Effect of Brahmi Ghrita and Saraswata Churna in Children with Attention Deficit Hyperactivity Disorder aged 6-12 years
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Changes in features of Attention Deficit Hyperactivity Disorder assessed using the ADHDT-2 scale
研究概览
简要总结
Children with an age group of 6- 12 years satisfying the DSM 5 criteria for ADHD will be selected for the study from the OPD of Government Ayurveda College Hospital for Women and Children, Poojappura, Informed consent will be taken from the parents of the selected participants. The participants in the study group will be made fit to take the ghrita yoga after administering ashtachurna [age-appropriate dose] having Deepana-pachana property for the correction of Agni, for a period of 5 days. Then the participants will be administered with Brahmi Ghritain age-appropriate dose twice daily with lukewarm water as anupana before foodandSaraswata Churnain age-appropriate dose twice daily with honey as anupana after fooddepending upon the age of the child. They will be advised on dietary regulations for ADHD. Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS). Trial drug will be given for sixty days. Further, the data will be collected, scored, and statistically analyzed using appropriate statistical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with Attention Deficit Hyperactivity Disorder of the age group of 6 to 12 years according to DSM-5 criteria.
排除标准
- •Presence of any other psychiatric comorbidity.
- •Presence of any other organic problem or brain damage iii.
- •Diagnosed cases of mental retardation iv.
- •Patients with other diagnosed genetic disorders.
结局指标
主要结局
Changes in features of Attention Deficit Hyperactivity Disorder assessed using the ADHDT-2 scale
时间窗: Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS).
and Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS).
时间窗: Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS).
次要结局
未报告次要终点
研究者
Dr Pooja Rose CJ
Govt. Ayurveda College Thiruvananthapuram