Explorative study of adjuvant Homoeopathic treatment as part of standard treatment in the management of sensory patterns of Autism Spectrum Disorder (ASD) in children aged 3 to 12 years- Randomized controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- scores on Autism spectrum evaluation checklist and Sensory Assessment checklist
研究概览
简要总结
Explorative study of adjuvant Homoeopathic treatment as part of standard treatment in the management of sensory patterns of Autism Spectrum Disorder (ASD) in children aged 3 to 12 years- Randomized controlled study
Primary objective To explore the role of adjuvant Homoeopathic treatment as part of standard treatment in the management of sensory patterns of Autism Spectrum Disorder (ASD) in children aged 3 to 12 years
Secondary objective 1 To compare the improvement in the sensory patterns of the patients prescribed adjuvant Homoeopathic treatment with the control group.
Secondary objective 2 To study the various sensory patterns of ASD and the indications of the Homoeopathic remedy for the same
Secondary objective 3 To explore the action of Homoeopathic treatment on the reduction of the intensity of the sensory patterns as assessed on the Sensory Assessment Checklist
Primary research question Does adjuvant Homoeopathic treatment as part of standard treatment help in the management of sensory patterns of Autism Spectrum Disorder (ASD) in children aged 3 to 12 years
Null Hypothesis Adjuvant Homoeopathic treatment does not improve the sensory patterns of autistic children better than the standard treatment, as reflected in the reduction in the scores measured on the Sensory Assessment Checklist
Alternate Hypothesis Adjuvant Homoeopathic treatment can improve the sensory patterns of autistic children better as compared to the standard treatment, as reflected in the reduction in the scores measured on the Sensory Assessment Checklist
The study group as well as control group will be given standard line of treatment which includes occupational therapy, homoeopathy will be given homoeopathy as well. The on-going standard treatment (if already been given before enrolling in the study) will not be disturbed. Scales will be applied before the study, after 3 months and after 3 months. Patients in the control group will be assessed after 3 months for need of any medicinal intervention if they no change with the therapies or symptoms are distressing, then they will be given homoeopathic treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with ASD as per DSM 5 Children diagnosed with ASD on (Indian Scale for Assessment of Autism) ISAA.
排除标准
- •Children suffering from chronic infections like tuberculosis, HIV Cases of severe autism as assessed on ISAA.
结局指标
主要结局
scores on Autism spectrum evaluation checklist and Sensory Assessment checklist
时间窗: 3 years
次要结局
- comparing the improvement of study with control froup(3 years)
研究者
Dr Sheikh Tanvir Abdul Hamid
Assistant Professor, Department of Homoeopathic Psychiatry