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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Endoscopic evaluation
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years;
- •confirmed diagnosis of AR already treated with scarce or absent results by general practitioners
排除标准
- •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;
研究组 & 干预措施
Intervention Group
Intranasal corticosteroids + oral fatty acids
干预措施: Oral fatty acid (Dietary Supplement)
Control group
Intranasal corticosteroids alone
干预措施: Mometasone Furoate Nasal Spray (MFNS) (Drug)
结局指标
主要结局
Endoscopic evaluation
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Pietro De Luca
MD, Consultant
Isola Tiberina - Gemelli Isola Hospital, Rome, Italy