CTRI/2019/09/021110尚未招募2 期
Effects of a standardized extract from Bacopa monnieri on the treatment of attention deficit & hyperactivity disorder in children and adolescents (ADHD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- ADHD symptoms as measured by the SNAP-IV andCGI-I Scale scores.
研究概览
简要总结
The study aimed to prove the superiority and tolerability of the investigational product, Cognitus/ Bacomind, compared to placebo in terms of efficacy in the treatment of Attention Deficit & Hyperactivity Disorder (ADHD) in children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children/ adolescent of both sexes between 6 years to 16 years old who exhibit mild to moderate ADHD with predominantly inattentive or combined presentation according to DSM V criteria.
- •2.Inattentive subset and hyperactivity subset of not greater than 23 on SNAP IV scale.
- •Voluntary assent to participate in the study from all whose are more then 7 years of age.
- •Informed Consent signed by legal guardian/research participant when possible.
- •Results of lab tests(chemistry, blood count and urine), physical examination and vital parameters with no clinically significant changes.
排除标准
- •WISC-IV-SF, subjects whose score are less than
- •2.Research participants with known hypersensitivity to the other medication.
- •History of alcohol or drug abuse by research participant.
- •Where the immediate concern is around another primary psychiatric diagnosis other than ADHD.
- •Diagnosis of psychiatric comorbidities, except for simple phobia, adjustment disorders, learning disorders, oppositional defiant disorder and sleep disorders.
- •History of seizures(except for mild febrile seizures) within 2 years from the time of recruitment.
- •Diagnosis of Tourette Syndrome and chronic tics.
- •Research participants who are making use of drugs for the treatment of ADHD in last three months.
- •Research participants who are making use of anticonvulsants, antidepressants and anti psychotics upto 6 weeks prior to study entry.
- •Positive beta HCG test for girls who have attained menarchy.
- •Patient at identified risk of suicide through clinical interview.
- •Children/ adolescents with ADHD predominantly hyperactive/impulsive.
结局指标
主要结局
ADHD symptoms as measured by the SNAP-IV andCGI-I Scale scores.
时间窗: 6 months
次要结局
- 1. Computer-based Continuous Performance Test scores and Rey Auditory Verbal Learning Test (RAVLT) scores.(2. Safety)
研究者
研究点 (4)
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