背景:含有西度天花提取物的膳食补充剂,蜂胶,锌,蜂蜜最近被开发出来,并被证明是临床实践中季节性疾病和呼吸道疾病治疗的有效佐剂。
目的:该试验旨在验证所测试的膳食补充剂在患有急性扁桃体咽炎/鼻咽炎(ATR)的儿科人群中的疗效。
方法:该试验包括ATR≤48h的3至10岁儿童,β-溶血性链球菌快速检测阴性或鼻和/或咽部分泌物的培养鉴定,和SARS-CoV-2感染。所测试的膳食补充剂是已经上市的基于PelagonP-70的口服溶液(相当于Pelargoniumsidoidesd.e.133.3mg/100ml),蜂胶,锌,还有蜂蜜.对于6岁以下的儿童,每天5毫升3次,持续6天,对于6岁以上的儿童,每天10毫升3次,持续6天。研究设计是开放标签,随机化,和控制,与测试的膳食补充剂加标准护理(SoC)相比,单独的SoC。患者来自罗马尼亚的3个地点。扁桃体炎严重程度评分和治疗失败次数(使用布洛芬或大剂量扑热息痛作为抢救药物)的变化是主要终点。根据扁桃体炎严重程度评分和5%显著性水平的均值公式的2样本比较,80%功率,和2(SD3.85)点的最低临床重要差异,需要120名患者。考虑到潜在的筛查失败和辍学,我们需要筛查大约150名儿童。
结果:患者登记于2021年6月3日开始(第一例患者的首次就诊),并于2021年8月12日结束(最后一位患者的最后一次访问)。数据收集期为2021年6月3日至2021年9月16日。该研究于2023年2月获得资助。目前正在进行数据分析(2024年4月)。我们预计研究结果将在2024年第三季度发表在同行评审的临床期刊上,并在2024年最后一个季度的科学会议上发表。
结论:本试验的数据可能有助于在快速试验阴性排除链球菌感染的情况下,为ATR患儿确定新的辅助治疗方法。从而避免不必要的抗生素给药。
背景:ClinicalTrials.govNCT04899401https://clinicaltrials.gov/study/NCT04899401。
■DERR1-10.2196/53703。
BACKGROUND: A dietary supplement containing
Pelargonium sidoides extract, propolis, zinc, and honey has been recently developed and proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders.
OBJECTIVE: This trial aims to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis (ATR).
METHODS: The trial includes children aged between 3 and 10 years with ATR ≤48 h, a negative rapid test for beta-hemolytic streptococcus or culture identification of nasal and/or pharyngeal exudates, and SARS-CoV-2 infection. The dietary supplement tested is an oral solution already on the market based on Pelagon P-70 (equivalent to
Pelargonium sidoides d.e. 133.3 mg/100 ml), propolis, zinc, and honey. The product is administered at 5 ml 3 times a day for 6 days for children younger than 6 years and 10 ml 3 times a day for 6 days for children older than 6 years. The study design is open label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from 3 sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary end points. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 (SD 3.85) points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children.
RESULTS: Patient enrollment began on June 3, 2021 (first patient\'s first visit), and ended on August 12, 2021 (last patient\'s last visit). The data collection period was from June 3, 2021, to September 16, 2021. The study was funded in February 2023. Data analysis is currently ongoing (April 2024). We expect the results to be published in a peer-reviewed clinical journal in the third quarter of 2024 and presented at scientific meetings in the last quarter of 2024.
CONCLUSIONS: The data from this trial may help identify new adjuvant treatments for children with ATR when streptococcal infection is excluded by a negative rapid test, thereby avoiding unnecessary antibiotic administration.
BACKGROUND: ClinicalTrials.gov NCT04899401 https://clinicaltrials.gov/study/NCT04899401.
UNASSIGNED: DERR1-10.2196/53703.