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

NCT ID: NCT07016763

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-01

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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Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Intranasal corticosteroids + oral fatty acids

Group Type: EXPERIMENTAL

Oral fatty acid

Intervention Type: DIETARY_SUPPLEMENT

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)

Control group

Intranasal corticosteroids alone

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

Standard therapy (control group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) only

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

OTHER

Sponsor Role: lead

Responsible Party

Pietro De Luca

MD, Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Isola Tiberina Hospital

Rome, Italy, Italy

Countries

Italy

Other Identifiers

11/2025

Identifier Type: -

Identifier Source: org_study_id