Evaluation of lakshadi taila shiropichu and jatamansyadi taila pratimarsha nasya in the management of attention deficit hyperactivity disorder in children-a randomised controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- There might be an effect of Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya in the management of ADHD in children which shall be assessed with Vanderbilt ADHD diagnostic parent rating scale
研究概览
简要总结
NEED OF THE STUDY
ADHD is widely acknowledged as the most prevalent neurobehavioral and psychiatric disorder, significantly impacting the functional abilities of the children. The global prevalence of ADHD in children and adolescents is estimated to be around 5.29%, with a higher occurrence in males. In India, the prevalence varies between 2% to 17%. The World Health Organization (WHO) refers to ADHD as Hyperkinetic Disorder, and throughout an individual’s life, the symptoms and consequences of this condition can vary significantly. Children with ADHD generally struggle with inattentiveness, hyperactivity/ impulsivity which impacts on their academic skills, interpersonal relationships and social functioning.Family functioning is also highly affected by the child’s ADHD. Recognition and management of ADHD in children is important so that their long-term outcomes can be improved.
In Modern Science, The preferred treatment for ADHD involves presynaptic dopaminergic agonists like Methylphenidate and Amphetamine , which are psychostimulant drugs. Adverse reactions are observed with these drug usage such as decreased appetite, irritability, tics, sleep issues, and an increased risk of adverse cardiovascular events. Prolonged use causes slowing of physical growth which is transient with an unclear cause. Consequently, there is an increasing need for an alternative treatment method.
In Ayurveda there are many drugs like Lakshadi taila, jatamansi, vacha , guduchi, durva, ashwagandhaetc that are known to be used in Manorogasand may be helpful in handling ADHD like conditions more effectively. Hence there is a growing need for an alternative treatment modality. Administering Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya, by virtue of their karma may be helpful in the management of Attention deficit hyperactivity disorder in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children fulfilling the diagnostic criteria will be included for the study.
- •Children of either sex between the age group of 6-16 years.
排除标准
- •Children with an acute or chronic, local or systemic infection will be excluded.
- •Children who are currently using other medications will be excluded owing to the possibility of drug interaction.
- •Known case of cerebral palsy, mental retardation, epilepsy and hearing defect etc.
- •Children with obvious congenital anomalies Children who have received any form of modern intervention for ADHD in last 1 month.
结局指标
主要结局
There might be an effect of Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya in the management of ADHD in children which shall be assessed with Vanderbilt ADHD diagnostic parent rating scale
时间窗: 0th day,7th day,30th day
次要结局
- There might be a significant effect of Lakshadi taila Shiropichu & Jatamansyadi taila Pratimarsha Nasya by the end of 30 days in children with ADHD which will be assessed by ADHD IMPACT MODULE-CHILD & Pediatric Quality of life Inventory(0th day,7th day,30th day)
研究者
Dr Mithila R Nadig
KAHER Shri BMK Ayurveda Mahavidyalaya