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临床试验/CTRI/2025/10/096436
CTRI/2025/10/096436尚未招募3 期

Clinical Evaluation of the Efficacy of Takradhara in Attention Deficit Hyperactive Disorder

BLDE Deemed to be University Vijayapura1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月4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
20
试验地点
1
主要终点
Improvement in attention Decrease in hyperactivity and impulsivity

研究概览

简要总结

The present study aims to evaluate the efficacy of Takradhara in Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, leading to academic, behavioral, and social difficulties in children. Takradhara, a Ayurvedic therapy involving the continuous pouring of medicated buttermilk over the forehead for 7days followed by Brahmi ghrita oral administration for 30 days will helps to calm, reduce stress and enhance concentration in children. The sample will be collected from our hospital of both gender, age 6yrs to 16yrs. Those who fulfil the inclusive will be included in the study. Sample size is 20. This study is designed to assess its role as in ADHD.The primary outcome will focus on the reduction of ADHD symptoms (inattention, hyperactivity, impulsivity) assessed using standardized rating scales. The secondary outcomes include improvement in cognitive functions, behavior, quality of life

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 16.00 Year(s)(—)
性别
All

入选标准

  • 1 Children aged between 6-16 years of age 2 Children fulfilling the DSM-V criteria for diagnosis of ADHD.
  • 3 Parents who are willing for treatment and giving concern.

排除标准

  • 1 Children under other medications or interventions such as behavior therapy are excluded from the study.
  • 2 Children with mild to severe mental retardation conduct disorders, 3 Pervasive disorder and other Psychotic disorders are excluded.
  • 4 Children with chronic ailments like tuberculosis, malignancy etc.are excluded.

结局指标

主要结局

Improvement in attention Decrease in hyperactivity and impulsivity

时间窗: After 90 days

次要结局

  • Improvement in concentration and academic school performance(after 90 days)

研究者

发起方
BLDE Deemed to be University Vijayapura
申办方类型
Other [BLDE DU University Vijayapura]
责任方
Principal Investigator
主要研究者

Dr Vijayalaxmi Benakatti

BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura

研究点 (1)

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