Efficacy & safety of a standardized extract from Bacopa monnieri in children and adolescents with attention deficit hyperactivity disorder (ADHD): A randomized, double blind, placebo-controlled with an extended open label study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- • CGI I Scale scores
研究概览
简要总结
Attention deficit &hyperactivity disorder (ADHD) is a common childhood disorder characterized bypersistent symptoms of lack of attention, hyperactivity, and impulsivity, beingassociated to decreased school performance and academic success and social rejection,and in adults, it is related to worst performance and success in professionalfield. Children with ADHD have a significantly greater probability than theirpeers to develop conduct disorders during adolescence and personality disordersin adulthood.
Ample number of resources are available in the public domain on the positive effectiveness of Bacopamonnieri in improving attention. Also many literature suggest this plant extract may be effective in treating young patients with Attention deficit &hyperactivity disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •1.Children adolescents of both sexes between 6 and 16 years old (both inclusive), who exhibit mild to moderate ADHD, with predominantly inattentive or combined presentation, according to DSM V criteria (assessed via the MINI KID).
- •2.Inattentive subset and hyperactivity subset of not greater than 22 on SNAP IV scale.
- •3.Voluntary Assent to participate in the study from all those who are more than 7 years of age.
- •4.Informed Consent Form signed by legal guardians.
- •5.Results of laboratory tests (chemistry, blood count and urine), physical examination and vital parameters with no clinically significant changes (clinically significant changes are defined as laboratory results requiring acute drug intervention, indicating severe illness, or requiring further medical evaluation according to the discretion of the investigator).
排除标准
- •1.Wechsler Intelligence Scale for Children Fourth Edition Short Form (WISC IVSF score) subjects whose scores are less than
- •To be administered by a psychiatrist or a clinical psychologist.
- •2.With the history of diagnosis with previous cognitive development delay.
- •3.Research participants with known hypersensitivity to the other medications.
- •History of alcohol or drug abuse by the research participant.
- •4.Where the immediate concern is around another Primary psychiatric diagnoses other than ADHD.
- •5.Diagnosis of psychiatric comorbidities, except for simple phobia, adjustment disorders, learning disorders, oppositional defiant disorder, sleep disorders, mild anxiety and or mild depressions.
- •6.History of seizures (except for mild febrile seizures) within 2 years from the time of recruitment.
- •7.Diagnosis of Tourette Syndrome and chronic tics 8.Research participants who are making use of drugs for the treatment of ADHD in the last three months.
- •9.Research participants who are making use of anticonvulsants, antidepressants, and antipsychotics up to 6 weeks prior to study entry or during the same.
- •11.Patients at identified risk of suicide through clinical interview.
- •12.Children or adolescents with ADHD predominantly hyperactive or impulsive 13.Other conditions considered by the investigator as reasonable for disqualification of the subject’s participation in the study.
- •(To be administered by a clinical psychologist).
结局指标
主要结局
• CGI I Scale scores
时间窗: • Timeframe on week 0,6,14 and 28 | • Timeframe on week 0,6,14 and 28
• ADHD symptoms as measured by the SNAP IV
时间窗: • Timeframe on week 0,6,14 and 28 | • Timeframe on week 0,6,14 and 28
次要结局
- • Computer based Continuous Performance Test scores(• Rey Auditory Verbal Learning Test (RAVLT) scores)