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

Early Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Dietary Supplement: Oral fatty acid; Drug: Mometasone Furoate Nasal Spray (MFNS)

• Registration Number: NCT07016763
• Lead Sponsor: Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

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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Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Oral fatty acid	Intranasal corticosteroids + oral fatty acids
Control group	Mometasone Furoate Nasal Spray (MFNS)	Intranasal corticosteroids alone

Primary Outcome Measures

Name	Time	Method
Endoscopic evaluation	From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)	Endoscopic evaluation of the nose using the Lund-Kennedy (LK) score.THe LK scoring system is based on the degree of polyps, discharge and edema in each nostril.
Symptoms and quality of life evaluation, VAS	From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)	Symptoms and quality of life evaluation using the Visual Analog Scale (VAS, range 0-10; \>5= uncontrolled disease)
Symptoms and quality of life evaluation, MiniRQoLQ	From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)	Symptoms and quality of life evaluation using the Visual Analog Scale (VAS, range 0-10; \>5= uncontrolled disease) and Mini Rhinoconjuctivitis Quality of Life Questionnaire (MiniRQoLQ, which utilizes a 7-point scale for each of its 14 questions, ranging from 0 (not impaired at all) to 6 (severely impaired), ranging 0-84).

Trial Locations

Locations (1)

Isola Tiberina Hospital; 🇮🇹 Rome, Italy