Evaluation of ayurveda treatment protocol in the management of Attention Deficit/Hyperactivity Disorder in children- A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the effect of Ayurveda Treatment protocol and Methylphenidate in
研究概览
简要总结
Title: Comparative Study on the Effect of Ayurveda Treatment Protocol and Methylphenidate in the Management of ADHD in Children
Background: Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children, characterized by inattention, hyperactivity, and impulsivity. While methylphenidate is the standard pharmacological treatment, it is associated with significant side effects. Due to these concerns, many parents seek alternative therapies, including Ayurveda. Ayurvedic texts compare ADHD to Unmada, and suggest various therapies for its management.
Aim: To evaluate and compare the effectiveness of an Ayurveda treatment protocol and methylphenidate in managing ADHD in children.
Objectives:
- Primary: Compare outcomes using the SNAP IV Rating Scale.
- Secondary: Assess reaction time (Vernier Chronoscope), functional impairment (Weiss Scale), comorbidities (Kiddie-SADS), quality of life (PedsQL), and severity/improvement (CGI scales).
Methodology:
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Design: Randomized Controlled Clinical Trial
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Participants: 80 children aged 6–12 years with ADHD (diagnosed per DSM-5), randomized into two groups
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Setting: KLE Shri BMK Ayurveda Hospital, Belagavi
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Duration: 28 months
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Groups:
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Group A: Ayurveda protocol including Abhyanga, Swedana, Basti, Shirodhara, Nasya, and oral Jatamansi
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Group B: Oral methylphenidate (1 mg/kg/day)
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Duration of Intervention: 60 days
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Outcome Measures: Clinical scales, reaction time, comorbidities, and quality of life
Inclusion Criteria: Children aged 6–12 with DSM-5 ADHD diagnosis.
Exclusion Criteria: Children with infections, comorbid neurological or congenital conditions, or those on current ADHD medication.
Significance: This study aims to provide evidence for the efficacy and safety of Ayurveda as an alternative to conventional pharmacotherapy in managing ADHD
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 of either sex between the age group of 6-12 years.
- •Children fulfilling the DSM-V diagnostic criteria for diagnosis of ADHD.
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 and epilepsy, hearing defect etc.
- •Children with obvious congenital anomalies like cleft palate, CHD etc.
- •Children who have received any form intervention for ADHD in last 3 months.
结局指标
主要结局
To compare the effect of Ayurveda Treatment protocol and Methylphenidate in
时间窗: baseline, 7th day, 30th day, 60th day
management of ADHD in children assessed through SNAP IV Rating Scale.
时间窗: baseline, 7th day, 30th day, 60th day
次要结局
- 1. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children(by assessing the reaction time through Vernier Chronoscope)