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Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis (LT)

I

Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

Status and phase

Completed
Early Phase 1

Conditions

Allergic Rhinitis

Treatments

Dietary Supplement: Oral fatty acid
Drug: Mometasone Furoate Nasal Spray (MFNS)

Study type

Interventional

Funder types

Other

Identifiers

NCT07016763
11/2025

Details and patient eligibility

About

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.

Translated with DeepL.com (free version)

Enrollment

400 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Intranasal corticosteroids + oral fatty acids
Treatment:
Dietary Supplement: Oral fatty acid
Control group
Active Comparator group
Description:
Intranasal corticosteroids alone
Treatment:
Drug: Mometasone Furoate Nasal Spray (MFNS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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