Management of Autism spectrum disorder in children with individualized homoeopathic remedy versus individualized homoeopathic remedy with Bach flower remedy as an adjuvant :A prospective single blind clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in behavioral, cognitive and emotional symptoms in children with ASD, measured using the ISAA pre, mid, and post stage .
研究概览
简要总结
A prospective, single-blind, computerized randomized clinical trial to compare the effectiveness of individualized homoeopathic remedy alone versus individualized homoeopathic remedy with Bach Flower Remedies (BFRs) as an adjuvant in the management of Autism Spectrum Disorder (ASD) in children of aged 5–12 years group .
A total of 30 pre-diagnosed cases of mild to moderate ASD will be enrolled and random allocated into two parallel groups each group will have 15 participants :
Group A: Individualized homoeopathic remedy
Group B: Individualized homoeopathic remedy with Bach flower remedies (BFRs) as adjuvant
The intervention will be administered for 6 months, with follow-up over 6 months. Outcomes will be assessed using the Indian Scale for Assessment of Autism (ISAA) at baseline, mid-point, and post-treatment.
Primary outcome: Improvement in behavioral, cognitive, and emotional symptoms in ASD children. Secondary outcomes: Improvement in quality of life and documentation of the effectiveness of Bach flower remedies BFRs as an adjuvant to individualized homoeopathic remedy .
Statistical analysis will be performed using the Independent T-test to compare differences between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children age 5-12 years .
- •2.Patient of both the sexes male and female 3.Mild and moderate autism according to ISAA scale 4.Parent able to provide written informed accent .
排除标准
- •1.Severe autism according to ISAA scale.
- •Presence of other neurological disorder.
- •3.Participation in other clinical trials in past 3 month.
- •4.Patient age of below 5 year and above 12 years.
结局指标
主要结局
Improvement in behavioral, cognitive and emotional symptoms in children with ASD, measured using the ISAA pre, mid, and post stage .
时间窗: 6 months
次要结局
- 1.Improvement in quality of life in children with ASD.(2.Effectiveness of Bach Flower Remedy as an adjuvant to individualized homoeopathic remedy .)
研究者
Dr Deepalika Sharma
BVDUHMC - PUNE