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

NCT07016763 | Completed Early Phase 1

• 1 other identifier: 11/2025
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. Translated with DeepL.com (free version)

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; intranasal corticosteroids; rhinosinusitis; fatty acid

Outcome Measures

Primary Outcomes (3)

• Endoscopic evaluation

  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.

  From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)

• Symptoms and quality of life evaluation, VAS

  Symptoms and quality of life evaluation using the Visual Analog Scale (VAS, range 0-10; \>5= uncontrolled disease)

  From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)

• Symptoms and quality of life evaluation, MiniRQoLQ

  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).

  From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intranasal corticosteroids + oral fatty acids

Dietary Supplement: Oral fatty acid

Control group

ACTIVE COMPARATOR

Intranasal corticosteroids alone

Drug: Mometasone Furoate Nasal Spray (MFNS)

Interventions

Oral fatty acid 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)

Intervention Group

Mometasone Furoate Nasal Spray (MFNS) DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Isola Tiberina - Gemelli Isola Hospital, Rome, Italy: lead

Study Sites (1)

Isola Tiberina Hospital

Rome, Italy, 00186, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinosinusitis

Interventions

Fatty Acids

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 12, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

IT (1)