NCT03963479Unknown2 期
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Autism Spectrum Disorder
研究概览
简要总结
To determine whether Vitamin B6 and Magnesium improve neurobehavioral status in terms of General observation, Cognitive working, Socialization, Communication and Sensory Dysfunction in patient with Autism Spectrum Disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool
- •Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial
- •Newly diagnosed patient
- •Co-morbid neurological disorder like hyperactivity
排除标准
- •Patients with chronic diseases or any known metabolic or hormonal diseases
- •Patients with any known chromosomal or genetic syndromes
- •Patients unable to give informed consent
- •Patients unable to travel to clinical visits or non co-operative
结局指标
主要结局
Autism Spectrum Disorder
时间窗: 3 months
General observation, Cognitive Working, socialization, Communication, Sensory Dysfunction. At first a autism will be diagnosed by DSM-5 .Then the above mention criterias along with the severity will be diagnosed by Autism Diagnostic Checklist tool by a psychologist.
次要结局
- Autism Spectrum Disorder(0 month)
研究者
Dr. Farhana Khan
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
研究点 (2)
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