Homoeopathic management for Attention Deficit Hyperactivity Disorder in children: A Randomized Placebo Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Global impession-Severity and Clinical Global impression-Improvement
研究概览
简要总结
A multicenteric single blind randomized placebo controlled trial shall be carried out to evaluate the efficacy of individualized homoeopathic therapy in the management of Attention Deficit Hyperactivity Disorder (ADHD), at one of the Institutes of Central Council for Research in Homoeopathy. Children in the age group of 6 years to 15 years, fulfilling the criteria of DSM-IV for ADHD shall be enrolled in the study. Individualized homoeopathic medicines in LM potency shall be prescribed to half of the enrolled patients whereas other half shall receive placebo. Severity of disease shall be rated on Conners parent rating scale-Brief and Clinical global impression scale, at the time of enrolment and on each subsequent follow-up visits. All enrolled patients shall be followed up for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 6-15 years and meeting Diagnostic and statistical Manual of mental Disorders- 4th edition (DSM-IV) criteria.
排除标准
- •1 Co-morbid medical or other psychological conditions (Psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive disorder, and severe anxiety disorder).
- •2Any chronic physical or neurological disorder 3 History of drug abuse 4 History of Seizure 5 History of Tic disorder 6 History of Tourette syndrome 7Patients who were on anti-ADHD or psychoactive medications in the last two weeks.
- •8 Any severely ill patient requiring hospitalization.
结局指标
主要结局
Clinical Global impession-Severity and Clinical Global impression-Improvement
时间窗: Baseline, Monthly, 12 months
Conners parent rating Scale-revised
时间窗: Baseline, Monthly, 12 months
次要结局
- To deduce feasibility of study design and to gather data for sample size calculation of definitive study(completion)