Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- side effects scale
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.
详细描述
ADHD is a common childhood disorder associated with concentration problems and disruptive behavior. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
This study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will come in for weekly study visits at which their ADHD symptoms and any side effects will be assessed by self-report rating scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD
- •Score of greater than 1.5 standard deviation above the age and gender norms on the ADHD-IV rating scale
- •Parents and children can understand English
- •Parents and children willing to attend all study visits
- •Able to swallow study medication
- •Willing to use acceptable methods of contraception
排除标准
- •Severe depression
- •History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions
- •Use of medications that may interact with the herbal product
- •Current use of medications to treat ADHD
- •Previous use of Hypericum
- •Pregnancy
研究组 & 干预措施
A
Herbal treatment
干预措施: Hypericum perforatum (Drug)
B
干预措施: Placebo (Other)
结局指标
主要结局
side effects scale
时间窗: Freqency of events during entire study
ADHD-IV rating scale
时间窗: Difference between baseline and end of study
次要结局
- Child Behavior Checklist, Youth Self Report Form(Baseline and end of study)