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临床试验/NCT01141634
NCT01141634已完成2 期

A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents

University of Toronto2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
36
试验地点
2
主要终点
Conners 3-Parent

研究概览

简要总结

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents during childhood, and is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment can reduce the symptoms of ADHD without serious side effects. This is an open label pilot feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic practitioner who will select treatments based on classical homeopathy principles. All participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the study is to assess feasibility of recruitment and patient retention, to obtain pilot data on which to base a sample size calculation for future study, and to identify major safety concerns. The study will use single homeopathic medicines approved for over-the-counter use in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males and females aged 6-16 diagnosed with ADHD of any subtype according to DSM-IV criteria.
  • Mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures.
  • Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

排除标准

  • Changes to participants' medication for ADHD within 6 weeks of study onset.
  • Diagnosis of additional mental health disorder including but not limited to: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder. The patient should not have current suicidal or homicidal ideation.
  • Participants should have no history of head injury of seizures, organ system damage and should have an estimated I.Q within the normal range.
  • Pregnancy and Lactation

结局指标

主要结局

Conners 3-Parent

时间窗: 36 weeks

次要结局

  • MYMOP2(36 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Boon

Principal Investigator

University of Toronto

研究点 (2)

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