跳至主要内容
临床试验/CTRI/2026/02/103412
CTRI/2026/02/103412尚未招募3 期

Randomized open-label clinical study on the efficacy of padamardana with mastu in comparison to padamardana with shatadhauta ghrita in anidra in children with ADHD.

Dr D Shri Gayathri1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

Sleep plays a vital role in the cognitive emotional and physical development of children and is essential for their overall growth and future contribution to society. Insomnia is a common yet underdiagnosed sleep disorder in the pediatric population and its prevalence is increasing due to lifestyle changes. It is characterized by difficulty in initiating or maintaining sleep leading to reduced total sleep duration. Sleep disturbances are frequently seen in children with Attention Deficit Hyperactivity Disorder and tend to worsen core symptoms such as inattention, hyperactivity, impulsivity, cognitive deficits and emotional dysregulation. Insomnia in these children also affects academic performance quality of life and significantly impacts parental mental health by increasing stress anxiety and fatigue.

Conventional management includes sleep hygiene measures and cognitive behavioral therapy but many children do not respond adequately to pharmacological interventions such as melatonin or sedatives leading parents to seek alternative approaches. In Ayurveda insomnia can be correlated to Anidra or Nidranasha which is associated with imbalance of Vata dosha disturbances of Manovaha srotas and predominance of Rajasika satwa. Children with ADHD are more prone to such sleep disturbances.

Ayurveda offers several therapeutic measures including lifestyle regulation Panchakarma procedures and psychological interventions to improve sleep. Among these Padamardana is a simple cost effective and well accepted therapy described in classical texts as sleep inducing. Padamardana with Mastu helps in Vata shamana and reduces fatigue while Shatadhauta ghrita promotes relaxation and pacifies Vata and Pitta. Modern evidence also supports the role of foot massage and reflexology in improving sleep quality through neurohormonal regulation.

Despite classical references and wide acceptability there is a lack of scientific studies standardizing Padamardana and evaluating its efficacy in children with ADHD related insomnia. Hence the present study is designed to assess the effectiveness of Padamardana with Mastu and Shatadhauta ghrita in the management of Anidra in children with Attention Deficit Hyperactivity Disorder.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Participants with ADHD having Mild-Moderate Insomnia as per diagnostic criteria will be included.
  • Participants with ADHD showing classical signs of Nidranasha (loss of sleep) will be included.
  • Participants whose parents are willing to sign the consent form, and children who give verbal assent will be included.

排除标准

  • Children with ASD will be excluded.
  • Children with ADHD taking long term oral medications for Insomnia will be excluded.
  • Children with ADHD who have severe Insomnia will be excluded.
  • Children with other systematic illness like Juvenile Diabetes, Thyroid disorders will be excluded.

研究者

发起方
Dr D Shri Gayathri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr D Shri Gayathri

Sri Sri College of Ayurvedic science and Research, Bangalore

研究点 (1)

Loading locations...

相似试验