NCT07016763|CompletedEarly Phase 1
Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis
LT
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LT
Sponsor study identifier
interventional
400
1 country
1
Study Start
September 1, 2024
Actual (reported)Primary Completion
March 1, 2025
Actual (reported)Study Completion
March 1, 2025
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2024
Actual (reported)March 1, 2025
Actual (reported)March 1, 2025
Actual (reported)May 20, 2025
Actual (reported)June 12, 2025
Actual (reported)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)
Intranasal corticosteroids + oral fatty acids
Intranasal corticosteroids alone
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)
Standard therapy (control group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) only
Isola Tiberina Hospital
Rome, Italy, 00186, Italy
400 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2025
First Posted
June 12, 2025
Study Start
September 1, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 1, 2025
Actual (reported)Study Completion
March 1, 2025
Actual (reported)Last Updated
June 12, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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