The aim of this trial was to assess the effectiveness of Sediflù, a medical device containing active herbal ingredients, on nocturnal and diurnal persistent coughs in children, with a duration of 3 to 7 days. Children with a dry and/or productive cough were enrolled in this prospective, interventional, multicenter, placebo-controlled, double-blind, randomized clinical study. Clinical efficacy was assessed through the evaluation of the soothing action of Sediflù against dry and/or productive coughing, both at night and during the day, and other effects of coughing associated with quality of sleep: frequency, child’s quality of sleep, parental quality of sleep and severity. Treatment with Sediflù improved both night-time and day-time cough scores from day 2. The diurnal score also improved significantly in the Sediflù group at days 3 and 7. Sediflù syrup can be considered a valid treatment for cough management in younger children with upper respiratory tract infections, shortening the cough duration.

中文翻译：

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SEDIFLÙ 治疗儿童干咳或排痰性咳嗽的功效和耐受性 (SEPEDIA)：一项试点、随机、双盲、安慰剂对照、多中心临床试验

该试验的目的是评估 Sediflu（一种含有活性草药成分的医疗设备）对儿童夜间和日间持续咳嗽（持续 3 至 7 天）的有效性。患有干咳和/或咳痰的儿童参加了这项前瞻性、介入性、多中心、安慰剂对照、双盲、随机临床研究。通过评估 Sediflù 对夜间和白天干咳和/或咳痰的舒缓作用以及咳嗽与睡眠质量相关的其他影响（频率、儿童的睡眠质量、父母的睡眠质量）来评估临床疗效。睡眠和严重程度。Sediflù 治疗从第 2 天开始，夜间和白天咳嗽评分均得到改善。Sediflù 组的昼间评分在第 3 天和第 7 天也显着改善。Sediflù 糖浆可被认为是治疗患有上呼吸道感染的年幼儿童咳嗽的有效治疗方法。呼吸道感染，缩短咳嗽持续时间。