A Controlled Clinical Study To Evaluate The Efficacy Of Deepa Ghrita Over Ashtamanagala Ghrita In The Management OF ADHD (Vataja Unmada) In Children
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- assessment of inattention, hyperactivity, impulsivity
研究概览
简要总结
ADHD often co-occurs with other emotional,behavioural,language and learning disorders.Treatment includes psychosocial treatment, behavioural management, medication includes psychostimulant drugs, antidepressant drugs which are not much effective and has various side effects such as headache,anorexia,abdominal pain,seizure,sedation and depression4,since lack of effective treatment for ADHDparents of the children become panic and worried about their child’s future.In Ayurvedic classicsvarious treatments mentioned in the management of unmada like snehana, swedana ,mrudushodhana, bastikarma, among them snehapana is the main stay of treatment in the management of vatajaunmada6.Hence the drug been selected in the form of ghrita,for which deepa ghrita7has been selected to prove its clinical efficacy in the management of ADHD.Where ghritas mentioned in Ayurveda not only having ketogenic effect but also having medhya ,sangnastapana, deepana and pachana properties, hence this concept is considered to prove its efficacy in the management of ADHD.So far few researches have been done on the effect of sneha in ADHD, but deepaghrita not been proven yet.Hence the present study has been taken to evaluate the efficacy of deepaghrita in the management of ADHD and which will be compared with ashtamangalaghrita9, which was proved to be effective in the management of ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Children those who are wishing to participate with the consent of parents will be included.
- •Children diagnosed with ADHD aged between 2-16years irrespective of gender, religion, socioeconomical status will be included for the present study.
排除标准
- •ADHD in children associated with other behavioural disorders like autism spectrum disorder, intellectual disability, learning disability, seizures and other systemic disorders will be excluded.
结局指标
主要结局
assessment of inattention, hyperactivity, impulsivity
时间窗: assessment done before treatment (1st day), after treatment (30th day), after follow up (60th day)
次要结局
- assessment of Hyperactivity(assessed on 1st day, 30th day, 60th day)
