Allergic RhinitisEarly Phase 1LTNCT07016763
Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis
A Early Phase 1 study testing Oral fatty acid and Mometasone Furoate Nasal Spray (MFNS) in people with Allergic Rhinitis, run by Isola Tiberina - Gemelli Isola Hospital, Rome, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Oral fatty acid and Mometasone Furoate Nasal Spray (MFNS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years;
- confirmed diagnosis of AR already treated with scarce or absent results by general practitioners
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Oral fatty acid, Mometasone Furoate Nasal Spray (MFNS)
- Keywords
- Allergic rhinitis, intranasal corticosteroids, rhinosinusitis, fatty acid
- Medical subject headings
- Rhinitis, Allergic, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fatty acidDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intranasal corticosteroids + oral fatty acids Receives: Dietary Supplement: Oral fatty acid |
| Control group | Active comparator | Intranasal corticosteroids alone Receives: Drug: Mometasone Furoate Nasal Spray (MFNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro De Luca, Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016763
- Sponsor's protocol ID
- 11/2025
- Acronym
- LT
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07016763
- Acronym / sponsor ID
- LT / 11/2025
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, intranasal corticosteroids, rhinosinusitis, fatty acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Isola Tiberina - Gemelli Isola Hospital, Rome, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Oral fatty acidIntranasal corticosteroids + oral fatty acids |
| Control group | Active comparator | Drug: Mometasone Furoate Nasal Spray (MFNS)Intranasal corticosteroids alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 80 years;
- confirmed diagnosis of AR already treated with scarce or absent results by general practitioners
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral fatty acidIntervention 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) | Dietary supplement | Intervention Group |
| 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 | Drug | Control group |
Primary outcome
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.
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral fatty acid and Mometasone Furoate Nasal Spray (MFNS) in people with Allergic Rhinitis, run by Isola Tiberina - Gemelli Isola Hospital, Rome, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic evaluation (time frame: From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.