Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
研究概览
简要总结
We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.
详细描述
In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).
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
- Single
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosis of autism made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised and with a score for Childhood Autism Rating Scale (CARS) greater than 30.
排除标准
- •Children with associated neurological disorders and epilepsy.
结局指标
主要结局
Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.
次要结局
未报告次要终点