteroids
rhinosinusitis
fatty acid
Lead sponsor: Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies on the association between the development of allergic diseases and diet indicate the involvement of dietary fatty acids (FA) in the acceleration and/or inhibition of allergic diseases. Edible oils contain various FAs, but their composition depends on the materials from which they are extracted. FAs are characterised by the presence or absence of a carbon double bond in their structure; saturated FAs (palmitic acid, stearic acid, etc.) have no carbon double bond, while unsaturated FAs contain at least one carbon double bond. Among the unsaturated FAs, omega-3 FAs (such as alpha-linolenic acid \[ALA\], eicosapentaenoic acid \[EPA\] and docosahexaenoic acid \[DHA\]) and omega-6 FAs (such as linoleic acid \[LA\] and arachidonic acid \[ARA\]) are classified as essential FAs. Various types of bioactivity of dietary essential FAs have been reported in health and disease studies, including immunity, allergy and inflammation. Human studies, for example, have shown an association between the quality of dietary FAs and the incidence of allergic diseases.

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Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years;
* confirmed diagnosis of AR already treated with scarce or absent results by general practitioners

Exclusion Criteria:

* pregnancy or breastfeeding;
* concomitant asthma without stable control;
* chronic obstructive and restrictive lung disease;
* autoimmune and collagen diseases;
* acute sinusitis, nasal or upper respiratory tract infections in acute phase;
* cardiovascular, hepatic, or renal disease;
* other poorly controlled serious or chronic diseases;
* taking medications that may affect the immune response;
* previous nasal surgery;
* immunotherapy in the 3 years prior to enrolment, or the ones who planned to receive immunotherapy;
* patients who did not sign the informed consent for;

Primary outcomes:
measure: Endoscopic evaluation
timeFrame: From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)
measure: Symptoms and quality of life evaluation, VAS
timeFrame: From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)
measure: Symptoms and quality of life evaluation, MiniRQoLQ
timeFrame: From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Isola Tiberina Hospital
Study officials:
References: