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NCT Number: NCT07016763

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

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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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Isola Tiberina Hospital

Rome, Italy, 00186

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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)

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

Primary outcomes

  1. Endoscopic evaluation

    Time frame: 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.

  2. Symptoms and quality of life evaluation, VAS

    Time frame: 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)

  3. Symptoms and quality of life evaluation, MiniRQoLQ

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

Other

Registry information

Official study title

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

Acronym: LT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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