Evaluating the efficacy of ayurvedic intervention as add on to conventional treatment and explore the interaction of epigenetics, neuro/gut biomarkers and neuroimaging in pediatric ADHD (Attention Deficit Hyperactivity Disorder)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1) Change in Conners Parent Rating Scale - Revised.
研究概览
简要总结
This study is a randomized single-blind, parallel-group trial comparing the safety and efficacy of Add-on Ayurveda intervention (Ayushmana, Bramha Rasayana, and Jyotishmati Taila) and Conventional treatment (Clonidine, Methylphenidate, and Atomoxetine) daily for six months in 160 subjects (80 in each group) with Attention Deficit Hyperactivity Disorder (ADHD) that will be conducted at National Institute of Mental health and Neurosciences (NIMHANS) Bengaluru. The primary outcome measure will be Changes in Conners’ Parent Rating Scale-Revised (CPRS-R) and Conners’ Teacher Rating Scale-Revised (CTRS-R) at six months. The secondary outcome measures are Changes in the modified AIIMS- INDT ADHD tool, Changes in T scores of Child behavior Checklist, Changes in the Gut microbiota, Changes in biomarkers ofneurological implications, modification in the inter-relationships among the gut and neurological biomarkers, Changes in methylation pattern in epigenome, Changes in neuropsychological functions (Assessed on children - Arousal of attention; reaction time; sustained attention; delay aversion;planning; and executive functions such as working memory, cognitiveinhibition, set/task shifting, and changesin parent’s report on the executive functions of their children), Modulation of the functional brain network connectivity and Safety of Ayurveda interventions at six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Children and adolescents of both sex in age group of 6-15 years •Fulfilling DSM -5 criteria for the diagnosis of ADHD •Patients receiving treatment as per Standard of care.
- •â€¢Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires.
- •â€¢Patients whose can understand and fill up required forms.
排除标准
- •Known or suspected severe mental retardation or significant learning disorder & Children with co-existing moderate – severe Neuro-psychological conditions or autism spectrum disorder.
- •Subjects who require drug therapy or hospitalization for treatment of a chronic psychiatric illness.
- •Patient with inability to swallow the medication whole, and those with any unstable medical illness.
- •Parents who do not give consent for the study.
结局指标
主要结局
1) Change in Conners Parent Rating Scale - Revised.
时间窗: 6 Months.
2) Change in Conners Teachers Rating Scale - Revised.
时间窗: 6 Months.
次要结局
- Change in modified AIIMS-INCLEN Diagnostic tool for ADHD.(6 months)
- Change in T scores of Child Behaviour Check List (CBCL)(6 months)
- Change in Gut Microbiota(6 months)
- Change in methylation pattern in epigenome(6 months)
- Change in neuropsychological functions(1) assessed on children (arousal of attention;)
- Changes in biomarkers of neurological(implications BDNF, beta endorphins and Telomere)
- Changes in modulation of the functional brain(network connectivity (during resting-state and stop-signal)
- Safety of Ayurveda interventions assessed clinically and(in biochemical parameters)
- Changes in inter-relationships(among the gut and neurological biomarkers)