Randomized, Double-Blind, Placebo-control, Multicenter Study, the Efficacy and Safety of Combination of Ginkgo Extract and Ginseng Extract(YY-162) in Children With ADHD(Attention Deficit Hyperactivity Disorder)in 8 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Korea-ADHD Rating scale
研究概览
简要总结
This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD
详细描述
This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2,4, and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA Conner's rating scale , CGI-S/I, ATA, Children's color trails test and stroop test, Intelligence test(from KEDI-WISC) and adverse event reporting.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged from 6 to 12
- •Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview
- •Subjects signed a written consent form voluntarily.
- •Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.
- •Subjects who can keep visit schedule and whose parent/ parent surrogates or legal guardian can willingly complete assessments defined in the study protocol
- •Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time
排除标准
- •Subjects who have difficulty swallowing tablet.
- •Subjects who have known allergy to plant extracts.
- •Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
- •Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
- •Subjects who have significant suicidal ideation.
- •Subjects with mental retardation
- •Subjects with Tourette's syndrome requiring drug therapy.
- •Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
- •Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
- •Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.
- •Subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil,anticonvulsant
- •Subjects who receive psychosocial treatment during the drug trial.
- •Subjects who are not able to swallow the study drug.
研究组 & 干预措施
YY-162
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
干预措施: YY-162 (Drug)
Placebo
Placebo 1T/twice a day(bid) for 8weeks, po medication
干预措施: Placebo (Drug)
结局指标
主要结局
Korea-ADHD Rating scale
时间窗: from baseline to 8 weeks
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.
次要结局
- IOWA Conner's rating scale(from baseline from 8 weeks)
- Advanced Test of Attention(baseline and 8 weeks)
- Intelligence test(from KEDI-WISC)(screening and 8 weeks)
- Clinical global Impression(Severity and Improvement)(from baseline to 8 weeks)
- Children's color trails test and stroop test(baseline and 8 weeks)