Effectiveness of Individualized homoeopathic treatment along with non-pharmacological care in Children with ADHD – Pragmatic open label Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Conners Parent rating scale-revised(L) in Homoeopathy group when compared to control group
研究概览
简要总结
Conventional treatment for ADHD consists of medication as well as behavioural interventions with educational accommodations to enhance the learning of the patient as well as the parents. Stimulants improve ADHD symptoms in most children; however, children either do not respond to this class of drug or are unable to tolerate them due to the wide range of adverse effects they may produce.
Research studies conducted so far support the therapeutic effect of individually selected homoeopathic medicines in children with ADHD. The current study is a Pragmatic open-label Randomized Control Trial to evaluate response to homoeopathic treatment along with non-pharmacological care in Children with ADHD with respect to symptom reduction when compared to the control group with standard nonpharmacological care i.e. Occupational Therapy, Speech therapy, Behavioural modification as an integrated approach in reducing the symptom severity in children with ADHD and improve their general health, sleep patterns as well as overall functioning when compared to control group receiving standard non-pharmacological care (Occupational Therapy, Speech therapy, Behavioural modification) only. The study is ethically approved by the central ethics committee and the scientific committee of the council.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnostic criteria of DSM V for ADHD confirmed by a clinical psychologist.
- •Intelligence Quotient (IQ) is above 35 (to be calculated using Binet Kamat test of Intelligence or any other test or if already available from medical records)
- •Patients willing and able to take homeopathic medicines (liquid or pills form) 4.
排除标准
- •Having any other known severe systemic illnesses like TB, HIV, or any additional mental health disorder like ASD, Conduct disorder, etc.
- •Currently taking Conventional medicine for ADHD like Atomoxetine, Methylphenidate, and Dexamphetamine or have taken in previous two weeks.
- •Any history of suicidal tendency, major drug abuse, or addiction to any substance.
结局指标
主要结局
Change in Conners Parent rating scale-revised(L) in Homoeopathy group when compared to control group
时间窗: Conners Parent rating scale-revised(L): 0,3,6,9,12 month
次要结局
- Change in sleep pattern in response to homeopathic treatment in ADHD with respect to control group using Children Sleep habits Questionnaire (CHSQ) by parent(Change in overall functioning in response to homeopathic treatment in ADHD)