NCT07016763

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Isola Tiberina - Gemelli Isola Hospital, Rome, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. Translated with DeepL.com (free version)

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral fatty acid	Intervention therapy (treatment group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) and oral supplementation of FAs (550 mg/tablet), vitamin B6 (0.21 mg/tablet), perilla frutescens (20 mg/tablet) and liquorice (200/mg/tablet) (2 tablets a day with meals)
DRUG	Mometasone Furoate Nasal Spray (MFNS)	Standard therapy (control group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) only

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: Italy