Evaluation of the Therapeutic Effect of a Formulation Based on Mullein, Thyme, Propolis, and Long-Chain Polyphosphates in Children Diagnosed with Acute Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- severity of symptoms - score of Italian Nasal Obstruction Symptom Evaluation
研究概览
简要总结
Acute rhinitis is an inflammatory process that primarily affects the nasal mucosa, with a high incidence in the pediatric population and a morbidity rate of 6-8 episodes annually during the first two years of schooling (1). It is one of the most common conditions causing discomfort and debilitation in children, compromising their quality of life, negatively affecting social interactions, school performance, and sleep quality. In most cases, the origin is viral and the course is seasonal, with higher incidence in the autumn and winter seasons (1).
More than 100 viral strains are known to be responsible for this condition, among which Rhinoviruses are considered the most widespread and contagious (2). Symptoms, which typically begin 1-2 days after infection, include nasal congestion, nasal breathing obstruction, rhinorrhea, sneezing, coughing, headache, malaise, and sometimes mild fever, with complete remission generally occurring within 8-10 days (2).
The therapeutic approach is exclusively symptomatic, mainly aimed at reducing nasal obstruction. Literature indicates that nasal irrigation with saline solution is the most useful treatment for cleansing the nasal passages, thinning nasal secretions, and allowing for easier elimination; in the presence of fever, antipyretics may be useful (3).
Given these premises, the aim of this clinical study was to evaluate the therapeutic efficacy of an isotonic saline solution containing mullein, thyme, propolis, and long-chain polyphosphates, which are known for their natural properties to promote nasal secretion fluidity, reduce inflammation, and improve the functionality of the upper respiratory mucosa (4). In addition, more recent pre-clinical data suggested that this formulation exerts an antiviral action characterized by inhibition of virus replication (Rhinovirus and SARS-CoV-2) and an anti-inflammatory action through modulation of NF-Kb signaling in cultured human nasal respiratory epithelial cells. These effects are also associated with antibacterial action thanks to mullein and thyme.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian subjects of both sexes,
- •aged between 4 and 14 years;
- •diagnosis of acute rhinitis based on the presence of ≥3 of the following symptoms that had onset within the last 24 hours: rhinorrhea, nasal congestion, nasal obstruction, sneezing, pharyngodynia, cough;
- •in addition to ≥1 of the following signs/symptoms: headache;
- •fever; malaise; burning eyes; myalgia;
- •written informed consent obtained from the parents of the participants and from the participants themselves if older than 6 years.
排除标准
- •non-Caucasian ethnicity; age <4 and >14 years; known hypersensitivity/allergy to any component of the dietary supplement;
- •previous diagnosis of severe nasal septal deviation or any other condition that could cause nasal obstruction, such as nasal polyps;
- •history of nasal or sinus surgery that could affect symptom scores; use of antibiotics, corticosteroids, or antihistamines within 2 weeks prior to the study; participation in other studies;
- •conditions that made compliance with the protocol unlikely.
结局指标
主要结局
severity of symptoms - score of Italian Nasal Obstruction Symptom Evaluation
时间窗: after 5 days of treatment
The primary endpoint was to assess the therapeutic efficacy of "Elysium Naso-gola" in reducing the severity of symptoms in children with acute rhinitis after 5 days of treatment with the Italian Nasal Obstruction Symptom Evaluation (I-NOSE questionnaire). A validated closed-question questionnaire with 5 items was administered to each enrolled subject to evaluate acute rhinitis symptoms. Each question was scored from 0 to 4 (0 = no problem; 4 = severe problem). The total score was multiplied by 5 to obtain the NOSE score, which classified the severity of nasal obstruction symptoms as follows: mild (5-25 points), moderate (30-50 points), severe (55-75 points), extreme (80-100 points).
次要结局
- nasal obstruction - score of Visual Analog scale(after 5 days of treatment)
- complete resolution of acute rhinitis symptoms(after 10 days)
研究者
Roberto Berni Canani, MD, PhD
Md, PhD, Principal Investigator
Federico II University