Combination of Supplements for Treating Autistic Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Modification on ATEC score
研究概览
简要总结
A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.
详细描述
A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 3-14 years
- •diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
- •the ability to follow an oral treatment, with TID/BID/QD administration
- •the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
- •the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months
排除标准
- •patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
- •known allergy to hive products or one of the substances studied
- •inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
- •diagnosis of diabetes
- •history of seizures/epilepsy
- •administration of anticoagulants, antiplatelets, thrombolytic agents, low molecular weight heparins, anticonvulsants, insulin, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs or thiazide diuretics
- •allergy to celery and other plants of the Fam. Apiaceaea (Umbelliferae)
- •abnormally elevated baseline (at V1) values of ferritin, homocysteine, HgbA1c, ESR
结局指标
主要结局
Modification on ATEC score
时间窗: 3 months each of administration of active treatment and respectively placebo
Total ATEC (Autism Treatment Evaluation Checklist) scores before and after each intervention, as well subscale scores; higher scores indicate worse status, score range between 0 (minimal, absence of pathology), to 180 - maximal intensity of symptoms
Modification of ASRS scores
时间窗: 3 months each of administration of active treatment and respectively placebo
Scores on Autism Spectrum Rating Scales (ASRS) tests, total and 8 subscales will be compared before and after each intervention; total scores vary between 50-255, with higher score indicating more severe symptoms
次要结局
- NSE level modifications(3 months each of administration of active treatment and respectively placebo)