A Randomized, Double-blinded, Parallel-group, Placebo-controlled Clinical Study of the Efficacy and Safety of an Oral Nutraceutical (Lertal®) as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NTC srl
- 入组人数
- 150
- 试验地点
- 32
- 主要终点
- Total Symptom Score (TSS) scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
详细描述
Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance.
Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults.
The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.
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
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 12 years
- •Male or female
- •Diagnosis of allergic rhinoconjunctivitis
- •Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
- •Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
- •Written informed consent of patient and of parent or legal guardian
排除标准
- •Uncontrolled asthma
- •Secondary rhinitis to other causes
- •Documented evidence of acute or chronic sinusitis
- •Nasal polyps
- •Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
- •Use of leukotriene antagonists
- •Continuous use of antihistamines
- •Inadequate washout of drugs:
- •Systemic or intranasal corticosteroids: 1 month
- •Leukotriene antagonists: 1 month
- •Sodium cromoglycate: 2 weeks
- •Systemic or intranasal decongestants: 3 days
- •Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days
- •Malformations of the nose, ear or throat
- •Upper or lower respiratory tract infection in the last 2 weeks
- •Participation in other clinical studies in the last month
- •Documented hypersensitivity to the study product or its excipients
- •Trip planned outside of the study area
研究组 & 干预措施
Lertal® + standard therapy
Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)
干预措施: Lertal® + standard therapy (Dietary Supplement)
Placebo + standard therapy
Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)
干预措施: Placebo + standard therapy (Other)
结局指标
主要结局
Total Symptom Score (TSS) scores
时间窗: At Baseline and after Visit 4 (Week 4)
Changes from baseline of Total Symptom Score (TSS) scores will be calculated after 4 weeks of treatment. The Total Symptoms score is a patient-reported evaluation of nine symptoms: * Nasal symptoms (Total Nasal Symptom Score): itching, sneezing, rhinorrhea, nasal congestion * Ocular symptoms (Total Ocular Symptom Score): itching, hyperemia of conjunctiva, tearing * Throat symptoms (Total Throat Symptom Score): itching, coughing With the help of their parents, patients will score symptoms on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Patients are asked to assign a score to the symptoms experienced in the last 12 hours and over the previous two weeks. The total symptom score is the sum of the scores of nasal symptoms, ocular symptoms and throat symptoms. The between-group analysis will be performed by means of a t-test for independent samples or analogous non-parametric test.
次要结局
- Number of exacerbations(From Visit 5 (Week 8) to Visit 6 (Week 16))
- Time to maximum effect on Total Symptom Score (TSS) vs placebo(From baseline to Visit 6 (Week 16))
- Number of patients using rescue treatment(From baseline to Visit 6 (Week 16))
- Total Ocular Symptom Score (TOSS)(At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4))
- Total Throat Symptom Score (TTSS)(At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4))
- Visual Analogue Scale (VAS) score(At Baseline, after Visit 3 (Week 2) and after Visit 4 (Week 4))
- Total Nasal Symptom Score (TNSS)(At Baseline, after Visit 3 (Week 2) and to Visit 4 (Week 4))
- Number of patients symptom-free or with mild symptoms(From V3 (Week 2) to Visit 4 (Week 4))
- Duration (number of days) of exacerbations(From Visit 5 (Week 8) to Visit 6 (Week 16))
- Total Symptom Score (TSS) scores(At Baseline and after Visit 3 (Week 2))
- Number of responders (30% reduction of TSS)(After Visit 3 (Week 2) and after Visit 4 (Week 4))
- Intensity (mild, moderate, severe) of exacerbations(From Visit 5 (Week 8) to Visit 6 (Week 16))